chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Laboratory test, Magnetic resonance imaging
Clinical narrative: headache; This is a spontaneous report received from a non-contactable consumer (patient) via Medical Information Team. An 80-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; Solution for injection in pre-filled syringe), via an unspecified route of administration on Sep2020 at single dose for immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient received a dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on Sep2020 after her physician recommended her to be immunized with the vaccine after the risk of Pneumonia and COVID-19 concomitantly. The patient developed a headache on an unspecified date after the administration of the vaccine pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and that persists up to this day. The patient reports that her Physician had studied her medical conditions with tests, and MRI and different medications but it has not taken away the headaches. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Pain
Clinical narrative: Diverticulitis; little bit of pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got her first shot of covid vaccine, sometimes she have Diverticulitis a little bit of pain and she wanted to find out if it's ok to take antibiotics and also get the second shot on the 28th. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Stomach upset; This is a spontaneous report from a contactable pharmacist.  A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246), intramuscular in the left arm on 10Jan2021 (at the age of 47-year-old) as a single dose for COVID-19 immunization. Medical history included hypertension. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. . The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL0140), intramuscular, left arm  on 20Dec2020 for COVID-19 immunization. On 10Jan2021, the patient experienced stomach upset. The patient took Compazine for the stomach upset. The clinical outcome of the event stomach upset was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder was sore and painful; This is a spontaneous report from a contactable consumer (patient's husband).  A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2), Batch/lot number was not provided, via an unspecified route of administration from an unspecified date as a SINGLE DOSE for COVID-19 vaccination.  Medical history was none.  There were no concomitant medications.   The consumer reported his wife had the same vaccine and her shoulder was sore and painful on an unspecified date. They still have pain when they move their shoulder. The consumer later clarified that her shoulder is not sore anymore. They put an ice on their shoulder. Outcome of the shoulder was sore and painful was recovered on unknown date. Information on lot number/batch number was requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperature is usually 97; Arm was extremely painful; Joint pain; Headache; Could not work today because I was not feeling good; This is a spontaneous report from a contactable consumer (patient).  A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot), via an unspecified route of administration, on 13Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history includes heart disorder. Concomitant medication included: Simvastatin, Atenolol, and medicine for my "heart". The patient reported that she received the first dose on 23Dec2021 and stated she had no reaction. On an unspecified date, the patient stated "I could not work today because I was not feeling good from the vaccine. I got it on the 13th I had off some work yesterday so I had a temperature aches and pains, fatigue and I had to call out last night. Today I am running still very slight fever, aches and pains - so it is improving." The first day, I was fine. I got it at the end of the day. The second day my arm was not red or anything but it was extremely painful, joint pain, headache, fatigue and my temperature was 99 (my temperature is usually 97). Today the temperature is lower and that does not hurt as much." The clinical outcome of the events malaise, aches and pain, fatigue, pyrexia, pain in arm, joint pain, and headache was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperature is usually 97; Arm was extremely painful; Joint pain; Headache; Could not work today because I was not feeling good; This is a spontaneous report from a contactable consumer (patient).  A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot), via an unspecified route of administration, on 13Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history includes heart disorder. Concomitant medication included: Simvastatin, Atenolol, and medicine for my "heart". The patient reported that she received the first dose on 23Dec2021 and stated she had no reaction. On an unspecified date, the patient stated "I could not work today because I was not feeling good from the vaccine. I got it on the 13th I had off some work yesterday so I had a temperature aches and pains, fatigue and I had to call out last night. Today I am running still very slight fever, aches and pains - so it is improving." The first day, I was fine. I got it at the end of the day. The second day my arm was not red or anything but it was extremely painful, joint pain, headache, fatigue and my temperature was 99 (my temperature is usually 97). Today the temperature is lower and that does not hurt as much." The clinical outcome of the events malaise, aches and pain, fatigue, pyrexia, pain in arm, joint pain, and headache was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID in between the doses for the vaccines; Tested positive for COVID in between the doses for the vaccines; This is a spontaneous report from a Pfizer sponsored program. A contactable registered nurse (not the patient) reported a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; COVID Vaccine a Pfizer product; lot number: EK9231) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter added they were exposed before getting it and did not realize that they were exposed. The patient was tested positive for COVID in between the doses for the vaccines, on an unspecified date. She was wondering what we suggest they do with the second dose. The outcome of event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician (patient).  