VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1154088
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Negative antibody test after receiving both doses of Covid-19 vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the second of three reports. A 69-year-old elderly female received the first and second doses of BNT162b2 (solution for injection; Lot reported as unknown) as single doses via unspecified route on unspecified dates in 2021 for COVID-19 immunization. There was no medical history, concomitant medications or past drug history reported. The reporter was inquiring about the efficacy of the COVID-19 vaccine. The reporter stated that on an unspecified date in Feb2021, the patient had a negative antibody test after receiving both doses of the Covid-19 vaccine. The outcome of event negative antibody test after receiving both doses of Covid-19 vaccine was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296623 same reporter/drug/AE, different patient.;US-PFIZER INC-2021293985 same reporter/drug/AE, different patient.

Other Meds:

Current Illness:

ID: 1154089
Sex: M
Age:
State: FL

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: skin was burning itchy and red; skin was burning itchy and red; sunburn; trouble breathing; tongue swelling and discoloring; tongue swelling and discoloring/ he saw that his tongue was dark chocolate like he had just eaten a black licorice; felt like breaking out in hives/chest was beat red was referring to hives; chest started to get broken out and got beat red; allergic reaction; got beat red; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the first dose of BNT162B2 (BNT162B2, lot number: EP6955), via an unspecified route of administration in the left arm, on 15Mar2021 3:00 PM (received at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included Attention deficit disorder, cholesterol, benign heart palpitations. He also had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED (emergency department). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unspecified date and ongoing for Attention deficit disorder; metoprolol from an unspecified date and ongoing for benign heart palpitations; simvastatin from an unspecified date and ongoing for cholesterol; vitamins and minerals; ubiquinol from an unspecified date and ongoing; fish oil from an unspecified date and ongoing. The patient previously had a flu shot in Aug2020. The patient previously took epinephrine and experienced insect bite were worse, and metoprolol and experienced reaction linger. The stated he thought he had an allergic reaction to the Pfizer covid19 vaccine on 15Mar2021. He states that his tongue was swollen (15 min after receiving the vaccine, at 03:15 PM), he broke out into hives. He was in the restroom of the facility where he received the vaccine and that he did not have hives yet after getting the vaccine, but then asked the nurse if he could take Benadryl and was told yes. He states they then let him go because he had no trouble breathing at that time. He drove home and was going to reroute to hospitals if needed. He took 50 mg fast melt Benadryl as soon as walked out of the facility. He drank water, drank two larger bottles of water. His chest started to get broken out and got beat red. He took another 25 mg of Benadryl and then drove home. He then proceeded with Benadryl 50 mg every 6 hours. At 1 AM, the next morning (16Mar2021), he woke up with trouble breathing and tongue swelling and went to ER. They gave him Prednisone 60 mg and then started on 5 days of prednisone. They told him to continue Benadryl, and water and to follow up at hospital if worsens and to follow up with his physician. He stated that he had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED. He added that this experience with the Covid19 vaccine was milder comparatively as they gave him just steroids and not epinephrine this time, and, they told him he was not having trouble breathing this time. Last night, 16Mar2021, at around 10:30 pm, a half hour before next dose of 6 hour Benadryl was due, his skin was burning itchy and red so he took Benadryl a half hour early and set alarm to wake up before next dose. He woke up 4 hours later and waited to see if he would have a reaction and he has not taken it since. He took the morning dose of Prednisone with improvement and is carrying Benadryl in his pocket just in case. He later clarified that he took his 11 o'clock dose last night and then set a 2:30 am alarm to see if it was worse again or about the same. Regarding the allergic reaction, he first noticed around 3 pm Monday 15Mar2021. Within 15 minutes after the vaccine, he was going through his phone and thought he felt strange while waiting at (Name) after the vaccine to see if he had a reaction. This feeling continued until 11 pm last night, 16Mar2021. He took 50 mg of Benadryl when this first happened on 15Mar2021 and then took another 25 mg 15 minutes after the first initial dose. At the time of call, he notices no redness or itchiness or swelling of the tongue. He feels like he is going in the right direction. He noticed tongue swollen within 15 minutes of receiving the vaccine and that it was also discolored (15Mar2021 15:15) and asked a friend who has allergic reactions if this happens and the friend told him that it sometimes happens to other people with allergic reactions. He went to the ER on Tuesday 16Mar2021 at 3 am, exactly 12 hours after he received his shot, because of the swelling of the tongue. This was his first-time experiencing difficulty breathing and gasping for air as well. States that he does not have it now. Prednisone and Benadryl have knocked it out. He was not admitted and was released from the ER about an hour and a half after he got there (discharged at 4:30 am from the ER). He did notice at 3:30 pm that his chest was beat red. He was hanging out and his body would tell him when it was close to 6 hours that he needed to take Benadryl because he would be breaking out in hives. He has to take Benedryl within 6 hours. This is ongoing but he has not had any today. He clarifies that the chest was beat red was referring to hives. He felt yesterday 16Mar2021 that he had a sunburn and that his face was kind of red but he had not been in the sun. He clarified on timeline that he went to check for swelling and hives in bathroom after receiving the vaccine on 15Mar2021. At that time, he saw that his tongue was dark chocolate like he had just eaten a black licorice. There was no redness or anything but he felt like it was going to be occurring so he asked the facility if he could take Benadryl. He is scheduled for his second dose of the vaccine on 05Apr2021 and may be possibly returning but is not sure. He also noticed on Tuesday 16Mar2021 that while sleeping on the couch at 3 am he was going to take the next dose of Benadryl and woke up gasping for air. He got up to drink more water and took a shower and made coffee. Then, he went to the ER. He was really tired. He wanted to be alert to drive. It seemed like the water helped and he drank a lot of water. He did not want to take the next dose of Benadryl. He noticed that it did get better, and he did not want to stay home so he went to the ER. Outcome of the event allergic reaction was recovered with sequel on 16Mar2021. Outcome of swollen tongue, skin was burning itchy and red, got beat red and hives was recovering. Outcome of other events was unknown.

