chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Seizure, Syncope
Clinical narrative: Fainted; Seizure; This is a spontaneous report received from a consumer.  A 16-year-old female patient received meningococcal serogroup B conjugate vaccine (TRUMENBA), in Jun2024 as dose number unknown, single (Lot number: HJ1516) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset Jun2024, outcome "unknown", described as "Fainted"; SEIZURE (medically significant) with onset Jun2024, outcome "unknown". The patient was getting Trumenba vaccine this was last week (Jun2024). The patient had fainted and had a seizure.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400191907 Same reporter, vaccine, and event; different patient;US-PFIZER INC-202400191908 Same reporter, vaccine, and event; different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from an Other HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28May2024 to 02Jun2024. Clinical course: Patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient had no Known allergies. Vaccination history included: comirnaty (2023-2024 formula) (DOSE NUMBER UNKNOWN, SINGLE, Anatomical location: left arm), administration date: 28Sep2023, when the patient was 60-year-old, for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "recovered" (2024); VACCINATION FAILURE (medically significant) with onset May2024, outcome "recovered" (2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 27May2024 to 31May2024.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Lot number: BT5236890) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 03Jun2024 to 08Jun2024.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted grade 2 COVID-19; contracted grade 2 COVID-19; This is a literature report.  An elderly patient (age range reported as 51-85 years old) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 07Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mantle cell lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Acalabrutinib for treatment-naive mantle cell lymphoma, notes: acalabrutinib when administered concomitantly with venetoclax and rituximab; Venetoclax for treatment-naive mantle cell lymphoma, notes: acalabrutinib when administered concomitantly with venetoclax and rituximab; Rituximab for treatment-naive mantle cell lymphoma, notes: acalabrutinib when administered concomitantly with venetoclax and rituximab. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 09Mar2022, outcome "recovered" (20Mar2022) and all described as "contracted grade 2 COVID-19".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Drug ineffective, COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202400193901 Same article/patient/drug and different dose/event;
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered a pentacel vaccine to a 4 month old patient today, but the vaccine used expired on the first of this month, 01jun2024 with no reported adverse event; Initial information received on 05-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] today, but the vaccine used expired on the first of this month, 01jun2024 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine and rotavirus vaccine both for Prophylactic vaccination.  On 05-Jun-2024, the patient received 0.5 ml once of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Powder and suspension for suspension for injection) (lot: UJ957AB; expiry date: 01-Jun-2024; strength: standard) but the vaccine used expired on the first of this month with no reported adverse event (expired product administered) (latency: same day) via unknown route in left thigh for Immunization.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: PENTACEL was administered in which only the diluent was given, dose was not reconstituted with the HIB component, with no reported adverse event; Initial information received on 11-Jun-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old female patient who diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] was administered in which only the diluent was given, dose was not reconstituted with the hib component, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine for Prophylactic vaccination.  On 10-May-2024, the patient received 0.5 ml dose 3 (Strength = standard) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Powder and suspension for suspension for injection (lot- UK039AA and expiration date- 30-Jun-2025) via intramuscular route in the left thigh (strength: not provided) for Immunisation (single component of a two-component product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV, IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: assistant gave a patient IPOL instead of a Hib vaccine (with no reported adverse event); Initial information received on 11-Jun-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves a 12 months old male patient who received Poliomyelitis Vaccine (Inactivated) (IPOL) IPV (VERO) instead of a hIB vaccine (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (hepatitis a), PCV 20 Vaccine, measles vaccine, mumps vaccine, rubella vaccine (mmr), varicella zoster vaccine all for prophylactic vaccination  On 11-Jun-2024, the patient received 0.5 ml (dose 3) of suspect IPV (VERO) Suspension for injection (lot number:  W1B511M) (Expiry date: 28-Sep-2025) (Strength: standard) (Frequency: once) via intramuscular route in the right thigh for immunization.  