chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hypersensitivity, Pyrexia, Vaccination site pain
Clinical narrative: 12 days post vaccination, circular rash appeared around injection site (potential delayed type hypersensitivity reaction); Rash is sensitive to touch; 12 days post vaccination, circular rash appeared around injection site (potential delayed type hypersensitivity reaction); Rash is sensitive to touch; low grade fever; chills; headache; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13May2021 16:45 (Lot number: EW0168) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE RASH (non-serious), HYPERSENSITIVITY (non-serious) all with onset 25May2021, outcome "not recovered" and all described as "12 days post vaccination, circular rash appeared around injection site (potential delayed type hypersensitivity reaction); Rash is sensitive to touch"; PYREXIA (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "low grade fever"; CHILLS (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "chills"; HEADACHE (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "injection site pain". Therapeutic measures were not taken as a result of vaccination site rash, hypersensitivity, pyrexia, chills, headache, vaccination site pain.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: suspect vaccine Route captured, Event's coding updated, Final sentence and clinical information updated.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: 12 days post vaccination, circular rash appeared around injection site (potential delayed type hypersensitivity reaction); Rash is sensitive to touch; 12 days post vaccination, circular rash appeared around injection site (potential delayed type hypersensitivity reaction); Rash is sensitive to touch; low grade fever; chills; headache; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13May2021 16:45 (Lot number: EW0168) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE RASH (non-serious), HYPERSENSITIVITY (non-serious) all with onset 25May2021, outcome "not recovered" and all described as "12 days post vaccination, circular rash appeared around injection site (potential delayed type hypersensitivity reaction); Rash is sensitive to touch"; PYREXIA (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "low grade fever"; CHILLS (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "chills"; HEADACHE (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "injection site pain". Therapeutic measures were not taken as a result of vaccination site rash, hypersensitivity, pyrexia, chills, headache, vaccination site pain.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: suspect vaccine Route captured, Event's coding updated, Final sentence and clinical information updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Had terrible diarrhea.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jun2021 10:30 (Lot number: EW0169) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "covid", start date: Dec2020 (unspecified if ongoing), notes: I had covid in Dec2020, if covid prior vaccination: Yes; "diarrhea " (unspecified if ongoing), notes: "diarrhea I experienced when I had covid in Dec2020". Concomitant medication(s) included: TYLENOL. Past drug history included: Flexeril, reaction(s): "Known allergies: Flexeril"; Nizoral, reaction(s): "Known allergies: Nizoral"; Claritin, reaction(s): "Known allergies: Claritin"; Chlorine, reaction(s): "Known allergies: Chlorine". The following information was reported: DIARRHOEA (non-serious) with onset 21Jun2021 12:00, outcome "recovered", described as "Had terrible diarrhea.". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: The patient had no other vaccine in four weeks. Other medications in two weeks: Tylenol one week earlier. Prior vaccinations: none. Diarrhea started approx. 1 1/2 hours after her first shot. It was bad and lasted all day. It was like the diarrhea patient had experienced when she had covid in Dec2020. It stopped after about 12 hours. Patient drank a lot of fluids and ate toast and felt better in a day or two. The patient also received 2nd dose of BNT162B2 administered in arm left, administration date 19Jul2021 10:30 (Batch/Lot number: Pfizer EW0162) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had not tested post vaccination. Patient did not have diarrhea with second shot. Patient reported it because she did not see it listed as a side effect on the information sheet she received.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Myasthenia gravis crisis, SARS-CoV-2 test
