chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: fatigue after the second dose; fever after the second dose; chills after the second dose; nausea after the second dose; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (fatigue after the second dose), PYREXIA (fever after the second dose), CHILLS (chills after the second dose) and NAUSEA (nausea after the second dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue after the second dose), PYREXIA (fever after the second dose), CHILLS (chills after the second dose) and NAUSEA (nausea after the second dose). At the time of the report, FATIGUE (fatigue after the second dose), PYREXIA (fever after the second dose), CHILLS (chills after the second dose) and NAUSEA (nausea after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-511202, MOD-2022-511195 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Fatigue after booster dose; Fever after booster dose; Chills after booster dose; Nausea after booster dose; Swollen lymph node in left arm pit; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue after booster dose), PYREXIA (Fever after booster dose), CHILLS (Chills after booster dose), NAUSEA (Nausea after booster dose) and LYMPHADENOPATHY (Swollen lymph node in left arm pit) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after booster dose), PYREXIA (Fever after booster dose), CHILLS (Chills after booster dose), NAUSEA (Nausea after booster dose) and LYMPHADENOPATHY (Swollen lymph node in left arm pit). At the time of the report, FATIGUE (Fatigue after booster dose), PYREXIA (Fever after booster dose), CHILLS (Chills after booster dose), NAUSEA (Nausea after booster dose) and LYMPHADENOPATHY (Swollen lymph node in left arm pit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product used was reported.  No treatment information was provided.   This case was linked to MOD-2022-511201, MOD-2022-511195 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patients are not immunocompromised, receiving a 0.5ml booster dose instead of a 0.25ml booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: J&J Vaccine (one dose). Past adverse reactions to the above products included No adverse event with J&J Vaccine. In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In December 2021, the patient experienced ACCIDENTAL OVERDOSE (Patients are not immunocompromised, receiving a 0.5ml booster dose instead of a 0.25ml booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Patients are not immunocompromised, receiving a 0.5ml booster dose instead of a 0.25ml booster dose) outcome was unknown. Concomitant medications were not reported. Patient was not immunocompromised. Treatment information was not reported. This case was linked to MOD-2022-511255 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Prescribed overdose
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRESCRIBED OVERDOSE (Receiving a 0.5ml booster dose instead of a 0.25ml booster dose as it was recommended by her doctor) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (one dose). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Heart disease, unspecified (had heart problems since decades ago) and Cancer (NOS) (was a cancer survival - diagnosis received 10 years before receiving the vaccine). In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In December 2021, the patient experienced PRESCRIBED OVERDOSE (Receiving a 0.5ml booster dose instead of a 0.25ml booster dose as it was recommended by her doctor). At the time of the report, PRESCRIBED OVERDOSE (Receiving a 0.5ml booster dose instead of a 0.25ml booster dose as it was recommended by her doctor) outcome was unknown. Patient was not immunocompromised. No concomitant medications information was not reported. No treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: i was wiped out the next day; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 19Aug2021 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 20Aug2021, outcome "unknown", described as "i was wiped out the next day".  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity, Periorbital oedema
Clinical narrative: arm soreness; puffiness around the eyes; light headedness; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; PERIORBITAL OEDEMA (non-serious), outcome "unknown", described as "puffiness around the eyes"; DIZZINESS (non-serious), outcome "unknown", described as "light headedness"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: Patient had history of reaction, mild reactions to medications. Reporter seriousness for puffiness around the eyes, light headedness, nausea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Testicular disorder, Testicular pain
Clinical narrative: Sharp Left Testicle Pain,Sore, Dull, Pain in Left Ball; pain in Left Ball and Lower Abdomen; sharp pain in lower Back; it feels like having an hernia on the left testicle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Oct2021 13:30 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose number: 1, Previous dose Vaccine location: Right arm), administration date: 21Sep2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: TESTICULAR PAIN (non-serious) with onset 12Oct2021 06:00, outcome "not recovered", described as "Sharp Left Testicle Pain,Sore, Dull, Pain in Left Ball"; ABDOMINAL PAIN LOWER (non-serious) with onset 12Oct2021 06:00, outcome "not recovered", described as "pain in Left Ball and Lower Abdomen"; BACK PAIN (non-serious) with onset 12Oct2021 06:00, outcome "not recovered", described as "sharp pain in lower Back"; TESTICULAR DISORDER (non-serious) with onset 12Oct2021 06:00, outcome "not recovered", described as "it feels like having an hernia on the left testicle". The events "sharp left testicle pain,sore, dull, pain in left ball", "pain in left ball and lower abdomen", "sharp pain in lower back" and "it feels like having an hernia on the left testicle" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of testicular pain, abdominal pain lower, back pain, testicular disorder.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks and no other medication received in two weeks. No covid prior vaccination and no covid tested post vaccination.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fear, Visual impairment
Clinical narrative: she does not know what's a matter and scared to death; She cannot see without her glasses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEAR (non-serious), outcome "unknown", described as "she does not know what's a matter and scared to death"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "She cannot see without her glasses".  Additional information: She had no adverse effects at all. This report is about the caller herself. She will not get another shot since she does not know what's a matter and scared to death. They got this vaccine to be safe.,she cannot see without her glasses.  She did not get the second dose. She declined to complete a report on herself. She has a heart condition, heart failure prior to getting the vaccine but nothing happened to her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Platelet count decreased
Clinical narrative: Routing bloodwork shortly after revealed platelets had crashed; my husband is getting weaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) 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: PLATELET COUNT DECREASED (non-serious) with onset 2021, outcome "not recovered", described as "Routing bloodwork shortly after revealed platelets had crashed"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "my husband is getting weaker". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of platelet count decreased.  Additional Information: It was reported that, her husband had his first Pfizer vaccination in Jan2021. Routing bloodwork shortly after revealed platelets had crashed. He was still battling, even after receiving platelet boosting meds. There has to be other people who have experienced this. They were running out of options, and her husband was getting weaker.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: vaccine that was diluted in the vial and exceeded the 6 hour mark after dilution by 14 minutes; vaccine that was diluted in the vial and exceeded the 6 hour mark after dilution by 14 minutes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "vaccine that was diluted in the vial and exceeded the 6 hour mark after dilution by 14 minutes".  Additional information: Reporter was asking if Pfizer had some information regarding stability for situation similar like hers.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms have been occurring in the tricep of the arm that the vaccine was administered.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 14:45 (Batch/Lot number: unknown) at the age of 43 years 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: MUSCLE SPASMS (non-serious) with onset 07Oct2021, outcome "not recovered", described as "Muscle spasms have been occurring in the tricep of the arm that the vaccine was administered.". Therapeutic measures were not taken as a result of muscle spasms.  Additional information: Patient did not received any vaccine in four weeks. No medications in two weeks. Patient did not covid prior to vaccination. Patient was not tested for covid post vaccination. No known allergies reported. No medical history reported.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: sore arm at injection site; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (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 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Oct2021, outcome "unknown", described as "sore arm at injection site"; CHILLS (non-serious) with onset 22Oct2021, outcome "unknown", described as "chills".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Somnolence
Clinical narrative: Insomnia; Extreme sleepiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Previous pulmonary embolism" (unspecified if ongoing); "pancreatic neuroendocrine tumor with liver metastasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 25Oct2021, outcome "recovering", described as "Insomnia"; SOMNOLENCE (non-serious) with onset 25Oct2021, outcome "recovering", described as "Extreme sleepiness". Therapeutic measures were not taken as a result of insomnia, somnolence.  Additional Information: 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 was not tested for COVID-19. The patient had no known allergies.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: also now has this tremor; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: Not Provided) 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 (first dose), for Covid-19 immunization; Bnt162b2 (second dose), for Covid-19 immunization. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "also now has this tremor".  Additional Information: Reporter states she would like to report a side effect that was unusual and rather interesting. States that her first 2 were fine. States that she got the booster sometime around 02Oct2021 and around 18Oct2021 she developed a tremor, a violent tremor that is controllable, she could stop it but if she didn't bother it would go on. Reporter states it is the arm where she got the shot and she doesn't notice it and if she puts her hand in a certain way it happens. While reporting the caller states the interesting thing is she has an identical twin sister and she got the booster and she also now has this tremor. Reporter states her sister's name was withheld and she had the Pfizer Covid booster.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101454971 Same reporter/drug/event, different patient.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear disorder, Tinnitus
Clinical narrative: left ear sounds like going up a mountain under water and a drun rill; left ear sounds like going up a mountain under water and a drun rill; left ear sounds like going up a mountain under water and a drun rill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Oct2021 13:00 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "some clod blood vessels in brainls" (unspecified if ongoing); "known allergies:penicillan" (unspecified if ongoing); "known allergies:sulphur" (unspecified if ongoing); "Acid relflex" (unspecified if ongoing); "Ibs" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 11Oct2021; RABEPRAZOLE; HYOSCYAMINE; CARBAMAZEPINE. Vaccination history included: Bnt162b2 (Dose: 2, Location of injection: Arm Right), administration date: 25Mar2021, when the patient was 75 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 1, Location of injection: Arm Right), administration date: 04Mar2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: EAR DISCOMFORT (non-serious), EAR DISORDER (non-serious), TINNITUS (non-serious) all with onset 2021, outcome "not recovered" and all described as "left ear sounds like going up a mountain under water and a drun rill". Therapeutic measures were not taken as a result of ear discomfort, ear disorder, tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Therapeutic response unexpected
Clinical narrative: Unexpected therapeutic effect - patient suffers from autonomic CNS disregulation, which was significantly better for several days following both 2nd and 3rd dose of Pfizer covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Apr2021 11:00 (Lot number: ER8729) as dose 2, single and intramuscular, administered in arm right, administration date 21Oct2021 14:00 (Lot number: FF2593) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autonomic nervous system dysregulation" (unspecified if ongoing), notes: Autonomic nervous system dysregulation; "Interstitial Cystitis", start date: 2010 (ongoing); "Autonomic Dysfunction", start date: 2019 (ongoing); "Small fiber muscle issue", start date: 2019 (ongoing); "Nerve/Muscle issue" (unspecified if ongoing); "Beta Blocker/heart" (unspecified if ongoing). Concomitant medication(s) included: NEURONTIN taken for muscle disorder, start date: 2018 (ongoing); ATENOLOL taken for cardiac disorder, start date: 2021. Vaccination history included: Bnt162b2 (Dose 1, Time (24hr): 11 am, Anatomical Site: Rt. Arm, Route: Intramuscular, Batch/Lot number: Lot # ER8727), administration date: 25Mar2021, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Oct2021, outcome "unknown", described as "Unexpected therapeutic effect - patient suffers from autonomic CNS disregulation, which was significantly better for several days following both 2nd and 3rd dose of Pfizer covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: I had a reduction of any daily chronic illness symptoms after taking vax 2 and 3. I felt more normal for 3-4 days after the vax. I had less shaking, nausea, muscle weakness, headache. I have a general diagnosis of an autonomic nervous system dysfunction and small fiber muscle issue after a cosmetic botox injection in my forehead in 2018. Illness/AE: Autonomic Dysfunction and Small fiber muscle issue. Pertinent Details: Chronic headaches, Internal Tremors, Muscle Weakness, Numb of skin, Muscle twitching, Heart palpitation.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastritis
Clinical narrative: Gastritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (COVID Vaccine Dose-1), administration date: Jan2021, for COVID-19 immunisation. The following information was reported: GASTRITIS (non-serious) with onset Mar2021, outcome "unknown", described as "Gastritis".  Additional Information: Caller was a consumer that was calling about the Pfizer Covid-19 vaccine and said that she took the first dose in Jan2021 and the second dose in Feb2021. Caller said that she took the booster in Sep2021. Caller reported that she developed Gastritis in Mar2021 and would like to know if this had anything to do with the Covid-19 vaccine or has this been reported with the vaccine. Caller said that she read something online about it and heard something about it.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: Experiencing neurological adverse events after receiving the booster dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "Experiencing neurological adverse events after receiving the booster dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: and said her was very sore at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient 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. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "and said her arm was very sore at injection site".  Follow-up (03Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstrual disorder
Clinical narrative: No menstrual cycle for 6 months; No menstrual cycle for 6 months; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: Unknown. Unable to locate or read the details), for Covid-19 immunization. The following information was reported: AMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious), outcome "not recovered" and all described as "No menstrual cycle for 6 months". Therapeutic measures were not taken as a result of amenorrhoea, menstrual disorder.  Additional information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Other medical history: None. Not Covid tested post vaccination. No known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal, Malaise
Clinical narrative: he had a temperature; Felt bad for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious), outcome "recovered" (2021), described as "he had a temperature"; MALAISE (non-serious), outcome "recovered" (2021), described as "Felt bad for a couple of days". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pain, Tinnitus
Clinical narrative: Body ached so bad couldn''t move; Nausea still after 4 days; Headache; foggy; fluttering in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single, administered in arm left (Batch/Lot number: unknown) as dose 2, single and administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Emphysema" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL HFA; SYMBICORT RAPIHALER. Past drug history included: Known allergies: tetracycline, reaction(s): "Drug allergy"; Known allergy: opioids, reaction(s): "Drug allergy".  The following information was reported: PAIN (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "Body ached so bad couldn''t move"; NAUSEA (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "Nausea still after 4 days"; HEADACHE (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "Headache"; FEELING ABNORMAL (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "foggy"; TINNITUS (non-serious) with onset 27Oct2021 13:00, outcome "recovering", described as "fluttering in ears". Therapeutic measures were not taken as a result of pain, nausea, headache, feeling abnormal, tinnitus.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she hurt a little bit more; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (141003).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization; Bnt162b2 (Second Dose), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "she hurt a little bit more". Additional information: The patient states MD instructed her to pause xeljanz for one week around covid booster shot. Patient states at that time she noticed that she hurt a little bit more. States she is taking xeljanz again and is now feeling more normal. no further details given. MD not aware. No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstruation irregular, Pregnancy test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 (Batch/Lot number: unknown) at the age of 22 years as dose 1, single and administration date 30Sep2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Endometriosis" (ongoing), notes: Stated that she was diagnosed when she was 18. There were no concomitant medications. The following information was reported: AMENORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Caller reports that she has not had her period since receiving the first dose of the Pfizer Covid-19 vaccine"; MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "not recovered", described as "Has not had a menstrual cycle since getting the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: She wants to know if any clinical trial with menstrual cycles on Pfizer vaccines. She got the first dose of the Pfizer vaccine on 08Sep2021, and before it, she had a regular 28 day cycle every month. Coincidentally, the day she got vaccine, she has missed having her cycle since then, so it has been for 3 months. She has negative pregnancy test results. Since the day she got the vaccine, she has not gotten a cycle yet. She spoke with the pharmacist and they said there is no correlation. She was supposed to get her period in Sep2021 and never got her cycle. She wanted to know if this is a side effect from the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: I have the pain and the redness and swelling around the injection site and a little bit further around it; I have the pain and the redness and swelling around the injection site and a little bit further around it; I have the pain and the redness and swelling around the injection site and a little bit further around it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown, Expiration Date: 30Nov2021) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Epilepsy" (unspecified if ongoing), notes: Verbatim: Epilepsy. Concomitant medication(s) included: FLU, administration date 07Oct2021; CLONAZEPAM; KEPPRA XR; VIMPAT. Vaccination history included: Bnt162b2 (Dose: 1st), for COVID-19 immunization; Bnt162b2 (Dose: 2nd), for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "I have the pain and the redness and swelling around the injection site and a little bit further around it". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain, vaccination site swelling.  Additional information: Consumer stated, she was just trying to report a safety like a safety incident a side effect. she have the pain and the redness and swelling around the injection site and a little bit further around it and a 'tight right arm' (not clear).Lot number: Consumer stated, "301458A can not read hand writing, it looks like 301458A, that make sense. A I think. Consumer stated, Yes she take clonezem. They have no interaction. Keppra 4000 mg a day, 2000 mg twice a day. 'Clonezam' 10 mg twice a day, tablet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: My first and second one was done at another center and I felt muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "moderate asthma with no 'general lungs' " (unspecified if ongoing), notes: she is suffering from asthma. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "My first and second one was done at another center and I felt muscle pain".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Chills, Fatigue, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Very swollen lymph gland in armpit of left arm which caused a lot of pain; Very swollen lymph gland in armpit of left arm which caused a lot of pain; Fatigue; chills; body aches; other vaccine same date product=Shingrix; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 11:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), administered in arm right, administration date 27Oct2021 (Batch/Lot number: unknown) as dose 2, single. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 27Oct2021, outcome "unknown", described as "other vaccine same date product=Shingrix"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 28Oct2021 21:00, outcome "recovered" and all described as "Very swollen lymph gland in armpit of left arm which caused a lot of pain"; FATIGUE (non-serious) with onset 28Oct2021 21:00, outcome "recovered", described as "Fatigue"; CHILLS (non-serious) with onset 28Oct2021 21:00, outcome "recovered", described as "chills"; PAIN (non-serious) with onset 28Oct2021 21:00, outcome "recovered", described as "body aches". Therapeutic measures were not taken as a result of product use issue, lymphadenopathy, lymph node pain, fatigue, chills, pain.  Additional information: Facility type Vaccine was reported as Pharmacy or Drug Store. The patient had no known allergies. The patient had not received any other vaccine four week prior to Pfizer vaccination. The patient was not diagnosed with Covid prior to vaccination. The patient was not tested for Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Product use issue
Clinical narrative: Very swollen lymph gland in armpit of left arm which caused a lot of pain; Very swollen lymph gland in armpit of left arm which caused a lot of pain; Fatigue; chills; body aches; other vaccine same date product=Shingrix; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 11:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), administered in arm right, administration date 27Oct2021 (Batch/Lot number: unknown) as dose 2, single. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 27Oct2021, outcome "unknown", described as "other vaccine same date product=Shingrix"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 28Oct2021 21:00, outcome "recovered" and all described as "Very swollen lymph gland in armpit of left arm which caused a lot of pain"; FATIGUE (non-serious) with onset 28Oct2021 21:00, outcome "recovered", described as "Fatigue"; CHILLS (non-serious) with onset 28Oct2021 21:00, outcome "recovered", described as "chills"; PAIN (non-serious) with onset 28Oct2021 21:00, outcome "recovered", described as "body aches". Therapeutic measures were not taken as a result of product use issue, lymphadenopathy, lymph node pain, fatigue, chills, pain.  Additional information: Facility type Vaccine was reported as Pharmacy or Drug Store. The patient had no known allergies. The patient had not received any other vaccine four week prior to Pfizer vaccination. The patient was not diagnosed with Covid prior to vaccination. The patient was not tested for Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching / the itch is where she got the shot on Saturday, at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 (Batch/Lot number: unknown, Expiration Date: 01Nov2021) at the age of 85 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Tremors" (unspecified if ongoing), notes: Verbatim: Tremors; "A-fib" (unspecified if ongoing), notes: Verbatim: A-fib. Concomitant medication(s) included: FLU VACCINE VII, administration date 11Oct2021. Vaccination history included: Bnt162b2 (Dose:1, SINGLE, Lot: EL3302 , Anatomical location : left arm, Expiry: Unknown.), administration date: 23Jan2021, when the patient was 84 years old, for Covid-19 immunization; Bnt162b2 (Dose:2, SINGLE, Lot: EL9264, Expiry: Unknown.), administration date: 10Feb2021, when the patient was 84 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 31Oct2021, outcome "not recovered", described as "Itching / the itch is where she got the shot on Saturday, at the injection site". Therapeutic measures were taken as a result of vaccination site pruritus.  Additional Information: It was stated that patient had the booster shot for the Pfizer Covid 19 Vaccine on Saturday at noon. The first 2 doses she sailed right through. She sailed through this dose until yesterday evening, then it started to itch. That's the only problem she had. She tried itch creams and it works for a little while. She also tried an ice pack and that stopped the itch. That morning she woke up and it started itching again, it's not bad, just annoying. She wanted to know if she was doing the right thing by putting cortisone itch medicine on it or using the ice pack. She stated that the ice seems to work the best, but it's hard to do things with an ice pack on it. Clarified that the itch was where she got the shot on Saturday, at the injection site. She did not have any hives or anything there. She thought she would call Pfizer first because she thought that it might be faster than trying to get through to the doctor's office or the pharmacy. Stated that the itch came and gone. It's just annoying, but she can live with it. The first 2 doses were done at a hospital. States that maybe the booster injection wasn't as good from because nurses did it at the hospital. Stated that her grandson did all her shopping, and he bought the cheapest stuff. She thought it's a brand Cortaid. She wanted the real stuff, and he bought the generic brand. No further details provided. Patient relevant tests wee none.  The lot/batch number is not available despite the follow-up attempts made. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: swelling on her tongue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient 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 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: SWOLLEN TONGUE (non-serious), outcome "unknown", described as "swelling on her tongue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Lactation disorder, SARS-CoV-2 test
Clinical narrative: Dose Number: 1 Batch/Lot No: FE3592 Location of injection: Leg Right Vaccine Administration Time: 01:30 PM; After I received my first Covid dose I could only pump 5oz of milk at work the entire day.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in leg right, administration date 07Sep2021 13:30 (Lot number: FE3592) at the age of 22 years 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: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "not recovered", described as "Dose Number: 1 Batch/Lot No: FE3592 Location of injection: Leg Right Vaccine Administration Time: 01:30 PM"; LACTATION DISORDER (non-serious), outcome "not recovered", described as "After I received my first Covid dose I could only pump 5oz of milk at work the entire day.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of incorrect route of product administration, lactation disorder. No follow-up attempts are possible. No further information is expected.  Follow-Up (09Nov2021): Follow-up attempts are completed. No further information is expected.