chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE occurred; dose of VARIVAX was administered after the labeled expiration date; This spontaneous report was received from a pharmacy student referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided.  On 17-FEB-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (valid lot #T002848, expiration date: 23-JAN-2022) (strength, dose and route were not provided). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; Expired vaccine being administered to a patient; This spontaneous report has been received from a pharmacy technician referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.   On 02-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 1 dose as prophylaxis (route of administration, dose, vaccine scheme, and anatomical site of vaccination were not reported; lot number T007235 has been verified to be valid, expiration date reported and established as 27-FEB-2022) (expired product administered).   The reporter inquired about the stability data of the expired vaccine. In addition, the reporter stated that the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) was properly stored up through administration. No adverse events were reported (no adverse event).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE reported/No additional information provided; PROQUAD and VARlVAX were inadvertently administered concomitantly; This spontaneous report has been received from a physician assistant referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 02-MAR-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (lot# T034610, expiration date 10-ARP-2022; strength, dose, and route were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# T021826, expiration date 25-JUN-2022; strength, dose, and route were not reported) concomitantly for prophylaxis (accidental overdose). No additional adverse event or information was reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a male patient who is over the age of 45 received the first dose; No additional AE reported.; This spontaneous report was received from a registered pharmacist and refers to a male patient who was over 45-years-old. The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's drug reactions or allergies.  On an unknown date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, formulation, route and site of administration, lot #, expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA001661:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Subcutaneous injection formulation administered by other route; no adverse event; Information has been received from a nurse Practitioner, referring to a patient of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported.   On unspecified date, the patient was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (0.5 ml, Intramuscularly, lot number: T037028 with expiration date on 03-NOV-2022) (Incorrect route of product administration (10081202) with sterile diluent MRK ( lot number: T027314 with expiration date on 19-MAR-2023) for prophylaxis. No adverse event was reported.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AE reported; HCP states she is calling to add a patient to the pregnancy registry for GARDASIL 9.Patient received GARDASIL 9 on Mar 4, 2022 while pregnant.; This prospective pregnancy spontaneous report was received from a register nurse and refers to a 14-year-old female patient. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were unknown by the reporter.  On 04-MAR-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, vaccination scheme frequency and anatomical site of application were not reported; lot number T036812 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 28-APR-2023) for prophylaxis while pregnant (exposure during pregnancy).  No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs were reported; patient received an expired Proquad; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) 0.5 milliliter / once, lot #T027117, expiration date: 07-FEB-2022 (expired product administered) (formulation, strength, dose number, site and route of administration were not provided) for prophylaxis. No additional adverse events (AEs) reported.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Antibody test negative, Condition aggravated, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Patient neverr developed antibodies to the GARDASIL; rheumatoid arthritis relapsed; This spontaneous report has been received from a physician (patient's father) regarding a 19-year-old non-pregnant female patient. The patient's concurrent conditions included latex allergy. Medical history included rheumatoid arthritis. Historical drugs included methotrexate 15 mg, weekly for rheumatoid arthritis. Concomitant medications were no reported.  On an unspecified date in 2013 (also reported as "7 years ago", conflicting information), the patient received her first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (reporter was not sure which of the vaccines was administered to the patient) (strength, dose, and anatomical location were not provided), intramuscularly (IM) as prophylaxis. On an unspecified dates between 2013 and 2014 (reported as "the patient had the 3-dose series in 2013 and 2014"), the patient received the second and third doses, respectively, of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, and anatomical location were not provided), IM, as prophylaxis, completing the vaccination series.  On an unspecified date (reported as "recently", also reported as "7 years ago" - conflicting information), the patient sought medical attention with her rheumatologist, who ran test and discovered that she never developed antibodies to the vaccine (antibody test negative); therefore, she was advised that she should be revaccinated.  The patient was on remission for 9 year until on approximately 07-DEC-2021 (reported as two or three months ago), when the treating healthcare professional (HCP) discovered during routine monthly rheumatoid arthritis (RA) testing, that the patient had relapsed after not taking methotrexate for 2 years. The patient resumed methotrexate as treatment for the event. No additional information was reported. The outcome of the events was unknown.   The causal relationship between antibody test negative, rheumatoid arthritis and the suspect vaccine was unknown. Upon internal review, rheumatoid arthritis was considered a medically significant event.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored ROTATEQ administered to patient; no adverse event; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot# U026663, expiration date: 09-FEB-2023, route unknown), administered for prophylaxis. The nurse reported that the vaccine was incorrectly stored for 24 minutes at a temperature of 0.3 Celsius degrees. There was no previous temperature excursion. The patient experienced no adverse event. Caller gave permission to be contacted in the future regarding the event. No further information provided.
