chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261; Expiration date was not reported) on 30Jan2021 (15:00) at a isngle dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma and allergies to non-steroidal anti-inflammatory drugs (NSAIDS). Concomitant medications included unspecified medications. The patient previously took omalizumab (XOLAIR), and had drug allergy. The patient was not pregnant at the time of vaccination. On 30Jan2021 (17:00), the patient had diarrhea. The patient did not receive any treatment for the reported event. The outcome of the event, diarrhea, was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Myalgia, Vomiting
Clinical narrative: pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contactable Other HCP (patient).  A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 10:00 at single dose in left arm for COVID-19 immunisation at the age of 48-year-old. Lot number was EL3248. Medical history included asthma, migraine headaches, thyroiditis. Concomitant medications included levothyroxine, fluoxetine, bupripion, clonazepam. The patient was not pregnant. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 48-year-old. On 02Feb2021 at 23:00, the patient experienced severe vomiting which kept the patient up most of the night, she had to stay by toilet; the patient was feeling like she was going to pass out with any movement, the patient experienced severe muscle pains that felt almost like bones were breaking inside; the patient experienced severe headache; the patient almost took her-self to the emergency room in the middle of the night, but she did not want to expose her compromised immune system to others. The patient was not treated for the events. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the LOC and other reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics including chemistry panel, Head CT/MRI and EKG, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of unspecified age received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization. It was unknown if patient was pregnant at the time of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Medical history and concomitant medications were not reported. The patient reported that after vaccine administration, she could barely lift her arm on 03Feb2021. It was unknown if treatment was received for the events. Outcome of the events was recovering. The reporter assessed the events as non-serious. Since the vaccination, it was unknown if patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Overdose
Clinical narrative: Bleeding down his arm afterward; He received a dose in his left arm, and noticed he was bleeding down his arm afterward/He had another dose given in his right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), first in the left arm and second dose in the right arm, both via an unspecified route of administration on 02Feb2021 at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received his first round of Pfizer-Biontech Covid19 vaccine yesterday 02Feb2021.  He received a dose in his left arm, and noticed he was bleeding down his arm afterward, which was out of character for him.  When he alerted his nurse who had administered the vaccine, she discussed it with a colleague who said "go ahead and give him another one".  He had another dose (second dose) given in his right arm on 02Feb2021.  Patient stated he's "feeling fine".  He wanted to know if he still needs to get the second dose in the series. It was also further reported as they gave him the shot in the left arm and he started to bleed.  He got a 2nd one in the right arm.  He was feeling fine. The nurse asked another nurs- and she said, "go ahead and give him another one". The outcome of the event bleeding down his arm afterward was unknown.   Information on the Batch/Lot number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Contusion
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history was none. There were no concomitant medications. The patient had soreness in the shoulder for only one day and he had bruising. No treatment received. The outcome was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: Bleeding; seeping from lower leg; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the right arm, on 03Feb2021 10:30, at a single dose, for COVID-19 immunization. Medical history included breast cancer and chronic obstructive pulmonary disease (COPD). The patient has no known allergies. The patient has many unspecified concomitant medications. The patient is 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 other facility. On 03Feb2021, at 11:00 A.M., the patient experienced bleeding/seeping from lower leg. The patient did not receive treatment for the events. Outcome of the events not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: Allergic to the pneumonia vaccine; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for Immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was Allergic to the pneumonia vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included ongoing eczema. Concomitant medications were not reported. The patient previously took dupilumab (DUPIXENT) for eczema. The patient experienced flare up of eczema on an unspecified date. Clinical outcome the event was unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lung carcinoma cell type unspecified stage I
