VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1353425
Sex: F
Age:
State: SC

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: tested positive on the 12Mar2021; feeling bad; lost taste and smell; lost taste and smell; had feeling chills; body ache; headache; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204; expiration date: Jun2021), via an unspecified route of administration in shoulder on 05Mar2021 (at 67-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient started feeling bad on Monday 08Mar2021, 3 to 4 days later. After she was feeling bad the whole week, she tested positive on the 12Mar2021. The patient got all the symptoms what people said, it's like having the COVID and she lost taste and smell, she had feeling chills, body ache, headache and all that. So, week later she went for a test COVID test and she tested Positive and the test was on 12Mar2021. Her second shot was due on 26Mar2021. Feeling bad was reported as worsened from 09Mar2021. The outcome of event feeling bad was not recovered. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1353426
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: getting sick; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient received both injection of suspect vaccine and she got sick after the second injection. The patient reported having antibody testing done afterwards that showed negative for IgM antibodies and positive for IgG antibodies. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353427
Sex: F
Age:
State: CT

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: The person experienced hives after; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) (non-pregnant at the time of vaccination) via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient was diagnosed with COVID-19 prior and since the vaccination. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced the person experienced hives on 17Mar2021 with outcome of recovered. It was reported that the reporter became aware of the adverse event on 20Mar2021 and reported the event on 20Mar2021. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353428
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Had hives; This is a spontaneous report from a contactable consumer or other non hcp who reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number unknown), 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. The patient reported that first time she had dose 1 of vaccine and had hives, the EMT gave benadryl. She asked if she should get the second dose. The clinical outcome of the events was unknown. It was unknown if the reporter was a health care professional. It was unknown if the reporter the prescribing HCP. Information on the lot/batch number has been requested. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1353429
Sex: F
Age:
State: UT

Vax Date: 03/20/2021
Onset Date: 03/23/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report received from a contactable consumer. A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6206 and Expire Date: unknown), in left arm via unknown route of administration, on 20Mar2021 at 16:00, as single dose for COVID-19 immunization. The patient previously received BNT162B2 (BNT162B2, lot number: EN6200) in arm on 27 Feb 2021 for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Medical history included measles, chicken pox, anemia, bee stings allergy, penicillin allergy. Concomitant medications were none. After 4th day of vaccination, a condition looking very much like flat hives was noticed at midnight. Itchiness was slight. This condition started on the back of her thighs, high up, then spread to the inside and front of the thighs, which she noticed at 5 a.m. There was also redness and a burning sensation. From midnight to 3 a.m. she was itchy on all her areas of skin but the location of the "rash." she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination. She then was having some difficulty sleeping all over but put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep; states she had a very fitful sleep, and her entire body itches every place there was skin except where the rash was where she put the hydrocortisone cream. Caller states she may be an allergic reaction to the ingredients in the Pfizer COVID-19 vaccine. Caller states she wanted to see if the reaction that she had that she is thinking is a reaction or if she is allergic to one of the ingredients for the Pfizer COVID-19 Vaccine. Prior to and since vaccination the patient was not diagnosed with COVID-19. The outcome of the events was not recovered without treatment. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353430
Sex: F
Age:
State: PA

Vax Date: 03/13/2021
Onset Date: 03/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: her hormones were over the top; soreness in her back/ It hurt and at times felt numb; No period in months. 2 days after the vaccine she ovulated; Soreness in back; Arm hurt really bad; Sensation of not feeling right; Skin feels like it's burning; body felt like it's vibrating; Ache in injection site; Pre-menstruation symptoms of sore breasts; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration, administered in right arm on 13Mar2021 at 14:00 (at 55-year-old) at dose 1, single dose for COVID-19 immunisation. Medical history included ongoing peri-menopause, she had off and on been having peri-menopause for at least 3 years. Patient reported that it has been this past year since she hasn't had a period and she thought she was done; ongoing hypertension, she was controlling her hypertension with food, specifically no salt. Patient reported that it makes her feel better when avoids salt. Patient reported that she was diagnosed with hypertension probably 4 years ago in 2017; ongoing asthma, she felt like sometimes she had asthma but it's seasonal; ongoing congenital heart defect, diagnosed when she was a baby; when patient got a period, she got anemic. She's high-risk; COVID-19 vaccine was recommended to her. None family medical history relevant to the events. There were no concomitant medications. The patient previously received flu shot in 1991 (reported as 30 years ago) and experienced that her arm got swollen and red and that the doctor had her come back in to look at her and stated that it looked like she was having an allergy to the egg in the vaccine. No Prior vaccinations within 4 weeks. The patient had no period in months. 2 days after the vaccine on 15Mar2021 she ovulated. She also reported having pre-menstruation symptoms of sore breasts in Mar2021. She was concerned about getting a period, as it made her anemic. Patient reported that she has been experiencing peri-menopause for the last year and hasn't had a period in 10 months. Patient reported that the Covid-19 vaccine has triggered her period and that her hormones were over the top. Patient reported that she was scheduled to get her next dose of the Covid-19 vaccine on 02Apr2021 and because she was having all those hormone experiences, she was unsure how to navigate this next shot. Her doctor was aware of what she was experiencing and that she didn't know what her physician can do. Patient reported that she has not yet had a period, but that it's coming, definitely coming even though she hasn't gotten it yet. Patient reported that if she does have her period she needs to go in to see her physician. Patient reported that while she hasn't had her period yet she has all of the symptoms that her period brings. Patient reported that she hasn't had these symptoms in 10 months. Patient reported that her boobs hurt and that she can't even touch them because they hurt so bad. Patient reported that she has had some weird things and that she was going back and forth with her doctor. Patient reported that she hasn't been to the doctor in a year and a half. Patient reported that she was afraid to go to the doctor and that her doctor was trying to evaluate her symptoms over the phone. Patient reported that she was getting frustrated as she didn't want to get the Covid-19 virus going to the doctor's office. The patient experienced arm hurt really bad on 13Mar2021. Patient reported that immediately after receiving the first dose of the Covid-19 vaccine, her arm hurt really bad. The patient experienced soreness in back on 15Mar2021. Patient reported that the pain from her arm the next day went into her back. Patient reported that she was having back pain for probably a good week after. Patient reported that her back pain has calmed down. Patient reported that she then started having a sensation of not feeling right in Mar2021. Then she was having pre-menopausal things that started probably 3 days after vaccine on 13Mar2021. She still had a sensation in her arm, that every once in a while her arm will ache. Patient reported that she had the pain in her arm for 2 days and that the pain then went into her back in between her shoulder blades. The back pain felt like someone was punching her in the back and she felt most winded. The sensation in her arm was like a dull ache in that spot, the injection site, and that she wanted to rub or put heat on it. Patient reported the soreness in her back was like pressure in her back. It hurt and at times felt numb. It hurt to the point where it felt like it was knocking the wind out of her. It was like the pain from her arm moved to her back. The back pain was not as bad, that it's calmed down a little bit. Her boobs hurt so bad but she didn't know if that's correlated to the Covid-19 vaccine. The breast tenderness started about a week ago, maybe 20Mar2021. The breast pain was ongoing but that it comes and goes. There are times where the breast pain has gotten worse and times where it's gotten better. When she woke in the morning the breast pain was worse. Once she started moving around the breast pain kind of went away but later in evening got really bad. She felt like her body was fighting the hormones to have a period and that she would feel a hundred times better if she got her period. Apparently her physician doesn't want her to get a period. The patient experienced sensation of not feeling right in Mar2021. Patient reported that the sensation of not feeling right started like a week ago, that there was week in between getting the Covid-19 vaccine and when she started experiencing weird things. She has talked to some people that have reported they have not had any side effects following the Covid-19 vaccine. Patient explained that the vaccine has just triggered so much in her, she was just frightened because everybody said the second dose was the worse. Patient reported that her doctor kept saying to give the side effects some time, maybe they'll settle down, but they haven't. All of her symptoms kind of gradually came a few days to a week after receiving the Covid-19 vaccine. The patient experienced skin feels like it's burning in Mar2021. Patient reported that she never felt like she was going to jump out of her skin, but the skin burning was an annoying feeling, like a sunburn. The patient experienced body felt like it's vibrating in Mar2021. Patient reported that she developed this symptom a week to a few days after receiving the Covid-19 vaccine. It was not a constant thing but when she was sitting still she felt it. The patient experienced ache in injection site in Mar2021. Patient reported that her right side, which was the same side that she received the first dose of the Covid-19 vaccine, was the side she was having back pain and that she had more pain in her right breast. Her doctor recommended that she get the second dose in the other side, her left arm. She did not take any medications. Patient reported that she has not had any relevant tests done but that she didn't know if she should or not. She doesn't know if how she is feeling now will impact if she should get the second dose of the Covid-19 vaccine. If she didn't feel a thing, she would go ahead and get that second dose, but because she has so many things going on, she's wondering how it is going to effect her. She was not sure if she should push out the date for the appointment for her second dose of the Covid-19 vaccine. For her, if she pushes out the second dose of the Covid-19 vaccine for a week, it might help her recover from the first dose. She definitely wanted to complete the series of vaccines for Covid-19, but she didn't want to die from this shot either. Patient reported that her second dose of the Covid-19 vaccine was originally scheduled for the 01Apr2021 and that she rescheduled the appointment to hopefully get the second dose Saturday, 03Apr2021. The events did not require a visit to emergency room or physician office. The outcome of events pre-menstruation symptoms of sore breasts, sensation of not f