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-FEB-2022, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot # 1741817, has been verified to be a valid lot number rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 30-JUL-2022) (strength, dose, route of administration and anatomical location were not provided) and diphtheria vaccine toxoid (+)  hepatitis b vaccine rhbsag (yeast) (+) hib vaccine conj (menigococcal protein) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (VAXELIS) (lot # U7124AA, expiration date reported as 13-JUL-2024) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 0.8° Celsius (C) for 35 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines experienced a previous temperature excursion.  No adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE reported; patent was administered improperly storgae VAQTA; Spontaneous information had been received from a nurse, referring a patient of unknown age or gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.   A dose of Hepatitis A Vaccine, Inactivated (VAQTA) (with a valid lot # U024504 with expiration date on 15-OCT-2022) experienced a temperature excursion at 0.8 degree Celsius on 05-FEB-2022 during 35 minutes. On 22-FEB-2022, the patient was vaccinated with the improper stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) (exact dose, formulation and route were not reported for prophylaxis. The vaccine had not experienced previous temperature excursion. No additional adverse event reported. This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2203USA003814:
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered both improperly stored ROTATEQ and improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.       On 05-FEB-2022, both rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1741817, expiration date 30-JUL-2022) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (lot #U7124AA, expiration date 13-JUL-2024) had occurred a temperature excursion in 0.8 degree Celsius for 35 minutes. And on 25-FEB-2022, the patient was vaccinated with both improperly stored vaccines (strength, dose and route of administration were not provided) for prophylaxis (product storage error). There was no previous temperature excursion. No additional adverse event (AE) reported.   This is one of multiple cases received from the same reporter.
Sex: U
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 10-FEB-2022, the patient was vaccinated with both improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (lot # 1741817, expiration date: 30-JUL-2022, strength and dose were unknown) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (V419) (lot # U7124AA, expiration date: 13-JUL-2024, strength, dose and route were unknown) for prophylaxis (product storage error). The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022 as confirmed by reporter. There was no previous excursion. No additional adverse event was reported.
Sex: U
Vaccine: DTPPVHBHPB, RV5, DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 10-FEB-2022, the patient was vaccinated with both improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (lot # 1741817, expiration date: 30-JUL-2022, strength and dose were unknown) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (V419) (lot # U7124AA, expiration date: 13-JUL-2024, strength, dose and route were unknown) for prophylaxis (product storage error). The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022 as confirmed by reporter. There was no previous excursion. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I gave a three for the Shingrix because I keep getting this reoccurring shingles/suspected vaccination failure; reoccurring shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was unable to get the information, why he/she kept getting these reoccurring shingles. Now the patient understand that, and he/she had to talk to dermatologist, but just wanted to give comments that, he/she gave a three for the Shingrix because he/she kept getting this reoccurring shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Peripheral swelling, Swelling
Clinical narrative: Arm swollen, all the left side was swollen; Had a bruise; All the patients left side was swollen; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on  an unknown date).   On 3rd March 2022, the patient received the 2nd dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, contusion and swelling. On an unknown date, the outcome of the swelling arm, contusion and swelling were unknown.   It was unknown if the reporter considered the swelling arm, contusion and swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist called regarding a patient how was vaccinated on 3rd March 2022 with Shingrix.  Now the patient had the arm swollen. All the patients left side was swollen and 5 inches below the breast had a bruise. The health care professional was aware that first dose lot number did not seem a Shingrix, GlaxoSmithKline vaccine, but it was the information. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had 2 doses about 1 month apart in error; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he/she recently had received 2 Shingrix vaccines about 1 month apart in error, which led to drug dose administration interval too short. The reporter enquired if that was going to harm him/her and whether he/she would need another one in 3 months.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I had my 1st shot 8 months ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 8 months before reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report.  