Clinical narrative: stage 1 lung cancer; This is a spontaneous report from Pfizer sponsored program.  A contactable consumer (patient herself) reported that a 59-year-old female patient received her first dose of  bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She informed that 3 days after the shot, she had CT with contrast for stage 1 lung cancer. She was scheduled to receive the Pfizer-BioNTech COVID-19 Vaccine Dose 2 on 12Feb2021. The outcome of event was unknown.  Information about batch/lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 21Jan2021 17:45 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products and patient was not pregnant. On 23Jan2021, the patient experienced Bell's Palsy about 48 hours after receiving the vaccine. The right side of her face was completely paralyzed. The patient was treated with prednisone and valacyclovir. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Loss of consciousness
Clinical narrative: I practically passed out and couldn't stand up; I practically passed out and couldn't stand up; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at 10:45 at single dose for COVID-19 immunization.  The patient medical history included ex-alcohol user (didn't drink anymore). Concomitant medications were not reported.  The patient reported he practically passed out and couldn't stand up on 03Feb2021 at 15:15.  Patient was pretty healthy and didn't drink anymore.  Things like that used to happen when he drank but not now.  He hoped it wasn't something neurologic going on with my body.  The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted; This is a spontaneous report from a contactable pharmacist.  A 19-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982), intramuscular in the left arm on 04Feb2021 12:00 at single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. The patient fainted on 04Feb2021 12:00 with outcome of recovered in Feb2021. No treatment was performed due to the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Based on  vaccine-event chronological association, a causal relationship between event syncope and BNT162B2 vaccine cannot be excluded. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: ultrasound revealed blood clots at right leg; Swollen ankle and foot after 5-6 days of first dose; Swollen ankle and foot after 5-6 days of first dose; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 20Jan2021 11:00 at single dose for COVID-19 immunisation. The patient was vaccinated in nursing home/senior living facility. Medical history included high blood pressure, monitored for lymph node growth. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included high blood pressure medication and clonazepam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen ankle and foot on 25Jan2021 12:00 AM after 5-6 days of first dose, ultrasound revealed blood clots at right leg. Doctor ordered to take apixaban (ELIQUIS) immediately during second week. The events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiopathy, Biopsy, Blood test, Joint swelling, Pain in extremity
Clinical narrative: ultrasound revealed blood clots at right leg; Swollen ankle and foot after 5-6 days of first dose; Swollen ankle and foot after 5-6 days of first dose; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 20Jan2021 11:00 at single dose for COVID-19 immunisation. The patient was vaccinated in nursing home/senior living facility. Medical history included high blood pressure, monitored for lymph node growth. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included high blood pressure medication and clonazepam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen ankle and foot on 25Jan2021 12:00 AM after 5-6 days of first dose, ultrasound revealed blood clots at right leg. Doctor ordered to take apixaban (ELIQUIS) immediately during second week. The events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Ultrasound scan
Clinical narrative: ultrasound revealed blood clots at right leg; Swollen ankle and foot after 5-6 days of first dose; Swollen ankle and foot after 5-6 days of first dose; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 20Jan2021 11:00 at single dose for COVID-19 immunisation. The patient was vaccinated in nursing home/senior living facility. Medical history included high blood pressure, monitored for lymph node growth. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included high blood pressure medication and clonazepam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen ankle and foot on 25Jan2021 12:00 AM after 5-6 days of first dose, ultrasound revealed blood clots at right leg. Doctor ordered to take apixaban (ELIQUIS) immediately during second week. The events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID after the 1st dose of Pfizer.; This is a spontaneous report from a consumer or other non hcp.   A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration left arm on 20Jan2021 09:45 at 0.3 mL, single dose, for COVID-19 immunisation. Medical history included obesity, hypertension. Concomitant drugs were not reported.  No other vaccine was received in four weeks.  The patient experienced tested positive for covid nasal swab test on 28Jan2021. The patient was hospitalized for 4 days. Patient was treated with oxygen. The outcome was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID after the 1st dose of Pfizer.; This is a spontaneous report from a consumer or other non hcp.   A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration left arm on 20Jan2021 09:45 at 0.3 mL, single dose, for COVID-19 immunisation. Medical history included obesity, hypertension. Concomitant drugs were not reported.  No other vaccine was received in four weeks.  The patient experienced tested positive for covid nasal swab test on 28Jan2021. The patient was hospitalized for 4 days. Patient was treated with oxygen. The outcome was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: tested positive for COVID after the 1st dose of Pfizer.; This is a spontaneous report from a consumer or other non hcp.   A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration left arm on 20Jan2021 09:45 at 0.3 mL, single dose, for COVID-19 immunisation. Medical history included obesity, hypertension. Concomitant drugs were not reported.  No other vaccine was received in four weeks.  The patient experienced tested positive for covid nasal swab test on 28Jan2021. The patient was hospitalized for 4 days. Patient was treated with oxygen. The outcome was recovering.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: still in the hospital with Covid Pneumonia; tested positive for covid; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient tested positive for Covid on 28Jan2021; at the time of report, the patient was still in the hospital with Covid pneumonia. The patient did not recover from the events. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: still in the hospital with Covid Pneumonia; tested positive for covid; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient tested positive for Covid on 28Jan2021; at the time of report, the patient was still in the hospital with Covid pneumonia. The patient did not recover from the events. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: still in the hospital with Covid Pneumonia; tested positive for covid; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient tested positive for Covid on 28Jan2021; at the time of report, the patient was still in the hospital with Covid pneumonia. The patient did not recover from the events. Information on the lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: cough; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Jan2021 (at the age of 57-years old) as a SINGLE DOSE for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported.  The patient was scheduled to get the second shot on 05Feb2021. Patient got COVID like symptoms, he had a cough and "all that stuff" starting about 3 days ago on unspecified date in 2021. He went to a pharmacy to get tested and waiting for results. He went to the hospital right after (pharmacy) and got admitted on 03Feb2021 and was still in hospital right now. His doctor suggested not to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 03Feb2021. Outcome of the cough was unknown.  Information about lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Dyspnoea, Erythema, Headache
Clinical narrative: Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown.  Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Insomnia, Myocardial necrosis marker, Peripheral swelling, Rash
Clinical narrative: Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown.  Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Skin discolouration
Clinical narrative: Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown.  Information on the batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc protrusion, Muscle rupture, Muscle tightness, Myalgia, Pain
Clinical narrative: either tore a muscle in my lower back or herniated a disc; either tore a muscle in my lower back or herniated a disc; achey muscles, particularly in my back; muscles were really tight; Acute pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247), via an unspecified route of administration on 03Feb2021 12:00 (at the age of 53 years) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 13Jan2021 at 09:00 AM (at the age of 53 years) at single dose in left arm. Medical history included thyroid cancer in past, euthyroid on medication. The patient has no known allergies. Concomitant medication included Levoxythyroid 137 mcg. The patient reported the following: 'The morning after 2nd dose on 04Feb2021 at 07:00 AM, I had achey muscles, particularly in my back. My muscles were really tight. I bent down to pick something up and either tore a muscle in my lower back or herniated a disc because my muscles were so tight. Acute pain now. Cannot get out of bed'. AE resulted in doctor or other healthcare professional office/clinic visit. The patient was receiving pain meds for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The events had not resolved.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Peripheral swelling, Rash, SARS-CoV-2 test
Clinical narrative: Trouble breathing with chest pressure; Trouble breathing with chest pressure; Rash on face with swollen fingers; Rash on face with swollen fingers; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose of BNT162B2 (Lot number: 9264), via an unspecified route of administration on 31Jan2021 10:15 at single dose in the left arm for covid-19 immunisation. Medical history included hypertension and penicillin allergy. The patient's concomitant medications were not reported. On 03Feb2021 09:30, the patient experienced rash on face with swollen fingers and trouble breathing with chest pressure. The events result in Emergency room/department or urgent care. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 03Feb2021. The outcome of the events was recovering.  The following information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Discomfort, Feeling hot, Hyperpyrexia, Vomiting
Clinical narrative: fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Epistaxis, Fatigue, Gait inability
