VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1391079
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Experienced itchy rash on torso and back (quarter sized circles) within a day or two of receiving second dose of vaccine; This is a Marketing Program spontaneous report from a non-contactable consumer or other non hcp (Patient) via a sales representative. A 21-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced Itchy rash on torso and back (quarter sized circles) within a day or two of receiving second dose of vaccine. The clinical outcome for the event was unknown. Reporter does not wish to be contacted for follow-up. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1391080
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Permanent disfigurement of my muscles; it's like my arm is sunken where they gave me the shot; permanent disfigurement of her 'nerve' and her muscles; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 59-years-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot Number: EL1284; Expiration Date: Apr2021), via intramuscular route of administration in left arm on 27Jan2021 (vaccination at the age of 59-year-old) as unknown, single dose for covid-19 immunisation. Medical history included allergy from an unknown date and unknown if ongoing. Concomitantly patient was taking allergy pills (Singulair, I think I do not know). Patient had not received any other vaccination within 4weeks. On 27Jan2021, almost immediately same day, the patient experienced permanent disfigurement of her muscles, it was like her arm was sunken where they gave her the shot. Patient reported that she got vaccine in Jan2021 and had permanent disfigurement of her 'nerve' and her muscles. Patient asked if it was part of side effect and had it happened to anyone else. No treatment was taken for the event, as patient stated that nobody knows what it was. They had not seen this before. Reporter seriousness was unspecified. No investigation assessment was done. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1391081
Sex: M
Age:
State:

Vax Date: 05/14/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: He states that the cramps are intermittent; "move around" his lower extremities to various areas; sometimes they are in his feet; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 14May2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of the Pfizer Covid vaccine on 22Apr2021 for Covid-19 immunization and experienced cramps in legs. The patient received his second dose of Pfizer Covid vaccine on 14May2021. He states that the cramps were intermittent and "move around" his lower extremities to various areas, sometimes they were in his feet. He said that he can be watching TV and he feel a cramp coming on then it goes away and pops up somewhere else and was getting cramps in his feet too in 2021. Outcome of the events was not recovered. Information about lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1391082
Sex: F
Age:
State: NC

Vax Date: 05/08/2021
Onset Date: 05/08/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Headache; Arm was a little sore; Low-grade temperature; This is a spontaneous report from a contactable consumer reported for herself. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in left arm on 08May2021 08:00 (Batch/Lot Number: ER8736) as a single dose for covid-19 immunisation at School or Student Health Clinic. Medical history included congestive cardiac failure, coronary artery disease, hypertension, asthma, migraines, narcolepsy, bipolar disorder, sleep apnoea, gastrooesophageal reflux disease, low potassium, low iron, tomatoes allergy, dust allergy, pollen allergy, grass allergy, ragweed allergy, allergy to medications included morphine allergy and ceclor allergy. Concomitant medications included carvedilol (COREG), clopidogrel bisulfate (PLAVIX), omega-3-acid ethyl ester (LOVAZA), bepotastine besilate (POTAS), furosemide (LASIX [FUROSEMIDE]), atorvastatin calcium and ezetimibe (STATIN EZ).The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been been tested for COVID-19. The patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 05Jun2021 09:45 (Batch/Lot Number: EW0179) as a single dose for covid-19 immunisation.On 08May2021, 08:00 after administration of first dose of vaccine the patient experienced arm was a little sore, low grade temperature and headache too for some days. Clinical course was reported as on the first shot my arm was a little sore, I got a low-grade temperature and a headache too for a few days. However, with all of my allergies to medication, etc this vaccine did not bother me at all in that regard.The patient underwent lab tests and procedures which included body temperature was low. There was no treatment given for the reported events. Outcome of the events arm was a little sore, low grade temperature and headache was recovered on an unspecified date in 2021..

Other Meds: COREG; PLAVIX; LOVAZA; POTAS; LASIX [FUROSEMIDE]; STATIN EZ

Current Illness:

ID: 1391083
Sex: F
Age:
State: AZ

Vax Date: 05/30/2021
Onset Date: 05/31/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: headache; horrible pain in her armpit and it swell up, whole area was swollen like part of her mammary gland, the middle of the armpit not quite to the breast but she mean the whole area was raised, swollen; horrible pain in my armpit and it swell up; whole area was swollen like part of my mammary gland; the middle of the armpit not quite to the breast but I mean the whole area was raised, swollen; it just hurt where she got the shot which she expected and then exclusive to the armpit; This is a spontaneous report from a contactable Other HCP (patient). A 65-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0178, Expiration date: Aug2021) via an unspecified route of administration in left deltoid on 30May2021 as 2nd dose, single dose for COVID-19 immunization. Medical history included asthma, osteoarthritis, pre-diabetic, increased cholesterol, barrett's oesophagus, hyporthyroid. Concomitant medications included levothyroxine at 25 microgram, pantoprazole once a day for Barrett's esophagus, rosuvastatin calcium (CRESTOR) at 5 mg for increased cholesterol. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 09May2021 in left deltoid as 1st dose, single dose for COVID-19 immunization. Registered nurse stated, So, I recently had the second Covid-19 shot and I wanted to report something that I went through within 24 hours and last 2 days. I had the second shot on 30May2021 and aside from the headache which did not surprised me within 24 hours I had a horrible pain in my armpit and it swell up like not like node like the whole area was swollen like part of my mammary gland it's like from the middle of the armpit unto the breast. I took that back the middle of the armpit not quite to the breast but I mean the whole area was raised, swollen and last two days cause vaccinated on Sunday I started noticing it early morning Sunday happened to be in the middle of the night and then it lasted all through Monday and Tuesday and finally started going away Wednesday and today right now it's back to normal at first I did not think much of it but then I realized that I mean I never have that happened before and that was of the same left arm where I got the Covid shot but it did not hurt from the deltoid around to the arm pit. It just hurt where I got the shot which I expected and then exclusive to the armpit so I did not know if that something was on record so that is why I was reporting. When probed for mailing address, registered nurse started, I was not sure what you were asking okay its (Withheld) okay I was just wondering why you wanted my physical street name. Okay but I did not get any mail at (Withheld) so that's not gonna help you at all my mailing address was (Withheld) let's start again my mailing address was (Withheld). Registered nurse stated, date of adverse event started, Well I guess in the middle night that would be 31st Monday the 31st Memorial day. (Clarified as 31may2021). When probed for facility's Zip-code: Registered nurse stated, I did not know would it be on the Pfizer card maybe are you gonna ask me like LOT numbers or whatever I should go get the card let me grab the card okay let me see I guess I could look it up let's see (Withheld). When probed for facility's email address, registered nurse stated, "I did not know email let me see if they had that I did not know if I can find there email. When confirmed the vaccine as Pfizer Covid vaccine, registered nurse stated, "I am yeah, can I ask a question from you real quick you said you were a pharmacist correct so I was wondering you know it's a multi dose vial and I am a nurse so I don't really like multi dose vial so the first time I went in there I asked them for the first shot for the vial and the next time I went in there it was a different nurse practitioner she had all the stuff already drawn up which I really like so you know I know I was administering stuff have given like lots of shots over 40 year career if you don't turn it upside and look around the last dose of the vial could be more potent could it not. Registered nurse was informed about the role of Pfizer medical Information. When probed about the date of first shot, patient stated, First shot was on 09May2021. (Consumed as 09may2021). Patient stated, I did not know what that is NDC and UPC. I did not have any of the code on this card that's all on there I gave you the EW code and of course the first dose has the different code.: Patient stated, anatomical site of the administration was left deltoid. I had them both on the left deltoid obviously not on the exact same spot but. Patient further stated, I can not think of any other reason I mean it was just too coincidental yes. I mean it was given 24 hours of receiving end and it went away within 2 days later so yeah I would yes say I would so. When probed about other medical conditions, Patient stated, Well I can not say I am suffering from anything but I do have a history of asthma cause its not you know I was not even taking medicines for it. It's not an issue so I would say asthma I do have a history of asthma and osteomyelitis in my knees I mean not Osteomyelitis, Osteoarthritis in my knees. I am Prediabetic. I had got you know increased cholesterol and hyporthyroid. I was taking thyroid medicine and cholesterol medicine and pantoprazole for very minimal Barrett's esophagus problem. Patient stated, No I was not taking any asthma controller drug you know what I did use inhaler but when was it you know what I had not used inhaler within that time period at all. So, I would say nothing for asthma. I forget the Venlafaxine, Effexor I take it extended release which like 150, once a day. Patient stated No, but I did take Tylenol (Treatment)that day 1000 mg cause my arms hurt pretty good yeah I took Tylenol that day specifically. Still experiencing these events, registered nurse stated, "I was up until this morning like it's slowly getting better and like right now it's fine it actually fine today. I would say like 3 O' clock on the morning on to the 31st then the first and second and a little bit yesterday. It is completely gone now as of today. Patient confirmed outcome as improved. Patient further stated, No just Acetaminophen 1000 mg I only took, actually I took it twice within 6 hours of each other. The reported mentioned causality as related for all the reported events with respect to Covid 19 vaccine. The outcome of the events was recovered on an unspecified date in 2021.