Other Meds: ADDERALL; METOPROLOL; SIMVASTATIN; UBIQUINOL; FISH OIL

Current Illness:

ID: 1154090
Sex: F
Age:
State: MD

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bell's palsy; Sore Arm; This is a spontaneous report from contactable consumers (one is the patient). A 66-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose, via an unspecified route of administration, administered in Arm Right on 03Mar2021 11:40 am (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. The patient was vaccinated at a hospital. Medical history included Type 2 diabetes mellitus: Diagnosed one year ago; Gastrooesophageal reflux disease (GERD) Diagnosed 2 years ago; Hashimoto's disease Diagnosed 5 or more years ago; High cholesterol and blood pressure abnormal (reported as Blood pressure); all from an unknown date and unknown if ongoing. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks, also no Family Medical History Relevant to the adverse events. Concomitant medications included metformin 500 mg once a day by mouth taken for diabetes (reputed Has been taking that about a year); pravastatin sodium (PRAVACOL) 40 mg once a day by mouth taken for High cholesterol; levothyroxine sodium (SYNTHROID) 50 mcg once daily by mouth taken for an unspecified indication; omeprazole 20 mg once a day by mouth taken for an unspecified indication; and losartan 50 mg once a day by mouth taken for blood pressure; all start and stop date were not reported. It was reported that the patient is calling about the COVID Pfizer vaccine shot. The patient took the first dose of the shot on Wednesday 03Mar2021. The patient now has been diagnosed with Bell's Palsy and she believes that it is from the shot. The patient's speech is impaired because of the bells palsy. The only thing the patient had was a sore right arm on 04Mar2021. Then on 10Mar2021 the left side of her neck started to really hurt and behind her ear, it was severe pain, frequently she would get a jolt of pain on top of the existing pain. The patient had this pain 10Mar2021, 11Mar2021, 12Mar2021, and by Saturday 13Mar2021 her face started to distort, now she couldn't close her eye, her lips were numb, and her speech was interfered. Monday (15Mar2021) morning the patient was seen by her primary care provider and her doctor told her it was Bell's Palsy. Blood was drawn at that time, but the patient doesn't have the results yet. The patient was given prednisone and an anti-viral which after she took them it helped with the pain significantly. The patient's face still has the paralysis on the left side of her face. No other parts of her body were affected other than a sore arm at the site on the right side, which was not a big deal. It was reported that the patient is taking COVID vaccine as she heard she should get it and her husband had the shots and was fine. The patient mentions that her husband had one bad day after the vaccines but he was fine, so she decided to get it. The patient wanted to know, she is going to follow up with her primary care provider on 22Mar2021 but she was scheduled for her second Pfizer shot on 24Mar2021, should she get the second dose. The patient read that 40,0000 people were given the vaccine and 4 people had bell's palsy and because of that they discounted it as a side effect, and the placebo group did not develop this. It was noted that the patient did not required emergency room visit but to the Physician's office (Primary Care Provider). The patient does not have the results of her blood work back yet. The outcome of the event a sore right arm was recovered on 06Mar2021; for the other event was not recovered. The relatedness of drug to reaction(s)/event(s) for the event Bell's palsy was reported to be related.

Other Meds: METFORMIN; PRAVACOL; SYNTHROID; OMEPRAZOLE; LOSARTAN

Current Illness:

ID: 1154091
Sex: F
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: could not sleep last night; shooting pains above ear into head; rheumatoid arthritis, it was the worst she's ever had her arthritis in 78 years/Her right arm, she couldn't lift her arm, her wrists, her arms, her foot. She knows this was her rheumatoid arthritis; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization; she had mild symptoms and was fine by the third day. The patient's concomitant medications included unspecified autoimmune pill. On Wednesday the day after second shot (10Mar2021), the patient was okay but from Thursday (11Mar2021) until Saturday (13Mar2021) she had shooting pains above her ear into her head. Every day the pains got milder. She's never had a migraine. She went to the dentist yesterday (15Mar2021). She was using process of elimination to figure out what was wrong. If it was her bridge or anything in her mouth. The dentist took x-rays and everything was normal. She was wondering what those shooting pains in her head could have been. She also stated that her rheumatoid arthritis, it was the worst she's ever had her arthritis in 78 years. She could not sleep last night. Her right arm, she couldn't lift her arm, her wrists, her arms, her foot. She knows this was her rheumatoid arthritis. When she goes to the bathroom, she can't even do that, her arm hurts so bad. She was on an autoimmune pill and she can't take her autoimmune medicine with the Covid shot. She started taking her medicine today. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154092
Sex: F
Age:
State: OH

Vax Date: 03/12/2021
Onset Date: 03/18/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot; Left side of mouth muscle not holding water while brushing teeth; Cannot close left eye/eye wasn't moving; Left eye burning during shower; sick; cannot move that part of your mouth; Sore Arm over Weekend; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Mar2021 08:15 (Lot Number: EN6204) at single dose for covid-19 immunization. Medical history was none. Concomitant medication included diphenhydramine hydrochloride (BENADRYL Tablet). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200) on 19Feb2021 and experienced felt really tired, and received flu shot. The patient experienced bell's palsy on 18Mar2021, sore arm over weekend on an unspecified date in 2021, Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot on 18Mar2021, left side of mouth muscle not holding water while brushing teeth on 18Mar2021, cannot close left eye/eye wasn't moving on 18Mar2021, left eye burning during shower on 18Mar2021, sick in 2021, cannot move that part of your mouth in 2021, hard of hearing on an unspecified date. She felt great over the weekend other than a sore arm. Morning on 18Mar2021 when she woke up her left eye felt weird. When brushing her teeth she noticed the left side of her mouth muscle was not holding water to spit out. Looked in the mirror and noticed when she smiled her left eye wasn't moving. Went to the emergency room and the doctor told her she has Bell's Palsy. Explained that was why she cannot close her left eye. Was given two medications to take; one a steroid and one a antiviral. Left eye has been feeling weird, like when you look away from your cell phone and one eye hasn't dilated or adjusted to the darkness yet. Stated she took a sick day from work today. Mentioned again her left eye burning in the shower and that she has to sleep with an eye patch. She was hard of hearing. Stated she had hearing aids and can currently hear call handler fine. Had a CAT scan and everything at the emergency room this morning. Her grandmother and aunt died from a stroke and she was concerned that she had one. She cannot close her left eye completely. Stated was a weird feeling like when went to the dentist and get the Novocain shot and cannot move that part of your mouth. The doctor told her he thought it will last for 2 weeks. Stated that it could've started overnight but she was uncertain as she was sleeping and didn't notice it until this morning. Mentioned her husband was at the hospital all day yesterday for procedures. After receiving her second dose of the vaccine she thought she didn't feel to bad at all, not tired like with the first one; until she woke up with this today. Stated no for medications but mentions that on 11Mar2021 she had bad allergies and was like a water faucet. She took Children's Benadryl 12.5mg 2 tablets and some eye drops. Stated that it helped. Thought she was allergic to something in the building. Stated was given Prednisone, as she was reading the label she notices she was supposed to take two a day and had only taken 1 this morning. Prednisone is prescribed as 20mg 2 tablets by mouth every day for 7 days. Spelt out name of antiviral medication as IC Valacyclov. Prescribed as 500mg 2 tablets by mouth three times a day. Also has eye drops to keep eye moist. Has eye patch for bedtime. Was instructed to manually close left eye and cover with eye patch at night. Mentioned that she had a flu shot in October no issues voiced. Nephew with Covid, Niece that had Covid. Stated she was not around them. There was no physician office visit reported. The patient underwent lab tests and procedures which included blood sugar: normal, blood pressure: normal, CAT scan: normal on 18Mar2021. There was treatment and emergency room visit except event hard of hearing. The outcome of the events was unknown.

