chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RAB
Symptoms: Product dose omission issue, Vomiting
Clinical narrative: Third dose of RabAvert was not administered because the patient was throwing up; Third dose of RabAvert was not administered; Case reference number US-BN-2022-002333 is a spontaneous case report initially received on 09-Sep-2022 from a health care professional via Communication (reference number: USBAV22-1332) and concerns a 15-year-old patient.  The patient's relevant medical history and concomitant medications were not reported.  On 02-Sep-2022, the patient was vaccinated with first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: unknown) administered at an unreported dose, unknown route, or anatomical site for post exposure for rabies.   On 05-Sep-2022, three days after the first dose, the patient was vaccinated with second dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: unknown) administered at an unreported dose, unknown route, or anatomical site.  On unspecified date, the patient experienced vomiting, which is why the third dose was delayed (explicitly coded as 'Missed dose').  Additional information received on 09-Sep-2022 included local case ID.; Reporter's Comments: A 15-year-old patient experienced vomiting, which is why the third dose of RabAvert was delayed and that is considered as missed dose, unknown time after the patient was vaccinated with the first dose (administered at an unreported dose, unknown route, or anatomical site for post exposure for rabies) and second dose of RabAvert (administered at an unreported dose, unknown route, or anatomical site). Vomiting is listed according to guidelines for RabAvert and product dose omission issue is considered listed per company convention. The outcome was unknown. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Product dose omission is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 15-year-old patient experienced vomiting, which is why the third dose of RabAvert was delayed and that is considered as missed dose, unknown time after the patient was vaccinated with the first dose (administered at an unreported dose, unknown route, or anatomical site for post exposure for rabies) and second dose of RabAvert (administered at an unreported dose, unknown route, or anatomical site). Vomiting is listed according to guidelines for RabAvert and product dose omission issue is considered listed per company convention. The outcome was unknown. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Product dose omission is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Booster dose missed, Product dose omission issue
Clinical narrative: The patient supposed to have the fourth dose of RabAvert on 29-Sep-2022; The patient supposed to have the fourth dose of RabAvert on 29-Sep-2022; Case reference number US-BN-2022-003831 is a spontaneous case report initially received on 30-Sep-2022 from a pharmacist (reference number: USBAV22-1585) and concerns 66-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 15-Sep-2022, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP); batch number: YRBA841A) at a dose of 1 ml, administered intramuscularly at an unknown site of administration for post-exposure immunisation against rabies.  On 18-Sep-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: YRBA841A) at a dose of 1 ml, administered intramuscularly at an unknown site of administration.  On 22-Sep-2022, seven days after the first dose, the patient as vaccinated with the third dose of RabAvert (batch number: YRBA841A) at a dose of 1 ml, administered intramuscularly at an unknown site of administration.  On 29-Sep-2022, 14 days after the first dose, the patient supposed to have the fourth dose of RabAvert (explicitly coded as 'booster dose missed' and 'missed dose').  At the time of this report, it was unknown if the patient experienced any adverse event due to RabAvert.   Additional information received from Bavarian Nordic on 03-Oct-2022 included local case ID.; Reporter's Comments: A 66-year-old female patient received three post-exposure RabAvert doses, 1 ml each, administered intramuscularly, on days 0, 3 and 7. On day 14, the patient was supposed to receive the fourth dose, but it was missed (which is considered booster dose missed and product dose omission issue). Booster dose missed and product dose omission issue are considered listed per company convention. No associated adverse events were reported. The patient's medical history and concomitant medications were unknown. Booster dose missed and product dose omission issue are considered not related to RabAvert, but to human factor. The case is non-serious.; Sender's Comments: A 66-year-old female patient received three post-exposure RabAvert doses, 1 ml each, administered intramuscularly, on days 0, 3 and 7. On day 14, the patient was supposed to receive the fourth dose, but it was missed (which is considered booster dose missed and product dose omission issue). Booster dose missed and product dose omission issue are considered listed per company convention. No associated adverse events were reported. The patient's medical history and concomitant medications were unknown. Booster dose missed and product dose omission issue are considered not related to RabAvert, but to human factor. The case is non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was coming three days late for the third vaccination dose; Case reference number US-BN-2022-003918 is a spontaneous case report initially received from a consumer (reference number: USBAV22-1638) on 06-Oct-2022 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 12-SEP-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) batch number not provided) at unknow dosage, at an unknown site of administration for post-exposure treatment to rabies and for unknown indication.  