chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; stiffed and inflamed hands; stiffed and inflamed hands,swelling; inflamed hands; osteoarthritis; can not close her hand all the way in the morning; severe pain; pain in her both wrists; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (stiffed and inflamed hands), PERIPHERAL SWELLING (stiffed and inflamed hands,swelling), PERIPHERAL SWELLING (inflamed hands), OSTEOARTHRITIS (osteoarthritis), MOBILITY DECREASED (can not close her hand all the way in the morning), PAIN (severe pain) and ARTHRALGIA (pain in her both wrists). The patient was treated with PREDNISONE at an unspecified dose and frequency; HYDROXYCHLOROQUINE at an unspecified dose and frequency; MELOXICAM at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis), MUSCULOSKELETAL STIFFNESS (stiffed and inflamed hands), PERIPHERAL SWELLING (stiffed and inflamed hands,swelling), PERIPHERAL SWELLING (inflamed hands), OSTEOARTHRITIS (osteoarthritis), MOBILITY DECREASED (can not close her hand all the way in the morning), PAIN (severe pain) and ARTHRALGIA (pain in her both wrists) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-260274 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Case has been  upgraded to Serious for the IME event of Rheumatoid Arthritis.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Thrombosis
Clinical narrative: Someone who received vaccine and is experiencing blood clots; Hair loss; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Someone who received vaccine and is experiencing blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Someone who received vaccine and is experiencing blood clots) (seriousness criterion medically significant) and ALOPECIA (Hair loss). At the time of the report, THROMBOSIS (Someone who received vaccine and is experiencing blood clots) and ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  Very limited information regarding these events has been provided at this time. No follow up is possible.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up  added event to main portion of report.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Bloody Stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bloody Stool) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High blood pressure), Anxiety, Depression and Asthma (Allergies).   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced HAEMATOCHEZIA (Bloody Stool) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Bloody Stool) outcome was unknown.            Concomitant product was not provided by the reporter. On 23-Jul-2021, Patient had blood stool. Consumer did not take any medications to alleviate the possible adverse events. Treatment information was not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Hypersensitivity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding of the scratching) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (Hard breathing), Allergy to animal dander (horse hair, rash/swelling) and Allergy to antibiotic (tetracycline. Rash). On 05-May-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding of the scratching) (seriousness criterion medically significant) and HYPERSENSITIVITY (Hypersensitive to vaccine). The patient was treated with TRIAMCINOLONE for Rash, at a dose of UNK, bid and HYDROXYZINE for Rash, at an unspecified dose and frequency. At the time of the report, HAEMORRHAGE (Bleeding of the scratching) and HYPERSENSITIVITY (Hypersensitive to vaccine) had not resolved.            No concomitant medications was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine (Unknown), the reporter assessed the causality as possible.  It was reported that patient received the second dose on 5th May. On 23rd July patient met with a allergy specialist because the rash still persists. Patient reported that it was more severe on the chest rather than back. Patient also reported symptoms did not change after the second vaccine.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-101848 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac failure congestive, Product dose omission issue
Clinical narrative: I have heavy heart problems; Congestive heart failure, supposedly severe; I never went back for my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (I have heavy heart problems) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure, supposedly severe) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardioversion. Concurrent medical conditions included Congestive heart failure. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID), SPIRONOLACTONE, METOPROLOL, AMIODARONE, HYDRALAZINE, APIXABAN (ELIQUIS) and BUMETANIDE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I never went back for my 2nd dose). On an unknown date, the patient experienced CARDIAC DISORDER (I have heavy heart problems) (seriousness criterion hospitalization) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure, supposedly severe) (seriousness criteria hospitalization and medically significant). At the time of the report, CARDIAC DISORDER (I have heavy heart problems) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure, supposedly severe) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I never went back for my 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Of note patient had CHF and CARDIOVERSION . Very limited information has been provided at this time .Please send the appropriate Adverse Event Follow-up form. Please close your Action Items when done Further information is expected; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Of note patient had CHF and CARDIOVERSION . Very limited information has been provided at this time.Please send the appropriate Adverse Event Follow-up form. Please close your Action Items when done Further information is expected