Other Meds: BENADRYL

Current Illness:

ID: 1154093
Sex: F
Age:
State: NM

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the side that she got the vaccine was cold; Second dose: pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2, dose 2, via intramuscular, administered in right arm on 16Mar2021 10:00 AM (Lot Number: EN6204; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included eczema from 2017, she had eczema all over her back and arms and had mild allergies to mold and juniper. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 at the age of 74-year-old on 23Feb2021 at 10:00AM (lot number: EN6198, Expiry: Jun2021) intramuscular injection in left arm and experienced pain at injection site and couldn't sleep. The patient also took Prolia shots for arthritis. The patient experienced headache, nausea, pain at injection site and hand on the side that she got the vaccine was cold on 16Mar2021, passed out, weakness and disorientation when walking on 17Mar2021, a little tired on 18Mar2021. The clinical course included: The patient was calling about the second vaccine that she got on 16Mar2021 (Tuesday). She was calling about the after effects. They were quite huge. She had a headache, nausea, weakness, and disorientation when walking. Stated she obviously had pain at the site of injection. Stated some of it was her own fault, and at first she felt fine. On the same day that she got her second dose of the covid vaccine, she had a glass of wine and was not too hungry. She ate a little that evening. The next morning she passed out. Clarified that she had two glasses of wine, not one. Caller's daughter was a doctor. Caller referd to her daughter as doctor daughter. Stated that she told her daughter about what happened. Her daughter told her it was because she was dehydrated. Her daughter told her that it was called vagus something or another. Her daughter was not there with the caller. Her daughter called it vagus something, she does not remember. Her daughter told her that it had to do with inflammation and her immune system. Caller stated she also has arthritis. Her daughter told her that she was stupid for drinking wine after receiving the second dose of the covid vaccine and not eating a full meal. Whenever she passed out and fell, she did not hurt herself but it was a wake up call. She realized she was vulnerable. She was calling because she did not know why no one told her to drink a lot of water after receiving the vaccine. She got a Prolia shot in July and the nurses told her to drink a lot of water. She was asking why the nurses who gave her the covid vaccine are not saying that to people. Her daughter told her to call the doctors office about this, and she told her daughter that it was over with now, she's 95%, she was a little tired on 18Mar2021. She was unconscious for 15 seconds per her husband. Her husband was shouting her name, and she did not hear anything. She wanted to call and report that the nurses should tell people to drink water. One more thing, her daughter told her that the covid vaccine was slowly released. About 10 hours after receiving the second dose of the covid vaccine her hand on the side that she got the vaccine was cold. She got the vaccine about 10AM, and about 10PM at night is whenever her hand got cold. She had pain at the injection site where she had the first dose of the vaccine too. She had more pain at injection site after the second dose of the vaccine. It was not awful, but only if she pressed on it. Clarified that she gets Prolia shots twice a year for her arthritis. Luckily whenever she started to get dizzy, she braced her self, whenever she fell, she did not fall from an upright position. She was crouched over, and fell against trays that fell with her. Her doctor daughter told her that inflammation was because of her immune system. One other thing was that she has been stung in the past and had extreme reactions from yellow jackets in the 90's. She thought her immune system was sensitive. One other things related to her autoimmune from 3 years ago. She moved to a city in 2012. Everyone told her after 5 years she would develop allergies. In 2017, she had eczema all over her back and arms. It was not just like a topical thing where she scratched and itched, it was under her skin. She went to a dermatologist and he took a biopsy, but the results just said eczema. She went to an allergist, he finally found a space on her underarms where he could do a test. The test showed that she had mild allergies to mold and juniper. Juniper is a tree that they have there, she has one in her back yard. Her allergy was very mild. She tried everything, and in 4 months it went away. Now she just latherers her skin with coconut oil. Her diagnosis that this autoimmune issue was related her immune response from the yellow jacket reaction is a self diagnosis. A doctor had never told her this, this was coming from her own self. Clarified that she is calling about the second dose of the pfizer covid 19 vaccine. Headache: It was not a bad headache, it was more like pressure all across the top. Whenever she went to sleep, the headache started. She got the second dose of the covid vaccine on 16Mar2021. She had a little bit of a headache this morning. A cup of coffee with milk made it better. Nausea: It started whenever she did not want to eat dinner. She could tell her stomach was not right. The nausea and headache started together about 12 hours after her vaccine at 10:00 PM. Weakness: She noticed weakness on the next day whenever she got up to use the bathroom. Clarified as the early morning of 17Mar2021. Her weakness was about 90 percent resolved. Disorientation when walking: Clarified that her disorientation was in reference to walking only right before she fell. She was not mentally disoriented. Mentally she knew that she was not doing well. Second dose: pain at injection site: The pain only lasted for about 2-3 hours. It was now absolutely minimal. She would have to press on it to feel anything. Her hand on the side that she got the vaccine was cold: She got the second dose of the covid vaccine around 10:00 AM, and noticed her hand was cold about 5:00 PM., about 7-8 hours later. Whenever she went to bed, she was cold. She thought that it resolved by the next morning. The morning after receiving the second dose of the covid vaccine, she passed out: She passed out about 8:15 AM. The outcome of the events headache, nausea, weakness, pain at injection site was recovering. The outcome of the events disorientation when walking and her hand on the side that she got the vaccine was cold was recovered on 17Mar2021. The outcome of the other events was unknown.

Other Meds:

Current Illness:

ID: 1154094
Sex: F
Age:
State:

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: sore mouth; She has swelling on her gums, on the side of her mouth and on the roof of her mouth; She has swelling on her gums, on the side of her mouth and on the roof of her mouth; She has swelling on her gums, on the side of her mouth and on the roof of her mouth; she developed a little bit of rash at the injection site; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration on 14Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got the Pfizer COVID-19 vaccine on 14Mar2021 and she developed a little bit of rash at the injection site and it has been going down. This morning (19Mar2021), she has developed a sore mouth. She has swelling on her gums, on the side of her mouth and on the roof of her mouth. She wanted to know if these have been reported adverse events associated with the Pfizer COVID-19 vaccine and if she should see a doctor for this reaction. The outcome of event rash at the injection site was recovering; for other events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154095
Sex: F
Age:
State:

Vax Date: 03/20/2021
Onset Date:
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: muscle stiffness; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization.The patient's medical history and concomitant medications were not reported. Caller states she received the first dose of the Pfizer COVID vaccine this morning between 09:30 and 10:00 am EST. Caller states she has some muscle stiffness and she already took some Tylenol. The outcome of the event was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154096
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: sleepy; tired; cannot put weight on her right leg; She has not been out of bed for over a week; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included arm and leg nerve damage; cardiac, liver and lung disease. Concomitant medications included lorazepam taken for an unspecified indication from an unspecified start date and ongoing; melatonin taken for an unspecified indication from an unspecified start date and ongoing; cetirizine hydrochloride (ZYTREC) taken for an unspecified indication from an unspecified start date and ongoing; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from an unspecified date; the patient also took her heart medication she did not know the name. The patient wanted to report that after taking shot she was sleepy and tired and could not put weight on her right leg. She took a Benedryl before taking the shot and was told she should not have done that after receiving the shot (pharmacy name) gave her another after taking the shot. She had not been out of bed for over a week. She was afraid to take the second shot. The patient further stated that she was experiencing serious adverse effect from COVID vaccine. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds: ZYTREC; BENADRYL; LORAZEPAM; MELATONIN