Other Meds:

Current Illness: Asthma (she felt like sometimes she had asthma but it's seasonal); Congenital heart block (Diagnosed when she was a baby); Hypertension (She was controlling her hypertension with food, specifically no salt.); Perimenopause (she had off and on been having peri-menopause for at least 3 years)

ID: 1353431
Sex: F
Age:
State: ID

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: her menstrual period began the day following the second covid vaccination (on 28Mar2021), which was one week early; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 27Mar2021 09:00 (Batch/Lot Number: EN6206) as 2ND DOSE,SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose, of bnt162b2 (lot number:EN6206) on 06Mar2021 at 09:00 AM in the left arm for covid-19 immunization. The patient stated that her menstrual period began the day following the second covid vaccination (on 28Mar2021), which was one week early. The patient have never started that early before. The outcome of event was unknown. Patient did not receive any treatment for the event No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353432
Sex: F
Age: 80
State: FL

Vax Date: 05/10/2021
Onset Date: 05/24/2021
Rec V Date: 05/27/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: none

Symptom List: Pharyngeal swelling

Symptoms: Pulmonary Embolism

Other Meds: Amlodipine, losartan, HCTZ, methimazole

Current Illness: Hypertension, Diastolic Congestive heart failure

ID: 1353433
Sex: F
Age:
State: IA

Vax Date: 04/09/2021
Onset Date: 04/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: I got really sick; Couldn't get out of bed; Dizzy; Throwing up; I was down all day, I couldn't get my head off the pillow; Nauseous; Achy; I have the flu; This is a spontaneous report from a contactable consumer. A 62-years-old female patient received(PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: ER8737) first dose via an unspecified route of administration on 09Apr2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient got vaccine last Friday and she got really sick on 10Apr2021, she had the flu on Apr2021, she couldn't get out of bed on 10Apr2021 i.e., Saturday, she was dizzy on 10Apr2021 and achy on Apr2021, throwing up on 10Apr2021. This is the first one she got and she had to go back on 04May2021 to get the second one but she got really sick with this. she just wanted to let you guys know, it started on Friday and she was down all day, she couldn't get her head off the pillow, nauseous on 10Apr2021. she had the Pfizer one the first dose. The patient got only sick and experienced all of the above on the day after the covid 19 vaccine. It lasted a week on and off. some days she felt good, others not so good. The out come of the events like illness, fatigue, dizziness, vomiting, Nausea were recovered and the outcome of the events like flu, pain was unknown. Follow up(11May2021):This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: The event onset dates updated. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353434
Sex: M
Age:
State: RI

Vax Date: 04/08/2021
Onset Date: 04/13/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: the shingles on the right side of my face, extending from my right ear down to my chin, and up to my right eye.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729, expiration date: unknown) dose 1 via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 59-year-old) as single dose for covid-19 vaccination at Pharmacy or Drug Store. Medical history included penicillin allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, the patient had not been tested with covid-19. Concomitant medication included VITAMIN D [VITAMIN D NOS]. On 13Apr2021, after five days from vaccination, patient developed the shingles on the right side of my face, extending from my right ear down to my chin, and up to my right eye. He would like to know if it is possible that the Pfizer BioNTech COVID-19 vaccine could have "triggered" the case of shingles of that her husband experienced 5 days after receiving his first dose of the vaccine. Response was that there is no information to suggest that the vaccine causes shingles, shingles was not listed as a commonly reported side effect with the clinical trial participants, this list does not include all possible side effects with the vaccine. Also that they do not have the safety data to speak from since the vaccine has been released to the public. Her wife wanted to know if this was a common thing, Is it from vaccine, if he did get second dose, how soon can he get second dose. she also wanted to know With the Pfizer COVID vaccine, like with the flu vaccine, which has a flu component, does this also have a Covid component in the vaccines. Patient wanted to know wanted to know how soon can he get next COVID shot. Patient's second dose is due on 01May2021. His dermatologist advised he not have second dose. Dermatologist said not to get one on Saturday if the Shingles would clear up. Patient was not sure if he should get it. If so, how soon. Patient also reported that the first vaccine did trigger the shingle's because of whatever in his immune, is he at a higher risk for getting a worse case with second vaccine. Patient received unspecified treatment which was prescribed by dermatologist. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. No Follow-up attempts are needed. No further information is expected

Other Meds: VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1353435
Sex: F
Age:
State: NY

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Fever; painful injection site; severe body aches; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0158) via an unspecified route of administration in the left arm on 24Apr2021 at 12:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine 150 ug from an unknown date for an unknown indication; and liothyronine 10 ug from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number ER8730) on 03Apr2021 at 12:30 (at the age of 52-years-old) for COVID-19 immunisation. The patient reported that within 15 hours she had a fever of 102 and over, severe body aches, and painful injection site. After 12 hours she reported taking 2 ibuprofen and her fever broke; 12 hours later her fever went back to 102.4 and had not broken yet after taking 3 ibuprofens. The clinical outcomes of fever, severe body aches and painful injection site were reported as not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOTHYROXINE SODIUM; LIOTHYRONINE SODIUM

Current Illness:

ID: 1353436
Sex: F
Age:
State: MN

Vax Date: 04/10/2021
Onset Date: 04/16/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Chest cramping and pain; Chest cramping and pain/cramping between shoulder blades; pain in left arm and left clavicle; pain in left arm and left clavicle; shortness of breath; burning and aching under skin; burning and aching under skin; This is a spontaneous report from a contactable consumer (patient) via COVAES. This non-pregnant 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8731) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 39-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines in the four weeks prior to the COVID vaccination. The patient previously received the first dose of BNT162B2 (lot number EW6207) on 13Mar2021 at 15:15 (at the age of 39-years-old) for COVID-19 immunisation. The patient experienced chest cramping and pain, pain in the left arm and left clavicle, cramping between shoulder blades, shortness of breath, and burning and aching under the skin on 16Apr2021. The events required an emergency room visit and physician office visit. No treatment was received for the events. The clinical outcomes of chest cramping and pain, pain in the left arm and left clavicle, cramping between shoulder blades, shortness of breath, and burning and aching under the skin were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353437
Sex: F
Age:
State:

Vax Date: 04/06/2021
Onset Date: 04/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: a rash on her hand and side of her hand; swelling under her lips with bumpps; swelling under her lips with bumps; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on Tuesday 06Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On Thursday (an unspecified date) the patient experienced a rash on her hand and side of her hand and swelling under her lips with bumps. The patient wanted to know if she should receive the second dose. The outcomes of rash, swelling, and bumps were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353438
Sex: F
Age:
State: NJ

Vax Date: 04/23/2021
Onset Date: 04/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: swelling in the lower part of the arm pits/this side effect of swollen lymph nodes; side effect of swollen lymph nodes/when it gets hot and swollen it really hurts; sometimes it was swollen and hard/it gets hard so fast; it gets hot /the warmth under her arm continues; Fever; Headaches; Chills; can barely move her arm; swelling underarms are painful; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced some considerable swelling in the lower part of the armpits. She had fever, chills, and headaches that had already gone away. The swelling underarms were painful about the size around a baseball, sometimes it was swollen and hard. Pain was always there. The patient asked what recommendations could be made about this side effect of swollen lymph nodes. When it got hot and swollen it really hurt so she might not be able to work tomorrow. The patient was treated with paracetamol (TYLENOL) on Saturday (24Apr2021) around 14:30 because she had a fever and it helped a little. It got swollen so fast and it got so hard and hot that she could barely move her arm and it happened all of a sudden. She also took paracetamol on Sunday (25Apr2021) when the pain was intense and constant. The warmth under her arm continued and the pain was always there and it was intense. The outcomes of hot and pain were not recovered. The outcomes of fever, chills, and headaches were recovered. The outcomes of swollen lymph nodes, hard, and could barely move her arm were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353439
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: a raspy voice/voice changing; congestion; This is a spontaneous report received from a contactable consumer (patient). This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unknown date for COVID-19 immunisation. The patient initially called to obtain information about vaccination for her brother; during the call she reported she had received both doses of BNT162B2 and was having a raspy voice and congestion; further stating she didn't know why her voice was changing. The clinical outcomes of raspy voice/voice changing, and congestion were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353440
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: she was violently throwing up; had severe diarrhea for about 3 days.; This is a spontaneous report from a contactable consumer (patient's parent). A 22-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date ("a few weeks ago on Friday") as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date ("by Sunday afternoon") the patient experienced violently throwing up and severe diarrhea for about 3 days. The patient was not herself for about 6 days before returning to normal. The outcomes of throwing up and diarrhea were recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353441
Sex: M
Age:
State: OK

Vax Date: 03/11/2021
Onset Date: 03/19/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Cognitive skills worse/Could not think clearly; Started a new drug a week earlier (prior to starting the GOCOVRI) to help urination (Flomax) and it seemed like the GOCOVRI was working against that; not feeling 100%; never felt he reached full potential with the drug; Real vivid dreams; Feeling tired and slow; Slower speech; Wasn't sleeping well; wasn't sleeping very soundly; Woke up talking; Drowsiness/falling asleep at the wheel; Slow urination; This is a solicited report based on the information received by Pfizer from a contactable consumer. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first vaccination dose via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Parkinson's disease, confusional state, dyskinesia. In patients with Parkinson's disease receiving levodopa-based therapy. Concomitant medications included mirabegron (MYRBETRIQ), (pramipexole dihydrochloride) MIRAPEX, (acetylsalicylic acid) BABY ASPIRIN and LEVODOPA. Concomitant products included an unspecified levodopa-based therapy. The patient previously took amantadine and experienced confusional state, tadalafil (CIALIS) and experienced inhibitory drug interaction. On or around 11Mar2021 (a week prior to the start of amantadine hydrochloride (GOCOVRI), the patient started Flomax (Batch/Lot number was not reported) to an unspecified date, at 0.4 mg for an unspecified indication. On 18Mar2021, the patient started treatment with GOCOVRI 137 MG at 137 mg, taken orally once day, at bedtime for dyskinesia. On 19Mar2021, the patient experienced slow urination and Drowsiness. It seemed like the GOCOVRI was working against the Flomax and it didn't seem as easy to go. On 25Mar2021, treatment with the product was increased to 274 mg 1x/day at bedtime. On 26Mar2021, the day after starting the 2 pills dose of GOCOVRI (274 mg), the patient felt tired and slow, further described as just a little fatigued and slower speech. Overall, he just did not feel as perky as he thought he should be. In addition, he had issues with sleeping, clarified as he was not sleeping very soundly, was rolling, tossing and turning, had real vivid dreams and woke up talking. On 05Apr2021, the patient's doctor subsequently reduced his dose back to 1 pill (137 mg) a day. As of 09Apr2021, treatment with GOCOVRI was ongoing, while the status of Flomax was not reported. The feeling tired, slow speech, drowsiness, not sleeping well, vivid dreams, waking up talking, slow urination and presumably the interaction between the GOCOVRI and Flomax had improved. On an unspecified date in 2021, after the start of GOCOVRI, the patient's cognitive skills worsened. It was also reported that the patient was drowsy in the morning and had urination trouble first thing in the am (morning) that got better throughout the day. As of 12Apr2021, treatment with GOCOVRI and the worsened cognitive skills were ongoing. The status of the Flomax was not reported. The outcome of all the events were reported as unknown. As of 21Apr2021, it was learned on an unspecified date in Apr2021, the patient discontinued Gocovri due to an unspecified SE (side effect). As of 30Apr2021, it was learned the patient had a history of off times. On an unspecified date(s) in Mar2021, right after he started taking 2 pills (274 mg) of Gocovri, the patient's cognitive skills worsened, clarified as he experienced drowsiness spells and could not think clearly. The patient did a lot of driving and was falling asleep at the wheel. Since the start of taking Gocovri, the patient felt he never got to 100%. He took Gocovri to balance out the carbidopa/levodopa and he had more balance but just never felt he reached full potential with Gocovri. When he was late with his medications he still experienced the off times. On 05Apr2021, the patient decreased his dose to 137 mg and on 15Apr2021, treatment with Gocovri was discontinued. A week ago (relative to 30Apr2021), treatment with Mirapex was also withdrawn. As of 30Apr2021, the status of Flomax was not reported. The cognitive skills, clarified as drowsiness spells and inability to think clearly improved. No additional information was provided or was requested. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. Follow-up (05May2021): New information received by Pfizer from a contactable consumer (patient) included: action taken with GOCOVRI, serious event mental impairment and non serious event therapeutic product effect incomplete added. The reporter' s assessment of the causal relationship of the event atrial fibrillation with the Pfizer suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known mechanism of action of the drugs, the event of somnolence, sleep talking, abnormal dreams is assessed as not related to suspect product BNT162B2 , and more likely due to concomitant Gocovri. However, The reported event of Mental Impairement, Cognitive disorder ,Slow speech, poor-quality sleep and Fatigue is assessed as not related to suspect product BNT162B2 , and more likely due to underlying medical condition of Parkinsonism and the reported event of Inhibitory drug interaction is assessed as unrelated to the suspected product BNT162B2. Therapeutic drug ineffective appears to be due to the co-suspect drug GOCOVRI. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.

