chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Horrible joint pain I couldn't move; Diarrhea; vomiting; headache; chills; low grade fever; sweating; my right hand got so inflamed that it looked weird; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Feb2021 10:15 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included Multiple epificial dysplasia. Known allergies: Penicillin, latex. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021, 09:00 AM (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunisation. No Other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 24Feb2021, 15.00, the patient had horrible joint pain she couldn't move, her right hand got so inflamed that it looked weird, she had diarrhea, vomiting, headache, chills, low grade fever, sweating. She has multiple epiphyseal dysplasia, she was thinking that's why her joints had such a reaction. It lasted less than 48 hrs. No treatment received. Outcome of the events was recovered in Feb2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pyrexia, Vomiting
Clinical narrative: Horrible joint pain I couldn't move; Diarrhea; vomiting; headache; chills; low grade fever; sweating; my right hand got so inflamed that it looked weird; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Feb2021 10:15 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included Multiple epificial dysplasia. Known allergies: Penicillin, latex. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021, 09:00 AM (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunisation. No Other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 24Feb2021, 15.00, the patient had horrible joint pain she couldn't move, her right hand got so inflamed that it looked weird, she had diarrhea, vomiting, headache, chills, low grade fever, sweating. She has multiple epiphyseal dysplasia, she was thinking that's why her joints had such a reaction. It lasted less than 48 hrs. No treatment received. Outcome of the events was recovered in Feb2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: As per caller she received her 1st dose on 27Dec2020 and they did a test for her on 14Jan2021 the test for covid came back positive on 17Jan2021; Had first vaccine dose then had rapid and PCR test done and tested positive; This is a spontaneous report received from a contactable nurse (patient). A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Unknown), via an unspecified route of administration on 27Dec2020 as single dose (48 years at the time of vaccination) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Follow-ups (26Feb2021) were received from same reporter and were processed together with initial information. On 14Jan2021, the patient had a rapid Covid-19 test and results came back positive on 17Jan2021. However, she was expected to get the second dose on the 17Jan2021, but she did not. Then on 19Jan2021, she had PCR test and was tested positive. She was told not to Pfizer doctor because of testing positive for COVID. She would like to know if she needs to start over or if she can take, make appointment for her second dose because she is getting conflicting information, her cardiologist says that she needs to wait 90 days and then she talked to pharmacist that said no, she doesn't need to, she can "fed up" (not clarified) her appointment and she would just like to know what she should do. In Feb2021 she was tested positive for Covid-19 again, and she was tested for Covid-19 again yesterday, but she doesn't have her results yet. The outcome of events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: Tingling in my left hand; severe throbbing pain in my left arm; This is a Spontaneous report from a Contactable other HCP (patient, self-reported). A 77-years-old female patient (patient was not pregnant) received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 17:30, as single dose for COVID-19 immunisation. The patient's medical history included allergy to amoxicillin. The concomitant medication included vitamins. On 11Feb2021 at 12:00 AM, the patient experienced tingling in left hand for 3-days still present time, 2nd day after COVID Vaccine she had severe throbbing pain in left arm and took tylenol-MAPP 650 Mg every 8 hrs. Also Ibuprofen 400MG 4-hrs after taking tylenol. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not take any other vaccine in four weeks. Patient took tylenol-MAPP 650 mg every 8 hrs and Ibuprofen 400mg as corrective treatment. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was considered as not recovered.  No follow up attempts are needed. Information on Lot/batch can not be requested. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vaccination site paraesthesia
Clinical narrative: Tingling in my left hand; severe throbbing pain in my left arm; This is a Spontaneous report from a Contactable other HCP (patient, self-reported). A 77-years-old female patient (patient was not pregnant) received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 17:30, as single dose for COVID-19 immunisation. The patient's medical history included allergy to amoxicillin. The concomitant medication included vitamins. On 11Feb2021 at 12:00 AM, the patient experienced tingling in left hand for 3-days still present time, 2nd day after COVID Vaccine she had severe throbbing pain in left arm and took tylenol-MAPP 650 Mg every 8 hrs. Also Ibuprofen 400MG 4-hrs after taking tylenol. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not take any other vaccine in four weeks. Patient took tylenol-MAPP 650 mg every 8 hrs and Ibuprofen 400mg as corrective treatment. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was considered as not recovered.  