chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Nausea
Clinical narrative: no immunity shown on the serologic labs; she needed to receive MMRII vaccination for work. Her other concern was that she is told she only needs to receive one; bleeding gums; Painful patchy white dots on gums; Painful patchy white dots on gums; stomach ache; nausea; muscle fatigue; This spontaneous report was received from a consumer referring to herself (34-year-old female patient). Her historical condition included thyroidectomy. Concomitant medications included levothyroxine sodium (SYNTHROID). She denied providing information about drug reaction/allergies.  On unknown day when she was a child, the patient was potentially (she did not have records nor documented proof) vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 02-JUN-2023, the patient was vaccinated with one dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (0.5 mL, lot #415124 which was verified as non-valid upon internal review, expiration date was reported as 13-FEB-2024 but could not be confirmed due to non-valid lot #, route of administration and anatomical location were not provided) for prophylaxis (Extra dose administered).  On unknown day, there was no immunity shown on serological laboratory which is why she needed to receive the extra dose for work. On 03-JUN-2023, the patient developed painful patchy white dots on gums, stomach ache, nausea and muscle fatigue. On 06-JUN-2023, the patient experienced bleeding gums. At the time of reporting, the patient was recovering from the events. The action taken with the suspect vaccine regarding the events was not applicable.  The relatedness between the events and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection was not provided.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired MMR II was administered.; This spontaneous report was received from an office manager and refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided     On 14-APR-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # U007686 and expiration date 09-MAR-2023, 0.5 milliliter, subcutaneously for prophylaxis (dose number was not provided) (expired product and no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: Inbound call from pharmacist calling to request information on whether a patient who received his first dose of GARDASIL-9 a year ago would have to restart the series.  Upon asking for additional to submit an AE, caller declined to provide any additi; No additional AE; This spontaneous report was received from Pharmacist and refers to a male patient of unknown age.  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, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, there was an inbound call from pharmacist calling to request information on whether a patient who received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) a year ago would have to restart the series. Upon asking for additional to submit an AE, caller declined to provide any additional information. Agent was able to confirm that there were no symptomatic adverse events.  Declined permission for correspondence.  No additional information at this time. No additional AE/PQC reported.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; HCP reported patient was accidently administered an expired dose of MMR II on Jun 7, 2023. Product expired on Apr 15, 2023. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC reported.; This spontaneous report was received from medical assistant refers to a 2-year-old female patient.    The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) lot #U011995, expiration date: 15-APR-2023 for prophylaxis (expired product administered). There were no additional adverse events reported (no adverse event).
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Deafness, Deafness bilateral, Tinnitus
Clinical narrative: Tinnitus; hearing loss in bilateral ears; This spontaneous report was received from a physician refers to a 71-year-old female patient.  The patient's concurrent condition was not reported. The patient's medical history included tinnitus (reported as: tinitis lowe grade). The patient's concomitant therapies included colecalciferol (VITAMINE D).  On 27-APR-2023, the patient was vaccinated with the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 0.5 milliliter, intramuscular (lot #, expiration date, and anatomical location were not reported) for prophylaxis.   On 28-APR-2023 the patient experienced tinnitus and deafness bilateral. The outcome of tinnitus and deafness bilateral was reported as recovering/resolving.  The causality assessment was not provided.  The significant disability was stated for the events of: tinnitus and deafness bilateral by physician due to the patient's loss of hearing.  The event of deafness bilateral was considered to be medically significant.
Age: 28.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP reporting VARIVAX was administered to a patient after it experienced a TE.; This spontaneous report was received from a pharmacy manager referring to a 28-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 19-APR-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 ml, lot #: W031811, expiration date: 05-OCT-2024; strength, route of administration, and anatomical location were not reported) for prophylaxis with sterile diluent. The vaccine administered experienced a temperature excursion (TE) at 46 F for 168 hours before (product storage error). No additional adverse event (AE) was reported (no adverse event).
Sex: M
Vaccine: TYP
Symptoms: Dry mouth, Foreign body in throat, Nausea, Vomiting
Clinical narrative: Feels like the medicine gets stuck in his throat; Feels like having dry mouth; Vomited; Feels like he needs to throw up; A spontaneous report was received from caregiver on 31MAY2023 regarding a male patient of unknown age who "feels like the medicine gets stuck in his throat" (PT: Foreign body in throat), "feels like having dry mouth" (PT: Dry mouth), "feels like he needs to throw up" (PT: Nausea) and "vomited" (PT: Vomiting) following the administration of Vivotif (Typhoid vaccine live oral Ty21A; lot number: 3003823) as an immunization.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient had a violent reaction to Vivotif. Reportedly, the patient vomited after taking the dose of Vivotif. Furthermore, it was reported that the patient felt like the medicine got stuck in his throat, was having a dry mouth, and felt like he needed to throw up.  The outcome of the reported events was unknown at the time of this report.  The action taken with Vivotif with respect to the reported events unknown.   No additional information was reported.  Company Comment: A patient took Vivotif for immunisation and felt like the medicine gets stuck in his throat (foreign body in throat), had dry mouth, felt like he needs to throw up (nausea), and vomited (vomiting). Considering the limited case information, the role of Vivotif cannot be ruled out, and the causality of foreign body in throat, dry mouth, nausea, and vomiting are assessed as possible given the time to onset. The case is considered serious due to the medical significance of the event foreign body in throat. Foreign body in throat and dry mouth is unlisted whereas nausea and vomiting are listed as per insert.; Sender's Comments: A patient took Vivotif for immunisation and felt like the medicine gets stuck in his throat (foreign body in throat), had dry mouth, felt like he needs to throw up (nausea), and vomited (vomiting). Considering the limited case information, the role of Vivotif cannot be ruled out, and the causality of foreign body in throat, dry mouth, nausea, and vomiting are assessed as possible given the time to onset. The case is considered serious due to the medical significance of the event foreign body in throat. Foreign body in throat and dry mouth is unlisted whereas nausea and vomiting are listed as per insert.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: provider did not initially think that dose was invalid; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (expiry date 30-APR-2023) for prophylaxis.   On 06-JUN-2023, the patient received Menveo (unknown arm). On 06-JUN-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: provider did not initially think that dose was invalid). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Jun-2023 The reporter stated that the clinic enforced a process for a second verifier of vaccines but the second check did not happen in this case.  The reporter stated that provider did not initially think that dose was invalid and that the patient did not need to receive a second dose. The reporter did not know the dose of the vaccine. The reporter did not consent to follow-up. The patient received an expired dose of Menveo, which led to expired vaccine used.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Allergy; This non-serious case was reported by a physician via other manufacturer and described the occurrence of allergy in a 57-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced allergy (Verbatim: Allergy). The outcome of the allergy was not reported.  It was unknown if the reporter considered the allergy to be related to Flu vaccine.  It was unknown if the company considered the allergy to be related to Flu vaccine.  Additional Information: GSK Receipt Date: 08-JUN-2023 The reporter had reported that the patient had experienced allergy after receiving the flu vaccine. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort, Pain in extremity
Clinical narrative: mild arm discomfort; arm turned beet red for 6 hours; This non-serious case was reported by a pharmacist and described the occurrence of arm discomfort in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received the 1st dose, refer case US2023081429).   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 arm discomfort (Verbatim: mild arm discomfort) and red hands (Verbatim: arm turned beet red for 6 hours). The outcome of the arm discomfort was not reported and the outcome of the red hands was resolved (duration 6 hrs).   It was unknown if the reporter considered the arm discomfort and red hands to be related to Shingrix.     It was unknown if the company considered the arm discomfort and red hands to be related to Shingrix.   Linked case(s) involving the same patient:  US2023081429   Additional Information: GSK Receipt Date: 09-JUN-2023 The second dose was received and he experienced mild arm discomfort.   On day 5 after the second dose, his arm turned beet red for 6 hours. Follow-up not possible as no contact details provided.; Sender's Comments:  US-GSK-US2023081429:Same patient, same reporter, First dose, different events
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Herpes zoster, Inability to afford medication, Loss of employment, Neuralgia