A 56-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient had a PCR test on 12Jan2021 and was COVID-19 positive, asymptomatic. The patient had a rapid test on 14Jan2021 and came out negative. The doctor was asking if he can be able to get the second vaccine a longer than 3 weeks which is in the 6th week, asking if it could make a difference since he was tested positive. The outcome of the events was recovered on 14Jan2021.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 30Dec2020, and a PCR COVID-19 test positive on 12Jan2021, asymptomatic. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information is needed for a full meaningful medical assessment.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable Other HCP. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date. Event outcome was unknown.  Information on Lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Sensation of foreign body
Clinical narrative: I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; This is a spontaneous report received from a contactable consumer (who is also the patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunization. Medical history included inflammatory bowel disease. Concomitant medication included diphenoxylate from 14Jan2021 for inflammatory bowel disease. The patient stated, "I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before. I never had that before and it feels like I have a hard time when I lay down to breathe and I was wondering if that has anything to do with the side effect of this vaccine." When asked for treatment, patient stated, "No, because it just started yesterday (15Jan2021). That is why I called you. I wanted to know if that dangerous. Do I have to go to an emergency clinic because today is Saturday and everything is closed or should I just do not worry about it." The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Dyspnoea, Fatigue, Malaise
Clinical narrative: woke up with little aches; Dizzy; Little breathless; Heart goes pumping; Nervous; Very tired; I don't know if I'm dehydrated; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 77-year-old patient of unspecified gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 14Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient  received the COVID vaccine on Thursday, 14Jan2021. The patient was doing well on the day of vaccination. The following day, 15Jan2021, the patient was very tired. At the morning of the report, 16Jan2021, the patient woke up with little aches, tired, but they don't know what it was. The night before, 15Jan2021, the patient got a little get upset from something, a door man, or some noise. But all of a sudden, they got a little breathless, and I felt little dizzy. And the patient had some orange juice, (Beverage company name withheld) and a little cereal. The patient commented, "I guess, it's the dizziness, lightheaded and you know, your heart goes pumping a little, a little dizzy and things like that. So, I just thought I'd call." The patient added, "I have Allegra here, I didn't take it though. I have a little (Beverage company name withheld). I just got a little nervous, I live alone and except the (Beverage company name withheld). I hope, I don't know if I could go or act to sleep or just a little lightheaded, you know, breathless and dizzy and I wasn't sure of that. And it's two days, Thursday afternoon and it's Friday. I don't know, this is strange, I don't know if I'm dehydrated or this reaction to the vaccine, Pfizer. I can't tell you, I am just a little scared. I am not feeling well, and I wanted to know if there is anything dangerous? Or anything I can do?" The patient's second dose was scheduled on 04Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Nervousness, Pain, Palpitations
Clinical narrative: woke up with little aches; Dizzy; Little breathless; Heart goes pumping; Nervous; Very tired; I don't know if I'm dehydrated; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 77-year-old patient of unspecified gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 14Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient  received the COVID vaccine on Thursday, 14Jan2021. The patient was doing well on the day of vaccination. The following day, 15Jan2021, the patient was very tired. At the morning of the report, 16Jan2021, the patient woke up with little aches, tired, but they don't know what it was. The night before, 15Jan2021, the patient got a little get upset from something, a door man, or some noise. But all of a sudden, they got a little breathless, and I felt little dizzy. And the patient had some orange juice, (Beverage company name withheld) and a little cereal. The patient commented, "I guess, it's the dizziness, lightheaded and you know, your heart goes pumping a little, a little dizzy and things like that. So, I just thought I'd call." The patient added, "I have Allegra here, I didn't take it though. I have a little (Beverage company name withheld). I just got a little nervous, I live alone and except the (Beverage company name withheld). I hope, I don't know if I could go or act to sleep or just a little lightheaded, you know, breathless and dizzy and I wasn't sure of that. And it's two days, Thursday afternoon and it's Friday. I don't know, this is strange, I don't know if I'm dehydrated or this reaction to the vaccine, Pfizer. I can't tell you, I am just a little scared. I am not feeling well, and I wanted to know if there is anything dangerous? Or anything I can do?" The patient's second dose was scheduled on 04Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: sugar was elevated a whole lot/went real high; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunization (wanted to get because of the virus). The patient's medical history included hard of hearing and diabetes (reported as "diabetes and stuff). Concomitant medications included empagliflozin (JARDIANCE), dulaglutide (TRULICITY), and other medications (as reported " I take stuff for blood pressure all kind of stuff"). The patient