Other Meds: MYRBETRIQ; MIRAPEX; BABY ASPIRIN; LEVODOPA

Current Illness:

ID: 1353442
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: arm soreness; This is a spontaneous report from a non-contactable other health professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353443
Sex: M
Age:
State: NY

Vax Date: 04/14/2021
Onset Date: 03/25/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: he has slight hearing loss which is normal with tinnitus/there was slight hearing loss going; after first shot on 24Mar I had severe tinnitus of the right ear. After second shot on 14Apr, it got progressively worse; Experienced a very disturbing ringing in the ears (Tinnitus); This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program . A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EJ1686 and Expiration date was not reported), via an unspecified route of administration on 24Mar2021 (at the age of 55-years-old) at 1st dose, single for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and Expiration date was not reported), via an unspecified route of administration on 14Apr2021 02:45 as 2nd dose, single for COVID-19 immunization. Medical history included gastric reflux. Concomitant medications included pantoprazole (a proton pump inhibitor for the indication of gastric reflux), Dosage: 140mg (as reported), Tablet, Twice a Day. No other vaccines were taken within four weeks. Other medications included Multivitamin-vitamin c, pantoprazole in two weeks. No known allergies were reported. No other medical history was reported. The patient did not have covid prior vaccination and was not tested post vaccination. The patient also reported that the day after first shot on 25Mar2021, he experienced a very disturbing ringing in the ears (Tinnitus), severe tinnitus in the right ear, there was slight hearing loss going. On an unknown date, after the second shot, the patient experienced worsening of the tinnitus. The patient wanted to make sure this was documented since it was life changing and because of this it was very hard for him to sleep, concentrate and was very depressing. The patient wanted to know if this was one of the side effects of Pfizer vaccine. He stated that he got the second shot thinking that tinnitus will go away, but it got worse after the second dose. The patient stated that he believed that it was certainly directly related to the vaccine. The patient stated that he had an audiology appointment Monday on 26Apr2021 with a follow-up ENT appointment Wednesday on 28Apr2021. The patient reported that he went to the ENT where his hearing was tested and told that he had slight hearing loss going but tinnitus was not explained. He was worried if this was some kind of permanent condition. He stated that no one had answers not even the immunologist and there were thoughts that it might be histamines or an irritation. The patient stated that he had not done any blood test. He had regular lab test to check his iron and cholesterol levels low or high. He reported that his blood levels were fine that was probably a couple of weeks before he got the shot. The patient reported that he had to ask his ENT to provide prednisone as treatment. Events caused to visit doctor or other healthcare professional office/clinic visit. The outcome of the event tinnitus was reported as not recovered whereas the outcome of the events slight hearing loss was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. Follow-up (24Apr2021): This is a follow-up report combining information from duplicate reports 2021457050, 2021494963 and 2021469710. The current and all subsequent information will be reported under manufacturer report number 2021469710. Patient demographics, Lot number, medical history, concomitant medications, event details updated. Follow up needed, further information was requested. Follow up (30Apr2021): This is a follow up spontaneous report from a contactable consumer. Patient details updated, events caused condition and Hcp information added.

Other Meds: PANTOPRAZOLE; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1353444
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: (name) states that "they" got their first dose and then "they" got covid that week; (name) states that "they" got their first dose and then "they" got covid that week; This is a spontaneous report from a contactable consumer. This consumer reported similar events for herself and another one patient (Husband). This is 1st of 2 reports. This female consumer reported that: A female patient of an unspecified age received BNT162B2 (BNT162B2 solution for injection), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number: unknown) as 1st, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that they got their first dose and then they got covid that week.She called because they are trying to get a second dose but are a little nervous about how its gonna hit us. She states her parents both had moderna and they have been around them and her parents did not catch covid.The patient inquired that someone said it can wait up to six weeks and asked if that was true.The patient thinks they caught covid from her husband work ("they" presumably is referring to her and her husband) and that it has nothing to do with the vaccine.The outcome of the event was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353445
Sex: F
Age:
State: AL

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

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

Symptoms: Neuropathy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 15Apr2021 10:45 (Batch/Lot Number: EP7534) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, diabetes type 2, and known allergies to any antibiotic with sulfur. The patient was not pregnant. Concomitant medications included lisinopril, metformin hcl and ezetimibe. The patient previously took vancomycin and experienced allergies. The patient received first dose of bnt162b2 for covid-19 immunisation on 25Mar2021, 10:45. On 15Apr2021, at 21:00, the patient experienced neuropathy and had burning pain in legs. The event resulted in doctor or other healthcare professional office/clinic visit. There was no therapy for the event. The patient had no other vaccine in 4 weeks. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.

Other Meds: LISINOPRIL; METFORMIN HCL; EZETIMIBE

Current Illness:

ID: 1353446
Sex: F
Age:
State: FL

Vax Date: 04/13/2021
Onset Date: 04/16/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Developed a cellulitis in injection arm requiring treatment at an Urgent Care Center with subsequent 10 day course of oral antibiotics.; This is a spontaneous report from a contactable nurse (patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 13Apr2021 at 14:45 (at the age of 59-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included Sjogren's syndrome, arthritis and sleep apnoea syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EP7534), administered in left arm on 23Mar2021 at 05:00 pm (at the age of 59-years-old) for COVID-19 immunisation. On 16Apr2021, the patient developed a cellulitis in injection arm requiring treatment at an Urgent Care Center with subsequent 10-day course of oral antibiotics. Adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event. The outcome of the event was recovered on an unspecified date.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event of Cellulitis and suspect drug BNT162B2 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.

Other Meds:

Current Illness:

ID: 1353447
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

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

Symptoms: headaches; weakness; chills; This is a spontaneous report received from a contactable consumer (the patient). A female patient (Age: 60, Units: unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), 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. The patient received the second dose of the vaccine yesterday (unspecified date). She has been having headaches, weakness, and chills. She asked what she should do. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353448
Sex: M
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: ANCA Positive Vasculitis; adverse event of vasculitis; This is a spontaneous report from a contactable consumer reported for a male patient received from a Pfizer sponsor program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. Medical history included vasculitis. The patient concomitant medications were not reported. On an unspecified date, following second dose of vaccination, the patient experienced adverse event of vasculitis and, ANCA positive vasculitis (anti-neutrophil cytoplasmic antibody positive vasculitis). It was reported that the patient had ANCA Positive Vasculitis and ended up getting a recurrence of it after getting the vaccine and they were not sure if it was related or not. The reporter mentioned that she was calling to see if there have been any other examples of this happening. The outcome of the events was unknown. Information about lot/batch number can be obtained. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1353449
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: feeling tired; This is a spontaneous report received from a contactable consumer (the patient's grandfather). A 20-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), 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. The patient received the second dose of the vaccine yesterday (unspecified date), and he was feeling tired. Tomorrow he needed to run 2 miles, and the patient's grandfather wanted to know should he run. The outcome of the event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353450
Sex: M
Age:
State: NY