On 11-JUN-2024, the patient received Poliomyelitis Vaccine (Inactivated)) instead of a hIB vaccine (with no reported adverse event) (with no reported adverse event) (wrong product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired pentacel was mistakenly given to a 4 month old child with no reported adverse event; Initial information received on 11-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who received expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] was mistakenly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Powder and suspension for suspension for injection) (lot UJ957AB,Expiry date: 01-Jun-2024, strength was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization) and expired pentacel was mistakenly given to a 4 month old child with no reported adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was on 25 April 2024 and patient came back to receive 3rd dose of Engerix-B today on 04-JUN-2024; 2nd dose was on 25 April 2024 and patient came back to receive 3rd dose of Engerix-B today on 04-JUN-2024; 1st dose was on 6 November 2023, 2nd dose was on 25 April, 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received HBV (Engerix B) (batch number 4T39P, expiry date 09-DEC-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 06-NOV-2023).   On 25-APR-2024, the patient received the 2nd dose of Engerix B. On an unknown date, the patient did not receive the 3rd dose of Engerix B. On 25-APR-2024, an unknown time after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 1st dose was on 6 November 2023, 2nd dose was on 25 April, 2024). On an unknown date, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose was on 25 April 2024 and patient came back to receive 3rd dose of Engerix-B today on 04-JUN-2024) and circumstance or information capable of leading to medication error (Verbatim: 2nd dose was on 25 April 2024 and patient came back to receive 3rd dose of Engerix-B today on 04-JUN-2024). The outcome of the drug dose administration interval too long, drug dose administration interval too short and circumstance or information capable of leading to medication error were 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: 04-JUN-2024 The pharmacist reported that the patient received 2nd dose of Engerix-B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient was back to receive 3rd dose of Engerix-B today (on the reporting day), which led to which led to circumstance or information capable of leading to medication error and shortening of vaccination schedule. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure/ Customer developed shingles shortly after receiving the vaccine in 2020; Customer developed shingles shortly after receiving the vaccine in 2020; Customer reports she also developed Postherpetic neuralgia after developing shingles in 2020; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ Customer developed shingles shortly after receiving the vaccine in 2020) (serious criteria GSK medically significant), shingles (Verbatim: Customer developed shingles shortly after receiving the vaccine in 2020) and post herpetic neuralgia (Verbatim: Customer reports she also developed Postherpetic neuralgia after developing shingles in 2020). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUN-2024 and 10-JUN-2024. The patient reported received Shingrix in 2020. The patient developed shingles shortly after receiving the vaccine in 2020. The patient reported she also developed postherpetic neuralgia after developing shingles in 2020. The patient was vaccinated and still got shingles and at the time of reporting the patient had postherpetic neuralgia for past 2 years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow-up.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: EMPLOYEE MIXED KINRIX WITH MMRV THINKING THAT SHE WAS MIXING THE DILUENT
Age: 67.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Gait disturbance, Headache
Clinical narrative: Symptoms: very weak, very, very stiff (couldn?t hardly walk), nausea, diarrhea, sore throat, sinus draining, runny nose, aching, chilling, bad headache, slight fever.   I sent a message to my Dr on the portal and they called me today and said it was probably a reaction to the RSV vaccine.
Age: 67.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Oropharyngeal pain, Pain, Paranasal sinus hypersecretion
Clinical narrative: Symptoms: very weak, very, very stiff (couldn?t hardly walk), nausea, diarrhea, sore throat, sinus draining, runny nose, aching, chilling, bad headache, slight fever.   I sent a message to my Dr on the portal and they called me today and said it was probably a reaction to the RSV vaccine.