reported that he got the vaccine on Tuesday (12Jan2021), he stated that he has diabetes and stuff and he noticed on Wednesday, Thursday, Friday his sugar was elevated a whole lot and he thought that would be possibly from the vaccine or it might be stressed because the Covid (unspecified). He stated that he doesn't know but it's unusual, he means it went real high. He wanted to know if there are any reports of like affects it might cause on hi sugar to go high. The patient checked this morning (unspecified date) it was high and just checked about 20 minutes ago and it has come down again so (further not clarified)." The patient mentioned that he takes Jardiance and Trulicity, once a week; he took Trulicity this morning (unspecified date) and stated, "so that probably helped". He had an unspecified laboratory test about 3 months ago, and there was no problem." The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swollen tongue
Clinical narrative: Did get a reaction and my hands swelled up about 20 minutes after the vaccine and my tongue swelled up; Doctor said I cannot take the 2nd dose of the vaccine; Did get a reaction and my hands swelled up about 20 minutes after the vaccine and my tongue swelled up; Doctor said I cannot take the 2nd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899 and expiration date Mar2021), via an unspecified route of administration first dose on 12Jan2021 at single dose for covid-19 immunisation. The patient's medical history included Asthma, Allergy, and Penicillin allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) for allergy at 180 mg, daily, budesonide (PULMICORT) for Asthma at Pulmicort is a inhaler 180, 2 puffs a day, montelukast sodium (SINGULAIR) for Asthma at 10 mg.  Historical vaccine includes Tetanus and experienced allergic reaction. Past drug includes Sulphur and experienced allergy. It was reported that the patient had the vaccine on 12Jan2021 and patient was working in long term care "administrator". The patient did get a reaction and the patient hands swelled up about 20 minutes after the vaccine and her tongue swelled up. The patient did take Benadryl. The patient called her primary care doctor and was told to stay on the Benadryl and the patient was okay. The patient stated that the pharmacist that gave her the vaccine gave the Benadryl right away when the patient started swelling up.  The patient spoke to her allergist and stated that she cannot take the second dose vaccine. So, the patient was concerned about her coverage because she work in a long term case. The doctor would not give me the shingle vaccine (unspecified vaccine) because they were afraid the patient would have a reaction to that.  The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Food refusal, Pneumonia aspiration, Restlessness, Urinary tract infection
Clinical narrative: acting weird and wouldnt eat; UTI; Aspirations phenomena; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The reporter was calling about mother. Said Mom is in E.R. Had received covid vaccine on Thursday. Friday she was ok. Saturday mom was acting weird and wouldn't eat. Saturday night she was thrashing around and wouldn't settle down so they took mom to E.R. was diagnosed with Aspirations phenomena and UTI. Treated the UTI then put her in nursing home. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal, Breast tenderness, Cardiac flutter, Electrocardiogram normal
Clinical narrative: Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization.  Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68.  There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Malaise, Oedema peripheral
Clinical narrative: Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization.  Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68.  There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Have swelling of Lymph Nodes; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunisation. The patient's medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide, losartan, and amlodipine for hypertension. The patient experienced swelling of lymph nodes on 15Jan2021. The outcome of the event was unknown.  Information on the Lot/Batch Number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: was supposed to get the second dose yesterday 19Jan2021 but location is closed/  could get it up to the 26Jan2021; paralysis of the chin and half of the face; and around the mouth; This is a spontaneous report from a contactable consumer report for self. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 29Dec2021 20:00 PM for COVID-19 immunization. Medical history included ongoing severe migraines. None family history. There were no concomitant medications. No Prior Vaccinations within 4 weeks. After an hour she had paralysis of the chin and half of the face; and around the mouth. It only lasted a few minutes, like 10 minutes and then it went away, she was fully recovered. She did not got to a doctor or the ER. Adds she was supposed to get the second dose yesterday 19Jan2021 but she has to go to another location as that location is closed. They told her she could get it up to the 26Jan2021 and then it would be more problematic to get. The event outcome was recovered on 29Dec2020.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, SARS-CoV-2 test positive
Clinical narrative: patient was positive; patient was positive; This is a spontaneous report from a contactable nurse. A 34-year-old female patient (nurse's daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK9231), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history was none.  There were no concomitant medications. The nursed reported that "The patient was positive, the whole family had COVID and they all came down which was about the same time which was 29Dec. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd dose. Probably close to 10 days ago, they did do some lab work at the hospital". The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 14Jan2021, 3 o'clock (unspecified in am or pm). Medical history and concomitant medication were not reported. The patient went swimming next day (15Jan2021) for an hour without stopping and did water aerobics and nothing hurt. The patient was doing great but came down with a little diarrhea, Friday, Saturday, and Sunday (from 15Jan2021 to 17Jan2021). The patient woke up this morning (17Jan2021) and stated probably had it during the night. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.   Information on the batch/lot number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin A decreased, Facial pain, Facial paralysis, Facial paresis, Pain