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cold sweat, Conjunctival haemorrhage, Conjunctivitis, Influenza like illness
Clinical narrative: the white area in his eye was bloody on the right side/blood in his eye; a little temperature/ low grade fever; back was hurting as if he did did 500 push ups; flu like symptoms; cold sweats; left eyelid started swelling/swollen eyelids; puffy eye; conjunctivitis/pink eye; muscle aches; This spontaneous case was reported by a pharmacist and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (the white area in his eye was bloody on the right side/blood in his eye) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (INSULIN NOVOLIN), METFORMIN, GLIMEPIRIDE (AMARYL), LOSARTAN POTASSIUM (COZAAR), CLOPIDOGREL BISULFATE (PLAVIX) and METOPROLOL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONJUNCTIVAL HAEMORRHAGE (the white area in his eye was bloody on the right side/blood in his eye) (seriousness criterion medically significant), PYREXIA (a little temperature/ low grade fever), BACK PAIN (back was hurting as if he did did 500 push ups), INFLUENZA LIKE ILLNESS (flu like symptoms), COLD SWEAT (cold sweats), SWELLING OF EYELID (left eyelid started swelling/swollen eyelids), PERIORBITAL SWELLING (puffy eye), CONJUNCTIVITIS (conjunctivitis/pink eye) and MYALGIA (muscle aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse reaction, at an unspecified dose and frequency. At the time of the report, CONJUNCTIVAL HAEMORRHAGE (the white area in his eye was bloody on the right side/blood in his eye), SWELLING OF EYELID (left eyelid started swelling/swollen eyelids), PERIORBITAL SWELLING (puffy eye) and CONJUNCTIVITIS (conjunctivitis/pink eye) outcome was unknown and PYREXIA (a little temperature/ low grade fever), BACK PAIN (back was hurting as if he did did 500 push ups), INFLUENZA LIKE ILLNESS (flu like symptoms), COLD SWEAT (cold sweats) and MYALGIA (muscle aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist states that he read on a website that the vaccine had been linked to infections such as conjunctivitis, pink eye, and swollen eyelids.     Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up contains new events; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Periorbital swelling, Pyrexia, Swelling of eyelid
Clinical narrative: the white area in his eye was bloody on the right side/blood in his eye; a little temperature/ low grade fever; back was hurting as if he did did 500 push ups; flu like symptoms; cold sweats; left eyelid started swelling/swollen eyelids; puffy eye; conjunctivitis/pink eye; muscle aches; This spontaneous case was reported by a pharmacist and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (the white area in his eye was bloody on the right side/blood in his eye) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (INSULIN NOVOLIN), METFORMIN, GLIMEPIRIDE (AMARYL), LOSARTAN POTASSIUM (COZAAR), CLOPIDOGREL BISULFATE (PLAVIX) and METOPROLOL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONJUNCTIVAL HAEMORRHAGE (the white area in his eye was bloody on the right side/blood in his eye) (seriousness criterion medically significant), PYREXIA (a little temperature/ low grade fever), BACK PAIN (back was hurting as if he did did 500 push ups), INFLUENZA LIKE ILLNESS (flu like symptoms), COLD SWEAT (cold sweats), SWELLING OF EYELID (left eyelid started swelling/swollen eyelids), PERIORBITAL SWELLING (puffy eye), CONJUNCTIVITIS (conjunctivitis/pink eye) and MYALGIA (muscle aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse reaction, at an unspecified dose and frequency. At the time of the report, CONJUNCTIVAL HAEMORRHAGE (the white area in his eye was bloody on the right side/blood in his eye), SWELLING OF EYELID (left eyelid started swelling/swollen eyelids), PERIORBITAL SWELLING (puffy eye) and CONJUNCTIVITIS (conjunctivitis/pink eye) outcome was unknown and PYREXIA (a little temperature/ low grade fever), BACK PAIN (back was hurting as if he did did 500 push ups), INFLUENZA LIKE ILLNESS (flu like symptoms), COLD SWEAT (cold sweats) and MYALGIA (muscle aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist states that he read on a website that the vaccine had been linked to infections such as conjunctivitis, pink eye, and swollen eyelids.     Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up contains new events; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Balance disorder, Fall