Clinical narrative: acute myasthenia gravis crisis; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLULAVAL QUADRIVALENT, administration date 07Oct2021; ELIQUIS; HYTRIN; PLAVIX. Vaccination history included: Bnt162b2 (Prev dose lot number: EL9261,, prev dose administration date:19Feb2021,, prev dose administration time: 03:30 PM, prev dose dose number: 2,), administration date: 19Feb2021, when the patient was 78 years old, for Covid-19 immunization; Bnt162b2 (prev dose vaccine location: Right arm , prev dose lot number:EL3246,, prev dose administration date: 28Jan2021,, prev dose administration time: 02:30PM, prev dose dose number: 1,, prev dose vaccine location: Left arm), administration date: 28Jan2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 02Nov2021, outcome "unknown", described as "Booster"; MYASTHENIA GRAVIS CRISIS (hospitalization, medically significant) with onset 11Nov2021, outcome "recovering", described as "acute myasthenia gravis crisis". The patient was hospitalized for myasthenia gravis crisis (hospitalization duration: 25 day(s)). The event "acute myasthenia gravis crisis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result, notes: If COVID tested post vaccination: Yes. Therapeutic measures were taken as a result of myasthenia gravis crisis. Clinical Course: Acute myasthenia gravis crisis began on evening of 11Nov2021 followed by emergency admission to ICU .Treatment given for AE was Ventilator, plex, medication, IVIG.COVID prior vaccination was no. COVID tested post vaccination was yes.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Body temperature, Feeling hot, Hyperaesthesia, Pain
Clinical narrative: fever; aches; hair loss; arm became very sore; was hot to the touch, felt like sunburn; was hot to the touch, felt like sunburn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 13:00 (Lot number: FH8020) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 18Oct2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Fever", "aches". The following information was reported: PYREXIA (disability) with onset 20Nov2021 16:30, outcome "not recovered", described as "fever"; PAIN (disability) with onset 20Nov2021 16:30, outcome "not recovered", described as "aches"; PAIN IN EXTREMITY (disability) with onset 13Nov2021, outcome "not recovered", described as "arm became very sore"; FEELING HOT (disability), HYPERAESTHESIA (disability) all with onset 13Nov2021, outcome "not recovered" and all described as "was hot to the touch, felt like sunburn"; ALOPECIA (disability) with onset 20Nov2021 16:30, outcome "not recovered", described as "hair loss". The patient underwent the following laboratory tests and procedures: body temperature: 102. Therapeutic measures were not taken as a result of pyrexia, pain, pain in extremity, feeling hot, hyperaesthesia, alopecia. Clinical course: On 20Nov started noticing hair loss, as of today 01Jan2021 hair continues to fall out and I have about 1/3 of volume left then prior to vaccine, noticed when I put a baseball hat I had not worn since October, I had to adjust back to tighten as hat was too loose on my head due to hair loss. Patient had not received any vaccine in last four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; aches; hair loss; arm became very sore; was hot to the touch, felt like sunburn; was hot to the touch, felt like sunburn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 13:00 (Lot number: FH8020) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 18Oct2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Fever", "aches". The following information was reported: PYREXIA (disability) with onset 20Nov2021 16:30, outcome "not recovered", described as "fever"; PAIN (disability) with onset 20Nov2021 16:30, outcome "not recovered", described as "aches"; PAIN IN EXTREMITY (disability) with onset 13Nov2021, outcome "not recovered", described as "arm became very sore"; FEELING HOT (disability), HYPERAESTHESIA (disability) all with onset 13Nov2021, outcome "not recovered" and all described as "was hot to the touch, felt like sunburn"; ALOPECIA (disability) with onset 20Nov2021 16:30, outcome "not recovered", described as "hair loss". The patient underwent the following laboratory tests and procedures: body temperature: 102. Therapeutic measures were not taken as a result of pyrexia, pain, pain in extremity, feeling hot, hyperaesthesia, alopecia. Clinical course: On 20Nov started noticing hair loss, as of today 01Jan2021 hair continues to fall out and I have about 1/3 of volume left then prior to vaccine, noticed when I put a baseball hat I had not worn since October, I had to adjust back to tighten as hat was too loose on my head due to hair loss. Patient had not received any vaccine in last four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bell's palsy, Hypoaesthesia, Paraesthesia
Clinical narrative: diagnosed with Bell's Palsy; Extreme pain in my right elbow; loss of strength; Numbing and tingling in my left arm; Numbing and tingling in my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 (Lot number: FH8030) at the age of 45 years as dose 1, single and administered in arm right, administration date 01Dec2021 (Lot number: FY8762) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BELL'S PALSY (medically significant) with onset 31Dec2021, outcome "recovered with sequelae", described as "diagnosed with Bell's Palsy"; ARTHRALGIA (non-serious) with onset 11Nov2021, outcome "recovered with sequelae", described as "Extreme pain in my right elbow"; ASTHENIA (non-serious) with onset 11Nov2021, outcome "recovered with sequelae", described as "loss of strength"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 11Nov2021, outcome "recovered with sequelae" and all described as "Numbing and tingling in my left arm". The events "diagnosed with bell's palsy", "extreme pain in my right elbow", "loss of strength", "numbing and tingling in my left arm" and "numbing and tingling in my left arm" were evaluated at the physician office visit. The patient did not receive any other vaccines within four weeks prior to the vaccination. covid prior vaccination was no. covid tested post vaccination was no. The patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Deep vein thrombosis, Drug ineffective, Pneumonia, Pulmonary embolism