Clinical narrative: typical Bell's Palsy; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; Weak feeling coming from the jaw; This is a spontaneous report from a non-contactable nurse (wife). A 38-year-old male patient (husband) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 18:00 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history included hypogammaglobulinaemia, from years low IGA, chickenpox and shingles in the past. The concomitant medications were not reported. No history and additional vaccines administered on same date. On 20Jan2021 when patient woke up, right now at 09:21 AM, he noticed right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw. Reporter stated this was typical Bell's Palsy and the usual treatment is the same as for herpes zoster; steroids and antivirals is the recommended treatment. Reporter is planning to call the doctor as she feels he needs treatment right away and she will get the doctor to prescribe this treatment. Patient has a weak feeling coming from the jaw. Patient had a history of chicken pox and chronic herpes zoster but this was the first time he had had Bell's Palsy. States the effects are persisting and medically significant. Patient was scheduled for the second dose 09Feb2021. Wanted to know about if patient should get the second dose of the vaccine. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: typical Bell's Palsy; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; Weak feeling coming from the jaw; This is a spontaneous report from a non-contactable nurse (wife). A 38-year-old male patient (husband) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 18:00 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history included hypogammaglobulinaemia, from years low IGA, chickenpox and shingles in the past. The concomitant medications were not reported. No history and additional vaccines administered on same date. On 20Jan2021 when patient woke up, right now at 09:21 AM, he noticed right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw. Reporter stated this was typical Bell's Palsy and the usual treatment is the same as for herpes zoster; steroids and antivirals is the recommended treatment. Reporter is planning to call the doctor as she feels he needs treatment right away and she will get the doctor to prescribe this treatment. Patient has a weak feeling coming from the jaw. Patient had a history of chicken pox and chronic herpes zoster but this was the first time he had had Bell's Palsy. States the effects are persisting and medically significant. Patient was scheduled for the second dose 09Feb2021. Wanted to know about if patient should get the second dose of the vaccine. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pain, Pyrexia
Clinical narrative: tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVID and result came out positive/ body ache, fever, headache and cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration, on 24Dec2020 at single dose as first dose, on left deltoid on 14Jan2021 as second dose at single dose to protect patient from COVID. Medical history included prediabetes and blood pressure high. Concomitant medication included metformin for prediabetes, losartan for blood pressure high. The patient's second vaccine (COVID 19 Vaccine) was just past this 14Jan2021. Then she had a lot of symptoms on 14Jan2021, the patient had like body ache, fever, headache and cough. The patient started to have suddenly with the side effects from the vaccine and then it was fine until yesterday and then she had to go in and get tested for COVID because she had never tested positive and her result came out this morning positive in Jan2021. The patient received Tylenol as treatment. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVID and result came out positive/ body ache, fever, headache and cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration, on 24Dec2020 at single dose as first dose, on left deltoid on 14Jan2021 as second dose at single dose to protect patient from COVID. Medical history included prediabetes and blood pressure high. Concomitant medication included metformin for prediabetes, losartan for blood pressure high. The patient's second vaccine (COVID 19 Vaccine) was just past this 14Jan2021. Then she had a lot of symptoms on 14Jan2021, the patient had like body ache, fever, headache and cough. The patient started to have suddenly with the side effects from the vaccine and then it was fine until yesterday and then she had to go in and get tested for COVID because she had never tested positive and her result came out this morning positive in Jan2021. The patient received Tylenol as treatment. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: Tested positive for the COVID-19; Tested positive for the COVID-19; Headache; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer (patient) reported for herself. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got her first dose of this Vaccine date is 29Dec2020 and now she had tested positive for the COVID-19, so she wants to know if what to do if she should take the second dose which is scheduled 19Jan2021. Physician confirmed it was COVID-19 Vaccine of Pfizer. She had got a headache. Events outcome was unknown.  Information about lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Cough, Eosinophil count increased, Hypersensitivity, Lung infiltration