Age: 67.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Symptoms: very weak, very, very stiff (couldn?t hardly walk), nausea, diarrhea, sore throat, sinus draining, runny nose, aching, chilling, bad headache, slight fever.   I sent a message to my Dr on the portal and they called me today and said it was probably a reaction to the RSV vaccine.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal distension, Abdominal pain upper, Dehydration, Diarrhoea, Headache
Clinical narrative: Approximately 2 hours after vaccine administration patient experienced vaginal hemorrhaging to the point of bleeding through clothes and bed sheets every 3-4 hours. The patient also experienced very intense pain that would not subside with over the counter medications. The vaginal bleeding/hemorrhaging/pain continued for 6 days and started decrease at day 5. Patient also experienced lethargy, irritability, and headaches during the 6 days and continued for 2 weeks from date of vaccination. Patient then experienced severe diarrhea starting at day 7. She also experienced severe bloating and stomach pain followed by diarrhea lasting intermittently for 7 days after vaginal bleeding had subsided. Patient also states that her menstrual cycle has not returned since the vaccination. At the date of vaccination patient was on day 14 of her menstrual cycle which rules out normal menstrual cycle bleeding. Patient also states she is constantly dehydrated (possibly from blood/fluid loss)
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Irritability, Lethargy, Pain, Vaginal haemorrhage
Clinical narrative: Approximately 2 hours after vaccine administration patient experienced vaginal hemorrhaging to the point of bleeding through clothes and bed sheets every 3-4 hours. The patient also experienced very intense pain that would not subside with over the counter medications. The vaginal bleeding/hemorrhaging/pain continued for 6 days and started decrease at day 5. Patient also experienced lethargy, irritability, and headaches during the 6 days and continued for 2 weeks from date of vaccination. Patient then experienced severe diarrhea starting at day 7. She also experienced severe bloating and stomach pain followed by diarrhea lasting intermittently for 7 days after vaginal bleeding had subsided. Patient also states that her menstrual cycle has not returned since the vaccination. At the date of vaccination patient was on day 14 of her menstrual cycle which rules out normal menstrual cycle bleeding. Patient also states she is constantly dehydrated (possibly from blood/fluid loss)
Age: 67.0
Sex: F
Vaccine: PNC20, RSV, TDAP
Symptoms: Erythema, Headache, Peripheral swelling
Clinical narrative: Patient came to get vaccines, the pharmacist recommended 3 vaccine , Prevnar 20, Arexvy and Boostrix, on 6/10/24 and she came on 6/14/24 in the morning and showed her left arm with redness and little bit of swelling. patient said she experienced a little headache after the shots the next day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Chills, Dizziness, Dysarthria, Hangover
Clinical narrative: Per patient report: On the evening of 6/10/24, she felt chills and "feverish", temperature not checked.  Difficulty sleeping 6/10/24 night. 6/11/24 am dizziness and then an episode of diaphoresis and nausea, then an episode of  unconsciousness that resolved afterabout 1 minute.  06/12/24 word finding difficulty with some slurred speech, difficulty thinking with being unable to do "simple math", and tongue felt "a little stiff".  6/13/24 Pt reports feels like what she imagines feeling "slightly hungover" would feel like;    a couple of episodes today of eyes being blurry for "a brief second".   -Pt denies experiencing any pain, one sided weakness or numbness, facial drooping.  This RN recommended pt. have family drive her directly to ED for evaluation, pt. agreed to this plan.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Insomnia, Loss of consciousness, Mental impairment, Nausea
Clinical narrative: Per patient report: On the evening of 6/10/24, she felt chills and "feverish", temperature not checked.  Difficulty sleeping 6/10/24 night. 6/11/24 am dizziness and then an episode of diaphoresis and nausea, then an episode of  unconsciousness that resolved afterabout 1 minute.  06/12/24 word finding difficulty with some slurred speech, difficulty thinking with being unable to do "simple math", and tongue felt "a little stiff".  6/13/24 Pt reports feels like what she imagines feeling "slightly hungover" would feel like;    a couple of episodes today of eyes being blurry for "a brief second".   -Pt denies experiencing any pain, one sided weakness or numbness, facial drooping.  This RN recommended pt. have family drive her directly to ED for evaluation, pt. agreed to this plan.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Stiff tongue, Vision blurred
Clinical narrative: Per patient report: On the evening of 6/10/24, she felt chills and "feverish", temperature not checked.  Difficulty sleeping 6/10/24 night. 6/11/24 am dizziness and then an episode of diaphoresis and nausea, then an episode of  unconsciousness that resolved afterabout 1 minute.  06/12/24 word finding difficulty with some slurred speech, difficulty thinking with being unable to do "simple math", and tongue felt "a little stiff".  6/13/24 Pt reports feels like what she imagines feeling "slightly hungover" would feel like;    a couple of episodes today of eyes being blurry for "a brief second".   -Pt denies experiencing any pain, one sided weakness or numbness, facial drooping.  This RN recommended pt. have family drive her directly to ED for evaluation, pt. agreed to this plan.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site erythema, Injection site injury, Injection site swelling, Needle issue