Clinical narrative: Platelets dropped significantly after taking the shot. Prior to the shot my platelets were 241.; Extreme fatigue; weakness; dizziness; heart racing; nose bleeds; unable to walk or stand up without assistance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biontech; lot number: unknown; lot unknown reason: true received at hospital & not sure what batch they gave her) via an unspecified route of administration at right arm on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was at hospital. Adverse events were reported as follows: platelets dropped significantly after taking the shot. Prior to the shot her platelets were 241. Extreme fatigue, weakness, dizziness, heart racing, nose bleeds, and also was unable to walk or stand up without assistance - overall poor health. Condition intensified to severe 1-3 days after the shot and she went to the (Hospital Name) ER on 26Jan2021. She was admitted to the hospital. During that stay her platelets dropped to 142 first day there then 126 when she was released from the hospital. A week later she went to (Name) MD for a planned office visit & my platelets were tested again and her platelets how now dropped to 89. A week after this she went back to (Name) MD and her platelets dropped again and this time now 47. Prior to the shot she have no history of low platelets or this type of unusual she'll feeling. The adverse event start date was reported as on 24Jan2021. AE resulted in emergency room/department or urgent care, hospitalization for 4 days. It was unknown if treatment received for events. The outcome of events was not recovered. No covid prior vaccination. Covid test type post vaccination included Nasal Swab on 26Jan2021: negative.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: Platelets dropped significantly after taking the shot. Prior to the shot my platelets were 241.; Extreme fatigue; weakness; dizziness; heart racing; nose bleeds; unable to walk or stand up without assistance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biontech; lot number: unknown; lot unknown reason: true received at hospital & not sure what batch they gave her) via an unspecified route of administration at right arm on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was at hospital. Adverse events were reported as follows: platelets dropped significantly after taking the shot. Prior to the shot her platelets were 241. Extreme fatigue, weakness, dizziness, heart racing, nose bleeds, and also was unable to walk or stand up without assistance - overall poor health. Condition intensified to severe 1-3 days after the shot and she went to the (Hospital Name) ER on 26Jan2021. She was admitted to the hospital. During that stay her platelets dropped to 142 first day there then 126 when she was released from the hospital. A week later she went to (Name) MD for a planned office visit & my platelets were tested again and her platelets how now dropped to 89. A week after this she went back to (Name) MD and her platelets dropped again and this time now 47. Prior to the shot she have no history of low platelets or this type of unusual she'll feeling. The adverse event start date was reported as on 24Jan2021. AE resulted in emergency room/department or urgent care, hospitalization for 4 days. It was unknown if treatment received for events. The outcome of events was not recovered. No covid prior vaccination. Covid test type post vaccination included Nasal Swab on 26Jan2021: negative.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal dreams, Anger, Belligerence, Crying, Hallucination
Clinical narrative: Hallucinations; He seems impaired mental and emotionally; He became unruly, hostile, angry, indignant; Unreasonable dreams; Belligerent, lost all sense of decorum, couldn't figure out where he was; Cried; This is a spontaneous report from a contactable consumer reporting for himself.   A 80-years-old male patient received bnt162b2 (BNT162B2; Lot #ENS318) vaccine , via an unspecified route of administration in the left arm on 30Jan2021 11:15 at single dose for covid-19 immunisation .  Medical history included Parkinson's disease, mobility decreased .  Concomitant medication included thyroid (THYROID), carbidopa, levodopa (RYTARY).  The patient previously took codeine and experienced drug hypersensitivity.  One hour after receiving the vaccine, the patient  experienced hallucinations on 30Jan2021 12:15 with outcome of recovering , he seems impaired mental and emotionally on 30Jan2021 12:15 with outcome of recovering , he became unruly, hostile, angry, indignant on 30Jan2021 12:15 with outcome of recovering , unreasonable dreams on 30Jan2021 12:15 with outcome of recovering , belligerent, lost all sense of decorum, couldn't figure out where he was  on 30Jan2021 12:15 with outcome of recovering , cried on 30Jan2021 12:15 with outcome of recovering.  All the reported events were considered Important Medical Events.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental impairment
