chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Inflammation, Mobility decreased, Peripheral swelling
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4358679-00 (RA). A 66-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years and in Aug2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), since 17Jul2019 (ongoing) at 40 mg (citrate free (40 mg, 1 in 14 day)), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant) with onset Aug2021, outcome "recovered", described as "Crohn's disease flare"; INFLAMMATION (non-serious) with onset Jan2022, outcome "recovered" (2022); MOBILITY DECREASED (non-serious) with onset Jan2022, outcome "recovered" (2022), described as "Loss of mobility of hand"; PERIPHERAL SWELLING (non-serious) with onset Jan2022, outcome "recovered" (2022), described as "Swelling in right hand". The action taken for adalimumab was dosage not changed. The reporter considered "crohn's disease flare" related to BNT162b2. The reporter's assessment of the causal relationship of "loss of mobility of hand", "inflammation" and "swelling in right hand" with the suspect product(s) BNT162b2 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. Causality for Humira (Adalimumab): The reporter's causality for the event(s) Mobility Decreased, Inflammation, Hand Swelling was no reasonable possibility. The reporter's causality for the event(s) of Crohn's disease flare with Humira (Adalimumab) was a reasonable possibility. Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran) (Tozinameran), unknown: The reporter's causality for the event(s) Mobility Decreased, Inflammation, and Swelling was nor reported. The reporter's causality for the event(s) of Crohn's disease flare with Pfizer BioNTech COVID-19 vaccine (Tozinameran) (Tozinameran), unknown was Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, the events of crohn's disease, inflammation, mobility decreased, and peripheral swelling 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.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cold; In Nov2021, the patient experienced tested positive for COVID-19; In Nov2021, the patient experienced tested positive for COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362657-00 (Agency).  An 11-year-old female patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 11 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159098) at unk, citrate free, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant) with onset Nov2021, outcome "recovered", DRUG INEFFECTIVE (medically significant) with onset Nov2021, outcome "unknown" and all described as "In Nov2021, the patient experienced tested positive for COVID-19"; NASOPHARYNGITIS (non-serious) with onset Dec2021, outcome "recovered", described as "Cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2021) Positive. The action taken for adalimumab was unknown.  The reporter considered "in nov2021, the patient experienced tested positive for covid-19" and "cold" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events covid-19 and drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: aches; Fever; Chills; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 2, single (Lot number: EN5318) at the age of 65 years for covid-19 immunisation. The patient's family history included: "multiple myeloma" (ongoing), notes: her daughter has multiple myeloma; "stem cell transplant" (unspecified if ongoing), notes: daughter had a stem cell transplant; "neutropenic" (ongoing), notes: daughter was neutropenic from all the chemotherapy. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose injected in left arm, LOT: EJ1686), administration date: 13Jan2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset Feb2021, outcome "unknown"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Fever"; HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021); PAIN (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "aches". Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient had booster on 30Sep2021 and experienced nausea the back of her thighs felt achy and kind of weak, was almost like she had been working out and had lactic acid buildup which lasted a few days then went away, fever was about 100.8 or 101.5 degrees Fahrenheit, it was not horribly high, she was sick, had headache, got nausea, aches, chills.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness, Gait inability, Interchange of vaccine products, Off label use
