chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: join pain; Difficulty breathing; fast heartbeat; dizziness; weakness; chills; diarrhea; nausea; vomit; tiredness; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 27Jan2021 12:30 as 1st dose, single (age at vaccination 66-years) for COVID-19 immunization. Medical history included depression and parkinsons disease from an unknown date and unknown if ongoing. Concomitant medications included donepezil hcl 5mg, sertraline hcl 50mg, and carbidopa taken for an unspecified indication, start and stop date were not reported (medications in two weeks before vaccination). The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient did not take any other vaccine in four weeks. Patient stated that 4 days after her first dose (31Jan2021 12:00am) she felt tiredness and headaches. The next day (01Feb2021), patient had chills, diarrhea, nausea and vomit a lot until was dehydrated. On 04Feb2021 12:00am, the patient had difficulty breathing, a fast heartbeat, dizziness, weakness and joint pain. Patient thought she was going to die and she did not go to the emergency room because she really do not want to get die there. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The treatment was received for the adverse events. Adverse event treatment given with pedialyte to get hydrated. The patient underwent lab tests and procedures which included heart rate increased: fast on 04Feb2021. The vaccination facility type was reported as hospital. . The clinical outcome of the events was reported as recovering.  Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: fever; dizziness; headache; muscle pain; joint pain; chills; sweating; nausea; I feel horrible/I feel like I was hit by a bus and I am still being dragged; Injection site pain as soon as I got the second dose; tiredness; weakness; This is a spontaneous report from a contactable Other healthcare professional (patient). A 29-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on 04Feb2021, administered into left arm as 2nd dose, single for COVID-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. patient was not diagnosed with COVID. Patient had no allergies. The patient previously had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration on 14Jan2021 into left arm for COVID-19 immunization at public health clinic. On 04Feb2021, the patient experienced Injection site pain as soon as she got the second dose. Followed by tiredness and weakness. On 05Feb2021 (next day), had a fever, dizziness, headache, muscle pain, joint pain, chills, sweating, and nausea, she feels horrible. Feel like she was hit by a bus and still being dragged. No treatment was given for the events. Patient did not receive any other vaccine in four weeks. Prior the vaccination. On 21Jan2021, the patient underwent lab tests which included sars-cov-2 test: negative. The clinical outcome of the Injection site pain, tiredness and weakness, fever, dizziness, headache, muscle pain, joint pain, chills, sweating, and nausea, she feels horrible were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: fever; dizziness; headache; muscle pain; joint pain; chills; sweating; nausea; I feel horrible/I feel like I was hit by a bus and I am still being dragged; Injection site pain as soon as I got the second dose; tiredness; weakness; This is a spontaneous report from a contactable Other healthcare professional (patient). A 29-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on 04Feb2021, administered into left arm as 2nd dose, single for COVID-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. patient was not diagnosed with COVID. Patient had no allergies. The patient previously had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration on 14Jan2021 into left arm for COVID-19 immunization at public health clinic. On 04Feb2021, the patient experienced Injection site pain as soon as she got the second dose. Followed by tiredness and weakness. On 05Feb2021 (next day), had a fever, dizziness, headache, muscle pain, joint pain, chills, sweating, and nausea, she feels horrible. Feel like she was hit by a bus and still being dragged. No treatment was given for the events. Patient did not receive any other vaccine in four weeks. Prior the vaccination. On 21Jan2021, the patient underwent lab tests which included sars-cov-2 test: negative. The clinical outcome of the Injection site pain, tiredness and weakness, fever, dizziness, headache, muscle pain, joint pain, chills, sweating, and nausea, she feels horrible were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: fever; dizziness; headache; muscle pain; joint pain; chills; sweating; nausea; I feel horrible/I feel like I was hit by a bus and I am still being dragged; Injection site pain as soon as I got the second dose; tiredness; weakness; This is a spontaneous report from a contactable Other healthcare professional (patient). A 29-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on 04Feb2021, administered into left arm as 2nd dose, single for COVID-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. patient was not diagnosed with COVID. Patient had no allergies. The patient previously had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration on 14Jan2021 into left arm for