Clinical narrative: Pneumonia; Eosinophil count high; allergic reaction; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had his first vaccine dose on 04Jan, then 7 days later he was in the hospital with a really high eosinophils count and infiltrate in his lungs, they did a CAT scan, and he had pneumonia in there. Patient's wife said that he was in the hospital for three days for Pneumonia, and now he was out of the hospital and he was supposed to get his second dose of the vaccine on the 25th. She would like to know if her husband should have the second dose, since she didn't know if the pneumonia was caused from the vaccine for sure, it could be an allergic reaction for the vaccine since his count was 22.2 for absolute eosinophils and that was down now to 2.4. She would like to know if it was safe for him get the second dose. She said her husband was still coughing and she didn't know, she was afraid for him to get it. The patient underwent lab tests and procedures which included a CAT scan in Jan2021 and he had pneumonia in there , absolute eosinophils: 22.2 (Eosinophil count high) in Jan2021, absolute eosinophils: 2.4 in Jan2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Eosinophil count high; allergic reaction; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had his first vaccine dose on 04Jan, then 7 days later he was in the hospital with a really high eosinophils count and infiltrate in his lungs, they did a CAT scan, and he had pneumonia in there. Patient's wife said that he was in the hospital for three days for Pneumonia, and now he was out of the hospital and he was supposed to get his second dose of the vaccine on the 25th. She would like to know if her husband should have the second dose, since she didn't know if the pneumonia was caused from the vaccine for sure, it could be an allergic reaction for the vaccine since his count was 22.2 for absolute eosinophils and that was down now to 2.4. She would like to know if it was safe for him get the second dose. She said her husband was still coughing and she didn't know, she was afraid for him to get it. The patient underwent lab tests and procedures which included a CAT scan in Jan2021 and he had pneumonia in there , absolute eosinophils: 22.2 (Eosinophil count high) in Jan2021, absolute eosinophils: 2.4 in Jan2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Biopsy, Body height decreased, Dermatitis diaper, Rash
Clinical narrative: rash that looks like measles; rash on right side that goes around to back looks like diaper rash; This is a spontaneous report from a contactable pharmacist.  An 87-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation.  Medical history was none.  There were no concomitant medications.  The patient stated she had this injection 08Jan2021, states the following Thursday, 14Jan2021, she broke out with 2 different reactions, a rash that looks like measles all over, the second reaction is part on her back looks like a little kid has not had their diaper changed, like diaper rash, like half a belt from the right side to the back. States she is very concerned, the patient went to a dermatologist who she had a lot of faith in, doctor met her at the door, read about it but has never seen a reaction like this. States that they injected her with something and it worked in two different places. States she did a biopsy on her hip and took movies to show her students, called her and stated she need to report this event. The patient states she wants to know if she should get the second vaccine. States she used to be 5 foot 2 inches, shrunk prior to vaccine. The patient last night to report but she could not get through. Stated she got injection on right arm. The patient stated the rashes are trying to improve. States the rash that looks like measles started on the right side and now is all over. The patient stated she is allergic to bromines and swims in a bromine salt water heated swimming pool and this has nothing to do with it but the point she is saying is that she says your allergic to things and then not have reactions and sometimes you do. Both events were serious with criteria of medially signicant. The patient underwent lab tests and procedures which included biopsy: unknown results, body height: 5 foot 2 inches (States she used to be 5 foot 2 inches, shrunk prior to vaccine).  The outcome of the event rash that looks like measles was not recovered, while the outcome of the other event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Roseola
Clinical narrative: rash that looks like measles; rash on right side that goes around to back looks like diaper rash; This is a spontaneous report from a contactable pharmacist.  An 87-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation.  Medical history was none.  There were no concomitant medications.  The patient stated she had this injection 08Jan2021, states the following Thursday, 14Jan2021, she broke out with 2 different reactions, a rash that looks like measles all over, the second reaction is part on her back looks like a little kid has not had their diaper changed, like diaper rash, like half a belt from the right side to the back. States she is very concerned, the patient went to a dermatologist who she had a lot of faith in, doctor met her at the door, read about it but has never seen a reaction like this. States that they injected her with something and it worked in two different places. States she did a biopsy on her hip and took movies to show her students, called her and stated she need to report this event. The patient states she wants to know if she should get the second vaccine. States she used to be 5 foot 2 inches, shrunk prior to vaccine. The patient last night to report but she could not get through. Stated she got injection on right arm. The patient stated the rashes are trying to improve. States the rash that looks like measles started on the right side and now is all over. The patient stated she is allergic to bromines and swims in a bromine salt water heated swimming pool and this has nothing to do with it but the point she is saying is that she says your allergic to things and then not have reactions and sometimes you do. Both events were serious with criteria of medially signicant. The patient underwent lab tests and procedures which included biopsy: unknown results, body height: 5 foot 2 inches (States she used to be 5 foot 2 inches, shrunk prior to vaccine).  The outcome of the event rash that looks like measles was not recovered, while the outcome of the other event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.