chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Patient received Prevnar 20 vaccine on 04/10/2024 and states two days later developed redness of the arm around the site of the injection.  Presented back to the office on 04/17/2024 to have this addressed.  No fever or pain.  Advised by provider to use Benadryl prn for the mild prurtus.
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Fatigue, Heart rate increased, Myalgia, Pain
Clinical narrative: 37 weeks at time of vaccination. Felt fine for the following 12 hours. Progressively got more achy muscles and soreness. Extremely fatigued. Sore in whole body. Only hot water would help. Could not regulate my body temperature. Fever reached  to 101 before taking Tylenol. Heart rate would jump from 95 to 125 when going from sitting to laying down (measured with smart Watch). Or from laying down from one side to the other. Would have to focus on deep breathing to slow down heart rate. Symptoms ceased by the time I woke up at 9 am, April 17th. We called Hospital around 3 am to report symptoms and see if we need to come to the ER and they said they weren't familiar enough with the symptoms to know what to recommend and call my provider in the morning.
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: 37 weeks at time of vaccination. Felt fine for the following 12 hours. Progressively got more achy muscles and soreness. Extremely fatigued. Sore in whole body. Only hot water would help. Could not regulate my body temperature. Fever reached  to 101 before taking Tylenol. Heart rate would jump from 95 to 125 when going from sitting to laying down (measured with smart Watch). Or from laying down from one side to the other. Would have to focus on deep breathing to slow down heart rate. Symptoms ceased by the time I woke up at 9 am, April 17th. We called Hospital around 3 am to report symptoms and see if we need to come to the ER and they said they weren't familiar enough with the symptoms to know what to recommend and call my provider in the morning.
Age: 71.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: none
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: None reported by family
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Blood lead increased, Bloody discharge, Decreased appetite, Extra dose administered, Rhinorrhoea
Clinical narrative: Pt was accidently given MMRV instead of MMR vaccine. This wasn't found until report was ran resulting in finding out that pt received 2 doses of varicella on the same day.  3 days after vaccine pt started with intermittent bloody nasal discharge, runny nose, and low appetite. Was assessed for FU visit in clinic, but no one knew she had been given an extra vaccine dose. Pt Dx with URI.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Upper respiratory tract infection
Clinical narrative: Pt was accidently given MMRV instead of MMR vaccine. This wasn't found until report was ran resulting in finding out that pt received 2 doses of varicella on the same day.  3 days after vaccine pt started with intermittent bloody nasal discharge, runny nose, and low appetite. Was assessed for FU visit in clinic, but no one knew she had been given an extra vaccine dose. Pt Dx with URI.
Age: 65.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: none
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pustule, Injection site vesicles
Clinical narrative: Patient had two lesions with pus that resemble chicken pox to the site of injection
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have severe Tinittus
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: PT HAS A RED, RAISED, ITCHY AREA THAT IS 3 INCHES LONG AND 5 INCHES WIDE AT THE WIDEST POINT.
