chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 19Apr2021 as dose 2, single (Lot number: ER8731) at the age of 29 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose number unknown (booster), single (Lot number: 67F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rapid test; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information:Known allergies: No.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 01Jun2021. The patient has no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Rebound of positive test on days 9-10 since symptom onset, following negative tests on day 7-8; Positive, notes: Rebound of positive test on days 9-10 since symptom onset, following negative tests on day 7-8. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (treatment start date: 20Sep2022, treatment stop date: 24Sep2022, Lot number: 2815236).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 at 14:30 as dose 3 (booster), single (Lot number: 301558A) at the age of 40 years, in right arm for covid-19 immunization; 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 immunization. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. Other medications in two weeks reported as no. The patient was not pregnant at the time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19. Clinical course: Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 29Sep2022 and stopped on 29Sep2022, Lot number: GF1750, Indication: Treatment of Covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypertransaminasaemia
Clinical narrative: transaminitis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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 series immunization complete but manufacturer unknown), for COVID-19 Immunization. The following information was reported: HYPERTRANSAMINASAEMIA (hospitalization), outcome "unknown", described as "transaminitis". The event "transaminitis" required emergency room visit.  Clinical Course: Patient presented to the emergency department with transaminitis and tested positive for COVID and was admitted to the hospital one day after COVID 19 booster vaccine was administered. Provider is unsure if this was a Pfizer product or not.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Investigation
Clinical narrative: headache; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4362815.  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 13:15 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Ovarian Cysts" (unspecified if ongoing); "Shingles" (unspecified if ongoing); "Wheelchair Bound/Use of a wheelchair" (unspecified if ongoing), notes: Wheelchair Bound/Use of a wheelchair; "Cut her wrists in high school" (unspecified if ongoing); "Multiple Sclerosis" (ongoing); "High Blood Pressure" (unspecified if ongoing); "Walker use" (unspecified if ongoing); "Use of a cane" (unspecified if ongoing); "Right hand swelling" (unspecified if ongoing); "unable to write/Loss of dexterity in right hand" (ongoing), notes: unable to write/Loss of dexterity in right hand; "PML" (unspecified if ongoing), notes: Positive for PML; "Asthma" (ongoing); "Cat Dander Allergy" (ongoing); "Mango Allergy" (ongoing); "Artificial Sweetener Allergy" (ongoing); "Macrobid Allergy" (ongoing); "Panic Attacks" (ongoing); "Costochondritis" (ongoing); "Depression" (ongoing); "Leg Spasms" (ongoing); "Multiple Sclerosis Pain" (ongoing); "Anxiety" (ongoing); "Heart Burn" (ongoing); "Vertigo" (ongoing); "Nausea" (ongoing); "Lack of appetite" (ongoing); "Migraines" (ongoing); "Loss of dexterity in right hand" (ongoing); "Right hand and wrist nerve issues" (ongoing); "Right hand and wrist nerve issues" (ongoing). Concomitant medication(s) included: ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; FLOVENT; FLONASE [FLUTICASONE PROPIONATE]; CELECOXIB; PANTOPRAZOLE; LYRICA; MECLIZINE [MECLOZINE]; TIZANIDINE; ESCITALOPRAM; SUMATRIPTAN; PROCHLORPERAZINE. Past drug history included: Tysabri for Multiple Sclerosis, reaction(s): "Multiple Sclerosis Flare-up", notes: Multiple Sclerosis Flare-up-when switching from Copaxone to Tysabri; Golytely, reaction(s): "Golytely Allergy". Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 26Mar2021, when the patient was 32-year-old, for COVID-19 immunization, reaction(s): "100 degree fever", "chills". The following information was reported: FATIGUE (non-serious) with onset 23Sep2022, outcome "unknown", described as "tiredness"; HEADACHE (non-serious) with onset 23Sep2022 at 19:30, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: terribly sick; could hardly move her limbs because it hurt so bad; body aches; fever; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EW0151) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (ongoing), notes: Heart Disease. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: ER8733), administration date: 29Mar2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Terribly sick", "Fever", "headache", "body aches"; BNT162b2 (Dose 1, Lot: ER8733), administration date: 29Mar2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "could hardly move limbs because it hurt so bad", "Metallic taste"; BNT162b2 (Dose 1, Lot: ER8733, Dates for itchy rash on palm of hand and once in a while on the sides of fingers on that hand: (From: 29Mar2021 To: Ongoing)), administration date: 29Mar2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "rash". The following information was reported: PAIN (non-serious) with onset 19Apr2021, outcome "recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 19Apr2021, outcome "recovered", described as "could hardly move her limbs because it hurt so bad"; PYREXIA (non-serious) with onset 19Apr2021, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 19Apr2021, outcome "recovered"; ILLNESS (non-serious) with onset 19Apr2021, outcome "recovered", described as "terribly sick". The events "terribly sick", "could hardly move her limbs because it hurt so bad", "body aches", "fever" and "headache" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient thought she had Covid but when she had the test done it was negative. Caller stated she did not think it was correct. Caller stated it was a really bad experience. She was not feeling well because she was sick, so she was in her PJs, because she did not have to go in when she goes and gets a Covid test done, so she just wore a long sweater over her PJs. Caller stated she drives that way all of the time and on the way home she got lost and ended up somewhere and she did not know where she was at, she pulled in to a quick trip and asked how to get home. She stated when she pulled out of the quick trip, she did not think she stopped to look for traffic before she pulled out of the parking lot. Caller stated that scared her to death. Caller stated the date was unknown, but it was in the Winter time, not last winter but the winter before, so 2020.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: terribly sick; could hardly move her limbs because it hurt so bad; body aches; fever; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EW0151) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (ongoing), notes: Heart Disease. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: ER8733), administration date: 29Mar2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Terribly sick", "Fever", "headache", "body aches"; BNT162b2 (Dose 1, Lot: ER8733), administration date: 29Mar2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "could hardly move limbs because it hurt so bad", "Metallic taste"; BNT162b2 (Dose 1, Lot: ER8733, Dates for itchy rash on palm of hand and once in a while on the sides of fingers on that hand: (From: 29Mar2021 To: Ongoing)), administration date: 29Mar2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "rash". The following information was reported: PAIN (non-serious) with onset 19Apr2021, outcome "recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 19Apr2021, outcome "recovered", described as "could hardly move her limbs because it hurt so bad"; PYREXIA (non-serious) with onset 19Apr2021, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 19Apr2021, outcome "recovered"; ILLNESS (non-serious) with onset 19Apr2021, outcome "recovered", described as "terribly sick". The events "terribly sick", "could hardly move her limbs because it hurt so bad", "body aches", "fever" and "headache" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient thought she had Covid but when she had the test done it was negative. Caller stated she did not think it was correct. Caller stated it was a really bad experience. She was not feeling well because she was sick, so she was in her PJs, because she did not have to go in when she goes and gets a Covid test done, so she just wore a long sweater over her PJs. Caller stated she drives that way all of the time and on the way home she got lost and ended up somewhere and she did not know where she was at, she pulled in to a quick trip and asked how to get home. She stated when she pulled out of the quick trip, she did not think she stopped to look for traffic before she pulled out of the parking lot. Caller stated that scared her to death. Caller stated the date was unknown, but it was in the Winter time, not last winter but the winter before, so 2020.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Eye irritation, Skin lesion, Sneezing, Swelling
Clinical narrative: Started sneezing several times 10 mins; after vaccine Noticed sore on right nostril about 25 min; right eye irritation; sore on nose turned into bean size blister that broke and resurfaced several times; Right side of nose and eye on right swelled during the night around 2am.; Wrong vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 10:00 as dose 1, single (Lot number: GH9693) at the age of 67 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN; LISINOPRIL; TRAZODONE; ASPIRINE; B-12. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 27Sep2022 at 10:00, outcome "unknown", described as "Wrong vaccine administered"; SWELLING (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "Right side of nose and eye on right swelled during the night around 2am."; SNEEZING (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "Started sneezing several times 10 mins"; SKIN LESION (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "after vaccine Noticed sore on right nostril about 25 min"; EYE IRRITATION (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "right eye irritation"; BLISTER (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "sore on nose turned into bean size blister that broke and resurfaced several times". Therapeutic measures were not taken as a result of sneezing, skin lesion, eye irritation, blister. Therapeutic measures were taken as a result of swelling.  Additional information: other medications in two weeks: rosuvastatin, lisinopril, trazodone, aspirin, B-12. Adverse event: Started sneezing several times 10 mins. after vaccine. Noticed sore on right nostril about 25 min. after vaccine and right eye irritation. sore on nose turned into bean size blister that broke and resurfaced several times. Right side of nose and eye on right swelled during the night around 2am. closing of air flow in nose. Eye was crusty. Used cold compress to reduce swelling. Swelling has decreased but still have blister on nose after 3 days. If treatment ae: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Started sneezing several times 10 mins; after vaccine Noticed sore on right nostril about 25 min; right eye irritation; sore on nose turned into bean size blister that broke and resurfaced several times; Right side of nose and eye on right swelled during the night around 2am.; Wrong vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 10:00 as dose 1, single (Lot number: GH9693) at the age of 67 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN; LISINOPRIL; TRAZODONE; ASPIRINE; B-12. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 27Sep2022 at 10:00, outcome "unknown", described as "Wrong vaccine administered"; SWELLING (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "Right side of nose and eye on right swelled during the night around 2am."; SNEEZING (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "Started sneezing several times 10 mins"; SKIN LESION (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "after vaccine Noticed sore on right nostril about 25 min"; EYE IRRITATION (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "right eye irritation"; BLISTER (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "sore on nose turned into bean size blister that broke and resurfaced several times". Therapeutic measures were not taken as a result of sneezing, skin lesion, eye irritation, blister. Therapeutic measures were taken as a result of swelling.  Additional information: other medications in two weeks: rosuvastatin, lisinopril, trazodone, aspirin, B-12. Adverse event: Started sneezing several times 10 mins. after vaccine. Noticed sore on right nostril about 25 min. after vaccine and right eye irritation. sore on nose turned into bean size blister that broke and resurfaced several times. Right side of nose and eye on right swelled during the night around 2am. closing of air flow in nose. Eye was crusty. Used cold compress to reduce swelling. Swelling has decreased but still have blister on nose after 3 days. If treatment ae: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, solution for injection), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm 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: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment for COVID-19 Test. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: It was reported as unknown if other medication in 2 weeks. anti viral details: COVID 19 Treatment, brand=Paxlovid, treatment start date=09Sep2022, treatment stop date=14Sep2022, indication=Treatment of COVID-19. Adverse event=Covid rebound, adverse event start date=13Sep2022, if patient recovered=Not recovered, if treatment ae=Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose was administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to a patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to a patient).    No concomitant medication was reported.    No treatment information was reported.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm 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 had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (01Aug2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (25Jul2022) Positive, notes: Symptoms reoccurred on day 10 along with a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- Patient received other vaccine. Patient did not received other medication in 2weeks. From 15Jul2022 patient received Paxlovid to 19Sep2022 for COVID 19 Treatment. Patient Symptoms reoccurred on day 10 along with a positive test.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller confirmed he contracted COVID-19; Caller confirmed he contracted COVID-19; 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 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller confirmed he contracted COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he contracted COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient reported that he was fully-vaccinated with the 2 Pfizer-BioNTech COVID-19 vaccines and 2 Pfizer boosters (did not specify monovalent/bivalent). The patient confirmed he contracted COVID-19 and was prescribed Paxlovid. He said he took the first dose and reported he "don't feel so good". He got the first dose yesterday and asked if there will be problems if he stops taking the Paxlovid?. "Do not stop taking PAXLOVID without talking to your healthcare provider, even if you feel better."   Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EW0151), in right arm and on 28Apr2021 as dose 2, single (Lot number: ER8736) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 058H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 31Oct2021 at 11:00 as dose 3 (booster), single (Lot number: fc3100) at the age of 67 years, in left arm 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: "Hypertension" (unspecified if ongoing); "hyperlipidism" (unspecified if ongoing); "type II diabetes" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive, notes: rebound covid after testing negative; (24Sep2022) Negative, notes: rebound covid after testing negative 2 days in a row 24Sep2022 and 25Sep2022; (25Sep2022) Negative, notes: rebound covid after testing negative 2 days in a row 24Sep2022 and 25Sep2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (Sep2022) Negative, notes: after testing negative; (Sep2022) Positive, notes: Rebound about 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid HR9 from 19Sep2022 to 23Sep2022 for COVID-19. Patient had no known allergy. Patient has received Other medication in 2weeks was yes.
Age: 71.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Chest pain, Dyspnoea, Fatigue, Loss of personal independence in daily activities, Off label use
Clinical narrative: Patient ended up in the hospital with Chest pain; shortness of breath; exhausted; struggle to function; Off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 11:30 as dose number unknown (booster), single (Lot number: GH9703) at the age of 71 years intramuscular, in right arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 27Sep2022 as unk, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 27Sep2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 27Sep2022, outcome "unknown", described as "Product use for unapproved combination"; CHEST PAIN (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "Patient ended up in the hospital with Chest pain"; FATIGUE (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "exhausted"; DYSPNOEA (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "shortness of breath"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "struggle to function". The events "patient ended up in the hospital with chest pain", "shortness of breath", "exhausted" and "struggle to function" required emergency room visit.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Chest pain, Fatigue, Dyspnoea and loss of personal independence in daily activities and  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Product use issue
Clinical narrative: Patient ended up in the hospital with Chest pain; shortness of breath; exhausted; struggle to function; Off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 11:30 as dose number unknown (booster), single (Lot number: GH9703) at the age of 71 years intramuscular, in right arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 27Sep2022 as unk, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 27Sep2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 27Sep2022, outcome "unknown", described as "Product use for unapproved combination"; CHEST PAIN (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "Patient ended up in the hospital with Chest pain"; FATIGUE (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "exhausted"; DYSPNOEA (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "shortness of breath"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization, medically significant) with onset 28Sep2022 at 01:45, outcome "recovered", described as "struggle to function". The events "patient ended up in the hospital with chest pain", "shortness of breath", "exhausted" and "struggle to function" required emergency room visit.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Chest pain, Fatigue, Dyspnoea and loss of personal independence in daily activities and  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension,; "hypoglycemia" (unspecified if ongoing), notes: Other medical history: hypoglycemia; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: POTASSIUM CHLORIDE; LOSARTAN; SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE. Past drug history included: Codeine, reaction(s): "Known allergies: codeine", notes: Known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication= Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received: Yes. Other medication in 2 weeks: Yes. Anti viral details: Product: COVID 19 Treatment, Brand= Paxlovid, Treatment start date: 18Sep2022, Treatment stop date: 22Sep2022, Indication: Treatment of COVID-19. Other medication in 2weeks: Product: Potassium chloride 20meq er tablets, brand: Zydus; product: Losartan 50mg, brand: Aurobindo; product: Spironolactone 25mg w/hctz 25mg, brand: Mylan.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Hypoacusis
Clinical narrative: Cataract; Hard of hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: 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 (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization.  The following information was reported: CATARACT (medically significant), outcome "unknown"; HYPOACUSIS (non-serious), outcome "unknown", described as "Hard of hearing".  Clinical Course: Caller's husband had brain surgery, hematoma, and brain bleed 6 weeks after booster shot of Covid vaccine. Can he still get another booster shot. Caller confirmed details provided by transfer agent. This report was for caller. Caller and her husband got the shot after comparing shots and deciding to get Pfizer. Caller and her husband have been isolated because those who have not gotten the shot are unsafe to be around. They don't go to church or do anything that will put them in danger. At the last visit the doctor said caller could get the booster, but the doctor was not going to say to get it. No further details provided. Caller told the doctor that she would call Pfizer to get Pfizer's advice. The doctor didn't say call CDC or FDA, but to call Pfizer. There are a lot of recordings to absorb at caller's age when she called. Caller didn't know that would involve all that. It was like someone needs a lawyer to handle a phone call. She has been on the phone for 43 minutes. If he doesn't get the booster will caller have increased chances of getting the virus because he won't be protected. Caller clarified her question. How does her husband not getting the booster effects her because both should be boosted. If they get in contact unknowingly they might get virus. Caller doesn't want to stay in for 2 year for nothing. She wants to come out a pandemic survivor. Caller was hard of hearing and can't tell if a person is still talking. Her husband is vision impaired and caller is too. Caller has a cataract. They don't have a computer.    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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing), notes: other medical history: Heart disease; "known allergies: Sulpha" (unspecified if ongoing), notes: known allergies: Sulpha. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (Sep2022) Positive, notes: After 14 days still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- Patient did not received other medication in 2weeks. From 12Sep202 to 16Sep2022 patient received Paxlovid for COVID 19 Treatment. After 10 days patient started feeling worse. After 14 days still testing positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Chronic obstructive pulmonary disease, Interchange of vaccine products, Monoplegia, Pneumonia
Clinical narrative: originally had Moderna for first two shots and first booster; month long hospitalization for pneumonia; ARDS; COPD; left arm 90% paralyzed; Believe left arm blood vessel poked by shot.; Arm black and blue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2022 at 15:30 as dose 4 (booster), single (Lot number: 59267102501W) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: 1 , (originally had Moderna for first two shots and first booster)), for COVID-19 Immunization; Moderna (Dose: 2, (originally had Moderna for first two shots and first booster)), for COVID-19 Immunization; Moderna (First booster, (originally had Moderna for first two shots and first booster)), for COVID-19 Immunization. The following information was reported: ACUTE RESPIRATORY DISTRESS SYNDROME (hospitalization, medically significant) with onset 11Aug2022, outcome "not recovered", described as "ARDS"; SKIN DISCOLOURATION (non-serious) with onset 11Aug2022, outcome "not recovered", described as "Arm black and blue"; VASCULAR INJURY (non-serious) with onset 11Aug2022, outcome "not recovered", described as "Believe left arm blood vessel poked by shot."; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization) with onset 11Aug2022, outcome "not recovered", described as "COPD"; MONOPLEGIA (medically significant) with onset 11Aug2022, outcome "not recovered", described as "left arm 90% paralyzed"; PNEUMONIA (hospitalization, medically significant) with onset 11Aug2022, outcome "not recovered", described as "month long hospitalization for pneumonia"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 11Aug2022, outcome "unknown", described as "originally had Moderna for first two shots and first booster". The events "month long hospitalization for pneumonia", "ards", "copd", "left arm 90% paralyzed", "believe left arm blood vessel poked by shot." and "arm black and blue" required physician office visit.  Clinical course: Believe left arm blood vessel poked by shot. Arm black and blue. Also, left arm 90% paralyzed as of 30Sep. May have contributed to month long hospitalization for pneumonia, ARDS, COPD. Still in hospital. Had originally had Moderna for first two shots and first booster. This would be 4th shot with switch to pfizer. (Name withheld) was still in the hospital. No Covid prior vaccination. No Covid tested post vaccination.