chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This patient was given Pfizer COVID vaccine for those 12 and older while he was 6 years old. Mother states no know adverse reactions after receiving. This is a vaccine administration error.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: After administering the vaccine there was a discrepancy concerning whether this immunization was the second or the third vaccine in the series.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pain
Clinical narrative: HEADACHE, BODYACHE, DIZINESS, AND  NAUSEA
Age: 28.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Administration to patient greater than 12 years of age; This spontaneous report was received from a nurse and refers to a 28-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 23-APR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (0.5 milliliter, lot #W030845 was not valid but expiration date was reported as 07-JUL-2025, route of administration and anatomical location were not provided) for prophylaxis (Product administered to patient of inappropriate age). Nurse reported no symptoms or side effects at this time (No adverse event). No additional AE details available. No additional AE reported. No PQC.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported.; Caller reported AE on behalf of a patient who was administered improperly stored VARIVAX on 4/27/2024.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 27-APR-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/dose, lot #X017490, expiration date: 25-JUN-2025, administered for prophylaxis (strength, frequency, route of administration and anatomical location were not provided) that was improperly stored.  The vaccine was stored at a temperature from 14 to 46 degrees Fahrenheit (18.5 F) for a duration of 53 hours and 28 minutes. There was no previous temperature excursion.  No symptoms were reported.  This is one of several cases from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reporting temperature excursion and a dose was administered.; No additional AE; 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 an unknown date, the patient was vaccinated with an improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #2014790, which had been confirmed to be a valid lot number, expiration date reported and confirmed as 22-APR-2026, administered for prophylaxis (strength, dose, route of administration, and anatomical location were not provided). The temperature excursion was reported as 10.76 degree Fahrenheit (F) for 13 hours 50 minutes and 10.69 F for 8 hours 21 minutes (product storage error). No previous temperature excursion was reported. No additional adverse event (AE) (no adverse event) or additional information provided.
Age: 1.83
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Pharmacist calling on behalf of HCP to report an expired dose of MMRII was inadvertently administered to a 22-month-old patient; This spontaneous report was received from a pharmacist and refers to a 22-month-old patient of unknow gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 01-MAY-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, expiration date: 15-APR-2024, administered for prophylaxis (strength, dose, frequency, lot #, route of administration and anatomical location were not provided).  No adverse events reported.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported VAQTA was administered after a temperature excursion to patient. Date of administration: 17-APR-2024.; This spontaneous report has been received from other health professional referring a male patient of an unknown age.  The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 17-APR-2024, he was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once, administered as prophylaxis (strength, dose, route and anatomical location of administration were not provided; lot # reported as X025482, which is a valid lot # for this vaccine, expiration date provided and validated to be on 12-APR-2025) after a temperature excursion (product storage error). The temperature of the vaccine administered was reported as 32.9 degree Fahrenheit (F) during a time frame of 3 hours 18 minutes. There were not previous temperature excursions reported. No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported VAQTA was administered after a temperature excursion to patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided  On 16-APR-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, dose frequency: reported as once, lot #X025482, expiration date: 12-APR-2025, administered for prophylaxis (strength, frequency, route of administration and anatomical location were not provided) that underwent a temperature excursion.  The vaccine reached a temperature of 32.9 degrees Fahrenheit for a time frame of 3 hours 18 minutes. There was no previous temperature excursion.  No adverse events were reported.