Age: 54.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 54 yr old received a dtap in plce of a tdap
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-MAR-2024, the patient received 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X024543, expiration date: 10-OCT-2025, for prophylaxis (strength, exact dose and route of administration were not provided) (Incorrect product storage). The vaccine was exposed to temperature excursion of -0.3 degrees Celsius for 4 hours 26 minutes. There was no previous temperature excursion. No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects reported; patient received less than required dose of MMR II; This spontaneous report was received from a Licensed Practical Nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported.   On 12-APR-2024, the patient was vaccinated with less than required dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.25 milliliter (unable to verify how much was administered, but reporter believed it to be about 0.25 ml; incorrect dose administered), lot #X014243, expiration date: 16-MAY-2025, administered for prophylaxis (strength, vaccination scheme, and route of administration were not provided). Concomitantly, on the same date during well child appointment, the patient was also vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and hepatitis a vaccine (+) inactivated (VAQTA).  No adverse events were reported.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: and the patient did not receive any additional doses; No other AE; This spontaneous report was received from pharmacist and refers to a 25-year-old patient with unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date (at age 11), the patient was vaccinated with the first and only dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). And the patient did not receive any additional doses (Incomplete course of vaccination). No other adverse events were reported (no adverse event).  Lot# is being requested and will be submitted if received.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Inbound call from nurse calling to report temperature excursion for PROQUAD.  HCP states that one dose was administered to a patient following the temperature excursion.  Confirmed no symptomatic adverse events were reported.  No other information at; This spontaneous report was received from a nurse referring to a 4-year-old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 12-APR-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, at a dose of 0.5 mL, once, for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number X024655 with an expiration date reported as 09-APR-2025; albumin status: rHA). The administered dose of the vaccine experienced a temperature excursion -11.6 degrees Celsius for 25 minutes. No data logger was implied. There was no adverse effect reported.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from a medical assistance concerning a 4-year-old female. Patient had private insurance. Facility was public clinic.   The patient's medical history, concurrent conditions and concomitant medication were not reported. Historical vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) and polio vaccine inact (IPV).   On 12-NOV-2020, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 04-JAN-2024, the patient was vaccinated with the second dose of improperly stored of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered in the left vastus lateralis (LVL) subcutaneously for prophylaxis (lot number W025567 has been verified to be valid, expiration date not reported but upon internal validation established as 14-AUG-2024) (albumin status recombinant human albumin). No adverse event reported.   This is one of the several cases created from the same source.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Dose of Jynneos was given intramuscularly; Case reference number US-BN-2024-000616 is a spontaneous case report initially received from nurse  (reference number: BN_2024_01409) on 11-Mar-2024 and concerns a patient of unspecified age or gender.  The patient's medical history and concomitant medications were not provided.  On an unknown date, the patient received dose of Jynneos (batch number: unknown), intramuscularly, at an unknown dose or site administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos.  Need for significant correction identified on 22-Mar-2024, for the information received on 11-Mar-2024: event 'Product administration error' removed.; Reporter's Comments: A patient of unspecified age or gender received dose of Jynneos, intramuscularly, at an unknown dose or site administration, for unknown indication which is considered as product administration error and inappropriate route of vaccination. Product administration error and incorrect route of product administration are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. Product administration error and incorrect route of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age or gender received dose of Jynneos, intramuscularly, at an unknown dose or site administration, for unknown indication which is considered as product administration error and inappropriate route of vaccination. Product administration error and incorrect route of product administration are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. Product administration error and incorrect route of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.
Age: 23.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient was administered an intramuscular dose of Jynneos instead of subcutaneously; Case reference number US-BN-2024-000673 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV24-0562) on 25-Mar-2024 and concerns a male patient born in 14-Jun-2000.  The patient's medical history and concomitant medication details were not provided.  On 25-Mar-2024, the patient was vaccinated with the first dose of Jynneos (batch number: FDP00016, expiry date: 31-Oct-2024) at an unknown dose, via intramuscular use and unknown site of administration, for unknown indication (explicitly coded as inappropriate route of vaccination').  At the time of the initial report, it was unknown whether the patient experienced any adverse event due to Jynneos.  No further information was provided.; Reporter's Comments: A male patient was vaccinated with the first dose of Jynneos at an unknown dose, via intramuscular use and unknown site of administration, for unknown indication, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of administration is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate route of administration is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A male patient was vaccinated with the first dose of Jynneos at an unknown dose, via intramuscular use and unknown site of administration, for unknown indication, which is considered as inappropriate route of vaccination. No associated adverse events were reported. Inappropriate route of administration is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate route of administration is not related to Jynneos, but to a human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product administration error, Product preparation error, Underdose
