chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Headache; dizziness; High blood pressure; Fever; general body aches; Migraine; extreme fatigue; Diarrhea; Rash on injection site; pain on injection arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Right on 24Apr2021 at 10:00 (Batch/Lot Number: EW0171) as dose 2, single for covid-19 immunization (at the age of 44-years-old). Medical history included asthma, osteoarthritis and covid-19 (prior vaccination) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in left arm on 22Mar2021 at 04:00 pm (Batch/Lot Number: EP6958) as single for covid-19 immunization (at the age of 44-years-old). Patient also took morphine and experienced allergy previously. It was reported that within 10 hours after receiving second dose of vaccine on 24Apr2021, the patient experienced fever, general body aches, migraine, extreme fatigue, diarrhea, rash on injection site and pain on injection arm. After 2 days on 26Apr2021 experienced headache, dizziness, diarrhea, and high blood pressure. Patient was treated with Imitrex, Tylenol which mildly helped. Patient was tested COVID post vaccination. The outcome of the events was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Migraine, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Headache; dizziness; High blood pressure; Fever; general body aches; Migraine; extreme fatigue; Diarrhea; Rash on injection site; pain on injection arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Right on 24Apr2021 at 10:00 (Batch/Lot Number: EW0171) as dose 2, single for covid-19 immunization (at the age of 44-years-old). Medical history included asthma, osteoarthritis and covid-19 (prior vaccination) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in left arm on 22Mar2021 at 04:00 pm (Batch/Lot Number: EP6958) as single for covid-19 immunization (at the age of 44-years-old). Patient also took morphine and experienced allergy previously. It was reported that within 10 hours after receiving second dose of vaccine on 24Apr2021, the patient experienced fever, general body aches, migraine, extreme fatigue, diarrhea, rash on injection site and pain on injection arm. After 2 days on 26Apr2021 experienced headache, dizziness, diarrhea, and high blood pressure. Patient was treated with Imitrex, Tylenol which mildly helped. Patient was tested COVID post vaccination. The outcome of the events was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Headache; dizziness; High blood pressure; Fever; general body aches; Migraine; extreme fatigue; Diarrhea; Rash on injection site; pain on injection arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Right on 24Apr2021 at 10:00 (Batch/Lot Number: EW0171) as dose 2, single for covid-19 immunization (at the age of 44-years-old). Medical history included asthma, osteoarthritis and covid-19 (prior vaccination) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in left arm on 22Mar2021 at 04:00 pm (Batch/Lot Number: EP6958) as single for covid-19 immunization (at the age of 44-years-old). Patient also took morphine and experienced allergy previously. It was reported that within 10 hours after receiving second dose of vaccine on 24Apr2021, the patient experienced fever, general body aches, migraine, extreme fatigue, diarrhea, rash on injection site and pain on injection arm. After 2 days on 26Apr2021 experienced headache, dizziness, diarrhea, and high blood pressure. Patient was treated with Imitrex, Tylenol which mildly helped. Patient was tested COVID post vaccination. The outcome of the events was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Oxygen level dropped; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), via an unspecified route of administration in arm left on 28Mar2021 as a dose 1, single for COVID-19 immunization. It was reported that, other vaccine same date product included Pfizer (Lot number: ER8729), via an unspecified route of administration in arm left on 28Mar2021 as a dose 2, single. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. No covid prior vaccination and no covid tested post vaccination. On 21Apr2021, the patient experienced oxygen level dropped. The AE resulted in doctor or other healthcare professional office/clinic visit. Treatment included was breathing exercise. On 21Apr2021, the patient underwent lab tests and procedures which included oxygen level dropped (oxygen saturation), resulted as decreased. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Local reaction
Clinical narrative: Fast heart rate; Breathing difficulties; Local reaction; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: En6206), via an unspecified route of administration, administered in Arm Left on 18Mar2021 (at the age of 41-years-old) as dose 1, single for covid-19 immunization at public health clinic/veterans administration facility. Medical history included known allergies to latex, adhesives, buckwheat from an unknown date and unknown if ongoing. The patient previously took lisinopril and motrin [ibuprofen] and experienced allergies. Concomitant medications (other medications in two weeks) included allergy shots. Could contact her for other medical history and for other medications in two weeks. No other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. On 18Mar2021, after first shot the patient had fast heart rate, breathing difficulties (throughout evening of shot), and local reaction that she still has 6 weeks later with use of topical steroids. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Er8727) via an unspecified route of administration, administered in Arm Right on 09Apr2021 as dose 2, single for covid-19 immunization. The patient was treated with topical steroid. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Depression, Hypoaesthesia, Joint swelling