Clinical narrative: I had a mixed dose because of my reaction to Moderna. I thought it would be different with, from Pfizer; I had a mixed dose because of my reaction to Moderna. I thought it would be different with, from Pfizer; My heart went haywire; dizzy; couldn't walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 80B09413-168C-4041-A1A0 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: Unknown, Manufacturer: Moderna), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "I had a mixed dose because of my reaction to Moderna. I thought it would be different with, from Pfizer"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "My heart went haywire"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; GAIT INABILITY (non-serious), outcome "unknown", described as "couldn't walk". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, SARS-CoV-2 test
Clinical narrative: Right arm pain in joints. Hands and finger joints. Elbow joints and shoulder joints; Muscle pain in entire arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number=1, Product=COVID 19, Brand=Pfizer, Administration date=22Mar2021, Administration time=12:00, Vaccine location=Left arm), administration date: 22Mar2021, when the patient was 45-year-old, for COVID-19 Immunization. The following information was reported: MYALGIA (disability) with onset 31Jan2022 at 12:00, outcome "not recovered", described as "Muscle pain in entire arm"; ARTHRALGIA (disability) with onset 31Jan2022 at 12:00, outcome "not recovered", described as "Right arm pain in joints. Hands and finger joints. Elbow joints and shoulder joints". The events "right arm pain in joints. hands and finger joints. elbow joints and shoulder joints" and "muscle pain in entire arm" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2021) Negative, notes: Nasal swab. Therapeutic measures were taken as a result of arthralgia, myalgia with Anti inflammatory meds and pain meds. The patient did not receive any other vaccines within four weeks prior to the vaccination. COVID-19 prior vaccination was unknown. Patient did not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Migraine, Nausea
Clinical narrative: Vertigo; nausea; stomach pain; migraine; fatigue; blurred vision; sleep disorder; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4348929-00 (Agency).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 30Mar2022 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (Batch/Lot number: unknown), oral. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]; HYDROXYZINE; VIIBRYD. Vaccination history included: covid-19 vaccine, administration date: 09Mar2022, for Covid-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 31Mar2022, outcome "not recovered"; VISION BLURRED (non-serious) with onset 31Mar2022, outcome "not recovered", described as "blurred vision"; FATIGUE (non-serious) with onset 31Mar2022, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 31Mar2022, outcome "not recovered", described as "joint pain"; MIGRAINE (non-serious) with onset 31Mar2022, outcome "not recovered"; NAUSEA (non-serious) with onset 31Mar2022, outcome "not recovered"; SLEEP DISORDER (non-serious) with onset 31Mar2022, outcome "not recovered"; ABDOMINAL PAIN UPPER (non-serious) with onset 31Mar2022, outcome "not recovered", described as "stomach pain". The action taken for levothyroxine sodium was unknown. Therapeutic measures were taken as a result of vertigo, nausea, abdominal pain upper, migraine, fatigue, vision blurred, sleep disorder, arthralgia.  Additional information: The patient was treated with Baclofen, Percocet, Zofran, Imitrex and Ubrelvy. The reporter causality for the events of vertigo, nausea, stomach pain, migraine, fatigue, blurred vision, unable to stay awake and joint pain was not provided. SYNTHROID (Levothyroxine): Causality as per reporter (Drug/Vaccine): Not reported for all the events. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN): Causality as per reporter (Drug/Vaccine): Not reported for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Sleep disorder, Vertigo, Vision blurred
Clinical narrative: Vertigo; nausea; stomach pain; migraine; fatigue; blurred vision; sleep disorder; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4348929-00 (Agency).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 30Mar2022 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (Batch/Lot number: unknown), oral. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]; HYDROXYZINE; VIIBRYD. Vaccination history included: covid-19 vaccine, administration date: 09Mar2022, for Covid-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 31Mar2022, outcome "not recovered"; VISION BLURRED (non-serious) with onset 31Mar2022, outcome "not recovered", described as "blurred vision"; FATIGUE (non-serious) with onset 31Mar2022, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 31Mar2022, outcome "not recovered", described as "joint pain"; MIGRAINE (non-serious) with onset 31Mar2022, outcome "not recovered"; NAUSEA (non-serious) with onset 31Mar2022, outcome "not recovered"; SLEEP DISORDER (non-serious) with onset 31Mar2022, outcome "not recovered"; ABDOMINAL PAIN UPPER (non-serious) with onset 31Mar2022, outcome "not recovered", described as "stomach pain". The action taken for levothyroxine sodium was unknown. Therapeutic measures were taken as a result of vertigo, nausea, abdominal pain upper, migraine, fatigue, vision blurred, sleep disorder, arthralgia.  Additional information: The patient was treated with Baclofen, Percocet, Zofran, Imitrex and Ubrelvy. The reporter causality for the events of vertigo, nausea, stomach pain, migraine, fatigue, blurred vision, unable to stay awake and joint pain was not provided. SYNTHROID (Levothyroxine): Causality as per reporter (Drug/Vaccine): Not reported for all the events. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN): Causality as per reporter (Drug/Vaccine): Not reported for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: in Jan2022, the patient experienced tested positive for COVID-19; in Jan2022, the patient experienced tested positive for COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362657-00 (Agency).  An 11-year-old female patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 1, single (Batch/Lot number: unknown) and on 14Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 11 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022), VACCINATION FAILURE (medically significant) with onset Jan2022, outcome "recovered" and all described as "in Jan2022, the patient experienced tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. The action taken for adalimumab was unknown. The reporter considered "in jan2022, the patient experienced tested positive for covid-19" related to BNT162b2. Clinical course included In Nov2021, the patient experienced tested positive for covid-19. In Dec2021, the patient experienced COLD. In January 2022, the patient experienced tested positive for COVID-19. In 2022, the tested positive for COVID-19 resolved. On unknown dates, tested positive for COVID-19 and COLD resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the [COVID-19 ] with the suspect product was provided possible at the time of this report. Since determination has been received, the case is managed based on the company causality assessment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be excluded.
Age: 21.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Joint swelling, Peripheral swelling
Clinical narrative: Joint swelling; Swelling of fingers; 05Aug2021/28Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): 22K-163-4361158-00 (Agency).  A 21-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 21 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Lot number: 1159098) subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Intramuscular), administration date: 05Aug2021, when the patient was 21-year-old, for Covid-19 Immunization, reaction(s): "Joint swelling", "swelling of fingers". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Sep2021, outcome "unknown", described as "05Aug2021/28Sep2021"; JOINT SWELLING (non-serious) with onset 28Sep2021, outcome "recovered" (29Sep2021); PERIPHERAL SWELLING (non-serious) with onset 28Sep2021, outcome "recovered" (29Sep2021), described as "Swelling of fingers". The action taken for adalimumab was unknown.  Additional information: The reported causality of the events as per reporter with Covid-19 vaccine was possible.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient received BNT162b2 (BNT162B2), on 05Sep2021 at 11:00 as dose 1, single (Lot number: FD8448) at the age of 40 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "syringomyelia" (unspecified if ongoing); "Muscle weakness" (ongoing); "Anxiety" (ongoing); "Pain" (ongoing); "Stomach" (ongoing), notes: Verbatim :Stomach. Concomitant medication(s) included: BACLOFEN oral taken for muscle relaxant therapy (ongoing); XANAX oral taken for anxiety (ongoing); TYLENOL oral taken for pain (ongoing); PROTONIX [OMEPRAZOLE] oral taken for abdominal discomfort (ongoing). The following information was reported: HYPOAESTHESIA (disability, medically significant) with onset 2021, outcome "not recovered", described as "numbness feet". The event "numbness feet" required physician office visit. It was unknown if therapeutic measures were taken as a result of hypoaesthesia. Clinical