On 15-Sep-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number not provided) at unknow dosage, at an unknown site of administration.  On 22-Sep-2022, ten days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch number not provided) at unknow dosage, at an unknown site of administration (explicitly coded as ' Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown whether the patient experienced any adverse events due to RabAvert vaccination, nor if the patient received the fourth dose.  No additional information was provided.  Non-significant case correction performed for information received from Bavarian Nordic on 06-Oct-2022 to include the local case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the third dose of RabAvert (second dose was administered three days after the first dose) at unknow dosage and site of administration, ten days after the first dose which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse events due to RabAvert vaccination, nor if the patient received the fourth dose. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the third dose of RabAvert (second dose was administered three days after the first dose) at unknow dosage and site of administration, ten days after the first dose which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse events due to RabAvert vaccination, nor if the patient received the fourth dose. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: Patient who received first dose on 9/28/22 was unable to return to clinic until today; Case reference number US-BN-2022-004216 is a spontaneous case initially received on 20-Oct-2022 from health care professional via Communication (reference number: USBAV22-1745) and concerns a female patient of unknown age.  The patient's relevant medical history, allergies and concomitant medications were not provided.  On 28-Sep-2022, the patient was vaccinated with a first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: unknown), at an unknown dose, unknown route of administration, at an unknown location, for pre-exposure prophylaxis for veterinary assisting classes.   As reported, the patient was unable to return to clinic in order to receive second dose of RabAvert in seven days (explicitly coded as 'Missed dose').  At the time of this report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received on 20-Oct-2022 included local case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert vaccine on 28-Sep-22. Dose, route and site of administration were unknown, but vaccine was administered for pre-exposure prophylaxis for veterinary assisting classes. Reportedly, the patient was unable to return to clinic in order to receive the second dose of RabAvert in seven days which is considered missed dose. The event is listed per the Company conventions. The patient's relevant medical history, allergies and concomitant medications were not provided. It was unknown if the patient experienced any adverse events. Missed dose is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert vaccine on 28-Sep-22. Dose, route and site of administration were unknown, but vaccine was administered for pre-exposure prophylaxis for veterinary assisting classes. Reportedly, the patient was unable to return to clinic in order to receive the second dose of RabAvert in seven days which is considered missed dose. The event is listed per the Company conventions. The patient's relevant medical history, allergies and concomitant medications were not provided. It was unknown if the patient experienced any adverse events. Missed dose is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of RabAvert was administered four days after the first dose; Case reference number US-BN-2022-004671, is a spontaneous case report initially received from a nurse (reference number: USBAV22-1952) on a 14-Nov-2022 and concerns a 24-year-old male patient.   The patient's medical history was not provided.   *The patient's concomitant medication were Motrin (ibuprofen) and Tylenol (paracetamol)*.   As reported, the patient was healthy.  On 10-Nov-2022, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP); batch number: YRBA841A), at a dose 1 mL, administered intramuscularly, *into left deltoid* and for pre-exposure rabies immunization.  On 14-Nov-2022, four days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: YRBA841A), at a dose 1 mL, administered intramuscularly, *into right deltoid* and for pre-exposure rabies immunization (explicitly coded as 'inappropriate schedule of vaccine administered').  *The patient did not experience any adverse events. *  *The reporter assessed the event as non-serious and non-related. *   Additional information received from Bavarian Nordic on 14-Nov-2022 included the local case ID.  