Current Illness:

ID: 1154097
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/01/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Caller got both doses of the Covid vaccine and within two and half weeks later after the 2nd dose she got Covid.; Caller got both doses of the Covid vaccine and within two and half weeks later after the 2nd dose she got Covid.; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received the 1st and the 2nd dose of BNT162b2 (BNT162B2, Batch/Lot number not reported), both an unspecified route of administration as single dose on an unspecified date for COVID-19 immunisation. Medical history included Covid-19. She stated she had Covid twice before vaccination, before getting the Covid vaccine. The patient's concomitant medications were not reported. Within two and half weeks after the 2nd dose the patient got Covid. She was in hospital 14 to15 days, she was on ventilator, she had very serious attack. The events were considered serious as per hospitalization and medically significant. She had Covid twice before this, before getting the Covid vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unknown date (before vaccination) and SARS-COV-2 test: positive on an unknown date (after vaccination). The outcome of the events was not reported. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154098
Sex: M
Age:
State: CO

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: he is experiencing middle finger tip pain, middle finger tip pain, then he mention the pain was in the first and second finger underneath the nail.; sensation as if you had oil on your skin.; he is experiencing middle finger tip pain, middle finger tip pain, then he mention the pain was in the first and second finger underneath the nail.; This is spontaneous report received from a contactable consumer (patient) via medical information team. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on thursday, on the same side he received the injection he is experiencing middle finger tip pain, middle finger tip pain, then he mention the pain was in the first and second finger underneath the nail Mar2021. Patient describes the pain as not severe, only noticeable when he touch something with his finger, he also called this symptom "jalapeno finger" from what he found on the internet and mentioned it was a sensation as if you had oil on your skin. Referred patient to his HCP. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154099
Sex: F
Age:
State: GA

Vax Date: 03/06/2021
Onset Date: 03/01/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: muscle and joint problems/pain; muscle and joint problems/pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not re-ported) as single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 13Feb2021 for Covid-19 immunization. The patient was experiencing muscle and joint problems/ pain in Mar2021. The outcome of the events was unknown. The information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154100
Sex: F
Age:
State: PA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest; Swelling of the tongue; numbness of the tongue; persistent disorientation; confusion; Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and asthma. The patient had no known medical allergens. Concomitant medications in two weeks included amoxicillin, clavulanic acid (AMOXCLAV 875-125 MG) and cetirizine hydrochloride (ZYRTEC 10 MG). The patient did not receive other vaccines in four weeks. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. On 17Mar2021 12:15 PM, the patient experienced anaphylaxis, swelling/tightness of the throat and chest, swelling of the tongue, numbness of the tongue, persistent disorientation and confusion, and rapid heartbeat. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment included 2 Epipens, Benadryl 25 mg, and intravenous Benadryl. Outcome of the events was not recovered. The patient was not tested for COVID post vaccination.

Other Meds: AMOXCLAV [AMOXICILLIN;CLAVULANIC ACID]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1154101
Sex: F
Age:
State: NH

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: anaphylactic reaction; Throat swelling; heart racing; irregular heart rate; gasping for air; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration in Right buttocks, at the age of 67-year-old, on 08Mar2021 10:00 as SINGLE DOSE, for covid-19 immunisation. Medical history allergies: Sulfites, urinary tract disorder, Birth defect bladder w/ recurrent kidney stones, kidney infection, Grave's disease, and lyme disease. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. Concomitant medications included levothyroxine and epinephrine. The patient previously took sulfur dioxide and experienced drug hypersensitivity. The patient experienced anaphylactic reaction with throat swelling, heart racing, irregular heart rate, gasping for air on 08Mar2021 10:45. Therapeutic measures taken in response to the events included self administration of epinephrine. The events were assessed as serious (life threatening). Outcome was recovering at the time of the report.

Other Meds: LEVOTHYROXINE; EPINEPHRINE

Current Illness:

ID: 1154102
Sex: M
Age:
State: NY

Vax Date: 03/05/2021
Onset Date: 03/08/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: he is shrinking now; He collapse while he was in the shower; weak/been getting weaker and weaker; feeling more unwell every day; This is a spontaneous report from a contactable consumer. A 92-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm (also reported as left upper arm) on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included Kidney cancer, bladder cancer, colon cancer, mantle cell lymphoma and was compromised health-wise. Concomitant medications included amlodipine, atorvastatin, losartan, sotalol, terazosin, and warfarin. On 08Mar2021, the patient was weak and feeling more unwell every day. On 09Mar2021, the patient collapse while he was in the shower. The wife of the patient reported regarding some possible side effects for her husband. He had been weak but on 09Mar2021, he collapse while he was in the shower and that was pretty dramatic but he has been getting weaker and weaker and feeling more unwell every day since 08Mar2021; at this point he was literally appointed for the second shot on the 26Mar2021, so wife was asking if it was advisable being he had what maybe side effects between the vaccine and his other health conditions, that he should take his second shot. On an unspecified date, the patient was shrinking now. The patient was due date for second shot on 26Mar2021. The reporter stated that the lot was EN6203, and it could be ENU203, the handwriting was very bad, and she don't know if it was U or 6. Outcome of events was unknown. Information about Lot/Batch number is requested.

Other Meds: AMLODIPINE; ATORVASTATIN; LOSARTAN; SOTALOL; TERAZOSIN; WARFARIN

Current Illness:

ID: 1154103
Sex: F
Age:
State: PA

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she wakes herself up with anxiety; Heart racing; felt like she was clunked over the head; she was tired and sleepy; she was tired and sleepy; right thigh area in the muscle feels throbbing and pain; Fluttering Heart Beat; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 18Mar2021 at 08:15 (batch/lot number: ER2613) as a single dose for COVID-19 immunisation (also reported as "preventing COVID-19 virus"). Medical history included ongoing rheumatoid arthritis diagnosed 15 years ago, type 2 diabetes from Jun2019 and ongoing, and ongoing high blood pressure diagnosed about 25 years ago. Concomitant medications included adalimumab (HUMIRA) taken for rheumatoid arthritis from 2020 (started it a year ago) and ongoing; insulin detemir (LEVEMIR) taken for type 2 diabetes from 2019 and ongoing; insulin aspart (NOVOLOG) taken for type 2 diabetes from 2019 and ongoing. The patient previously took tofacitinib citrate (XELJANZ) prior to adalimumab. The patient stated that she has a question. She received her first dose today at the in (City name). Stated they gave out a fact sheet upon leaving after vaccine. She stated the sheet stated that she should mention if she was immunocompromised or on medication that compromises the immune system. Asked should she be expecting something different. Stated no one asked her or told her before she got the vaccine. On 18Mar2021, she stated that she felt a fluttering heart beat that lasted for a half hour. She stated that she got the vaccine at 08:15, and about a half hour after (08:45) that she had a racing heart. She stated that she felt like she was clunked over the head, she was tired and sleepy but that has passed. She stated that her brother mentioned he had this too after his vaccine but resolved. Stated her right thigh area in the muscle feels throbbing and pain, nothing excruciating. Stated it was nothing to notice, her brother said he felt the same thing after his vaccination 2 days ago. For the event fluttering heart beat, stated that she had to sit down because she didn't know what was happening but it went away. For the event right thigh area in muscle throbbing and pain, stated it could be muscle of thigh, pain throbbing, not injection site. For the event tired and sleepy, stated that when she got home she first wanted to lay down and take a nap but thought she needed to stay awake. Stated sometimes she wakes herself up with anxiety or maybe it was side effects but she felt like she was starting to come around. She stated that she only has 10 minutes before she needed to walk out the door for an appointment. She still wanted to speak with Medical Information so she wanted to be transferred since she doesn't have much time before she needs to go. The outcome was recovered on 18Mar2021 for the events "fluttering heart beat" and "heart racing", and recovering for the rest of the events.; Sender's Comments: Linked Report(s) : PFIZER INC-2021307886 same reporter/drug/events, different patient