Clinical narrative: She started with loss of taste in middle of June and it is still there.; After receiving 2nd dose, when she was coming back she fell again; She had imbalance of left side of knee; This spontaneous case was reported by a consumer and describes the occurrence of FALL (After receiving 2nd dose, when she was coming back she fell again) and BALANCE DISORDER (She had imbalance of left side of knee) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]) and VITAMINS NOS for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FALL (After receiving 2nd dose, when she was coming back she fell again) (seriousness criterion medically significant) and BALANCE DISORDER (She had imbalance of left side of knee) (seriousness criterion medically significant). On an unknown date, the patient experienced AGEUSIA (She started with loss of taste in middle of June and it is still there.). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FALL (After receiving 2nd dose, when she was coming back she fell again) and BALANCE DISORDER (She had imbalance of left side of knee) outcome was unknown and AGEUSIA (She started with loss of taste in middle of June and it is still there.) had not resolved.            Patient had bunch of tests done in April with Neurologist.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-269894 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Ear congestion, Hypoacusis
Clinical narrative: lost some ability to hear as well as I could before the vaccination; Right ear congestion; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0180), via an intramuscular route on 13Jul2021 (at the age of 70-years) as dose 2, single in the left arm for COVID-19 immunisation. The patient medical history was not reported. The patient had no known allergies. The patient concomitant medications included Meloxicam, ginger, B12 and vitamin C from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single in the left arm for COVID-19 immunisation. 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. On 14Jul2021, the patient experienced right ear congestion the next day after 2nd dose vaccine and it still persist today and also lost some ability to hear as well as he could before the vaccination. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not received treatment for events (as reported). The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Tinnitus
Clinical narrative: Tinnitus on right started 29Dec2020 and has not subsided since.; This is a spontaneous report from a contactable Nurse (Patient). A non-pregnant adult (Age: 55; Unit: Unknown) female patient of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection, Batch/Lot Number: El1284), via an unspecified route of administration, administered in left arm on 28Dec2020 at 13:00 as dose 1, single for COVID-19 immunisation in Hospital. Medical history included skin cancer and arthritis. Patient had no known allergies. Concomitant medication(s) included psyllium (PSYLLIUM [PLANTAGO AFRA]). Patient did not receive other vaccine in four weeks. Patient did not have Covid prior vaccination. On 29Dec2020 at 07:00 PM, patient experienced Tinnitus on right and has not subsided since. The event resulted in doctor or other healthcare professional office/clinic visit. The event was considered serious (disability or permanent damage). The patient underwent a lab test which included audiology exam: unknown results on an unspecified date. Patient not tested for Covid post vaccination. The treatment received included an audiology exam and still waiting for ENT. The outcome of the event was not recovered.; Sender's Comments: Based on the information in the case report, a possible causal relationship between Tinnitus and suspect product BNT162B2 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.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Impaired quality of life, Magnetic resonance imaging, Neuropathy peripheral, Paraesthesia
Clinical narrative: diagnosis is idiopathic sensory neurology; impacting his quality of life; I developed a persistent pins & needles sensation in both hands & both feet; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW1071) via an unspecified route, administered in Left Arm on 07May2021 (43-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient's medical history included peanuts and almonds allergy. Overall healthy person. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8730) via an unspecified route, administered in Left Arm on 16Apr2021 (43-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. Facility type vaccine was reported as Other. The patient neither receive any other vaccine in four weeks of Covid-19 vaccination nor received any other medications in two weeks. Prior vaccination the patient was not diagnosed with Covid. On 02Jun2021 (approximately 3.5 weeks after the 2nd dose), he developed a persistent pins and needles sensation in both hands and both feet. The symptoms developed over the course of 24 hours on both sides. He visited his regular physician as well as a neurologist and went through a number of prescribed tests (contrast MRI of the brain and spine, as well as specific neuropathy-related bloodwork). All tests appeared negative or within range. Yet, the symptoms have continued for over a month now, impacting his quality of life. At this point his diagnosis was idiopathic sensory neurology. These adverse events resulted the patient to visit doctor or other healthcare professional office/clinic visit. No treatment had been prescribed. Post vaccination the patient was not tested for Covid. The patient had not received any treatment medication for resulted events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information was expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Confusional state, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: extremely tired; cant focus; cant work due to slow response time and confusion; arm went numb and cold; arm went numb and cold; Chest pains; blacked out 15 minutes after shot; Dizzy; vertigo; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EW-196 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 17Jul2021 at 14:30(at the age of 50-years-old) at dose 1, single for COVID-19 immunization. Medical history included diabetes. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not have any other medications in two weeks. Patient had no allergies to medications, food or other products; was not diagnosed with COVID-19 prior vaccination and since the vaccination, patient had not tested for covid-19. The patient experienced dizzy, vertigo and blacked out 15 minutes after shot on 17Jul2021at 14:45. Two days later the vaccination(19Jul2021), patient's arm went numb and cold and this would come and go, had the chest pains where the heart was. 3 days after shot patient felt extremely tired, cant focus, cant work due to slow response time and confusion. This has been ongoing since day 3 and now on day 7 (at the time of report). The patient had most recent COVID-19 vaccine at Pharmacy or Drug Store. Patient was given Ibuprofen to resolve the chest pains and unspecified treatment was given for the events. The outcome of the events (tired, cant focus, cant work due to slow response time and confusion) was not recovered where as outcome of ret of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of consciousness, Peripheral coldness, Vertigo
Clinical narrative: extremely tired; cant focus; cant work due to slow response time and confusion; arm went numb and cold; arm went numb and cold; Chest pains; blacked out 15 minutes after shot; Dizzy; vertigo; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EW-196 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 17Jul2021 at 14:30(at the age of 50-years-old) at dose 1, single for COVID-19 immunization. Medical history included diabetes. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not have any other medications in two weeks. Patient had no allergies to medications, food or other products; was not diagnosed with COVID-19 prior vaccination and since the vaccination, patient had not tested for covid-19. The patient experienced dizzy, vertigo and blacked out 15 minutes after shot on 17Jul2021at 14:45. Two days later the vaccination(19Jul2021), patient's arm went numb and cold and this would come and go, had the chest pains where the heart was. 3 days after shot patient felt extremely tired, cant focus, cant work due to slow response time and confusion. This has been ongoing since day 3 and now on day 7 (at the time of report). The patient had most recent COVID-19 vaccine at Pharmacy or Drug Store. Patient was given Ibuprofen to resolve the chest pains and unspecified treatment was given for the events. The outcome of the events (tired, cant focus, cant work due to slow response time and confusion) was not recovered where as outcome of ret of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Fibromyalgia, Hyperhidrosis, Meniere's disease
Clinical narrative: meuniere in my right ear; Migraine; fibromyalgia flare ups; sweating; restless sleep; severe back aches; nausea; All my conditions are exasperated; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Jul2021 at 11:30 (at the age of 65-years-old) as a dose number unknown, single for COVID-19 immunization. Medical history included allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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 experienced meuniere in her right ear, migraine, fibromyalgia flare ups, sweating, restless sleep, severe back aches, nausea and all her conditions were exasperated on 17Jul2021. The patient did not receive any treatment. The clinical outcome for the events was not recovered.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Sleep disorder
Clinical narrative: meuniere in my right ear; Migraine; fibromyalgia flare ups; sweating; restless sleep; severe back aches; nausea; All my conditions are exasperated; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Jul2021 at 11:30 (at the age of 65-years-old) as a dose number unknown, single for COVID-19 immunization. Medical history included allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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 experienced meuniere in her right ear, migraine, fibromyalgia flare ups, sweating, restless sleep, severe back aches, nausea and all her conditions were exasperated on 17Jul2021. The patient did not receive any treatment. The clinical outcome for the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: fatigue; glands swollen on left side; This is a solicited report based on the information received by Pfizer from regulatory authority. (MFR Control No. # 21K-163-3987976-00).  