All follow-up information's' are blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from nurse on 17-Nov-2022 included patient's date of birth and concomitant medication's, vaccine details: date of vaccination, anatomical site location for first and second dose of RabAvert vaccine and seriousness.; Reporter's Comments: A 24-year-old male patient was vaccinated with the second dose of RabAvert four days after the first dose for pre-exposure rabies immunization, which is considered as inappropriate schedule of vaccine administered. 1 mL dose was applied intramuscularly into the right deltoid. The patient did not experience any adverse events. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 24-year-old male patient was vaccinated with the second dose of RabAvert four days after the first dose for pre-exposure rabies immunization, which is considered as inappropriate schedule of vaccine administered. 1 mL dose was applied intramuscularly into the right deltoid. The patient did not experience any adverse events. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: The patient did not receive the second dose of RabAvert; Case reference number US-BN-2022-004969 is a spontaneous case initially received from other health professional via Communication (reference number: USBAV22-2199) on 28-Dec-2022 and concerns a female patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On 29-Nov-2022, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown) at an unknown dose, route or site of administration for rabies pre-exposure prophylaxis (rabies immunisation).  On an unspecified date, reported as 'on day 28', the patient thought was supposed to come for a second dose of RabAvert (batch number: unknown), however, the patient did not receive the second dose (explicitly coded as 'missed dose').  At the time of this report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received on 28-Dec-2022 included confirmation that the patient did not receive the second dose of RabAvert.  Additional information received on 29-Dec-2022 included local case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert, at an unknown dose, route or site of administration for rabies pre exposure prophylaxis. 28 days after the first dose, the patient was supposed to come for a second dose of RabAvert, however, the patient did not receive the second dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert, at an unknown dose, route or site of administration for rabies pre exposure prophylaxis. 28 days after the first dose, the patient was supposed to come for a second dose of RabAvert, however, the patient did not receive the second dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Limb injury
Clinical narrative: One of the patient's arms was injured; Case reference number US-BN-2023-000194 is a spontaneous case report initially received from other health care professional via Communication (reference number: USBAV23-0208) on 06-Feb-2023 and concerns a female patient of unknown age.  The patient's relevant medical history and concomitant medication details were not provided.  On unspecified dates, the patient was vaccinated with the first, second dose and third dose of RabAvert vaccine (rabies virus (inactivated, strain flury lep) (pcec); batch number: not provided) at an unknown dose, site or route of administration for rabies pre or post prophylaxis.   On an unspecified date, an unknown amount of time after the first dose of RabAvert, the patient experienced injury on one of the arms.   At the time of the initial report, the outcome of the event 'limb injury' was unknown.   The reporter did not provide seriousness or causality assessment.   Additional information received on 07-Feb-2023 included local case ID.; Reporter's Comments: A female patient of unknown age experienced a non-serious event of injury on one of the arms, on an unspecified date, an unknown amount of time after the patient was vaccinated with the first, second dose and third dose of RabAvert vaccine, at an unknown dose, site or route of administration for rabies pre or post prophylaxis. Limb injury is unlisted for RabAvert according to the guidelines. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the event, limb injury has been considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age experienced a non-serious event of injury on one of the arms, on an unspecified date, an unknown amount of time after the patient was vaccinated with the first, second dose and third dose of RabAvert vaccine, at an unknown dose, site or route of administration for rabies pre or post prophylaxis. Limb injury is unlisted for RabAvert according to the guidelines. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the event, limb injury has been considered as related to RabAvert. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received first dose of Rabipur on 21-Dec-2021 and no additional doses since then; Case reference number US-BN-2023-000274 is a spontaneous case report initially received from a nurse via Communication (reference number: USBAV23-0257) on 14-Feb-2023 and concerns an elderly female patient born in 1943.  The patient's relevant medical history and concomitant medication details were not provided.  