Clinical narrative: The Jynneos vaccine was mixed with 0.5 mL of sterile diluent and administered to the patient as 50 percent of the vaccine; The Jynneos vaccine was mixed with 0.5 mL of sterile diluent and administered to the patient as 50 percent of the vaccine; The Jynneos vaccine was mixed with 0.5 mL of sterile diluent and administered to the patient as 50 percent of the vaccine; Case reference number US-BN-2024-001733 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV24-0590) on 28-Mar-2024 and concerns a 20-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 25-Mar-2024, the patient received the first dose of Jynneos (batch number: unknown), at a dose stated as 50 percent of the vaccine, reported as mixed with 0.5 mL of sterile diluent, subcutaneously, at unknown site of administration, for unknown indication (explicitly coded as 'product preparation error', 'vaccine underdose' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos.  Non-significant case correction received from other health care professional via Med Communication on 01-Apr-2024 included an additional reference number.; Reporter's Comments: A 20-year-old male patient received the first dose of Jynneos vaccine, at a dose stated as 50 percent of the vaccine, reported as mixed with 0.5 mL of sterile diluent, subcutaneously, at unknown site of administration, for an unknown indication, which is considered as product preparation error, underdose and product administration error. No associated adverse events were reported. Product preparation error, underdose and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product preparation error, underdose and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A 20-year-old male patient received the first dose of Jynneos vaccine, at a dose stated as 50 percent of the vaccine, reported as mixed with 0.5 mL of sterile diluent, subcutaneously, at unknown site of administration, for an unknown indication, which is considered as product preparation error, underdose and product administration error. No associated adverse events were reported. Product preparation error, underdose and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product preparation error, underdose and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain, Pyrexia
Clinical narrative: He is feverish; Very achy; given a shingles shot after already having had the suggested dosages; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (unknown dose received on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: He is feverish), pain (Verbatim: Very achy) and extra dose administered (Verbatim: given a shingles shot after already having had the suggested dosages). The outcome of the fever and pain were not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingles vaccine.     It was unknown if the company considered the fever and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-APR-2024 The reporter was a patient's friend. The patient received shingles vaccine after already having had the suggested dosages, which led to extra dose administered.  The reporter wanted to know was there concern with getting too much. The patient was feverish and very achy. The reporter asked for the advise. This US2024042667 case has been linked to the case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024042667:Same reporter/Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: achiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (Prior vaccination with one dose shingles vaccine at age 55) and Shingrix with an associated reaction of pain (1st dose received 3 to 4 years ago for tolerance of 1st dose refer case US2024042667).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: achiness). Rechallenge with Shingrix was positive. The outcome of the pain was resolved.   The reporter considered the pain to be related to Shingrix.     The company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:US2024042667   Additional Information: GSK Receipt Date: 04-APR-2024 The reporter self reported the case.  The patient received dose of Shingrix about 3 to 4 years ago.  The patient experienced achiness the dose, which was resolved.  The patient attributed the achiness to the vaccination.   No further information was provided. The reporter did not consent to follow-up. The reporter did not wanted to provide the doctor of Medicine contact information. This case had been link with US2024AMR043917, reported by the same reporter but different patient.; Sender's Comments:  US-GSK-US2024AMR043917:Same reporter/Different patient US-GSK-US2024042667:Same patient/Dose 1
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: red area where I got the vaccine; painful area where I got the vaccine; hot area where I got the vaccine; This non-serious case was reported by a consumer and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-APR-2024, the patient received Shingrix. In APR-2024, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: red area where I got the vaccine), injection site pain (Verbatim: painful area where I got the vaccine) and injection site warmth (Verbatim: hot area where I got the vaccine). The outcome of the injection site erythema, injection site pain and injection site warmth were not reported.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2024 The patient self reported this case. The patient had a red hot painful area where he/she got the vaccine 2 days ago from the reporting date. No other symptoms were reported. The reporter asked whether it was normal.
