chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Syncope, Tinnitus, Vibratory sense increased
Clinical narrative: Standing syncope on 5-25-22, Adverse reaction to TDAP 3-15-23, Standing syncope 3-31-23, Enterocolitis 3-31-23, Extreme Fatigue 4-8-23 to 10-5-23, Labile hypertension 4-8-23 to present now controlled by additional medications, Insomnia 4-8-23 to present, Lack of appetite 4-8-23 to 10-15-23, Severe anxiety (agoraphobic type) 4-8-23 to present now controlled by medication, Vibration and tingling in body and extremities 4-8-23 to January 2024, Standing syncope on 9-12-23, Tinnitus and right ear pain 4-8-23 to present.
Age: 18.0
Sex: F
Vaccine: HEP, MENB
Symptoms: Expired product administered
Clinical narrative: HEP B VACCINE WAS EXPIRED. EXPIRATION DATE 3/31/24.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Tenderness
Clinical narrative: Arm tenderness. 3 blisters on inner bicept, itching
Age: 1.42
Sex: F
Vaccine: HEP, HEPA
Symptoms: Expired product administered
Clinical narrative: HEP B VACCINE WAS EXPIRED AT TIME IT WAS ADMINISTERED. EXPIRATION DATE 3/31/24. RETURNING THIS WEEK FOR REPEAT DOSE.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Dyspnoea, Migraine
Clinical narrative: An hour after receiving first vaccine, started to develope migraine headache along with nausea, dizziness, total body aches/pain, and blurried vision. Spoke to Health Authority and they said it was normal and okay to get second shot. After second vaccine, I was in the ER a couple weeks after due to worsening migraine, nausea, trouble breathing, fever, body pain. Went to the ER 4 times before being admitted into the hospital. No one would acknowledge I got the vaccines and said it was an intractable migraine. Left hospital still presenting symptoms of migraine, weakening in body, body pain, nausea, and loss of balance.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Postural orthostatic tachycardia syndrome, Pyrexia, Tilt table test positive
Clinical narrative: An hour after receiving first vaccine, started to develope migraine headache along with nausea, dizziness, total body aches/pain, and blurried vision. Spoke to Health Authority and they said it was normal and okay to get second shot. After second vaccine, I was in the ER a couple weeks after due to worsening migraine, nausea, trouble breathing, fever, body pain. Went to the ER 4 times before being admitted into the hospital. No one would acknowledge I got the vaccines and said it was an intractable migraine. Left hospital still presenting symptoms of migraine, weakening in body, body pain, nausea, and loss of balance.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: An hour after receiving first vaccine, started to develope migraine headache along with nausea, dizziness, total body aches/pain, and blurried vision. Spoke to Health Authority and they said it was normal and okay to get second shot. After second vaccine, I was in the ER a couple weeks after due to worsening migraine, nausea, trouble breathing, fever, body pain. Went to the ER 4 times before being admitted into the hospital. No one would acknowledge I got the vaccines and said it was an intractable migraine. Left hospital still presenting symptoms of migraine, weakening in body, body pain, nausea, and loss of balance.
Age: 12.0
Sex: F
Vaccine: COVID19-2, COVID19-2, FLU4, HEPA, HPV9, VARCEL
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Incorrect dose for age originally administered. COVID Pfizer 5-11y. Immediately administered correct dose of Comirnaty ag 12+.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant called to report an excursion.; This spontaneous report was received from a medical assistant, referring to a patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant therapies were not reported.  On 01-APR-2024, the patient was administered of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, lot # X018732 has been verified to be a valid lot number, expiration date  reported and validated as 06-JAN-2025 for prophylaxis (strength, dose, frequency, and route of administration were not provided), after undergoing a temperature excursion (product storage error). Temperature excursion was as following: the vaccine was stored under 7.9 Fahrenheit (F)/6 F up to 14 F for 38 minutes. Previous temperature excursion included 6.3 F / 6 F to 14 F for 13 hours. No additional adverse event (AE)/ product quality concern (PQC) was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2404USA007180:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HBP reported AE on behalf of a patient who received PROQUAD and VARIVAX concomitantly due to staff error on 4/25/2024. HBP confirmed no product confusion. No symptoms reported. Obtained consent to contact HCP. MIR Filed (Case #02591864). No additiona; This spontaneous report was received from an other referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 25-APR-2024, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter, lot #X019557, expiration date 19-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X017485, expiration date 25-JUN-2025, both administered for prophylaxis (strength, and route of administration were not provided) for prophylaxis (extra dose administered). No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical assistant reported VAQTA was administered after a temperature excursion to patient. Date of administration: 4/25/2024.  Names of vaccines involved (including lot/exp): VAQTA (X025482 4/12/2025) Temperature: 32.9°F Time frame: 3 hours 18 minu; Medical assistant reported VAQTA was administered after a temperature excursion to patient. Date of administration: 4/25/2024.  Names of vaccines involved (including lot/exp): VAQTA (X025482 4/12/2025) Temperature: 32.9°F Time frame: 3 hours 18 minu; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 25-APR-2024, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (once, lot number: X025482, expiration date: 12-APR-2025; strength, dose, and route of administration were not reported) by a health professional for prophylaxis. The vaccine administered experienced temperature excursion before at the temperature of 32.9 F for 3 hours and 18 minutes (product storage error). No prior temperature excursion. No additional adverse events (AE) were reported (no adverse event).
