chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient was not sure which brand she received and does not know why the series were stopped. Patient called the Pharmacist to see if she can get the reminder of the doses to complete vaccination for Gardasil 9.; No additional AE reported; Patient was not sure which brand she received; This spontaneous report was received from Pharmacist and refers to a 21-year-old female.  The patient's medical history, concurrent conditions were not reported and concomitant therapies were not reported.  In 2015 (also reported as at age 12 [exact date unknown]), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (Manufacturer unknown) or with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (Manufacturer unknown) administered for prophylaxis (strengths, lot #, expiry dates, and routes of administration were not provided). The Company unidentified HPV vaccine administered (name and lot numbers not provided).  Pharmacist stated that the patient was not sure which brand she received (Product origin unknown) and did not know why the series were stopped (Incomplete course of vaccination). Patient called the Pharmacist to see if she could get the remainder of the doses to complete vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse event (AE) report.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient received one dose of GARDASIL 9 when patient was 12 years old but did not complete the vaccine series.; No additional AEs; This spontaneous report was received from Pharmacist and refers to a 21-year-old patient of unspecified gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  In 2015 (At the age of 12-yo), the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) but did not complete the vaccine series (Incomplete course of vaccination). No additional adverse events (AEs).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC/No symptoms reported.; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD on 9/27/2024. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE Filed (Case #02680342). No additional AE/PQC.   Produc; This spontaneous report was received from a Registered Nurse (R.N) concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter. On 27-SEP-2024, the patient was vaccinated with an improperly stored dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # Y008785, expiration date: 30-OCT-2025, 0.5 milliliter/dose (route and frequency were not reported) for prophylaxis (product storage error). No additional AE/PQC (no adverse event).    Duration of temperature excursion (TE): -13.8C / -14°C up to-10°C for 0 Hours 25 Minutes 0 Seconds. No previous TE were reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Faeces discoloured
Clinical narrative: child having green stool after and since the 2 month year old dose of Rotateq; This spontaneous report was received from Company Representative and refers to a 2-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, after and since the 2 month year old dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient experienced green stool. This happened recently and was stated that the green stool was ongoing, but the date of onset was not specified.  No further details were articulated.  The action taken with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) regarding green stool was Not Applicable.   The causal relationship between green stool and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to device use error, Scratch, Underdose
Clinical narrative: patient's arm was scratched by the needle when he pulled away; Customer calling to request information on revaccination after a patient moved during administration of GARDASIL 9 and did not receive a full dose. Nurse states that the patient's arm was scratched by the needle when he pulled away. Nurse did not kn; This spontaneous report was received from a nurse referring to a 12-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 04-OCT-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis. However, while being vaccinated, the patient moved and did not received the full dose (underdose) and when he pulled back, his arm got scratched by the needle (scratch).      The outcome of scratch was unknown. The causal relationship between scratch and the vaccine was not reported.  Lot # is being requested and will be submitted if received.