A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 2021 (batch/lot number was not reported) as dose 2, single for COVID-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (batch/lot number was not reported) and ongoing, at an unspecified dose (citrate free) for psoriatic arthritis. Medical history included patient was ill with breast cancer in 2017, she had cold in 2018 (cold resolved), and she had osteoporosis. The patient's concomitant medications were not reported. The patient previously received BNT162B2, intramuscular in Apr2021 as dose 1, single for COVID-19 immunization and experienced fatigue. In 2021, she received 2nd dose of COVID-19 vaccine manufactured by Pfizer. After second shot, she had fatigue and two days later she had glands swollen on left side. Events were reported as other medically important conditions. The action taken in response to the events for adalimumab was dose not changed. The outcome of the events was unknown. The reporter's causality for the events of breast cancer, osteoporosis, fatigue onset in Apr2021, fatigue onset in 2021, glands swollen on left side and cold with adalimumab was no reasonable possibility. The reporter's causality for the events fatigue and glands swollen with BNT162B2 was probable.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information in the case, the causal association between the events fatigue, lymphadenopathy and the suspect drug BNT162B2 cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, Loss of consciousness, Nausea, SARS-CoV-2 test, Seizure
Clinical narrative: Fluid on brain; Unconscious on bathroom floor; Seizures; Sepsis; Nausea; Vomiting; Unresponsive; This is a spontaneous report from a contactable other hcp (patient). A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via intramuscular, administered in left arm on 05Mar2021 (age at vaccination was 38 years) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included known allergies from an unknown date and unknown if ongoing. The patient received first dose of bnt162b2 on an unspecified date via unspecified route as dose 1, single for covid-19 immunization. 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 did not test COVID-19 positive prior to vaccination. On 08Mar2021, 3 days after receiving the second vaccine, the patient experienced with nausea and vomiting and visited to 6 times to her doctor and her doctor said that was due to the virus. On 20Apr2021 patient was found unconscious on bathroom floor, then patient was taken to hospital where patient spent 9 days out of 2 days on ventilator, in the hospital the patient was diagnosed with seizures, sepsis, fluid on brain and unresponsive. The events resulted in physician office visit and hospitalization where the seriousness was hospitalization, disability, or permanent damage. The patient received treatment for the events with all kinds of antibiotics. The patient had tested with nasal swab for COVID-19 since the vaccination which came negative on 20Apr2021. The outcome of the events was recovered with sequelae on an unspecified date in 2021.  Information about the Lot/batch number has been requested. ; Sender's Comments: Based on plausible dose-event relationship the causal role of BNT162B2 cannot be excluded for the reported events..   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis, Unresponsive to stimuli, Vomiting
Clinical narrative: Fluid on brain; Unconscious on bathroom floor; Seizures; Sepsis; Nausea; Vomiting; Unresponsive; This is a spontaneous report from a contactable other hcp (patient). A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via intramuscular, administered in left arm on 05Mar2021 (age at vaccination was 38 years) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included known allergies from an unknown date and unknown if ongoing. The patient received first dose of bnt162b2 on an unspecified date via unspecified route as dose 1, single for covid-19 immunization. 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 did not test COVID-19 positive prior to vaccination. On 08Mar2021, 3 days after receiving the second vaccine, the patient experienced with nausea and vomiting and visited to 6 times to her doctor and her doctor said that was due to the virus. On 20Apr2021 patient was found unconscious on bathroom floor, then patient was taken to hospital where patient spent 9 days out of 2 days on ventilator, in the hospital the patient was diagnosed with seizures, sepsis, fluid on brain and unresponsive. The events resulted in physician office visit and hospitalization where the seriousness was hospitalization, disability, or permanent damage. The patient received treatment for the events with all kinds of antibiotics. The patient had tested with nasal swab for COVID-19 since the vaccination which came negative on 20Apr2021. The outcome of the events was recovered with sequelae on an unspecified date in 2021.  Information about the Lot/batch number has been requested. ; Sender's Comments: Based on plausible dose-event relationship the causal role of BNT162B2 cannot be excluded for the reported events..   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Metamorphopsia, Ophthalmic migraine, Visual impairment