Other Meds: LEVOTHYROXINE; PANTOPRAZOLE; CRESTOR

Current Illness:

ID: 1391084
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: daughter had a blood after the vaccine was administered; daughter had a blood after the vaccine was administered; daughter had a blood after the vaccine was administered; This is a spontaneous report from contactable consumer (patient father) from a Pfizer sponsored program . A 14-year-old female patient received first dose of bnt162b2 (PFIZER COVID 19 VACCINE, Solution for Injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date at a 1st dose, single dose; patient received second dose of bnt162b2 (PFIZER COVID 19 VACCINE, Solution for Injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date at a 2nd dose, single dose, both doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced daughter had a blood after the vaccine was administered on an unspecified date. Reporter called for his 14 year old daughter who got the second dose of the vaccine (Unspecified Medication) yesterday, now he said that when it was administered, the one who administered the vaccine said that he hit a blood vessel and his daughter had a blood after the vaccine was administered (on an unspecified date). The reporter had a question whether they need to watch out for others signs or side effects that might arise since a blood vessel that was hit when the vaccine was administered and if there was something that they need to concerned with. Reporter stated patient was not really having any major side effects right now. Reporter just had a question whether they should be concerned for having hit the blood vessel. Outcome of the events was unknown. Information about Lot Batch number has been requested.

Other Meds:

Current Illness:

ID: 1391085
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: He got his blood work with low platelets; first one was low and the second one was even lower; This is a spontaneous report received from a contactable consumer or other non-health professional (patient wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, patient got his blood work with low platelets. Reporter stated that she was concerned for patient as for the second time since he had the vaccine which was in January. Patient got his blood work with low platelets. The first one was low and the second one was even lower. Reporter was reading about some concerns and people quaking with same issues even people dying from this. So, reporter wanted to know how many people do you like have reporting this issue and what was the best way to approach this and what Pfizer can do because this was the first time that patient had this problem.Reporter stated that was her suspicion because after speaking to several physicians. They told that patient was not the only case. They have seen people with the side effect reaction. Reporter was wondering tomorrow her son 12 years old was going to get the second shot, so reporter was really concerned what was happening, she asked could you tell me what was happening with this situation specifically with the Pfizer vaccine from any people are you getting this issue. The patient underwent lab tests and procedures which included blood test: with low platelets. The report was not related to study or programme. The outcome of the event was unknown Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1391086
Sex: M
Age:
State:

Vax Date: 06/05/2021
Onset Date: 06/05/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Sweaty; Threw up; Lethargic; Fever; Chills; This is a spontaneous report from a contactable consumer (parent). A 12-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date: unknown), via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration on unspecified date for COVID-19 immunization. On 05Jun2021, the patient received the vaccine in the morning and developed a fever and had chills. The patient was given Tylenol before bed around 21:00 and he woke up sweaty and threw up around 03:30 (on 06Jun2021). The patient went back to bed and woke up Sunday (06Jun2021) with a fever of 100.2 and was lethargic but in good spirits. The patient underwent lab tests and procedures which included body temperature: 100.2 on 06Jun2021. Therapeutic measures were taken as a result of fever and chills. The outcome of the events was unknown. Reporter does not wish to be contacted for follow-up. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1391087
Sex: M
Age:
State: CO

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Fever like 101.44; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 13-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0178, Expiration date: unknown), via an unspecified route of administration, administered in left arm on 03Jun2021 as 2nd dose, single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. He was a healthy kid before vaccination. Patient received dose 1 of bnt162b2 on 13May2021 for Covid-19 immunization and experienced mild side effects. On 03Jun2021 the patient experienced fever like 101.44. He started running fever after second dose of vaccine. The patient underwent lab tests which included body temperature 101.44 on Jun2021. Therapeutic measures were taken as a result of fever like 101.44 includes Its going down with Ibuprofen and Acetaminophen that seemed to get under control, but it kept coming back and the reporter just didn't know that was something normal that she should expect. Reporter was just curious that her 13-year-old got his second dose of Pfizer on 03Jun2021, so its 06Jun2021 and he was still running a fever like 101.4. The outcome of fever was not recovered.

Other Meds:

Current Illness:

ID: 1391088
Sex: F
Age:
State: PR

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Diarrhea for the past month after receiving 2nd vaccine on May 4, 2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0175) via an unspecified route of administration on 04May2021 (at the age of 52-year-old) as a single dose for COVID-19 immunization. The patient had no medical history and known allergies. Concomitant medications were not reported. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0161) via an unspecified route of administration in left arm on 13Apr2021 as a single dose for COVID-19 immunization and experienced mensural cycles again after 5 months into menopause. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021, the patient experienced diarrhea for the past month after receiving the second vaccine. The patient did not receive any treatment for the event. The outcome of event was not recovered. Follow up attempts needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1391089
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Palpitation; Headache; Diarrhea; I felt like I have a heart inflammation or something; Heart beating was 140 one time, 147 something right after the next day; Severe panic attack; symptoms are getting worse; This is a spontaneous report from a contactable consumer (patient). This is the first case out of the 2 cases. A 35-year-old patient of an unspecified gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0167) via an unspecified route of administration in left arm as 1st dose, single dose for COVID-19 immunization. Medical history included COVID in April 2018. Concomitant medications were not reported. Patient stated, I got the first shot for COVID-19 and I have, like a lot of reaction and it was taking various days for me, as well as my son but he is 14 so, we just decide not to take it since the side effects were very severe we both got COVID (History) on April 2018 and we recovered and we took the shot again, I am sorry we took the shot after recovery and then my side effects were like palpitation, severe like headache for 3 weeks and then diarrhea and I don't have fever but I had a lot of like, I even went to the hospital because I felt like all of my symptoms were getting worse, they did test and everything and they told me that I was not having any heart problem or anything that might cause palpitations. I was actually going to the cardiologist now like I was taking some test because I felt like I have a heart inflammation or something so I just decided that I will do it and then my son he is 14, he got the first shot and then he could not walk for a week, he was like he can walk but he was like limping like from one place to another, he had like severe pain in both leg and the arm was like a sore a little bit at the first day, for hours then the next day and he was like he could not really walk normally he was like jumping with thorns for a whole week. I just want to report this because I just did not see such symptoms like I mean I saw the palpitation were the part of side effect. When paraphrased the above concern, patient stated, I did not have the fever but I had the weird like the heart beating was 140 one time, 147 something right after the next day. I took the shot so I was having severe panic attack it was really sad I mean for a whole week. This was my third week, I mean I was supposed to get the second shot but I decided to go to my doctor and he told me I should reconsider since I have these palpitations. Consumer stated, why do you need the address. I don't want to give my mailing address. Patient further stated, Yes were you going to report these symptoms, I saw in the page where the people gave me the medication, I mean with the vaccine they told me that it will show the side effect, palpitation and stuff like that. Patient stated, No, I mean now I do because I am going to see a cardiologist to check my heart and all. Patient added, I just want to report this because I was not getting the second one because I had like a very bad side effect, so I do not want any problem, so I just do not want to get the second shot and I just do not want my son to get that either. The outcome of the event Palpitation was not recovered and outcome of the other events was unknown. QR comment: Since manufacturer name was not available over the call, hence 'Is this the Pfizer product?' Tab was left unchecked. This LRN W2021387350 is cross linked to LRN W2021387349