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report possible inadvertent administrations of MMR-II  and VARIVAX after a temperature excursion; This spontaneous report as received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 11-SEP-2024, the following vaccines suffered a temperature excursion of 11.55 degree Celsius (°C) for  9 hours and 45 minutes: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot numbers X020654, X022986 and X018902 with expiration dates 21-OCT-2024, 11-JUN-2025 and 12-JUL-2025 respectively; rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot numbers 2003174 and 2032350 with expiration dates 14-SEP-2025 and 09-OCT-2025 respectively 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 numbers U7899AA and U7907AA with expiration dates 31-AUG-206 and 30-SEP-2026 respectively and varicella virus vaccine live (oka/merck)(VARIVAX), lot numbers Y000201, Y004554 and Y006582 with expiration dates 03-JAN-2026, 20-FEB-2026 and 26-MAR-2026 respectively that had a excursion of 1.34 °C for 12 hours. Between 16-SEP-2024 and 19-SEP-2024 the vaccines were administered as prophylaxis (doses and routes of administration not reported) (product storage error). No adverse event was reported.  No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the Licensed Practical Nurse regarding a 16 -month-old female patient.   On 19-SEP-2024, at private Doctor's Office/Hospital, the patient was inadvertently vaccinated in her left thigh with the improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number: X020654, expiration date 21-OCT-2024, subcutaneous, first dose and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number: Y004554, expiration date not reported but upon validation stablished  as: 20-FEB-2026, subcutaneous, first dose (product storage error). The licensed practical nurse further specified that a power outage resulting in stored temperature >8°C for 10 hours.  No adverse reactions reported. This is one of several reports received from the same reporter. This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA007895:
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC20
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; inadvertent administrations of MMR-II, Prevnar 20 and Havrix after a temperature excursion; This spontaneous report as received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 11-SEP-2024, the following vaccines suffered a temperature excursion of 11.55 degree Celsius (°C) for  9 hours and 45 minutes: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot numbers X020654, X022986 and X018902 with expiration dates 21-OCT-2024, 11-JUN-2025 and 12-JUL-2025 respectively; rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot numbers 2003174 and 2032350 with expiration dates 14-SEP-2025 and 09-OCT-2025 respectively 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 numbers U7899AA and U7907AA with expiration dates 31-AUG-206 and 30-SEP-2026 respectively and varicella virus vaccine live (oka/merck)(VARIVAX), lot numbers Y000201, Y004554 and Y006582 with expiration dates 03-JAN-2026, 20-FEB-2026 and 26-MAR-2026 respectively that had a excursion of 1.34 °C for 12 hours. Between 16-SEP-2024 and 19-SEP-2024 the vaccines were administered as prophylaxis (doses and routes of administration not reported) (product storage error). No adverse event was reported.  No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the Licensed Practical Nurse regarding a 13-month-old female patient.   On 18-SEP-2024, at private Doctor's Office/Hospital, the patient was inadvertently vaccinated with an improperly stored doses in her right thigh with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) first dose, lot number: X020654, expiration date 21-OCT-2024, subcutaneous for prophylaxis, in her left thigh with the fourth dose of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) Intramuscular, lot number: HL3889, expiration date: 31-MAY-2025 and in her left thigh with the first dose of hepatitis a vaccine inact (HAVRIX) Intramuscular, lot #: LM99N, expiration date: 04-MAR-2026.  The licensed practical nurse further specified that a power outage resulting in stored temperature >8°C for 10 hours.  No adverse reactions reported. This is one of several reports received from the same reporter. This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA007895:
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Proquad administered after temperature excursion; This spontaneous report was received from a licensed practical nurse referring to an 8-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 02-OCT-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (rHA), 0.5 milliliters, lot #Y012074, expiration date: 05-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided) that underwent a temperature excursion and were administered after being stored improperly at minus 11.25 degrees Celsius (prior) for 30 minutes, then at minus 11.63 degrees Celsius (prior) for 30 minutes, then at minus 8.69 degrees Celsius (prior) for 44 minutes, then at minus 9.63 degrees Celsius (prior) for 36 minutes, finally at minus 8.25 degrees Celsius (current) for 44 minutes. No additional information was provided. No adverse event was reported.; Sender's Comments:  US-009507513-2410USA003525:MSD US-009507513-2410USA003178: US-009507513-2410USA003167:
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional information provided. No Additional AE/ No PQC.; HCP called to report TE where products were administered after stored improperly.; This spontaneous report has been received from a health care professional, regarding a 18-year-old patient of unknown gender. The patient's previous allergies, medical history, concurrent conditions, and concomitant medications were not provided.   On 04-OCT-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, dose of 0.5 mL (strength, frequency, route of administration, vaccination scheme, and site of administration were not provided; lot # y010374 which has been verified to be a valid number, expiration date was reported and validated as 05-JUN-2026) as a prophylaxis. However, this vaccine was administrated to the patient after a stored improperly (product storage error). The vaccine administered was stored at temperatures of -11.25 degrees Celsius (C) (prior) for a time frame of 30 minutes, -11.63 degrees Celsius (C) (prior) for a time frame of 30 minutes, -8.69 degrees Celsius (C) (prior) for a time frame of 44 minutes, -9.63 degrees Celsius (C) (prior) for a time frame of 36 minutes, -8.25 degrees Celsius (C) (current) for a time frame of 44 minutes (product storage error). No additional information was provided. No additional adverse events were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA003525:MSD US-009507513-2410USA003178: US-009507513-2410USA003126: US-009507513-2410USA003533: US-009507513-2410USA003497: US-009507513-2410USA003474: US-009507513-2410USA003473: US-009507513-2410USA003188: US-009507513-2410USA003185:
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; HCP called to report TE where products were administered after stored improperly.; This spontaneous report was received from a Licensed Practical Nurse (L.P.N) and refers to a 6-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-OCT-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, valid lot #Y010374, expiration date reported and confirmed as 05-JUN-2026, administered for prophylaxis (strength, route of administration, and anatomical location were not provided) (product storage error). The current temperature excursion of the suspect vaccine was reported as -8.25 degree Celsius for 0 hours, 44 minutes, and 0 seconds. Prior temperature excursion were reported as -11.25 degree Celsius for 0 hours 30 minutes 0 seconds, -11.63 degree Celsius for 0 hours, 30 minutes, and 0 seconds; -8.69 degree Celsius for 0 hours, 44 minutes, and 0 seconds; -9.63 degree Celsius for 0 hours, 36 minutes, and 0 seconds. No additional adverse events reported (no adverse event).; Sender's Comments:  US-009507513-2410USA003090: US-009507513-2410USA003126: US-009507513-2410USA003167: US-009507513-2410USA003188: US-009507513-2410USA003525:MSD
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; HCP called to report TE where products were administered after stored improperly.; This spontaneous report was received from a Licensed Practical Nurse (L.P.N) and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-OCT-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin [rHA]) (PROQUAD) injection, 0.5 milliliter, valid lot #Y012074, expiration date reported and confirmed as 05-JUN-2026, administered for prophylaxis (strength, route of administration, and anatomical location were not provided) (product storage error). The current temperature excursion of the suspect vaccine was reported as -8.25 degree Celsius for 0 hours, 44 minutes, and 0 seconds. Prior temperature excursion were reported as -11.25 degree Celsius for 0 hours 30 minutes 0 seconds, -11.63 degree Celsius for 0 hours, 30 minutes, and 0 seconds; -8.69 degree Celsius for 0 hours, 44 minutes, and 0 seconds; -9.63 degree Celsius for 0 hours, 36 minutes, and 0 seconds. No additional adverse events reported (no adverse event). ; Sender's Comments:  US-009507513-2410USA003178: US-009507513-2410USA003525:MSD US-009507513-2410USA003167: US-009507513-2410USA003126: US-009507513-2410USA003090: US-009507513-2410USA003126: US-009507513-2410USA003185: US-009507513-2410USA003473: US-009507513-2410USA003474: US-009507513-2410USA003497: US-009507513-2410USA003533:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report a TE. HCP also called yesterday for a TE and was mistakenly given supported outcomes for MMR II and VARIVAX. (Case 02685548). Due to this, MMR II and VARIVAX were administered to patients. No additional AE/No PQC.