chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fall, Pyrexia
Clinical narrative: patient experienced dizziness and fell twice; patient experienced dizziness and fell twice; slight fever of 99; This is a spontaneous report from a non-contactable consumer. An elderly male patient (reported as 65+ years) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The day after the vaccination (on 12Mar2021), the patient experienced dizziness and fell twice. The patient also had a slight fever of 99. It was unknown if a treatment was given for the adverse events. It was also unknown if the patient had COVID prior to vaccination and unknown if the patient was tested for COVID post vaccination. The outcome of the events was recovered in Mar2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms; Extreme fatigue; muscle aches; diminished appetite; headaches; nausea; mild diarrhea; This is a spontaneous report from a contactable Other Health Professional. This Other HCP reported for a consumer (Patient) that.  A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Right on 25Feb2021 14:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included anaemia and b12 anemia from an unknown date and unknown if ongoing, Known allergies was Penicillin. Concomitant medications included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) and ibuprofen taken for an unspecified indication, start and stop date were not reported. on 06Mar2021 11:00 patient experienced flu like symptoms, extreme fatigue, muscle aches, diminished appetite, headaches, nausea and mild diarrhea. Outcome of the events was recovering.   No follow-up attempts are possible; Information about Lot/batch number cannot been obtained
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Flu like symptoms; Extreme fatigue; muscle aches; diminished appetite; headaches; nausea; mild diarrhea; This is a spontaneous report from a contactable Other Health Professional. This Other HCP reported for a consumer (Patient) that.  A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Right on 25Feb2021 14:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included anaemia and b12 anemia from an unknown date and unknown if ongoing, Known allergies was Penicillin. Concomitant medications included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) and ibuprofen taken for an unspecified indication, start and stop date were not reported. on 06Mar2021 11:00 patient experienced flu like symptoms, extreme fatigue, muscle aches, diminished appetite, headaches, nausea and mild diarrhea. Outcome of the events was recovering.   No follow-up attempts are possible; Information about Lot/batch number cannot been obtained
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Loss of consciousness, Rash
Clinical narrative: Pt. was denoted while at work passed out in employee bathroom and she hit her head. It was also denoted she had a rash over 1/3 of her body.  She told the charge nurse that she didnt know what happen she was just getting ready to sit down to use the restroom and she blacked out.  Originally thought it was blood pressure related but her blood pressure was within normal limits.  Reactions are she passed out and rash.  She informed charge nurse she was going to see her primary on 06/16/2021.
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: She got a little sick after last pneumonia vaccine; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein, Solution for injection in pre-filled syringe, Lot number and Expiration date was not reported) via an unspecified route of administration on 2018 as SINGLE DOSE for immunisation. Medical history included allergies (mostly preservatives and dyes), Compromised immune status, respiratory illness, genetic/ chromosomal abnormalities, diabetes (endocrine abnormalities (including diabetes) and obesity), Obesity (Overweight began 20 years ago. After 40 when she stopped exercising), Has had allergic reactions. Mostly preservatives and dyes and Pneumonia (She had pneumonia a few times and that is why she got it prior to 65. That was prior to getting vaccine. She had it in Jan 2018 - the actual Pneumonia). The patient concomitant medications were not reported. Patient got a little sick after last pneumonia vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus post vaccine. Has not abated for a full month after vaccine . No tinnitus history prior to vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Polymenorrhoea
Clinical narrative: After 7 years without menstruation due to Mirena IUD, patient experienced regular menstrual spotting and a 2 day period in the months following the second vaccination
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Blood sodium decreased, Computerised tomogram head normal, Headache, Nausea
Clinical narrative: facial swelling N/V headache
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vomiting
Clinical narrative: facial swelling N/V headache
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she had her first Pfizer COVID-19 vaccine in left arm and had a little sore but no redness; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from  (manufacturer control number. This case was split from master case  A 75-year-old patient received first dose of BNT162B2 (Comirnaty, Formulation: Solution for injection) via intramuscular route of administration on 05Feb2021 (at the age 75-year-old) in arm left as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included etanercept (ENBREL) for Psoriatic arthropathy. On 05Feb2021 patient received first dose of Pfizer COVID-19 vaccine in left arm and had sore but no redness. The outcome of the event was unknown.   The reporter declined consent for follow up.  No follow- up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: knocked him out/feel asleep at work; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation and reported came down with COVID between 1st and 2nd shot. Patient reported after second dose on unspecified date, it really knocked him out. He felt asleep at work Patient took Tylenol as treatment for the event. Outcome of event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Pneumonia booster the caller had swelling in the arm; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. The patient medical history and concomitant medications were not reported. It was reported that Pneumonia booster the caller had swelling in the arm on an unspecified date. Outcome of the event was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV, COVID19
Symptoms: Pain
Clinical narrative: has had more of a soreness reaction to the pneumonia shot; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (Solution for injection in pre-filled syringe, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient medical history and concomitant medications were not reported. Patient previously took flu shot. The patient had more of a soreness reaction to the pneumonia shot on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: PPV, COVID19
Symptoms: Contusion, Limb discomfort, Pain in extremity, Vaccination site discomfort, Vaccination site pain
Clinical narrative: has had more of a soreness reaction to the pneumonia shot; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (Solution for injection in pre-filled syringe, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient medical history and concomitant medications were not reported. Patient previously took flu shot. The patient had more of a soreness reaction to the pneumonia shot on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: PPV, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: has had more of a soreness reaction to the pneumonia shot; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (Solution for injection in pre-filled syringe, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient medical history and concomitant medications were not reported. Patient previously took flu shot. The patient had more of a soreness reaction to the pneumonia shot on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Outbreak of cold sores on lip; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6201, Expiry date: Unknown) via an unspecified route of administration in the right arm on 08Mar2021 at 09:30 (at the age of 62-years-old) as unknown, single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Patient did not have known allergies. Patient's medical history was not reported. Concomitant medications included vitamin E, probiotic, fish oil (OMEGA 3), dexpanthenol, lidocaine hydrochloride, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B COMPLEX) and vitamin D. Patient does not have COVID, prior vaccination. Patient has not been tested for COVID post vaccination. No other vaccine in four weeks. On 11Mar2021, the patient experienced outbreak of cold sores on lip. Therapeutic measures were not taken as a result of adverse events. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Liver function test increased
Clinical narrative: Increase in his AST/ALT/ liver function test/blood test were high; This is a spontaneous report from two contactable consumers (including patient's wife) via a Pfizer-sponsored program. A 77-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 28Feb2021, as 1st dose, single dose, for COVID -19 immunisation. Medical history included COVID-19 from Oct2020 to an unknown date. The patient tested positive of COVID-19 way back October last year and mentioned that he still has the antibody. The patient's concomitant medications were not reported. On unspecified date in Mar2021, it was reported that the patient was scheduled for the 2nd dose on 21Mar2021. However, less than a week ago he had an increased in his AST/ALT. The physician stated yes to taking the 2nd dose, another physician said no. The patient had some liver function tests and blood tests after the 1st dose. Consulting along with his condition if they should get the 2nd dose of Covid-19 vaccine. The patient took a blood test (ALP & AST) and the results of those both liver function test/blood test were high. He queried how long will the side effects last, and whether the patient should get the 2nd dose of the vaccine with his history of COVID-19 infection and elevated liver enzymes. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cranial nerve disorder, Drooling, Hypoaesthesia, Paraesthesia
Clinical narrative: pin pricking; drooling; It was just a cranial nerve interrelated to the centers on the right side of my face; tingling; numbness; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date, she had tingling and numbness 10 days after her first dose of Pfizer's COVID vaccine. She stated "she went to her PCP yesterday and she didn't have Bell's palsy. The PCP told her it looks like a rare reaction and it was only her 2nd patient. her side effects were 10 days after the first dose with pin pricking, tingling, and numbness on the right side over by the eye, by the temple, by the cheek, and by the mouth, even drooling." Tingling and the numbness on the Thursday on the right side of her face; It was just a cranial nerve interrelated to the centers on the right side of her face. She had some questions and what she had was the tingling and the numbness on the Thursday on the right side of her face. she just went to her primary care doctor today and she confirmed that it was not the stroke. she had not the palsy. It was just a cranial nerve interrelated to the centers on the right side of her face. her question was it had improved. It was almost gone. The outcome of event cranial nerve disorder was recovering and outcome for the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tooth fracture, Tooth infection
Clinical narrative: tooth is fractured; tooth infection; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported ), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, it was reported that first dose was taken 2.5 weeks ago, and second dose on Friday, learned about a week ago, crown put on the tooth. Oral surgeon, diagnosed that tooth fractured and currently, she have an infection. The patient was pressing for treatment recommendation. he declined demographics. Upon follow-up received on 16Mar2021, it was reported that, she had an appointment for vaccine injection number two this Friday morning. She has a tooth infection. She must have the tooth extracted. A friend suggested that she wait. Is there any reason she should do the vaccine before or after or any other suggestions.  She was taking an antibiotic for a little bit and finished that a week ago. The outcome of the events was an unknown.   follow-up received on 16Mar2021, this is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported that, New information was received.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaginal haemorrhage
Clinical narrative: lymph node swelling in right armpit; Vaginal spotting; This is a spontaneous report from a non-contactable consumer (patient).   A 30-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 12Mar2021 08:30 (Batch/Lot Number: EN6206) as single dose at the age of 30-year-old for COVID-19 immunisation, administered at hospital.  Medical history included seasonal allergy. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA); fluticasone propionate (FLONASE), both taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 19Feb2021 08:15 (Batch/Lot Number: EM9810) as single dose at the age of 30-year-old for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. The patient experienced lymph node swelling in right armpit (non-serious) on 13Mar2021 with outcome of unknown, vaginal spotting (non-serious) on 13Mar2021 with outcome of unknown.  No treatment received. COVID was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Vertigo
Clinical narrative: woke up sweating; felt like room was spinning; a bit dizzy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 11Mar2021 at 11:15 (Lot Number: EN6205) (at the age of 67-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. The patient medical history was not reported. No known allergies.  The patient did not have COVID-19 before vaccination and not tested positive to COVID-19 since vaccination. Concomitant medications included atorvastatin at 20 mg; vitamin d [vitamin d nos] and xantofyl/zeaxanthin, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 18Feb2021 at 12:15 (Lot Number: EL9267) (at the age of 67-year-old) as single dose for COVID-19 immunisation. On 12Mar2021 at 03:00 the patient woke up sweating and felt like room was spinning. Felt a bit better after a few hours but still a bit dizzy, particularly when turning head or standing. Felt fine at end of day but next day dizziness again. Not too bad but enough to make me avoid stooping for fear of getting dizzy when I stand up again. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under ear on the left side; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 10Mar2021 at 15:15 (Lot Number: EL3248) (at the age of 30-year-old) as single dose for COVID-19 immunisation.  The patient was not pregnant. The patient medical history was not reported. No known allergies.  The patient did not have COVID-19 before vaccination and not tested positive to COVID-19 since vaccination. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Feb2021 (Lot Number: EL3247) (at the age of 30-year-old) as single dose for COVID-19 immunisation.  The patient experienced swollen lymph node under ear on the left side on 13Mar2021 at 15:30. No therapeutic measures were taken as a result of the event. The patient outcome of the event was outcome of recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Malaise, Vomiting
Clinical narrative: Throwing up; feel like sick; And I am breast feeding my daughter; This is a spontaneous report from a contactable consumer (parent). This consumer reported similar events for two patients. This is 2nd of two reports. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6202), 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. Patient got her first dose of the COVID-19 vaccine (later confirmed) yesterday. patient got it on Thursday afternoon, Central Time. And I am breast feeding my daughter and I am having just kind of normal reactions. But yesterday, when we were outside, she started throwing up and feel like sick or anything (hence split case made). And now again, she woke up feeling like throwing up. And I am just having hard time not thinking it is not related. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: site administration tenderness; This is a spontaneous report from a contactable pharmacist. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunisation. The vaccination facility type was at the workplace clinic. The patient's medical history and concomitant medications were not reported. It was unknown if other vaccine was administered in four weeks. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH 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. On 12Mar2021, the patient experienced site administration tenderness after receiving second COVID-19 dose. The event did not result in any visit to Emergency Room or Physician office. It was unknown if treatment was given. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Body temperature, Body temperature increased
Clinical narrative: funky headache; getting cramps in the arm and hand that I got the shot in; ears were ringing loudly; muscles and joints ached badly; muscles and joints ached badly; felt tired and weak; felt tired and weak; Checked temp. was 100/temp was up to 104; cough; Felt like I was run over by a truck; Bottom line felt like I was having Covid all over; chills; upset stomachache/stomach was upset/waves of upset stomach; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:45 (at the age of 58-years-old), as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to Dec2020 and started with cough which she had horribly from an unknown date. There were no concomitant medications reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not receive any other medicine prior to COVID-19 Vaccine. The patient was tested COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 03Mar2021 15:00, the patient experienced chills, upset stomachache/stomach was upset/waves of upset stomach. On 04Mar2021, the patient also experienced, ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The patient underwent lab tests and procedures which included body temperature: 100 on 04Mar2021, body temperature: 104 on 04Mar2021 When I went to bed My temp was up to 104, body temperature: 100 on 04Mar2021 When I woke up Temp was 100, body temperature: normal on 04Mar2021. Treatment was received for chills and upset stomachache/stomach was upset/waves of upset stomach. Treatment was not received for ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The outcome of the events chills, upset stomachache/stomach was upset/waves of upset stomach, ears were ringing loudly, felt tired and weak, checked temp. was 100/temp was up to 104, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in were reported as recovering and for events muscles and joints ached badly and cough were reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: funky headache; getting cramps in the arm and hand that I got the shot in; ears were ringing loudly; muscles and joints ached badly; muscles and joints ached badly; felt tired and weak; felt tired and weak; Checked temp. was 100/temp was up to 104; cough; Felt like I was run over by a truck; Bottom line felt like I was having Covid all over; chills; upset stomachache/stomach was upset/waves of upset stomach; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:45 (at the age of 58-years-old), as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to Dec2020 and started with cough which she had horribly from an unknown date. There were no concomitant medications reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not receive any other medicine prior to COVID-19 Vaccine. The patient was tested COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 03Mar2021 15:00, the patient experienced chills, upset stomachache/stomach was upset/waves of upset stomach. On 04Mar2021, the patient also experienced, ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The patient underwent lab tests and procedures which included body temperature: 100 on 04Mar2021, body temperature: 104 on 04Mar2021 When I went to bed My temp was up to 104, body temperature: 100 on 04Mar2021 When I woke up Temp was 100, body temperature: normal on 04Mar2021. Treatment was received for chills and upset stomachache/stomach was upset/waves of upset stomach. Treatment was not received for ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The outcome of the events chills, upset stomachache/stomach was upset/waves of upset stomach, ears were ringing loudly, felt tired and weak, checked temp. was 100/temp was up to 104, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in were reported as recovering and for events muscles and joints ached badly and cough were reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Suspected COVID-19, Tinnitus
Clinical narrative: funky headache; getting cramps in the arm and hand that I got the shot in; ears were ringing loudly; muscles and joints ached badly; muscles and joints ached badly; felt tired and weak; felt tired and weak; Checked temp. was 100/temp was up to 104; cough; Felt like I was run over by a truck; Bottom line felt like I was having Covid all over; chills; upset stomachache/stomach was upset/waves of upset stomach; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:45 (at the age of 58-years-old), as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to Dec2020 and started with cough which she had horribly from an unknown date. There were no concomitant medications reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not receive any other medicine prior to COVID-19 Vaccine. The patient was tested COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 03Mar2021 15:00, the patient experienced chills, upset stomachache/stomach was upset/waves of upset stomach. On 04Mar2021, the patient also experienced, ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The patient underwent lab tests and procedures which included body temperature: 100 on 04Mar2021, body temperature: 104 on 04Mar2021 When I went to bed My temp was up to 104, body temperature: 100 on 04Mar2021 When I woke up Temp was 100, body temperature: normal on 04Mar2021. Treatment was received for chills and upset stomachache/stomach was upset/waves of upset stomach. Treatment was not received for ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The outcome of the events chills, upset stomachache/stomach was upset/waves of upset stomach, ears were ringing loudly, felt tired and weak, checked temp. was 100/temp was up to 104, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in were reported as recovering and for events muscles and joints ached badly and cough were reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Tooth infection
Clinical narrative: possible sinus or tooth infection; possible sinus or tooth infection; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was scheduled to take the second dose of the COVID-19 vaccine on Saturday, 20Mar2021. She was just put on an antibiotic for a possible sinus or tooth infection. She was put on Clindamycin. It was stated that she went to the dentist for her tooth infection and was prescribed clindamycin which she has taken one dose of. It was asked if there were any interactions with the vaccine and the drug. She would like to know if the antibacterial drug she took would possibly affect the vaccine effectiveness. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient (age reported as "67" unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization. Medical history included irritable bowel syndrome (IBS) from an unknown date and ongoing. The patient concomitant medications were not reported. The patient has a history of IBS but diarrhea has been worse today (17Mar2021), had severe diarrhea for the last couple of hours. She is scheduled for second dose this morning. She asked if she should still get the second dose and stated that she did not know what to do because she had a hard time getting an appointment for the vaccine. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Had reactions to the vaccine thinks its allergy related; This is a spontaneous report from a contactable consumer (patient). A female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), dose 1, via unspecified route of administration on an unspecified date (Batch/Lot number: not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had reactions to the vaccine and thought that it was allergy related. On 24Mar2021, the physician will do a skin test before getting the second dose and will have more information once test was done. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: bloody nose; This is a spontaneous report received via Medical Information Team. A contactable consumer (patient) reported a male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/lot number: not reported) as 1st dose, single dose for COVID-19 immunisation. On 17Mar2021, the patient had a bloody nose while he was exercising in the morning. He was asking if it was a common side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nervousness
Clinical narrative: feeling really shaky; very dizzy; This is a spontaneous report from a non-contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 at 12:30 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included vestibular dysfunction. The patient's concomitant medications were not reported. On 12Mar2021, the patient started feeling really shaky and very dizzy. The patient stated she has been dealing for 40 years with "pre-existing vestibular dysfunction" and she wanted to know if there had been any complaints about Pfizer second shot causing "excessive dizzy, shaking, type of feeling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: some stiffness / soreness in the arm; some stiffness / soreness in the arm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection; Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband received the first dose of Pfizer COVID-19 vaccine and the patient experienced some stiffness/soreness in the arm on an unspecified date. The patient also reported that her husband was scheduled for cortisone shot in the knee on 19Mar2021 after the first dose. Their second dose is scheduled on 23Mar2021 and patient wanted to know if that would interact with the COVID-19 vaccine. The patient also wanted to know if she can take ibuprofen. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Swelling face
Clinical narrative: her left side of the cheek was very hot and swollen; her left side of the cheek was very hot and swollen; left arm was hurting; This is a spontaneous report received via Medical Information Team. A contactable consumer (patient) reported a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1,  via an unspecified route of administration on 16Mar2021 (Batch/lot number: not reported) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that her left side of the cheek was very hot and swollen (feeling hot & swelling face), but went away after 1 hour. She was asking if she should be concerned and if she should get the second dose. The patient also reported that her left arm was hurting (pain in extremity). The outcome for the event left side of the cheek was very hot and swollen was recovered while pain in extremity was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Pruritus
Clinical narrative: little red pimple; itching on her right shoulder (opposite to where she received the injection); This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 12Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced itching on her right shoulder (opposite to where she received the injection) on 16Mar2021 and little red pimple on 17Mar2021. It was reported that the patient received the first dose of the Pfizer COVID 19 vaccine on Friday 12Mar2021 and last night she felt an itching on her right shoulder (opposite to where she received the injection), this morning she noticed like a little red pimple and it is red, but it didn't look like the one she noticed last night. The patient was asking if this has been reported before. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: shooting pain that goes from deltoid to my elbow around the injection site; couldn't lift up my arm, pain comes and goes / some tenderness; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (Age: 76, Unit: Unknown as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 04Feb2021 as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced shooting pain that goes from deltoid to my elbow around the injection site and couldn't lift up my arm, pain comes and goes / some tenderness. It was reported that the patient was asking if there was a list of reported side effects that last for weeks and months. The patient had her second dose of the Pfizer COVID vaccine on 04Feb2021. Ever since she has been experiencing intermittent shooting pain that goes from deltoid to my elbow around the injection site. One night she was laying down with a book in her hand, she couldn't lift up her arm. The pain comes and goes and there was some tenderness. The patient wanted to know if it's normal for the side effects to last that long. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: shooting pain that goes from deltoid to my elbow around the injection site; couldn't lift up my arm, pain comes and goes / some tenderness; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (Age: 76, Unit: Unknown as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 04Feb2021 as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced shooting pain that goes from deltoid to my elbow around the injection site and couldn't lift up my arm, pain comes and goes / some tenderness. It was reported that the patient was asking if there was a list of reported side effects that last for weeks and months. The patient had her second dose of the Pfizer COVID vaccine on 04Feb2021. Ever since she has been experiencing intermittent shooting pain that goes from deltoid to my elbow around the injection site. One night she was laying down with a book in her hand, she couldn't lift up her arm. The pain comes and goes and there was some tenderness. The patient wanted to know if it's normal for the side effects to last that long. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: sore arms weeks after shots/ had both doses, one shot in each arm, now has shooting, intermittent pains in both arms; This is a spontaneous report received from Pfizer sponsor program and from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient previously received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to learn if sore arms weeks after shots were usual AE. She had searched for information and had not been able to find. The reporter had both doses, one shot in each arm. At time of report, she had shooting, intermittent pains in both arms. The outcome of event was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms weeks after shots/ had both doses, one shot in each arm, now has shooting, intermittent pains in both arms; This is a spontaneous report received from Pfizer sponsor program and from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient previously received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to learn if sore arms weeks after shots were usual AE. She had searched for information and had not been able to find. The reporter had both doses, one shot in each arm. At time of report, she had shooting, intermittent pains in both arms. The outcome of event was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable nurse (parent). This nurse reported similar events for two patients and 20 other people. This is the first of three reports. A 25-year-old female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date was not reported), via unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm pain. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021297074 same reporter, drug, and event; different patient;US-PFIZER INC-2021297073 same reporter, drug, and event; different patient