Clinical narrative: Hallucinations; He seems impaired mental and emotionally; He became unruly, hostile, angry, indignant; Unreasonable dreams; Belligerent, lost all sense of decorum, couldn't figure out where he was; Cried; This is a spontaneous report from a contactable consumer reporting for himself.   A 80-years-old male patient received bnt162b2 (BNT162B2; Lot #ENS318) vaccine , via an unspecified route of administration in the left arm on 30Jan2021 11:15 at single dose for covid-19 immunisation .  Medical history included Parkinson's disease, mobility decreased .  Concomitant medication included thyroid (THYROID), carbidopa, levodopa (RYTARY).  The patient previously took codeine and experienced drug hypersensitivity.  One hour after receiving the vaccine, the patient  experienced hallucinations on 30Jan2021 12:15 with outcome of recovering , he seems impaired mental and emotionally on 30Jan2021 12:15 with outcome of recovering , he became unruly, hostile, angry, indignant on 30Jan2021 12:15 with outcome of recovering , unreasonable dreams on 30Jan2021 12:15 with outcome of recovering , belligerent, lost all sense of decorum, couldn't figure out where he was  on 30Jan2021 12:15 with outcome of recovering , cried on 30Jan2021 12:15 with outcome of recovering.  All the reported events were considered Important Medical Events.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Aggression, Anger, Belligerence, Personality change
Clinical narrative: Hallucinations; He seems impaired mental and emotionally; He became unruly, hostile, angry, indignant; Unreasonable dreams; Belligerent, lost all sense of decorum, couldn't figure out where he was; Cried; This is a spontaneous report from a contactable consumer reporting for himself.   A 80-years-old male patient received bnt162b2 (BNT162B2; Lot #ENS318) vaccine , via an unspecified route of administration in the left arm on 30Jan2021 11:15 at single dose for covid-19 immunisation .  Medical history included Parkinson's disease, mobility decreased .  Concomitant medication included thyroid (THYROID), carbidopa, levodopa (RYTARY).  The patient previously took codeine and experienced drug hypersensitivity.  One hour after receiving the vaccine, the patient  experienced hallucinations on 30Jan2021 12:15 with outcome of recovering , he seems impaired mental and emotionally on 30Jan2021 12:15 with outcome of recovering , he became unruly, hostile, angry, indignant on 30Jan2021 12:15 with outcome of recovering , unreasonable dreams on 30Jan2021 12:15 with outcome of recovering , belligerent, lost all sense of decorum, couldn't figure out where he was  on 30Jan2021 12:15 with outcome of recovering , cried on 30Jan2021 12:15 with outcome of recovering.  All the reported events were considered Important Medical Events.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a fever; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration at the age of 37-years, on 26Jan2021 at single dose for COVID-19 immunization, in workplace clinic. There was no other medical history, no known allergies, no other vaccine in four weeks, no COVID-19 prior vaccination. Concomitant medications were not reported. At 18:30 (06:30 PM) on 26Jan2021, the patient developed a fever overnight after receiving first dose. No treatment received. Outcome of the event was recovered/resolved in Jan2021. No COVID-19 tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Facial paralysis, Headache, Lymph node pain
Clinical narrative: Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: they described it as a nasal swab and that test came back positive; they described it as a nasal swab and that test came back positive; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported similar events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  On 26Jan2021, the patient did a rapid test which came negative. The patient did a 2 day test, and get the results back within a 2 days that was, they described it as a nasal swab and that test came back positive. The outcome of events was unknown.  Information on lot number/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123778 same report/drug/AE, different patient.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: swelled her arm up from the injection site all the way down to her wrist; swelled her arm up from the injection site all the way down to her wrist; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program Pfizer First Connect. A 73-year-old female patient received first dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (trade name unknown, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose and second dose via an unspecified route of administration on 2019 (about 6 months after first dose) at single dose for immunization. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. It was reported that, patient received first dose of pneumonia vaccine and she had no adverse event with; Second dose was given in 2019 about 6 months after first dose. Second dose of Pneumonia Vaccine swelled her arm up from the injection site all the way down to her wrist on an unspecified date in 2019; she went to the urgent care for that. They gave her some medicine (unspecified) and eventually the adverse events went away. Second dose was when she experienced adverse event. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: they described it as a nasal swab and that test came back positive; they described it as a nasal swab and that test came back positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported similar events for 2 patients. This is 2nd of 2 reports. This consumer reported for a female patient (wife) of an unspecified age received the first dose of 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. On 26Jan2021, they did 2 test, they did a rapid test which both of them came negative. And then they did what they call a 2 day test, could get the results back within a 2 days that was, they described it as a nasal swab and that test came back positive for both of them. The outcome of the events was unknown.  Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123696 same report/drug/event, different patient.