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-OCT-2024, the patient wasvaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #X018902, expiration date: 12-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #Y006582, expiration date: 26-MAR-2026, administered for prophylaxis (strength, and route of administration were not provided). Those vaccines underwent temperature excursion (Product storage error) No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; HCP called to report TE where products were administered after stored improperly. No Additional information provided. No Additional AE/ No PQC.    0 hours 30 minutes 0 seconds @ -11.25c (prior) o hours 30 minutes 0 seconds @-11.63c (prior) 0 hours 44; This spontaneous report was received from legal practitioner nurse and refers to a 5-year-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 30-SEP-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #y012074, expiration date: 05-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent multiple temperature excursion in -11.25 degree Celsius for 30 minutes, in -11.63 degree Celsius for 30 minutes, in -8.69 degree Celsius for 44 minutes, in -9.36 degree Celsius for 36 minutes and -8.25 degree Celsius for 44 minutes (Produst storage error). No additional adverse event was reported.; Sender's Comments:  US-009507513-2410USA003525:MSD
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; TE where products were administered after stored improperly; This spontaneous report was received from a licensed practical nurse and refers to a 16-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 01-OCT-2024, the patient was vaccinated with improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot # reported and confirmed as: y010374, expiration date reported and confirmed as: 05-JUN-2026, administered for prophylaxis by a health professional (strength, site and route of administration were not provided). Temperature excursion details: 30 minutes at -11.25 degree Celsius (C) (prior), 30 minutes at -11.63 C (prior), 44 minutes at - 8.69 C (prior), 36 minutes at -9.63 C (prior), 44 minutes at -8.25 C (current). There was no additional adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA003525:MSD US-009507513-2410USA003167:
Sex: F
Vaccine: HPV9, MMR
Symptoms: Dizziness
Clinical narrative: felt slightly faint; Was also slightly needle phobic; This spontaneous report has been received from a nurse, regarding a currently 19-year-old female patient. The patient's previous allergies, medical history, concurrent conditions, and concomitant medications were not provided.   On unspecified date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administrated in the right deltoid (arm) (strength, dose, frequency, route of administration, and vaccination scheme were not provided; lot # 3022585 which has been verified to be a valid number, expiration date was reported as unspecified date in January 2025 and validated as 31-JAN-2025); and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin [rHA]) (M-M-RVAXPRO) subcutaneous injection, administrated in the left deltoid (arm) (strength, dose, frequency, route of administration, and vaccination scheme were not provided; lot # X003546 which has been verified to be a valid number, expiration date was reported as unspecified date in January 2025 and validated as 31-JAN-2025) as a prophylaxis. The patient was slightly needle phobic (fear of injection).   On unspecified date reported as 4 minutes after vaccination, the patient felt slightly faint (dizziness). A glass of water and chocolate biscuit were given. On unspecified date, the event of dizziness was spontaneously resolved. At the reporting time, the outcome of the event of fear of injection was not provided and there were no other problems knew to expected.   The causal relationship between suspect vaccine with the events was not reported.
Age: 62.0
Sex: F
Vaccine: PNC15
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Rash, Rash erythematous
Clinical narrative: she developed a "big red rash the size of my palm", arm pain in which the patient "cannot lift her arm", and a fever; she developed a "big red rash the size of my palm", arm pain in which the patient "cannot lift her arm", and a fever; she developed a "big red rash the size of my palm", arm pain in which the patient "cannot lift her arm", and a fever; she developed a "big red rash the size of my palm", arm pain in which the patient "cannot lift her arm", and a fever; the rash was "very warm to the touch"; This spontaneous report was received from a patient referring to herself, a 62-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 01-OCT-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (0.5mL, lot#: Y005465, expiration date was not provided but upon internal validation indicated as 08-JAN-2027) intramuscularly (IM) at the facility for pneumonia (product use in unapproved indication).  On 01-OCT-2024, the same day of vaccination, the patient developed a big red rash the size of her palm, arm pain in which the patient cannot lift her arm. Since an unknown date in October 2024, the rash was very warm to touch. Later in the week, on an unknown date in October 2024, the patient developed fever. The reporter contacted the pharmacy regarding her side effects, and they informed her to put ice on the rash and to take Benadryl. At the time of reporting, the patient did not recover from the events above. The causal relationship between the events above and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) was unknown.