course: Prior vaccination reported as none. No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she got the Moderna Covid vaccine for her 1st and 2nd dose but her booster was Pfizer Covid vaccine/tested positive for Covid 19 this past Sunday; she got the Moderna Covid vaccine for her 1st and 2nd dose but her booster was Pfizer Covid vaccine/tested positive for Covid 19 this past Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Primary biliary cirrhosis" (unspecified if ongoing), notes: Primary biliary cirrhosis She takes medication for cirrhosis of the liver; "Emphysema" (unspecified if ongoing), notes: Emphysema diagnosed in the last 3 years and she takes a once a day inhaler. Concomitant medication(s) included: FLU taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Apr2022, outcome "unknown" and all described as "she got the Moderna Covid vaccine for her 1st and 2nd dose but her booster was Pfizer Covid vaccine/tested positive for Covid 19 this past Sunday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) positive, notes: tested positive for Covid 19 this past Sunday. Therapeutic measures were taken as a result of covid-19.  Clinical course: Additional Vaccines Administered on Same Date of the Pfizer Suspect: she thinks she got her flu shot that same day Adverse Event (AE) Details: Provide the time of onset of AE(s): started around 3 am this morning. Prior Vaccinations (within 4 weeks) was unknown. Caller states her mom has COVID 19 and last night started Paxlovid, the antiviral. Caller states that she was on the website looking and her mom has a massive headache. Caller is asking has that has been reported as a side effect. Caller states the massive headache started earlier this morning around 3 am and is persisting.  Suspect Product: Paxlovid. Caller states she does not have any information to provide as her mom has the medication. Caller does not have dose, NDC, lot or expiry to provide. Indication: States she got COVID 19 and is at high risk, she has emphysema and her age. Caller states she was boostered and everything and she got it. Caller states she got the Moderna COVID vaccine for her 1st and 2nd dose but her booster was Pfizer COVID vaccine. Caller does not have dates, NDC, lot or expiry to provide for any doses. States that her last dose was over 6 months ago, she has not gotten the most recent booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: arm soreness; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (Pfizer COVID-19 booster; Solution for injection), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 3, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Apr2022, outcome "unknown", described as "arm soreness"; NAUSEA (non-serious) with onset 19Apr2022, outcome "unknown". Additional information: Description of Event: 56 yo  female experienced arm soreness and nausea following second Pfizer COVID-19 booster. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fracture
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Sep2021 as dose 4 (booster), 0.3 ml single (Lot number: FC3183, Expiration Date: 28Sep2021) at the age of 76 years for Covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (ongoing), notes: Emphysema/COPD Diagnosed 30-40 years ago; "COPD" (ongoing), notes: Emphysema/COPD Diagnosed 30-40 years ago; "Hashimoto's disease" (ongoing); "Water builds up in her brain" (ongoing); "Thyroid" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Water pill" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for thyroid disorder; HYDROCHLOROTHIAZIDE taken for diuretic therapy; XANAX taken for anxiety; FLU VACCINE VII, in Sep2021 as dose number unknown, single. Vaccination history included: BNT162b2 (Dose 1, received on 03Feb2021 around 10am, in right arm, Lot/NDC/Expiry: Unknown), administration date: 03Feb2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, received on 03Mar2021, Lot/NDC/Expiry: Unknown), administration date: 03Mar2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, received on 03Aug2021, Lot: FA7484, NDC:59267-1000-03 Expiry:26Aug2021, Dose:0.3mL), administration date: 03Aug2021, when the patient was 76-year-old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 03Sep2021, outcome "unknown", described as "booster"; OFF LABEL USE (medically significant) with onset 03Sep2021, outcome "unknown"; FRACTURE (medically significant) with onset 25Jan2022, outcome "unknown", described as "broke her pelvis in 2 places; both the ischium and coccyx are broken on both sides"; FALL (non-serious) with onset 25Jan2022, outcome "unknown", described as "the fall occurred on 25Jan2022".
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid on Sunday, 17Apr2022; Tested positive for Covid on Sunday, 17Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EK4176), on 15Feb2021 as dose 2, single (Lot number: EL9266) and on 04Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 57 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 17Apr2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Tested positive for Covid on Sunday, 17Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) positive. Therapeutic measures were taken as a result of covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (previous dose details , prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=2,), for COVID-19 immunization; Covid-19 vaccine (prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: lot unknown reason was Not available/provided to reporter at the time of report completion,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Device breakage
Clinical narrative: PREVNAR 13 Vaccine syringe broke into two pieces when the needle was screwed onto the syringe; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 07Apr2022, this case now contains all required information to be considered as valid.  This is a spontaneous report received from a contactable nurse from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13), as dose number unknown, single (Lot number: EW2019, Expiration Date: Dec2023) for immunisation, Device Lot Number: EW2019, Device Expiration Date: Dec2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "PREVNAR 13 Vaccine syringe broke into two pieces when the needle was screwed onto the syringe".  Additional Information: PREVNAR 13 vaccine syringe broke into two pieces when the needle was screwed onto the syringe. The glass is still connected to the vaccine. The nurse clarified it as the area where the neck of the syringe screws into the vaccine is connected to the needle. The syringe had all the PREVNAR 13 medicine in it and broke at the seal in the tube. This occurred with two PREVNAR 13 Vaccines from the same box. The sample of the product is available to be returned, if requested. The nurse confirms there was no patient involvement.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Colonoscopy, Deafness, Ear disorder, Tinnitus
Clinical narrative: 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), on 13Apr2021 at 16:00 as dose 1, single (Lot number: ER8731), in left arm and on 04May2021 at 11:00 as dose 2, single (Lot number: EW0170) at the age of 61 years, in left arm, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "Irritable Bowel", start date: 2007 (ongoing); "Pancreatic exocrine insufficiency" (ongoing), notes: Onset Date:; "Mast cell Activation Syndrome", start date: 2021 (ongoing), notes: Diagnosis not completely confirmed.; "Neuropathy" (unspecified if ongoing); "Colon Spasms" (unspecified if ongoing); "Anti histaminic" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for neuropathy peripheral, start date: 2017, stop date: 2021; GABAPENTIN taken for neuropathy peripheral, start date: 2017, stop date: 2021; PANCREAZE [AMYLASE; LIPASE; PROTEASE NOS] taken for pancreatic failure, start date: 2020 (ongoing); CHLORDIAZEPOXIDE; CLIDINIUM taken for gastrointestinal pain, start date: 2019, stop date: 2021; HYDROXYZINE taken for antiallergic therapy, start date: 2021, stop date: 2022. The following information was reported: DEAFNESS (medically significant, medically significant) with onset 01May2021, outcome "not recovered", described as "hearing loss"; TINNITUS (non-serious) with onset 2021, outcome "not recovered"; COLONOSCOPY (non-serious) with onset 10Dec2021 at 09:00, outcome "recovered"; EAR DISORDER (non-serious), outcome "unknown", described as "felt like moisture in my ears". The events "hearing loss" and "colonoscopy" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (06Dec2021) Loss of hearing, notes: Lost more in right ear; Colonoscopy: (10Dec2021) Normal. Therapeutic measures were not taken as a result of deafness, colonoscopy. Clinical course: May to Jun2021, tinnitus. Felt like moisture in my ears. Ear popping and liquid-like sound when moving my head. Took several months to see ENT doctor. He performed a hearing test and exam. No fluid in ears and no physical abnormalities. Hearing test indicated hearing loss both ears with more loss in the right ear. Tinnitus continues. I am happy to provide the records if needed. Just ask. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Myalgia
Clinical narrative: Muscle pain; Stomach problems; 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), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, Manufacture: Unknown, Primary vaccination complete), for Covid-19 Immunization. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Stomach problems".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Muscular weakness, Myalgia, Pyrexia, Vomiting
Clinical narrative: Tossed his cookies, threw up yellow, black, thick, dark mucus; Stomach problems; Got sick with a low grade temperature of 100 degrees; Body muscles were not responding, specifically felt like his arms and legs got tired; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (medically significant), outcome "unknown", described as "Tossed his cookies, threw up yellow, black, thick, dark mucus"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Stomach problems"; PYREXIA (non-serious), outcome "unknown", described as "Got sick with a low grade temperature of 100 degrees"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Body muscles were not responding, specifically felt like his arms and legs got tired"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain". The patient underwent the following laboratory tests and procedures: Pyrexia: 100 degree. It was reported that, the caller states, he was called about the Pfizer Covid vaccine, booster. The caller stated that, everything was fine with all three previous shots. Stated that, when he got the second booster, he tossed his cookies, clarifies as threw up yellow, black, thick, dark mucus, stomach problems, got sick with a low grade temperature of 100 degrees, felt like he lost the next day and his body muscles were not responding, specifically felt like his arms and legs got tired. The caller declined to complete a safety report and just wanted to state his events, as informational. The caller stated that, he has Pfizer stock and felt he had a vested interested in telling his events. Caller stated that, his granddaughter told him to ask questions. Reason for no lot number of Covid vaccine: Caller was unwilling to complete the report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 2, single (Lot number: FK9894) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First Dose, Lot Number / Expiry Date: FJ6369/unknown, Route, Anatomical Location: left arm, left upper shoulder), administration date: 14Mar2022, when the patient was 22-year-old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 18Apr2022, outcome "unknown", described as "shoulder a little sore".
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Since I received my 2 covid vaccines last year I have been losing hair, it's also happening to my other family members/ slowly going bald; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 64-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), administration date: 2021, for Covid-19 immunisation. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Since I received my 2 covid vaccines last year I have been losing hair, it's also happening to my other family members/ slowly going bald".  Additional information: Patient stated, since she received her 2 covid vaccines last year (2021) she has been losing hair, it was also happening to her other family members. Was there something could do to help her, woman slowly going bald.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Nausea
Clinical narrative: "vaccine second shot, he developed constant headaches, nausea,(Allergies related symptoms)from that time."; nausea; Allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. An 11-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1; Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as ""vaccine second shot, he developed constant headaches, nausea, (Allergies related symptoms) from that time.""; NAUSEA (non-serious), outcome "unknown"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergies". Additional information Subject: Patient Assistance, Customer Verbatim: Dec2021 my son, 11-year-old, received Pfizer kids vaccine second shot. He developed constant headaches, nausea (allergies related symptoms) from that time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, SARS-CoV-1 test, Swelling face, Urticaria
Clinical narrative: Caller stated that on her 2nd dose in the evening, she had allergic reaction and went to the ER; lips and face swell; lips and face swell; itchy welts; 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 76-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller stated that on her 2nd dose in the evening, she had allergic reaction and went to the ER"; SWELLING FACE (non-serious), LIP SWELLING (non-serious), outcome "unknown" and all described as "lips and face swell"; URTICARIA (non-serious), outcome "unknown", described as "itchy welts". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200462735 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Having heavy, menstrual bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the parent.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacture Unknown), for Covid-19 immunization.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Having heavy, menstrual bleeding".  Additional Information: Verbatim: Both of my teen daughters have your shots and booster. It was after the second shot that my oldest started having heavy, menstrual bleeding. She already had bad periods but, the bleeding has become so bad that, even the heaviest flow pads cannot absorb the blood fast enough. Our entire house is fully vaccinated and boosted, I just need some questions answered about side effects like my 18-year-old is experiencing. Sincerely, a concerned mom.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: we got covid; we got covid; 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), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "we got covid". Therapeutic measures were taken as a result of suspected covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Since my booster in Nov my hair has been falling out; 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 patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but manufacturer unknown), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Since my booster in Nov my hair has been falling out".  Additional information: Customer Verbatim: Since my booster in Nov my hair has been falling out. I have not had a Covid infection. I've just read online hair loss is occurring to women nationwide as a result of the Vaccines. What is the recommended cure to stop it? I will see a Dermatologist in a week and want to ensure she is up to speed on the recommended fix. Thank you.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: we got covid; we got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 single (Batch/Lot number: unknown) and as dose 2 single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cerebral palsy" (unspecified if ongoing); "lung issue" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering", described as "we got covid"; SUSPECTED COVID-19 (medically significant), outcome "recovering", described as "we got Covid". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Like most mothers these past two years reporter had anguished about his family was getting Covid. Patient was a son who has cerebral palsy and a lung issue, plus he moved my sweet 95-year-old mother-in-law into their home to protect her. They all were vaccinated and had their boosters. But they got Covid and took Paxlovid. It was like a miracle, and they all were 75% better in three days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: we got covid; we got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "unknown", described as "we got covid"; SUSPECTED COVID-19 (medically significant), outcome "recovering", described as "we got Covid". Therapeutic measures were taken as a result of suspected covid-19. The patient was treated with Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.