chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: felt itchy; nausea; headache; body aches from head to toe; tired/I felt so exhausted; chills; fever; have pain in the arm.; I had sweats and felt cold; I had sweats and felt cold; couldn't even wake up or move/I couldn't even get out of bed; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection , Lot number was not reported), dose 2 via an unspecified route of administration in May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunisation. The patient reported felt itchy, nausea, headache, body aches from head to toe,chills, fever, have pain in the arm , tired/I felt so exhausted, i had sweats and felt cold , couldn't even wake up or move/i couldn't even get out of bed in May2021. It was further stated by the patient that "I received both doses of the Pfizer COVID-19 vaccine. After receiving both shots, I felt itchy. The nurse told me it was normal. When I received the first shot, one hour after I experienced nausea and headache. Towards the end of night, I was having body aches from head to toe and tired. I also had chills with fever. I kept taking Tylenol that's why my temperature was 99. I couldn't even wake up or move. I felt so exhausted. I couldn't even get out of bed. I received the second dose on Tuesday. I have the same symptoms, but my chills lasted longer. I still don't feel great today. I still have pain in the arm. Today I was able to get out of med. This morning I had sweats and felt cold. I still feel nauseas and have a headache". Therapeutic measures were taken as a result of felt itchy, nausea, headache, body aches from head to toe, tired, chills, fever, have pain in the arm, i felt so exhausted, couldn't even wake up or move/i couldn't even get out of bed. Treatment for I had sweats and felt cold was not reported. Patient was asking about booster dose 3.Relevant laboratory tests included body temperature was 99 in May2021. The outcome of the events nausea and headache was not yet recovered. The outcome of the rest of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Rhinorrhoea
Clinical narrative: Coughing up phelm; Occasional running of the nose; Little horseness in her voice; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional via medical information team. A 64-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received her first Pfizer Covid 19 Vaccine on Thursday 06May2021. She is scheduled to receive the second Pfizer Covid 19 Vaccine on 27May2021. On 09May2021 she reports coughing up phelm with occasional running of the nose. Patient has been outside some with head wet not covered up. She has noticed a little horseness in her voice along with coughing. Description of COVID-19 Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include fever or chills; cough; shortness of breath; fatigue; muscle or body aches, headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: in the same arm that he got the shot under his armpit its swollen; This is a spontaneous report received from a contactable consumer. This consumer (patient's wife) reported for a patient (reporter's husband) that:  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and not ongoing. On an unspecified date the patient experienced his armpit its swollen. The reporter stated that the patient got the shot on Monday the second one in the same arm that he got the shot under his armpit its swollen and today is Thursday. The outcome of the event was unknown. No follow attempts are needed; information about lot/batch number cannot be obtained
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia
Clinical narrative: Voice goes in and out; Little nagging cough; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number: EW0165; Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Apr2021 at 13:20 (age at vaccination: 62-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing sciatica (started 5-6 years ago when she was in a really bad car accident). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number: ER2613) via an unspecified route of administration, administered in left arm on 25Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, patient had shingles vaccine and experienced sore arm. Concomitant medications included ongoing ibuprofen for pain, ongoing hydrocodone and methocarbamol both taken for back, start dates were not reported. It was reported that patient was taking concomitant medication for couple of years. On an unspecified date in Apr2021, the patient experienced little nagging cough and on an unspecified date in May2021 patient voice goes in and out. It was reported that patient had vaccine to protect herself from getting the corona and to protect herself from others. She got the second dose of the Covid-19 vaccine on 16Apr2021 and right after that started to cough, she had this little nagging cough and that since Apr2021 the cough had been ongoing. She thought that the cough would have gone away but it's like constant. Patient added, at first, she thought the cough was something unrelated to the Covid-19 vaccine, but she knew that the cough didn't start until she took that. She added that the cough began a day or two after she received the second dose of the Covid-19 vaccine on 16Apr2021. Patient reported that her son also received the Covid-19 vaccine and was experiencing the same symptoms. Patient had her second vaccination at Health Department. Patient had not been administered with any additional vaccines, neither she had any prior vaccinations within 4 weeks. AEs did not require to visit emergency room/ physician office. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: First Dose: Fever/Second Dose: Fever; This is a spontaneous report from a contactable consumer or other non-HCP, who reported for her mother.  A female of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as a dose 1, single and the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was Not reported) via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced first dose: fever/second dose: fever. Caller called to report adverse events for herself and mentioned her mother adverse event below during questions for the supplemental form. The reporter stated her mother had a hard time with the vaccine, she had a fever both times but she did not have the arm thing. Declined to complete a safety report for her mother. The clinical outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Cough, Diarrhoea