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: lock disconnected while administering the vaccine to a patient and the medication spilled out onto the exam table; leur lock disconnected while administering the vaccine; prepared vaccines of HIBERIX disconnected from the luer lock syringe; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 2-month-old patient who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental underdose (Verbatim: lock disconnected while administering the vaccine to a patient and the medication spilled out onto the exam table), syringe connection issue (Verbatim: leur lock disconnected while administering the vaccine) and pharmaceutical product complaint (Verbatim: prepared vaccines of HIBERIX disconnected from the luer lock syringe). The outcome of the accidental underdose, syringe connection issue and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 04-APR-2024 The other health profession reported that the 3 different prepared vaccines of Hiberix disconnected from the luer lock syringe. The reported that one event the leur lock disconnected while administered vaccine to a patient and medication spilled out onto the exam table, which led to the accidental underdose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia, Burning sensation, COVID-19, Fatigue
Clinical narrative: had a burning,; red rash on the tip of her nose; fatigued and tired lately; lost sense of smell; lost sense of smell/taste; COVID test and was positive; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of smell in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma. Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received Shingrix. In MAR-2024, less than 2 months after receiving Shingrix, the patient experienced loss of smell (Verbatim: lost sense of smell), taste absent (Verbatim: lost sense of smell/taste) and covid-19 (Verbatim: COVID test and was positive). On an unknown date, the patient experienced burning sensation (Verbatim: had a burning,), red rash (Verbatim: red rash on the tip of her nose) and fatigue (Verbatim: fatigued and tired lately). The patient was treated with diclofenac sodium (Anti-Inflammatory). The outcome of the loss of smell and taste absent were unknown and the outcome of the covid-19, burning sensation, red rash and fatigue were not resolved.   It was unknown if the reporter considered the loss of smell, taste absent, covid-19, burning sensation, red rash and fatigue to be related to Shingrix.     It was unknown if the company considered the loss of smell, taste absent, covid-19, burning sensation, red rash and fatigue to be related to Shingrix.   Additional Information: GSK Receipt date: 04-APR-2024 The patient self-reported. She received Covid shot 4 months ago and Shingrix about 2 months ago because she wanted to space them out and she did not remember the exact dates.  She stated about 7 days ago she lost her sense of smell and taste and did a home Covid test and was positive.  Her health care professional (HCP) ordered Covid medication and anti-inflammatory medicine because she had a history of asthma.  She stated that she also had a burning, red rash on the tip of her nose, she asks if it could be shingles, and she also stated that she had been fatigued and tired lately.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, SARS-CoV-2 test positive
Clinical narrative: had a burning,; red rash on the tip of her nose; fatigued and tired lately; lost sense of smell; lost sense of smell/taste; COVID test and was positive; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of smell in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma. Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received Shingrix. In MAR-2024, less than 2 months after receiving Shingrix, the patient experienced loss of smell (Verbatim: lost sense of smell), taste absent (Verbatim: lost sense of smell/taste) and covid-19 (Verbatim: COVID test and was positive). On an unknown date, the patient experienced burning sensation (Verbatim: had a burning,), red rash (Verbatim: red rash on the tip of her nose) and fatigue (Verbatim: fatigued and tired lately). The patient was treated with diclofenac sodium (Anti-Inflammatory). The outcome of the loss of smell and taste absent were unknown and the outcome of the covid-19, burning sensation, red rash and fatigue were not resolved.   It was unknown if the reporter considered the loss of smell, taste absent, covid-19, burning sensation, red rash and fatigue to be related to Shingrix.     It was unknown if the company considered the loss of smell, taste absent, covid-19, burning sensation, red rash and fatigue to be related to Shingrix.   Additional Information: GSK Receipt date: 04-APR-2024 The patient self-reported. She received Covid shot 4 months ago and Shingrix about 2 months ago because she wanted to space them out and she did not remember the exact dates.  She stated about 7 days ago she lost her sense of smell and taste and did a home Covid test and was positive.  Her health care professional (HCP) ordered Covid medication and anti-inflammatory medicine because she had a history of asthma.  