No follow up attempts are needed. Information on Lot/batch can not be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: She missed her second dose; she had no taste or smell and tested positive for COVID-19; she had no taste or smell and tested positive for COVID-19; This is a spontaneous report from a contactable consumer(patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 10Jan2021 as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. Patient stated she received the first dose of the Pfizer COVID vaccine on 10Jan2021 and her second dose was scheduled on 31Jan2021. On 28Jan2021 when she woke up she had no taste or smell and tested positive for COVID-19. She missed her second dose on 31Jan2021 and wanted to know when can she take her second dose. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This is a spontaneous report from a contactable consumer or other non-helath care professional via Medical Information Team. An 89-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunization. Medical history included knee issues. The patient's concomitant medications were not reported. On 13Feb2021, patient tested positive for COVID using the rapid test and a PCR. Reporter was not sure whether the patient was exposed to COVID before or after the first dose. On 13Feb2021, patient underwent lab tests and procedures which included sars-cov-2 test: positive. Patient's second dose was due on 02Mar2021 and the reporter wanted to know if patient should continue with her second dose after she has recovered. Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I just got up today to get tested and the covid test was positive; I just got up today to get tested and the covid test was positive; This is a spontaneous report from a contactable consumer. This 66-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection) via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The next morning, the patient woke work up and it was the worst day ever. On an unknown date, the patient had the flu the before and it was like that. The patient couldn't move, stayed in bed for 24 hours and just got up today to get tested and the COVID test was positive. The patient went to get tested when found out and was told it was too early to be tested. So she went back 8 days later and tested negative. When she saw that they were offering free vaccinations, the patient went on Wednesday to get the vaccine. The patient reported that her husband was positive for COVID 3 weeks ago. The outcome for the events were unknown. Attempted to connect caller for event reporting. Due to prolonged hold time, caller declined to continue holding and agreed to received follow up regarding this event via phone or email. Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: My patient received the first dose of the Pfizer COVID-19 vaccine on 22Jan2021. The patient was tested positive for COVID-19 last Friday; My patient received the first dose of the Pfizer COVID-19 vaccine on 22Jan2021. The patient was tested positive for COVID-19 last Friday; This is a spontaneous report received from a contactable Pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was tested positive for COVID-19 last Friday and feeling better now. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE  to the reported 'COVID 19' cannot be excluded. However, more information is needed regarding the date of COVID19 test done.Once the information is received the case can be further reassessed
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Nasopharyngitis, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested again on the 20Feb, this test was positive; tested again on the 20Feb, this test was positive; Head cold; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3247), via unspecified route of administration in left arm on 04Feb2021 at 11:15 AM for COVID-19 immunisation. The patient's medical history was not reported. Patient had other vaccine in four weeks. The patient had no concomitant medications (there was no other medications in two weeks). The patient experienced head cold on 09Feb2021 and tested again on the 20Feb, this test was positive on 20Feb2021. Patient reported contracted a head cold about 5 days out on the 12 tested negative for covid. Then cold did not get any better. Tested again on the 20Feb2021, this test was positive. Still just feels like recovering from a cold. The patient did not receive any treatment. The patient did not have covid prior vaccination and patient tested for covid post vaccination. The patient underwent lab test and procedures nasal swab was negative on 12Feb2021 and positive on 20Feb2021. The outcome of the event was recovering.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Malaise, Nausea
Clinical narrative: started to feel ill; dizziness; headaches; Body aches; Chills; nausea; This is a spontaneous report from a contactable consumer(Patient herself). A 72-Year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiration date unknown) via an unspecified route of administration, administered in left arm on 27Jan2021 05:30 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, on 17Feb2021 04:00 PM Left arm (at the age of 72 years old) both as single dose or COVID-19 immunisation. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19.Medical history included migraine headaches. Concomitant medications included metoprolol, synthroid, hydrochloride, Enalapril, 81 within 2 weeks of vaccination. On 19Feb2021 03:00 AM, the patient experienced to feel ill, dizziness, headache, body aches, Chills and nausea. Treatment was received in response to the adverse events included Ibuprofen self-administered. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: started to feel ill; dizziness; headaches; Body aches; Chills; nausea; This is a spontaneous report from a contactable consumer(Patient herself). A 72-Year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiration date unknown) via an unspecified route of administration, administered in left arm on 27Jan2021 05:30 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, on 17Feb2021 04:00 PM Left arm (at the age of 72 years old) both as single dose or COVID-19 immunisation. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19.Medical history included migraine headaches. Concomitant medications included metoprolol, synthroid, hydrochloride, Enalapril, 81 within 2 weeks of vaccination. On 19Feb2021 03:00 AM, the patient experienced to feel ill, dizziness, headache, body aches, Chills and nausea. Treatment was received in response to the adverse events included Ibuprofen self-administered. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Stepmother) that an elderly female patient (not pregnant) received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunisation with no adverse reactions. It was unknown if other vaccine received in four weeks. During A Text Message Conversation on 26Feb2021, the Patient Wrote, "I Had No Adverse Reactions for the First and Second Shot. Just A Little Sore Arm and Slight Headache after the Second Shot." It was unknown if treatment received for the events. It was unknown if Covid Prior Vaccination an if Covid Tested Post Vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Pain in extremity
Clinical narrative: muscle aches,; severe back ache; soreness in arm; fatigue; This is a spontaneous report from a contactable consumer.A 68-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN60205), via an unspecified route of administration on arm left on 25Feb2021 10:00 AM at single dose for COVID-19 immunization. The patient medical history included scoliosis, high cholesterol and has allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines in 4 weeks. The patients concomitant medications included Preservision Areds 2, Atorvastatin 10 mg, Vitamins. On 25Feb2021, the patient experienced soreness in arm and fatigue same night as vaccine. Next morning muscle aches, severe back ache, fatigue - arm had improved.. The events resulted in doctor or other healthcare professional office/clinic visit. The patient treatment included chiropractic adjustment. It was unknown if the patient recovered from the events..  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Headache, Lymphadenopathy, Nausea
Clinical narrative: disoriented; Fever; Headache; swollen lymph node under left armpit for 4 days; body aches; tiredness; mild nausea; This is a spontaneous case is received from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, high cholesterol and acid reflux. It was unknown if the patient had known allergies. The patient's concomitant medications were not reported. On 24Feb2021 at 02:00, the patient experienced disoriented, fever, headache, swollen lymph node under left armpit for 4 days, body aches, tiredness and mild nausea. Therapeutic measures were taken as a result of fever. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: disoriented; Fever; Headache; swollen lymph node under left armpit for 4 days; body aches; tiredness; mild nausea; This is a spontaneous case is received from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, high cholesterol and acid reflux. It was unknown if the patient had known allergies. The patient's concomitant medications were not reported. On 24Feb2021 at 02:00, the patient experienced disoriented, fever, headache, swollen lymph node under left armpit for 4 days, body aches, tiredness and mild nausea. Therapeutic measures were taken as a result of fever. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling of body temperature change, Headache, Nausea
Clinical narrative: Severe headache/centered in forehead radiating slightly back; I couldn't eat due to nausea and minor vomiting in first half of the day; I couldn't eat due to nausea and minor vomiting in first half of the day; couldn't eat due to feeling weak and lightheaded; couldn't eat due to feeling weak and lightheaded; I was hot and cold throughout the day; Unable to locate thermometer to take temperature; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered on left arm 25Feb2021 02:00 PM at single dose for COVID-19 immunisation. Patient medical history included asplenic, cochlear implant, survived bacterial meningitis, PTSD, anxiety, depression, neck and back pain and allergies. Allergies to medications, food, or other products: Bactrim. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Tizanidine, clonazepam, Lamictal and singular. On 26Feb2021 11:00 AM, the patient had experienced severe headache centered in forehead radiating slightly back Ice on patient's head made the headache worse Tylenol helped a bit, couldn't eat due to nausea, minor vomiting, feeling weak and lightheaded, hot and cold throughout the day. Unable to locate thermometer to take temperature and visual impartment. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of event is Recovering.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: Severe headache/centered in forehead radiating slightly back; I couldn't eat due to nausea and minor vomiting in first half of the day; I couldn't eat due to nausea and minor vomiting in first half of the day; couldn't eat due to feeling weak and lightheaded; couldn't eat due to feeling weak and lightheaded; I was hot and cold throughout the day; Unable to locate thermometer to take temperature; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered on left arm 25Feb2021 02:00 PM at single dose for COVID-19 immunisation. Patient medical history included asplenic, cochlear implant, survived bacterial meningitis, PTSD, anxiety, depression, neck and back pain and allergies. Allergies to medications, food, or other products: Bactrim. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Tizanidine, clonazepam, Lamictal and singular. On 26Feb2021 11:00 AM, the patient had experienced severe headache centered in forehead radiating slightly back Ice on patient's head made the headache worse Tylenol helped a bit, couldn't eat due to nausea, minor vomiting, feeling weak and lightheaded, hot and cold throughout the day. Unable to locate thermometer to take temperature and visual impartment. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of event is Recovering.  Information on the lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Nausea, Vomiting