Clinical narrative: chills; like a had a fever; loss of taste; sneezing; diarrhea; slight cough; migraine; complete body aches and pains; headache; arm soreness; slight finger tingles; This is a spontaneous report from a contactable other hcp (Patient). A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration on 03May2021 at 13:00 (at the age of 43-years-old) in right arm as dose 2, single for COVID-19 immunization. Medical history included allergy to plants. Concomitant medications were not reported. The patient previously took Ceclor and experienced drug hypersensitivity. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 12Apr2021 at 13:00 (at the age of 43-years-old) in left arm as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. Since the vaccination, the patient has been tested for COVID-19. Patient received 2nd injection dose, 1 PM on Monday. On 03May2021 around 8 PM, (Monday evening), started to experience typical arm soreness and slight finger tingles (which she also experienced after the first dose) around 10 PM is when a headache started to come. Tuesday (04May2021), head pain continued and turned into a migraine along with complete body aches and pains. Wednesday (05May2021) arm no longer was sore but all of the other above symptoms continued-adding in a slight cough. Thursday (06May2021) all of above continued in addition to getting the chills and feeling like a had a fever however, temp was 98.4-98.6 throughout the day. Thursday (5/6) at lunch is when she started to notice loss of taste. That was confirmed that evening when she was eating dinner and could not taste anything at all. Today she still continued to have loss of taste, headache, bodyaches, chills, cough, and now sneezing and diarrhea. She did a rapid test which came back negative and she was still awaiting the PCR results. It was the lost of taste that concerned her. The Patient did not received treatment for the events. The patient underwent lab tests and procedures which included body temperature: 98.4 - 98.6 on 06May2021, sars-cov-2 test: pending (PCR) and sars-cov-2 test: Negative (Rapid test) on 07May2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Pain, Pain in extremity, Paraesthesia
Clinical narrative: chills; like a had a fever; loss of taste; sneezing; diarrhea; slight cough; migraine; complete body aches and pains; headache; arm soreness; slight finger tingles; This is a spontaneous report from a contactable other hcp (Patient). A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration on 03May2021 at 13:00 (at the age of 43-years-old) in right arm as dose 2, single for COVID-19 immunization. Medical history included allergy to plants. Concomitant medications were not reported. The patient previously took Ceclor and experienced drug hypersensitivity. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 12Apr2021 at 13:00 (at the age of 43-years-old) in left arm as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. Since the vaccination, the patient has been tested for COVID-19. Patient received 2nd injection dose, 1 PM on Monday. On 03May2021 around 8 PM, (Monday evening), started to experience typical arm soreness and slight finger tingles (which she also experienced after the first dose) around 10 PM is when a headache started to come. Tuesday (04May2021), head pain continued and turned into a migraine along with complete body aches and pains. Wednesday (05May2021) arm no longer was sore but all of the other above symptoms continued-adding in a slight cough. Thursday (06May2021) all of above continued in addition to getting the chills and feeling like a had a fever however, temp was 98.4-98.6 throughout the day. Thursday (5/6) at lunch is when she started to notice loss of taste. That was confirmed that evening when she was eating dinner and could not taste anything at all. Today she still continued to have loss of taste, headache, bodyaches, chills, cough, and now sneezing and diarrhea. She did a rapid test which came back negative and she was still awaiting the PCR results. It was the lost of taste that concerned her. The Patient did not received treatment for the events. The patient underwent lab tests and procedures which included body temperature: 98.4 - 98.6 on 06May2021, sars-cov-2 test: pending (PCR) and sars-cov-2 test: Negative (Rapid test) on 07May2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sneezing
Clinical narrative: chills; like a had a fever; loss of taste; sneezing; diarrhea; slight cough; migraine; complete body aches and pains; headache; arm soreness; slight finger tingles; This is a spontaneous report from a contactable other hcp (Patient). A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration on 03May2021 at 13:00 (at the age of 43-years-old) in right arm as dose 2, single for COVID-19 immunization. Medical history included allergy to plants. Concomitant medications were not reported. The patient previously took Ceclor and experienced drug hypersensitivity. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 12Apr2021 at 13:00 (at the age of 43-years-old) in left arm as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. Since the vaccination, the patient has been tested for COVID-19. Patient received 2nd injection dose, 1 PM on Monday. On 03May2021 around 8 PM, (Monday evening), started to experience typical arm soreness and slight finger tingles (which she also experienced after the first dose) around 10 PM is when a headache started to come. Tuesday (04May2021), head pain continued and turned into a migraine along with complete body aches and pains. Wednesday (05May2021) arm no longer was sore but all of the other above symptoms continued-adding in a slight cough. Thursday (06May2021) all of above continued in addition to getting the chills and feeling like a had a fever however, temp was 98.4-98.6 throughout the day. Thursday (5/6) at lunch is when she started to notice loss of taste. That was confirmed that evening when she was eating dinner and could not taste anything at all. Today she still continued to have loss of taste, headache, bodyaches, chills, cough, and now sneezing and diarrhea. She did a rapid test which came back negative and she was still awaiting the PCR results. It was the lost of taste that concerned her. The Patient did not received treatment for the events. The patient underwent lab tests and procedures which included body temperature: 98.4 - 98.6 on 06May2021, sars-cov-2 test: pending (PCR) and sars-cov-2 test: Negative (Rapid test) on 07May2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This is a spontaneous report from a contactable consumer (patient's mother). This is the 3 of 8 reports. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unknown date in Jan2021 (at the age of 52-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing Thyroid condition from unknown date in 2021(it was reported as she was in her first year of being diagnosed with thyroid condition started this year), ongoing menopause, Exercises daily (it was reported as she is strong, athlete, exercises daily rides her bike or walks after work, is pretty strong), ongoing endometriosis, diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities, obesity. Family Medical History Relevant to AE(s) was None. The patient's concomitant medications included ongoing Unknown product from 2021. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. On unknown date in Jan2021 the patient experienced shortness of breath. The patient waited in observation after the first dose of the Pfizer Covid-19 Vaccine for the 15 or 20 minutes, and this event started while she was driving home after that first dose of the Pfizer Covid-19 Vaccine; so within an hour or 2. The event was not long-lasting, she had to stop driving, pull off the road and called a nurse. Nurse told her to get over the counter Zyrtec (Zyrtec Lot/NDC/UPC/Expiry: not provided) for the shortness of breath and the patient did take it and drove home, and the Zyrtec worked. When she got the second dose of the Pfizer Covid-19 Vaccine shot she told the people who were giving the vaccinations she had that reaction with the first dose; so they put her in a little room with a bed for observation after the second dose. They watched her for the first hour after second vaccination because she was alone and she didn't get a reaction, no reaction with the second dose. Relevant tests reported as none. The event did not cause visit to Emergency Room or Physician Office. Outcome of the event was recovered on unknown date in Jan2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise
Clinical narrative: feeling unwell; hard breathing; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0161, expiry date: unknown) via an unspecified route of administration, administered in left arm on 21Apr2021 (at the age of 58-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, over two weeks of vaccine, the patient was feeling unwell. It was kind of hard breathing. The patient received Tylenol treatment for the event. The patient stated that he would receive the second vaccine on 12May2021. Outcome of the events was unknown at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Fatigue, Headache, Illness
Clinical narrative: Trouble breathing; stomach problems; Exhaustion; over all feeling of sick; headache; This is a spontaneous report from a contactable consumer who reported for patient (son-in- law). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number/ NDC number/ Expiry date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced trouble breathing, stomach problems, exhaustion, over all feeling of sick and headache. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021527264 same reporter/drug/event, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Dyspnoea, SARS-CoV-2 test
Clinical narrative: 12 hours after the vaccine  I felt shortness  of breath. Then I developed  a large lump on my collar bone area. I still can't breathe  right and get winded very easily.; 12 hours after the vaccine  I felt shortness  of breath. Then I developed  a large lump on my collar bone area. I still can't breathe  right and get winded very easily.; 12 hours after the vaccine  I felt shortness  of breath. Then I developed  a large lump on my collar bone area. I still can't breathe  right and get winded very easily.; This is a spontaneous report from contactable consumer (patient). A 49-years-old non-pregnant female patient received  bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8734, expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 31Mar2021 14:30 (at the age of 49-year-old) as Dose 2, Single for covid-19 immunization. The patients historical vaccine included first dose of BNT162B2 (lot number = EN6204) via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:30 as Dose 1, Single for Covid-19 immunization. Medical history included Gastric sleeved and Known allergies: Penicillin. Concomitant medications included Oxycodone, Ambien, Trazadone, and Vitamins. It was reported that patient was not taken any other vaccine in four weeks. The patient had not covid prior to vaccination. On 01Apr2021 01:00, the patient experienced 12 hours after the vaccine I felt shortness of breath. then I developed a large lump on my collar bone area. I still can not breathe right and get winded very easily. The patient received Steriods and an inhaler, still being treated as therapy for the events. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative   on 06May2021 on Nasal Swab. The patient was not recovered from the events.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Apr2021 as dose 1, single for COVID-19 immunization. The patient's medical history included allergy to shellfish and shrimps. The patient's concomitant medications were not reported. On an unspecified date on 2021 following vaccination, the patient had experienced a slight allergic reaction. The patient's doctor wanted to enquire whether she could receive second dose vaccination which was due on 11May2021. The outcome of the event was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Clonus, Mydriasis, Myoclonus, Pyrexia
Clinical narrative: myoclonic jerking of all four extremities with mydriasis and ocular clonus; mydriasis; ocular clonus; fever 39.1; This is a spontaneous report from a contactable Physician.   A 16-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via intramuscular route on 08May2021 as dose 1, single (age at vaccination 16 years) for covid-19 immunisation. Medical history included depression and anxiety since an unknown date. The patient did not have any known allergies. The patient did not have covid prior vaccination. The patient did not get any other vaccine in four weeks. Concomitant medication included fluoxetine hydrochloride (PROZAC) since an unknown date. The patient presented with fever 39.1 and myoclonic jerking of all four extremities with mydriasis and ocular clonus on 09May2021 at 21:00. The events resulted in emergency room/department or urgent care. The patient received therapeutic treatment for the events with PO Diazepam. The patient underwent lab tests included body temperature: 39.1 centigrade on 09May2021. The patient was tested for covid post vaccination via nasal swab, (PCR/NAAT) with result as negative on 09May2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: myoclonic jerking of all four extremities with mydriasis and ocular clonus; mydriasis; ocular clonus; fever 39.1; This is a spontaneous report from a contactable Physician.   A 16-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via intramuscular route on 08May2021 as dose 1, single (age at vaccination 16 years) for covid-19 immunisation. Medical history included depression and anxiety since an unknown date. The patient did not have any known allergies. The patient did not have covid prior vaccination. The patient did not get any other vaccine in four weeks. Concomitant medication included fluoxetine hydrochloride (PROZAC) since an unknown date. The patient presented with fever 39.1 and myoclonic jerking of all four extremities with mydriasis and ocular clonus on 09May2021 at 21:00. The events resulted in emergency room/department or urgent care. The patient received therapeutic treatment for the events with PO Diazepam. The patient underwent lab tests included body temperature: 39.1 centigrade on 09May2021. The patient was tested for covid post vaccination via nasal swab, (PCR/NAAT) with result as negative on 09May2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hypersensitivity
Clinical narrative: Headache; Allergy type feeling in chest; Diarrhea; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient has had a headache and felt like he had an allergy type feeling in chest. The patient had a mild headache and a little reaction, some type of reaction in his chest, but it had disappeared, but by Monday he had diarrhea and it had not stopped. It went away and now (at the time of report) had diarrhea for 8 days. The patient wanted to know how long it will last. Did read it as one of the side effects, but he has had no history of that kind of problem. Wants to know what is suggested for this side effect with the diarrhea, how long it will last. Investigation assessment was not provided. On an unknown date in 2021, the patient recovered from events headache and allergy type feeling in chest and the clinical outcome of diarrhea was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: kind of pain in chest; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0153) via an unspecified route of administration at left arm on 04May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0171) via an unspecified route of administration at left arm on 13Apr2021 as dose 1, single for COVID-19 immunisation. The patient had kind of pain in chest and reporter wanted to know these side effects were severe. Reporter confirmed that side effects were after taking the second dose. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Fatigue, Lethargy