Other Meds:

Current Illness:

ID: 1391090
Sex: M
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: got his blood work with low platelets, first one and second one was even lower/blood platelets very low; got his blood work with low platelets, first one and second one was even lower/blood platelets very low; blood RBCs and blood platelets very low; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an un-specified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an un-specified route of administration in Jan2021 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In 2021, patient got his blood work done which showed low blood red blood cells count (RBCs) and very low blood platelets. The first one was low but the second one was even lower for platelets. Patient's wife stated that she understood that this was an issue but could lead to fatality because the platelets were not working properly and if patient found an injury he could be at risk. The outcome of all the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1391091
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: I am having a same concern with my father-in-law he got period is very heavy/So I have 2 members in my family with same situation.; This is a spontaneous report received from a contactable consumer or other non-health professional (patient daughter-in-law). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her father-in-law got period is very heavy. So, she has 2 members in her family with same situation. Reporter was wondering tomorrow her son 12 years old was going to get the second shot, so reporter was really concerned what was happening, she asked could you tell me what was happening with this situation specifically with the Pfizer vaccine from any people are you getting this issue. The patient underwent lab tests and procedures which included blood test: with low platelets. The report was not related to study or programme. The outcome of the events was unknown Follow-up attempts are needed; information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1391092
Sex: F
Age:
State:

Vax Date: 06/02/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Had a little temperature; Under her shoulder, arm as her whole arm, the bottom of her shoulder it's just swollen/Like the under pit and a little bit down there; Itchy; This is a spontaneous report from a consumer (patient's daughter) reported for the patient. A 82-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 02Jun2021 (age at vaccination was 82 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The reporter stated that her mom got her Pfizer vaccine shot (unspecified vaccine) the second one on 02Jun2021 and she was fine maybe had a little temperature but now she saw under her shoulder, arm as her whole arm, the bottom of her shoulder it's just swollen, asked if that was normal. Like the under pit and a little bit down there. This was the same site she got a needle. It was little itchy too. The reporter was informed about Pfizer Medical information department and was provided with the number. The reporter was informed for the role of Pfizer drug safety. The reporter stated that last night, she noticed it. She didn't know he just checked today but last night it started. Last night, she found out she didn't know if it was like maybe after and she noticed it now. The reporter stated that she just really needed to call to see if she gets the info, they were almost done. The outcome of the events was unknown. Follow attempts are needed; information about lot number/batch number can be requested.

Other Meds:

Current Illness:

ID: 1391093
Sex: M
Age:
State:

Vax Date: 05/03/2021
Onset Date: 05/03/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Not been able to sleep, started insomnia; he try to go to sleep and within an hour or 2 hours his body jerks and wake him back up; Not been able to sleep, started insomnia; he try to go to sleep and within an hour or 2 hours his body jerks and wake him back up; Started developing a cough; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03May2021, as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03May2021, right after his first vaccine, the patient started to have a cough. As time went on, the patient was not able to sleep and started insomnia. Patient tried to sleep and within an hour or 2 hours, his body started to jerk and woke him up. Patient never experienced this before. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1391094
Sex: M
Age:
State: TX

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: I experienced a pain like somebody has punched me it went away but then it returned; continues to be sore. I've got limited motion and being able to reach back with it; the pain is almost constant; I experienced a pain like somebody has punched me it went away but then it returned; continues to be sore. I've got limited motion and being able to reach back with it; the pain is almost constant; This is a spontaneous report from a contactable consumer (patient, self-reported). A 75-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EWD150 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 28Apr2021 at 13:15, as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 13:15, as a single dose for COVID-19 immunization and it was in his left arm and he experienced a pain like somebody has punched him, it went away but then it returned. Prior Vaccination (4 weeks prior) the patient did not receive any vaccine. The last vaccine he received was for shingles and that was a 2-part vaccine but it was too away at least a couple of months before receiving the vaccine. The patient's medical history included blood pressure and blood cholesterol. Concomitant medications included atorvastatin calcium (the tablet was 20mg and he only took half so that would be 10 mg and that was my cholesterol) and lisinopril. The patient reported that on an unspecified date, he experienced a pain like somebody had punched him, it went away but then it returned; continues to be sore. He had got limited motion and being able to reach back with it; the pain was almost constant and its beginning to worry. When paraphrased, the patient stated, he wanna report that, it happened because that arm was fine, he had no problem with that with his left arm on and he expected soreness to go away and it started getting the limited motion and really pain really increases anytime he moved it towards his back. The patient stated, he had an appointment with his doctor, and they required him to have a lab work done and he was looking at his report, the lab was on 21Apr2021. The patient stated, he saw his doctor about a week later and he told him about it, and he said when he had his injection his arm was very sore and felt like its gonna fall off. He said just continue to stay active and that's what he had done but it's been over a month now and it's not getting better. It felt worst. He was having a hard time sleeping. He got his lab report, and he was sure they could pass you on to where you need to got its a bog facility. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: ATORVASTATIN CALCIUM; LISINOPRIL

Current Illness:

ID: 1391095
Sex: M
Age:
State: IN

Vax Date: 05/03/2021
Onset Date: 05/01/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable consumer. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on 03May2021 (at the age of 40 years) and second dose of BNT162B2 on 26May2021, as a single dose for COVID-19 immunization. The patient medical history included Ventricular tachycardia and concomitant medications included Amiodarone used for Ventricular tachycardia on an unknown date. Reporter stated that he took the highest dose in that medicine, yes the highest, I do not know what the highest is that he is taking I know it is the highest since they said they cannot give him anything now". Reporter stated, "My son might be having a reaction to the Pfizer vaccine and he has a test in the morning, but he already been into the emergency room and all these and I need to ask or talk to somebody that can medically give me some advice before his test specifically we do not know he can actually have this test now. Reporter added, "Now do you need to know his side effects that he is having from the vaccine that came from the vaccine. Okay the side effects he is having started right after his first vaccine on 03May2021 he started getting the sleep apnea well not sleep apnea sorry about that he started getting insomnia and he cannot sleep and he ended up getting a cough so when he went back to his second vaccine his insomnia started getting worse, he is like he cannot sleep at all and when he does fall asleep its only for 2 hours and he gets so tried, his body start jerking and makes him wake up. Report-er stated, "They are worsening". The patient underwent laboratory test and procedures which included chest X-ray, Nuclear test on Friday and have not got results for that test. Outcome of events was reported as unknown. Reporter seriousness for Insomnia, Cough, his body start jerking was unspecified.