Age: 62.0
Sex: F
Vaccine: PNC15
Symptoms: Skin warm
Clinical narrative: she developed a "big red rash the size of my palm", arm pain in which the patient "cannot lift her arm", and a fever; she developed a "big red rash the size of my palm", arm pain in which the patient "cannot lift her arm", and a fever; she developed a "big red rash the size of my palm", arm pain in which the patient "cannot lift her arm", and a fever; she developed a "big red rash the size of my palm", arm pain in which the patient "cannot lift her arm", and a fever; the rash was "very warm to the touch"; This spontaneous report was received from a patient referring to herself, a 62-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 01-OCT-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (0.5mL, lot#: Y005465, expiration date was not provided but upon internal validation indicated as 08-JAN-2027) intramuscularly (IM) at the facility for pneumonia (product use in unapproved indication).  On 01-OCT-2024, the same day of vaccination, the patient developed a big red rash the size of her palm, arm pain in which the patient cannot lift her arm. Since an unknown date in October 2024, the rash was very warm to touch. Later in the week, on an unknown date in October 2024, the patient developed fever. The reporter contacted the pharmacy regarding her side effects, and they informed her to put ice on the rash and to take Benadryl. At the time of reporting, the patient did not recover from the events above. The causal relationship between the events above and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant calling to report inadvertently administering ROTATEQ vaccines after experiencing a temperature excursion.; No additional AE reported; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (dose and route of administration were not reported; lot number 2003138 has been verified to be valid, expiration date 29-APR-2025), after experiencing a temperature excursion at 10.3 Celsius degree (C) for 2 hours and 14 minutes (product storage error). There was no previous temperature excursion, and no additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA004231:MSD US-009507513-2410USA004047:MSD
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection was painful/injection site pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-OCT-2024, the patient received the 1st dose of Shingrix (right deltoid). On 03-OCT-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection was painful/injection site pain). The outcome of the injection site pain was not resolved.   The reporter considered the injection site pain to be related to Shingrix.     The company considered the injection site pain to be related to Shingrix.   Additional Information: GSK receipt Date: 03-OCT-2024 The patient received Shingrix vaccine and experienced a pain at injection site.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Electric shock sensation, Headache, Neck pain, Pain
Clinical narrative: I feel the sharp pain/Feeling like a burning/sharp pain when I walked; I can move my left arm and turn my head very slowly; I'm still having pain in my neck; feeling of shock; I'm still having pain in my neck going up my left side of the back of my head; Feeling like a burning/sharp pain when I walked. Moving from my arm to my left side of my head; This non-serious case was reported by a consumer and described the occurrence of pain upon movement in a 53-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J4349, expiry date 17-JUN-2025) for prophylaxis.   On 26-SEP-2024, the patient received FluLaval 2024-2025 season .5 ml. On 27-SEP-2024, 1 days after receiving FluLaval 2024-2025 season, the patient experienced pain upon movement (Verbatim: I feel the sharp pain/Feeling like a burning/sharp pain when I walked), mobility decreased (Verbatim: I can move my left arm and turn my head very slowly), neck pain (Verbatim: I'm still having pain in my neck), electric shock sensation (Verbatim: feeling of shock), headache (Verbatim: I'm still having pain in my neck going up my left side of the back of my head) and pain in arm (Verbatim: Feeling like a burning/sharp pain when I walked. Moving from my arm to my left side of my head). The outcome of the pain upon movement, mobility decreased, neck pain, electric shock sensation, headache and pain in arm were not resolved.   It was unknown if the reporter considered the pain upon movement, mobility decreased, neck pain, electric shock sensation, headache and pain in arm to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the pain upon movement, mobility decreased, neck pain, electric shock sensation, headache and pain in arm to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 04-OCT-2024 The patient self-reported this case. The patient could move her left arm and turn her head very slowly because she felt the sharp pain and get a feeling of shock.  So, patient just turned her body when she need to turn her head. The patient still had pain in my neck going up left side of the back of head. The patient not able to move left arm or turn her head to the left side. Felt like a burning/sharp pain when she walked. Moving from her arm to her left side of head. The symptoms were not treated.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Severe shingles/bilateral shingles on abdomen and arms. Unilateral shingles on face, neck and head will small amount of shingles bilateral on nose.; Drug dose administration interval too long; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number K7T79) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number EZ4TD) for prophylaxis.   