On 01-Dec-2021, the patient was vaccinated with the first dose of RabAvert (batch number: ARBA911C), administered intramuscularly at a dose of 1 mL, at an unknown site of administration for pre-exposure rabies, and didn't receive any additional doses since then (explicitly coded as 'incomplete course of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received on 14-Feb-2023 included local case ID.; Reporter's Comments: An elderly female patient born in 1943 was vaccinated with the first dose of RabAvert in Dec-2021, administered intramuscularly at a dose of 1 mL, at an unknown site of administration for pre-exposure rabies, and didn't receive any additional doses since then, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: An elderly female patient born in 1943 was vaccinated with the first dose of RabAvert in Dec-2021, administered intramuscularly at a dose of 1 mL, at an unknown site of administration for pre-exposure rabies, and didn't receive any additional doses since then, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; severe pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 73-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles at the age of 20). Concurrent medical conditions included decreased immune responsiveness.   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) and pain (Verbatim: severe pain). The patient was treated with gabapentin and ibuprofen. The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUN-2023. This case was reported by a patient via interactive digital media. The reporter reported that age plays a factor in possibly getting shingles due to weakened immune system.  The patient had shingles when he/she was 20.  Now patient had inward shingle no rash, but severe pain in patient case.  The patient age was 73 years. The patient got shingles after taking the shots this year.  They had spread all over patient abdomen. Each outbreak was worse than the last.  The patient just went today to doctor.  The doctor prescribed a medication patient had never heard of, increased gabapentin and ibuprofen 800mg hope it all helps.  The patient think shingles were strange in that they come and go so quickly.  The patient think it was not fun. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-Jun-2023 This case was reported the patient via interactive digital media. The patient got the shot and two years later, got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hyperhidrosis, Hypersomnia, Impaired work ability, Pyrexia
Clinical narrative: Fever; sweat; felt very tired; This non-serious case was reported by a consumer and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anxiety, diabetes, hot flush and heart rate. Concomitant products included metoprolol, venlafaxine hydrochloride (Effexor), omeprazole (Prilosec), semaglutide (Ozempic) and metformin.   On 26-JUN-2023 08:30, the patient received Shingrix (left arm). On 26-JUN-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Fever), sweating (Verbatim: sweat) and tiredness (Verbatim: felt very tired). On 27-JUN-2023, the outcome of the fever was resolved (duration 1 day). The outcome of the sweating and tiredness were resolved.   The reporter considered the fever to be related to Shingrix. It was unknown if the reporter considered the sweating and tiredness to be related to Shingrix.     The company considered the fever to be related to Shingrix. It was unknown if the company considered the sweating and tiredness to be related to Shingrix.   Additional Information: GSK receipt date: 26-JUN-2023 This report was submitted via the online direct entry reporting system. The patient got the Shingrix Vaccine on Monday and ran a low grade fever until 2 am on 27th June 2023.  The highest was documented with forehead thermometer was 100 Fahrenheit.   However patient did sweat through all the bedding while sleeping so it was possible that it ran higher at some point.   The patient also felt very tired and slept for about 16 hours waking up only to go to the bathroom and had a few short conversations with family.  The patient had to take a sick day for half day on Monday and half day on Tuesday to recover. The reporter consented to follow up
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypotension
Clinical narrative: HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Urticaria
Clinical narrative: Hives about 2 hours after vaccine administration
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Induration, Nausea
Clinical narrative: welt that grew in size daily, hot in touch, arm sore for days, hard ball still after 2 weeks, nausea, diarrhea, loss of appetite, fatigue
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Skin warm, Urticaria
Clinical narrative: welt that grew in size daily, hot in touch, arm sore for days, hard ball still after 2 weeks, nausea, diarrhea, loss of appetite, fatigue
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Tremor
Clinical narrative: Patient presented rash and tremor in the hands upon arriving home after vaccination. Mother bought him PO BENADRYL and he is taking it every 6 hrs. Yesterday he stopped taking it and the rash returned. Consulted with the Pediatrician who indicated to continue treatment for two more days. Recommended visiting the ER if symptoms worsen.