The patient had not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The patient wanted to know was it too late to get the second dose. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Shingrix shot Feb 2021, failed to get 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient stated that, he/she got 1st Shingrix shot and failed to get the 2nd shot because he/she focused on getting Covid vaccine. Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The patient asked was it too late to do a 2nd shot now.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose prior to Covid 19. Can get her 2nd now?; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date prior to Covid 19 pandemic).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by pharmacist. The age at vaccination was not applicable for this report. The patient had received the 1st dose of Shingrix prior to Covid 19 pandemic. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if she could get her 2nd dose now or if patient need to restart the series. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body aches and pain; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included central core disease.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     Additional details were provided as follows: The patient self-reported the case. The age at vaccination was unknown. The patient stated that for the type of MS he had more prone to pain than the average population, and he experienced more than average muscle pain for average activity. The reporter stated that he had his first dose of Shingrix approximately 2 years ago and he only recalled experiencing body aches and pain  after received his first dose of Shingrix. The patient provided limited information (unknown lot and expiration date). The reporter consented to follow-up with health care professional (Pharmacy). For the tolerance of the 2nd dose, refer case US2022044832, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022044832:Same patient, same reporter
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient received expired 1st dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The license practice nurse reported that today at the day of reporting, a patient received an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 6 months old received a Kinrix dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a clinical supervisor. The reporter stated that a 6 months old patient received a Kinrix dose, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: administered Rotarix via intramuscular route; This case was reported by a other health professional via call center representative and described the occurrence of wrong route of administration in a 1-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3594G, expiry date 2nd May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 9th March 2022, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 9th March 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was practice manager. The reporter reported that patient was administered Rotarix vaccine via intramuscular route, which led to wrong route of administration. The vaccine was given into the thigh, but reporter did not have information regarding if it was right or left. The reporter stated that the parents had been notified. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st vaccine on 2019, 2nd dose had not been administered; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose administered on 21st March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter reported the patient wished to receive 2nd Shingrix vaccine. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose in 11FEB2022, second on 7MAR2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 5F953, expiry date 20th April 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 7th March 2022, the patient received the 2nd dose of Shingrix. On 7th March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details reported were as follows: The reporter was a medical assistant. On 11th February 2022, the patient received 1st dose of Shingrix, batch number 5F953, expiry date 20th April 2023. The patient received 2nd dose of Shingrix earlier than recommended time frame, which led to shortening vaccination schedule. The consent to follow up was given.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 17Sep2021 second on 24Feb2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old female patient who received HAV (Havrix) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Havrix (received 1st dose of Havrix on 17th September 2021 from batch number CE74N with expiry date 19th March 2022).   On 24th February 2022, the patient received the 2nd dose of Havrix. On 24th February 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The nurse reported that patient received second dose of Havrix earlier than recommended, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: Prescription for Bexsero for 65 y/o patient; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 65-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Pharmacist received prescription for Bexsero for 65 year old patient, which led to intercepted drug prescribing error. Till the time of reporting, patient did not receive Bexsero vaccination. No lot number or expiration date was applicable. Health care professional gave consent for safety team to follow up.