Concomitant products included aciclovir (Acyclovir).   On 22-FEB-2022, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 29-OCT-2021, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 22-FEB-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On 30-SEP-2024, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Severe shingles/bilateral shingles on abdomen and arms. Unilateral shingles on face, neck and head will small amount of shingles bilateral on nose.). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt date:06-October-2024 The patient experienced severe shingles, bilateral shingles on abdomen and arms, and unilateral shingles on face, neck and head will small amount of shingles bilateral on nose. Patient were also taking other drugs such as acyclovir 800mg in 5 times a day for 7 days which was still ongoing. Patient stated that, she was concerned vaccination wasn't effective.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(1 and 2 dose).                 Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix(1 and 2 dose).
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (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 sickness (Verbatim: felt very sick). The outcome of the sickness was not resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2024 and 04-OCT-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine and felt very sick. The patient would be getting the 2nd dose the day after reporting and the patient dreading the side effects.  The patient stated that hopefully it would not be as bad as the first one.  The patient guessed it was not as bad as getting shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity, Pyrexia
Clinical narrative: did not sleep; fever; arm pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of insomnia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 06-OCT-2024, the patient received Shingles vaccine. In OCT-2024, an unknown time after receiving Shingles vaccine, the patient experienced insomnia (Verbatim: did not sleep), fever (Verbatim: fever) and pain in arm (Verbatim: arm pain). The outcome of the insomnia, fever and pain in arm were not reported.   It was unknown if the reporter considered the insomnia, fever and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the insomnia, fever and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 07-OCT-2024 This case was reported by a patient via interactive digital media. The reporter reported that day before reporting he/she received Shingles vaccine and he/she did not sleep because of the fever and lot of arm. The reporter think it was worth it to had such a horrible disease.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: received Arexvy diluent mixed with Shingrix diluent by error; received Arexvy diluent mixed with Shingrix diluent by error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-SEP-2024, the patient received Arexvy. On 19-SEP-2024, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: received Arexvy diluent mixed with Shingrix diluent by error) and inappropriate dose of vaccine administered (Verbatim: received Arexvy diluent mixed with Shingrix diluent by error). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-SEP-2024 The pharmacist reported that a couple received Arexvy full dose vaccine and Arexvy diluent mixed with Shingrix diluent by error.  The patient received Arexvy reconstituted with Shingrix adjuvant alone ( no data available about lot numbers in this case), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The other patient received Arexvy properly dose (lot number: G75S4 for the powder portion and lot number for the adjuvant portion was  354Z9). The Vaccine Administration Facility was the same as Primary Reporter. This case is linked with US2024118285, reported by same reporter; Sender's Comments:  US-GSK-US2024118285:Same reporter
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: received Arexvy diluent mixed with Shingrix diluent by error.; received Arexvy diluent mixed with Shingrix diluent by error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 62-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-SEP-2024, the patient received Arexvy. On 19-SEP-2024, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: received Arexvy diluent mixed with Shingrix diluent by error.) and inappropriate dose of vaccine administered (Verbatim: received Arexvy diluent mixed with Shingrix diluent by error). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-SEP-2024 The pharmacist reported that a couple received Arexvy full dose vaccine and Arexvy diluent mixed with Shingrix diluent by error.  The patient received Arexvy reconstituted with Shingrix adjuvant alone ( no data available about lot numbers in this case), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The other patient received Arexvy properly dose (lot number: G75S4 for the powder portion and lot number for the adjuvant portion was  354Z9). The Vaccine Administration Facility was the same as Primary Reporter. This case is linked with US2024118283, reported by same reporter; Sender's Comments:  US-GSK-US2024118283:Same reporter
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to a 9 month-old patient; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 9 month-old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-OCT-2024 The physician reported that there was an administration of Kinrix vaccine to the patient of an inappropriate age, which led to inappropriate age at vaccine administration. The call got disconnected while collecting patient and vaccine information.