Clinical narrative: both caught covid; both caught covid; he got two blood clots/one in his leg and and one in his lung; he got two blood clots/one in his leg and and one in his lung; then got pneumonia; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received COVID-19 Vaccine - Manufacturer Unknown, (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 (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "both caught covid"; DEEP VEIN THROMBOSIS (hospitalization, medically significant), PULMONARY EMBOLISM (hospitalization, medically significant), outcome "unknown" and all described as "he got two blood clots/one in his leg and and one in his lung"; PNEUMONIA (hospitalization, medically significant), outcome "unknown", described as "then got pneumonia". Therapeutic measures were taken as a result of drug ineffective, covid-19, deep vein thrombosis, pulmonary embolism, pneumonia. Clinical course: It was reported that mom and dad both caught covid around Christmas, and it may have started even closer to Thanksgiving. Dad got covid, and then got pneumonia after catching covid, causing hospitalization. (Individual implied that pneumonia may have been aggravated by reckless activity, like doing activity outside in the snow.) He was in the hospital 4 to 5 days on oxygen reporter believe at least, and he got two blood clots, one in his leg and and one in his lung, while in the hospital (some clotting may have been attributed to little bodily movement). Believe the situation is better now either the dad is ok or is believed will pull through. Unsure if the situation is still ongoing. And also stated do not know the vaccine status of any of these individuals whether they are vaccinated or not and with what vaccine. Dad could have received more treatments while in hospital, but unsure what.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Migraine, Ocular hyperaemia, Pain, Pruritus
Clinical narrative: Severe migraines behind left eye, radiating throughout skull; Severe migraines behind left eye, radiating throughout skull; Sharp shooting chest pains; Swollen left eyelid, red itchy; Swollen left eyelid, red itchy; Swollen left eyelid, red itchy; skin peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 08:00 (Lot number: fg3527) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: fg3527, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 05Nov2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious), PAIN (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Severe migraines behind left eye, radiating throughout skull"; CHEST PAIN (non-serious) with onset 28Nov2021, outcome "not recovered", described as "Sharp shooting chest pains"; SWELLING OF EYELID (non-serious), OCULAR HYPERAEMIA (non-serious), PRURITUS (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Swollen left eyelid, red itchy"; SKIN EXFOLIATION (non-serious) with onset 28Nov2021, outcome "not recovered", described as "skin peeling". The events "severe migraines behind left eye, radiating throughout skull", "severe migraines behind left eye, radiating throughout skull", "sharp shooting chest pains", "swollen left eyelid, red itchy", "swollen left eyelid, red itchy", "swollen left eyelid, red itchy" and "skin peeling" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of migraine, pain, chest pain, swelling of eyelid, ocular hyperaemia, pruritus, skin exfoliation. Additional information: Patient had no known allergies and no other medical history. Patient had no other vaccine in four weeks. And had no other medications in two weeks.  Patient had no COVID prior vaccination and was not COVID tested post vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Swelling of eyelid
Clinical narrative: Severe migraines behind left eye, radiating throughout skull; Severe migraines behind left eye, radiating throughout skull; Sharp shooting chest pains; Swollen left eyelid, red itchy; Swollen left eyelid, red itchy; Swollen left eyelid, red itchy; skin peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 08:00 (Lot number: fg3527) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: fg3527, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 05Nov2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious), PAIN (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Severe migraines behind left eye, radiating throughout skull"; CHEST PAIN (non-serious) with onset 28Nov2021, outcome "not recovered", described as "Sharp shooting chest pains"; SWELLING OF EYELID (non-serious), OCULAR HYPERAEMIA (non-serious), PRURITUS (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Swollen left eyelid, red itchy"; SKIN EXFOLIATION (non-serious) with onset 28Nov2021, outcome "not recovered", described as "skin peeling". The events "severe migraines behind left eye, radiating throughout skull", "severe migraines behind left eye, radiating throughout skull", "sharp shooting chest pains", "swollen left eyelid, red itchy", "swollen left eyelid, red itchy", "swollen left eyelid, red itchy" and "skin peeling" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of migraine, pain, chest pain, swelling of eyelid, ocular hyperaemia, pruritus, skin exfoliation. Additional information: Patient had no known allergies and no other medical history. Patient had no other vaccine in four weeks. And had no other medications in two weeks.  Patient had no COVID prior vaccination and was not COVID tested post vaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Immunisation, Loss of consciousness
Clinical narrative: passed out; Fell on floor; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 19:00 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. There were no other vaccine in 4 weeks. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose administration date=20Mar2021 , previous dose dose number=2), administration date: 20Mar2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (previous dose product=COVID 19, previous dose administration date=27Feb2021, Previous dose number = 1), administration date: 27Feb2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (non-serious) with onset 03Dec2021 04:00, outcome "unknown", described as "passed out"; IMMUNISATION (non-serious) with onset 02Dec2021 19:00, outcome "unknown", described as "Booster"; FALL (non-serious) with onset 03Dec2021 04:00, outcome "unknown", described as "Fell on floor". The events "passed out" and "fell on floor" were evaluated at the physician office visit and emergency room visit. The night patient received the vaccine at 4 am got up to go to the bathroom and than passed out in the bathroom for about a minute. Patient fell on floor. Therapeutic measures were not taken as a result of loss of consciousness, fall. Patient was not diagnosed with covid prior to vaccination and had not been tested post-vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: stabbing chest pains and had to be brought to the ER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 (Batch/Lot number: unknown) at the age of 15 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: 22Nov2021, when the patient was 15 years old, for COVID-19 immunization. The following information was reported: CHEST PAIN (hospitalization) with onset 16Dec2021 01:00, outcome "not recovered", described as "stabbing chest pains and had to be brought to the ER". The patient was hospitalized for chest pain (hospitalization duration: 3 day(s)). The event "stabbing chest pains and had to be brought to the er" was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of chest pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid positive after the 1st dose of Comirnaty; Covid positive after the 1st dose of Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 8 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (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 "Covid positive after the 1st dose of Comirnaty". The patient got the 1st vaccine dose of the vaccine and between the 21 days period between there 1st and 2nd dose, she tested positive for the Covid 19. The caller wanted to know what the recommendation is for the patient's 2nd dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Immunisation
Clinical narrative: Booster; diagnosed about a week ago with Covid/have been asymptomatic; diagnosed about a week ago with Covid/have been asymptomatic; This is a spontaneous report received from contactable reporter (Consumer) from a Pfizer sales representative. The reporter is the patient. A male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) (Batch/Lot numbers: unknown) as dose 1,2 and 3 (booster), all given single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient received the dose 3 (booster) on unknown date. It was later reported that the patient had drug ineffective as he was diagnosed about a week ago with Covid (on unknown date) and have been asymptomatic due to the booster as reported. Outcome of the events were unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: 102 fever; aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 15:00 (Lot number: FH8020) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies: Morphine". No other vaccine in four weeks. There were unspecified medications in two weeks. With both doses, patient had 102 fever and aches. The following information was reported: PYREXIA (disability) with onset 2021, outcome "not recovered", described as "102 fever"; PAIN (disability) with onset 2021, outcome "not recovered", described as "aches". The patient underwent the following laboratory tests and procedures: body temperature: 102, notes: had 102 fever. Therapeutic measures were not taken as a result of pyrexia, pain. There was no covid prior vaccination. COVID was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Rash, Urticaria
Clinical narrative: hives; rash; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Jan2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single and administered in arm, administration date 21Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "He has a history of allergies" (unspecified if ongoing), notes: He has a history of allergies; "blood pressure" (unspecified if ongoing), notes: he just recently started on blood pressure medication , he is taking metoprolol because his blood pressure was creeping up.; "Cholesterol" (unspecified if ongoing), notes: His Cholesterol was at 200 and he is taking metoprolol because his blood pressure was creeping up. Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal; LIPITOR taken for blood cholesterol abnormal. The following information was reported: URTICARIA (medically significant), outcome "not recovered", described as "hives"; RASH (non-serious), outcome "not recovered", described as "rash". The patient underwent the following laboratory tests and procedures: blood cholesterol: 200, notes: His Cholesterol was at 200. Therapeutic measures were taken as a result of urticaria, rash.  Clinical course- The patient on steroids, creams, and every type of allergy medication and nothing was getting rid of this. The rash and hives started after he got the injections too. The patient was scarred up from all of the scratching he did, even in his sleep and that they changed detergents and filtered the water they use for bathing. They was using baby laundry detergent. He just recently started on blood pressure medication and Lipitor. He was not on any medication prior to the event. His Cholesterol was at 200 and he was taking metoprolol because his blood pressure was creeping up. It was reported that, causality unknown, but stated that it was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID Positive; COVID Positive; Dose Number:3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 (Lot number: FL3197) at the age of 44 years as dose 3 (booster), single, administered in arm right, administration date 28Apr2021 (Lot number: EW0176) as dose 2, single and administered in arm right, administration date 06Apr2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021, outcome "unknown", described as "Dose Number:3"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 29Dec2021, outcome "recovered" and all described as "COVID Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. Therapeutic measures were not taken as a result of covid-19.  Additional information: The patient did not have any other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Immunisation, Urticaria
Clinical narrative: Patient received Dose Number:3; Chronic Spontaneous Urticaria (hives); Chronic Spontaneous Urticaria (hives); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 15:00 (Lot number: FF2590) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; HYDROCHLOROTHIAZID; AMLODIPINE. Past drug history included: Ace inhibitors, reaction(s): "Allergies: Drug Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 01Apr2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Chronic Spontaneous Urticaria (Hives)", "Chronic Spontaneous Urticaria (Hives)"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 06Oct2021 15:00, outcome "unknown", described as "Patient received Dose Number:3"; CHRONIC SPONTANEOUS URTICARIA (medically significant), URTICARIA (medically significant) all with onset 2021, outcome "not recovered" and all described as "Chronic Spontaneous Urticaria (hives)". The event "chronic spontaneous urticaria (hives)" and "chronic spontaneous urticaria (hives)" was evaluated at the physician office visit. Therapeutic measures were taken as a result of chronic spontaneous urticaria, urticaria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient never had hives before the covid vaccine and was having hive outbreaks ever since the covid vaccine. The patient received Cortisone Shots (3 rounds) Pepcid and 4x antihistimes daily for the treatment of adverse event. Prior to vaccination, he patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Has caught coronavirus recently; Has caught coronavirus recently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient received bnt162b2 (BNT162B2) (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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Has caught coronavirus recently". Clinical Course: It was reported that the patient caught with coronavirus recently (end of Dec/Jan), even though her twin had not. The patients father had also caught the virus and it might be where she got the virus from. There was a strong chance was vaccinated, and unknown regarding her father. Unsure which vaccine and when received and what dosage.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200004727 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Thrombosis
Clinical narrative: More clots noted; Menstrual period was eight days late.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: Flg1611) as dose 2, single and administered in arm left (Lot number: FH8030) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "More clots noted"; MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "Menstrual period was eight days late.". Therapeutic measures were not taken as a result of thrombosis, menstruation delayed.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and the patient had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID-19 pcr test; Positive COVID-19 pcr test; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 05Feb2021 (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: IMMUNISATION (medically significant) with onset 27Sep2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Positive COVID-19 pcr test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: positive COVID19 pcr test.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Immunisation
Clinical narrative: booster; splitting headache; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: Bnt162b2 (1st Dose), for Covid-19 immunization; Bnt162b2 (2nd Dose), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; HEADACHE (medically significant), outcome "unknown", described as "splitting headache". The event "splitting headache" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: normal, notes: they did a cat scan on my head and the doctor said everything was normal.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Cerebrovascular accident, Feeling abnormal, Illness, Nausea
Clinical narrative: I went to bed for 12 hours before I could even get up and function, its kind of stroke'; nauseous; lack of balance; I went to bed for 12 hours before I could even get up and function; I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times; I got terrible adverse effect; I got definitely ill on both of the shot, terribly ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: 330258D) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Enlarged prostate" (unspecified if ongoing), notes: Verbatim: Enlarged prostate. Concomitant medication(s) included: TAMSULOSIN HYDROCHLORIDE taken for prostatomegaly. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), administration date: 06Mar2021, when the patient was 79 years old, for COVID-19 Immunization, reaction(s): "I had no adverse event from this first shot.".  The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function, its kind of stroke'"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nauseous"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "lack of balance"; SLEEP DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I got terrible adverse effect; I got definitely ill on both of the shot, terribly ill". Therapeutic measures were not taken as a result of cerebrovascular accident, nausea, balance disorder, feeling abnormal, illness. Therapeutic measures were taken as a result of sleep disorder. NDC and UPC number of COVID-19 Vaccine were unknown. Treatment for Adverse Event: Consumer stated, "No I didn't take any treatment for that except sleep."  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: I went to bed for 12 hours before I could even get up and function, its kind of stroke'; nauseous; lack of balance; I went to bed for 12 hours before I could even get up and function; I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times; I got terrible adverse effect; I got definitely ill on both of the shot, terribly ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: 330258D) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Enlarged prostate" (unspecified if ongoing), notes: Verbatim: Enlarged prostate. Concomitant medication(s) included: TAMSULOSIN HYDROCHLORIDE taken for prostatomegaly. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), administration date: 06Mar2021, when the patient was 79 years old, for COVID-19 Immunization, reaction(s): "I had no adverse event from this first shot.".  The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function, its kind of stroke'"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nauseous"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "lack of balance"; SLEEP DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I got terrible adverse effect; I got definitely ill on both of the shot, terribly ill". Therapeutic measures were not taken as a result of cerebrovascular accident, nausea, balance disorder, feeling abnormal, illness. Therapeutic measures were taken as a result of sleep disorder. NDC and UPC number of COVID-19 Vaccine were unknown. Treatment for Adverse Event: Consumer stated, "No I didn't take any treatment for that except sleep."  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient was diagnosed with COVID-19; patient was diagnosed with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2021 (Lot number: EL3248) at the age of 66 years as dose 2, single and administered in arm left, administration date 24Dec2020 (Lot number: EK9231) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "patient was diagnosed with COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (nasal swab): (03Jan2022) pending result.; Sender's Comments: Event "COVID-19" is assessed as related to BNT162B2 in the setting of lack of drug effect. Case will be reassessed upon receipt of additional information.