Clinical narrative: Site was red and puffy, Parents reported part of the tip of the needle broke off in the injection site. Family was able to pull it out with tweezers. Looking better the next day per mother the bump was gone.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and fever
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Expired product administered, Lymphadenopathy
Clinical narrative: vaccine administered was past BUD (3/20/24) but before expiration date (8/30/24). Patient's mother reports that he has been experience pain in the armpit and enlarged lymph nodes, and they are reaching out to PCP about it.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Varicose vein
Clinical narrative: Significant fatigue and muscle aches starting a few hours after administration and consistently continued to today (06/14). This morning I experienced a dizzy spell and nearly fainted trying to retrieve toast from my oven. Later today I noticed about a quarter sized, bulging, varicose vein on top of my left hand which is concerning because I'm 27 y/o and that was never there before.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Fever, body aches, joint aches, pain at injection site, large red raised lump 3" diameter at injection site,  fatigue.  Lasting 5 days
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, body aches, joint aches, pain at injection site, large red raised lump 3" diameter at injection site,  fatigue.  Lasting 5 days
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: protective antibodies to only 5 out of 23 serotypes of streptococcus pneumonia post-vaccination;  This literature marketed report was received from the authors and refers to a male child patient of unknown age. The patient had a family history of Common variable immune deficiency (CVID), which was later diagnosed in him. The patient's historical conditions and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) as prophylaxis.  On an unspecified date (reported as post-vaccination), an protective antibody test showed that there were only 5 out of 23 serotypes of streptococcus pneumoniae (antibody test abnormal). At the reporting time, the outcome for the event of antibody test abnormal was unknown.  The authors considered the event of antibody test abnormal to be related to pneumococcal 23v polysaccharide vaccine (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  Lot# is being requested and will be submitted if received.  This is one of two cases received from the same literature article.; Sender's Comments:  US-009507513-2406USA005008:
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC; administered after temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported  On 04-JUN-2024, the patient was vaccinated with  the second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # X023403, expiration date: 03-APR-2025, oral  (strength and dose were not provided) for prophylaxis and a dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(V419) (0.5 ml) lot# U7801AA, expiration date: 30-JUN-2026 (dose, route and anatomical location were not provided) for prophylaxis.  It was reported that both vaccines were administered after temperature excursions (product storage error). The temperature excursion was of 48.4°F during a time frame of 58 minutes. There was no previous temperature excursión. No additional adverse events reported.  ; Sender Comments: Keywords : BP
Sex: U
Vaccine: RV5, UNK, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported vaccines were administered after temperature excursions.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-JUN-2024, the patient was vaccinated with improperly storage doses of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 0.5 milliliter, lot #U7801AA, expiration date: 30-JUN-2026, administered for prophylaxis (strength, and route of administration were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, vial 2 (units not provided), lot #X023403, expiration date: 03-APR-2025, administered orally for prophylaxis (strength was not provided) (Product storage error). Temperature excursion occurred at 48.4 F for 58 minutes. No previous temperature excursion reported. No additional adverse event reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sofia, reaction(s): "known allergies: Sofia", notes: known allergies: Sofia. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30May2024 to 04Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 includes paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 6.0
Sex: F
Vaccine: TYP
Symptoms: Erythema, Periorbital swelling
Clinical narrative: Patient developed a red bump underneath her left eye. Progressed into periorbital swelling limited to lower left eye. Event happened within 1-2 hours of vaccine administration.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Muscular weakness, Swelling
Clinical narrative: progressive erythema and swelling or right shoulder are, measuring up to 21X 16cm with associated pain. and distal arm weakness
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypersensitivity, Hypoaesthesia, Influenza virus test negative, Insomnia
Clinical narrative: Symptoms started 3/2/2023 -Rash on face, trunk, arms & legs; Fevers with normal temperature readings; Cramping & numbness/tingling/hypersensativity in feet/shins, hands/forearm; Arthralgias of hands/wrists, knees/ankles/feet & spine; swelling of ankles, knees, wrists, elbows; insomnia due to severe spinal/joint pain .
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Muscle spasms, Nausea, Paraesthesia, Rash
Clinical narrative: Symptoms started 3/2/2023 -Rash on face, trunk, arms & legs; Fevers with normal temperature readings; Cramping & numbness/tingling/hypersensativity in feet/shins, hands/forearm; Arthralgias of hands/wrists, knees/ankles/feet & spine; swelling of ankles, knees, wrists, elbows; insomnia due to severe spinal/joint pain .