COVID-19 immunization at public health clinic. On 04Feb2021, the patient experienced Injection site pain as soon as she got the second dose. Followed by tiredness and weakness. On 05Feb2021 (next day), had a fever, dizziness, headache, muscle pain, joint pain, chills, sweating, and nausea, she feels horrible. Feel like she was hit by a bus and still being dragged. No treatment was given for the events. Patient did not receive any other vaccine in four weeks. Prior the vaccination. On 21Jan2021, the patient underwent lab tests which included sars-cov-2 test: negative. The clinical outcome of the Injection site pain, tiredness and weakness, fever, dizziness, headache, muscle pain, joint pain, chills, sweating, and nausea, she feels horrible were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pityriasis rosea, Rash, SARS-CoV-2 test
Clinical narrative: Date of start of drug: 26Dec2020, Dose Number: 1 /Date of start of drug: 12Jan2021, Dose Number: 2; Rash on right breast and then all over trunk.; Diagnosed with pityriasis rosea; This is a spontaneous report from a contactable other health care professional. A 32-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 12Jan2021 (Batch/Lot Number: EL1283) as SINGLE DOSE for COVID-19 immunisation. Concomitant medication included piroxicam (PAXIL [PIROXICAM]), gabapentin (GABAPENTIN), medroxyprogesterone acetate (DEPO-PROVERA). The patient experienced date of start of drug: 26dec2020, dose number: 1 /date of start of drug: 12jan2021, dose number: 2, rash on right breast and then all over trunk on 21Jan2021, diagnosed with pityriasis rosea on 21Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Jan2021 Roche cobas 6800, sars-cov-2 test: negative on 04Feb2021 Roche cobas 6800. Therapeutic measures were taken because of rash on right breast and then all over trunk. (rash), diagnosed with pityriasis rosea (pityriasis rosea). The outcome of the event Inappropriate schedule of vaccine administered was unknown and outcome of other events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: Chills; body aches; injection site soreness; This is a spontaneous report from a non-contactable consumer. This 35-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Solution for injection) via an unspecified route of administration to her left arm on 04Feb2021 05:00 PM (Lot number: EL9269) as single dose for Covid-19 immunisation. Facility type vaccine: Hospital. The patient's medical history included COVID (Covid prior vaccination). Patient had known allergies Nickel (Ni). Concomitant medications were not reported. On 05Feb2021 07:00 AM, the patient experienced chills, body aches and injection site soreness. Covid was not tested post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Influenza like illness, Listless
Clinical narrative: flu-like symptoms; body aches; chills; slight fever; listlessness; headaches; This is a spontaneous report from a contactable consumer(patient). A 42-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: Not available) via unspecified route of administration on 02Feb2021 07:30 as single dose in left arm for Covid-19 immunisation in hospital. No other vaccine in four weeks was reported. Medical history reported was HIV+. Concomitant medications reported was bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) and clarithromycin (CLARITIN), both as 1 a day. No Known allergies were reported. Patient was not tested positive covid prior vaccination nor covid tested post vaccination. Patient wanted to report that he had flu-like symptoms yesterday (04Feb21), he felt better today, but he did experience, body aches, chills, slight fever, and listlessness. He felt a little better today but truly felt like he was hit by a bus yesterday. He will continue to monitor symptoms as he felt much better today, but wanted to make aware of what he experienced. It started on 03Feb2021 with headaches. Patient did not receive any treatment in response to the events. Outcome of all the events was recovering.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: flu-like symptoms; body aches; chills; slight fever; listlessness; headaches; This is a spontaneous report from a contactable consumer(patient). A 42-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: Not available) via unspecified route of administration on 02Feb2021 07:30 as single dose in left arm for Covid-19 immunisation in hospital. No other vaccine in four weeks was reported. Medical history reported was HIV+. Concomitant medications reported was bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) and clarithromycin (CLARITIN), both as 1 a day. No Known allergies were reported. Patient was not tested positive covid prior vaccination nor covid tested post vaccination. Patient wanted to report that he had flu-like symptoms yesterday (04Feb21), he felt better today, but he did experience, body aches, chills, slight fever, and listlessness. He felt a little better today but truly felt like he was hit by a bus yesterday. He will continue to monitor symptoms as he felt much better today, but wanted to make aware of what he experienced. It started on 03Feb2021 with headaches. Patient did not receive any treatment in response to the events. Outcome of all the events was recovering.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Headache, Sleep paralysis
Clinical narrative: Dizziness; headache; Multiple bouts of sleep paralysis and sense of impending doom throughout the night; Multiple bouts of sleep paralysis and sense of impending doom throughout the night; This is a spontaneous report from a non-contactable Other-HCP. A 25-year-old male patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EL9265, Expiration date: unknown), dose 2 intramuscular, administered in Arm Left on 04Feb2021 17:45 as 2nd dose, single for covid-19 immunization. Medical history included food Allergic to shellfish from an unknown date. The patient previously received the first dose of bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown), dose 1. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No other medications in two weeks. On 04Feb2021 20:30 about three hours post-vaccination the patient experienced dizziness, went to bed around that time and woke up several times throughout the night with dizziness and headache, multiple bouts of sleep paralysis and sense of impending doom throughout the night (both personally very abnormal). No treatment received. The outcome of all events was recovered on an unspecified date in Feb2021 with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pre-existing condition improved
Clinical narrative: he had a significant reduction in stiffness; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Num-ber: EL9265; Expiration Date: 31May2021), via intramuscular, administered in Deltoid Right on 04Feb2021 08:18 (at the age of 66-year-old) as unknown, 0.3ml, single for covid-19 immunisation. Medical history included ongoing mild case of diabetes diagnosed two years ago, he has been stiff for many years and when he woke up he had a significant reduction in stiffness. There were no concomitant medications. On 05Feb2021, the patient reported that he has been stiff for many years and when he woke up this morning he had a significant reduction in stiffness. The patient underwent lab tests and procedures which included blood serum was slightly off on an unknown date. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise
Clinical narrative: Diarrhea; Is not feeling well; This is a spontaneous report from a contactable consumer. A 87-years-old female patient (age at vaccination: 87years) received first dose BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in right arm on 04Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation (at clinic) patient stated the appointment time of vaccination was 10:30. Medical history of the patient was allergic to molds and mucus and concomitant medications unspecified allergy spray indicated for stuffy mucus, allergy shots indicated for allergy to molds from unknown to ongoing. No relevant tests were performed to patient prior to vaccination. Patient didn't receive any other vaccinations with in 4weeks time of vaccination. The patient stated that she got the vaccine she did not report that she takes a shot for allergies. Since getting the vaccine she has not been feeling up to par. On 04Feb2021 She has also been having diarrhea. she stated that the diarrhoea was not watery. It was soft and not much is coming out, Patient is not feeling well. Events did not require a visit to emergency room or physician office. The outcome of the events Malaise was unknown and the outcome of diarrhoea was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: feeling like he had the flu; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (brother-in-law).   A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number and Expiration date: Not reported), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single; and patient previously received first dose of BNT162B2 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported patient was fine after first dose but he had few symptoms after second dose, patient felt like he had the flu after second dose on an unspecified date. The outcome of event was unknown.   Information about lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Eye pain, Gastric disorder, Headache, Insomnia
Clinical narrative: Gastric issues; Headache; No energy; Pain in the eyes, eye lashes, eye brows; Sensation that the wall is moving away/previously able to watch TV for a long time, but now after 5 minutes it looked like it was rotating; Vomiting; Not being able to sleep; This is a spontaneous report from a contactable consumer (patient's son).  A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration date: Unknown), via an unspecified route, administered in Right Arm on 27Jan2021 09:30 AM (at an age of 70-year-old during vaccination) as a 1st dose, single for COVID-19 immunization. The patient's medical history included hand pain, Diabetes, Sleep disorder, Iron deficiency, Blood pressure abnormal and blood thinner condition. The patient's family history was reported as none. The patient concomitant medication included metformin taken for diabetes from a long time and ongoing, paracetamol (ACETAMINOPHEN) taken orally for hand pain from two or three months and ongoing, lisinopril taken orally for blood pressure abnormal from a long time and ongoing, acetylsalicylic acid (ASPIRIN) taken for a long time and ongoing, atorvastatin taken for blood thinner from a long time and ongoing, cyanocobalamin (VITAMIN B 12) from a long time and ongoing, ropinirole taken for sleep disorder from a long time and ongoing, ferrous sulfate taken for iron deficiency from an unspecified start date and ongoing; insulin detemir (LEVEMIR) injected to his stomach at night daily for diabetes mellitus from a long time and ongoing. The patient was vaccinated at hospital not on other facility. The patient had not received any additional vaccines administered on same date of COVID-19 vaccine. The patient had not received any other vaccine with 4 weeks prior to COVID-19 vaccine. On 28Jan2021, the patient was not being able to sleep since the day of the vaccine. After one day (29Jan2021) he noticed gastric problems/gastric issues, headache on the top of his head, and no energy. His gastric problem gets better in the day and worse at night. He had been vomiting a lot after eating. Also complained of pain in the eyes, eye lashes, eyebrows, and the sensation that the wall was moving away. Added he was previously able to watch TV for a long time, but now after 5 minutes it looked like it was rotating. The patient was scheduled to get the next dose of the vaccine 18Feb2021. The reporter called on behalf of his father and mentioned that his father was diabetic, and he had some questions about his medicine. He wanted to know if the symptoms of his father had after getting the vaccine are related to the vaccine or to his usual medications and what was needed to be done. The patient was neither visited physician office nor emergency room. The patient had not undergone any relevant test and investigation assessments. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information was expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance, Vomiting
Clinical narrative: Gastric issues; Headache; No energy; Pain in the eyes, eye lashes, eye brows; Sensation that the wall is moving away/previously able to watch TV for a long time, but now after 5 minutes it looked like it was rotating; Vomiting; Not being able to sleep; This is a spontaneous report from a contactable consumer (patient's son).  A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration date: Unknown), via an unspecified route, administered in Right Arm on 27Jan2021 09:30 AM (at an age of 70-year-old during vaccination) as a 1st dose, single for COVID-19 immunization. The patient's medical history included hand pain, Diabetes, Sleep disorder, Iron deficiency, Blood pressure abnormal and blood thinner condition. The patient's family history was reported as none. The patient concomitant medication included metformin taken for diabetes from a long time and ongoing, paracetamol (ACETAMINOPHEN) taken orally for hand pain from two or three months and ongoing, lisinopril taken orally for blood pressure abnormal from a long time and ongoing, acetylsalicylic acid (ASPIRIN) taken for a long time and ongoing, atorvastatin taken for blood thinner from a long time and ongoing, cyanocobalamin (VITAMIN B 12) from a long time and ongoing, ropinirole taken for sleep disorder from a long time and ongoing, ferrous sulfate taken for iron deficiency from an unspecified start date and ongoing; insulin detemir (LEVEMIR) injected to his stomach at night daily for diabetes mellitus from a long time and ongoing. The patient was vaccinated at hospital not on other facility. The patient had not received any additional vaccines administered on same date of COVID-19 vaccine. The patient had not received any other vaccine with 4 weeks prior to COVID-19 vaccine. On 28Jan2021, the patient was not being able to sleep since the day of the vaccine. After one day (29Jan2021) he noticed gastric problems/gastric issues, headache on the top of his head, and no energy. His gastric problem gets better in the day and worse at night. He had been vomiting a lot after eating. Also complained of pain in the eyes, eye lashes, eyebrows, and the sensation that the wall was moving away. Added he was previously able to watch TV for a long time, but now after 5 minutes it looked like it was rotating. The patient was scheduled to get the next dose of the vaccine 18Feb2021. The reporter called on behalf of his father and mentioned that his father was diabetic, and he had some questions about his medicine. He wanted to know if the symptoms of his father had after getting the vaccine are related to the vaccine or to his usual medications and what was needed to be done. The patient was neither visited physician office nor emergency room. The patient had not undergone any relevant test and investigation assessments. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information was expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia, Paraesthesia