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Crying, Electric shock sensation, Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; Nerve pain; Crying; electrical lightening bolt; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis and Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis.   On an unknown date, the patient received Shingrix, COVID-19 vaccine and Zostavax. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), post herpetic neuralgia (Verbatim: Nerve pain), crying (Verbatim: Crying) and electric shock sensation (Verbatim: electrical lightening bolt). The outcome of the vaccination failure was unknown and the outcome of the shingles, post herpetic neuralgia, crying and electric shock sensation were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, crying and electric shock sensation to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia, crying and electric shock sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2024 The case was received from the patient via interactive digital media. The reporter was patient and reported that shingles feels like an electrical lightning bolt was going through you. The nerve pain was the absolute worst. The pain was at like a 20 even with zostavax at age 55 and Shingrix vaccine. He/she contracted this after getting a covid booster shot. The pain was so bad he/she was crying. Never want this again and if you get it take Tegretol or neurotin to stop or decrease the nerve pain. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Sensory disturbance, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; Hurt; Itched; Felt like something was stabbing me inside; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Hurt), pruritus (Verbatim: Itched) and feeling abnormal (Verbatim: Felt like something was stabbing me inside). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving and the outcome of the pain, pruritus and feeling abnormal were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, pruritus and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-APR-2024 This case was reported by a patient via interactive digital media. The patient had the chicken pox and  had the shingles shots but the patient was just now getting over another case of shingles. It didn't sting but they sure itched. It also started inside the body on one of the intestines.  That one hurt.  The patient felt like something was stabbing inside.  The follow-up could not be possible as no contact details were available.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2021) and Shingrix (received 2nd dose in January 2021 or February 2021).   On 17-APR-2024, the patient received the 3rd dose of Shingrix. On 17-APR-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 29-APR-2024 The patient received 3rd dose of Shingrix which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Influenza like illness
Clinical narrative: sick day on Tuesday; flu like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick day on Tuesday) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the sickness and influenza-like symptoms were not reported.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the sickness and influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-APR-2024 This case was reported by a patient via interactive digital media. The patient got his/her first dose on Monday and had to take a sick day on Tuesday.  The patient said not saying not to do it, but be prepared for flu like symptoms for about 24 hours after vaccination The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I was covered with Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2024, the patient received Shingles vaccine. In APR-2024, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I was covered with Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-APR-2024 This case was reported the patient via interactive digital media. The patient got Shingles shot last week and in the morning was covered with Shingles.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Incorrect route of product administration, Injection site discharge
Clinical narrative: When he retracted the needle, some fluid came out of injection site; he believes the dose may have been administered subcutaneously; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site leaking in a 51-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 22-APR-2024, the patient received Boostrix (subcutaneous). On 22-APR-2024, immediately after receiving Boostrix, the patient experienced injection site leaking (Verbatim: When he retracted the needle, some fluid came out of injection site) and intramuscular formulation administered by other route (Verbatim: he believes the dose may have been administered subcutaneously). The outcome of the injection site leaking was not reported and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site leaking to be related to Boostrix.     It was unknown if the company considered the injection site leaking to be related to Boostrix.   Additional Information: GSK Receipt Date: 23-APR-2024 The nurse reports that he was administering a dose of Boostrix to a large sized patient, so he used a 1.5 inch needle, but did not go in all the way, when he retracted the needle, some fluid came out of injection site, so he believed the dose might had been administered subcutaneously, which led to intramuscular formulation administered by other route. At the time of reporting, dose had not been repeated. The vaccine administration facility was the same as primary reporter.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 5 month old was administered Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number T343T, expiry date 25-JAN-2025) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 5 month old was administered Kinrix). The outcome of the inappropriate age at vaccine administration 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: 24-APR-2024 The pediatric nurse practitioner reported that a 5-month-old patient was administered Kinrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pediarix dtap/ipv/hebB/polio, it expired on the 15th April but a nurse accidentally gave it on the 17th April; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number BZ24H, expiry date 15-APR-2024) for prophylaxis.   On 17-APR-2024, the patient received Pediarix. On 17-APR-2024, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix dtap/ipv/hebB/polio, it expired on the 15th April but a nurse accidentally gave it on the 17th April). The outcome of the expired vaccine used 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: 24-APR-2024 The nurse practitioner reported that she had the Pediarix (dtap or ipv or hebB or polio) and was expired on the 15th of April 2024 but a nurse accidentally gave it to the patient, and did not had any reactions to the vaccine like no negative reactions at all or anything like that. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: 1 powder vial of Shingrix in the fridge, indicating one patient received only the adjuvant portion at some point; one patient received only the adjuvant portion at some point; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 4RX2T, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: 1 powder vial of Shingrix in the fridge, indicating one patient received only the adjuvant portion at some point) and inappropriate dose of vaccine administered (Verbatim: one patient received only the adjuvant portion at some point). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-APR-2024 The pharmacist stated they recently discovered there was only 1 powder vial of Shingrix in the fridge, indicating that one patient received only the adjuvant portion at some point, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  They administered 5 Shingrix vaccines so far, and for all of those patients it was indicated in the system that they received the reconstituted vaccine. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Possibility of extra doses being administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 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 extra dose administered (Verbatim: Possibility of extra doses being administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 24-APR-2024 A healthcare professional contacted GSK to solicit information about the possibility of administering extra doses of Shingrix in a patient who did not recall administering a previous dose. An adverse event case was filed since the status was unknown and the amount of vaccines was unknown. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; 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 72-year-old male patient who received HBV (Engerix B) (batch number YY37B, expiry date 24-AUG-2026) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 07-SEP-2023).   On 25-APR-2024, the patient received the 2nd dose of Engerix B. On 25-APR-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long 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: 25-APR-2024 The pharmacist explained a patient did not follow the schedule for Engerix-B and received the 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. Pharmacist did not have lot number or expiration date for first dose. The reporter consent to follow up.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was administered a dose of Kinrix instead of separate DTaP and IPV; 1 year old male patient was administered a dose of Kinrix; Kinrix was the patient's 3rd DTaP dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 19-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 23-APR-2024, the patient received the 3rd dose of Kinrix. On 23-APR-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Patient was administered a dose of Kinrix instead of separate DTaP and IPV), inappropriate age at vaccine administration (Verbatim: 1 year old male patient was administered a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was the patient's 3rd DTaP dose). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 25-Apr-2024 The reporter was a director of nursing. The reporter reported that the 1 year old patient was administered a dose of Kinrix instead of separate DTaP and IPV, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter stated that the Kinrix was the patient's 3rd DTaP dose, which led to inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter. This case was 1 of 3 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024053397:Same reporetr/Diffrent patient US-GSK-US2024053392:Same reporetr/Diffrent patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 07 April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 25-APR-2024 The reporter was the son of the patient. The patient received the first dose of Shingrix on April 7, 2023, and never received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024053393:Same reporter / different patient US-GSK-US2024053398:Same reporter / different patient
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: the administration of an expired Kinrix dose to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   In APR-2024, the patient received Kinrix. In APR-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: the administration of an expired Kinrix dose to a patient). The outcome of the expired vaccine used 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: 26-APR-2024 The healthcare professional called to report the administration of an expired Kinrix dose to a patient which led to expired vaccine used. The healthcare professional wanted to confirm if the vaccine was good to use until the end of the month. The reporter did not provide patient information.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Illness
Clinical narrative: I got very sick last week from vaccine; I got a really bad reaction; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got very sick last week from vaccine) and ADVERSE DRUG REACTION (I got a really bad reaction) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got very sick last week from vaccine) and ADVERSE DRUG REACTION (I got a really bad reaction). At the time of the report, ILLNESS (I got very sick last week from vaccine) had not resolved and ADVERSE DRUG REACTION (I got a really bad reaction) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The reporter stated, she was a person who's involved in Lyme disease study. She got bitten by a tick and they told her to not alert anyone to that and they owe her money. It was also reported that she did not want them to have her information anymore. She was not gonna bear with Moderna anymore been through enough. She got very sick last week from vaccine, and they don't pay her for 200 bucks. She got a bad reaction, and they think it's all funny. Everything was loosey goosey there on vacation like she was tired of it.  The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood bilirubin abnormal, Fatigue, Jaundice
Clinical narrative: Jaundice; Bilirubin was 4; Extreme fatigue; This is a spontaneous report received from a nurse.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2022 as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Unknown. There were no concomitant medications. Vaccination history included: Pfizer BioNTech (DOSE 1 (reported as Dec2022)), administration date: 2022, for COVID-19 immunization. The following information was reported: BLOOD BILIRUBIN ABNORMAL (non-serious) with onset Dec2022, outcome "recovered", described as "Bilirubin was 4"; FATIGUE (non-serious) with onset Dec2022, outcome "recovered", described as "Extreme fatigue"; JAUNDICE (non-serious) with onset Dec2022, outcome "recovered". The events "jaundice", "bilirubin was 4" and "extreme fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of jaundice, blood bilirubin abnormal, fatigue.  Additional Information: No other vaccine was administered in four weeks. The patient experienced jaundice, bilirubin was 4, and extreme fatigue. The patient was never hospitalized. It took two months for symptoms to resolve.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Post-acute COVID-19 syndrome
