chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort
Clinical narrative: ended up in the ER with heaviness around his chest; "fluttering chest"; ended up in the ER with heaviness around his chest; "fluttering chest"; This is a spontaneous report from a contactable Other-HCP.  A 72-year-old male patient (Dad) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. One day after the 1st COVID19 vaccine dose, the patient ended up in the ER with heaviness around his chest; "fluttering chest". Felt fine 2 days later. Outcome of the events were recovered.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  to the onset of heaviness chest and futtering chest cannot be excluded due to temporal relationship. However, it is worth nothing that the patient was 72-year-old, and medical history and concomitant drugs not provided.  This case will be reassessed should additional information become available.  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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Nausea, Pain in extremity
Clinical narrative: Arm got a tad sore; makes her tired; Nausea; Chills; Hot flash; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program Pfizer First Connect. A 79-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunization. Medical history included gastroparesis. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), mirtazapine, calcium, colecalciferol (VITAMIN D). It was reported that the patient got the vaccine on the 13Jan2021. Wednesday and Thursday night, she was fine. On Friday (15Jan2021), she started getting nausea and chills. Then Saturday she was ok again. Then Sunday the nausea came back. She had had nausea since then. It comes in waves. When it is kind of mild, she doesn't feel so bad. This morning it has been bad. It makes her tired when the nausea gets like this. It may subside during the day. When she firsts get nausea, she gets hot flash. The patient's arm got a tad sore, but only a little. The outcome of the event chills was recovered on an unspecified date, nausea was not recovered while unknown for the other event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Feeling hot, Headache
Clinical narrative: blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient).  The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization.  Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021.  It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed.  Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient).  The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization.  Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021.  It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed.  Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a Pfizer sponsored program  via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. She received her first COVID-19 vaccine at Pharmacy on 28Dec2020. She was supposed to get her second vaccine after 21 days on 18Jan2021. She ended up testing positive for Covid-19 on 13Jan2021, so she missed that second appointment on 18Jan2021 because she had to quarantine since she tested positive. They are coming back again on Monday, 25Jan2021, which would be 28 days. She mentioned she has already recovered from the virus, and wants to know if she could now receive the 2nd dose of the vaccine even if it is already 28 days after her 1st dose. She wants to know can she get the second vaccine on Monday or does she need to wait 3 months re-do the whole thing? Events outcome was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pain, Migraine, Oropharyngeal pain
Clinical narrative: fever; body aches; chills; sore throat; earache; achy joints; right arm where the injection was given is swollen to the elbow; right arm where the injection was given is swollen to the elbow; migraine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, body aches, chills, sore throat, earache, and achy joints all over, all on an unspecified date. Her right arm where the injection was given was swollen to the elbow and she had a migraine, as well, on an unspecified date. She did not have this kind of reaction to the first dose of the vaccine. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Vaccination site swelling
Clinical narrative: fever; body aches; chills; sore throat; earache; achy joints; right arm where the injection was given is swollen to the elbow; right arm where the injection was given is swollen to the elbow; migraine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, body aches, chills, sore throat, earache, and achy joints all over, all on an unspecified date. Her right arm where the injection was given was swollen to the elbow and she had a migraine, as well, on an unspecified date. She did not have this kind of reaction to the first dose of the vaccine. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a non-contactable physician received via Pfizer sales representative.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date to an unspecified date at SINGLE DOSE  second dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent the first dose of bnt162b2 on unspecified date. The patient experienced fever on an unspecified date with outcome of unknown. The action taken was not applicable.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: HCP had both doses of Covid vaccine and then tested positive for Covid.; HCP had both doses of Covid vaccine and then tested positive for Covid.; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Other Health Professional (HCP) reported for herself. A female patient of unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via unspecified route of administration on unspecified dates at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient had both doses of Covid vaccine and then tested positive for Covid on an unspecified date. She was wondering if there were any clinical trials going on that were studying people that tested positive after being vaccinated. The outcome of the events was unknown.  Information on the batch number/lot number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Mild headache; Soreness at injection site; This is a spontaneous report from a non-contactable consumer (the patient).  A patient of unspecified age and gender received  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiration date unknown), via an unknown route of administration, on an unknown date (at an unknown age) as a single dose for COVID-19 vaccination.  Medical history was not reported. The patient's concomitant medications were not reported.  On an unspecified date the patient experienced mild headache and soreness at the injection site. The clinical outcomes of mild headache and soreness at the injection site was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Condition aggravated, Fall, Gait disturbance, Walking aid user
Clinical narrative: Became very unsteady walking; Became very unsteady walking; Have fallen several times; took 1 extra pill of amantadine after the first dose by mistake; balance became bad; This is a spontaneous report from a contactable consumer reported for self. This 79-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284) via an unspecified route of administration on 08Jan2021 at 14:30 PM as a single dose in right arm for COVID-19 immunisation. Co-suspect medication included amantadine from an unspecified date at unspecified dosage for Parkinson's Disease. Medical history included Parkinson's, penicillin allergy and ongoing unsteady. Concomitant medications included medications for Parkinson's disease. The patient had no vaccine in four weeks. The patient became very unsteady walking, had fallen several times 09Jan2021 at 07:30 AM. Patient was already unsteady before the vaccine, but not falling down which started soon after receiving the first dose of vaccine. The patient was scheduled for the second dose on 30Jan2021. Patient also took 1 extra pill of amantadine after the first dose of vaccine by mistake and balance became bad and remained so since. The patient suspected that maybe combo of the vaccine and Parkinson's Disease medication is an issue. The patient purchased walker and was recommended to physical as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had no COVID prior and post vaccination. The action taken of amantadine was unknown. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a slightly sore arm after vaccine; This is a spontaneous report from a contactable Consumer via Pfizer sales representative. This Consumer reported about a patient of unknown age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on unknown date via unknown route of administration at single dose for covid-19 immunization. Relevant medical history and concomitant medication were not provided. On unknown date, the patient reported of having a slightly sore arm after vaccine. The outcome of the event was unknown. It was unknown if patient received any treatment for the event.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever; chills; body aches; vomiting; diarrhea; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. This Nurse reported similar events for 3 patients. This is 1st of 3 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever, chills, body aches, vomiting and diarrhea. Symptoms began almost immediately after receiving shot and lasted for about 12 hours. Event took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021072646 same reporter/drug/event, different patient;US-PFIZER INC-2021072647 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever; chills; body aches; vomiting; diarrhea; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. This nurse reported same events for 3 patients. This is third of 3 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches, vomiting and diarrhea all on an unspecified date. Symptoms began almost immediately after receiving shot and lasted for about 12 hours. Event took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021072645 same reporter/drug/event, different patient;US-PFIZER INC-2021072646 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive for the virus; Positive for the virus; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient).  A 70-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received his 1st dose of Covid 19 Vaccine 11Jan2021 and after a couple of days showed positive for the virus, but in other results, it shows negative, but he doesn't want to take the risk that's why he's concerned now for his safety. He's aware that his 2nd dose of Covid 19 Vaccine will be on 01Feb2021. He's feeling good now but just wants to let us know. On 21Jan2021, he tested positive. The outcome was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experienced soreness at the injection site; This is a spontaneous report from a Non-contactable Consumer A female patient of an unspecified age started to receive bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced soreness at the injection site on an unspecified date with outcome of unknown. The action taken was not applicable. No follow-up attempts are possible, information about lot/batch cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program, Pfizer First Connect. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took the first dose 2 days ago (21Jan2021) and then started vomiting on an unspecified date. The reporter asked if the patient can take Zofran without having any reactions. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a contactable consumer (niece) who reported for her grandfather  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration at single dose on 23Jan2021 for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain on an unspecified date. The patient was hospitalized for chest pain from 24Jan2021. The outcome was unknown  Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pharyngeal swelling
Clinical narrative: Muscle pain; Joint pain pretty bad; Very weird feeling on the throat like swollen; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number: not provided), via an unspecified route of administration on 11Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient started to feel bad on the 18-21Jan2021 namely having muscle pain, joint pain pretty bad and very weird feeling on the throat like swollen. Outcome of the events were unknown.  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.  A patient of unknown gender and age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient got Bell's palsy after the 1st dose on unknown date. The outcome of the vent was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia
Clinical narrative: headache; swollen lymph nodes; muscle Aches; This is a spontaneous report from a contactable other healthcare professional. This report was received via a sales representative. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date (reported as Wednesday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at single dose for COVID-19 immunization. Patient had swollen lymph nodes, headache plus muscle aches on an unspecified date (reported as Friday). Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: severe chills; muscle aches all over; rhabdo-like and mild fever; This is a spontaneous report from a contactable physician reported for himself via Pfizer sales representative. A male patient of an unspecified age started to receive bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE second dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of vaccine bnt162b2 on unknown date. On an unspecified date the patient experienced severe chills, muscle aches all over and rhabdo-like and mild fever on an unspecified date all with outcome of recovering. The action taken was not applicable. Therapeutic measures were taken: Advil. .  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 after being exposed to others who were positive for COVID-19; Tested positive for COVID-19 after being exposed to others who were positive for COVID-19; She had some sniffles; This is a spontaneous report from a contactable Consumer (Patient). A female patient of unspecified age (reported as 45, Units: Unknown) received the first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient received first shot of the Pfizer COVID-19 vaccine, but then tested positive for COVID-19 after being exposed to others who were positive for COVID-19. She had some sniffles but experienced no other symptoms. Events took place after use of product. The outcome of the events was unknown.  The information on the batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Colonoscopy, Investigation, Pain in extremity
Clinical narrative: little bit sore on the arms; This is a spontaneous report from a contactable consumer (patient) A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3284), via an unspecified route of administration in right arm on 21Jan2021 15:00 at first single dose for COVID-19 immunization. Medical history included: diabetes, the patient was told his labs look really good, his diabetes was down around 100 when he pokes his finger, and his blood pressure was really good. He had no fever, only minor colds in the last year (2020). Last summer he had a minor surgery and colonoscopy and every thing was clear on that. The patient had not had COVID. Concomitant medication included amlodipine, acetylsalicylic acid (ASPIRIN), atorvastatin, glipizide for diabetes, lisinopril, pioglitazone, tamsulosin, all from 2014. The patient previously took flu shot and shingles shot for immunization. The patient got his first vaccine shot. He hadn't really had any reaction. When he took the Band-Aid off this morning there was no blood spot on the Band-Aid and it didn't really hurt when he got the shot. He had a little soreness in his arm, he was left handed but did a lot of things with his right hand and has done that today. The caller confirmed the shot was given in his right arm. This was not anything like the flu shot or the other shot he got a couple weeks ago, he can't remember the name of that shot but it is the one that made a person break out. He noted that he and his wife went through that with that shot. Caller remembered it was the shingles, the second shot he couldn't remember, that he hated. He was not looking forward to that second dose. He got it at a local pharmacy, the flu shot was first and about a month later he got the shingles shot. In 2-4 months got to get the second dose and he is not looking forward to that. The patient's second bnt162b2 dose is due 10Feb2020 at 8 am. Outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient got covid vaccine yesterday. Got positive the day after.; Patient got covid vaccine yesterday. Got positive the day after.; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient got covid vaccine yesterday (on 21Jan2021), got positive the day after (on 22Jan2021). Caller said the patient may have Covid before getting the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: the patient experienced some swelling just above the hip bone; This is a spontaneous report from a contactable consumer.A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 18Jan2021 at SINGLE DOSE for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced some swelling just above the hip bone in Jan2021. The reporter said the swelling is kind of a nut lumpy spot under skin. The outcome of event was unknown.    Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Electrocardiogram normal, Fatigue, Hypertension, Renal disorder
Clinical narrative: hypertension/Blood pressure high; Really tired; some stuff with her kidneys; This is a spontaneous report a Pfizer Sponsored Program from a contactable consumer (patient).  A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL8982) on 16Jan2021 14:30 at single dose in right arm for to prevent Covid-19. Medical history included ongoing sjogren's syndrome, hypertension.  Prior vaccinations, the patient maybe tired and unwell from the flu vaccine and shingles vaccine (SHINGRIX) for immunization. There were no concomitant medications.  No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient got her first vaccine on 16Jan2021. About 3 days later, on 19Jan2021, she was really tired but it only lasted for that one day. States that on 19Jan2021, 20Jan2021, and 21Jan2021, her blood pressure shot way up and she went to the ER on 21Jan2021 because it had been so high for a few days. States that at home it was 172/104, 172/107, and 200/103. When she got to the ER it was 200/110. States that her blood pressure has improved on it's own today. While she was in the ER, they checked her Troponin's which were low, her EKG was normal, and the doctor said everything looked okay, except some stuff with her kidneys but that doesn't have anything to do with her blood pressure. Before she got the first dose she had a history of hypertension but it was already managed by medication and her BP was on normal range prior to vaccination. The AEs High blood pressure and Really tired require a visit to Emergency room on 21Jan2021. The patient was on BP medications. The patient was hospitalized for hypertension and Really tired. The outcome of hypertension was recovering, of Really tired was recovered on 19Jan2021, of other events were unknown. Second dose was scheduled on 06Feb2021.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: hypertension/Blood pressure high; Really tired; some stuff with her kidneys; This is a spontaneous report a Pfizer Sponsored Program from a contactable consumer (patient).  A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL8982) on 16Jan2021 14:30 at single dose in right arm for to prevent Covid-19. Medical history included ongoing sjogren's syndrome, hypertension.  Prior vaccinations, the patient maybe tired and unwell from the flu vaccine and shingles vaccine (SHINGRIX) for immunization. There were no concomitant medications.  No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient got her first vaccine on 16Jan2021. About 3 days later, on 19Jan2021, she was really tired but it only lasted for that one day. States that on 19Jan2021, 20Jan2021, and 21Jan2021, her blood pressure shot way up and she went to the ER on 21Jan2021 because it had been so high for a few days. States that at home it was 172/104, 172/107, and 200/103. When she got to the ER it was 200/110. States that her blood pressure has improved on it's own today. While she was in the ER, they checked her Troponin's which were low, her EKG was normal, and the doctor said everything looked okay, except some stuff with her kidneys but that doesn't have anything to do with her blood pressure. Before she got the first dose she had a history of hypertension but it was already managed by medication and her BP was on normal range prior to vaccination. The AEs High blood pressure and Really tired require a visit to Emergency room on 21Jan2021. The patient was on BP medications. The patient was hospitalized for hypertension and Really tired. The outcome of hypertension was recovering, of Really tired was recovered on 19Jan2021, of other events were unknown. Second dose was scheduled on 06Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer. A male patient (Husband) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose for covid-19 immunisation. He went to his family physician for a cough and was prescribed amoxicillin for a few days. 21Jan2021 he received the first dose Covid vaccine, wondering if he can start a prescription of amoxicillin right now. It was not confirmed if he had cough before getting Covid vaccine or not. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: headache; chills; arm ache; aches all over his body; This is a spontaneous report . A contactable consumer (patient's wife) reported that a male patient an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got aches all over his body, headache and chills, while had an arm ache. The outcome of events was unknown.   Information on the batch number/lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for self. A female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On the 4th patient received 1st dose then about a week later tested positive for COVID (Jan2021) and wanted to know if it is safe to receive 2nd dose. The outcome of event was unknown.   Information about Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: got their 1st Covid vaccine and now has Covid; got their 1st Covid vaccine and now has Covid; This is a spontaneous report from a Pfizer sponsored program Pfizer. A contactable pharmacist reported a male patient (another pharmacist) of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date. Medical history and concomitant medication were not reported. The patient got the first dose of COVID vaccine and now had COVID. Action taken for BNT162B2 was not applicable and outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: malaise; fever; chills; This is a spontaneous report from a non-contactable Nurse via sales representative.  A nurse of unspecified age reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization.The patient medical history was not reported.  The patient's concomitant medications were not reported.  12-48 hours after the vaccine administration, the patient felt malaise, fever, and chills  The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: both test showed inactive antibodies/The patient was worried he didn't have any antibodies; This is a spontaneous report . A contactable consumer(patient) reported that a male patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration first dose on 23DEC2020 and second dose on 13JAN2021, at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported.  The patient got 1st COVID shot on23Dec2020. At 10 days ago the patient had the 2nd shot on 13JAN2021. He tested his antibodies after the 1st and 2nd dose of the vaccine and both test showed inactive antibodies. The patient was worried he didn't have any antibodies. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Polymerase chain reaction, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Headache; Pain in the left arm; This is a spontaneous report from a contactable consumer (patient).  A 59-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 25Jan2021 at 14:30 at 59-years-old at a single dose for COVID-19 immunization; administered in an unspecified facility (reported as "other").  The patient medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications were unspecified; and the medications were received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Jan2021 at 04:15, the patient experienced headache (non-serious) and pain in the left arm (non-serious); for which no treatment was received.  The patient underwent lab tests and procedures which included polymerase chain reaction (PCR): negative on 21Dec2020, Nasal Swab (SARS-CoV-2 test): negative on 21Dec2020.  The clinical outcome of the events was unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19; no results were provided.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in jaw after the vaccine; This is a spontaneous report . A non-Contactable Consumer reported information for himself and his wife. This is the first of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient reported that he and his wife both had tingling in jaw after the vaccine. The outcome was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076002 Same reporter, same product, same event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in jaw after the vaccine; This is a spontaneous report A non-Contactable Consumer reported information for himself and his wife. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient reported that he and his wife both had tingling in jaw after the vaccine. The outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021075995 Same reporter, same product, same event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a Spontaneous report . A contactable consumer (patient) reported that a female patient in her later 70s received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. Medical history included she had arthritis since she was in her 20's and ongoing, has severe pain in back, problems with her hips, has bone spurs in one shoulder, and her hands and fingers sometimes hurt with the arthritis. The patient's concomitant medications were not reported. The patient experienced sore arm in Jan2021. Patient had her 1st shot on 16Jan, due for her 2nd shot and was experiencing arthritic symptoms which she claimed was pre-existing and not related to the vaccine. She wanted to know if she could take Tylenol. She was currently refraining from taking Tylenol. Patient explained that the only reason she was calling was regarding a couple of post that had been going around about the Pfizer vaccine. She wanted to know if she could take Tylenol or pain killers after having the vaccine. The post said that they cause the immune system to not function with the vaccine like it was supposed to. She is in her late 70's, because of arthritis she sometimes took Tylenol or her doctor would give her a pain pill. She had the fact sheets and paperwork, she knew everything she needed to know about the vaccine except this one thing. The patient confirmed she had taken the vaccine and had no reaction other than sore arm. The patient explained she was upset and didn't feel like going through a report as she had been on the phone for 15-20 minutes just to try and get to this agent. She had no problems and just wanted to know if she could take a pain pill. If she had to hold much longer she was just gonna take and if it messes it up, then it would just have to be messed up. Patient remarked she should never have called, she thought it was a simple question but should have known nothing was simple anymore. It required a conversation and all her information just got an answer to her question. She was upset and was going to hang up, she was tired being on the phone; she was not upset at this agent but at not being able to speak with some regarding this issue. The outcome of the event sore arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive after 1st dose; Patient tested positive for Covid after 1st dose; This is a spontaneous report from a Pfizer-sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, batch/lot number and expiration date not provided), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter has patient who had 1st dose of COVID vaccine on 13Jan and then tested positive for COVID. She is calling today because her patient is scheduled for her next dose on 15Feb and she wants to make sure that date is ok. The patient underwent lab tests and procedures which included tested positive for COVID on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of bnt162b2(COMIRNATY), on 13Jan2021, and COVID-19 test positive on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Very sick; This is a spontaneous report from a non-contactable other HCP. The other HCP reported same event for six patients. This is the first of six reports.   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021, both at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 at single dose for COVID-19 immunisation. The reporter explained that 6 coworkers were very sick after the injections on Jan2021. The reporter did not share any symptoms. Rather, reporter noted that they were miserable the day after, and were all now back at work today. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076652 Same drug and event, different patient;US-PFIZER INC-2021076656 Same drug and event, different patient;US-PFIZER INC-2021076654 Same drug and event, different patient;US-PFIZER INC-2021076655 Same drug and event, different patient;US-PFIZER INC-2021076653 Same drug and event, different patient
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Insomnia, Limb discomfort
Clinical narrative: he lost sense of taste and smell; he lost sense of taste and smell; legs feeling heavy and hard to move; restless sleep; This is a spontaneous report from a contactable consumer (patient). An 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation.  Medical history included Patient has recently had a pacemaker implanted. Concomitant medication included potassium Once a day, hydrochlorothiazide (DIURETIC), 20 mg Twice a day, dutasteride (AVODART), Once a day, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg Once a day and a multivitamin QD (Once a day). The patient had the COVID-19 vaccine administered on 14Jan2021. That evening he began waking up several times after a restless sleep approximately six times on 14Jan2021. This lasted approximately two more evenings. On 19Jan2021 he lost sense of taste and smell for approximately three days. As of 20Jan2021 he has regained some sense of taste. The patient's temperature has been normal with no fever and pulse oximetry has been approximately 96%. Lastly on 17Jan2021 patient reported his legs feeling heavy and hard to move which lasted approximately three days. The outcome was recovering.  Information on the lot/batch number has been requested.