Other Meds: HUMIRA; LEVEMIR; NOVOLOG

Current Illness: Blood pressure high (Diagnosed about 25 years ago); Rheumatoid arthritis (Diagnosed 15 years ago); Type 2 diabetes mellitus

ID: 1154104
Sex: M
Age:
State: KY

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

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

Lab Data:

Allergies:

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

Symptoms: Clot blood; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced clot blood on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1154105
Sex: F
Age:
State: NC

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.

Other Meds:

Current Illness: Blood pressure abnormal; Sinus disorder

ID: 1154106
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: caller received his first dose of the covid-19 vaccine in January, caller states 10 days later tested positive for covid-19; This is a spontaneous report from a Pfizer-sponsored program Covax Support. A non-contactable male consumer, the patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, consumer stated 10 days later tested positive for covid-19, caller was questioning second dose. The outcome of the event was unknown. Information about the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154107
Sex: F
Age:
State: AZ

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as SINGLEDOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergic reaction (hypersensitivity) (non-serious) on an unspecified date. The outcome of the event was reported as unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154108
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: she was diagnosed with COVID-19 following the first dose of the vaccine; COVID-19; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number and expiration date: not provided), 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, following the first dose of the vaccine patient was diagnosed covid-19. Patient further enquired, if she should delay the second shot of the Pfizer COVID-19 vaccine as she was diagnosed with covid-19 following first. The patient underwent lab tests and procedures which included sars-cov-2 test which resulted positive for covid-19.. The outcome for the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154109
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: legs are weak, shaking and trembling; legs are weak, shaking and trembling; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on an unspecified date in Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced legs are weak, shaking and trembling. Caller stated he already spoke to the safety department and was transferred to us. Caller disconnected the call before agent could finish the call or get additional information about the AE. Caller wanted to know what she can do to stop it. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154110
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: intermittent brief periods of dizziness; This is a spontaneous report from a contactable consumer (Wife) via medical information team. A 28-years-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced intermittent brief periods of dizziness. On 25Feb2021 lists side effects reported for seven days after each dose. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1154111
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: she has diverticulitis and is on an antibiotic; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had the first shot of COVID vaccine on an unspecified date and stated that she had the shot and issue arose that she has diverticulitis on an unspecified date and was on an antibiotic from an unspecified date. Patient was due to get her second and wanted to know if this would interfere with getting second shot of COVID vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154112
Sex: F
Age:
State: MO

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: she is a heart attack survivor; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first vaccine ended up being a Pfizer vaccine. She received her Pfizer vaccine on 10Mar2021 and the next is scheduled 07Apr2021. She was wondering if she should schedule somewhere else to get another vaccine sooner. The patient was a heart attack survivor on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154113
Sex: F
Age:
State:

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Medical Information Potential AE; rash on her lower stomach area; This is a spontaneous report from a contactable consumer (patient). A 60 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 Immunization. The patient's medical history and concomitant medication were not reported. It was reported that Yesterday morning patient developed a rash on her lower stomach area. Patient wanted to know she could treat this at home with cortaid or anti itch cream or should she see her family physician and get an antibiotic. The outcome for the events was unknown. Information on the lot number and batch number has been requested.

Other Meds:

Current Illness:

ID: 1154114
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: bleed as much as he did; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wanted to know if he was supposed to bleed as much as he did on an unspecified date with outcome of unknown. No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1154115
Sex: F
Age:
State: RI

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: her arm was sore; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 01Mar2021 as single dose for covid-19 immunization. Medical history included having cancer twice and concomitant medications were not reported. Patient stated that her first dose was no problem at all, and her arm was sore for a couple of days, and that's it. Patient had an issue when she went to the for second vaccine. She went to a for her second dose and states that the nurse who was administering vaccines was very busy and distracted, the patient does not remember being stuck, but that the nurse just put a bandaid on her arm. No other bystanders were able to confirm administration of the vaccine, either. Patient does not believe she received her 2nd dose of Pfizer-Biontech Covid19 vaccine on 01Mar2021. She was asking if there was a clinical trial to evaluate a booster dose. The outcome for the event was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1154116
Sex: M
Age:
State:

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 2 weeks later the urgent care facility told him he was positive to Covid; 2 weeks later the urgent care facility told him he was positive to Covid; Wasn't feeling well after 1st dose; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) via an unspecified route of administration on 11Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, he took 1st vaccine on 11Mar2021 and scheduled for the 2nd on 01Apr2021. Took 2 covid test on 09Mar2021 and came back negative. Wasn't feeling well after 1st dose. 2 weeks later the urgent care facility told him he was positive to Covid and has to isolate for 10 days. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154118
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 03/15/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has already received the first dose, she was diagnosed with COVID-19 8 days ago (15Mar2021). The second dose was originally scheduled (today) on 23Mar2021, but the doctor recommended waiting 30 days after the COVID-19 diagnosis before considering receiving the next dose. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154119
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Positive for syphilis; This is a spontaneous report from Pfizer Sponsored Patient Support Program. A non-contactable consumer (patient) reported that a male patient of unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (solution for injection/Batch/lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. In between the first and second shot of the dose the patient had experienced positive for syphilis, inquiring that it was a false report by the lab data and the patient refused to share the information. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1154120
Sex: F
Age:
State:

Vax Date: 02/28/2021
Onset Date:
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: chills; off and on; This is a spontaneous report from a contactable female consumer (patient herself) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 28Feb2021 and first dose was on 04Feb2021 via unspecified route of administration both as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced chills, off and on. Patient chills were elevated when she had taken Tylenol, as a therapeutic measure. Patient stated that she had an appointment with HCP tomorrow and would like to know anyone else had reported the same symptoms. Outcome of the events was unknown. Information regarding batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1154121
Sex: F
Age:
State: TN