Other Meds: AMIODARONE

Current Illness:

ID: 1391096
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: He said when he had his injection his arm is very sore and felt like its gonna fall off; He said when he had his injection his arm is very sore and felt like its gonna fall off; This is a spontaneous report from a contactable consumer. This report is for doctor of consumer. A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient had his injection his arm is very sore and felt like its gonna fall off. The outcome of event was unknown,

Other Meds:

Current Illness:

ID: 1391097
Sex: M
Age:
State: NJ

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a hot room like 78 degrees with the window open he can not take the heat like he used to; Hot flashes; rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing; Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging; felt like he was drugged; pulse rate has been a little elevated; Palpitations: Caller stated this started the same day 10 to 12 hours after getting the first shot. Caller stated it was getting somewhat better but after the second shot it got worse.; getting out of breath was reported as worsened; felt like there was pressure in his skull; he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall ove; Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183; expiry date: 31Aug2021) via unspecified route of administration in left arm on 01Jun2021 as single dose of COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0173; expiry date: 31Aug2021) via unspecified route of administration in left arm on 11May2021 as single dose of COVID-19 immunization and experienced palpitations, felt like he was drugged, felt like there was pressure in his skull, getting out of breath, rash got bright pink, respiratory rate was somewhere around 16, blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle. On an unspecified date in Jun2021, after second dose of vaccination, the patient experienced palpitations, getting out of breath like when he was walking up and down the stairs especially when carrying laundry or a garbage can and he never had this problem doing that unless he had an upper respiratory infection and prior to the vaccine he was perfectly fine, palpitations was reported as worsened, getting out of breath was reported as worsened, rash on his left side where he got the shot on his hand, specifically the top of hand and on his first, second, third, fourth, and fifth finger was reported as worsened, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle was reported as worsened, crack in the knuckle area on the second finger was reported as worsened, rash got bright pink was reported as worsened, felt like he was drugged, Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, felt like there was pressure in his skull, felt like he was going sideways, and on 01Jun2021 experienced hot flashes. On 02Jun2021, he was in a hot room like 78 degrees with the window open he cannot take the heat like he used to. On an unspecified date in Jun2021, patient stated that palpitations got worse after the second shot it was started on the same day of first shot of vaccination, 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse. On 03Jun2021, that next day of vaccination, patient had a rash and explained that on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle, this stopped a week to ten days after the first dose and then it came back after the second. Patient had a crack in the knuckle area on the second finger: patient stated he was scheduled for the dose around 12:20 and they had to get more vaccines and so he had to get it around 3:00pm. The patient stated this started to feel bad in the first two hours. For the event of rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing. Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging. For the event "felt like he was drugged" patient stated this started within 4 hours of first dose, he started to feel better in 5 days and then 10 days after he was completely better and stated he got this again from the second shot and it was getting better but the more he exerts himself the slower he feels but he does not feel like he is on anesthesia. The patient stated that his pulse rate has been a little elevated, stated on the following day after first dose his pulse rate was 114 and 120 was the highest. He stated after the first dose it was between 116 to 120 and after the second dose it was slightly elevated like 90 or something. The patient stated but his pulse rate has been 86, 87, 90 so the pulse rate has been a little elevated. The patient reported he also had hot flashes. He felt like there was pressure in his skull, 10 to 12 day after the first vaccine and this got better, then within 7 to 10 days after the second shot he got it again and he anticipates that for 7 to 10 days he will have to deal with the same crap. The patient felt like he was going sideways, this stopped within two days after the first dose and then it happened within one day or a day in half after the second shot. The patient stated that hot flashes lasted a day or day in a half. The other problem he had noticed is when he is in a hot room like 78 degrees with the window open, he cannot take the heat like he used to. Reportedly, after the second shot they had the patient sit for 15 minutes and so he went to the hospital main area after to get a pass to eat and he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over. He stated the first hour or so after the vaccine he felt like he was drug and he even had caffeine and got his car cleaned, but he felt like his body was behind him like woozy to stomach like in slow motion with exertion and it felt like he was drugged. The patient stated he just wished the vaccine dosage had a high of like if it was 0.3 maybe should be 0.2. The patient stated there should be a different regimen based on height and weight. The outcome of the event "hot flush" was resolved on 01Jun2021, for the event "Palpitations: The patient stated this started the same day 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse", "getting out of breath was reported as worsened", "The patient stated he got the second shot two days ago and that next day he had a rash", "he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over", "felt like there was pressure in his skull", "Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine", "felt like he was drugged", "pulse rate has been a little elevated", "when he is in a hot room like 78 degrees with the window open he cannot take the heat like he used to" was not resolved and for the event "Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging" was unknown, for the event "rash got bright pink, the patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing" was recovering.

Other Meds:

Current Illness:

ID: 1391098
Sex: M
Age:
State: IL

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: After the first dose the caller's arm was still sore and tight before the second shot; After the first dose the caller's arm was still sore and tight before the second shot; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route on 20Mar2021 as 1st dose, single dose in the left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Mar2021, after the first dose the patient experienced arm was still sore and tight. After the first shot, the patient had arm soreness but nothing that was different from the reports. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1391099
Sex: U
Age:
State: CA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction; fatigued; Severe pain/The pain is terrible it is ongoing. Her right forehead temporal all the way down the jaw line to her right ear; Blurry vision; right side of her face was flaccid; That day they diagnosed four other patients with Bell's Palsy who received Pfizer.; Sore arm; This is a spontaneous report from a contactable other hcp. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in arm right on 26Feb2021 at a 1st dose, single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in arm right on 19Mar2021 at 2nd dose, single dose, both the doses for covid-19 immunisation. Medical history included tremor (she take's Topamax because she has a very fine essential hand tremor so they wanted to try that in her right hand). Concomitant medication included topiramate (TOPAMAX) taken for tremor. Prior Vaccinations within 4 weeks was no, adverse event following prior vaccinations was none she has had the flu vaccine and shingles no reaction. The patient did not had additional vaccines administered on same date of the pfizer suspect. On an unknown date, the patient experienced fatigued, Her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction, on 26Feb2021 the patient experienced Sore arm, on 04May2021, the patient experienced That day they diagnosed four other patients with Bell's Palsy who received Pfizer, right side of her face was flaccid, on 06May2021, the patient experienced Blurry vision, on 10May2021 Severe pain/The pain is terrible it is ongoing. Her right forehead temporal all the way down the jaw line to her right ear. All the adverse events lead to emergency room visit. Patient received treatment as eye drops for the event Her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction and prednisone 60 mg a day for a week. And the other one was acyclovir an anti-viral 1 gram 3 times a day for a week as a treatment for the event that day they diagnosed four other patients with Bell's Palsy who received Pfizer, right side of her face was flaccid. Event Details: Patient talked to Pfizer. Patient had to gone to ER on 06May2021. She woke up actually on the 04May2021. She looked in mirror and the right side of her face was flaccid and muscles weren't moving and she said her lips were numb. Right side of her face was flaccid: Attempted to clarify seriousness criteria with patient. Patient stated it was disfiguring initially then said it was disabling. Patient stated it was a slight improvement. Treatment - When she got this patient called an MD live where you talk to a doctor. Patient wanted to know if it was one of her medications that could cause this. He said she take's Topamax because she has a very fine essential hand tremor so they wanted to try that in her right hand. He said that if it was that medication they would stop it and in a few days it would go away and it persisted and her eye closed. Muscles weren't moving: treatment - On 06May2021 patient went to the ER. Patient had her friend take her there. Two ER doctors saw it and they said it Bell's palsy. Patient has some other symptoms that have occurred about 2.5 to 3 weeks ago with the right side of your face she had severe pain. Severe pain: The pain is terrible it is ongoing. Her right forehead temporal all the way down the jaw line to her right ear. It is disabling you can't imagine. Why did she get this. The pain is still persisting day and night. Treatment - Her primary doc-tor ordered physical therapy she hasn't started treatment. Its not until 08Jun2021 she guesses they are going to do ultrasound she will get an evaluation with the ultrasound to see if they can reduce the inflammation to all those areas where her face isn't moving, the muscle. She thinks it is important to add that coffee or any liquids drips out of her mouth and onto her top. She has to bend over the kitchen table she can't chew her food on the right side and the food goes up to the gum line and doesn't go anywhere. The inside of her cheek muscles aren't moving. Causality: She was fine. Yes, patient was healthy she would walk visit her friends with the covid thing patient hasn't been visiting that much just on the phone talking or going grocery store. Patient wasn't sick with the cold or flu, nothing. She wasn't stressed. Time the Vaccination Was Given: Her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction. Blurry vision: It is ongoing she can't even look at phone. Patient has to get the non prescriptive reading glasses. He said she didn't need eye glasses. Treatment - He said to put in eye drops, prescriptive, now they sell it over the counter for allergic reaction to eye. One drop in both eyes. It is persisting patient has never had vision problems before all of this. Adverse event require a visit to Emergency Room, on 06May2021 she went to the ER and they had two ER doctors verify that it was Bell's Palsy. Just a tid bit the ER doctor said we never had so many Bell's Palsy patients. That day they diagnosed four other patients with Bell's Palsy who received Pfizer. DSU agent asked caller if she had any further information on the patients or would like to file a safety report on their behalf. Reporter declined to provide any further information and declined to complete a safety report on their behalf stating no that would be against HIPPA. Sore arm: start - The day she got her first injection on 26Feb2021. Then it went away she would say 48 hours. The second vaccine her arm was sore like the first one and she felt fatigued for about 72 hours but then it went away. The CDC had told her on the phone that 10% of people either get neurological or Bell's Palsy from the Pfizer vaccine. The pain is severe and just so unbearable. They are going to do an MRI to see if the virus is still occurring to the 7th cranial never. The event that day they diagnosed four other patients with Bell's Palsy who received Pfizer was considered as serious with seriousness disability, medically significant, the events Blurry vision, right side of her face was flaccid, Severe pain/The pain is terrible it is ongoing. Her right forehead temporal all the way down the jaw line to her right ear was considered as serious with seriousness disability. Out-come of the events severe pain/the pain is terrible it is ongoing. her right forehead temporal all the way down the jaw line to her right ear, her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction was not re-solved and that day they diagnosed four other patients with Bell's Palsy who received Pfizer, Blurry vision, right side of her face was flaccid, fatigued, Sore arm was unknown. Causality as per reporter was related to the events Severe pain, Sore arm, fatigued, right side of her face was flaccid, the patient experienced That day they diagnosed four other patients with Bell's Palsy who received Pfizer, right side of her face was flaccid. PSCC Communication: DSU agent attempted to clarify with caller if she had any medically related questions that we suggest she reaches out to her primary care provider. Provided caller with Report Reference PSBNIJOC. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of bell'spalsy,hypersensitivity,hypotonia,blurred vision,hypotonia,pain cannot be excluded But also consider concomitant medications a

Other Meds: TOPAMAX

Current Illness:

ID: 1391100
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: rash on your legs; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the reporter just wanted to know if it was a normal reaction from Pfizer Vaccine to get a rash on your legs and all that. The reporter seriousness for the event was reported as unspecified. The reporter was informed about Pfizer Medical information department and was provided with the number. QR Comment included it could not be clarified if the caller was calling for self or for some other user, hence was the patient also the reporter. The outcome of the event was unknown. Information on batch/lot number is requested.

Other Meds:

Current Illness:

ID: 1391101
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: That day they diagnosed four other patients with Bell's Palsy who received Pfizer.; This is a spontaneous report from a contactable other hcp (nurse). A non-pregnant female patient of unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, on an unspecified date, as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06May2021, the patient experienced that day they diagnosed four other patients with bell's palsy who received Pfizer. The evet was medically significant. The patient was visited to emergency room. The outcome of the event was unknown. Follow-up attempts needed; information about lot/batch no. requested. Further information expected.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of Bell's Palsy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021662119 same reporter/product/event, different patient

Other Meds:

Current Illness:

ID: 1391102
Sex: F
Age:
State: TX

Vax Date: 06/03/2021
Onset Date: 06/04/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; Tiredness; Headache; Nausea; Feeling unwell; Arm pain; Weakness; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration, administered in Left arm on 03Jun2021 at 17:00 (at the age of 55-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. and the patient had no known allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, probiotic supplement (PROBIOTICS NOS) taken for an unspecified indication, on an unspecified date received in two weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185, Expiration date: unknown), via an unspecified route of administration, administered in Left arm on 13May2021 17:00 at the age of 55-years-old for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 04Jun2021 at 11:00, the patient experienced side effect Injections pain, swelling, redness, itching, Tiredness, Headache, Nausea, feeling unwell, Arm pain, Weakness and Short of breath. patient did not received any treatment for adverse events. The outcome of the events was unknown. .

Other Meds: LEVOTHYROXIN; PROBIOTICS NOS

Current Illness:

ID: 1391103
Sex: M
Age:
State:

Vax Date: 06/02/2021
Onset Date: 06/03/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Slight headache; Sore arm; Tired; This is a spontaneous report from a contactable consumer (parent). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 02Jun2021 at 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 03Jun2021, patient woke up around 11am and had slight headache, which lasted all day, sore arm and tired. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1391104
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: had an extreme reaction with her menstruation; extreme cramping which was shocking; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had the covid vaccine and had an extreme reaction with menstruation and extreme cramping which was shocking since there was no mention of this. After she started reading about other women facing the same issue, after first shot she found out Pfizer could not be bothered to care about what affects women participants. It was reported that she wants to understand, she matters, exist, and his gender makes up approximately 50% of the nation. This was disappointing and why there was a lack of trust with big pharma. The outcome of events were unknown. Follow-up attempts are needed. Information on the lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1391105
Sex: M
Age:
State: IL