She stated that she also had a burning, red rash on the tip of her nose, she asks if it could be shingles, and she also stated that she had been fatigued and tired lately.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient did not recived 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix on 25-SEP-2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Patient did not recived 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-APR-2024  The pharmacist reported that patient had received first dose of Twinrix vaccine and just came back today on the day of reporting and requested to the second dose.  The pharmacist would like to know if the patient needs to restart series and what the timing of doses should be. The reporter reported that at the time of call, he has not yet administered the second dose. The pharmacist did not have the lot number, expiration date and information of the first dose. Till the time of reporting patient did not receive 2nd dose which led to, incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter consent the follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered a dose of Twinrix that was expired; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 03-APR-2024, the patient received Twinrix. On 03-APR-2024, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Twinrix that was expired). 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: 04-APR-2024 The pharmacist stated he was contacted by staff who stated they administered a dose of Twinrix that was expired.   The reporter believed the dose was given on 3rd April 2024 which had expiration date of 22nd September 2023 which led to expired vaccine used. At the time of call, the Pharmacist did not have any patient details. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: 18 year old patient the Engerix 20 mcg adult dose.; inadvertently gave an 18 year old patient the Engerix 20 mcg adult dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 18-year-old male patient who received HBV (Engerix B adult) (batch number xs27b, expiry date 17-MAR-2025) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (HEPLISAV B).   On 30-MAR-2024, the patient received the 2nd dose of Engerix B adult 20 ug. On 30-MAR-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: 18 year old patient the Engerix 20 mcg adult dose.) and accidental overdose (Verbatim: inadvertently gave an 18 year old patient the Engerix 20 mcg adult dose). The outcome of the adult product administered to child and accidental overdose 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-APR-2024 The patient received the Heplisav B previous to this one first dose administration January 20th 2024.  The reporter asked did he had to still complete with another dose of Engerix then if he had Heplisav and Engerix. The reporter reported they inadvertently gave an 18 year old patient the Engerix 20 mcg adult dose on March 30th 2024 which led to adult product administered to child and accidental overdose. The reporter called to inquired how to proceeds, was there any ill effects they might receive from getting the higher dose. The heath care professional declined follow-up from Safety Warm transfer for further assistance. The Vaccine Administration Facility was the same as primary reporter. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient administered pediatric dose of Engerix-B; adult patient administered pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient administered pediatric dose of Engerix-B) and adult use of a child product (Verbatim: adult patient administered pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product 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: 05-APR-2024 The reporter reported that a adult patient administered pediatric dose of Engerix B, which led to underdose and adult use of a child product. The reporter did not had any details on the patient yet, she was waiting on informatics team to finish record search. The reporter said that the dose was given sometime between OCT-2023 to DEC-2023. The vaccine administration facility was the same as primary reporter. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024043623:Same reporter / different patient US-GSK-US2024043624:Same reporter/ diffrerent patient
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: she accidentally gave a pediatric dose of Havrix to a 19 year old patient; she accidentally gave a pediatric dose of Havrix to a 19 year old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 19-year-old male patient who received HAV (Havrix 720) (batch number ZYX23, expiry date 10-FEB-2025) for prophylaxis.   On 09-APR-2024, the patient received the 2nd dose of Havrix 720. On 09-APR-2024, an unknown time after receiving Havrix 720, the patient experienced accidental underdose (Verbatim: she accidentally gave a pediatric dose of Havrix to a 19 year old patient) and adult use of a child product (Verbatim: she accidentally gave a pediatric dose of Havrix to a 19 year old patient). The outcome of the accidental underdose and adult use of a child product 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: 09-APR-2024 The reporter stated that she accidentally gave a pediatric dose of Havrix to a 19 year old patient, which led to accidental underdose and adult use of a child product. The Vaccine Administration Facility was the same as Primary Reporter. The lot number provided by the health care professional not identify as a valid GSK vaccine.  