chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Immunisation, Pyrexia
Clinical narrative: Pfizer booster; Fever; Arthralgias; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 12:30 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm right, administration date 16Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. I don't have the card with me, Location of injection: Arm Left), when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 12:30, outcome "unknown", described as "Pfizer booster"; PYREXIA (non-serious) with onset 16Dec2021 12:00, outcome "not recovered", described as "Fever"; ARTHRALGIA (non-serious) with onset 16Dec2021 12:00, outcome "not recovered", described as "Arthralgias"; DIARRHOEA (non-serious) with onset 16Dec2021 12:00, outcome "not recovered", described as "Diarrhea". Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient needed to take ibuprofen to reduce the fever. The fever reduced but today started again with fever and arthralgias. The treatment received for the adverse event was Ibuprofen. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been tested for COVID-19 as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Immunisation
Clinical narrative: Heart Failure; Dose Number :3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Lot number: Ff8842) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation.  Relevant medical history included: "Diabetes" (unspecified if ongoing). No known allergies. Prior to vaccination, the patient was  not diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1. Batch/Lot No: EL9269. Location of injection: Arm Right), administration date: 05Feb2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2. Batch/Lot No: EN6202. Location of injection: Arm Right), administration date: 26Feb2021, when the patient was 67 years old, for COVID-19 immunization. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: CARDIAC FAILURE (disability, medically significant) with onset 16Oct2021, outcome "not recovered", described as "Heart Failure"; IMMUNISATION (non-serious) with onset 11Oct2021, outcome "unknown", described as "Dose Number :3". The event "heart failure" was evaluated at the physician office visit. Therapeutic measures were taken as a result of cardiac failure: patient received  medications. Since the vaccination, the patient has not been tested for COVID-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Immunisation, Pruritus, Swelling
Clinical narrative: redness; Swelling/knot; itching at site; general joint pain; Dose Number : 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Dec2021 15:45 (Lot number: 331308A) at the age of 59 years 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 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 04May2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 15Apr2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 15:45, outcome "unknown", described as "Dose Number : 3"; ERYTHEMA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "redness"; SWELLING (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Swelling/knot"; PRURITUS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "itching at site"; ARTHRALGIA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "general joint pain". Therapeutic measures were not taken as a result of erythema, swelling, pruritus, arthralgia.   Additional Information: Patient dose not have covid prior vaccination. Patient was not tested covid positive post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive Covid PCR test results; positive Covid PCR test results; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 2, 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 18Dec2021, outcome "unknown" and all described as "positive Covid PCR test results". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Dec2021) positive. It was also reported that the patients daughter was also double vaccinated with Pfizer vaccine in May and Jun2021 and neither of them had a booster and they both were received positive Covid PCR test results on the day of the reporting.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101815391 same reporter/drug/event, different pt
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive Covid PCR test results; positive Covid PCR test results; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (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 18Dec2021, outcome "unknown" and all described as "positive Covid PCR test results". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101815362 same reporter/drug/event, different pt
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Magnetic resonance imaging, Muscular weakness, Neuralgic amyotrophy, Neuropathy peripheral
Clinical narrative: Dose number=3; Parsonage-Turner syndrome triggered by Pfizer vaccine; Neuropathy in hands still persists; weakness in left arm; This is a spontaneous report received from contactable patient (Consumer or other non HCP)..A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: FF2587) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: VITAMINS NOS; FISH OIL; TURMERIC [CURCUMA LONGA RHIZOME]. Past drug history included: Known allergies:amoxicillin, reaction(s): "Drug Allergy". Vaccination history included: Bnt162b2 (Dose number: 1, Lot number unknown, Left arm, brand: Pfizer), administration date: 05Mar2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose number: 2, Lot number unknown, Left arm, brand: Pfizer), administration date: 26Mar2021, when the patient was 66 years old, for COVID-19 Immunization, reaction(s): "Neuropathy in left hand, which later spread to right hand", "Severe sharp pain in bicep, shoulder and radiating into hand.", "Severe sharp pain in bicep, shoulder and radiating into hand.", "Severe sharp pain in bicep, shoulder and radiating into hand.", "pinched nerve in neck". The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: NEURALGIC AMYOTROPHY (disability) with onset 2021, outcome "recovering", described as "Parsonage-Turner syndrome triggered by Pfizer vaccine"; NEUROPATHY PERIPHERAL (disability) with onset 2021, outcome "not recovered", described as "Neuropathy in hands still persists"; MUSCULAR WEAKNESS (disability) with onset 2021, outcome "recovering", described as "weakness in left arm"; IMMUNISATION (non-serious) with onset 05Oct2021, outcome "unknown", described as "Dose number=3". The events "parsonage-turner syndrome triggered by pfizer vaccine", "neuropathy in hands still persists" and "weakness in left arm" were evaluated at the physician office visit. Since the vaccination, has the patient been tested for COVID-19. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (unspecified date) no evidence; polymerase chain reaction: (Sep2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of neuralgic amyotrophy, neuropathy peripheral, muscular weakness. Additional info: Severe sharp pain in bicep, shoulder and radiating into hand.  Neuropathy in left hand, which later spread to right hand.  Pain began about 3 weeks after second dose. Initially diagnosed as pinched nerve in neck.  However, no evidence in MRI.  8 months later diagnosed as Parsonage-Turner syndrome triggered by Pfizer vaccine.  Neuropathy in hands still persists as well as weakness in left arm.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: Dose number=3; Parsonage-Turner syndrome triggered by Pfizer vaccine; Neuropathy in hands still persists; weakness in left arm; This is a spontaneous report received from contactable patient (Consumer or other non HCP)..A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: FF2587) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: VITAMINS NOS; FISH OIL; TURMERIC [CURCUMA LONGA RHIZOME]. Past drug history included: Known allergies:amoxicillin, reaction(s): "Drug Allergy". Vaccination history included: Bnt162b2 (Dose number: 1, Lot number unknown, Left arm, brand: Pfizer), administration date: 05Mar2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose number: 2, Lot number unknown, Left arm, brand: Pfizer), administration date: 26Mar2021, when the patient was 66 years old, for COVID-19 Immunization, reaction(s): "Neuropathy in left hand, which later spread to right hand", "Severe sharp pain in bicep, shoulder and radiating into hand.", "Severe sharp pain in bicep, shoulder and radiating into hand.", "Severe sharp pain in bicep, shoulder and radiating into hand.", "pinched nerve in neck". The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: NEURALGIC AMYOTROPHY (disability) with onset 2021, outcome "recovering", described as "Parsonage-Turner syndrome triggered by Pfizer vaccine"; NEUROPATHY PERIPHERAL (disability) with onset 2021, outcome "not recovered", described as "Neuropathy in hands still persists"; MUSCULAR WEAKNESS (disability) with onset 2021, outcome "recovering", described as "weakness in left arm"; IMMUNISATION (non-serious) with onset 05Oct2021, outcome "unknown", described as "Dose number=3". The events "parsonage-turner syndrome triggered by pfizer vaccine", "neuropathy in hands still persists" and "weakness in left arm" were evaluated at the physician office visit. Since the vaccination, has the patient been tested for COVID-19. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (unspecified date) no evidence; polymerase chain reaction: (Sep2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of neuralgic amyotrophy, neuropathy peripheral, muscular weakness. Additional info: Severe sharp pain in bicep, shoulder and radiating into hand.  Neuropathy in left hand, which later spread to right hand.  Pain began about 3 weeks after second dose. Initially diagnosed as pinched nerve in neck.  However, no evidence in MRI.  8 months later diagnosed as Parsonage-Turner syndrome triggered by Pfizer vaccine.  Neuropathy in hands still persists as well as weakness in left arm.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Prior to vaccination, was the patient diagnosed with COVID-19: Yes; Prior to vaccination, was the patient diagnosed with COVID-19: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), 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 "Prior to vaccination, was the patient diagnosed with COVID-19: Yes".  Clinical Course: It was reported that prior to the second dose of vaccination, the patient was diagnosed with 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, SARS-CoV-2 test
Clinical narrative: Positive COVID test on 16Dec2021.; Positive COVID test on 16Dec2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old female patient (not pregnant) 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) with onset 16Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 16Dec2021, outcome "recovering" and all described as "Positive COVID test on 16Dec2021.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive. Therapeutic measures were not taken as a result of covid-19. 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Incorrect dosage administered, Interchange of vaccine products, Off label use
Clinical narrative: Off-label use (due to interchange); Interchange of vaccine products; Booster; were able to withdraw 4 doses only with no other left pre-drawn doses/adult Pfizer COVID-19 vaccine that was diluted with 1.8mL of correct diluent and instead of 6 doses they only got 4 doses; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 73-year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Dec2021 (Lot number: 330308D, Expiration Date: 28Feb2022) at the age of 73 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (Dose: 1, Lot number: 021B21A), administration date: 03May2021, when the patient was 72 years old, for COVID-19 immunization; Moderna covid-19 vaccine (Dose:2, Lot number: 045B21A), administration date: 03Jun2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 16Dec2021, outcome "unknown", described as "Off-label use (due to interchange)"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 16Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "Booster"; INCORRECT DOSAGE ADMINISTERED (non-serious) with onset 16Dec2021, outcome "unknown", described as "were able to withdraw 4 doses only with no other left pre-drawn doses/adult Pfizer COVID-19 vaccine that was diluted with 1.8mL of correct diluent and instead of 6 doses they only got 4 doses".  additional information: Caller is a nurse at withheld, reporting an event where they have diluted the vial of Pfizer Biontech Covid vaccine purple top with 1.8mL of diluent.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101812501 Same reporter / drug / event, different patients.;US-PFIZER INC-202101815604 Same reporter / drug / event, different patients.;US-PFIZER INC-202101815603 Same reporter / drug / event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Malaise, Sinus disorder
Clinical narrative: Booster; sinus drainage; had not felt well; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (ongoing), notes: current medical condition. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose number UNKNOWN, Lot number UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; SINUS DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "sinus drainage"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "had not felt well"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "feeling tired". Therapeutic measures were taken as a result of sinus disorder.  Additional information: She stated that she also got the COVID Booster shot on 0Nov2021and had not felt well after that for several days, feeling tired and had sinus drainage. 2 days after her first Enbrel shot, her sinus symptoms worsened, to the point that she went to her PCP and was put on antibiotics.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gastritis, Immunisation, Multiple organ dysfunction syndrome, Renal failure
Clinical narrative: Issues with her organs shutting down; Kidney failure; Inflammation in the stomach; booster; This is a spontaneous report received from contactable patient (Consumer or other non HCP) and Other HCP. Other Case identifier(s): UNT-2021-025221. A 47 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation; treprostinil diolamin (ORENITRAM), first regimen oral since 05Jan2018 (Batch/Lot number: unknown), second regimen oral (Batch/Lot number: unknown) till Nov2021 at 1.25 mg, third regimen oral (Batch/Lot number: unknown) at 1.25 mg 3x/day and fourth regimen oral (ongoing) (Batch/Lot number: unknown) at 1.5 mg 3x/day (1.5 mg) for pulmonary arterial hypertension. Relevant medical history included: "Pulmonary arterial hypertension", start date: 05Jan2018 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot # unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, Lot # unknown), for COVID-19 Immunization. The following information was reported: MULTIPLE ORGAN DYSFUNCTION SYNDROME (hospitalization, medically significant) with onset 09Nov2021, outcome "unknown", described as "Issues with her organs shutting down"; RENAL FAILURE (hospitalization, medically significant) with onset 09Nov2021, outcome "unknown", described as "Kidney failure"; IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "booster"; GASTRITIS (non-serious), outcome "unknown", described as "Inflammation in the stomach". The patient was hospitalized for multiple organ dysfunction syndrome, renal failure (start date: 09Nov2021, discharge date: 14Nov2021, hospitalization duration: 5 day(s)). The action taken for treprostinil diolamin was temporary withheld on an unreported date in Nov2021 due to the events of renal failure and multiple organ dysfunction syndrome.  Additional info: The patient was not doing well after receiving her booster of COVID-19 Pfizer vaccine on 04Nov2021 and as a result on 09Nov2021, 3 years 10 months and 5 days after initiating PO Orenitram, the patient was admitted to the hospital due to kidney failure and issues with her organs shutting down. The patient was not able to take PO Orenitram while in the hospital. She had to restart the medication and titrate at a slower rate due to inflammation in the stomach.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Pyrexia
Clinical narrative: Dose Number:3; The patient developed a low fever after half a day, and recovered next morning; His arm where the vaccine was injected was still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Lot number: FF8841) at the age of 54 years 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 (Dose Number: 1), administration date: 03Apr2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2), administration date: 24Apr2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "Dose Number:3"; PYREXIA (non-serious) with onset 16Dec2021, outcome "recovered" (17Dec2021), described as "The patient developed a low fever after half a day, and recovered next morning"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "recovering", described as "His arm where the vaccine was injected was still sore". It was unknown if therapeutic measures were taken as a result of pyrexia, pain in extremity. No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Headache, Migraine, Nerve compression
Clinical narrative: I had COVID twice since I got the vaccine/I test positive twice; I had COVID twice since I got the vaccine/I test positive twice; I have like prick feeling in my head/ it's a neurological side effect/it's like prick nerve feeling and really bad headache like it won't stop/weird headache/it's a migraine headache; I have like prick feeling in my head/ it's a neurological side effect/it's like prick nerve feeling and really bad headache like it won't stop/weird headache/it's a migraine headache; I have like prick feeling in my head/ it's a neurological side effect/it's like prick nerve feeling and really bad headache like it won't stop/weird headache/it's a migraine headache; have like prick feeling in my head/have like prick feeling in my head/It's like prick nerve feeling; This is a spontaneous report received from a contactable patient (Consumer or other non HCP). A 32 year-old patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in arm left, administration date 09Feb2021 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single and intramuscular, administered in arm left, administration date 20Jan2021 (Lot number: EL0982) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I had COVID twice since I got the vaccine/I test positive twice"; MIGRAINE (non-serious), FEELING ABNORMAL (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "not recovered" and all described as "I have like prick feeling in my head/ it's a neurological side effect/it's like prick nerve feeling and really bad headache like it won't stop/weird headache/it's a migraine headache"; NERVE COMPRESSION (non-serious) with onset 2021, outcome "unknown", described as "have like prick feeling in my head/have like prick feeling in my head/It's like prick nerve feeling". The event "have like prick feeling in my head/have like prick feeling in my head/it's like prick nerve feeling" was evaluated at the physician office visit. The patient stated, "I have like prick feeling in my head. I went to my neurologist so it's like nerve pinch nerve. So it's a neurological side effect. It's like prick nerve feeling and really bad headache like it won't stop. Like a weird headache. It won't stop. It's a migraine headache." The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive; (2021) positive. Therapeutic measures were taken as a result of covid-19, migraine, feeling abnormal, headache, nerve compression. Treatment included Vitamin D, Vitamin B12, Vitamin B2, Magnesium, Multivitamin.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had COVID twice since I got the vaccine/I test positive twice; I had COVID twice since I got the vaccine/I test positive twice; I have like prick feeling in my head/ it's a neurological side effect/it's like prick nerve feeling and really bad headache like it won't stop/weird headache/it's a migraine headache; I have like prick feeling in my head/ it's a neurological side effect/it's like prick nerve feeling and really bad headache like it won't stop/weird headache/it's a migraine headache; I have like prick feeling in my head/ it's a neurological side effect/it's like prick nerve feeling and really bad headache like it won't stop/weird headache/it's a migraine headache; have like prick feeling in my head/have like prick feeling in my head/It's like prick nerve feeling; This is a spontaneous report received from a contactable patient (Consumer or other non HCP). A 32 year-old patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in arm left, administration date 09Feb2021 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single and intramuscular, administered in arm left, administration date 20Jan2021 (Lot number: EL0982) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I had COVID twice since I got the vaccine/I test positive twice"; MIGRAINE (non-serious), FEELING ABNORMAL (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "not recovered" and all described as "I have like prick feeling in my head/ it's a neurological side effect/it's like prick nerve feeling and really bad headache like it won't stop/weird headache/it's a migraine headache"; NERVE COMPRESSION (non-serious) with onset 2021, outcome "unknown", described as "have like prick feeling in my head/have like prick feeling in my head/It's like prick nerve feeling". The event "have like prick feeling in my head/have like prick feeling in my head/it's like prick nerve feeling" was evaluated at the physician office visit. The patient stated, "I have like prick feeling in my head. I went to my neurologist so it's like nerve pinch nerve. So it's a neurological side effect. It's like prick nerve feeling and really bad headache like it won't stop. Like a weird headache. It won't stop. It's a migraine headache." The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive; (2021) positive. Therapeutic measures were taken as a result of covid-19, migraine, feeling abnormal, headache, nerve compression. Treatment included Vitamin D, Vitamin B12, Vitamin B2, Magnesium, Multivitamin.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Immunisation, Throat irritation
Clinical narrative: Itchy throat trouble breathing coughing for 1.5 hours; Itchy throat trouble breathing coughing for 1.5 hours; Itchy throat trouble breathing coughing for 1.5 hours; Dose Number:3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) solution for injection dose 3, (Batch/Lot number: unknown) via unspecified route of administration at arm right, on 16Dec2021 12:45 at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Medical tape" (unspecified if ongoing), notes: Medical tape allergy. There were no concomitant medications. Vaccination history included: Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. via unspecified route of administration on an unspecified date, as a dose 1 single for Covid-19 immunization, Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), via unspecified route of administration on 06May2021, when the patient was 41 years old, as a dose 2 single for Covid-19 immunization;. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 12:45, outcome "unknown", described as "Dose Number:3"; THROAT IRRITATION (non-serious), DYSPNOEA (non-serious), COUGH (non-serious) all with onset 16Dec2021 13:00, outcome "recovered" (16Dec2021 14:30) and all described as "Itchy throat trouble breathing coughing for 1.5 hours". Therapeutic measures were not taken as a result of throat irritation, dyspnoea, cough.  Additional information: Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: Itchy throat trouble breathing coughing for 1.5 hours. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Immunisation, Malaise, Product dose omission issue
Clinical narrative: Covid booster; Skipped a dose; not feeling good; weird feeling; headachy; something pulsing through body after Covid booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): 2021US005225 (Radius).  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunisation; Abaloparatide (TYMLOS), subcutaneous since 29Oct2021 (ongoing) (Batch/Lot number: unknown) at 80 ug daily for senile osteoporosis. The patient relevant medical history was not reported. Concomitant medication(s) included: CHLORTHALIDONE; LORAZEPAM; METHYLPREDNISOLONE [METHYLPREDNISOLONE SODIUM SUCCINATE]; VITAMIN D NOS. Vaccination history included: COVID-19 vaccine (Dose number unknown, Unknown Manufacturer), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Covid booster"; PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "Skipped a dose"; MALAISE (non-serious), outcome "unknown", described as "not feeling good"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "weird feeling"; HEADACHE (non-serious), outcome "unknown", described as "headachy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "something pulsing through body after Covid booster".  Follow-up attempts are completed. The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Crohn's disease, Discomfort, Pyrexia, Vaccination site pain
Clinical narrative: crohn's disease flare up; sore arm after getting pfizer vaccines; Discomfort; Upset stomach; Low grade fever; 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-163-4157953-00.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 12Sep2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 22Aug2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm after getting pfizer vaccines"; DISCOMFORT (non-serious), outcome "unknown", described as "Discomfort"; CROHN'S DISEASE (non-serious), outcome "not recovered", described as "crohn's disease flare up"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Upset stomach"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  Additional information: Causality for Humira (Adalimumab) The reporter's causality for the event(s) of crohn's disease flare up with humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of discomfort and upset stomach was not provided. The  reporter's causality for the event(s) of low grade fever and sore arm after getting pfizer vaccines with  humira (ADALIMUMAB) was no reasonable possibility.; Sender's Comments:  Based on available information the events of  Crohn's disease, Vaccination site pain, Discomfort , Abdominal discomfort , Pyrexia are assessed as possibly related to the suspect vaccine BNT162B2 based on  temporal association. 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: Blister, Pruritus, Rash papular
Clinical narrative: small red bumps that itched appeared about 20Mar2021 which developed into blisters which were filled with blood or white fluid; small red bumps that itched appeared about 20Mar2021 which developed into blisters which were filled with blood or white fluid; small red bumps that itched appeared about 20Mar2021 which developed into blisters which were filled with blood or white fluid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cardiac failure" (unspecified if ongoing), notes: other medical history: heart failure. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication(s) included: ASPRIN; VIT B; VIT C; CARVEDILOL; ELIQUIS; ENTRESTO. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EN6199, Location of injection: Arm Left), administration date: 2021, when the patient was 77 years old, for COVID-19 immunization. The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: RASH PAPULAR (medically significant), PRURITUS (non-serious), BLISTER (non-serious) all with onset 20Mar2021, outcome "not recovered" and all described as "small red bumps that itched appeared about 20Mar2021 which developed into blisters which were filled with blood or white fluid". Therapeutic measures were taken as a result of rash papular, pruritus, blister. Treatment included 2 steroid injections and 500 MG of mycophenolate. Since the vaccination, the patient has not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Immunisation, Joint range of motion decreased, Myalgia
Clinical narrative: I am so sick I got the Pfizer booster yesterday at 4 O'clock; I am so sick; I can''t move, my muscles hurt; I can''t move, my muscles hurt; Fever; I can''t do anything and I feel like I am gonna throw up; I feel horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Dec2021 16:00 (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 X. Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "I am so sick I got the Pfizer booster yesterday at 4 O'clock"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "I am so sick"; JOINT RANGE OF MOTION DECREASED (non-serious), MYALGIA (non-serious) all with onset Dec2021, outcome "unknown" and all described as "I can''t move, my muscles hurt"; PYREXIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Fever"; VOMITING (non-serious) with onset Dec2021, outcome "unknown", described as "I can''t do anything and I feel like I am gonna throw up"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "I feel horrible". Therapeutic measures were taken as a result of illness, joint range of motion decreased, myalgia, pyrexia, vomiting, feeling abnormal.  Additional information: Patient stated, I don't know what the lot number of the booster shot was. Patient stated, I am so sick I got the Pfizer booster (Captured as unspecified booster) yesterday at 4 O'clock. I can't move, my muscles hurt I have a fever. I can't do anything, and I feel like I am gonna throw up. I have taken Advil twice today and it didn't help what do I need to do to make my fever go away. Patient further stated, What am I suppose to do I feel horrible. Who can help me with my (voice distortion) I wish I never got this booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: I am so sick I got the Pfizer booster yesterday at 4 O'clock; I am so sick; I can''t move, my muscles hurt; I can''t move, my muscles hurt; Fever; I can''t do anything and I feel like I am gonna throw up; I feel horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Dec2021 16:00 (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 X. Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "I am so sick I got the Pfizer booster yesterday at 4 O'clock"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "I am so sick"; JOINT RANGE OF MOTION DECREASED (non-serious), MYALGIA (non-serious) all with onset Dec2021, outcome "unknown" and all described as "I can''t move, my muscles hurt"; PYREXIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Fever"; VOMITING (non-serious) with onset Dec2021, outcome "unknown", described as "I can''t do anything and I feel like I am gonna throw up"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "I feel horrible". Therapeutic measures were taken as a result of illness, joint range of motion decreased, myalgia, pyrexia, vomiting, feeling abnormal.  Additional information: Patient stated, I don't know what the lot number of the booster shot was. Patient stated, I am so sick I got the Pfizer booster (Captured as unspecified booster) yesterday at 4 O'clock. I can't move, my muscles hurt I have a fever. I can't do anything, and I feel like I am gonna throw up. I have taken Advil twice today and it didn't help what do I need to do to make my fever go away. Patient further stated, What am I suppose to do I feel horrible. Who can help me with my (voice distortion) I wish I never got this booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Nausea, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An adolescent male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 16Dec2021 17:00 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 12Jun2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 23May2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:00, outcome "unknown", described as "Dose Number:3"; HEADACHE (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "pain at injection site"; NAUSEA (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "nausea". Therapeutic measures were not taken as a result of headache, fatigue, vaccination site pain, nausea.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, The patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.