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative, Spinal pain
Clinical narrative: Symptoms started 3/2/2023 -Rash on face, trunk, arms & legs; Fevers with normal temperature readings; Cramping & numbness/tingling/hypersensativity in feet/shins, hands/forearm; Arthralgias of hands/wrists, knees/ankles/feet & spine; swelling of ankles, knees, wrists, elbows; insomnia due to severe spinal/joint pain .
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test negative, Asthma, Bronchoscopy normal, Computerised tomogram head abnormal, Computerised tomogram thorax abnormal
Clinical narrative: Chronic cough developed Nov 2022, then sinus surgery for nasal polyps, pathology indicated high eosinophils, and this has morphed into eosinophilic asthma of unknown origin.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Eosinophil count increased, Nasal polyps, Pneumonitis, Polypectomy
Clinical narrative: Chronic cough developed Nov 2022, then sinus surgery for nasal polyps, pathology indicated high eosinophils, and this has morphed into eosinophilic asthma of unknown origin.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus disorder
Clinical narrative: Chronic cough developed Nov 2022, then sinus surgery for nasal polyps, pathology indicated high eosinophils, and this has morphed into eosinophilic asthma of unknown origin.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Lymphadenopathy, Rash, Swelling
Clinical narrative: Swollen glands in left armpit, rash above and below left armpit, swelling and bruising
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash
Clinical narrative: Pt had a break out of rash on his face that subsequently spread to his arms within 24 hours of receiving these vaccines.  The rash was typical of his atopic derm. He is on Dupixent every two weeks to control his atopic derm and had received it recentlyl
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV, COVID19-2, FLUX, RSV
Symptoms: Arthralgia, Blood test, Computerised tomogram, Coordination abnormal, Fatigue
Clinical narrative: 11/3/2023 Went to ER Hospital, with serious pain mainly in lower extremities. Sent home. 11/4/2023 admitted to Hospital, with excruciating pain and inability to stand. (Had had Spinal Laminectomy on 10/24/2023 at facility.)  Neruology team did x-rays, etc., and laminectomy looked good. Multiple MRIs and they could not determine a diagnosis, but considered Guillain Barre Syndrome so sent me to hospital neruology (they have an immunologist in their neurology group) for assessment) on 11/9/2023. By then I was losing my ability to coordinate my arms, my entire body was in severe, constant pain. They did multiple tests and diagnosed me with GBS when the nerves exiting my spinal column "lit up" and nerve conduction tests determined I had medical issues. On 11/16/2023 I was sent to Rehab Hospital in where I stayed until 12/23. I eventually with PT was able to walk and gained most of my other functions back. I still have nerve pain in my fingers, hands and wrists. I have numbness, tingling and pain in my feet, sometime shooting pain in my legs. I suffer from fatigue. Pain is more difficult at night.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV, COVID19-2, FLUX, RSV
Symptoms: Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging, Nerve conduction studies abnormal
Clinical narrative: 11/3/2023 Went to ER Hospital, with serious pain mainly in lower extremities. Sent home. 11/4/2023 admitted to Hospital, with excruciating pain and inability to stand. (Had had Spinal Laminectomy on 10/24/2023 at facility.)  Neruology team did x-rays, etc., and laminectomy looked good. Multiple MRIs and they could not determine a diagnosis, but considered Guillain Barre Syndrome so sent me to hospital neruology (they have an immunologist in their neurology group) for assessment) on 11/9/2023. By then I was losing my ability to coordinate my arms, my entire body was in severe, constant pain. They did multiple tests and diagnosed me with GBS when the nerves exiting my spinal column "lit up" and nerve conduction tests determined I had medical issues. On 11/16/2023 I was sent to Rehab Hospital in where I stayed until 12/23. I eventually with PT was able to walk and gained most of my other functions back. I still have nerve pain in my fingers, hands and wrists. I have numbness, tingling and pain in my feet, sometime shooting pain in my legs. I suffer from fatigue. Pain is more difficult at night.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV, COVID19-2, FLUX, RSV
Symptoms: Neuralgia, Pain, Pain in extremity, Paraesthesia, Spinal laminectomy