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Susac's syndrome
Clinical narrative: 23 pneumococcal serotypes were only 8 out of 23; Literature article. This literature-marketed report has been received from the authors of a published article, titled as stated above, concerning a 37-year-old female patient.  Allergies or any other type of previous drug reactions were not reported.  On an unspecified date, when the patent was a child, she was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) injection, as prophylaxis (Strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported).  Then, on an unreported date, due to a past diagnose of Susac Syndrome(SS) and some other diagnosis and symptoms, the patient was required to do some workup before starting a treatment, including a titers test to the 23 pneumococcal serotypes which by that time were only 8 out of the 23 (Antibody test negative).  The outcome of the event was not provided.   It was stated that this antibody test negative was deemed to be related to timing from her administration of the pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) when she was a child.   A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VAQTA was administered after a temperature excursion to patient. Date of administration: 4/15/2024.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.    On 15-APR-2024, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X025482, expiration date: 12-APR-2025, administered for prophylaxis (strength, dose and route of administration were not provided). It was reported that the suspect vaccine was underwent temperature excursions of 32.9 degree Fahrenheit (F) (the time frame was 3 hours 18 minutes) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).  This is one of the 33 cases reported by same reporter. ; Sender's Comments:  US-009507513-2405USA000864:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported VAQTA was administered after a temperature excursion to patient. Date of administration: 4/12/2024.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.    On 12-APR-2024, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X025482, expiration date: 12-APR-2025, administered for prophylaxis (strength, dose and route of administration were not provided). It was reported that the suspect vaccine was underwent temperature excursions of 32.9 degree Fahrenheit (F) (the time frame was 3 hours 18 minutes) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).  This is one of the 33 cases reported by same reporter. ; Sender's Comments:  US-009507513-2405USA000864:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported RECOMBIVAX HB was administered after a temperature excursion to patient. Date of administration: 4/19/2024.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.    On 19-APR-2024, the patient was vaccinated with improperly stored hepatitis b vaccine thimerosal free (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #X006977, expiration date: 01-OCT-2025, administered for prophylaxis (strength, dose and route of administration were not provided). It was reported that the suspect vaccine was underwent temperature excursions of 32.9 degree Fahrenheit (F) (the time frame was 3 hours 18 minutes) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).  This is one of the 33 cases reported by same reporter. ; Sender's Comments:  US-009507513-2405USA000864:
Age: 0.42
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Reported that GARDASIL 9 was inadvertently administered to a 5 month old.; No additional AE; This spontaneous report was received from a physician and refers to a 5-month-old patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, at the age of 5 moths, the patient was inadvertently vaccinated with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, dose, dose#,  lot #, expiry date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional averse event (AE) was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; Medical assistant reported ROTATEQ was administered after a temperature excursion to patient. Date of administration: 4/30/2024 Names of vaccines involved (including lot/exp): ROTATEQ (1968386 5/23/2024) Temperature: 32.9°F Time frame: 3 hours 18 mi; This spontaneous report was received from a medical assistant and refers to a. patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 30-APR-2024, the patient was vaccinates with a one dose of improperly stored rotavirus vaccine (reported as: after a temperature excursion), live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968386, expiration date: 23-MAY-2024, orally,  (strength, exact dose, and dose#  was not provided) (product storage error). The suspect vaccine undergo temperature excursion of 32.9 Fahrenheit (F) degrees for 3 hours and 18 minutes. There was no previous temperature excursion. No additional  adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further information provided. No additional AE reported.; Medical assistant reported RECOMBIVAX HB was administered after a temperature excursion to patient. Date of administration: 4/11/2024.  