Vax Date: 04/12/2021
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Chills; Fever; Weakness; I had couple of days when I had cough at night and little bit of this and that; I am worrying about the reaction because I didn't realize that I probably had Covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive; Muscle ache; Tired; I had like laryngitis type like my vocal cords were little bit swelled; Aches; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 12Apr2021 (at the age of 83-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure and mild case of COVID-19 both from an unknown date. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date was not reported. On an unspecified date, the patient experienced chills, fever, weakness, i had couple of days when i had cough at night and little bit of this and that, I am worrying about the reaction because I didn't realize that I probably had covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive, muscle ache, tired, I had like laryngitis type like my vocal cords were little bit swelled and aches. It was reported that the patient had his first Pfizer shot last week and Monday, he had quite a reaction about four to five hours later and had chills, fever and weakness and so forth. He called one of the pharmacists about it and was asked if he had COVID before. The patient said that he was checked in for that but last month or so and was not checked down but he had couple of days when he had cough at night and little bit of this and that and he suspected that he might have something. The patient had COVID before he got the first shot within 5 or 30 days and that is why he got that reaction when that shot hit him. Now, the patient was concerned about the second shot, like if he will have a problem with that too, he was worrying to go to from about 2 or 3 days for that shot which was scheduled for next Monday, believed it is 3rd of May. The patient was really bit apprehensive about getting the shot simply because they usually recommend 90 days, in other words, after someone had COVID, to not get vaccination until at least 90 days afterwards. So, he was not sure what to do. The patient took as recommended for the fever, he took Tylenol and it was helpful as far as the aches, muscle ache and all that. Also, he was still very tired and the fever that he got after the shot was only for one day or he got it that night and lasted maybe till the next day and he was sure that it's going to come down and he will feel better. The weakness that linked, had a cough anyway, was going through this cough a little bit and had muscle ache. He also had like laryngitis type like his vocal cords were little bit swelled but was now getting better and it took like a good week like week and a half and that's why he was concerned about the second shot. The patient thought what he was hoping to do, was to stop a week or two and give it a little bit of time because he may be close to the 90 day window, it appeared the best way to do that but he thought that it was what the experts should be able to tell him. The patient underwent lab tests and procedures which included COVID-19 virus test: No- Negative on 23Feb2021. Therapeutic measures were taken as a result of events fever, muscle ache and aches included TYLENOL. The outcome of the event I had like laryngitis type like his vocal cords were little bit swelled was recovering and the outcome of all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: LISINOPRIL

Current Illness:

ID: 1353451
Sex: F
Age:
State: MD

Vax Date: 03/12/2021
Onset Date: 04/15/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: heavy bleeding clot like; heavy bleeding clot like; extreme low back pain; nausea; sweating; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at 33 years old, not pregnant) as unknown, single for covid-19 immunisation. Medical history included allergies: Penicillin, Have not had menstrual cycle in years (Have not had menstrual cycle in years as taking continuous birth control.) all from an unknown date. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D); ethinylestradiol, levonorgestrel (LESSINA); sertraline hydrochloride (ZOLOFT). No other vaccine in four weeks. On 15Apr2021, patient experienced heavy bleeding clot like, extreme low back pain, nausea, and sweating. Has been occuring for 3 weeks. Went to doc to rule out serious issues. Everything came back negative.The outcome of the events was not recovered. No treatment for the adverse events. No covid prior vaccination.Not covid tested post vaccination. Information about lot/batch number has been requested.

Other Meds: CLARITIN-D; LESSINA; ZOLOFT

Current Illness:

ID: 1353452
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Flu syndrome; Pain; dizziness; fever; This is a spontaneous report from a non-contactable other healthcare professional. This reporter reported similar events for two patients. This is the first of two reports. A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose, for COVID-19 immunisation; atorvastatin calcium (manufacturer unknown), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; gabapentin (manufacturer unknown), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; sertraline hcl (ZOLOFT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication included daratumumab (DARZALEX) taken for an unspecified indication, start and stop date were not reported. It was reported that patient experienced side effects from COVID vaccine and other drugs (atorvastatin, gabapentin, and ZOLOFT) of flu syndrome, pain, fever, dizziness. Patient couldn't even work. The action taken in response to the events for bnt162b2 was not applicable while for atorvastatin calcium, gabapentin and sertraline hcl was unknown. The outcome of events was unknown. Pfizer is a marketing authorization holder of atorvastatin calcium, gabapentin in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of atorvastatin calcium, gabapentin has submitted the same report to the regulatory authorities. No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021494017 Same reporter and product, similar events, different patients

Other Meds: DARZALEX

Current Illness:

ID: 1353453
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

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Lab Data:

Allergies:

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

Symptoms: A little headache; Low grade fever.; This is a spontaneous report from a non-contactable other healthcare professional. This reporter reported similar events for two patients. This is the second of two reports. A 6-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that in the second dose, side effects and symptoms are a little bit intense which included a little headache and low grade fever. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021493997 Same reporter and product, similar events, different patients

Other Meds:

Current Illness:

ID: 1353454
Sex: U
Age:
State:

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2(solution for injection,Batch/Lot number was not reported) first dose via an unspecified route of administration on 28Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 28Apr2021 after the vaccine my arm started hurting from my elbow to my shoulder it started hurting a lot and than this morning I still have the pain in my arm and than my right breast started hurting. I wanted to see if that was normal. The outcome of the events was not recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1353455
Sex: F
Age:
State: RI

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: I had lost control of my bladder not completely but enough/incontinence; After the day and half the covid symptoms came back; This is a spontaneous report from a contactable consumer (the patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) via an unspecified route of administration on 23Feb2021 at age of 77-year-old at single dose for COVID-19 immunisation. Medical history included COVID-19 from 17Dec2020. The patient had no concomitant medications (reported as "no other products"). The patient had COVID, 17Dec2020 her system started and then about 90 days later she had the Pfizer vaccine and then had Pfizer vaccine again and it was been a while since it is been over two weeks what she had COVID. She had lost control of her bladder, not completely but enough so that she had to change her pajamas bottoms quite often. When she had first Pfizer shot about day and half she had the same problem. The patient's doctor often said that incontinence was not symptom of COVID but it might was. it was just after the shot. The patient had COVID symptoms started in 17Dec2020 and lasted for about 2 or 3 weeks. She had experience of COVID. Her experience of COVID was incontinence not all the time but particularly night and when she have first Pfizer shot about 3 months later after the day and half the COVID symptoms came back including the incontinence. No treatment received for the events. No investigation assessment. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353456
Sex: M
Age:
State: TX

Vax Date: 04/02/2021
Onset Date: 04/03/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
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Allergies:

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

Symptoms: Eyes swollen; big water bags underneath them; It is now worse than it was; This is a spontaneous report from a contactable consumer (patient) . A 59-year-old male patient received initial dose of bnt162b2 (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown) dose 1 via unspecified route of administered on 02Apr21 as 1st DOSE SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced eyes swollen; big water bags underneath them eyes swollen; big water bags underneath them was reported as worsened and had been having problems ever since then. The patient did not have any trouble breathing or anything like that and laughs and says he just looks ugly when he looks in the mirror.The patient says that he called about a week ago and was told to go to the Emergency Room. He says he did not do a report at that time. On 03Apr2021, the patient states that his symptoms started on and it was now worse than it was and says he must be allergic to something. The patient was told not to get the second dose of the vaccine due to this reaction. the patient thinks he had Covid virus last year during the summer; he had a cough that would not go away. Caller states he was going to go get medical attention this morning to see if there was anything they could do about the swelling. States he has decided he isn't going to; he was going to tough it out. Also states that he just got done with his mother's funeral service. States she lived a long life. States he just seems to have a lot going on but it was going to all be okay. The patient says his neighbor took the same Covid vaccine and had told the caller to go get it. The patient neighbor didn't have any reaction.The Caller states he was glad he had Benadryl at home. The 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: 1353457
Sex: M
Age:
State: IN

Vax Date: 04/12/2021
Onset Date: 04/17/2021
Rec V Date: 05/27/2021
Hospital:

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Allergies:

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

Symptoms: covid like symptoms and tested positive on 22Apr2021; sick; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient's wife) via medical information team. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 12Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Apr2021, the patient got sick. On22Apr2021, patient had COVID like symptoms and was tested positive for COVID-19. The reporter wanted reassurance that having COVID and getting the vaccine will not affect the vaccine and wants to know if they should wait for a certain period of time before getting the 2nd dose. The outcome of the events was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353458
Sex: F
Age:
State: IL

Vax Date: 04/18/2021
Onset Date: 04/01/2021
Rec V Date: 05/27/2021
Hospital:

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Allergies:

Symptom List: Tremor

Symptoms: pain in her arm in the muscle where the needle was placed; pain in her arm in the muscle where the needle was placed; she almost fainted; had so much tightness in her throat; couldn't swallow; the other arm pain; 8-10 days late for her period; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8731 and expiration date not provided), via an unspecified route of administration, in arm left, on 18Apr2021 09:30 (at the age of 50-year-old), at single dose, for COVID-19 immunization. Medical history reported as no. Concomitant medications were not reported. No prior vaccinations within 4 weeks. Patient was scheduled for the second dose on 09May2021 but she had doubts because of her reaction to the first dose. The patient experienced 8-10 days late for her period in Apr2021; pain in her arm in the muscle where the needle was placed on 18Apr2021; almost fainted on 18Apr2021; had so much tightness in her throat on 18Apr2021;couldn't swallow on 18Apr2021; and the other arm pain on 18Apr2021. Patient stated this was not an allergic reaction and the vaccination provider was about to administer the epi-pen but then she did not. Patient would like to know if her side effects are normal and if she should receive the second dose. Patient got the first shot on 18Apr2021 and she was scared of needles so she just didn't look at them but this one... Patient stated as soon as she got the shot, she had pain in her arm in the muscle where the needle was placed. Patient stated it's not a big deal. Patient stated the pharmacy said it's ok to feel pain and told caller to go sit down and they would be with her in half an hour or so. Patient stated she didn't even make it through the door, she almost fainted and could not hear what she was saying, she had so much tightness in her throat and she couldn't swallow. Patient stated it lasted about 2 to 3 minutes (also reported "lasted for 3-4 minutes"). Patient stated they called an ambulance but it took them 15 minutes to get there and she felt better by then. Patient stated because they told her to wait and she couldn't even get through the door so she just laid on the floor and her throat got so tight, she was frightened. Patient stated it lasted about 5 minutes, actually. Patient confirmed her symptoms began and ended on 18Apr2021. As for "hurting in her muscle; arm pain", patient stated she had the arm pain for two days but then her whole arm started hurting in that arm, but that was a different pain. Patient stated she got the shot at 09:30 in the morning and by 16:00 afternoon she started feeling the pain. Patient stated the pain from the needle when she got the shot, that pain lasted 5 to 6 hours or maybe she would say less. Patient stated after 16:00, then the other arm pain started. Patient stated she was putting ice on and off it for arm soreness overnight and into the next day. Patient confirmed her arm pain ended 19Apr2021. Patient confirmed she had recovered completely from all symptoms. Patient stated she didn't have any pains or anything so she would think she has recovered. Patient stated she went to her physician and the doctor suggested that she should take the second shot. Patient stated she also was 8-10 days late for her period. Patient stated something happened and she said she couldn't do it because she was going to get her period and then it didn't come and days passed by. Patient stated she was supposed to get it 21Apr2021 or 22Apr2021, supposed to get it between 21Apr2021 and 25Apr2021 and she got it yesterday, 04May2021. Patient stated as soon as it passed 26Apr2021, but she was also 51 and menopausal so it might be that, but she doubts it. No emergency room or physician office require for events. Treatment received for event "the other arm pain" included putting ice on and off. The outcome of the event "8-10 days late for her period" was recovered on 04May2021; of "pain in her arm in the muscle where the needle was placed/ almost fainted/ had so much tightness in her throat/ couldn't swallow" was recovered on 18Apr2021, of "arm pain" was recovered on 19Apr2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1353459
Sex: F
Age:
State: MO

Vax Date: 05/03/2021
Onset Date: 05/05/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Where the caller had her shot there's a little bit of a bump; hurts to the touch; redness at the injection site/red; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 20-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 and expiry date: unknown), via an unspecified route of administration in arm left on 03May2021 13:15 as second dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737 and expiry date: unknown), via an unspecified route of administration on 12Apr2021, as single dose for COVID-19 immunisation and flu shot. On Monday, 03May2021 (Time the Vaccination Was Given: 1:15 pm), the caller received her second dose of the vaccine. The caller wanted to report that she had a little bit of a reaction. Where the caller had her shot there's a little bit of a bump that is swollen, red, and hurts to the touch. The patient was asking is this common. The patient was asking about any other people that got this reaction. The caller has been taking Ibuprofen and icing her arm and it helps but it is not going away. (Ibuprofen: expiration date Nov2021, unknown NDC, unknown lot number). The patient experienced where the caller had her shot there's a little bit of a bump, swollen red on 05May2021. Vaccination facility type was college. The adverse event did not require a visit to emergency room and physician's office. No prior vaccinations within 4 weeks. The outcome of the events was recovering. Follow up- # 1 (06May2021): This is follow-up a spontaneous report from contactable consumer. This consumer (patient) reported that: event details updated. Follow up #2 (06May2021): This is follow-up a spontaneous report from contactable consumer. No new information updated. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353460
Sex: F
Age:
State: CA

Vax Date: 04/10/2021
Onset Date: 04/13/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, ER8729) via an unspecified route of administration, administered in Arm Right on 10Apr2021 09:30 at age of 44-year-old at single dose for COVID-19 immunisation. Medical history included ongoing endometriosis, allergy: penicillin and heavy periods pertains to her endometriosis. The patient had no concomitant medications (reported as "no other products"). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6203) via an unspecified route of administration in right arm on 14Mar2021 at 09:30, at age of 44-year-old for COVID-19 immunization, with the first dose everything was fine, she had a little fatigue, but all fine. The patient had some symptoms that were normal and subsided. Caller had a delay in her menstrual cycle after her second dose on 30Apr2021 and was still delayed. She took pregnancy tests to rule out pregnancy. She was not irregular, that's why she did the test. She had heavy periods, cycles every 25-28 days and heaviness pertains to her endometriosis. It abnormal for her and she was thinking on behalf of her 14 year old daughter. Caller asked if the vaccine affecting girls that are menstruating and would it affect their fertility or delay or affect them in the long term. Caller would normally go through her normal OBG/GYN, but was referred to call Pfizer. Caller asked if other women called with similar experience, she was trying to get alleviated that it was normal. She obviously didn't care, she had her 4 kids. She didn't want her daughter to be dealing with this down the line. Caller was 4 days late, but was still in the window to get it on time. Caller felt this is important to report. Caller may be a week or so late. She took an iron supplement. Caller had nothing after the 1st dose. On 13Apr2021, she had fatigue, low grade fever, nausea for 2-3 weeks after the second dose with lower back pain. The nausea was a concern to caller because it didn't lift after a few days. She had read about it through the CDC, but had no symptoms until 2 days after. Caller's low back pain was centralized, middle of back, like tailbone, and has not resurfaced. Her temperature was like 100 degrees and lasted 24-48 hours, not as long as back pain and nausea. Caller had fatigue with her endometriosis and issues. She is still doing her normal routine, she was pretty fatigued that 2 weeks, and not like herself. Caller wanted to make sure and she got a pregnancy test, because the nausea hadn't lifted and the last time she felt that kind of sickness was with her pregnancy. The nausea stopped, but her period hasn't come. It was all the second dose. After the first dose, for 24-48 hours, she took it easy and monitored herself. She was lightheaded more with the whole 2 weeks and dizzy at times. She was not eating as well, her appetite was suppressed and she feels is was all related. It was on and off, but caller didn't document the exact dates, but she recovered from all the symptoms for the most part. Caller didn't expect a lengthy call, she was seeing if she experienced normal side effects and wanting to know about her daughter. The events did not require a visit to emergency room. Nausea and back pain fatigue and lightheaded require a visit to physician office. The outcome of events "nausea", "lower back pain" was recovered on 27Apr2021, the outcome of event "low grade fever" was recovered on 15Apr2021, the outcome of event "delayed menstrual cycle" was not recovered, the outcome of event "severe fatigue" was recovered in Apr 2021, the outcome of other events was recovered on an unspecified date.