Clinical narrative: 11/3/2023 Went to ER Hospital, with serious pain mainly in lower extremities. Sent home. 11/4/2023 admitted to Hospital, with excruciating pain and inability to stand. (Had had Spinal Laminectomy on 10/24/2023 at facility.)  Neruology team did x-rays, etc., and laminectomy looked good. Multiple MRIs and they could not determine a diagnosis, but considered Guillain Barre Syndrome so sent me to hospital neruology (they have an immunologist in their neurology group) for assessment) on 11/9/2023. By then I was losing my ability to coordinate my arms, my entire body was in severe, constant pain. They did multiple tests and diagnosed me with GBS when the nerves exiting my spinal column "lit up" and nerve conduction tests determined I had medical issues. On 11/16/2023 I was sent to Rehab Hospital in where I stayed until 12/23. I eventually with PT was able to walk and gained most of my other functions back. I still have nerve pain in my fingers, hands and wrists. I have numbness, tingling and pain in my feet, sometime shooting pain in my legs. I suffer from fatigue. Pain is more difficult at night.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV, COVID19-2, FLUX, RSV
Symptoms: X-ray normal
Clinical narrative: 11/3/2023 Went to ER Hospital, with serious pain mainly in lower extremities. Sent home. 11/4/2023 admitted to Hospital, with excruciating pain and inability to stand. (Had had Spinal Laminectomy on 10/24/2023 at facility.)  Neruology team did x-rays, etc., and laminectomy looked good. Multiple MRIs and they could not determine a diagnosis, but considered Guillain Barre Syndrome so sent me to hospital neruology (they have an immunologist in their neurology group) for assessment) on 11/9/2023. By then I was losing my ability to coordinate my arms, my entire body was in severe, constant pain. They did multiple tests and diagnosed me with GBS when the nerves exiting my spinal column "lit up" and nerve conduction tests determined I had medical issues. On 11/16/2023 I was sent to Rehab Hospital in where I stayed until 12/23. I eventually with PT was able to walk and gained most of my other functions back. I still have nerve pain in my fingers, hands and wrists. I have numbness, tingling and pain in my feet, sometime shooting pain in my legs. I suffer from fatigue. Pain is more difficult at night.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV, COVID19-2, FLUX, RSV
Symptoms: Arthralgia, Blood test, Computerised tomogram, Coordination abnormal, Dysstasia
Clinical narrative: 11/3/2023 Went to ER Hospital, with serious pain mainly in lower extremities. Sent home. 11/4/2023 admitted to Hospital, with excruciating pain and inability to stand. (Had had Spinal Laminectomy on 10/24/2023 at facility.)  Neruology team did x-rays, etc., and laminectomy looked good. Multiple MRIs and they could not determine a diagnosis, but considered Guillain Barre Syndrome so sent me to hospital neruology (they have an immunologist in their neurology group) for assessment) on 11/9/2023. By then I was losing my ability to coordinate my arms, my entire body was in severe, constant pain. They did multiple tests and diagnosed me with GBS when the nerves exiting my spinal column "lit up" and nerve conduction tests determined I had medical issues. On 11/16/2023 I was sent to Rehab Hospital in where I stayed until 12/23. I eventually with PT was able to walk and gained most of my other functions back. I still have nerve pain in my fingers, hands and wrists. I have numbness, tingling and pain in my feet, sometime shooting pain in my legs. I suffer from fatigue. Pain is more difficult at night.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV, COVID19-2, FLUX, RSV
Symptoms: Fatigue, Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: 11/3/2023 Went to ER Hospital, with serious pain mainly in lower extremities. Sent home. 11/4/2023 admitted to Hospital, with excruciating pain and inability to stand. (Had had Spinal Laminectomy on 10/24/2023 at facility.)  Neruology team did x-rays, etc., and laminectomy looked good. Multiple MRIs and they could not determine a diagnosis, but considered Guillain Barre Syndrome so sent me to hospital neruology (they have an immunologist in their neurology group) for assessment) on 11/9/2023. By then I was losing my ability to coordinate my arms, my entire body was in severe, constant pain. They did multiple tests and diagnosed me with GBS when the nerves exiting my spinal column "lit up" and nerve conduction tests determined I had medical issues. On 11/16/2023 I was sent to Rehab Hospital in where I stayed until 12/23. I eventually with PT was able to walk and gained most of my other functions back. I still have nerve pain in my fingers, hands and wrists. I have numbness, tingling and pain in my feet, sometime shooting pain in my legs. I suffer from fatigue. Pain is more difficult at night.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV, COVID19-2, FLUX, RSV