Clinical narrative: A numb/tingling feeling on the left side of my face; A numb/tingling feeling on the left side of my face; Tingling sensation in both cheeks; My face feeling/looking flush that night; This is a spontaneous report from a contactable other hcp (Patient).  A 41-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 01Feb2021 15:45 (age at vaccination: 41-year-old) as single dose for an covid-19 immunization. Medical history included graves disease in remission. There were no concomitant medications. The patient previously took amoxicillin and experienced drug allergies. Patient not tested covid prior and post of vaccination. It was reported that patient experienced Tingling sensation in both cheeks while drive home (approximately 30 minutes after shot). Went away after a few minutes but left her face was feeling/looking flush that night. About 24 hours on 02Feb2021 later she was developed a numb/tingling feeling on the left side of her face. This feeling continued so called her Drs office on 03Feb2021 to let them know. They told if symptoms worsened she should go to the ER. She woke up on 04Feb2021 and the feeling had gone away, but returned in the afternoon and persisted. Woke up this morning 05Feb2021 and the feeling was gone but returned by 10 am and is still persisting. The outcome for the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Hypersomnia
Clinical narrative: Diarrhea; feeling weak; slept over half the week; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 28Jan2021 (at the age of 55-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) diagnosed years ago. There were no concomitant medications. On 01Feb2021 the patient reported of feeling weak and on 02Feb2021 she had diarrhea. Reporter stated she had the first Pfizer shot on 28Jan2021, states all week she has felt weak and the last few days she has had the runs in the morning. Reporter stated that she had diarrhea in the morning only since Tuesday. Stated she started feeling weak on Monday, had slept over half the week on an unspecified date in Feb 2021, stated she never had to call out of work. At the time of report, outcome for events feeling weak and diarrhea were not resolved and slept over half the week was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report from a contactable consumer (the patient, reported herself). This 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EN5318 and expiration date was not provided), via an unspecified route of administration in left arm near the shoulder, on 04Feb2021 at 15:26 PM (at the age of 68-year old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an 04Feb2021, patient experienced sore throat began early evening about 6 PM. Patient queried that one of Pfizer sites didn't have sore throat listed but a different site did have sore throat as one of the possible side effects. So patient was calling to report that and try to clarify if that is associated with the product and asks was it going to be another lengthy hold. Patient did not require a visit to emergency room and physician office for event sore throat. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome for event was not recovered.    Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dry throat, Insomnia, Malaise, Oropharyngeal pain
Clinical narrative: Full blown sore throat; Not feeling that well; Barely slept the night before; Throat dry; This is a spontaneous report from a contactable consumer (patient himself). An unspecified aged male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 04Feb2021, as single dose for COVID-19 immunization. The patient medical history and concomitant drugs were not reported. On 04 Feb2021 A couple hours later after vaccine his throat was started to get dry now it is a full blown sore throat and barely slept the night before. On 05Feb2021 he had full blown sore throat, not feeling well. He Had been looking online and it did not say anything about sore throat being a side effect. Wants to know if sore throat was a possible side effect. No further details provided. Outcome of all event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; fatigue; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:30 (Batch/Lot Number: EL3247) as 2nd dose single for covid-19 immunization. Age at vaccination was 30-year-old. The patient's medical history and medications was not reported. No Known allergies. No other medical history. Covid was not tested prior vaccination and post vaccination. Historical vaccine of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Batch/Lot Number: EL3247) as 1st DOSE SINGLE for covid-19 immunization. The patient experienced chills and fatigue on 05Feb2021. The patient did not had any treatment. The outcome of events chills and fatigue was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash left thigh; This is a spontaneous report from a contactable other health care professional (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: Not reported) dose 2 via an unspecified route of administration, in left arm on 22Jan2021 16:30 (at the age of 37-year-old) as single dose for COVID-19 immunisation. Medical history included Pots (postural orthostatic tachycardia syndrome) from an unknown date and unknown if ongoing. No covid prior vaccination and not covid tested post vaccination. Concomitant medications were not reported. The patient historical vaccine included BNT162B2 (Lot Number: Not reported) dose 1 via an unspecified route of administration, in right arm on 23Dec2021 08:00 as single dose for COVID-19 immunisation. Other vaccine within four weeks included flu vaccine on 09Jan2021, dose 1 administered in left arm. The patient experienced rash left thigh on 01Feb2021 08:00. No treatment received for the event. The outcome of the event was reported as not recovered.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash that traveled outside the 6x6 area; This is a spontaneous report from two contactable Consumer. This Consumer reported for a female patient.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Jan2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced rash that travelled outside the 6x6 area. The outcome of the event was unknown.   Follow-up attempts have been completed and no further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy rash just near injection site on left arm 6 days after second dose; Itchy rash just near injection site on left arm 6 days after second dose; This is a spontaneous report from a non-contactable other hcp (Patient). A 40-year-old non pregnant female patient received of second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 29Jan2021 (age at vaccination: 40-Year-old) as single dose for covid-19 immunization. Medical history included hypertension, hashimotos thyroiditis. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported, levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported, bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported, curcuma longa (TURMERIC [CURCUMA LONGA]) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08-JAN-2021 for covid-19 immunization. No known allergies. No Covid prior to vaccination. On 04Feb2021 at 16:00 The patient experienced itchy rash just near injection site on left arm 6 days after second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome for the event was not resolved.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain, Sleep disorder
Clinical narrative: Couldn't lift or use arm; Awake all night with pain; Awake all night with pain/soreness; This is a spontaneous report from a contactable consumer or other non HCP (patient's spouse). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Feb2021 16:00 as unknown single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the shot (yesterday) on 04Feb2021 at 4PM. It was reported that, the patient can't lift or use his arm and he was awake all night with pain (Feb2021). When the shot went in, her husband felt the shot. Asked if the patient can take Ibuprofen or Aleve or something for the pain. Asked if it was normal to have that kind of soreness. Stated the guy who gave it to her husband might have hit a muscle. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was really sore; This a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 04Feb2021 at 16:00 as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient's arm was really sore. When the shot went in, the patient did not feel the shot. She was doing fine. The outcome of event was unknown.  Information on Lot /Batch Number has been requested.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Nausea, Pain
Clinical narrative: Nausea; Weakness; few pain; In bad shape; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea, weakness, few pain and in bad shape. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: They both had a reaction of arm pain from the first and second dose.; This is a spontaneous report from a contactable consumer (patients daughter). A 93-years-old female patient received bnt162b2 (COVID 19 vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Reporter stated that her mother and her both received their second doses of the COVID vaccine and both had a reaction of arm pain from the first and second dose on an unspecified date. Patient received the second dose last Friday, and a couple of days later patient developed a red blotch below the injection site. The red blotch was 4-5 inches long, and 3 inches wide. It was warm to the touch. It would not go away. Patient was concerned about the blotch on her arm. It was a couple of inches below the injection site. She would just like to get over to Medical Information to ask them. She did not feel like it was a life or death situation so she would just like more information. Patient said the blotch did not hurt. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Thinks his gout is starting to act up; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 05Feb2021 as 2nd dose, unknown for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 and had no reaction. On an unknown date, patient's wife thinks that her husband's gout is starting to act up. She called to ask is it ok to take his gout medication Colchicine which is an anti-inflammatory medication. She was just curious whether the Colchicine would interact with the Pfizer covid-19 vaccine or not. She saw that Colchicine is being used experimentally as a treatment for covid-19, so it seems there is some kind of interaction. The clinical outcome of thinks his gout is starting to act up were unknown.  Follow-up attempts are completed. Information on the lot/batch number has been requested. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pruritus, Rash, Rash erythematous
Clinical narrative: Today whelps are fading, but light red; Itching; Was sitting on the sofa and it felt like something bit her/Awful; Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; This is a spontaneous report from a contactable consumer or other non hcp.   This consumer (patient) reported that a 77-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL8982), dose 1 via an unspecified route of administration, administered in Deltoid Right on 27Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included heart surgery from 17Mar2020 to an unknown date. There were no concomitant medications. Patient did not had family medical history and illness. Patient did not had any history of previous immunization. On 04Feb2021, the patient experienced Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; Itching and was sitting on the sofa and it felt like something bit her; On 05Feb2021, Today whelps are fading, but light red. Patient did not performed any relevant test. Patient took COVID vaccine because she wanted to be protected from the virus, it was awful. It was reported that caller reports she had the COVID shot on 27Jan and everything was fine. Yesterday she had some whelps on her back near the shoulder and on the side of her breast. It was so very red, like blood red yesterday and itching. Today they are fading, but are light red. Yesterday she was sitting on the sofa and it felt like something bit her. Then she noticed the whelps and they were raised. Still has a few on the breast and one almost on the dark area near the nipple and still itching right now. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. They called her to come get the vaccine due to her age group. Patient had no AE prior vaccination. Patient was not visited to emergency room and physician room. The clinical outcome of event Whelps very red, like blood red, raised was recovering; Was sitting on the sofa and it felt like something bit her was unknown; while all other event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: only side effect from the first one was a sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER COVID VACCINE, Solution for injection) via an unspecified route of administration to her left arm on 13Jan2021 10:45 (age at vaccination: 78-year-old) (Lot number: EL8982, NDC number: Unknown, No Expiration) as single dose for prevention. Vaccination facility type: Clinic. The patient's medical history was reported as none. Concomitant medications were not reported. Family medical history reported as none. The patient previously took flu shots and experienced sore arm at site (annual flu shots). The patient had the first one three weeks prior and the only side effect from the first one was a sore arm. It was sore for about 30 hours. That was on the left arm. She received it on 13Jan2021. It was the Pfizer COVID vaccine with Lot EL8982, No expiration. Time of day was 10:45. No relevant test reported. Outcome of the event recovered on an unspecified date in Jan2021.  Communication: Attempted to warm transfer caller to Pfizer Medical Information, however, due to extended hold time, caller opted to be transferred to hold place in the queue. Provided caller with websites along with phone, with hours of 8a-8p, Monday-Sunday.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Delusional perception
Clinical narrative: neck felt really weird, her whole neck was hurting; very tired; Fever; pain in the stomach; Dry heaves; back was hurting; no energy; knee hurting; got so sick; delusional; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EL2346) via unspecified route of administration on 15Jan2021 09:57 as single dose in arm right for COVID-19 Immunization. Medical history reported was thyroid, blood thinner and degenerative disc disease, all ongoing. Concomitant medications reported was rivaroxaban (XARELTO) ongoing as blood thinner taking for many years, levothyroxine ongoing for thyroid it was 25 and they no product taking for 5 years and prednisone from 21Jan2021 till 26Jan2021 for degenerative disc disease as Blister pack take six, then five, and down to one daily by mouth for six days. No prior vaccinations within 4 weeks was reported. Consumer called to report side effects. Stated she received the first dose of the Pfizer COVID 19 vaccine 15Jan2021 at 09:57AM in the right arm. Six days later all of the sudden in the evening she got so sick with pains in her stomach; dry heaves but she didn't throw up; felt horrible with no energy. She didn't even brush her teeth or undress to go to bed. In the night she had a fever, but she was so sick she couldn't reach overtake her temperature. She heard a voice saying, "what is your temperature". She thought she was delusional. She woke up and her knee was hurting, and her back was hurting. She had a knee replaced in Jul2020 and sometimes has trouble with it. She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain. The next day she felt better but her stomach was still bothering her, and she was so very tired. She hasn't been out, and it wasn't like she picked up anything. The next night Saturday her neck felt really weird, her whole neck was hurting. She was tired until Wednesday. Outcome of the event pain in the stomach was recovered on 24Jan2021, Dry heaves recovered on 21Jan2021, no energy, neck felt really weird, her whole neck was hurting was recovered on 22Jan2021, very tired was recovered on 27Jan2021, back was hurting, knee hurting, fever was recovering and for remaining events its unknown.  Follow-up attempts are completed. No further information is expected.