Clinical narrative: 3 to 4 episodes of orocular migraines/ocular migraines; Vision was impaired during the Monday and Tuesday events while on computer for work; w zig zag lines.  Mon June 1 and Tuesday June 2 same thing but with colors redbone, orange bars; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 03May2021 17:45 (age at vaccination: 63-year-old) (Batch/Lot Number: Ew0179) as single dose for COVID-19 immunization. The patient past medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing. Concomitant medications included atenolol taken for an unspecified indication, irbesartan taken for an unspecified indication, levothyroxine taken for an unspecified indication. The allergy includes valdecoxib, verapamil and nifedipine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 28May2021 at 11:00 pm, The patient experienced 3 to 4 episodes of oracular migraines starting Friday and again Saturday 29May2021 w zig zag lines. On Monday 01Jun2021 and Tuesday 28Jun2021 same thing but with colors redbone, orange bars. Each lasted about 20 minutes. Vision was impaired during the Monday and Tuesday events while on computer for work. she has never experienced ocular migraines until this time. The events result in Doctor or other healthcare professional office/clinic visit. The patient not received treatment. The events outcome was recovered on unknown date in 2021.  No follow-up attempts are possible. No further information was expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: having the burning in the arm; This is a spontaneous report from a contactable consumer reporting for himself. A 57-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8731, expiry date: unknown) via unspecified route of administration on 17Apr2021 (age at vaccination: 57-years) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (Lot: EP6955), via unspecified route on 27Mar2021 as single dose for Covid-19 immunization. There was no other vaccination within 4 weeks prior to the first administration of the suspect vaccine. No other medical conditions and the patient was not taking any medications. After vaccination, patient had no side effects, it's been 3 months and now he was having the burning in the arm when he had the second injection, on an unspecified date in 2021. He would like to report it and was also curious if anybody else's having that or if he should go see somebody. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reporter had a friend die from the covid vaccine.; This is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter had a friend die from the covid vaccine. Outcome of event was fatal.The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Reporter had a friend die from the covid vaccine.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Gingival swelling, Headache, Mental impairment
Clinical narrative: mental fog; swollen gums; mouth irritation; weakness; nausea; Fever; chills; severe muscle pain; severe headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0196) via an unspecified route of administration on 14Jul2021 at 18:00 (at the age of 46-years-old) in right arm as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. No known allergies were reported. Concomitant medications received in two weeks included rosuvastatin (ROSUVASTATIN) and ezetimibe (EZETIMIBE) both taken for an unspecified indication, start and stop date were not reported. The patient's previously received BNT162B2 (COVID Pfizer vaccine; lot number: EW0168) on 23Jun2021 at 18:00 in right arm as dose 1, single for COVID-19 immunization. The patient experienced fever, chills, severe muscle pain, weakness, severe headache, mental fog, swollen gums, mouth irritation and nausea on 15Jul2021 at 06:00. The patient did not receive any treatment. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Stomatitis
Clinical narrative: mental fog; swollen gums; mouth irritation; weakness; nausea; Fever; chills; severe muscle pain; severe headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0196) via an unspecified route of administration on 14Jul2021 at 18:00 (at the age of 46-years-old) in right arm as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. No known allergies were reported. Concomitant medications received in two weeks included rosuvastatin (ROSUVASTATIN) and ezetimibe (EZETIMIBE) both taken for an unspecified indication, start and stop date were not reported. The patient's previously received BNT162B2 (COVID Pfizer vaccine; lot number: EW0168) on 23Jun2021 at 18:00 in right arm as dose 1, single for COVID-19 immunization. The patient experienced fever, chills, severe muscle pain, weakness, severe headache, mental fog, swollen gums, mouth irritation and nausea on 15Jul2021 at 06:00. The patient did not receive any treatment. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Fall, Weight
Clinical narrative: fall; This is a spontaneous report from a contactable consumer. An 81-year-old male patient (reporter's father) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 27Feb2021 via an unknown route at 81-year-old for Covid-19 immunization. It was reported that "guess his height would be 5 foot 6 his weight would probably between 175 to 200". Medical history was not provided. Regarding concomitant drug , it was reported that patient was taken "divan" (not further clarified), and some other medications but the reporter did not know exactly what they were. The patient did not take any other vaccine 4 week prior to COVID 19 Vaccine, but he could have taken the flu shot but the reporter did not know how long prior to the COVID vaccine, he got it.  It was further reported that reporter had no idea whether he even took it, it was just possible that he may have taken one.  Patient had a fall just before he took the second shot so, they give it to him in the hospital before he went to the nursing home for Rehab and he was back home "now" (as reported). It was two weeks after the 1st dose, probably about 11Mar2021 or so was not certain. Outcome of the event was unknown.    Information on the lot/batch number has been requested.