Symptoms: Nerve conduction studies, Nerve conduction studies abnormal, Neuralgia, Pain, Pain in extremity
Clinical narrative: 11/3/2023 Went to ER Hospital, with serious pain mainly in lower extremities. Sent home. 11/4/2023 admitted to Hospital, with excruciating pain and inability to stand. (Had had Spinal Laminectomy on 10/24/2023 at facility.)  Neruology team did x-rays, etc., and laminectomy looked good. Multiple MRIs and they could not determine a diagnosis, but considered Guillain Barre Syndrome so sent me to hospital neruology (they have an immunologist in their neurology group) for assessment) on 11/9/2023. By then I was losing my ability to coordinate my arms, my entire body was in severe, constant pain. They did multiple tests and diagnosed me with GBS when the nerves exiting my spinal column "lit up" and nerve conduction tests determined I had medical issues. On 11/16/2023 I was sent to Rehab Hospital in where I stayed until 12/23. I eventually with PT was able to walk and gained most of my other functions back. I still have nerve pain in my fingers, hands and wrists. I have numbness, tingling and pain in my feet, sometime shooting pain in my legs. I suffer from fatigue. Pain is more difficult at night.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV, COVID19-2, FLUX, RSV
Symptoms: Paraesthesia, X-ray
Clinical narrative: 11/3/2023 Went to ER Hospital, with serious pain mainly in lower extremities. Sent home. 11/4/2023 admitted to Hospital, with excruciating pain and inability to stand. (Had had Spinal Laminectomy on 10/24/2023 at facility.)  Neruology team did x-rays, etc., and laminectomy looked good. Multiple MRIs and they could not determine a diagnosis, but considered Guillain Barre Syndrome so sent me to hospital neruology (they have an immunologist in their neurology group) for assessment) on 11/9/2023. By then I was losing my ability to coordinate my arms, my entire body was in severe, constant pain. They did multiple tests and diagnosed me with GBS when the nerves exiting my spinal column "lit up" and nerve conduction tests determined I had medical issues. On 11/16/2023 I was sent to Rehab Hospital in where I stayed until 12/23. I eventually with PT was able to walk and gained most of my other functions back. I still have nerve pain in my fingers, hands and wrists. I have numbness, tingling and pain in my feet, sometime shooting pain in my legs. I suffer from fatigue. Pain is more difficult at night.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Malaise, Myalgia, Pyrexia
Clinical narrative: Patient initially had normal and anticipated adverse reactions, such as fever, malaise, and myalgias. These have resolved within a couple of days, with soreness persisting. However, 4 days after vaccination, patient developed a red rash. The rash occurred on the left arm, approximately 4 to 6 inches below the injection site. It started as a red spot in the morning, which then became a square spot about 2x2 in in size by the evening of 06/14. By the morning of 06/15/2024, the rash elongated to about 6 inches horizontally by 2 inches vertically. Patient reported no pain or itching initially, but the site started to itch a day after its appearance. Another small pencil eraser sized spot appeared 06/15 right below the large spot. No pustules present, except red area. The area is on the same arm, but significantly below initial vaccination spot.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient initially had normal and anticipated adverse reactions, such as fever, malaise, and myalgias. These have resolved within a couple of days, with soreness persisting. However, 4 days after vaccination, patient developed a red rash. The rash occurred on the left arm, approximately 4 to 6 inches below the injection site. It started as a red spot in the morning, which then became a square spot about 2x2 in in size by the evening of 06/14. By the morning of 06/15/2024, the rash elongated to about 6 inches horizontally by 2 inches vertically. Patient reported no pain or itching initially, but the site started to itch a day after its appearance. Another small pencil eraser sized spot appeared 06/15 right below the large spot. No pustules present, except red area. The area is on the same arm, but significantly below initial vaccination spot.