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9mo old infant received Kinrix as their 3rd dose of DTaP and IPV; 9mo old infant received Kinrix as their 3rd dose of DTaP and IPV; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 04-OCT-2024, the patient received Kinrix. On 04-OCT-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 9mo old infant received Kinrix as their 3rd dose of DTaP and IPV) and inappropriate schedule of vaccine administered (Verbatim: 9mo old infant received Kinrix as their 3rd dose of DTaP and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 04-OCT-2024 The infant received Kinrix as their 3rd dose of DTaP and IPV. The child was meant to receive both but reporter noticed the age indication after administration today (on the day of reporting), which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue, Syncope
Clinical narrative: Administration of only the liquid component; Administration of only the liquid component; experienced an episode of syncope after the administration of the vaccine.; This serious case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA989A, expiry date 30-NOV-2024) for prophylaxis.   On 06-OCT-2024, the patient received the 1st dose of Menveo. On 06-OCT-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the liquid component) and inappropriate dose of vaccine administered (Verbatim: Administration of only the liquid component). In OCT-2024, the patient experienced syncope (Verbatim: experienced an episode of syncope after the administration of the vaccine.) (serious criteria GSK medically significant). The outcome of the syncope was not reported and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the syncope to be related to Menveo.     The company considered the syncope to be unrelated to Menveo.   Additional Information: GSK Receipt date : 07-OCT-2024 Pharmacist was a reporter. HCP called to report that a patient received only the liquid portion of the Menveo 2 vial presentation.  Reporter asked if they need to repeat the dose also HCP mentioned that patient experienced an episode of syncope after the administration of the vaccine. The patient received only the liquid portion of the Menveo 2-vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments: Syncope is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Menveo.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity
Clinical narrative: Sore arm; covid twice after vaccinations in January 2023 and in May 2024; covid twice after vaccinations in January 2023 and in May 2024; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), the first episode of COVID-19 (covid twice after vaccinations in January 2023 and in May 2024) and the second episode of COVID-19 (covid twice after vaccinations in January 2023 and in May 2024) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In January 2023, the patient experienced the first episode of COVID-19 (covid twice after vaccinations in January 2023 and in May 2024). In May 2024, the patient experienced the second episode of COVID-19 (covid twice after vaccinations in January 2023 and in May 2024). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and the last episode of COVID-19 (covid twice after vaccinations in January 2023 and in May 2024) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The patient had all doses of Moderna vaccine only. She mentioned that all the previous times she had only a sore arm. She also mentioned having covid twice after vaccinations in Jan 2023 and in May 2024. The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-774853 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774853:Same patient diffrent moderna product
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (little bit of sore arm) in a 72-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concomitant products included Celecoxib (Celexal) and Pantoprazole sodium sesquihydrate (Pantoprazole) for an unknown indication.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little bit of sore arm). The patient was treated with Ibuprofen (Advil) at a dose of when needed. At the time of the report, PAIN IN EXTREMITY (little bit of sore arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient stated that the first four or five that she had, she just whizzed through that with no problem at all, just a little bit of a sore arm. which didn't bother her. The patient insisted that for these vaccines, she didn't have any problems except the sore arm.   This case was linked to MOD-2024-774810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2024: Live non-significant follow-up added: references added. On 08-Oct-2024: Live significant follow-up accepted. narrative was updated. On 08-Oct-2024: Live non-significant follow up added: references  added.