Vax Date: 06/04/2021
Onset Date: 06/05/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Head was hurting; Temperature was 101.4; This is a spontaneous report from a contactable consumer. A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0185) via an unspecified route of administration, administered in right arm on 04Jun2021 (age at vaccination: 15 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any prior vaccinations. On 05Jun2021, the patient experienced head was hurting, and temperature was 101.4. The patient was given paracetamol (TYLENOL) 500mg (1 pill) for headache. Reporter stated just gave him the pill a minute ago before calling, so it was not going to work that fast. It was reported that, the patient was scheduled in 26th for the second shot. Therapeutic measures were taken as a result of adverse events. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1391106
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Had a cold after first vaccine/ Reports a cold and took antibiotics, after the first vaccine; This is spontaneous report from contactable consumer (mother) reported for her daughter via medical information team. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Consumer stated that her daughter has a cold, later reclarified as a common cold and had tested negative, later reclarified as tested negative for Covid. Consumer said that her daughter's doctor had started her on an antibiotic and last dose was finished today (on reported date). Consumer stated that she was also due for her second dose of vaccine today (on reported date) and wants to know whether it is alright for her to get the second vaccine. Consumer was with her daughter, was waiting to be called, to get the vaccine and clarified that her daughter's antibiotic was a Z-Pak. Consumer stated that her daughter did not get a cold until weeks after the first vaccine. Patient underwent lab test included SARS-CoV-2 test with result: Negative on an unknown date. The event was considered as non-serious by the reporter. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1391107
Sex: F
Age:
State: NY

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Right on 13 May 2021 (at the age of 41-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing blood pressure high and diabetes, asthma and vertigo from an unknown date and unknown if ongoing. Concomitant medication included amlodipine taken for blood pressure high from an unspecified start date and ongoing; metformin taken for diabetes from an unspecified start date and ongoing; atenolol taken for an unspecified indication, start and stop date were not reported; olmesartan taken for blood pressure, start and stop date were not reported; cinnarizine taken for vertigo, start and stop date were not reported; diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to Covid vaccine. Facility where the COVID-19 vaccine was administered was Hospital. Patient stated, first time she didn't take anything she just took TYLENOL but her arm swell up the same day on 13May2021 and she couldn't move my arm for 2 days, it was stiff she couldn't move my hand. she put some heating pad and ice pad like stuff on it and about on the third day it started to get better but then 2 days after that she woke up swollen and she couldn't move on an unspecified date in May 2021. This was freaking me out. Under my arm and all the way down she don't think it should swell up like that and it is on whole body on an unspecified date in May 2021. Patient stated, she took TYLENOL for relief joint discomfort and inflammation on an unspecified date in 2021. The patient underwent lab tests and procedures which included TSH test: unknown results on 22Apr2021. There was investigation assessment reported. Therapeutic measures were taken as a result swollen arm, mobility decreased, limbs stiffness, joint discomfort and inflammation. The outcome of events was unknown.

Other Meds: AMLODIPINE; METFORMIN; ATENOLOL; OLMESARTAN; CINNARIZINE; VALIUM

Current Illness: Blood pressure high; Diabetes

ID: 1391108
Sex: M
Age:
State: FL

Vax Date: 06/04/2021
Onset Date: 06/05/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Woke up with chest pain; He said his upper back was aching; temperature of 100 degree; Sinus pain; Sinus pain and Congestion; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine; Solution for injection; Batch/Lot Number: EW0185) intramuscular, administered in Arm Right on 04Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot Number: EW0182) on right upper arm on 14May2021 for covid-19 immunisation. The patient reported, had his 2nd vaccine on Friday 2 days ago yesterday he just had congestion, today on 06Jun2021, he woke up with chest pain and he said his upper back was aching and he has chest pain. He is also having temperature of 100 degree, so Tylenol was given. Sinus congestion and pain was yesterday on 05Jun2021. He does not have congestion today. Yesterday for sinus pain and congestion, the patient was given Sudafed 1 tablet. It is an over-the-counter medicine, 30 milligrams 1 tablet. A history of sinus was reported for about everybody in his family got sinus one time in life. The outcome for the events sinus congestion and pain was recovered on 06Jun2021. Outcome for the events chest pain, upper back was aching and having temperature of 100 degree was unknown.

Other Meds:

Current Illness:

ID: 1391109
Sex: U
Age:
State:

Vax Date: 06/05/2021
Onset Date: 06/06/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: I feel very bad; all my body hurts; Fever; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (Pfizer COVID 19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient got COVID shot yesterday (05Jun2021), but today (06Jun2021), the patient felt very bad and stated that, "all my body hurts and I have a fever". The outcome of events was reported as unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1391110
Sex: F
Age:
State: VT

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: experienced anaphylaxis after receiving the second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, patient received first dose PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unknown date, the patient reported that as someone who experienced anaphylaxis after receiving the second dose of your COVID vaccine, she was wondering whether Pfizer was attempting to modify future RNA vaccines, in particular the booster, so that they were less likely to cause allergic reactions. She hoped she will not need to forego the benefits of this wonderful new technology in the future and said thank you very much. The outcome for was unknown. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1391111
Sex: M
Age:
State: OH

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: I got some red, blotchiness in different pars of my left forearm and left hand; They are anywhere quarter by quarter squares to pinpoint sized red dots; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration Mar2021 at 1st dose, single dose for COVID-19 immunization and second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 01Apr2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he experienced some red, blotchiness in different parts of his left forearm and left hand and they are anywhere quarter by quarter squares to pinpoint sized red dots on an unspecified date. The patient stated that when he went to doctor he said it is from burst capillaries. But he didn't know what the cause of it was. The only thing they were coming up with is that is the arm he got the vaccine in. He had received both doses. Second dose was April 1st and the first dose was 3 weeks before that. The patient was still experiencing it. Some have faded away. But more have showed up. He noticed it about 2 1/2 weeks after his vaccine. His doctor kept him on prednisolone treatment. Therapeutic measures were taken as a result of event which included prednisone and that helped stop it a little bit and was concerning because if this is reaction he may be hard pressed to get a booster. The patient stated "I don't like what's going on because I don't know what's going on. If the CDC says I should get one every year, I wouldn't want to get a Pfizer because I don't know if that's what caused that. This is a little un-nerving because I was all in favor of these vaccines, but now I don't know. Is the reaction on my left arm connected to the vaccine?". The outcome of the events was reported as resolving. Information about batch no/lot no has been requested.

Other Meds:

Current Illness:

ID: 1391112
Sex: M
Age:
State: NY

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 28Feb2021 18:00 as single dose for COVID-19 immunization. Medical history included reaction to flu shot many years ago and known allergies from clams. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]); lisinopril; amitriptyline hydrochloride (AMITRIPTYLIN); rosuvastatin. No COVID prior to vaccination. The patient had not been tested for COVID post vaccination. On 28Feb2021 18:15, the patient experienced within 20 minutes my throat felt tight and he had trouble swallowing, his voice sounded froggy. The patient visited the emergency room/department or urgent care for the events. Treatment medications included Epipen, Benadryl and steroids. Outcome of the events were reported as recovered with sequel. No follow-up attempts are needed. No further information is expected.

Other Meds: VITAMIN E [TOCOPHEROL]; LISINOPRIL; AMITRIPTYLIN; ROSUVASTATIN

Current Illness:

ID: 1391113
Sex: F
Age:
State:

Vax Date: 06/03/2021
Onset Date: 06/05/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: developed 'bumps' that are big like mosquito bites; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left arm really swollen; left arm really swollen and irritated; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0182), via an unspecified route of administration in Arm Right on 03Jun2021 (age at vaccination 44years old) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus diagnosed from 20 years ago. The patient's concomitant medications were not reported. She received her first dose of the Pfizer Biontech Covid 19 vaccine on 03Jun2021 in right arm/shoulder. On 05Jun2021, she started have problems with opposite side; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection) and then she noticed the 'bumps'. Not only bumps but also itching and left arm really swollen and irritated. So to clarify, on the left side, she has 8 bumps on arm and elbow and one on her index finger. On her right side, she has one bump on right index finger and one on right arm (that was just noticed today). The area is Irritated, and she has tried cortisone, alcohol, hair dryer, but nothing is working. She took Benadryl last night and it helped her to get some sleep. The bumps are getting worse; they are not as swollen today, compared to yesterday. This was about mid-night on 05Jun2021. she has these little bumps, some are really big bumps, kind of like mosquito bites. there is no bite puncture, the bumps are hard and itchy. It is the same reaction she gets to a mosquito bite. she knows everybody is different. The bumps are hard and risen and hot to the touch and just itchy. her whole arm where the bumps are just itches. the bumps are on both hands, especially worse is on the left hand. The outcome of the events was unknown. Therapeutic measures were taken as a result of developed 'bumps' that are big like mosquito bites, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left arm really swollen, left arm really swollen and irritated. Follow-up (07Jun2021): This is a follow-up spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported that: Report Type, HCP postal address, Dates for Reading through side effects and is getting, has like these bumps, Suspect product information, Other Products, Patient History. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Diabetic (diagnosed with diabetes years ago, 20 years ago.)

ID: 1391114
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: My arm is itchy (started after the 2nd dose a week later).; For my 2nd dose I had every single side effect listed; Constipation; For my period this was amazing. First time every I had zero cramps; Instead of cramps I got headache which normally doesn't happen for me; my period was affected.; bloating; diarrhea; Nausea; This is a spontaneous report from a non-contactable consumer (patient) via company representative. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), 2nd dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included eczema, other period symptoms bloating, diarrhea and nausea, birth control and cramps (when the patient was on birth control). The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, the patient experienced "My arm is itchy (started after the 2nd dose a week later)" and "my period was affected". She mentioned that "for my 2nd dose I had every single side effect listed", even constipation (which was not on the list). Her arm was still itchy and she was definitely worried. She don't need that on her arm since she already deals with eczema. She further stated that "for my period this vaccine was amazing, first time every I had zero cramps" and that happened only when she was on birth control in the past. All her other period symptoms were there which included bloating, diarrhea and nausea. "Instead of cramps I got headache which normally doesn't happen for me". She did not report this to her health care professional. The outcome of the event pruritus was not resolved and was unknown for rest all other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1391115
Sex: M
Age:
State:

Vax Date: 05/08/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: side effects in my arm around the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 41-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 08May2021 as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced still having side effects in his arm around the injection site. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1391116
Sex: F
Age:
State: NC

Vax Date: 05/27/2021
Onset Date: 05/28/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Runny nose; Runny eyes; Sore arm; Nauseated; I couldn't make a fist with my hand. I couldn't close my hand; Had left side numbness and tingling from my fingertips down to my toes; little tingling and stuff today in my legs and on the bottom of my feet; Had left side numbness and tingling from my fingertips down to my toes; little tingling and stuff today in my legs and on the bottom of my feet; Every day I was experiencing that, like my skin was burning, like I was on fire and my skin was burning all over; My blood pressure went up it was elevated a little bit in the ER on Friday. When I got to Urgent Care, my bottom number was like 102 when I checked it here at home, it was like 105 bottom number; Felt like something popped in my head like air or something like that; This is a spontaneous report from a contactable consumer (reporting on herself). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: EW0179 and Expiration Date was not reported), via intramuscular route of administration in Arm Left on 27May2021, as 1st dose, single dose for COVID-19 immunization; hydrochlorothiazide (HYDROCHLOROTHIAZIDE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 12.5 mg, 1x/day (12.5 mg, one tablet every day ) for blood pressure measurement. Medical history included hyper-sensitivity from an unknown date and unknown if ongoing , blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity, start and stop date were not reported. It was reported that patinet had received the Pfizer Vaccine on 27May2021 and had some side effects and her PCP had told her to call you guys to report it and what she had went through and see what advice you give me as far as getting the second dose scheduled on 16Jun2021. she guess you all don't send out like a confirmation or nothing like that she mean to say will something be emailed to me or nothing she won't hear anything else from you guys now that Pfizer will call back with other questions. Patient just saying do she get an email or anything on confirmation that she just called in or anything or she will need anything like that. Patient stated that well, her blood pressure went up and so it was elevated a little bit in the Emergency Room on Friday. But when she got to the Urgent Care, her bottom number was like 102 and when she checked it here at home, it was like 105, the bottom number. So the doctor at Urgent Care, she prescribed me some blood pressure medicine (Hydrochlorothiazide) and so she started on that (Hydrochlorothiazide) on Wednesday and her blood pressure went down but it's still like going up and down, up and down but the most part it is down. Like she said today she had some of the tingling in her leg and then the bot-tom of her feet but not all over like it was before the burning sensation like her skin and stuff. Yeah, also they tried the morning when she was lying in there, when she was, you know, experiencing all of this, all of this on left side, it felt like something popped in her head like air or some-thing like that, she cant, really can't just describe it. she mean it just felt like something popped in the inside of her head, like air or something like air or something like air, its hard to describe. But like she said they did a CT on my brain and all of that stuff and they ruled out stroke and heart at-tack and they ruled out blood clot at the Urgent Care. The outcome of the events was unknown. Follow up needed, further information has been requested.

Other Meds: ZYRTEC ALLERGY

Current Illness:

ID: 1391117
Sex: F
Age:
State: FL

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Redness in the left arm; Soreness in the left arm; This is a spontaneous report received from a contactable consumer. A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EP7533, Pfizer NTEC), via an unspecified route of administration in Arm Left on 17May2021 at 10:00 (age at vaccination was 54) as 1st dose, single dose for covid-19 immunisation. Medical history included and concomitant medications were not reported. The patient previously took metoprolol 50mg twice a day has been taking this medication for about 5 years for hypertension. After 1st dose of the vaccine she has been experienced redness and soreness in her arm has been persisting since the day she got her first vaccine, on 17May2021. She was not allowed to get the 2nd dose today 07June2021 due to she still have redness and soreness in the left arm and asked to secure medical clearance in order for her to get the 2nd dose she was just waiting for her primary care doctor's response she wants to know what will happen if she was not able to get the 2nd dose on time she will be in Hawaii in 2 weeks time. Caller states that she was calling about the Covid 19 Vaccine. Stated they told her to call and report this. Caller states that she called her primary care provider. Said that she needs to get her vaccines because she was traveling soon and needs them for that. And patient said she tried to fill out the report online but had issues with the website not letting her press the enter button. Caller states she went to the emergency room this past Friday due to the pain in her left arm being worse that day. She was not admitted to the hospital. The outcome of the events was reported as not recovered.

Other Meds:

Current Illness:

ID: 1391118
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: her arm started to hurt; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 01Jun2021 as 1st dose,0.3 ml single dose for COVID-19 immunization. Medical history included lipoma from an unknown date and unknown if ongoing she has a lipoma in that arm since it doesn't bother her. The patient's concomitant medications were not reported. On an unspecified date the She thought of it later that day when her arm started to hurt and she rubbed it. So know she was not sure if the vaccine was injected into the muscle or her lipoma. She should like to know if she should get another shot or just oto continue with the series as planned. Response received as Read from PI LAB-# Revised: 19May2021. The outcome of even was unknown. Information about batch/ lot number has been requested.