Other Meds:

Current Illness: Endometriosis

ID: 1353461
Sex: F
Age:
State:

Vax Date: 04/21/2021
Onset Date: 04/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: I had burning from my stomach up to my throat.; I had headache that came from back to neck and ears.; My ears don't feel right.; I feel tired and weak.; My head feels heavy.; I felt very bad; Pain; my hand is so heavy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 75-year-old female patient received BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: EJ6788, Expiration Date: Unknown), Solution for injection, via an unspecified route of administration on 21Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. In Apr2021 the patient experienced burning sensation from stomach up to my throat and also experienced headache that came from back to neck and ears. Her ears don't feel right and she feel tired and weak. Her head feels heavy and she had pains. Doctor told her to take Pepcid 3 days before and after her 2nd dose. The Patient took Tylenol PM as the treatment for pain so that she can go to sleep. She also stated that she take Synthroid '88 mg' every morning in empty stomach (dose not clarified, hence not captured in tab). The Information included that the patient head is not painful like before but it is so heavy and that comes from her ribs up then neck up and comes all the way in her head. The Patient raised that should she take the second shot. she will feel much better or she will not feel fine because that is not normal how she feel like in her head and her neck and her ribs, she never had this feeling before. Patient hand was so heavy. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds: SYNTHROID

Current Illness:

ID: 1353462
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: loss of taste and smell; loss of taste and smell; fever; congestion (including runny nose); congestion (including runny nose); This is a spontaneous report from a contactable consumer (patient's wife) via medical information team. A 26-year-old male patient received 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 single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced loss of taste and smell; fever; and congestion (including runny nose). The reporter stated that she was calling on behalf of her husband who had the Pfizer Covid vaccine on Monday and reported loss of taste and smell, fever, and congestion (including runny nose); her husband (the patient) was asking as if this was normal. The outcome of all events was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : 2021523850 Original Case : 2021513846 (Different patient with same reporter and drug)

Other Meds:

Current Illness:

ID: 1353463
Sex: F
Age:
State: WI

Vax Date: 05/04/2021
Onset Date: 05/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

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

Symptoms: It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown. Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot. No follow-up attempts are needed. No further information is expected.

Other Meds: DICLOFENAC

Current Illness:

ID: 1353464
Sex: F
Age:
State:

Vax Date: 05/05/2021
Onset Date: 05/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: I had my menstrual cycle. My last day of my menstrual cycle was 27Apr2021 which was just last week and now I am having my cycle again today; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05May2021 (Batch/Lot Number: EW0162) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was reported as EK873 or CK873) in the left arm on 13Apr2021 COVID-19 Immunization. The patient reported that she had her menstrual cycle in May2021. Patient's last day of menstrual cycle was on 27Apr2021 which was just last week and now she is having her cycle again today. Patient did not received treatment for the event. Outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353465
Sex: F
Age:
State: TX

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: eyes seemed to move quickly back and forth; felt weak and had no energy; heart began to beat fast like it was going to beat out of chest; shake all over her body; vision came back blurry; blood pressure and heart beat were high; vision went in and out while driving down the freeway; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received bnt162b2 (Pfizer product), dose 2 via an unspecified route of administration, administered in arm left on 06May2021 11:45 (Lot Number: Ew0175) as single dose for covid-19 immunisation. Medical history and concomitant medications were none. No any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of bnt162b2 (lot number: Ew0161) in left arm on 15Apr2021 at 11:30 for covid-19 immunisation. The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stayed for 20 minutes after getting the second vaccine and was fine so she headed to work. A total of 40 minutes after vaccine (06May2021 12:25), her vision went in and out while driving down the freeway. At 12: 45, she started to shake all over her body and heart began to beat fast like it was going to beat out of chest. Her vision came back blurry and was able to pull over on the side of the freeway and call 911. They took her blood pressure and heart beat, both were high. After 30 minutes her heart beat and blood pressure returned to normal. For the remainder of that day the episodes happened 3 times, but only lasted 2-3 minutes at a time. Two days after (08May2021), her vision was blurry and eyes seemed to move quickly back and forth and she felt weak and had no energy. The adverse events result in Emergency room/department or urgent care. Unknown if treatment received. The outcome of events was recovered with lasting effects.

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Current Illness:

ID: 1353466
Sex: F
Age:
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Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 05/27/2021
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Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Cough; Throat itchiness; Tongue tingling; Anxiety; This is a spontaneous report from a non-contactable other HCP reporting for a patient. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 07May2021 (Batch/Lot Number: EW0167) as a single dose (at the age of 39-years-old) for COVID-19 immunisation. The patient medical history included recent visit to the ED on 02May2021 for tongue swelling, the patient took Benadryl prior to her arrival to the ED at that time, symptoms had resolved for her then. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 on an unknown date (Lot number: ER8731) for COVID-19 immunisation. On 07May2021 the patient experienced cough, throat itchiness, tongue tingling and anxiety. The clinical course is as follows: The patient received the second dose of bnt162b2 on 07May2021. During her 30 minute waiting period after the injection, the patient began to experience cough, throat itchiness, tongue tingling. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Follow up response to treatment: good. The patient was transported to ED by POV. The Differential Diagnosis was reported as: Differential Diagnosis: Systemic reaction (headache, itching, tachycardia, hypoglycemia, hypotension, generalized rash). The patient had stable and improving symptoms. The reporter stated: Certainly anxiety may be a factor playing into this but recommended that she seek emergency care for observation and follow up with her primary care along with allergist to look into her two reactions that she has had this week. Therapeutic measures were taken as a result of the event and included unspecified treatments. The clinical outcome of the events cough, throat itchiness, tongue tingling and anxiety were unknown. No follow-up attempts are possible. No further information is expected.

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Current Illness:

ID: 1353467
Sex: F
Age:
State: WV

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 05/27/2021
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Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.