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 04/01/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; having arrhythmias and blood pressure issues; having arrhythmias and blood pressure issues; have continued to have. Cardiac issues; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 28Dec2020 06:30 PM into right arm at single dose for COVID-19 immunization in Hospital. Medical history included Migraines, high blood pressure that was controlled. 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 allergies to medications, food, or other products. Concomitant medication (medications the patient received within 2 weeks of vaccination) included hydrochlorothiazide and furosemide (LASIX [FUROSEMIDE]). patient took injection and started swelling in face, hands, eyes. Then started having arrythmias and blood pressure issues. She has continued to have. Cardiac issues as well as blood pressure problems. ill was hospitalized. Duration of hospitalization was 2 days. blood pressure and arrythmias. Patient was currently seeing cardiologist on April 14th to see what can be done. events start date and time was 28Dec2020 06:45 PM. It was unknown if the adverse event result in doctor or other healthcare professional office/clinic visit or Emergency room/department or urgent care. "Location of injection information is available for all vaccines received on the same date". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Lab test included Nasal Swab on 23Jan2021 with negative result. Treatment for the events included medication, in process of seeing a Cardiologist. Outcome of the events was not recovered. Serious criteria is hospitalized and life threatening. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of swelling in face, hands, eyes, arrhythmias, cardiac issue and blood pressure issues 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: HYDROCHLOROTHIAZIDE; LASIX [FUROSEMIDE]

Current Illness:

ID: 1154122
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: After the first dose she experienced fatigue; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported after the first dose she experienced fatigue on an unspecified date. Patient has received both doses of the Pfizer BioNTech Covid vaccine. After the first dose she experienced fatigue. However, after the second dose on 4Feb2021 she had a "fairly large response." She is still dealing with these side effects over six weeks later. She is experiencing extreme fatigue and is still experiencing a fever. Her temperature is usually normal in the morning and then raises to 100.5 to 101.2 in the evening. She has already seen her HCP several times and they have no recommendations. She has been tested for Covid and different viruses but they've all been negative. She's had a chest Xray, urinanalysis, put on antibiotics just incase there was something latent. She has had blood work done several times, her WBC was 5.4 and was only slightly anemic. Her doctor may start her on iron supplements. The patient underwent lab tests and procedures which included blood test: only slightly anemic, chest x-ray: unknown on Unknown, sars-cov-2 test: negative, urine analysis: unknown (put on antibiotics just incase there was something latent), viral test: negative and white blood cell count: 5.4 (Her doctor may start her on iron supplements). The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154123
Sex: F
Age:
State: IL

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; chills; headache; body ache; joint pain; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female (not pregnant) received the first dose (dose number 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202) via an unspecified route of administration in the left arm on 15Mar2021 08:15 AM at a single dose or COVID-19 immunization. Medical history included Hashimoto's disease, pulmonary hypertension, obstructive sleep apnea, dermatomyositis. Concomitant medication(s) included escitalopram; tramadol; levothyroxine; all from Mar2021 (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to morphine. The patient was seen in the Emergency Room at a hospital on 20Mar2021 for pinprick blood rash all over the body on 16Mar2021; a doctor diagnosed it as immune thrombocytopenia from the Covid vaccine received 5 days earlier. On 16Mar2021, she had also been experiencing rash on chest and neck, fever, chills, headache, body ache, joint pain, fatigue, nausea for the past 5 days. The adverse event(s) result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the events included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.

Other Meds: ESCITALOPRAM; TRAMADOL; LEVOTHYROXINE

Current Illness:

ID: 1154124
Sex: F
Age:
State: PA

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: her legs gave away and she sat down on the floor and was unconscious; felt groggy and nauseated and her stomach acting funny.; felt groggy and nauseated and her stomach acting funny.; felt groggy and nauseated and her stomach acting funny.; light pain in her head; legs gave away; This is as spontaneous report received from a contactable consumer (patients husband). A female patient on unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: not reported) via unspecified route on 23Mar2021 at 15:00 and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot/Batch number: not reported) on an unspecified date as single dose for COVID-19 immunization. Relevant medical history and concomitant medications were unkown. It was reported that the patient who received her second dose vaccine was fine until next day early morning. The following day in the morning the patient felt groggy and nauseated also her stomach acted funny while she was brushing. She tried to throw up but could not. Then her legs gave away and she sat down on the floor and was unconscious. The patients husband started to call 911 but his wife was only unconscious for a few seconds and then became alert again and had been fine since then except for a light pain in her head. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1154125
Sex: F
Age:
State: CA

Vax Date: 02/23/2021
Onset Date: 03/01/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: severe anaphylactic shock; High blood pressure; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 23Feb2021 09:30 (Lot Number: EN6200) as single dose for covid-19 immunisation at age 84 years old. Medical history included low thyroid and allergies to grasses. The patient was not pregnant. The patient had no Covid prior to vaccination and was not Covid tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. No other vaccine taken in four weeks. The patient previously received the first dose of BNT162B2 administered in left arm on 02Feb2021 09:30 AM (lot no: EC9265) for COVID-19 immunization. On 16Mar2021 09:15 AM, 15 minutes after eating usual breakfast: avocado/toast, coffee, almond milk, the patient went into severe anaphylactic shock: extreme itching on palms, red welts on body, explosive diarrhea, dizzy/fainted, extreme blood pressure drop to 60/XX, in/out of consciousnes, loss of bowel/urine. Rushed to ER. High blood pressure 7 days after (Mar2021). The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, emergency room/department or urgent care and were considered life threatening illness (immediate risk of death from the event). Treatment given in the emergency room includes unknown (as reported), prednisone, Pepcid. Outcome of the event was unknown.

Other Meds: SYNTHROID

Current Illness:

Date Died: 03/21/2021

ID: 1154126
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Diabetic ketoacidosis; This is a spontaneous report from a contactable consumer. A contactable consumer reported for her nephew. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (at the age of 33-years-old) at single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, impaired gastric emptying from an unknown date and unknown if ongoing, ulcer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced diabetic ketoacidosis on an unspecified date. The patient died on 21Mar2021 due to diabetic ketoacidosis. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Diabetic ketoacidosis

Other Meds:

Current Illness:

ID: 1154127
Sex: F
Age:
State: MN

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

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

Lab Data:

Allergies:

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

Symptoms: Seventeen days after my second dose, my appendix almost rupture and had to have surgery to remove it; Dose 1:17Feb2021; Dose 2: Feb2021; Dose 1:17Feb2021; Dose 2: Feb2021; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Feb2021 at 02:30 (Lot Number: EN6200) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right in Feb2021 at 14:30 (Lot Number: EL9262), both (at the age of 68-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history was none. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient reported that: "seventeen days after my second dose, my appendix almost rupture and had to have surgery to remove it" on Mar2021. The event was serious, the patient was admitted to emergency room and was hospitalized for seventeen days after the event, the event was also assessed as life-threatening. The patient underwent lab tests and procedures which included SARS-COV-2 (nasal swab) test: negative on 09Mar2021. Therapeutic measures were taken as a result of the appendix rupture and included surgery to remove it. The patient outcome of the event was recovering. Follow-up attempts are possible. Further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1154134
Sex: M
Age:
State: NJ