Clinical narrative: Ghost nerve pain; Stinging tingling needles feeling; Shingles; suspected vaccination failure; This serious case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) powder for injection for asthma and dupilumab (Dupixent) for drug use for unknown indication.   On an unknown date, the patient received Shingles vaccine. In 2015, the patient started Nucala (subcutaneous). On an unknown date, the patient started Dupixent. On an unknown date, an unknown time after receiving Shingles vaccine and an unknown time after starting Nucala, the patient experienced post herpetic neuralgia (Verbatim: Ghost nerve pain), tingling (Verbatim: Stinging tingling needles feeling), shingles (Verbatim: Shingles) and vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant). The action taken with Nucala was unknown. The action taken with Dupixent was unknown. The outcome of the post herpetic neuralgia was resolved and the outcome of the tingling was not resolved and the outcome of the shingles and vaccination failure were not reported.   It was unknown if the reporter considered the post herpetic neuralgia, tingling and vaccination failure to be related to Shingles vaccine and Nucala. It was unknown if the reporter considered the shingles to be related to Nucala.     It was unknown if the company considered the post herpetic neuralgia, tingling and vaccination failure to be related to Shingles vaccine and Nucala. It was unknown if the company considered the shingles to be related to Nucala.   GSK receipt date: 02-JUN-2023 This case was reported by a consumer via call center representative. Consumer stated she was taking Nucala for asthma in the spring of 2015 (she could not recall exactly when she started). She said she was going in to the Health care professional office and that they used the Nucala vial. She said that shortly after starting Nucala, she got shingles. She said that after recovering from shingles, she would on occasion still got a stinging tingling needles feeling that she described as ghost nerve pain. She said it felt as if she was about to got the shingles again but she would not got it. She said she was on Nucala until sometime in 2020 when she lost her job and she could not afford it. She said she was later put on Dupixent and that she started to got the same ghost nerve symptoms while on that. She said she was given the Shingles vaccine but it was after she got the shingles. She was trying to got patient assistance to restart Nucala. This case was considered as suspected vaccination failure since details regarding time to onset, completion of primary vaccination schedule and laboratory confirmation of shingles was not reported.  It was unknown if the reporter considered the event to be related to Dupixent . Did not consent to follow-up
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Ghost nerve pain; Stinging tingling needles feeling; Shingles; suspected vaccination failure; This serious case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) powder for injection for asthma and dupilumab (Dupixent) for drug use for unknown indication.   On an unknown date, the patient received Shingles vaccine. In 2015, the patient started Nucala (subcutaneous). On an unknown date, the patient started Dupixent. On an unknown date, an unknown time after receiving Shingles vaccine and an unknown time after starting Nucala, the patient experienced post herpetic neuralgia (Verbatim: Ghost nerve pain), tingling (Verbatim: Stinging tingling needles feeling), shingles (Verbatim: Shingles) and vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant). The action taken with Nucala was unknown. The action taken with Dupixent was unknown. The outcome of the post herpetic neuralgia was resolved and the outcome of the tingling was not resolved and the outcome of the shingles and vaccination failure were not reported.   It was unknown if the reporter considered the post herpetic neuralgia, tingling and vaccination failure to be related to Shingles vaccine and Nucala. It was unknown if the reporter considered the shingles to be related to Nucala.     It was unknown if the company considered the post herpetic neuralgia, tingling and vaccination failure to be related to Shingles vaccine and Nucala. It was unknown if the company considered the shingles to be related to Nucala.   GSK receipt date: 02-JUN-2023 This case was reported by a consumer via call center representative. Consumer stated she was taking Nucala for asthma in the spring of 2015 (she could not recall exactly when she started). She said she was going in to the Health care professional office and that they used the Nucala vial. She said that shortly after starting Nucala, she got shingles. She said that after recovering from shingles, she would on occasion still got a stinging tingling needles feeling that she described as ghost nerve pain. She said it felt as if she was about to got the shingles again but she would not got it. She said she was on Nucala until sometime in 2020 when she lost her job and she could not afford it. She said she was later put on Dupixent and that she started to got the same ghost nerve symptoms while on that. She said she was given the Shingles vaccine but it was after she got the shingles. She was trying to got patient assistance to restart Nucala. This case was considered as suspected vaccination failure since details regarding time to onset, completion of primary vaccination schedule and laboratory confirmation of shingles was not reported.  It was unknown if the reporter considered the event to be related to Dupixent . Did not consent to follow-up
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Shingles like rash /rash occurred on her neck and back; This non-serious case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 76-year-old female 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 vesicular rash (Verbatim: Shingles like rash /rash occurred on her neck and back). The outcome of the vesicular rash was resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     It was unknown if the company considered the vesicular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUN-2023 The patient received 1st dose about a year ago. After the vaccination, she got a shingles like rash off and on over the year. She informed that she was never diagnosed with Shingles and rash occurred on her neck and back (no side indicated). She waited to get her second Shingrix vaccine due to these symptoms, which ended up later than the recommended 6 months. She received the 2nd dose on June 02, 2023 on the left arm. The reporter did not consent to follow up the health care professionals (HCP).
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: down to their hand, since receiving dose; Pain from their shoulder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in hand in a female patient who received Herpes zoster (Shingrix) (batch number 2HC4L) for prophylaxis.   On 12-APR-2023, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in hand (Verbatim: down to their hand, since receiving dose) and shoulder pain (Verbatim: Pain from their shoulder). The outcome of the pain in hand and shoulder pain were not resolved.   It was unknown if the reporter considered the pain in hand and shoulder pain to be related to Shingrix.     It was unknown if the company considered the pain in hand and shoulder pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient received the dose and reported experiencing a sharp, shooting pain from their shoulder down to their hand, since receiving the dose. The reporter did not know which arm dose was received in, nor did they state whether this was the patient's first or second dose. The reporter did not consent to follow up.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: extra dose Engerix-B accidentally administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   Previously administered products included Engerix-B (received primary immunization of Engerix-B on an unknown date).   On 06-JUN-2023, the patient received the 4th dose of Engerix B. On 06-JUN-2023, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: extra dose Engerix-B accidentally administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 7-Jun-2023 The nurse stated that in the system it looked as though the patient needed her third and final dose, but then after the dose was given it was realized the patient had already finished the series. No further information provided at the time of the call. The reporter was initially hesitant to provide details due to privacy concerns, but consented to safety follow up. The patient received fourth dose of Engerix-B, which led to extra dose administered.
Sex: M
Vaccine: MENB
Symptoms: Incorrect dose administered, Product complaint, Syringe issue
Clinical narrative: underdose/received half of dose/other half went on to the table; luer lock device leaked; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a male patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero (unknown arm) .5 ml. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: underdose/received half of dose/other half went on to the table), syringe leak (Verbatim: luer lock device leaked) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, syringe leak and pharmaceutical product complaint 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: 8-Jun-2023 The nurse reported Bexsero product quality complaint. The vaccine leaked at the luer lock device.  No at the back through the stopper, no the blister and/or carton was damaged, no the luer lock was damaged and there was damage/breakage on the syringe barrel. The reporter reported that the syringe was pre-assembled with needle sometime before administration (30 second so for long). The size of gauge needle used was 25 G. The needle which was used was available, the reporter asked if so return of this needle was also required. The reporter stated that yes leaking from plunger stopper, there were liquid traces observed on the plunger stopper rings. The replacement was pending. The reporter needs to determine if they want a credit for one Bexsero vaccine. If yes, please obtain all wholesale information. Please verify if the reporter was returning suspect vaccine. The reporter consented to follow-up. The nurse reports the luer lock device leaked as she was injecting the vaccine to the patient and the patient received half of dose, which led to incomplete dose administered and syringe leak.
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of an expired Havrix dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30-SEP-2022) for prophylaxis.   On 07-JUN-2023, the patient received Havrix. On 07-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Havrix dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2023 The reporter was a nurse manager. The healthcare professional asked if they had to repeat the dose. The reporter consented to follow up. The patient received Havrix beyond the expiration date, which led to expired vaccine used.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 25-year-old female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX-B).   On 26-MAY-2023, the patient received the 2nd dose of Engerix B. On 26-MAY-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 08-Jun-2023 The pharmacist reported that the patient was going to start nursing school and need to receive hepatitis series. At the time of reporting, the third dose has not been received. The vaccine administration facility was the same as primary reporter. Inadvertently did not obtain permission for follow-up. The patient received the second dose of Engerix-B earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a couple of years ago he received Shingrix shot 1 but he never got shot number 2; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix a couple of years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a couple of years ago he received Shingrix shot 1 but he never got shot number 2). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2023 The reporter was the patient.  The patient did not want to give his date of birth. The patient never got shot number 2 of Shingrix. The reporter did not get a chance to ask for MD contact.  It was difficult to communicate with this customer over the phone.  He was fine with safety sending him a letter. The reporter provided limited information. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 8-Jun-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: his wife got her first dose of SHINGRIX in 2018 and has not yet received her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: his wife got her first dose of SHINGRIX in 2018 and has not yet received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 08-JUN-2023 This case was reported by patient's husband.  The patient had not yet received her second dose. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: states dose 2 was given a month ago.; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In MAY-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: states dose 2 was given a month ago.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2023 The patient received second dose of Shingrix a month ago.  Referred to healthcare professional. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently administered the Menveo liquid component without the lyophilized component to a patient today on 6/8/23; inadvertently administered the Menveo liquid component without the lyophilized component to a patient today on 6/8/23; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA944A, expiry date 31-JUL-2024) for prophylaxis.   On 08-JUN-2023, the patient received Menveo (left deltoid). On 08-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered the Menveo liquid component without the lyophilized component to a patient today on 6/8/23) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Menveo liquid component without the lyophilized component to a patient today on 6/8/23). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 8-Jun-2023 The phlebotomist called to inquired that they should revaccinate with a complete dose. The reporter asked that how to proceed. The reporter did not consent to follow-up. The patient inadvertently administered the Menveo liquid component without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was administered to a 4-month-old patient; Intention was to give one vaccine for DTap and one for IPV but by mistake they gave Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   In JUL-2022, the patient received Kinrix. In JUL-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 4-month-old patient) and wrong vaccine administered (Verbatim: Intention was to give one vaccine for DTap and one for IPV but by mistake they gave Kinrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUN-2023 The Vaccine administration facility was the same as primary reporter. The reporter reported that the intention was to gave one vaccine for DTap and one for IPV but by mistake they gave Kinrix as a combo instead. The reporter did consent to follow up via email. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administered one vaccine for DTap and one for IPV and inadvertently administered Kinirix instead of one vaccine for DTap and one for IPV, which led to wrong vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Monoplegia
Clinical narrative: LEG PARALYSIS; SEVERE HEADACHE; This spontaneous report received from a patient via other manufacturer (Moderna) concerned an elderly of unspecified sex, age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and concurrent conditions included: genetically immunocompromized, and allergies to dye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: UNKNOWN) dose was not reported, first dose, 1 total administered on 08-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On 08-APR-2021, the patient experienced leg paralysis, and severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg paralysis, and severe headache on 18-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230619846- leg paralysis. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the  Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain; On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) and ARTHRALGIA (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) and ARTHRALGIA (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain). At the time of the report, PAIN IN EXTREMITY (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) and ARTHRALGIA (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.   This case was linked to MOD-2023-727742 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to device use error, No adverse event
Clinical narrative: looked at the printout of my Vaccine history the 5th injection was listed as Invalid; No Adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO DEVICE USE ERROR (looked at the printout of my Vaccine history the 5th injection was listed as Invalid) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO DEVICE USE ERROR (looked at the printout of my Vaccine history the 5th injection was listed as Invalid) and NO ADVERSE EVENT (No Adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO DEVICE USE ERROR (looked at the printout of my Vaccine history the 5th injection was listed as Invalid) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.            No concomitant medication was provided.  It was reported that patient was going to Italy later this month. When the patient looked at the printout of Vaccine history it was reported that the 5th injection was listed as "Invalid".  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2023: Follow up received and included nonsignificant information.
Age: 65.0
Sex: U
Vaccine: COVID19-2
Symptoms: Immunodeficiency, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; I'm an immunecompromise person; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) and IMMUNODEFICIENCY (I'm an immunecompromise person) in a 65-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) (seriousness criterion medically significant) and IMMUNODEFICIENCY (I'm an immunecompromise person) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) and IMMUNODEFICIENCY (I'm an immunecompromise person) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient got primary dose and first booster of Moderna. After the patient received the 1st booster, immune system did respond with double vision for 10 days and now patient was an immunocompromised person. Patient had Rheumatoid Arthritis.  No treatment medication reported. Company comment- This spontaneous case concerns a 65-year-old patient of unknown gender with no medical history reported, who experienced the unexpected serious (medically significant) events Rheumatoid Arthritis (AESI) and immunodeficiency. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a booster dose of COVID vaccine schedule, was administered. Latency unknown as the onset date of the events and vaccination date were not specified. Details of symptoms, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023; No adverse event; Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7173b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown . The vial did not underwent temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case