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Current Illness:

ID: 1353468
Sex: F
Age:
State: PA

Vax Date: 02/19/2021
Onset Date: 04/01/2021
Rec V Date: 05/27/2021
Hospital: Y

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 at the age of 29-years-old (Lot Number: EL9266) as single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included vaginal delivery on 16May2020; known allergies to Bactrim, sulfa; historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 27Jan2021 at the age of 29-years-old, Lot number EL8982. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS); lecithin (reported as sunflower lecithin). Back pain, urinary urgency and frequency began 25Apr2021. Went to urgent care and was prescribed antibiotic. 28Apr2021, extreme back pain with nausea and vomiting occurred, so presented to the emergency department and was admitted. Abdominal CT scan was performed in Apr2021, revealing kidney stones, one stuck in the left ureter 2 mm in size, an additional 2 mm stone in the left kidney with other smaller stones; left kidney was swollen and right kidney was unremarkable. Multiple pain medications, Flomax, and Zofran administered throughout the hospital admission. Left ureteral stent placed on 30Apr2021 and discharged from the hospital that evening. Stent removed 10May2021 in urology clinic. Additional kidney stones still in fact. Pending follow up ultrasound and 24 hour urine profile due in 5-6 weeks. AE treatment included medications and left ureteral stent. The outcome of events was recovering.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; LECITHIN

Current Illness:

ID: 1353469
Sex: F
Age:
State: IL

Vax Date: 03/26/2021
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Rec V Date: 05/27/2021
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Symptom List: Vomiting

Symptoms: have some spotting blood in urine at night; This is a spontaneous report from a contactable consumer(patient). The consumer reported similar events for herself with two doses. This is the first of two reports. The 53-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 10:15 (Lot Number: Er8732) as 1st dose, single for covid-19 immunization. Medical history included paroxysmal nocturnal haemoglobinuria(PNH anemia) from 2006 to an unknown date , Latex allergy, bactrim allergy. Concomitant medications included iron (FE 10), cyanocobalamin (B12-VITAMIIN) and one a day women vitamins. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced minor side effects after first dose but did have some spotting blood in urine at night. (She was a PNH anemia patient). There was physician office visit for event. Outcome of event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547423 same patient/drug, similar AE, different dose of vaccine

Other Meds: FE 10; B12-VITAMIIN

Current Illness:

ID: 1353470
Sex: F
Age:
State: IN

Vax Date: 05/10/2021
Onset Date: 05/11/2021
Rec V Date: 05/27/2021
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Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Elevates heart rate 120-130 BPM at rest; This is a spontaneous report from contactable other HCP (patient). A 30-years-old female patient (No Pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 30-years-old, intramuscular, administered in Arm Left on 10May2021 15:30 as single dose for covid-19 immunisation. No medical history and known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. No other medications the patient received within 2 weeks of vaccination. Patient received first dose of bnt162b2 at the age of 29-years-old, intramuscular, administered in Arm Left on 14Apr2021 09:45 AM for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced elevates heart rate 120-130 bpm at rest on 11May2021 09:00 AM with outcome of recovering. The adverse event result in Doctor or other healthcare professional office/clinic visit. No treatment received. Reporter Serious was No. Since the vaccination, the patient has not been tested for COVID-19. Information about lot/batch number cannot be obtained. No further information expected.

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Current Illness:

ID: 1353471
Sex: F
Age:
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Onset Date: 05/01/2021
Rec V Date: 05/27/2021
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Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: I found out 07May2021 that I am positive for COVID; I found out 07May2021 that I am positive for COVID; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I lost my taste and smell for 2 days which is how I found out; I lost my taste and smell for 2 days which is how I found out; This is a spontaneous report from a contactable other HCP (nurse) for herself. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Jan2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as sing dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She found out 07May2021 that she was positive for COVID. She was having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. She was currently day 4. she lost her taste and smell for 2 days in May2021 which is how she found out. Outcome for event lost my taste and smell was recovered in May2021, for the rest was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded.

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Current Illness:

ID: 1353473
Sex: F
Age:
State: CA

Vax Date: 04/30/2021
Onset Date: 05/02/2021
Rec V Date: 05/27/2021
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Symptom List: Injection site swelling, Limb discomfort

Symptoms: Left side of my lips paralysis, affecting my ability to use American Sign Language accurately and to smile; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:00 (Lot Number: ER8729) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history reported as none. The patient's concomitant medications were not reported. The patient previously took morphine for drug hypersensitivity. The patient experienced Left side of lips paralysis on 02May2021 06:00, affecting ability to use American Sign Language accurately and to smile. The patient was told by Dr. to go into the ER to rule out, Bell Palsy or a Stroke. The patient had an MRI done with and without contrast in 2021. All looked good. This leaves the COVID vaccine as the cause of my problem. The patient received treatment for the event. The outcome of event was not recovered. No other vaccine in four weeks; Prior to vaccination, the patient was diagnosed with COVID-19.

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Current Illness:

ID: 1353474
Sex: F
Age:
State: MD

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 05/27/2021
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Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Caller states she received the first dose on 10 APR 2021 and her arm is still severely sore; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 10Apr2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously had historical vaccine of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration as a single dose for covid-19 immunization. Caller states she received the second dose on 10Apr2021 and her arm was still severely sore. Left arm still severely painful, cannot raise arm. Caller states she went to the doctor on wednesday and she needs to have an X-ray done because your product has done something to my arm. Treatment was pain pills, which was not working. As of 11May2021 she was still experiencing pain in her arm. She does not think this is normal. She saw her primary care last Wednesday. She was in so much pain she had to seek out help and was placed on pain medication. That is how severe the pain is. She cannot raise her arm above her head. She reached out to Pfizer since it's their medication to seek assistance and to try and find out what is going on with her arm. She wants to know why she is still in pain and it's a month and a day later. Caller upset when informed even though this agent is a registered nurse would have to transfer to Medical Information. She stated the number she called previously asked if she was calling about COVID and if any questions to select #1 and that is what she selected. Caller questioned whose fault is that hers or ours. Caller confirmed she has reported this event to numerous people here at Pfizer and stated it's unfortunate we do not keep good records. She confirmed she reported these events yesterday. No reference number provided from previous report. Outcome of the event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1353475
Sex: F
Age:
State: IL

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 05/27/2021
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Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: she was dying with the pain, it was severe cramping; severe stomach cramping; She's feeling a lot pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:20 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient had her 1st dose on 01Feb2021 at the age of 61 years old. Medical history included scoliosis, osteoporosis, major spine surgery from an unknown date. Concomitant medications included teriparatide (FORTEO) taken for osteoporosis from Jul2020 and ongoing. The patient received the 2nd dose of the Pfizer covid vaccine in the morning. By that evening, after eating, she had severe stomach cramping that has gone on for 2 months now. She has had everything looked at to see where the pain is coming from and is also now on antispasmatic drug. Feels like menstrual cramps. She is trying to eliminate all possible causes and is now down to the covid vaccine or a medication for her osteoarthritis. Additional Information for Concomitant Products forteo: It is daily injection. For her it is for bone growth because she had a major spine surgery. Had it 2.5 months before surgery it was a requirement from surgeon. She puts the pin needle on and inject. She has been having pain for the last 2 months. Every single stomach test and no one can find out the cause. They put her on Levsin, the generic for Levsin. It stops cramping. It is not all the way but it what GI doctors have given her. No further information provided. She asks if they have heard of severe stomach cramping from the vaccine. She's feeling a lot pain. She has dealt with so many doctors. She went through all the testing. Its either one of the injections she is taking or the vaccine. So we are ruling everything out to try to figure it out. She is recovering from a nine level spinal fusion, attempted to clarify what caller said. Caller stated she had a spinal fusion in October from scoliosis. She is having pain after meals. She has been having severe cramping. She was dying with the pain, it was severe cramping. She is on the medication Levsin. It doesn't work. The generic name is Hyoscyamine 0.125 mg sublingual. She clarifies when she said pain she meant the pain from the severe stomach cramping. She hasn't stopped the Forteo waiting for stomach cat scan results clarified as CT pelvis with contrast last test to see if something shows, to have an explanation to see if there is something like gastritis that is causing stomach cramping or vaccine. Only two things, it is either the vaccine or the Forteo injections she gets. Outcome of events was not recovered. Information on lot/batch number has been requested.

Other Meds: FORTEO

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am