The reporter consented to follow up via postal.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: CARDIAC ARREST; This solicited report received from a patient via social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced cardiac arrest (Dose number in series 1). On an unspecified date, the patient died from cardiac arrest. My brother was no longer with us because of that thing. Patient passed away after going into cardiac arrest 3 times.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and cardiac arrest was not related.  This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: This report concerns to a male patient of unspecified age, who died due to cardiac arrest unspecified duration after administration of COVID-19 vaccine ad26.cov2.s (Dose number in series 1) for prophylactic vaccination. Patients past medical history or concurrent conditions were reported. Details on events preceding death, investigation, treatment details not provided. Based on the available information, it is not possible to establish a reasonable causal relationship between the event of cardiac arrest and study vaccine, Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related. Further details requested.; Reported Cause(s) of Death: CARDIAC ARREST
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Chills, Cough, Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia; Low grade fever (pyrexia); Chills; Fatigue; Runny nose; Coughing; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of RHINORRHOEA (Runny nose), COUGH (Coughing), MYALGIA (Myalgia), PYREXIA (Low grade fever (pyrexia)) and CHILLS (Chills) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Prophylactic vaccination.    Concomitant products included ROSUVASTATIN and OMEPRAZOLE for an unknown indication.   In November 2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) (unknown route) 1 dosage form. On 30-Nov-2023, the patient experienced RHINORRHOEA (Runny nose) and COUGH (Coughing). On 30-Nov-2023 at 7:00 AM, the patient experienced MYALGIA (Myalgia), PYREXIA (Low grade fever (pyrexia)), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) from 30-Nov-2023 to 02-Dec-2023 for Fever and Myalgia, at a dose of UNK UNK, prn. On 03-Dec-2023, MYALGIA (Myalgia), PYREXIA (Low grade fever (pyrexia)), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, RHINORRHOEA (Runny nose) and COUGH (Coughing) was resolving.            It was not reported if the patient received a corrective treatment for the events of runny nose, coughing, chills and fatigue.  The patient received a 1 dosage form of suspect influenza quadrivial A-B vaccine, suspension for injection (strength, expiry date was unknown).
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Myalgia; Low grade fever (pyrexia); Chills; Fatigue; Runny nose; Coughing; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of RHINORRHOEA (Runny nose), COUGH (Coughing), MYALGIA (Myalgia), PYREXIA (Low grade fever (pyrexia)) and CHILLS (Chills) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Prophylactic vaccination.    Concomitant products included ROSUVASTATIN and OMEPRAZOLE for an unknown indication.   In November 2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) (unknown route) 1 dosage form. On 30-Nov-2023, the patient experienced RHINORRHOEA (Runny nose) and COUGH (Coughing). On 30-Nov-2023 at 7:00 AM, the patient experienced MYALGIA (Myalgia), PYREXIA (Low grade fever (pyrexia)), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) from 30-Nov-2023 to 02-Dec-2023 for Fever and Myalgia, at a dose of UNK UNK, prn. On 03-Dec-2023, MYALGIA (Myalgia), PYREXIA (Low grade fever (pyrexia)), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, RHINORRHOEA (Runny nose) and COUGH (Coughing) was resolving.            It was not reported if the patient received a corrective treatment for the events of runny nose, coughing, chills and fatigue.  The patient received a 1 dosage form of suspect influenza quadrivial A-B vaccine, suspension for injection (strength, expiry date was unknown).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: increased heart rate; weird blood pressure symptoms/blood pressure issues; pain in area of leg; standing up he would feel light headed; blood clot/The blood clot was in lower calf on the left side; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: SJ8757) at the age of 22 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Broken leg as kid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number:EW0172), administration date: 29Apr2021, when the patient was 21-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number:EW0167, Anatomical Location:right arm), administration date: 20May2021, when the patient was 21-year-old, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 2024, outcome "recovered with sequelae" (2024), described as "blood clot/The blood clot was in lower calf on the left side"; HEART RATE INCREASED (non-serious), outcome "not recovered", described as "increased heart rate"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "recovering", described as "weird blood pressure symptoms/blood pressure issues"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in area of leg"; DIZZINESS (non-serious), outcome "recovering", described as "standing up he would feel light headed". The events "blood clot/the blood clot was in lower calf on the left side", "increased heart rate", "weird blood pressure symptoms/blood pressure issues", "pain in area of leg" and "standing up he would feel light headed" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Abnormal; Heart rate: increased; Ultrasound scan: Blood clot resolved; Unknown results. Therapeutic measures were taken as a result of thrombosis. Clinical course: It was reported that patient got couple doses, Clarified as the 2 initial doses and one booster. However, lately he was having weird blood pressure symptoms. He explained he would be go from sitting to standing up and also his heart rate increases a lot. It was a lot of different and weird symptoms. He has been experiencing some strange heart increased heart rate since about 6 month ago and then he got a blood clot recently got on a blood clot and got rid of the blood clot. He later added he also had a blood clot. Clarified this occurred two and half months ago. He had to get  another ultrasound it showed it was resolved. It resolved about a month ago. However, dos not have the specific date
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: increased heart rate; weird blood pressure symptoms/blood pressure issues; pain in area of leg; standing up he would feel light headed; blood clot/The blood clot was in lower calf on the left side; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: SJ8757) at the age of 22 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Broken leg as kid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number:EW0172), administration date: 29Apr2021, when the patient was 21-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number:EW0167, Anatomical Location:right arm), administration date: 20May2021, when the patient was 21-year-old, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 2024, outcome "recovered with sequelae" (2024), described as "blood clot/The blood clot was in lower calf on the left side"; HEART RATE INCREASED (non-serious), outcome "not recovered", described as "increased heart rate"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "recovering", described as "weird blood pressure symptoms/blood pressure issues"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in area of leg"; DIZZINESS (non-serious), outcome "recovering", described as "standing up he would feel light headed". The events "blood clot/the blood clot was in lower calf on the left side", "increased heart rate", "weird blood pressure symptoms/blood pressure issues", "pain in area of leg" and "standing up he would feel light headed" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Abnormal; Heart rate: increased; Ultrasound scan: Blood clot resolved; Unknown results. Therapeutic measures were taken as a result of thrombosis. Clinical course: It was reported that patient got couple doses, Clarified as the 2 initial doses and one booster. However, lately he was having weird blood pressure symptoms. He explained he would be go from sitting to standing up and also his heart rate increases a lot. It was a lot of different and weird symptoms. He has been experiencing some strange heart increased heart rate since about 6 month ago and then he got a blood clot recently got on a blood clot and got rid of the blood clot. He later added he also had a blood clot. Clarified this occurred two and half months ago. He had to get  another ultrasound it showed it was resolved. It resolved about a month ago. However, dos not have the specific date
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: We both have had covid 3 times. The 1st time was 02Aug2021/Drug ineffective; We both have had covid 3 times. The 1st time was 02Aug2021/Suspected COVID-19; This is a spontaneous report and received from Consumer or other non HCPs.  A 71-year-old male patient received BNT162b2 (COMIRNATY), on 22Jan2021 as dose 1, single (Lot number: FL3302) and on 12Feb2021 as dose 2, single (Lot number: EL9263, Expiration Date: 31May2021) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 02Aug2021, outcome "unknown", described as "We both have had covid 3 times. The 1st time was 02Aug2021/Drug ineffective"; SUSPECTED COVID-19 (medically significant) with onset 02Aug2021, outcome "unknown", described as "We both have had covid 3 times. The 1st time was 02Aug2021/Suspected COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included with monoclonal antibody.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400049964 Same reporter, product, AE different patient;US-PFIZER INC-202400053122 Same reporter, Patient, different doses and events;