Other Meds:

Current Illness:

ID: 1391119
Sex: M
Age:
State:

Vax Date: 04/09/2021
Onset Date: 06/04/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: He said he had just started having muscle pain in his leg; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: ER8729; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 09Apr2021 (at the age of 36-years-old) 09:30 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient had no medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 19Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient had no prior vaccinations (within 4 weeks). No additional administered Vaccines. On 04Jun2021, the patient experienced muscle pain in leg. Patient stated that he wanted to know if this was still associated with the vaccine and heard of people who had side effects 1 week or just 24 hours after receiving the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if there had been reports of people having side effects almost 2 months after receiving the vaccine and had tried to find out if the side effect he was having from the Pfizer vaccine. He has a primary care doctor but declined to provide HCP information and he just put ice on it. Patient had not visited emergency room and physician office. The patient had no relevant tests. The outcome of event was not resolved.

Other Meds:

Current Illness:

ID: 1391120
Sex: M
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: received both covid vaccines and has fatigue; This is a spontaneous report from a sponsored program. A contactable Consumer reported. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose, dose 1 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received both COVID vaccines and had fatigue and wants to know if it was a side effect of vaccine. The outcome of event was unknown. Follow up attempts needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1391121
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: numbness; Pain in the arm; Bloating; This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unspecified) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that she took her first shot of the vaccine and experienced a lot of side effects such as pain in the arm, numbness, and bloating on an unspecified date. The clinical outcome for the events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1391122
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Sore throat with a runny nose; Sore throat with a runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had sore throat with a runny nose and wanted to know if Tylenol can be taken or if it would interfere with the efficacy of the vaccine. She asked if she could take Tylenol or allergy pills for her symptoms, after the vaccine. The outcome for the events was reported as unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1391123
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: sore for about a month and a half; shoulder is hurting really bad; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 80-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) as single dose on unspecified date for COVID-19 Immunization. The patient experienced sore for about a month and a half and shoulder was hurting really bad on an unspecified date. Caller (male, 80 years old) reported getting a second dose of PFIZER-BIONTECH COVID-19 VACCINE almost 3 months ago, stated, it was sore for about a month and a half, now hurting bad upon further clarification the shoulder was hurting bad. Looking for information about it. The outcome for the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1391124
Sex: F
Age:
State:

Vax Date: 05/25/2021
Onset Date: 05/26/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: hot; chilled; liver enzymes were elevated; iron levels very low; stomach pain; irritation in her throat; This is a spontaneous report from a contactable consumer or other non HCP (patient herself). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25May2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received the first dose of Pfizer's COVID vaccine on 25May2021. She began to have some stomach pain the next day and irritation in her throat (on 26May2021). About a week later on (Wednesday) 02Jun2021, she had very bad stomach pain. She was hot, then very chilled, and she went to her doctor the next day and to the ER the day after. She had some blood work done and ultrasound, and the imaging came back normal. But her liver enzymes were elevated and iron levels very low. Only the tests and the pain indicated that something was wrong. She was asking has anything like this been reported before and was it safe for her to receive the 2nd covid vaccine. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1391125
Sex: U
Age:
State: CA

Vax Date: 05/25/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: I am having a very bad cough; My sinus are uncontrolled and running all over the place; the cough is so bad my left side is really hurting bad almost like I got fight somebody had big time punch me; This is a spontaneous report from a contactable consumer (patient). A 63-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0183 and Expiration date: unknown), dose 1 via intramuscular route, in left arm on 25May2021 at 08:15 as single dose for covid-19 immunisation. Medical history included High blood pressure and ongoing diabetes. The patient's concomitant medication included insulin. After first shot of vaccination, the patient experienced a very bad cough and sinus are uncontrolled and running all over the place, the cough was so bad that patient's left side was really hurting bad almost like got fight somebody and had big time punch. Patient had some lab work done about two three, three four weeks ago, don't know the test name. No treatment received other than, over the counter cough syrup (Robitussin). Outcome of events was unknown.

Other Meds: INSULIN

Current Illness: Diabetes (Verbatim: Diabetes)

ID: 1391126
Sex: F
Age:
State:

Vax Date: 05/19/2021
Onset Date: 05/20/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: bumping on the day after; flared up and was red, bumpy and itchy; flared up and was red, bumpy and itchy; as hives that are covering her entire belly, under her breasts, on her arms and some spots on her legs and it is going to the sides of her abdomen under the armpits was mostly her upper body.; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 19May2021 as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient stated that she had the second dose of the Pfizer covid 19 vaccine on 19May2021. Patient stated that she started bumping on the day after (20May2021) then it flared up and was red, bumpy and itchy. Caller described it as hives that are covering her entire belly, under her breasts, on her arms and some spots on her legs. Caller stated it is going to the sides of her abdomen under the armpits Patient stated it was mostly her upper body. Patient sated it did not cover her face. Patient stated she called out of work on 27May2021, 28May2021 and 30May2021 because the benadryl made her sleep Caller stated she had been taking benadryl and using eucerin since 20May2021. Caller stated this is helping some. Patient stated yesterday it flared up again. Patient stated she took two benadryl last night so she could sleep. Patient wanted to know when it should clear up. Patient wanted to report AE. The outcome of the events was unknown. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1391127
Sex: F
Age:
State: PA

Vax Date: 04/30/2021
Onset Date: 05/14/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: She reported having injection site swelling; the second shot hurt her; her arm was swore 2-3 days/arm a little sore after second shot; and was tired after; right hand swollen/Her index finger on the left hand is swollen back to the palm; right ankle swollen/swollen down to her wrist; thumb swollen and stiff; left index finger swollen/thumb swollen/her middle finger swelled; This is a spontaneous report from a contactable consumer or other non healthcare professional. An 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 30Apr2021 at 15:00 (Batch/Lot Number: ER8735) (at the age of 84 years) as 2nd dose, single dose for COVID-19 immunization. Medical history included arthritis, patient's mother had arthritis but she had it much younger than patient's age. Concomitant medication(s) included ubidecarenone (COQ 10) 100mg, once a day for health reasons and ongoing, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg, once a day for heart and ongoing, losartan (LOSARTAN) for cardiac disorder and ongoing (Had been taking over 10 years), carvedilol (CARVEDILOL) for cardiac disorder and ongoing (Had been taking over 10 years). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm 02Apr2021 (at the age of 84 years) as single dose for COVID-19 immunization. On 14May2021, patient experienced, left index finger swollen/thumb swollen/middle finger swelled. She went to the doctor on 14May2021, when she showed the doctor her finger they said it could possibly be arthritis. On an unspecified date, patient experienced injection site swelling, the second shot hurt her, her arm was sore 2-3 days/arm a little sore after second shot, was tired after, right hand swollen/her index finger on the left hand is swollen back to the palm, patient had to take her rings off, it hadn't gotten as bad as the index finger but it was swollen, it was not as stiff to bend as the index finger, it was hard to bend and was stiff when she got up right ankle swollen/ swollen down to her wrist, thumb swollen and stiff. She thought that the doctor said to take Tylenol as treatment, but she didn't care for Tylenol, so she didn't take anything. The outcome of the left index finger swollen/thumb swollen/middle finger swelled was not recovered while for the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: COQ 10; ASPIRIN (E.C.); LOSARTAN; CARVEDILOL

Current Illness:

ID: 1391128
Sex: M
Age:
State:

Vax Date: 05/31/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Diarrhea; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient's wife) reported for husband. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration on 31May2021 as 2nd dose, single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration on 10May2021 as 1st dose, single dose for COVID-19 immunisation. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced diarrhea. Although reporter knew that diarrhea was a part of side effects of vaccine and she was wondering how long it can, how long he can experience this one. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm