chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Orthostatic intolerance, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; orthostatic intolerance; autonomic dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 18-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2009 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, syncope and autonomic dysfunction. At the time of the report, the patient's outcome was unknown. According to reporter, the events were related to the suspect therapy.   Upon internal review, the event of syncope was considered medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 16-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2010 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS). At the time of the report, the patient's outcome was unknown. According to reporter, the event was related to the suspect therapy.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; joint pain; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 18-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2010 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS) and arthralgia. According to reporter, the events were related to the suspect therapy.
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 18-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2010 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS) and fatigue. According to reporter, the events were related to the suspect therapy.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 18-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2012 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS), syncope and dizziness. At the time of the report, the patient's outcome was unknown. According to reporter, the events were related to the suspect therapy.   Upon internal review, the event of syncope was considered medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: syncope; POTS; fatigue; headache; dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 11-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2013 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS), fatigue, headache, dizziness, and syncope. At the time of the report, the patient's outcome was unknown. According to reporter, the events were related to the suspect therapy.   Upon internal review, the event of syncope was considered medically significant.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Caller had no further AE to report.; Caller stated the first dose of the vaccine was administered to a patient who was 7 months 26 days.; This spontaneous report has been received from other reporter, concerning a 7-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 19-JAN-2023, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliters (ml) (vaccination scheme, frequency, lot number, and expiration date were not provided) for prophylaxis, who was 7 months and 26 days (product administered to patient of inappropriate age ).  No additional adverse events (AE) were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HBP reported a dose of VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from an office manager, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 06-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliters (ml) (valid lot number W020540 [expiration date 28-JUN-2024]) (vaccination scheme, and frequency were not provided) for prophylaxis, after a temperature excursion of 41.4 degrees Fahrenheits (F) with a time frame of 1 hour (h) and 58 minutes (min) (product storage error).   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA007926:02321654 US-009507513-2301USA008267:02321655
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Caller states a 4 year old male patient was administered ROTATEQ on 20JAN2023 in error; This spontaneous report has been received from a medical assistant concerning a 4-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 20-JAN-2023, the patient was vaccinated in error with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1908328, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date not reported, but upon internal validation established as 17-NOV-2023) (dose, anatomical location and route of administration were not reported) (Product administered to patient of inappropriate age).  No additional adverse event was reported.
Sex: F
Vaccine: TYP
Symptoms: Feeling hot, Rash pruritic
Clinical narrative: Slightly hot and itchy rash on collarbone area; Slightly hot and itchy rash on collarbone area; A spontaneous report was received from a patient on 28DEC2022. It described a 46-year-old female patient who developed a "slightly hot and itchy rash on collarbone area" (PT: Rash pruritic, PT: Feeling hot) following administration of oral Vivotif (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that on 26DEC2022 at noon, the patient took the first dose of Vivotif following which, she developed a slightly hot and itchy rash on the collarbone area which she did not notice until the evening of that day. Reportedly, the rash persisted into day two of the dosing schedule and she did not take her second dose of Vivotif. Furthermore, it was reported that the rash slightly improved since stopping the medication, but not to much extent. Additionally, the patient had not received any treatment for the reported events and had not conducted any lab work/tests. The patient was recovering from the reported events, at the time of this report.  Action taken with Vivotif with respect to the reported events was drug withdrawn.  The patient's medical history included thyroid problems and a shoulder injury in the past for which she received a cortisone shot on 15DEC2022. The patient had no allergies.  Concomitant medications included 1 tablet of levothyroxine (75 mcg; daily by mouth), 1 tablet of vitamin C (ascorbic acid; 1000 mg; daily by mouth), 1 capsule of vitamin D (ergocalciferol; 2500 units; daily by mouth), 1 tablet of vitamin B12 (cyanocobalamin; 1000 mcg; daily by mouth), turmeric (Curcuma longa; 400 mg capsule, 2-3 times a day for a few weeks) and Oregano oil capsule (Origanum minutiflorum oil; 230 mg once or twice a day).  No additional information was reported.  Company comment: A consumer developed a slightly hot and itchy rash on collarbone area (rash pruritic and feeling hot) following administration of oral Vivotif. In response to the events, the Vivotif was discontinued. Considering the case information and the positive dechallenge, the causality of the events rash pruritic and feeling hot is assessed as probable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer developed a slightly hot and itchy rash on collarbone area (rash pruritic and feeling hot) following administration of oral Vivotif. In response to the events, the Vivotif was discontinued. Considering the case information and the positive dechallenge, the causality of the events rash pruritic and feeling hot is assessed as probable with Vivotif. The case is considered non-serious as per medical assessment.
Age: 0.17
Sex: F
Vaccine: FLUX, MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 2 months-old received MMR and Influenza vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   Concomitant products included VARICELLA VACCINE, LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX), PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) and VAXELIS.   On 12th December 2022, the patient received Influenza vaccine and MMR vaccine. On 12th December 2022, unknown after receiving Influenza vaccine and MMR vaccine, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: The patient who was administered too many vaccines the infant was scheduled to receive Vaxelis, Prevenar 13, and Rotarix, however, the patient also received Measles mumps and rubella (MMR), Varicella vaccine, live and Influenza vaccine which were not scheduled with no reported adverse event. The patient's past medical history, medical treatments, vaccinations and family history were not provided. It was not reported if the patient received a corrective treatment for the event. The reporter consented to follow-up. Additional supportive information: The patient received Influenza vaccine and Measles mumps and rubella vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthma, Condition aggravated, Fatigue, Headache
Clinical narrative: Muscle pain; Headacxhe; Tiredness; Upset stomach; Assthma flare up; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, headache, tiredness, upset stomach and asthma aggravated. On an unknown date, the outcome of the muscle pain, headache, tiredness, upset stomach and asthma aggravated were unknown.   It was unknown if the reporter considered the muscle pain, headache, tiredness, upset stomach and asthma aggravated to be related to Shingrix.     Additional Information: GSK receipt date: 19-JAN-2023 Reporter Comment: The reporter reported that, the patient received Shingrix vaccine and experienced side effects such as muscle pain, headache, tiredness, upset stomach, asthma flare up. The reporter did not consent to follow up. The reporter asked how long the side effects of the shingles vaccine last.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; Headacxhe; Tiredness; Upset stomach; Assthma flare up; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, headache, tiredness, upset stomach and asthma aggravated. On an unknown date, the outcome of the muscle pain, headache, tiredness, upset stomach and asthma aggravated were unknown.   It was unknown if the reporter considered the muscle pain, headache, tiredness, upset stomach and asthma aggravated to be related to Shingrix.     Additional Information: GSK receipt date: 19-JAN-2023 Reporter Comment: The reporter reported that, the patient received Shingrix vaccine and experienced side effects such as muscle pain, headache, tiredness, upset stomach, asthma flare up. The reporter did not consent to follow up. The reporter asked how long the side effects of the shingles vaccine last.
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Feeling abnormal, Insomnia
Clinical narrative: Insomnia/couldn't sleep; Felt weird; Anxious; This case was reported by a nurse via sales rep and described the occurrence of insomnia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced insomnia, weird feeling and anxiety. On an unknown date, the outcome of the insomnia, weird feeling and anxiety were unknown.   It was unknown if the reporter considered the insomnia, weird feeling and anxiety to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The patient could not sleep, insomnia, felt weird and anxious. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment:  This case was reported via (Shingrix GSK) interactive digital media. The reporter wanted to know how long did the redness at injection site commonly last. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5CE5S, expiry date unknown) for prophylaxis.   On 13th October 2022, the patient received the 1st dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The patient received Shingrix and was seen back in the clinic 5 days later on 18th October 2022 with shingles. The patient also received 2nd dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Hyperhidrosis
Clinical narrative: Dizziness; Weakness; Sweating hands; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2022, immediately after receiving Shingrix, the patient experienced dizziness, weakness and sweaty hands. On 1st November 2022, the outcome of the dizziness was recovered/resolved. On 2nd November 2022, the outcome of the weakness and sweaty hands were recovered/resolved.   It was unknown if the reporter considered the dizziness, weakness and sweaty hands to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix into left deltoid and started feeling of dizziness, weakness and his hands were sweating immediately after vaccination. Dizziness lasted 20 minutes and the weakness and sweating hands went away the following day. The reporter reported that education provided on adverse reactions per package insert. The reporter consented to follow up. Additional supportive information: As per narrative outcome date captured for event dizziness, weakness and sweaty hands, conservatively.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month-old received Flulaval; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 79ED9, expiry date 30th June 2023) for prophylaxis.   On 17th January 2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 17th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: The patient received a dose of Flulaval quadrivalent by error at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: 2 episodes of shingles; 1st dose 12Feb2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 52LX4, expiry date 23rd April 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt date: 19-JAN-2023 Reporter comment: The pharmacist reported that, the patient developed 2 episodes of shingles following dose 1 of Shingrix.  The first episode occurred a month or two after the 1st dose and the pharmacist was unaware of when the 2nd episode occurred. Both episodes have cleared up (unknown time frame). The second dose of Shingrix had not been administered. The reporter asked for email address but pharmacist states they did not get external emails. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st 3 doses ok, year later 4th dose missed; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (On an unknown date ,received 1st dose), Twinrix (On an unknown date ,received 2nd dose) and Twinrix (On an unknown date ,received 3rd dose).   On an unknown date, the patient received the 4th dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 19-Jan-2023. Reporter's Comments: Reporter stated that they called to inform that a patient went under the accelerated dosing schedule for Twinrix and received the first three doses as they should be but missed the last one by more than a year. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, patient did not received 4th dose of Twinrix which led to incomplete course of vaccination.
Sex: U
Vaccine: PNC13
Symptoms: Illness, Immunodeficiency, Viral titre
Clinical narrative: immunocompromised condition; has been sick; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A 5-year-old patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein) (PREVNAR 13), as dose 4, single (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (dose 1), for immunization; Prevnar 13 (dose 2), for immunization; Prevnar 13 (dose 3), for immunization. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised condition"; ILLNESS (non-serious), outcome "unknown", described as "has been sick". The patient underwent the following laboratory tests and procedures: titer test: neither patient had titers of Prevnar.  Additional information: The nurse was describing 2 recent patients at the age of 5 years of age that has been sick and titer tests were conducted and neither patient had titers of Prevnar. She felt both had 4 doses as infants. Thought was strange that they had no titers. One of the patients also had no titers of Hep B. The patients were going to have further testing to uncover if why been sick and/or if they immunocompromised condition or another condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the events "immunocompromised condition" and "has been sick" with PREVNAR 13 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300011939 same reporter/product/event, different patients;
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose number unknown, single (Lot number: Fj1620) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid for COVID-19 from 11Jan2023 to 16Jan2023.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN6201), on 10Mar2021 as dose 2, single (Lot number: EN6208) and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Jul2022 as dose 4 (booster), single (Lot number: 060A22A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 28Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Jul2022, outcome "unknown", described as "Name of Drug as Reported: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment with Paxlovoid from 10Jan2023 to 14Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right 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's relevant medical history included: "Prostate cancer hypertension" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID-19 Treatment with Paxlovid orally from 09Jan2023 to 14Jan2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose 4 (booster), single (Lot number: 9J6738) at the age of 68 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's relevant medical history was not reported. Concomitant medication(s) included: CORICIDIN COLD & FLU. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid started from 12Jan2023 to 17Jan2023.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
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) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 13:00 as dose 5 (booster), single (Lot number: GJ6738) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 08Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 19Jul2022 as dose 4 (booster), single (Lot number: FP7139), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Salmon" (unspecified if ongoing), notes: known allergies: Salmon; "Osteoarthritis" (unspecified if ongoing); "Cutaneous Lupus" (unspecified if ongoing); "Obstruct Sleep Apnea" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "HBP" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Nsaids, reaction(s): "lichen planus".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2023 at 08:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2023) Positive, notes: I tested positive 13Jan2023 took the 5 days medication; (21Jan2023) Negative, notes: Retest on Saturday 21Jan2023 w 2 tests negative; (22Jan2023) Positive, notes: Then 22Jan2023 Sunday got positive test and negative test with one kit; (22Jan2023) Negative, notes: Then 22Jan2023 Sunday got positive test and negative test with one kit; (22Jan2023) Positive, notes: Follow up same day 6 hrs later and got 2 positive tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Periorbital swelling
Clinical narrative: his eyes are swollen for a month now after getting the booster; double bags under his eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 complete; manufacturer unknown), for COVID-19 immunization. The following information was reported: EYE SWELLING (non-serious) ,outcome "not recovered", described as "his eyes are swollen for a month now after getting the booster"; PERIORBITAL SWELLING (non-serious), outcome "not recovered", described as "double bags under his eyes".  Additional information: The next day after receiving the injection, he woke up and there were double bags under his eyes, which is not normal, and they have not gone away. He doesn't remember the date he received the injection, but states that it's been about a month. The reporter is seeking information covid 19 booster confirms most recent bivalent for adult vaccine, wondering if double bags under his eyes for a month is a usual symptoms. It was reported that starting the next morning when he got out of bed it was within 12 hours of vaccination. The patient has taken very good care of eyes, no crows feet, avoided sun and use lotion. This has not gone away in almost a month.  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.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack".  Clinical information: I just wanted to let you know I have never taken any of these jabs, by the fake president and I never will and I will live to see my 62nd birthday. I wouldn't be a bit surprised if that jab isn't what killed and knocked down this football player that had a heart attack right on the field and he lived but she didn't. STOP PUSHING THE JAB".Agent asked if caller had any medical information questions that they would be able to assist with today, in which caller stated, "Nope" "STOP PUSHING THE JAB" Caller was thanked and wished a wonderful day, in which they responded back with "STOP PUSHING THE JAB" agent warned caller of disconnection and disconnected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 51-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2023, outcome "not recovered" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The event "since the vaccination, has the patient been tested for covid-19?:yes" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, an association between the reported events  DRUG INEFFECTIVE & COVID-19 and The suspected drug cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: 3 members of my family who had Heart problems after taking the vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "3 members of my family who had Heart problems after taking the vaccines". Additional information: According to the reporter, these vaccines were dangerous. Just look at then news and you see all the healthy people dying from heart failure. The reporter had 3 members of my family who had heart problems after taking the vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300014688 same reporter/vaccine/event, different patient;US-PFIZER INC-202300034770 same reporter/vaccine/event, different patient;
Age: 70.0
Sex: F
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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS-D" (unspecified if ongoing), notes: other medical history: IBS-D; "Diverticulitis" (unspecified if ongoing); "Known allergies: Penicillin" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral COVID 19 Treatment Paxlovid from 12Jan2023 to 16Jan2023. Other medication in 2weeks: No.  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: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes, COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EM9809), in left arm and on 09Sep2021 as dose 2, single (Lot number: FF2588) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 08Aug2022, outcome "unknown" and all described as "Covid-19". The patient was hospitalized for drug ineffective (start date: 08Aug2022); for covid-19 (start date: 08Aug2022, hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Blood electrolytes: (unspecified date) Low, notes: electrolytes were very low; Oxygen saturation: (unspecified date) Low, notes: oxygen was low; SARS-CoV-2 test: (08Aug2022) Positive; Weight: (unspecified date) 152 lbs, notes: He went from 177lbs to 152lbs.  Clinical course: It was reported by the patients Wife that patient had a reaction to the serum on 25Mar2021. Got another Covid-19 booster. Was on a ventilator for 30 days last Aug2022 after catching Covid-19. Had adverse reactions to the first Covid shot. On 09Sep2021, he got the booster and the same thing happened with the foot. He ended up getting covid anyway and on 08Aug2022, the ambulance had to come get him. He couldn't keep any food down before the ambulance came to get him, not even water or crushed ice. When he got to the hospital, his electrolytes were very low, oxygen was low, kidneys were shutting down. He was lucky to be alive. Got the vaccine in his left arm at a hospital parking lot vaccine drive. Can't remember which arm the Dose was given in.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EM9809), in left arm and on 09Sep2021 as dose 2, single (Lot number: FF2588) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 08Aug2022, outcome "unknown" and all described as "Covid-19". The patient was hospitalized for drug ineffective (start date: 08Aug2022); for covid-19 (start date: 08Aug2022, hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Blood electrolytes: (unspecified date) Low, notes: electrolytes were very low; Oxygen saturation: (unspecified date) Low, notes: oxygen was low; SARS-CoV-2 test: (08Aug2022) Positive; Weight: (unspecified date) 152 lbs, notes: He went from 177lbs to 152lbs.  Clinical course: It was reported by the patients Wife that patient had a reaction to the serum on 25Mar2021. Got another Covid-19 booster. Was on a ventilator for 30 days last Aug2022 after catching Covid-19. Had adverse reactions to the first Covid shot. On 09Sep2021, he got the booster and the same thing happened with the foot. He ended up getting covid anyway and on 08Aug2022, the ambulance had to come get him. He couldn't keep any food down before the ambulance came to get him, not even water or crushed ice. When he got to the hospital, his electrolytes were very low, oxygen was low, kidneys were shutting down. He was lucky to be alive. Got the vaccine in his left arm at a hospital parking lot vaccine drive. Can't remember which arm the Dose was given in.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes, Blood electrolytes decreased, Cardiac stress test, Gait disturbance, Inappropriate schedule of product administration
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EM9809), in left arm and on 09Sep2021 as dose 2, single (Lot number: FF2588) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 08Aug2022, outcome "unknown" and all described as "Covid-19". The patient was hospitalized for drug ineffective (start date: 08Aug2022); for covid-19 (start date: 08Aug2022, hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Blood electrolytes: (unspecified date) Low, notes: electrolytes were very low; Oxygen saturation: (unspecified date) Low, notes: oxygen was low; SARS-CoV-2 test: (08Aug2022) Positive; Weight: (unspecified date) 152 lbs, notes: He went from 177lbs to 152lbs.  Clinical course: It was reported by the patients Wife that patient had a reaction to the serum on 25Mar2021. Got another Covid-19 booster. Was on a ventilator for 30 days last Aug2022 after catching Covid-19. Had adverse reactions to the first Covid shot. On 09Sep2021, he got the booster and the same thing happened with the foot. He ended up getting covid anyway and on 08Aug2022, the ambulance had to come get him. He couldn't keep any food down before the ambulance came to get him, not even water or crushed ice. When he got to the hospital, his electrolytes were very low, oxygen was low, kidneys were shutting down. He was lucky to be alive. Got the vaccine in his left arm at a hospital parking lot vaccine drive. Can't remember which arm the Dose was given in.