Names of vaccines involved (including lot/exp): RECOMBIVAX HB (X006977 10/01/2025) Temperature: 32.9°F Time frame; This spontaneous report was received from medical assistant and refers to a unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-APR-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, once, lot #X006977, expiration date: 01-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 32.9 Farenheit for 3 hours 18 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported VAQTA was administered after a temperature excursion to patient.; This spontaneous report was received from an other health professional (Medical Assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 17-APR-2024, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (formulation pre-filled syringe), once, lot #X025342, expiration date: 12-MAY-2025, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 32.9 Fahrenheit degrees (F) for 3 hours and 18 minutes (product storage error, onset date: 17-APR-2024). Previous temperature excursion was reported as no. There was no additional adverse event reported (no adverse event).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; RECOMBIVAX HB was administered after a temperature excursion to patient; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 29-APR-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dosage form, lot #X002469, verified to be valid as formulation vial, expiration date: 22-MAY-2025, administered for prophylaxis (anatomical location, strength, and route of administration were not provided), and the product was after a temperature excursion to patient; temperature: 32.9 F degrees, time frame: 3 hours 18 minutes. No previous temperature excursion. No further information provided. No additional adverse events reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptoms reported / no additional AE; Caller reported AE on behalf of a patient who received expired dose of GARDASIL 9; This spontaneous report has been received from a consumer, referring to a 14-year-old patient of an unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 02-MAY-2024, the patient was vaccinated with expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, at a dose of 0.5 mL, lot# U029033, expiry date 13-MAR-2024, for prophylaxis (route of administration and anatomical location were not reported) (expired product administered). No symptoms reported (no adverse event).
Sex: F
Vaccine: RV5
Symptoms: Underdose, Vomiting
Clinical narrative: patient received a dose of ROTATEQ but the patient threw it up; patient received a dose of ROTATEQ but the patient threw it up; This spontaneous report was received from a physician via field employee and refers to a female patient of unknown age. The patient's medical history concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (strength, dose description, lot #, expiry date, anatomical location and route of administration were not provided) and the patient threwit up (vomiting,accidental underdose). The outcome of the event was not provided.   The causal relationship between the event and suspect vaccine was not reported.   Lot # was being requested and will be submitted if received.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received first dose of GARDASIL 9 in 2015, and then second/third dose within the past year; No additional AE reported; This spontaneous report was received from a pharmacist and refers to a 38-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2015, the was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection,  administered for prophylaxis (strength, vaccine scheme, lot #, expiry date, and route of administration, anatmical location were not provided) an on an unknown date in 2023 (reported as past year), received the second and third dose (strengths, vaccine schemes, lot #, expiry dates, routes of administration and anatmical location were not provided) (Inappropriate schedule of product administration). No additional Adverse event reported.   Lot # was being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: still have pain under my arm; Suspected vaccination failure/ I also got the shot and also got shingles; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAY-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ I also got the shot and also got shingles) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). On an unknown date, the patient experienced pain in arm (Verbatim: still have pain under my arm). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2024 This case was reported by a patient via interactive digital media. The patient reported that did not get to confident, as he/she also got the shot and also got shingles last May, still have pain under his/her arm. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; It gave some people shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: It gave some people shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 30-APR-2024 This case was reported by a patient via interactive digital media. The reporter reported that when he/she went to see his/her physician, physician told that it had to be administered after got better. The patients received Shingles vaccine and experienced shingles. The vaccine can cause paralysis. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had the vaccine and still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had the vaccine and still got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2024 The case was received from the patient via interactive digital media. The patient self reported this case for himself/herself. The reporter reported that, had the vaccine and still got them.  At the time of reporting the patient was suffering for about a month. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Sensory loss