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 month old was administered Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old female patient who received DTPa-IPV (Kinrix) (batch number uj434aaa, expiry date 17th May 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received Kinrix .5 ml and Kinrix Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: The 10 month old patient received Kinrix, which led to inappropriate age at vaccine administration. The consent to follow up was given.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Investigation, Tachycardia, Vertigo, White blood cell count
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included, gallbladder removal, and concurrent conditions included, irregular heart rhythm for years (reported as never waiver, never different), weak immunity, kidney problem, and sepsis, and other pre-existing medical conditions included patient was very sick from an unspecified date in JAN-2021 to on an unspecified date in APR-2021. Patient stated one day she even passed out and her heart stopped for a second. She was hospitalized and her white blood cell count was 22,000 (Unit not specified). She stated her heart rhythm still behaved the same way even after the sickness. Number of days hospitalized and discharge information was not reported. Patient looks younger than she was and she takes care of herself. She was very beautiful and slender. She is a very active person but since receiving the booster she was a very different person. The patient received Covid-19 vaccine ad26. cov2. s (suspension for injection, route of administration not reported, batch number: unknown, and expiry: unknown) dose was not reported, dose number in 01, 01 in total, administered on left arm on an unspecified date in JUL-2021 for prophylactic vaccination. On an unspecified date, following vaccination with Covid-19 vaccine ad26.cov2.s, it was unknown if patient had any side effects (dose number in series 01). The patient additionally received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1855194, and expiry: unknown) dose was not reported, dose number in series 02, 01 in total, administered on right arm on an unspecified date in NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, concern started since the rhythm was intermittent. Due to booster vaccine her heart beats faster than usual. According to patient rhythm mostly came from heart atrium but sometimes from ventricle. She had bad tachycardia, also had dizziness and vertigo (dose number in series was 02). Patient went to an electrophysiologist and got some tests done but she won't hear back. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad tachycardia/heart beats faster than usual, and the outcome of dizziness and vertigo was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: VIRUS; This spontaneous report received from a consumer via a media via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose, dose number in series 01, 01 in total was administered, start therapy date were not reported for prophylactic vaccination. No adverse event was reported following covid-19 vaccine ad26. cov2.s (Dose number in series 01). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose, dose number in series 02, 01 in total was administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26. cov2.s, the patient had spent a month in the hospital with virus and still on oxygen months later (Dose number in series 02). Treatment medications (dates unspecified) included: oxygen. Hospitalization date, number of days of hospitalization and discharge date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of virus was not reported. This report was serious (Hospitalization Caused/Prolonged). The case was associated with product quality complaint (PQC): 90000220698. The suspected product quality complaint has been confirmed that the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220313639-COVID-19 VACCINE AD26.COV2.S-virus. The event(s) 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(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocarditis, Troponin
Clinical narrative: SUSPECTED MYOCARDITIS; This spontaneous report was received from literature.  This report concerned a patient of unspecified age, sex, race and ethnicity. The objective of this study was to understand clinical course and short-term outcomes of suspected myocarditis after the coronavirus disease 2019 (COVID-19) vaccination has important public health implications in the decision to vaccinate youth. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN,expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected myocarditis. Laboratory data (dates unspecified) included: ECG (NR: not provided) was abnormal, and Troponin (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected myocarditis was not reported. The authors emphasized that case series demonstrates that myocarditis temporally related to COVID-19 vaccination is characterized by a mild illness with rapid resolution of symptoms in most patients. However, longer-term outcome data are lacking. We emphasize the importance of reporting suspected myocarditis cases after COVID-19 vaccination to the Vaccine Adverse Events Reporting System or similar reporting systems for patients in other countries to better define the characteristics of this syndrome and its relationship to the receipt of COVID-19 vaccines. Future studies that focus on determining risk factors and mechanisms of development of myocarditis are urgently needed, in particular, as COVID-19 vaccines become more widely available to younger children in the future.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220314046-COVID-19 VACCINE AD26.COV2.S-Suspected myocarditis. The event(s) 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(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine (dose number in series 1).  The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced hives (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age and sex, race and ethnic origin. Initial information was processed along with the additional information received on 10-MAR-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, and heart issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in mid JAN-2022, the patient experienced suspected covid-19 infection and had suspected clinical vaccination failure. As per reporter, "We got the J and J shot last May, We traveled the whole country for work, ended up with covid mid January, felt like flu for a week, no issues at time of shot or after, I am diabetic and have heart issues, no side affects." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000220818. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20220316300-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse event nos. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from adverse event nos. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 204B21A, and expiry: unknown) dose was not reported, 1 total, administered to the left arm on unspecified date SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JAN-2022, the patient started having fever, sore throat, congestion and headaches (suspected covid-19 infection). On 30-JAN-2022, covid-19 Home test was positive (suspected clinical vaccination failure). The patient recovered from fever, sore throat, congestion and headaches on 03-FEB-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000221157.; Sender's Comments: V0: 20220319142-Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.