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: arm pain; Also reports joint stiffness around neck and shoulder; Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest; Lymphadenopathy-Lymph node pain around left clavicle; Lymphadenopathy-Lymph node pain around left clavicle; This is a spontaneous report received from a contactable pharmacist (patient himself). A 52-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot Number: EN6205, Expiry date: Jun2021), via intramuscularly to the left arm on 26Feb2021 at single dose for COVID-19 immunization. The patient medical history included Hypertriglyceridaemia ongoing. Concomitant medication included Fenofibrate. The patient previous vaccination included Shingrix used for shingles and experienced with sore arm. The patient lab test included Sar-cov-2 which was negative. Patient reported that he received his first dose of the Pfizer BioNTech covid vaccine on 26Feb2021. He is due for his second dose this Friday 19Mar2021. He is calling because he experienced lymphadenopathy- explains he experienced Lymph node pain/tenderness around his left clavicle. Caller clarified that the injection was on his left side. The pain/tenderness occurred the next day, 27Feb2021 and it was self limiting and it lasted about 5-7 days. He didn't think anything of it, everything else was ok, the arm pain resolved after one day. On 12Mar2021, he developed similar pain on the right side, but it was a more intense pain/tenderness and lasted maybe 4 days. He still experiences it, but less frequently. He is not sure if he is describing it correctly. During the afternoon, it gets a bit more tender. He doesn't feel it in the morning, but by the afternoon he notices the pain/tenderness. He did not know if there were any reports of contralateral lymphadenopathy (lymph node pain). He clarified that there is no redness or lump- he doesn't feel anything, even if he touches it there's no pain, but periodically there will be a shooting tenderness. He feels like it's getting better, but it is still persisting. He clarified that on the right side- he is experiencing pain near the axilla, underneath the arm next to the chest. He is waiting to see if it is improving and doesn't know how long he should wait. He stated that it wasn't that painful on the left side, it was just a little tender; he knew something was different. The pain wasn't always there. Sometimes there's a little pain on the left side still, but not as intense as the right side. The pain is there, it's not worsening but it is not improving. The patient also reports joint stiffness around neck and shoulder and describes discomfort as ongoing intermittent tenderness. The reporter reported events Lymphadenopathy-Lymph node pain around left clavicle, Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest to be serious due to Medically significant. The outcome of events was not recovered. No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the available information, temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported events Lymphadenopathy, Lymph node pain and Tenderness. 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: FENOFIBRATE

Current Illness: Hypertriglyceridaemia

ID: 1154135
Sex: F
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 04/01/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; This is a spontaneous report from a contactable physician. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot umber ad expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine. The patient previously took morphine, and had allergies; and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization, and had polymyalgia rheumatica, RS3PE, elevated ESR and elevated CRP. On an unspecified date in 2021, after the second dose of vaccination, the patient's developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened. The reported events have resulted into doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized on an unspecified date in 2021 for two days due to the reported events. The patient had received methylprednisolone (MEDROL) and prednisone as treatment for the reported events. The outcome of the events, 'developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination; and had a nasal swab test in Mar2021 that was negative post-vaccination. Information about lot/batch number has been requested.; Sender's Comments: Considering the plausible temporal association, a causal association between the reported 'polymyalgia rheumatica and RS3PE including elevated ESR and CRP ' (aggravated, already reported after the first dose of vaccine) and 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: LEVOTHYROXINE

Current Illness:

ID: 1154136
Sex: F
Age:
State: OR

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: dramatic increase in Rheumatoid Arthritis symptoms; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, in Feb2021 (reported as "last month"), as single dose, for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took tofacitinib (XELJANZ XR) for rheumatoid arthritis. The patient reported that she missed two weeks of XELJANZ XR last month (Feb2021) due to receiving COVID-19 vaccine. She said she experienced a dramatic increase in rheumatoid arthritis symptoms (unspecified date) as a result of this but she feels like overall Xeljanz XR is managing her rheumatoid arthritis well. The outcome of the event was unknown. No follow-up attempts are possible. Information on lot/number cannot be obtained. No further information is expected.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1154139
Sex: M
Age:
State: NY

Vax Date: 03/12/2021
Onset Date: 03/01/2021
Rec V Date: 04/01/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: back started hurting/back aching and hurting; Chills; coughed once and stomach rolled; chest tightness; coughed once and stomach rolled; arm started hurting; my neck got stiff; can't sleep; This is a spontaneous report from a contactable consumer via medical information team. A 78-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included HIV positive ongoing (Diagnosed 8 years ago); Psoriasis ongoing (over 5 years that he was diagnosed); Diabetes from 2017 and ongoing; Family History includes operation on face for melanoma. Concomitant medication included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) at 600 mg, 1x/day; then 50 mg, 1x/day; then 300 mg, 1x/day ongoing all were via orally for hiv infection; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) orally 50 mg, 1x/day for diabetes ongoing; adalimumab (HUMIRA) from an unspecified start date and ongoing at 40 mg every 14 days for psoriasis. It was reported on friday the 12Mar2021 week patient took the shot at a hospital. On the 13Mar2021 his arm started hurting and his neck got stiff. The 14Mar2021 his back started hurting like a knife, chest and back was tight. He states his back hurts and has chest tightness; coughed once and his stomach rolled up on 14Mar2021. On the 15Mar2021 same result, back aching and hurting. The 16Mar2021 he went to the hospital and took the x ray of his back and front and couldn't find nothing. States his lungs were ok and everything was ok so he doesn't know what is going on. Clarified that he went to the Emergency Room at the hospital, he was not hospitalized. He was treated in the ER and released the same day. on the 17Mar2021 his back was killing him. he can't sleep in Mar2021. He states that he still hurts this morning and has chills on 17Mar2021. The outcome of the events Cough; Stomach discomfort; Neck stiff; vaccination site pain was recovered on 14Mar2021; Chest tightness; Chills, Back pain was not recovered; Sleep disorder was unknown.

Other Meds: TRIUMEQ; JANUMET XR; HUMIRA

Current Illness: Diabetes; HIV positive (Diagnosed 8 years ago); Psoriasis (over 5 years that he was diagnosed)

ID: 1154147
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: blackout/blacked out; The next day I was weak; I personally have very high antibodies; This is a spontaneous report from a contactable Physician (self-reported). A male patient an unspecified age, received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date in Feb2021, as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced blackout, the next day was weak, personally had very high antibodies. Patient stated that, he personally had very high antibodies, had, on the scale of over 1, had an antibody of 164 in Feb2021. Patient was recommended by his physician to take the vaccine. So, took the first shot three weeks ago, the shot (Covid-19 Vaccine) and that night he actually blacked out and was very out of it for about a day and a half. Then he thought he got better but blacked out twice, the night took the first shot. Now he was fine. He supposed to take the second shot today, three weeks later and he was debating whether it is smart to take it or not. Seriousness of the events was reported as non-serious. Outcome of the events blackout and Weakness was recovered on an unknown date in 2021; for the event high antibodies, it was unknown. Information on lot number/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event blackout is considered possibly based on temporal association. 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: 1154148
Sex: F
Age:
State: CO