Clinical narrative: Severe and chronic inflammation in the spine, joints and muscles.; Severe and chronic inflammation in the spine, joints and muscles.; Tingling and numbing sensation from the neck down.; Tingling and numbing sensation from the neck down.; Swelling in the lower legs, ankles and feet; Swelling in the lower legs, ankles and feet; Sciatica in both legs; Left leg calf pain; Loss of appetite; Depression; anxiety; This is a spontaneous report from a non-contactable consumer.  This 27-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWQ17Q) via an unspecified route of administration into the left arm on 21Apr2021 at 11:15 AM (at the age of 27-year-old) as single dose for COVID-19 immunisation. The patient medical history included lupus-like syndrome from an unknown date and unknown if ongoing. The patient previously took plaquenil [hydroxychloroquine sulfate] and experienced drug hypersensitivity, meloxicam and experienced drug hypersensitivity. Known allergies to Plaquenil and Meloxicam. Concomitant medications were not reported. On 23Apr2021 at around 10:00 AM, the patient experienced severe and chronic inflammation in the spine, joints and muscles, tingling and numbing sensation from the neck down, swelling in the lower legs, ankles and feet, sciatica in both legs, left leg calf pain, loss of appetite, depression and anxiety. No other vaccine in four weeks, no other medications in two weeks. AE resulted in doctor or other healthcare professional office/clinic visit. No treatments, no COVID prior vaccination, no COVID tested post vaccination. Outcome was not resolved for all the events.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myositis, Pain in extremity, Paraesthesia, Peripheral swelling, Sciatica
Clinical narrative: Severe and chronic inflammation in the spine, joints and muscles.; Severe and chronic inflammation in the spine, joints and muscles.; Tingling and numbing sensation from the neck down.; Tingling and numbing sensation from the neck down.; Swelling in the lower legs, ankles and feet; Swelling in the lower legs, ankles and feet; Sciatica in both legs; Left leg calf pain; Loss of appetite; Depression; anxiety; This is a spontaneous report from a non-contactable consumer.  This 27-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWQ17Q) via an unspecified route of administration into the left arm on 21Apr2021 at 11:15 AM (at the age of 27-year-old) as single dose for COVID-19 immunisation. The patient medical history included lupus-like syndrome from an unknown date and unknown if ongoing. The patient previously took plaquenil [hydroxychloroquine sulfate] and experienced drug hypersensitivity, meloxicam and experienced drug hypersensitivity. Known allergies to Plaquenil and Meloxicam. Concomitant medications were not reported. On 23Apr2021 at around 10:00 AM, the patient experienced severe and chronic inflammation in the spine, joints and muscles, tingling and numbing sensation from the neck down, swelling in the lower legs, ankles and feet, sciatica in both legs, left leg calf pain, loss of appetite, depression and anxiety. No other vaccine in four weeks, no other medications in two weeks. AE resulted in doctor or other healthcare professional office/clinic visit. No treatments, no COVID prior vaccination, no COVID tested post vaccination. Outcome was not resolved for all the events.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Spondylitis
Clinical narrative: Severe and chronic inflammation in the spine, joints and muscles.; Severe and chronic inflammation in the spine, joints and muscles.; Tingling and numbing sensation from the neck down.; Tingling and numbing sensation from the neck down.; Swelling in the lower legs, ankles and feet; Swelling in the lower legs, ankles and feet; Sciatica in both legs; Left leg calf pain; Loss of appetite; Depression; anxiety; This is a spontaneous report from a non-contactable consumer.  This 27-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWQ17Q) via an unspecified route of administration into the left arm on 21Apr2021 at 11:15 AM (at the age of 27-year-old) as single dose for COVID-19 immunisation. The patient medical history included lupus-like syndrome from an unknown date and unknown if ongoing. The patient previously took plaquenil [hydroxychloroquine sulfate] and experienced drug hypersensitivity, meloxicam and experienced drug hypersensitivity. Known allergies to Plaquenil and Meloxicam. Concomitant medications were not reported. On 23Apr2021 at around 10:00 AM, the patient experienced severe and chronic inflammation in the spine, joints and muscles, tingling and numbing sensation from the neck down, swelling in the lower legs, ankles and feet, sciatica in both legs, left leg calf pain, loss of appetite, depression and anxiety. No other vaccine in four weeks, no other medications in two weeks. AE resulted in doctor or other healthcare professional office/clinic visit. No treatments, no COVID prior vaccination, no COVID tested post vaccination. Outcome was not resolved for all the events.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: with shortness of breath and pressure on my chest.; with shortness of breath and pressure on my chest.; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in left arm on 23Mar2021 11:00, at 46 years of age, (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included pernicious anaemia from an unknown date and allergy to sulfa and pethydine hydrochloride (DEMEROL). Concomitant medications included iron, cyanocobalamin (B12-VITAMIN), zinc, folic acid (FOLATE), ascorbic acid (C) and colecalciferol (D), all taken for an unspecified indication since an unknown date. The patient didn't receive any other vaccine within the previous 4 weeks and was not diagnosed with COVID-19 prior vaccination. The patient reported that, on an unknown date after the first vaccine dose, she ended up at hospital with shortness of breath and pressure on her chest. They sent her home after hours of observation saying it was vaccine related symptoms. The events resulted in Emergency room/department or urgent care, the patient received an unspecified treatment and the events resolved with sequelae on an unknown date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021487210 Same drug/reporter/patient, different dose