Clinical narrative: exhausted; weak; Lethargic; Chills; lost her sense of taste; could barely move; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261; NDC number: unknown; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 26Jan2021 at 11:00 AM as dose 1, single (age at vaccination: 90-year-old) for COVID-19 immunisation. Medical history included multiple allergies, food allergy (shellfish) from on an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient previously had allergy to Penicillin B, sulfa 12, mercury and latex. On 26Jan2021, the patient had exhausted, weak, lethargic, chills, lost her sense of taste, could barely move. Patient had vaccination as she lives in a residence, and it was mandated, and she is vulnerable because of her age. Additional information stated that patient was exhausted, it started that night before she went to bed. Patient had the vaccine at 11:00 am and as the day wore on, she became more and more exhausted, so she went to bed early. She was weak, so lethargic she could barely move, she never got a fever, she had chills, and lost her sense of taste, it is just now starting to return. These symptoms lasted maybe four days and she was recovering and then she had the second dose. On an unspecified date, patient underwent lab tests and procedures which included positive SARS-COV-1 test. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, SARS-CoV-1 test positive
Clinical narrative: exhausted; weak; Lethargic; Chills; lost her sense of taste; could barely move; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261; NDC number: unknown; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 26Jan2021 at 11:00 AM as dose 1, single (age at vaccination: 90-year-old) for COVID-19 immunisation. Medical history included multiple allergies, food allergy (shellfish) from on an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient previously had allergy to Penicillin B, sulfa 12, mercury and latex. On 26Jan2021, the patient had exhausted, weak, lethargic, chills, lost her sense of taste, could barely move. Patient had vaccination as she lives in a residence, and it was mandated, and she is vulnerable because of her age. Additional information stated that patient was exhausted, it started that night before she went to bed. Patient had the vaccine at 11:00 am and as the day wore on, she became more and more exhausted, so she went to bed early. She was weak, so lethargic she could barely move, she never got a fever, she had chills, and lost her sense of taste, it is just now starting to return. These symptoms lasted maybe four days and she was recovering and then she had the second dose. On an unspecified date, patient underwent lab tests and procedures which included positive SARS-COV-1 test. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Computerised tomogram, Inappropriate schedule of product administration, Magnetic resonance imaging
Clinical narrative: When he urinated there was pure red; The second vaccination was two weeks later; This is a spontaneous report from a contactable consumer (Patient). This consumer is reported that:  A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date (at the age of 81 years old) as dose 2, single for covid-19 immunisation. Medical history included Crohns colitis diagnosed around 20 years ago, or 25 years ago when he quit smoking, brittle diabetic type 1 and lung neoplasm malignant from Jul2018 to an unknown date lung cancer, non small cell. Concomitant medications included insulin glargine (LANTUS) taken for diabetes mellitus inadequate control, insulin aspart (NOVOLOG) and mesalamine. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration, administered in left arm on 20Mar2021 as dose 1, single for covid-19 and experienced when he urinated there was pure red. On an unspecified date, the patient experienced when he urinated there was pure red two weeks after the second vaccination. Caller adds it is pure, it looked like pure blood. It was not light red, it was dark red. It was about the same color when he cut his hand the last time. Caller turned around and had an MRI the other day and they said his urinary tract is normal, they found nothing. He does not understand that at all. He does not know if it has anything to do with the Pfizer stuff or not. He searched and cannot find anything. Caller is going to have to go in and have the doctor go in his bladder with a scope which he is not happy about. He hopes that the doctor finds nothing but then if he finds nothing what does that mean. He was went to the physician office. He does not like the emergency room so he did not go. He did not want to go to the emergency room because Covid is going around. It has been over a month since the second shot and there is no more redness. The patient underwent lab tests and procedures which included computerised tomogram: normal and magnetic resonance imaging: normal on an unspecified date. The outcome of the event he urinated there was pure red was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Pyrexia
Clinical narrative: Had Fever all night; My son is sick; Horrible Headache; This is a spontaneous report from a contactable consumer (Patient's parent). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Lot number: not reported) via an unspecified route of administration on 07May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 07May2021, the patient had fever all night. On an unspecified date in May2021, the patient experienced horrible headache and was sick. It was reported that the reporter's son was sick and the reporter had been holding on line for like 30 minutes, so can give the patient tylenol or ibuprofen or what to give him because he had his second vaccine (unspecified vaccine) of pfizer yesterday, he had a horrible headache and he has had fever all night. The outcome of the events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she ran a very high fever; This is a spontaneous report from a contactable consumer, the patient.  A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was getting her covid shot tomorrow and after the last dose she ran a very high fever. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pyrexia
Clinical narrative: Loss of taste and smell; Loss of taste and smell; Bad fever; This is a spontaneous report from a contactable consumer, the patient's wife.  A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the vaccination on monday and was still having a bad fever and lost his sense of taste and smell on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Malaise
Clinical narrative: Allergies; did not feel well; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 19Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergies and did not feel well. The patient wanted to know where she could call to re-schedule her appointment for the second dose of Pfizer's COVID-19 vaccine, she received the first dose of the vaccine on 19Apr2021 and was trying to postpone her appointment for the second dose as she has allergies and does not feel well. She was supposed to get her second dose today. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: they got allergic reactions (after he got the 2nd dose 9 days later and he ended up in the hospital 3 times felt like his throat was swollen and went to the ER they put some injection for allergie; This is a spontaneous report received from a non-contactable consumer. This consumer reported for a 41-year-old male patient . A 41 year old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on unspecified date as DOSE 2, SINGLE for covid-19 immunization.The patient medical history and concomitant medications were not reported . The patient previously took received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date the patient had experienced allergic reactions (after he got the 2nd dose 9 days later and he ended up in the hospital 3 times felt like his throat was swollen and went to the ER they put some injection for allergies. The clinical outcome of the event was recovering/resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dysgeusia, Dysphagia, Fatigue, Headache
Clinical narrative: 1st Inj - immediately tasted a metallic taste; swelling of the throat; swelling of the throat, lips; swelling of the throat, lips and tongue; hard to swallow; joint pain; headaches; feeling unwell; tiredness; some itching; This is a spontaneous report received from a contactable consumer, the patient. A 51-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE,Formulation: Solution for injection, Lot number: ER8733), via an unspecified route of administration, in arm left on 01Apr2021 at 09:30 as Dose 1, Single (at the age of 51-year-old) for Covid-19 immunization. Medical history included allergy to Penicillin and Vicodin. The patient did not take any other vaccine in four weeks or any other medications in two weeks. The patient did not receive any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient, after first injection, on 01Apr2021, immediately tasted a metallic taste, had swelling of the throat, lips and tongue, hard to swallow ( all of these w/in the first 5 mins), had joint pain, headaches, was feeling unwell, tiredness, some itching. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation:Solution for injection, lot number: EW0169), via an unspecified route of administration, in arm left on an unknown date in Apr2021 at as Dose 2, Single for covid-19 immunization. Therapeutic measures were taken as a result of the events, the patient was advised to take Benadryl and received Benadryl an hour after appt. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknow n if the patient had if covid prior vaccination. She was not covid tested post vaccination. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 or not. Since the vaccination, the patient has not been tested for COVID-19. The outcome of all the events was recovered with lasting effects.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Malaise, Pharyngeal swelling, Pruritus, Swollen tongue
Clinical narrative: 1st Inj - immediately tasted a metallic taste; swelling of the throat; swelling of the throat, lips; swelling of the throat, lips and tongue; hard to swallow; joint pain; headaches; feeling unwell; tiredness; some itching; This is a spontaneous report received from a contactable consumer, the patient. A 51-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE,Formulation: Solution for injection, Lot number: ER8733), via an unspecified route of administration, in arm left on 01Apr2021 at 09:30 as Dose 1, Single (at the age of 51-year-old) for Covid-19 immunization. Medical history included allergy to Penicillin and Vicodin. The patient did not take any other vaccine in four weeks or any other medications in two weeks. The patient did not receive any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient, after first injection, on 01Apr2021, immediately tasted a metallic taste, had swelling of the throat, lips and tongue, hard to swallow ( all of these w/in the first 5 mins), had joint pain, headaches, was feeling unwell, tiredness, some itching. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation:Solution for injection, lot number: EW0169), via an unspecified route of administration, in arm left on an unknown date in Apr2021 at as Dose 2, Single for covid-19 immunization. Therapeutic measures were taken as a result of the events, the patient was advised to take Benadryl and received Benadryl an hour after appt. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknow n if the patient had if covid prior vaccination. She was not covid tested post vaccination. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 or not. Since the vaccination, the patient has not been tested for COVID-19. The outcome of all the events was recovered with lasting effects.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.