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Feeling abnormal, Nausea, Pyrexia
Clinical narrative: Donor reported that he had a fever and nausea as well as what he described as " A spacey feeling" the day after his immunization at the donation center. He stated that his symptoms lasted 4 days and he did not report this information to us until 06/27/2023. Donor on this date reported that he was free from all symptoms and an internal donor adverse report was initiated.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema
Clinical narrative: After vaccines given, MA checked pt and she  noted  patient to have redness on r thigh. Ma then went to get provider and when provider entered patient room , she  noticed that left thigh also had redness. PA placed ice packs to area and monitored pt .   Pt continued with redness and was released by provider.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 3/1/21 lot# 010A21A; Moderna 4/2/21 lot# 018B21A;  Moderna 12/20/21 lot# 066H21A
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 10/14/21 Lot# FF2590;  Pfizer 9/24/22 lot# GH969
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired Covid vaccine on 4/3/2023. This health facility was notified that the expired vaccine was given on 6/20/2023. Pfizer and the Health State Department were both notified. Pfizer advised that the vaccine was still fine and should not result in any adverse outcomes since it was given within a 7 day expiration window. This facility did attempt to contact the patient to let them know that an expired Covid vaccine was given in April but this facility has been unable to reach the patient. No adverse reactions have been reported. This health facility will complete continuing education for nurses to double check expiration dates on vaccines.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Shock
Clinical narrative: SHOCK, UNSPECIFIED
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Moderna 3/8/21 lot# 037K20A;  Moderna 4/9/21 lot# 027L20A
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Pfizer 4/14/21 lot# Ew0162;  Pfizer 5/6/21 lot# EW0164;
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was given Hep A when the vaccination schedule calls for a Hep B. No reports of adverse effects. Pt will need to receive his Hep B at next visit to meet the recommendations.
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test negative, Wrong product administered
Clinical narrative: patient was given shingrix instead of varicella vaccine; This non-serious case was reported by a physician and described the occurrence of wrong vaccine administered in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: patient was given shingrix instead of varicella vaccine). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date 29 Jun 2023. The patient was given shingrix instead of varicella vaccine. The patient had not had shingrix vaccine. In reviewing the patient's medical history the provider asked if the patient had ever had chicken pox and the patient said he didn't know. HCP decided to get titers (even though did not necessarily have it. In the meantime the patient went to the pharmacy and while at the pharmacy got vaccinated with Shingrix. Titer levels came back low or negative and provider instructed the patient to get varicella vaccination instead of Shingrix, and patient told HCP that he had already gotten Shingrix. In speaking with the HCP he felt like this patient was varicella naive and should have gotten varicella vaccination instead of Shingrix. Although this patient was not immunocompromised, so it could have been assumed that the patient had previous exposure to varicella since they are 55 yrs of age, and were not immunocompromised.  The patient was given shingrix instead of varicella vaccine which led to wrong vaccine administered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Moderna 7/28/21 lot# 059E21A;  Moderna 8/25/21 lot# 062E21A
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Patient was expecting to get Moderna Vaccine
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines MOderna 2/28/21 lot# 004M20a;  Pfizer 12/13/21 lot# FE3594
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Patient was expecting to receive Moderna vaccine
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Symptom recurrence
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN 2/22/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO ADVERSE EVENT.  Pt. should have be given MMR but was inadvertently given MMRV. No reaction to this vaccine, just wrong vaccine was given.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Paranasal sinus discomfort
Clinical narrative: Nasal Congestion, pressure, closed my abilities to breath with my nose, it took 2 weeks. I tried nasal spray & a Neti treatment.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 4/23/21 lot# ER8732;  Pfizer 5/27/21 lot# Ew0172;  Pfizer 1/10/22 lot# FJ6369
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 2/11/21 lot# 015M20A;  Moderna 3/11/21 lot# 030A21A
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 4/16/21 lot# Ew0169;  Pfizer 5/7/21 lot# Ew0172;  Pfizer 11/18/21 lot# FH8028
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines ; Moderna 1/29/21 lot# 010M20A; Moderna 2/25/21 lot# 011A21A
Age: 100.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 2/23/21 lot# 031M20A;  Moderna 3/23/21 lot# 044A21A;  Moderna 12/7/21 lot# 077C21B;  Moderna 6/15/22 lot# 014B22A
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, red streaks and pain.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever; sore all over; This non-serious case was reported by a consumer via sales rep and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever) and general body pain (Verbatim: sore all over). The outcome of the fever and general body pain were not reported.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.     It was unknown if the company considered the fever and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 28-JUN-2023 The patient was sore all over and had fever. The reporter did not agreed to follow up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 2/10/21 lot# 01520A;  Modern 3/10/21 lot# 030A21A;  Moderna 1/4/22 lot# 066H21A
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood glucose normal, Dizziness, Headache, Nausea, Pallor
Clinical narrative: five minutes after getting the Bexero Vaccine in clinic. Pt. c/o N/dizzyness/visual tunneling.  Vomited x2. Pt.  in char. Transferred to clinic RN observation area from the Vaccination area by RN.  moved to stretcher w head of bed at 30 degrees.  VSS checked q 10 minutes.  Face pale. c/o slight HA. After 15 minutes: Color returned; no further N/V/ or abdominal pain..  Afebrile.  Symptoms resolved.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Tunnel vision, Vomiting
Clinical narrative: five minutes after getting the Bexero Vaccine in clinic. Pt. c/o N/dizzyness/visual tunneling.  Vomited x2. Pt.  in char. Transferred to clinic RN observation area from the Vaccination area by RN.  moved to stretcher w head of bed at 30 degrees.  VSS checked q 10 minutes.  Face pale. c/o slight HA. After 15 minutes: Color returned; no further N/V/ or abdominal pain..  Afebrile.  Symptoms resolved.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines  Pfizer 1/22/21 lot# El9261;  Pfizer 2/12/21 lot# EL9267;  Pfizer 8/30/21 lot# FC3182;  Pfizer 3/31/22 lot# FK9895
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Dyspnoea, Fatigue, Laboratory test, Pyrexia
Clinical narrative: I had a fever after receiving the vaccine for three days. Towards the end of May, I was feeling tired and out of breath. I went to the doctor and was diagnosed with anemia and my BNT was at 231. I did not receive any prescriptions to help with my symptoms. My BNT number has been fluctuating for several months. I have had to go to the emergency room for observation twice.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Pfizer 4/13/21 lot# Ew0150;  Pfizer 5/7/21 lot# ER2613;  Pfizer 12/27/21 lot# FL3197
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 3/25/21 lot# ER8727;  Pfizer 4/16/21 lot# EW0161;  Pfizer 12/15/21 lot# FD7218;  Pfizer 5/9/22 lot# FM9992
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 4/14/21 lot# Ew0164;  Pfizer 5/5/21 lot# Ew0179
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Obstructive sleep apnoea syndrome, Respiratory failure
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Induration, Mass, Muscle swelling, Pain
Clinical narrative: Deltoid swelling, feverish feeling, redness, hard lump, hot to the touch, pain.
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, Skin warm
Clinical narrative: Deltoid swelling, feverish feeling, redness, hard lump, hot to the touch, pain.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 2/18/21 lot# 023M20A; Moderna 3/18/21 lot# 002B21A;  Moderna 12/6/21 lot# 029H21B;
Age: 51.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after writtin "expiration" date (8 weeks after delivery)
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 9/18/21 lot# Ew0162;  Pfizer 10/13/21 lot# EW0186
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, Blood test, Dizziness, Immediate post-injection reaction
Clinical narrative: He got his vaccine, he got dizzy immediately, faint feeling.  They needed him to stay there for 10 minutes right before he felt dizzy.  Then later on that day his nose started dripping uncontrollably.  He has never had anything like this prior with any cold or flu that he has had in his entire life ever.  He went to an clinic as he had no insurance at that time.  They tried to give him some codeine syrup which he declined and some antibiotics that helped some.  After he took that he was still having the runny nose.  He then had the 2nd vaccine and it continued after that, as well as the third vaccine which he continued with that.  He was fine prior to the vaccine.  He has not been able to taste or smell since then and has a continuous runny nose  nonstop.  He does not use anything up his nose or any nose drops.     He has had allergies in the past, but nothing like this type of drainage.  He was given a promethazine with codeine syrup and it helped in the past, but since the vaccine it does not help anymore.    2nd vaccine on 9/7/21 PFizer, FC3181, 3rd vaccine 2/26/22 Pfizer, FM6098.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea
Clinical narrative: He got his vaccine, he got dizzy immediately, faint feeling.  They needed him to stay there for 10 minutes right before he felt dizzy.  Then later on that day his nose started dripping uncontrollably.  He has never had anything like this prior with any cold or flu that he has had in his entire life ever.  He went to an clinic as he had no insurance at that time.  They tried to give him some codeine syrup which he declined and some antibiotics that helped some.  After he took that he was still having the runny nose.  He then had the 2nd vaccine and it continued after that, as well as the third vaccine which he continued with that.  He was fine prior to the vaccine.  He has not been able to taste or smell since then and has a continuous runny nose  nonstop.  He does not use anything up his nose or any nose drops.     He has had allergies in the past, but nothing like this type of drainage.  He was given a promethazine with codeine syrup and it helped in the past, but since the vaccine it does not help anymore.    2nd vaccine on 9/7/21 PFizer, FC3181, 3rd vaccine 2/26/22 Pfizer, FM6098.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 3/4/21 lot# 040A21A;  Moderna 4/2/21 lot# 026B21A; Moderna 7/22/22 lot# 060A22A
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: vaccine administered after written "expiration" date (8 weeks after delivery date)
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: received the adjuvant only that was not reconstituted with the antigen; received the adjuvant only that was not reconstituted with the antigen; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: received the adjuvant only that was not reconstituted with the antigen) and inappropriate dose of vaccine administered (Verbatim: received the adjuvant only that was not reconstituted with the antigen). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29 Jun 2023 The nurse reported that they had 2 vials of antigen left in a box of Shingrix so they believed that most likely 2 patients were given The adjuvant only that was not reconstituted with the antigen.  The reporter consented to follow up. The patient only received adjuvant that was not reconstituted with the antigen which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR090895:Same reporter, different patient
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypotension
Clinical narrative: HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines moderna 2/8/21 lot# 013M20A;  Moderna 3/8/21 lot# 030A21A
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 4/6/21 lot# EW0153;  Pfizer 5/4/21 lot# Ew0171;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 vaccines Moderna 2/20/21 lot# 023M20A;  Moderna 3/6/21 lot# 002B21a;  Moderna 3/16/21 Lot# 002B21A;  Moderna 11/12/21 lot# 034F21A;  Moderna 6/16/22 lot# 037A22B
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/2/21 lot# 006B21A;  Moderna 4/22/21 lot# 043B21A;
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 1/15/21 lot# 011J20A;  Moderna 2/12/21 lot# 013M20A;  Moderna 11/3/21 lot# 077C21B
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines MOderna 2/2/21 lot# 013M20A;  Moderna 3/2/21 lot# 010A21A;  Moderna 11/12/21 lot# 034F21A;  Moderna 7/25/22 lot# FJ2602