Clinical narrative: interchange of vaccine product; when caller caught COVID; when caller caught COVID; Long COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 43-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty, for COVID-19 immunisation. The following information was reported: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset Dec2022, outcome "unknown", described as "Long COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "interchange of vaccine product"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "when caller caught COVID".  Clinical course: Patient is on either  7th or 8th COVID shot, but one time caller got Moderna COVID shot, and when caller got that one, that is when caller caught COVID, caller stated caller is never going to switch again. Confirmed caller having long COVID was after getting the Pfizer COVID vaccines and the one Moderna COVID vaccine. Caller got all of the vaccines on time.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 24Apr2024 to 28Apr2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine
Clinical narrative: dizziness; migraines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient 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 and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown"; MIGRAINE (non-serious), outcome "unknown", described as "migraines".  Additional information: The patient called in for herself as she would like to get some assistance for Nurtec. Patient said she is having migraines and dizziness as a result of covid booster. The caller said the prescription is over a thousand dollars and even with insurance her co-pay is extremely high.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: I have been at the emergency room seven or eight times with heart problems.; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 79-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 1, 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: CARDIAC DISORDER (hospitalization, medically significant), outcome "unknown", described as "I have been at the emergency room seven or eight times with heart problems.". The event "i have been at the emergency room seven or eight times with heart problems." required emergency room visit.  Clinical course: The reporter stated that Two years ago my wife and I got the first vaccine recommended by your Company and the Government. Since then I have been at the emergency room seven or eight times with heart problems. My health situation is not getting better.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 59.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: vaccine had already been reconstituted and administered using sterile water, not the saline solution with no reported AE; Initial information received on 24-Apr-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 59 years old male patient where yellow fever vaccine - us [YF-Vax] vaccine had already been reconstituted and administered using sterile water, not the saline solution with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Jan-2024, the patient received a dose of suspect yellow fever vaccine - Solution for injection (lot- UJ819AA and expiration date- 18-Apr-2024) via unknown route in unknown administration site (dose and strength: not provided) for Immunisation (product preparation error) (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.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Gestational hypertension
Clinical narrative: Gestational hypertension;   This is a non-interventional study report and received from Other HCPs for protocol.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Feb2024 as dose number unknown, 120 ug single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Gestational hypertension", start date: Apr2024, stop date: Apr2024, notes: Pertinent Details: Gestational hypertension diagnosed during third trimester; "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient was 32 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 39 weeks pregnant at the event onset. Concomitant medication(s) included: SERTRALINE oral taken for depression, anxiety. The following information was reported: GESTATIONAL HYPERTENSION (non-serious) with onset Apr2024, outcome "recovered" (Apr2024). Clinical course: An adult pregnant individual who received the Abrysvo vaccine at 32 weeks developed subsequent gestational hypertension (diagnosed April 2024 at 39 weeks)  The investigator considered there was not a reasonable possibility that the event gestational hypertension was related to concomitant drugs.  The reporter's assessment of the causal relationship of "gestational hypertension" with the suspect product(s) rsv vaccine prot.subunit pref 2v was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Based on the information currently provided, the company considers there is not a reasonable possibility that the event gestational hypertension is related to the study vaccine. The event is triggered by pregnancy associated with subject underlying predisposing factors
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Guillain-Barre syndrome, Pain, Postural orthostatic tachycardia syndrome
Clinical narrative: GBS; pots; constant pain; unable to walk; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 OMI XBB.1.5), as dose 1, 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "GBS"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "pots"; PAIN (non-serious), outcome "unknown", described as "constant pain". Additional information: the patient stated, "Hi yes my name is (name withheld). I received the Covid19 vaccine and developed GBS pots and other medical issues. My medical care team has deemed it from the Pfizer COVID-19 vaccine. GPS was not on the list of possibilities of symptoms. My life has taken a turn from the worst. I am in constant pain, unable to work and my credit debt is skyrocketing. I am also in huge medical debt. I would like to come to an agreement with y'all without having to get lawyers involved. Please get back to me."
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Laboratory test normal, Palpitations
Clinical narrative: Lightheaded, dizzy, chest pain, racing heart
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Rash
Clinical narrative: Patient presented with rash on upper chest, upper back, face, and ears approximately 20-30 minutes after administration of vaccines.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Ischaemic stroke, Magnetic resonance imaging, Scan, Transient global amnesia
Clinical narrative: Ischemic Stroke, leading to TGA.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 5/4/24 and was accidentally given to patient on 5/6/24. No adverse signs or symptoms noted.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Auditory disorder, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Paraesthesia
Clinical narrative: My patient experienced a Vasovagal response to vaccination of MMR and Boostrix. Both shots were given in the same arm at least an inch apart. The patient immediately voiced that she could feel the medication going through her arm and was feeling a tingling sensation running down her arm. After a few moments she said she was feeling very lightheaded and thought she might faint. I asked if she needed some cold water but she asked for a cold rag instead. She was sweating and still feeling dizzy at this point. She said she might need to lie down but did not at that time. The technician brought us wet paper towels immediately then went and got ice water and candy from the the breakroom. She complained that it felt like noise was sounding like she was going through a tunnel. At this point she said she really needed to lie down. I helped her safely to the ground and put my lab coat down to act as a pillow. She never loss consciousness but laid there for about 10 minutes. She had not eaten that day and had some anxiety about getting shots. We had already given her some candy to help give her a quick boost and I had the technician bring some peanut butter crackers as well. She said she was feeling much better and wanted to sit up. We sat together for a few more minutes I remained with her the whole time she felt lightheaded. I could tell by how she was talking that she was feeling better. She stayed for 10-15 minutes after she sat up before leaving the store on her own.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Presyncope, Sensory disturbance
Clinical narrative: My patient experienced a Vasovagal response to vaccination of MMR and Boostrix. Both shots were given in the same arm at least an inch apart. The patient immediately voiced that she could feel the medication going through her arm and was feeling a tingling sensation running down her arm. After a few moments she said she was feeling very lightheaded and thought she might faint. I asked if she needed some cold water but she asked for a cold rag instead. She was sweating and still feeling dizzy at this point. She said she might need to lie down but did not at that time. The technician brought us wet paper towels immediately then went and got ice water and candy from the the breakroom. She complained that it felt like noise was sounding like she was going through a tunnel. At this point she said she really needed to lie down. I helped her safely to the ground and put my lab coat down to act as a pillow. She never loss consciousness but laid there for about 10 minutes. She had not eaten that day and had some anxiety about getting shots. We had already given her some candy to help give her a quick boost and I had the technician bring some peanut butter crackers as well. She said she was feeling much better and wanted to sit up. We sat together for a few more minutes I remained with her the whole time she felt lightheaded. I could tell by how she was talking that she was feeling better. She stayed for 10-15 minutes after she sat up before leaving the store on her own.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RED, WARM SWELLED AREA ON THE SITE WHERE THE VACCIN WAS GIVEN. THE AREA IS ABOUT 6 INCHES OVALE-SHAPED.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Discomfort, Mobility decreased, Neck pain
Clinical narrative: Severe and persistent shoulder pain lasting over a week and moved through to back and neck, heaviness and loss of range of movement
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Cellulitis, Injection site streaking, Skin reaction
Clinical narrative: Localized skin reaction - now turned cellulitic - mother tried topical steroid without help- now streaking down arm
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Pain, Pyrexia, Tachycardia
Clinical narrative: Extreme fatigue, extreme tachycardia, fever, aches and chills
Age: 32.0
Sex: M
Vaccine: CHIK
Symptoms: Arthralgia, Back pain, Joint injury, Myalgia
Clinical narrative: Myalgia; back pain; joint pain in shoulders, right elbow, knees, pain strongest in knuckle of right ring finger
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site, soreness, fatigue, temperature 99.4
Age: 34.0
Sex: F
Vaccine: HEPAB, HPV9
Symptoms: Dry skin, Erythema, Pruritus, Skin exfoliation
Clinical narrative: A few hours after vaccination, patient started feeling itching below her right nostril and on top of the lips. She started to scratch. The skin at the right nostril turned red and peeling. It is 5 days since the vaccination, the skin of on the corner of nostril appeared red and dried and peeling. Patient will observed for a few days and will call md if it doesn't get better.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Adverse reaction
Clinical narrative: patient took benadryl and tylenol and rxns resolved
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Back pain, Blood test, Chest pain
Clinical narrative: Cold flu, pain in back, aniexty, short of breathe, couldn?t sleep, weak, chest pains.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Influenza, Nasopharyngitis, Pericardial effusion, Pleural effusion
Clinical narrative: Cold flu, pain in back, aniexty, short of breathe, couldn?t sleep, weak, chest pains.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: Cold flu, pain in back, aniexty, short of breathe, couldn?t sleep, weak, chest pains.
Age: 68.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Magnetic resonance imaging, Pain, Pain in extremity, X-ray
Clinical narrative: Pain down the arm that has not gone away. gone to a orthopedic MD, PT continues to have problems with pain with use of arm.
Age: 0.67
Sex: F
Vaccine: FLU4, PNC15
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administration error
Clinical narrative: No adverse reaction noted. PCV15 was given in error and too early for the 4th dose.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Condition aggravated, Electrocardiogram, Exercise tolerance decreased
Clinical narrative: He got his vaccine, he usually walks up to 3 miles a day and after 1 ½ miles he turned around, when he got back at the end of the walk he could see the end point and could not stop his legs, was glassy eyed and fell down to try and stop himself and he fell and bumped his head.  A couple of days later he called and saw his doctor, he had 2 MRI's, 2 EKG's and some other tests through a program he went through.  He was confirmed to have a light stroke.  He has slowly declined and used to be able to use a cane, but now has to use a walker.  He no longer drives as he cannot see, and he sold his truck.  He did call Pfizer and they sent him some papers to fille out, which he did and they continued to send him paperwork, which he did not fill out.  He continues to see a neurologist, and sees one every 6 months, and has slowly used the loss of his legs and has neuropathy really bad, and asked for something to ease his pain.  He had a bleeding ulcer in the past and is unable to take antiinflammatories but is going to prescribe Gabapentin.   He has fallen a couple of times and fallen and had to go to the ER.  He had a very light case of neuropathy prior to the vaccine, and it has now tripled since then.  He is no longer to walk very much.