Vax Date: 03/01/2021
Onset Date: 03/17/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basilic vein; right arm swelling in the setting of receiving her Pfizer covid vaccine in the right arm 1 week prior; This is a spontaneous report received from a contactable healthcare professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm right in Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included hyperlipidemia, acute pancreatitis, May-Thurner syndrome, and allergies: penicillin, IV contrast. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ), fenofibrate, and levothyroxine. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient was seen at the ED for right arm swelling in the setting of receiving her Pfizer COVID vaccine in the right arm 1 week prior. She was found to have a DVT (deep vein thrombosis) in right medial subclavian and superficial thrombosis in right proximal basilic vein. The events started on 17Mar2021 09:00. AE resulted in emergency room/department or urgent care. Patient was recovering from the events. Treatment for AEs include anticoagulation. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the DVT and other reported events, based on temporal relationship. However the reported events may likely represent intercurrent medical conditions in this patient. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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: YAZ; FENOFIBRATE; LEVOTHYROXINE

Current Illness:

ID: 1154149
Sex: F
Age:
State: FL

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: tongue was swollen/The front half of her tongue was swollen and stinging; tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging; had white dots and a sore tip on the tongue; Sinus Pressure; Body Aches; Tired; Dizzy; Nausea; This is a spontaneous report from a contactable licensed practical nurse (LPN) reporting on behalf of physician. A 39-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on 09Mar2021, at 39 years of age, (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient had no medical history; concomitant medications were not reported. On 09Mar2021, a few minutes after receiving the vaccine, the patient felt sinus pressure that lasted the rest of the day, she was tired and dizzy for two days and also had nausea for two days and body aches for the first 3 days, all assessed as non-serious. Then the patient stated that when she woke up on 11Mar2021, her tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging. The patient stated she did not feel as if though her throat was swollen, just her tongue, but it resolved after 3 days. These events were assessed as medically significant and the tongue swelling was what the reporter was mainly concerned about. There were no treatments, no medication was given, the patient was not seen in the Emergency Department, she was not hospitalized and was not admitted to an Intensive Care Unit. She visited the Physician Office on 15Mar2021 and Physician Assistant advised the patient not to get the second COVID vaccine. The event "sinus pressure" resolved on 09Mar2021, the events "Tired", "Dizzy" and "Nausea" resolved on 11Mar2021, the event "body aches" resolved on 12Mar2021, the events "tongue was swollen and had white dots and a sore tip on the tongue; the front half of her tongue was swollen and stinging" resolved on 14Mar2021.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported serious events 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

Date Died: 02/26/2021

ID: 1154152
Sex: M
Age: 71
State:

Vax Date: 02/16/2021
Onset Date: 02/26/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: death Narrative: Patient was a 71 y/o gentleman with PMHx schizoaffective-bipolar, major neurocognitive disorder, hx covid- 19 in 12/15/20, chronic insomnia, BPH s/p LUTS, OA/DJD at unspecified joint, and acquired hypothyroidism who presented to the clinic for hospital follow up and monitoring while on clozapine. Pt received covid19 vaccine on 2/16/2019 while inpatient, right before his discharge on 2/17/2021.Of note, pt was put on hospice care at the time of discharge to patient's home. He passed away on 2/26/2021. I could not find the death notice in the chart (which usually contains the medical cause of death). This was reported to us from an staff. The following describes his hospitalization: At facility, was noted to be dehydrated and reported to not have been taking his medications or having good PO intake. Per reports from nursing home, patient wasnoted to have difficulty swallowing" and spit up meals and medications. SLP evaluation with concerns for mastication and dysphagia. At time of hospitalization his Na was at 153, also noted to have AKI2. His hypernatremia, aki, and dehydration resolved with fluid replacement. His potassium was also replaced. His constipation resolved with laxatives which also improved his abdominal discomfort. Also, his olanzapine was changed to disintegrating tablet which helped with his intermittent agitation. Currently, he was calm, amenable, and with medication compliance. To help with his poor appetite, his mirtazapine dose was increased to 30 mg from 15 mg. Pt was discharged on 2/17/2021 when family decided to place him under hospice care.

Other Meds:

Current Illness:

Date Died:

ID: 1154153
Sex: M
Age: 72
State:

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 04/01/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Cardiac Arrest Narrative: Pt went into cardiac arrest 2/13 when he was being taking off dialysis machine. Per wife, he was unresponsive, but they were able to revive him with CPR and then called 911 who took pt to Hospital. Pt ultimately died at Hospital 2/26/21. Pt received second dose COVID-19 vaccine 2/12/21 (day prior to cardiac arrest)

Other Meds:

Current Illness:

Date Died: 02/24/2021

ID: 1154154
Sex: M
Age: 88
State:

Vax Date: 02/08/2021
Onset Date: 02/24/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: death Narrative: 88 yo male with PMH CAD, aortic valve stenosis, sensorineural hearing loss, impaired fasting glucose, thrombocytopenia, obesity, GERD, and mixed hyperlipidemia was found to have passed away when staff did an outreach on 3/8/2021 for patient to come back for his second vaccine dose. Per family member, patient passed away on 2/24/2021. Patient has no prior positive for COVID19, no recent hospitalization (none found within the facilities record). Patient received the vaccine on 2/8/2021 with no complications. We have no other records to review. Pt was not hospitalized prior to vaccination or post vaccination. Possible cause of death unknown, no death note found in chart.

Other Meds:

Current Illness:

Date Died: 02/16/2021

ID: 1154155
Sex: M
Age: 66
State:

Vax Date: 02/09/2021
Onset Date: 02/16/2021
Rec V Date: 04/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DEATH Narrative: 66 yo male with PMH of HTN, HFpEF, COPD, T2DM, CKD, tobacco use disorder and bipolar disorder was found dead in his home on 2/16/2021 after police did a wellness check per request of patient's sister. Patient received the covid19 vaccine (Pfizer) on 2/9/2021, vaccine was administered without complications. No prior positive for covid19. After patient received his covid19 vaccine, he was seen at same day access for increased SOB/DOE, worsened orthopnea. Per progress notes, at this last appt, patient had expressed a number of medications which he was not willing to take, attributing his worsened health to their effects. Pt has continued spironolactone despite being advised to stop it by his medical provider. At the time of visit, provider noted that this kidney function was declining (patient does have CKD). Provider discussed the importance of medication adherence and patient was started on torsemide. Hctz was discontinued, minoxidil was increased due to patient preference. Prior to this same day access/express care visit, patient was hospitalized from 1/26 through 1/28/2021 for hypertensive urgency (211/105) and that at that time, pt already had orthopnea, SOB, and dyspnea. Patient was also admitted from 1/7 to 1/8 and left AMA. While inpatient, his MRI revealed a pontine lacunar infarct that was found to be chronic. It was recommended that patient be treated with aspirin/plavix for 21 days then aspirin alone but patient declined.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm