chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hair texture abnormal, Immunisation, Pyrexia
Clinical narrative: she took the 3rd dose; felt so hot; fever; hair got curly and frizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization, reaction(s): "felt tired", "sleepy", "in pain on the injection site"; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization, reaction(s): "felt tired", "sleepy", "in pain on the injection site". The following information was reported: IMMUNISATION (non-serious) with onset Jul2021, outcome "unknown", described as "she took the 3rd dose"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "felt so hot"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; HAIR TEXTURE ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "hair got curly and frizzy".  Additional information: The medical questions addressed by this program forwarded/referred to Medical Information. Customer and/or medical inquiry forwarded or referred to MI.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid after being double vaccinated; tested positive for Covid after being double vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid after being double vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. The clinical course of events was as follows: I learned of another individual who tested positive for Covid after being double vaccinated. Her name is # and she is sixteen years old. Her mother's contact information is below. Her mother informed me Friday evening and I confirmed today that withheld had been vaccinated by Pfizer. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Headache, Immunisation
Clinical narrative: Booster; Pain at injection site; Pain in armpit as well as neck and shoulder; Pain in armpit as well as neck and shoulder; Pain in armpit as well as neck and shoulder; Nausea; Body ache; Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain at injection site"; AXILLARY PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "Pain in armpit as well as neck and shoulder"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; PAIN (non-serious), outcome "unknown", described as "Body ache"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional event: Description of Event:  5'1, 31 years old. After COVID booster experienced pain at injection site, in armpit as well as neck and shoulder, all lasting for more than 24 hours. Nausea, body ache, headache, chills  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Vaccination site pain
Clinical narrative: Booster; Pain at injection site; Pain in armpit as well as neck and shoulder; Pain in armpit as well as neck and shoulder; Pain in armpit as well as neck and shoulder; Nausea; Body ache; Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain at injection site"; AXILLARY PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "Pain in armpit as well as neck and shoulder"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; PAIN (non-serious), outcome "unknown", described as "Body ache"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional event: Description of Event:  5'1, 31 years old. After COVID booster experienced pain at injection site, in armpit as well as neck and shoulder, all lasting for more than 24 hours. Nausea, body ache, headache, chills  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blindness, Immunisation, Interchange of vaccine products, Off label use, Visual impairment
Clinical narrative: He is losing vision in his right eye, he might see that with one eye right now and he is losing vision in that eye; the words when he looks at a picture or a sentence it is running of its angle and it is curved; Booster; Interchange of vaccine products; Off Label Use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date 17Dec2021 10:00 (Batch/Lot number: unknown) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown) as single dose for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson & johnson covid-19 vaccine (1st dose), for Covid-19 immunisation; Johnson & johnson covid-19 vaccine (2nd dose), for Covid-19 immunisation. The following information was reported: BLINDNESS (medically significant) with onset 17Dec2021 13:00, outcome "unknown", described as "He is losing vision in his right eye, he might see that with one eye right now and he is losing vision in that eye"; VISUAL IMPAIRMENT (non-serious) with onset 17Dec2021 13:00, outcome "unknown", described as "the words when he looks at a picture or a sentence it is running of its angle and it is curved". The events were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of blindness, visual impairment. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Chills, Myocarditis, Palpitations
Clinical narrative: Heart palpitations; chills; myocarditis; Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old adult male received the first dose of intramuscular BNT162b2 (solution for injection; batch/lot reported as unknown expiry not provided) as a single dose in the left arm on an unspecified date in 2021 for COVID-19 immunisation. Relevant medical history included COVID-19 (diagnosed prior to vaccine). There were no concomitant medications reported. The patient denied receiving any other vaccine within four weeks of receiving this vaccine. The patient denied being tested for COVID since receiving the vaccine. On 01Dec2021 the patient experienced heart palpitations, chills, and myocarditis; which resulted/required visit(s) to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. A few days later, on an unspecified date in Dec2021, the patient experienced Bell's Palsy: which resulted/required visit(s) to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient received unspecified treatment. The outcome of the events heart palpitations, chills, myocarditis, and Bell's Palsy was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test Nasal Swab Positive; covid test Nasal Swab Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Aug2021, outcome "unknown" and all described as "covid test Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Aug2021) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Vaccination failure ,COVID-19cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202101814804 same reporter and patient, different AE
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Syncope
Clinical narrative: fainting; Hair loss; This is a spontaneous report received from contactable reporter, nurse. The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm right, administration date 03Jul2021 10:30 (Lot number: EW0198) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took unspecified concomitant medications. Vaccination history included: Bnt162b2 (lot# EW0181, administration time: 10:30 AM, first dose, location: Left arm), administration date: 12Jun2021, when the patient was 40 years old, for covid 19 immunization. The following information was reported: syncope (medically significant) with onset 17Jul2021 20:00, outcome recovering", alopecia (non-serious) with onset 17Jul2021 20:00, outcome recovering. Therapeutic measures were not taken as a result of syncope, alopecia. No other vaccine in four weeks, no covid prior vaccination. No covid tested post vaccination.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported event syncope and other reported events and the suspect drug 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Localised infection, Neuropathy peripheral, Rheumatoid arthritis
Clinical narrative: neuropathy; fatigued; infected toe; Rheumatoid arthritis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 1K-163-4195946-00 (Abbvie).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "HIP REPLACEMENT" (unspecified if ongoing); "KNEE REPLACEMENT" (unspecified if ongoing); "SHOULDER REPLACEMENT" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Feb2021, outcome "unknown", described as "Rheumatoid arthritis"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; LOCALISED INFECTION (non-serious) with onset Aug2021, outcome "unknown", described as "infected toe"; FATIGUE (non-serious), outcome "unknown", described as "fatigued". The action taken for upadacitinib was unknown.  Additional information: The patient In August 2021 with experienced right big toe became infected after getting a thorn and it was not healing. In Feb2021, patient's arthritis symptoms increased for several months after having the covid vaccine and also mentioned being fatigued. He also had Neuropathy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events rheumatoid arthritis flare up, infected toe and neuropathywas not provided with RINVOQ (UPADACITINIB). The reporter's causality for the events rheumatoid arthritis flare up, infected toe and neuropathy was not related with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of Rheumatoid arthritis, Neuropathy peripheral and Localised infection are assessed as Unrelated to the suspect drug bnt162b2 based on  possible contributory effects from patient's medical history and/or concomitant medications.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Dizziness, Flank pain, Haematuria, Herpes zoster
Clinical narrative: I?m a retired physician in generally good health for 85 years. In March 2020 I had a mild case of Covid-19 with no late after effects and in February 2021 twice received mRNA Covid vaccines (Pfizer) without incident. A routine health exam on October 13, 2021 included basic laboratory tests, all of which were normal except for elevated glucose, and I was given a Flu shot. The very next day I had a Covid-19 booster at a local pharmacy ? then things got complicated.  On October 15, 2021 I attended an outdoor event and stood for nearly two hours in 80 degree heat. Feeling faint, I lay down and drank water and that night was surprised to note gross hematuria. I had no history of kidney disorders and only the next day was there moderate left flank pain. A CT urogram revealed a radiolucent 7 mm stone obstructing the mid left ureter. I was hospitalized and when a urologist inserted a ureteral stent to decompress the kidney, the stone was pushed back up into the renal pelvis. Three weeks later ureteroscopy and lithotripsy was performed, the stent then was reinserted for three more weeks. (Follow-up CT urogram performed on 1/3/22?..)   Almost unnoticed amidst all this, a rash had developed behind my left eyebrow, soon followed by small lesions on the temple, forehead and nose. Then there was unilateral neck and scalp tenderness that initially I attributed to cervical arthritis ? until I awoke on December 4 with slightly blurred vision and noted conjunctivitis of the left eye. I realized that the rash corresponded with the dermatome of the ophthalmic division of the trigeminal nerve and only then did I understand that Herpes Zoster (HZ) from long forgotten childhood chickenpox must have become activated. An ophthalmologist confirmed presence of acute iritis and increased intraocular pressure and I was begun on eye drops, including tapering doses of a steroid.. I?d never received a shingles vaccination and it was decided not to begin an antiviral because by now, it probably was several weeks since initial eruption of the rash and scalp tenderness ? too late for benefit. Pain was managed with nonprescription analgesics.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Intraocular pressure increased, Iritis, Nephrolithiasis, Pain, Pain of skin
Clinical narrative: I?m a retired physician in generally good health for 85 years. In March 2020 I had a mild case of Covid-19 with no late after effects and in February 2021 twice received mRNA Covid vaccines (Pfizer) without incident. A routine health exam on October 13, 2021 included basic laboratory tests, all of which were normal except for elevated glucose, and I was given a Flu shot. The very next day I had a Covid-19 booster at a local pharmacy ? then things got complicated.  On October 15, 2021 I attended an outdoor event and stood for nearly two hours in 80 degree heat. Feeling faint, I lay down and drank water and that night was surprised to note gross hematuria. I had no history of kidney disorders and only the next day was there moderate left flank pain. A CT urogram revealed a radiolucent 7 mm stone obstructing the mid left ureter. I was hospitalized and when a urologist inserted a ureteral stent to decompress the kidney, the stone was pushed back up into the renal pelvis. Three weeks later ureteroscopy and lithotripsy was performed, the stent then was reinserted for three more weeks. (Follow-up CT urogram performed on 1/3/22?..)   Almost unnoticed amidst all this, a rash had developed behind my left eyebrow, soon followed by small lesions on the temple, forehead and nose. Then there was unilateral neck and scalp tenderness that initially I attributed to cervical arthritis ? until I awoke on December 4 with slightly blurred vision and noted conjunctivitis of the left eye. I realized that the rash corresponded with the dermatome of the ophthalmic division of the trigeminal nerve and only then did I understand that Herpes Zoster (HZ) from long forgotten childhood chickenpox must have become activated. An ophthalmologist confirmed presence of acute iritis and increased intraocular pressure and I was begun on eye drops, including tapering doses of a steroid.. I?d never received a shingles vaccination and it was decided not to begin an antiviral because by now, it probably was several weeks since initial eruption of the rash and scalp tenderness ? too late for benefit. Pain was managed with nonprescription analgesics.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Skin lesion, Stent placement, Tenderness, Urogram
Clinical narrative: I?m a retired physician in generally good health for 85 years. In March 2020 I had a mild case of Covid-19 with no late after effects and in February 2021 twice received mRNA Covid vaccines (Pfizer) without incident. A routine health exam on October 13, 2021 included basic laboratory tests, all of which were normal except for elevated glucose, and I was given a Flu shot. The very next day I had a Covid-19 booster at a local pharmacy ? then things got complicated.  On October 15, 2021 I attended an outdoor event and stood for nearly two hours in 80 degree heat. Feeling faint, I lay down and drank water and that night was surprised to note gross hematuria. I had no history of kidney disorders and only the next day was there moderate left flank pain. A CT urogram revealed a radiolucent 7 mm stone obstructing the mid left ureter. I was hospitalized and when a urologist inserted a ureteral stent to decompress the kidney, the stone was pushed back up into the renal pelvis. Three weeks later ureteroscopy and lithotripsy was performed, the stent then was reinserted for three more weeks. (Follow-up CT urogram performed on 1/3/22?..)   Almost unnoticed amidst all this, a rash had developed behind my left eyebrow, soon followed by small lesions on the temple, forehead and nose. Then there was unilateral neck and scalp tenderness that initially I attributed to cervical arthritis ? until I awoke on December 4 with slightly blurred vision and noted conjunctivitis of the left eye. I realized that the rash corresponded with the dermatome of the ophthalmic division of the trigeminal nerve and only then did I understand that Herpes Zoster (HZ) from long forgotten childhood chickenpox must have become activated. An ophthalmologist confirmed presence of acute iritis and increased intraocular pressure and I was begun on eye drops, including tapering doses of a steroid.. I?d never received a shingles vaccination and it was decided not to begin an antiviral because by now, it probably was several weeks since initial eruption of the rash and scalp tenderness ? too late for benefit. Pain was managed with nonprescription analgesics.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: I?m a retired physician in generally good health for 85 years. In March 2020 I had a mild case of Covid-19 with no late after effects and in February 2021 twice received mRNA Covid vaccines (Pfizer) without incident. A routine health exam on October 13, 2021 included basic laboratory tests, all of which were normal except for elevated glucose, and I was given a Flu shot. The very next day I had a Covid-19 booster at a local pharmacy ? then things got complicated.  On October 15, 2021 I attended an outdoor event and stood for nearly two hours in 80 degree heat. Feeling faint, I lay down and drank water and that night was surprised to note gross hematuria. I had no history of kidney disorders and only the next day was there moderate left flank pain. A CT urogram revealed a radiolucent 7 mm stone obstructing the mid left ureter. I was hospitalized and when a urologist inserted a ureteral stent to decompress the kidney, the stone was pushed back up into the renal pelvis. Three weeks later ureteroscopy and lithotripsy was performed, the stent then was reinserted for three more weeks. (Follow-up CT urogram performed on 1/3/22?..)   Almost unnoticed amidst all this, a rash had developed behind my left eyebrow, soon followed by small lesions on the temple, forehead and nose. Then there was unilateral neck and scalp tenderness that initially I attributed to cervical arthritis ? until I awoke on December 4 with slightly blurred vision and noted conjunctivitis of the left eye. I realized that the rash corresponded with the dermatome of the ophthalmic division of the trigeminal nerve and only then did I understand that Herpes Zoster (HZ) from long forgotten childhood chickenpox must have become activated. An ophthalmologist confirmed presence of acute iritis and increased intraocular pressure and I was begun on eye drops, including tapering doses of a steroid.. I?d never received a shingles vaccination and it was decided not to begin an antiviral because by now, it probably was several weeks since initial eruption of the rash and scalp tenderness ? too late for benefit. Pain was managed with nonprescription analgesics.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain, Rash erythematous, Rash papular
Clinical narrative: Red raised hot air, with severe pain
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccine breakthrough infection
Clinical narrative: suspect COVID breakthrough
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: Systemic: looking pale-Mild, Additional Details: child was conscious all the time, parents chose not to go the hospital after EMS arrieved.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient reported to a technition that she was having some swelling of the tonge. I was administering vaccines to other patients and attended to her as soon as possible. When I got to her she said she had taken a drink of water and the swelling was coming down. She wasn't having any difficulty breathing. Since the swelling was coming down, i gave her some benadryll and checked back with her in 5-10 min. at that point she had not taken the benadryll and the swelling had subsided completely.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Face injury, Fall, Fatigue
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patietn was asked to wait for 15 minutes after his 2nd dose , 7 minutes after his father informed us his son was not feeling well ,at that time Patient fainted and fell on his face , 911 contacted immediately , Patient was confused and not aware of his surroundings , however patient was breathing normal , medics arrived few minutes later and took his vitals and advised father he needs to be taken to ER for heart monitoring
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Syncope
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patietn was asked to wait for 15 minutes after his 2nd dose , 7 minutes after his father informed us his son was not feeling well ,at that time Patient fainted and fell on his face , 911 contacted immediately , Patient was confused and not aware of his surroundings , however patient was breathing normal , medics arrived few minutes later and took his vitals and advised father he needs to be taken to ER for heart monitoring
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Site: Pain at Injection Site-Mild, Error: Patient Too Young for Vaccine Administered-, Additional Details: Patient's parents registered child under false birthday, errantly creating a situation where the pharmacy unknowingly administered the vaccine to a child that is too young.  Pediatrician and health department notified the pharmacy staff of the difference in the reported birthdays.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Multiple sclerosis
Clinical narrative: I have Multiple Sclerosis; dose received 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Chronic Migraines" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose lot unknown reason=Other,, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, prev dose lot unknown reason=Other,, Location of injection: Arm Left), administration date: 12Apr2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (disability), outcome "recovering", described as "I have Multiple Sclerosis. I had the worst MS attack of my life after getting the Vacinnes.  I''m on Ocrevus and have been stable for quite some time.  Because my immunotherapy is a T-cell depleting therapy"; IMMUNISATION (non-serious) with onset 01Oct2021, outcome "unknown", described as "dose received 3". Therapeutic measures were taken as a result of multiple sclerosis.  Clinical indication:I had an exacerbation of MS symptoms after getting the 3rd dose, and my doctor ordered a blood test that measures the amount of antibodies in my system to fight and hopefully protect me from COVID-19.Ae treatment: Solu-medrol and other high dose steroids  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: booster shot; my throat has been hurting/I have a sore on the left side of my throat/sore throat; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (Pfizer-BioNTech COVID-19), administration date 27Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "booster shot"; OROPHARYNGEAL PAIN (non-serious) with onset 27Nov2021, outcome "not recovered", described as "my throat has been hurting/I have a sore on the left side of my throat/sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient have no fever no other symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Pneumonia, Respiratory rate decreased
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4104075-00. A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single and intramuscular, administration date 13Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. Relevant medical history included: "Pneumonia", start date: 1969 (unspecified if ongoing); "Pneumonia", start date: 2002 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "Pneumonia four times"; BRONCHITIS (non-serious), outcome "recovered", BRONCHITIS (non-serious), outcome "not recovered" and all described as "Bronchitis". The patient underwent the following laboratory tests and procedures: respiratory rate decreased: unknown results. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of pneumonia, bronchitis, bronchitis.  Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with HYCODAN.  The reporter considered "pneumonia four times" and "bronchitis" related to bnt162b2.  The reporter's causality for the event(s) of BRONCHITIS unknown onset and BRONCHITIS unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of PNEUMONIA FOUR TIMES was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "pneumonia four times" and "bronchitis" and the suspect vaccine 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Pain, Pain in extremity, Shoulder operation
Clinical narrative: Shoulder operation; Pain in upper extremities; Shoulder pain; Vaccination site pain; Asthmatic attack; Pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4197893-00.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 06Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155992) at citrate free for crohn's disease. The patient had no relevant medical history. Concomitant medication(s) included: CORTISONE. The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown", described as "Shoulder operation"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in upper extremities"; ARTHRALGIA (non-serious), outcome "unknown", described as "Shoulder pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain"; ASTHMA (non-serious), outcome "unknown", described as "Asthmatic attack"; PAIN (non-serious), outcome "unknown", described as "Pain". The action taken for adalimumab was unknown.  Clinical course: Causality as per reporter (Drug/Vaccine): Probable. The patient reported that she had shoulder surgery on right shoulder and had cortisone shot in both shoulders. Her both both arms/shoulders hurt she got trouble in getting out of a chair due to arm pain. She had side effects of covid-19 vaccination first 2 made arm hurt at injection site. She also got asthma attack got hurt when gets in cold. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event SHOULDER OPERATION, "Shoulder operation";"Pain in upper extremities"; "Shoulder pain";  "Vaccination site pain"; ASTHMA ,"Pain" and the suspect drug BNT162B2.  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: Vaccination site pain
Clinical narrative: Shoulder operation; Pain in upper extremities; Shoulder pain; Vaccination site pain; Asthmatic attack; Pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4197893-00.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 06Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155992) at citrate free for crohn's disease. The patient had no relevant medical history. Concomitant medication(s) included: CORTISONE. The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown", described as "Shoulder operation"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in upper extremities"; ARTHRALGIA (non-serious), outcome "unknown", described as "Shoulder pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain"; ASTHMA (non-serious), outcome "unknown", described as "Asthmatic attack"; PAIN (non-serious), outcome "unknown", described as "Pain". The action taken for adalimumab was unknown.  Clinical course: Causality as per reporter (Drug/Vaccine): Probable. The patient reported that she had shoulder surgery on right shoulder and had cortisone shot in both shoulders. Her both both arms/shoulders hurt she got trouble in getting out of a chair due to arm pain. She had side effects of covid-19 vaccination first 2 made arm hurt at injection site. She also got asthma attack got hurt when gets in cold. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event SHOULDER OPERATION, "Shoulder operation";"Pain in upper extremities"; "Shoulder pain";  "Vaccination site pain"; ASTHMA ,"Pain" and the suspect drug BNT162B2.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Fighting covid; Fighting covid; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4191108-00.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jun2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single and intramuscular, administration date 01May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2021, outcome "recovered" (2021), DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown" and all described as "Fighting covid". The action taken for adalimumab was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease
Clinical narrative: Crohn's related issue; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4196913-00 (Agency).  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant) with onset 2021, outcome "unknown", described as "Crohn's related issue". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of CROHNS RELATED ISSUES was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) The reporter's causality for the event(s) of CROHNS RELATED ISSUES was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information , the causal association between the event Crohns disease and the suspect drug 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.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram ambulatory, Palpitations
Clinical narrative: atrial fibrillation; palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "unknown", described as "atrial fibrillation"; PALPITATIONS (medically significant) with onset 2021, outcome "unknown", described as "palpitations". The clinical course was reported as follows: The patient was prescribed apixaban (ELIQUIS) after atrial fibrillation occurred follow the first dose in Mar2021. The patient noticed palpitations and confirmed the occurrence of atrial fibrillation with my cardiologist, and by a portable electrocardiogram (ECG) monitor. The patient underwent the following laboratory tests and procedures: electrocardiogram ambulatory: (2021) occurrence of atrial fibrillation. Therapeutic measures were taken as a result of atrial fibrillation, palpitations. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4197629-00 (AbbVie).  A 32 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single and intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01Dec2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 01Dec2021, outcome "not recovered" and all described as "COVID-19". The action taken for upadacitinib was unknown.  Additional information: No relevant medical history. No known allergies. Action taken with covid vaccine was drug discontinued, causality as per reporter (Vaccine) was probable.  The reporter considered "covid-19" related to bnt162b2.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Suspected COVID-19  and Drug Ineffective
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Fully vaccinated with booster; Tested positive for COVid; Tested positive for COVid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Tested positive for COVid"; IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Fully vaccinated with booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: Tested positive for Covid.  Clinical course: Patient has tired, sniffles and sore throat. Event took place after use of product. .   The lot number for bnt162b2 was not provided and will be requested during follow up.