Clinical narrative: Nauseous; laying down on couch, then on bed, sitting on toilet, had bowel movements.; Then VOMITING started.14 times at HOME, 3 more times in ER.; This is a spontaneous report from a contactable nurse.   A 84-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Exp6202), dose 1 intramuscular, administered in LEFT ARM ON 24FEB2021 AT 13:30 AS SINGLE DOSE FOR COVID-19 immunisation.  Medical history included arthritis, sciatica, sinusitis, allergic sinusitis, surgery. The patient's concomitant medications were not reported.  No other vaccine in four weeks. No covid tested prior and post vaccination. 25Feb2021 01:00 PM, she had nauseous, laying down on couch, then on bed, sitting on toilet, had bowel movements. then vomiting started. 14 times at home, 3 more times in ER. The event assessed as non-serious. Therapeutic measures of GI Cocktail with Lidocaine, Carafate. RX: Ondansetron HCL 4 MG were taken for all events. Outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: joint and muscle ache and pain in arms, legs and buttocks began to be noticeable February 21, 2021; joint and muscle ache and pain in arms, legs and buttocks began to be noticeable February 21, 2021; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266) via an unspecified route of administration at arm left on 16Feb2021 13:00 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included prostatic disorder, Rx control for prostate and cholesterol, blood cholesterol abnormal. Concomitant medications included finasteride (FINASTERIDE) and rosuvastatin (ROSUVASTATIN). On 21Feb2021 the patient experienced joint and muscle ache and pain in arms, legs and buttocks began 07:00 and has been escalating each day since then, the aches and pain are becoming unbearable while moving, or walking. The outcome of the event aches and pain are becoming unbearable while moving, or walking was unknown and rest events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Nausea, SARS-CoV-2 test
Clinical narrative: I had a slight tightness of heart; Nausea; This is a spontaneous report from a contactable Other-Health Care Professional. A 39-years-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 06Jan2021 (Batch/Lot number was not reported), as SINGLE DOSE for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Medical history included, the patient previously took doxycycline and caffeine, experienced drug hypersensitivity and allergy to raw tomatoes and peach peels. There were no concomitant medications. In Jan2021, the patient experienced a slight tightness of heart (chest discomfort) and nausea. The patient underwent lab tests and procedures which included COVID-19 Nasal Swab test and COVID PCR both were negative on 10Feb2021. The outcome of the events were recovered on an unspecified date in Jan2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo occurring 10 days after each injection; This is a spontaneous report from a contactable consumer (herself). A 70-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 16Feb2021 at 14:45 as single dose for covid-19 immunisation. Patient did not take other medication in four week. The patient medical history and concomitant medication(s) included alirocumab (PRALUENT), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). Historical Vaccine included first dose of bnt162b2. On an unspecified date, the patient had vertigo occurring 10 days after each injection. Patient took other medications in two weeks was included praluent, BREO, allergy medications and vitamins. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal pain, Nausea
Clinical narrative: Severe GI cramping; diarrhea; nausea; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 10Feb2021 12:15 (Batch/Lot Number: EN6201) (at the age of 40-years-old) as single dose for covid-19 immunisation. The patient medical history included none. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Right on 20Jan2021 11:00 (Batch/Lot Number: EL-9261) (at the age of 40-years-old) for covid-19 immunisation. On 12Feb2021 03:00, the patient experienced severe GI cramping, diarrhea and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events included 2 litres of fluids, IV, IM and po medications. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and know drug profile a  contributory role of BNT162B2  to the reported severe GI cramping, diarrhea and nausea cannot be totally excluded. Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 5 days after the 2 vaccine I experienced large swelling in the lymph node area between my jaw and ear lobe on the right side.  My vaccine was on the left arm.; This is a spontaneous report from a contactable consumer. A 73-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 21Feb2021 12:00 as single dose for covid-19 immunisation. Medical history included tachycardia. Concomitant medication(s) included aspirin, amlodipine, omeprazole, Multivitamin and Vita. The patient previously took tetracycline, tramadol and codeine for all experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 18:00, the patient experienced 5 days after the 2 vaccine I experienced large swelling in the lymph node area between my jaw and ear lobe on the right side. My vaccine was on the left arm. The patient did not receive any treatment. Outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Fatigue, Nausea