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathic muscular atrophy, Pyrexia, Tremor
Clinical narrative: couldn't control any of my muscles; All my muscles, my whole body shaked; fever 103.4; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 05May2021 14:15 (lot number and expiry date: unknown) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Facility. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Apr2021 at 13:45 in left arm for COVID-19 immunisation. Concomitant medication included IBUPROFEN taken for an unspecified indication from 03May2021 to an unspecified stop date. On 05May2021, 7-8 hours later than second vaccination, all her muscles shook for at least 2 hours, she couldn't stop shaking, she couldn't control any of the muscles. She also had extreme fever of 103.4. She took Ibuprofen, it decreased to 102. It was day 3 at the time of the report, and she still had fever around 101 after Ibuprofen. Without Ibuprofen, it was still around 103. She didn't inform health providers because she was alone, and she was not able to do anything in that situation. The patient did not receive treatment for the other events. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was recovering.  Information on lot/batch number has been requested. Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events neural atrophy. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Muscle twitching, Myoclonus
Clinical narrative: Involuntary movements; Hypnic jerks; Muscle twitching; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 intramuscular, administered in Arm Left on 27Apr2021 11:30 (age at vaccination 37 years) as dose 1, single for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient had no allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 07:00 the patient experienced hypnic jerks, muscle twitching, involuntary movements on 01May2021. Patient visited physician office for involuntary movements. Patient did not receive any treatment for hypnic jerks and muscle twitching. Patient received treatment for involuntary movements. Also take medication Citalopram anxiety medication. The outcome of events was unknown for involuntary movements rest of events outcome was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Illness, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: fever; bodyswell; colds; eyes hurt; sore throat; Sickness; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A male contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as Dose 2,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. on 2021 The patient second dose 27APR2021 last month. Patient experienced fever, body swell, colds and eyes hurt, sore throat and sickness after his second dose. Caller would like to know if he can take medications or go to Doctor. Outcome of events was unknown.    Information on lot/batch number has been requested.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: fever; bodyswell; colds; eyes hurt; sore throat; Sickness; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A male contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as Dose 2,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. on 2021 The patient second dose 27APR2021 last month. Patient experienced fever, body swell, colds and eyes hurt, sore throat and sickness after his second dose. Caller would like to know if he can take medications or go to Doctor. Outcome of events was unknown.    Information on lot/batch number has been requested.  Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Peripheral swelling
Clinical narrative: Multiple Palpable lymph nodes New onset Headaches Swelling of extremities/fingers; Multiple Palpable lymph nodes; New onset Headaches; Swelling of extremities/fingers; This is a spontaneous report form a contactable Nurse (patient). A 51-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8737), via an unspecified route of administration in arm left on 15Mar2021 (at the age of 51-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included Hashimoto's from an unknown date and unknown if ongoing. The patient had no known allergies. The concomitant medications of the patient included levothyroxine sodium (SYNTHROID) taken for an unspecified indication start and stop date were not reported. It was reported that patient took first dose of BNT162B2(solution for injection, Batch/Lot number: EN6207), via unspecified route of administration on 15Mar2021 at 14:00. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 01May2021, the patient experienced multiple palpable lymph nodes new onset headaches swelling of extremities/fingers, multiple palpable lymph nodes, new onset headaches, swelling of extremities/fingers. The events resulted in the physician office visit. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: felt dizzy; heart beats very strong; This is a spontaneous report from a contactable consumer (caregiver) via Medical Information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 12May2021 (Batch/Lot number was not reported) for COVID-19 immunisation. On 02Jun2021 (also reported as yesterday), she got the second dose; after that she felt dizzy, like her heart beat very strong. The reporter asked if this was normal. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus
Clinical narrative: received the second dose of vaccine 50 days between the first dose; Itchiness on upper extremities; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date: Not reported) via an unspecified route of administration in the left arm on 03Jun2021 at 11:00 AM (at the age of 42-year-old) as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included blood pressure and anxiety medications (Unspecified). The patient previously received acetaminophen-codeine (TYLENOL 3) for unknown indication on an unknown date and experienced itch. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date: Not reported) via an unspecified route of administration in the right arm on 15Apr2021 at 12:45 PM (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced itchiness on upper extremities on 03Jun2021 and received the second dose of vaccine 50 days between the first dose on 03Jun2021 11:00. Pruritus event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the Pruritus event. The clinical outcome of the Pruritus event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Inflammation, Pain in extremity
Clinical narrative: some really bad shoulder pain and in her right hand; some really bad shoulder pain and in her right hand; some inflammation on the top of one hand; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on the left arm on 18Mar2021 (Batch/Lot Number: EN6208) (at age 64-years-old) as dose 2,single for covid-19 immunisation; and  tofacitinib citrate (XELJANZ), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 5 mg for rheumatoid arthritis. The first dose was received on 25Feb2021 (lot number: EN6203). The patient's medical history and concomitant medications were not reported.  Before patient did her second COVID vaccine her rheumatologist suggested she go off the medication for a week. So the night before the second vaccine patient stopped taking tofacitinib and made it a week without it which was difficult when she had been used to taking it, that how much it 'feels'. Patient stated that, so that way she had full effect and have effectiveness of the Pfizer COVID 19 Vaccine, the second one. It worked great and on 02Jun2021, patient had some really bad shoulder pain and in her right hand, and some inflammation on the top of one hand, which was there in morning and evening. It was gone on 03Jun2021, she meant XELJANZ helped so much. When confirmed if the pain was due to the Xeljanz or the COVID 19 Vaccine, patient stated that no, the COVID vaccine she took was way back, and finished the second one like in March. Patient further stated that it was not due to the vaccine. She was telling how much tofacitinib medication helped. She thinks Xeljanz does work for her, she is happy with the medication. Patient was not saying that this shoulder problem had anything to do with the vaccine, her vaccine was given in left arm, the problem that she had for just one day in shoulder was in the right arm. She doesn't think it has to do anything with Pfizer Outcome of the events was recovered on 03Jun2021.Action taken for tofacitinib was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information the reported event is attributed to  an underlying or  an intercurrent medical condition and  it is assessed as unrelated to the  suspect drug bnt162b2.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, SARS-CoV-2 test, Swelling
Clinical narrative: I started to get very achy knee joints.; The achy joints progressed to my hands and ankles and feet.; swollen; had difficulty walking and clenching and grasping with my hands; This is a spontaneous report from a contactable consumer. A 63-year-old male consumer received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8730, Expiration date: unknown) via an unspecified rout in right arm on 03Apr2021 at 07:30 am (at the age of 63-year-old) as dose 2, single for COVID-19 immunisation. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6203, Expiration date: unknown) via an unspecified rout in left arm on 13Mar2021 at 08:30 am (at the age of 63-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Non-Hodgkins Lymphoma. Patient had no known allergies. Concomitant medications were not reported. The patient reported that on 06Apr2021 "3 days following the second Covid 19 vaccine he started to get very achy knee joints. The achy joints progressed to his hands and ankles and feet. The symptoms progressed further and his hands, feet, and ankle became very swollen, very painful and he was unable to wear my regular shoes, and had difficulty walking and clenching and grasping with his hands. My joints are very painful". It was reported that the patient had other medications in two weeks, had not covid prior vaccination, not covid tested post vaccination. Treatment was given with Prednisone since symptoms occurred. Patient underwent laboratory test included Nasal Swab on May2021 resulted Negative. Outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Pain
Clinical narrative: pain / 3 other patienst complained about the same issue; severe pain in my left ear / 3 other patienst complained about the same issue; This is a spontaneous report from a contactable consumer. This consumer reported for herself and 3 other patients. This is the 3rd of 3 reports. This consumer reported for a patient that:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain / 3 other patients complained about the same issue, severe pain in my left ear / 3 other patients complained about the same issue. Patient reported, she had a physical last Tuesday and her Doctor mentioned to me that 3 other patients complained about the same issue. She saw that hospital were doing research on this, but they would not give her any information. Patient visited physician office for reported events. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: A friend had severe masseter muscle tightness to the extent that she could barely open her mouth after both of her vaccines.; This is a spontaneous report from a contactable consumer and reported for a female patient (her friend). A 67-years-old non pregnant female patient received first dose bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration on 29Jan2021 in left arm as DOSE 1, SINGLE and also received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE and also for covid-19 immunization at other vaccine facility. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not experienced covid prior vaccination and no covid tested post vaccination. The patient did not received other vaccine in four weeks and also no other medications in two weeks. On 25feb2021, the patient had experienced severe masseter muscle tightness to the extent that she could barely open her mouth after administration of 2 dose. It was reported that, patient wondered if more people are reporting this kind of muscle tension and it has been more than 3 months muscle tensions persist. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.    Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected. Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Headache, Malaise, SARS-CoV-2 test
Clinical narrative: Not feeling well; Headaches; Dizzy; Big bruises on my body; Very low blood platelets count; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 30Mar2021 at 17:45 (at the age of 40-year-old), as dose 1, single; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 20Apr2021 at 17:45 (at the age of 40-year-old), as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of COVID vaccine. On 01Apr2021, after receiving the vaccine, the patient was not feeling well, had headaches, and felt dizzy; had big bruises on her body. Doctor did blood test and it showed very low blood platelets count. Patient believed it was related to vaccine as she didn't experience these problems before. Patient's blood platelets count was normal before that. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive treatment for the adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown result post vaccination on an unspecified date; platelet count: normal before vaccination on an unspecified date; and very low after vaccination on 01Apr2021. The patient had no COVID prior vaccination and was tested COVID post vaccination. The clinical outcome of all the events was not resolved.  Information about lot/batch has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Started menstrual cycle 6 days early; Its been 11 days and im still menstruating; This is a spontaneous report from a Non-contactable consumer(herself). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0191 and expiration date), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date. The patient experienced started menstrual cycle 6 days early its been 11 days and I am still menstruating. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Corneal reflex decreased, Facial paresis, Hypoaesthesia, Physical examination
Clinical narrative: developed left side facial weakness and numbness/left sided forehead and mouth weakness; developed left side facial weakness and numbness; loss of left side blink; This is a spontaneous report from a contactable physician.A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0178 and Expiry date: Unknown), via an dose 2 intramuscular, administered in Arm Right on 11Jun2021 11:15 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On 13Jun2021 11:15 the patient experienced developed left side facial weakness and numbness/left sided forehead and mouth weakness, loss of left side blink. The patient underwent lab tests and procedures which included physical examination left sided forehead and mouth weakness  on 13Jun2021 His physical exam was notable for left sided forehead and mouth weakness, with loss of left side blink although forced eye closure intact on the left side. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hyperhidrosis
Clinical narrative: about an hour after the injection uncontrollable coughing for about 30 min. and heavy sweating. did not do anything different or new after the shot just drove home and walked up 3 flights of stairs as; about an hour after the injection uncontrollable coughing for about 30 min. and heavy sweating. did not do anything different or new after the shot just drove home and walked up 3 flights of stairs as; This is a spontaneous report from a contactable consumer (patient) reported for herself. An 18-years-old (non-pregnant) female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 mRNA Vaccine, Solution for injection, bath/lot number: ew0186), via an unspecified route of administration in left arm on 16Jun2021 at 16:00 (at the age of 18-years-old) as single for COVID-19 immunisation (lot unknown reason: Not available/provided to reporter at the time of report completion). The patient's medical history and concomitant medications were not reported. No covid prior vaccination. The patient was not aware that she had any known allergies. No other vaccine in four weeks. On 16Jun2021, the patient experienced about an hour after the injection uncontrollable coughing for about 30 min. and heavy sweating. did not do anything different or new after the shot just drove home and walked up 3 flights of stairs as usual. No covid tested post vaccination. No treatment received. The outcome of the events was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb mass, Neck pain, Nerve injury, Pain in extremity
Clinical narrative: Second dose: Big knot by her neck on top of her shoulder; Second dose: Slight headache; The hurting has gone down from her neck on the side all the way down her arm.; The hurting has gone down from her neck on the side all the way down her arm.; The emergency room doctor thinks she could have nerve damage. She could have this for the rest of her life.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. Patient stated was having some bad side effects from the Pfizer Covid-19 Vaccine. She was calling to see what can be done. She had been to the emergency room. At first, she had a big knot by her neck on top of her shoulder. Usually, she could take Tylenol or Aleve and it would relieve her pain, but now she can barely turn her neck to the left. The hurting had gone down from her neck on the side all the way down her arm. The first shot was not so bad, it was bad for a couple of days and went away. The second one lingered and now nothing will stop it. She went to the emergency room on Sunday, and they gave her a muscle relaxer for pain that was not helping anymore. She kept having a slight headache. She did not have any more questions. She wishes she never took the vaccine. What she can tell about her experience was that it was a bad experience. It did not do her any good to answer questions for a report if she will get no advice on what to do. She did not have these problems before. The emergency room doctor thinks she could have nerve damage. She could have this for the rest of her life. There was nothing anyone can do. She will hurt for the rest of her life behind the crap that Pfizer came out with. She was the one who ended up with medical bills she will have to pay. The events resulted in visit to emergency room visit. The clinical outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Took the vaccine a week before my period date. My period was delayed. Yesterday I only had 2 spots on my underwear. Today it came a bit more but not like it used too.; This is a spontaneous report from a contactable consumer. A 25-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration administered left arm 02Jul2021 20:00 (at the age of 25-years-old) as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took aspirin and experienced allergies. On 09Jul2021, the patient experienced took the vaccine a week before my period date. my period was delayed. yesterday I only had 2 spots on my underwear. today it came a bit more but not like it used too. The patient did not received any treatment for the adverse event. The outcome of event was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; stomach cramps; daily diarrhea still 4 months later; This is a spontaneous report from a contactable other health care professional (patient). A 59-year-old nonpregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown) via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:00 (age at vaccination 59-year-old) as single dose for COVID-19 immunisation. Medical history included High blood pressure, degenerative erasure disc disease, arthritis. Patient had no covid prior vaccination. Concomitant medication(s) included lisinopril, pravastatin, hydrocodone all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any prior vaccination in four weeks. Patient had known allergies to penicillin. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown) via an unspecified route of administration, administered in Arm Left on 13Mar2021, 12:00 PM (age at vaccination 59-year-old) as single dose for COVID-19 immunisation. On 09Apr2021 12:00, the patient experienced sore arm, stomach cramps and daily diarrhea still 4 months. AE resulted in physician office visit. The patient received treatment for the events with medication (unspecified). Patient tested covid post vaccination. The patient underwent lab tests and procedures which included rapid test (nasal swab) negative on 05May2021. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; headaches; extreme muscle pain and extreme exhaustion; extreme muscle pain and extreme exhaustion; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 02Jul2021 at 17:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis, cardiac failure chronic, drug hypersensitivity (Known allergies: Penicillin). Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever, headaches and extreme muscle pain and extreme exhaustion on 02Jul2021 at 17:15. No treatment was received for the events. Outcome of the events was not recovered.  Information about lot/batch has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Chest pain; shortness of breath; elevated heart rate; fever; joint pain; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration in left arm on 13Jul2021 12:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy to tomatoes, bell peppers, mushrooms, almonds, gluten sensitivity, covid-19. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 14Jul2021 11:00, the patient experienced chest pain, shortness of breath, elevated heart rate, fever, joint pain and muscle pain. The patient underwent lab tests and procedures which included heart rate: elevated on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.