Clinical narrative: Guillain Barre Syndrome; permanent loss of feeling in feet and both legs, to the knees; This serious case was reported by a nurse via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included whipple's operation.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant) and peripheral neuropathy (Verbatim: permanent loss of feeling in feet and both legs, to the knees) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and peripheral neuropathy were not reported.   It was unknown if the reporter considered the guillain barre syndrome and peripheral neuropathy to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome and peripheral neuropathy to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-MAY-2024 This case was reported by a patient via (social media) interactive digital media. The patient reported that be careful before taking dual vaccine injections, talk to your physician or specialist, if you had an immunity problem or had undergone major surgeries such as whipple (pancreas) surgery, or have had epstein barre. The patient stated that you could wind up with guillain barre syndrome like she did, now (at the time of reporting) had permanent loss of feeling in feet and both legs, to the knees.  The patient did not know or was told of the possible side effect of the vaccine. The patient asked if it was worth it and also stated that she made a mistake.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Flank pain, Muscle strain
Clinical narrative: Feels like a very bad lupus flare (Extreme body aches); Fever; Chills; Fatigue extreme; Joint pain; Flank pain; Back strain; Arm pain; Inappropriate age at vaccine administration; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus, bronchial asthma and gastroesophageal reflux disease. Concomitant products included methotrexate, hydroxychloroquine, dupilumab (Dupixent) and omeprazole (Protonix).   On 22-SEP-2023, the patient received Shingrix. On 22-SEP-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 23-APR-2024, the patient experienced pain in arm (Verbatim: Arm pain). On 24-APR-2024, the patient experienced general body pain (Verbatim: Feels like a very bad lupus flare (Extreme body aches)), fever (Verbatim: Fever), chills (Verbatim: Chills), fatigue (Verbatim: Fatigue extreme), joint pain (Verbatim: Joint pain), flank pain (Verbatim: Flank pain) and back strain (Verbatim: Back strain). The outcome of the general body pain, fever, chills, pain in arm, fatigue, joint pain, flank pain and back strain were not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the general body pain, fever, chills, pain in arm, fatigue, joint pain, flank pain and back strain to be related to Shingrix.     It was unknown if the company considered the general body pain, fever, chills, pain in arm, fatigue, joint pain, flank pain and back strain to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2024 The patient was received Shingrix vaccine and experienced feels like a very bad lupus flare (Extreme body aches), fever, chills, arm pain, fatigue extreme, joint pain, flank pain and back strain. The expiry date and bath/lot number of Shingrix vaccine was unknown. The patient was received Methotrexate, Plaquenil, Dupixent and Protonix for the treatment. The symptoms feels like a very bad lupus flare (Extreme body aches), fever, chills, arm pain, fatigue extreme, joint pain, flank pain and back strain was treated. The reporter consent to follow up.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Feels like a very bad lupus flare (Extreme body aches); Fever; Chills; Fatigue extreme; Joint pain; Flank pain; Back strain; Arm pain; Inappropriate age at vaccine administration; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus, bronchial asthma and gastroesophageal reflux disease. Concomitant products included methotrexate, hydroxychloroquine, dupilumab (Dupixent) and omeprazole (Protonix).   On 22-SEP-2023, the patient received Shingrix. On 22-SEP-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 23-APR-2024, the patient experienced pain in arm (Verbatim: Arm pain). On 24-APR-2024, the patient experienced general body pain (Verbatim: Feels like a very bad lupus flare (Extreme body aches)), fever (Verbatim: Fever), chills (Verbatim: Chills), fatigue (Verbatim: Fatigue extreme), joint pain (Verbatim: Joint pain), flank pain (Verbatim: Flank pain) and back strain (Verbatim: Back strain). The outcome of the general body pain, fever, chills, pain in arm, fatigue, joint pain, flank pain and back strain were not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the general body pain, fever, chills, pain in arm, fatigue, joint pain, flank pain and back strain to be related to Shingrix.     It was unknown if the company considered the general body pain, fever, chills, pain in arm, fatigue, joint pain, flank pain and back strain to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2024 The patient was received Shingrix vaccine and experienced feels like a very bad lupus flare (Extreme body aches), fever, chills, arm pain, fatigue extreme, joint pain, flank pain and back strain. The expiry date and bath/lot number of Shingrix vaccine was unknown. The patient was received Methotrexate, Plaquenil, Dupixent and Protonix for the treatment. The symptoms feels like a very bad lupus flare (Extreme body aches), fever, chills, arm pain, fatigue extreme, joint pain, flank pain and back strain was treated. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Body aches; fever; chills; felt bad/felt terrible; This non-serious case was reported by a other health professional via sales rep and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (1st dose received on an unknown date, reference case US2024AMR058348).   