Clinical narrative: GI upset; nausea; abdominal pain; extreme tiredness; This is a spontaneous report from a contactable other HCP.   A 73-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 21Feb2021 14:30 as SINGLE DOSE for covid-19 immunization.  Medical history included scleroderma and gastro esophageal reflux disease. Concomitant medications included omeprazole, metoprolol, crestor, zetia, and multivits. The patient previously took epinephrine and experienced drug hypersensitivity. On an unspecified date, the patient experienced GI upset. nausea, abdominal pain, and extreme tiredness. The outcome of the events was reported as recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: Headache; Sleepy; This is a spontaneous report from a contactable consumer (patient). A 61-years-old non-pregnant female patient received of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 20Feb2021 14:45 (Lot Number: El9269 and Expiration date: Unknown) as single dose for covid-19 immunization. Medical history included lupus. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), levothyroxine sodium (SYNTHROID) and esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unspecified indication. On 20Feb2021 at 18:15, patient experienced Headache and sleepy. 3-4 hours after receiving the shot the patient became so sleepy she could not hold her eyes open and felt like she was melting. The patient also had a slight headache for about 2 days. She did take a nap for about 1.5 hours - woke up for a couple hours and then went to bed for the night. she felt ok in the morning except for the slight headache. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives one week after 2nd shot; This is a spontaneous report from a contactable consumer. A 73-year-old non-pregnant female patient received BNT162B2 (solution for injection) dose 2 via an unspecified route of administration, in left arm on 19Feb2021 at 11:30 as single dose for covid-19 immunization. Medical history included penicillin, Sulphur products. Historical vaccine included on 24Jan2021 BNT162B2 (product=COVID19; lot number: unknown; dose number 1; Anatomical location=Left arm). No prior vaccination of covid and no covid tested post vaccination. The patient's concomitant medications was not reported. On 26Feb2021 at 09:00, the patient experienced hives, one week after 2nd shot and there was no event treatment received for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: Open sore at injection site oozing clear fluid; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown Expiry date: unknown) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization. Patient medical history included known allergies to penicillin, codeine. Patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 05Feb202 at 10:15 AM for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not diagnosed with COVID-19. On 28Feb2021 at 08:30, patient experienced open sore at injection site oozing clear fluid. Patient did not receive the treatment for event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Circumstance or information capable of leading to medication error, SARS-CoV-2 test
Clinical narrative: covid test and it came back on 22Feb2021 as positive; What I understood is that if you had Covid, you are not supposed to be on the vaccine for 70 days. I cannot have it 90 days or something around that time after having a positive Covid test; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EM9809) via an unspecified route of administration on 12Feb2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested covid and it came back on 22feb2021 as positive. Patient thought that she is not supposed to be on the vaccine for 70 days. She cannot have it 90 days or something around that time after having a positive Covid test. The patient underwent lab tests and procedures which included Nasal swab test positive on 22Feb2021. Her second shot scheduled on 05Mar2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: I have been throwing up; This is a spontaneous report from a Pfizer sponsored program . A female patient of unspecified age (consumer) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/LOT no unknown) dose 1 on unspecified date and second dose on 10Feb2021 via an unspecified route of administration as single dose for COVID-19 immunisation. The medical history and concomitant medication were not provided. Patient reported she just wanted to talk to somebody. Patient needed to start over with her situation she had been throwing up. patient needed to find out if this was related to vaccine. Patient was having an adverse reaction last 14Feb2021 and 19Feb2021. Product details (Lot, Expiration Date, NDC and UPC) and other consumer details could not be probed. Medical information had been requested. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Only for 1.5 days sore injection sight; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received BNT162B2 (Solution for injection, Lot number: EN6203) via an unspecified route of administration on the left arm on 25Feb2021 at 15:00 for Covid-19 Immunisation. The patient medical history included asthma and heart murmur. The patients concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 25Feb2021 at 16:00 PM, the patient experienced sore injection site approximately 2 inches for 1.5 days. The patient did not receive any treatment for the event. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Urinary incontinence
Clinical narrative: hard to get a breath; anxious; my heart began to race; felt the urge to use the bathroom; This is a spontaneous report from a contactable consumer. A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in arm right on 25feb2021 at 16:15 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. No Known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 25Feb2021 16:15 after about 1 minute she began to fill anxious, her heart began to race, and she noticed it was hard to get a breath. She also immediately felt the urge to use the bathroom. She raised her mask up slightly and was able to take deep breaths and she tried to calmly read the vaccine pamphlet as she thought maybe she was just nervous as she have never had a reaction before. No treatment received. The events outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: cannot walk; left leg from hip to knee, severe ache; This is a spontaneous report from a contactable other-HCP (patient himself). A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6198) via an unspecified route of administration in left arm on 25Feb2021 16:30 as single dose for covid-19 immunization. Patient was 65-years-old at the time of vaccination. Patients medical history and  concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left leg from hip to knee, severe ache, cannot walk, very painful on 26Feb2021 05:00. No treatment received for reported adverse event. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Slight headache after shot into evening.; Slight nausea second night; Slight arm soreness on and off second and third day.; This is a spontaneous report from a contactable consumer. An unspecified age elderly (65+ Years) female patient (patient was not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266 and expiration date was not reported), via an unspecified route of administration in left arm on 26Feb2021 at 03:00 PM, at single dose for COVID-19 immunisation. The patient had medical history of High blood pressure and tachycardia. The concomitant medication included metoprolol, lovastatin, losartan and amlodipine besylate. It reported that, patient experienced slight headache after shot into evening, slight nausea second night and slight arm soreness on and off second and third day. Vaccine facility: Hospital. There was no other vaccine in four weeks and there is no treatment required to the adverse event. No COVID prior vaccination and not tested COVID post vaccination. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Productive cough, Throat irritation
Clinical narrative: started having to clear throat; vocal changes; semi-wet cough; This is a spontaneous report from a contactable consumer. A 70-Year-Old Female Patient (non-pregnant) received first dose of of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN8202), via an unspecified route of administration, administered at left arm, on 28Feb2021, 11:00 AM at single dose for COVID-19 immunisation. Patient medical history included cancer, lymphocytic colitis and PI 1 deficiency. Patient was known to allergies reactions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient did not received other medications within 2 weeks of vaccination. On 28Feb2021, 45 min after administration, patient started having to clear throat, with vocal changes (hoarse voice went to a squeeky voice) with constant clearing of throat and semi-wet cough. Patient was treated with Benadryl, Epinephrine injectable and prednisolone. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the evens are recovered on 28Feb2021.  No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Antibody test, Incomplete course of vaccination
Clinical narrative: started having to clear throat; vocal changes; semi-wet cough; This is a spontaneous report from a contactable consumer. A 70-Year-Old Female Patient (non-pregnant) received first dose of of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN8202), via an unspecified route of administration, administered at left arm, on 28Feb2021, 11:00 AM at single dose for COVID-19 immunisation. Patient medical history included cancer, lymphocytic colitis and PI 1 deficiency. Patient was known to allergies reactions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient did not received other medications within 2 weeks of vaccination. On 28Feb2021, 45 min after administration, patient started having to clear throat, with vocal changes (hoarse voice went to a squeeky voice) with constant clearing of throat and semi-wet cough. Patient was treated with Benadryl, Epinephrine injectable and prednisolone. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the evens are recovered on 28Feb2021.  No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer(patient). A 41-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6202), via an unspecified route of administration on arm left on 27Feb2021 11:45 AM at single dose for COVID-19 immunization. The patient medical history included Polycystic Ovarian Syndrome and allergies to Sulfa Drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines in 4 weeks. The patient Concomitant medications included ethinylestradiol, norethisterone (VYFEMLA), Prazosin, Buspirone, Metformin. On 27Feb2021 12:30 PM, the patient experienced Extreme fatigue, headache, achy joints, sore injection site, nausea. The lab test included PCR (Nasal swab), result: Negative on 05Feb2021. The patient did not receive any treatment for the events. The outcome of the events was reported as Recovering. No follow-up attempts are possible. No further information is expected.