In APR-2023, the patient received the 2nd dose of Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: Body aches), fever (Verbatim: fever), chills (Verbatim: chills) and feeling abnormal (Verbatim: felt bad/felt terrible). Rechallenge with Shingrix was positive. The outcome of the general body pain, fever, chills and feeling abnormal were resolved.   The reporter considered the general body pain, fever and chills to be related to Shingrix. It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.     The company considered the general body pain, fever and chills to be related to Shingrix. It was unknown if the company considered the feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR058348   Additional Information: GSK Receipt Date: 25-APR-2024 The patient self-reported this case. The patient experienced body aches, fever and chills approximately a year ago (from reporting date) after a subsequent dose of Shingrix. The patient felt terrible and that it lasted for 36 to 48 hours. The patient felt bad after both shots and never worse after second dose in series. It was unknown if patient was taking other medications. This case had been link with US2024AMR058348, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR058348:Same reporter, US2024AMR058348 1st dose
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This non-serious case was reported by a physician and described the occurrence of extra dose administered in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3372J, expiry date 17-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (1st dose received on an unknown date).   On 19-DEC-2023, the patient received the 2nd dose of Arexvy. On 19-DEC-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 26-APR-2024 and 27-APR-2024 Vaccine Reimbursement Center representative transferred the above Healthcare professional over to Medical Information as a patient was given a 2nd dose of Arexvy which led to extra dose administered. The reporter stated that she was provided with the lot number and expiration date for the first dose of Arexvy but forgot to get the lot number and expiration for the 2nd dose administered by the pharmacy.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Periorbital swelling, Swelling face
Clinical narrative: swelling and redness above/around only one eye and then appeared on her cheek (only one side of face); swelling and redness above/around only one eye and then appeared on her cheek (only one side of face); swelling and redness above/around only one eye and then appeared on her cheek; swelling and redness above/around only one eye and then appeared on her cheek; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of eye swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-MAR-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced eye swelling (Verbatim: swelling and redness above/around only one eye and then appeared on her cheek (only one side of face)), eye red (Verbatim: swelling and redness above/around only one eye and then appeared on her cheek (only one side of face)), red face (Verbatim: swelling and redness above/around only one eye and then appeared on her cheek) and facial swelling (Verbatim: swelling and redness above/around only one eye and then appeared on her cheek). The outcome of the eye swelling, eye red, red face and facial swelling were resolved.   It was unknown if the reporter considered the eye swelling, eye red, red face and facial swelling to be related to Shingrix.     It was unknown if the company considered the eye swelling, eye red, red face and facial swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2024 The reporter did not know which dose number of this vaccine. It was reported that the patient had swelling and redness above and around only one eye and then appeared on her cheek only one side of face. The patient had taken an allergy pill but felt it did not much and swelling went away on its own after a few days. She described the feeling being similar to a mosquito bite. No blister formation or scabs noted. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Cough, Throat clearing
Clinical narrative: Cough nonproductive; clearing of throat; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough nonproductive in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough nonproductive (Verbatim: Cough nonproductive) and throat clearing (Verbatim: clearing of throat). The outcome of the cough nonproductive and throat clearing were resolved (duration 2 months).   It was unknown if the reporter considered the cough nonproductive and throat clearing to be related to Arexvy.     It was unknown if the company considered the cough nonproductive and throat clearing to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-APR-2024 This case was reported by a patient via interactive digital media. The patient had cough non productive and clearing of throat steady for 2 months since vaccine for RSV. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero instead of Menquadfi; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero instead of Menquadfi). The outcome of the wrong vaccine administered 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: 24-APR-2024 The pharmacist called to inform about a situation where Bexsero was given instead of Menquadfi, according to reporter, there were 'a couple of different doses' given to an unknown number of patients that were over 16 years old , which led to wrong vaccine administered. The reporter did not had information on dates of administration. The reporter agreed to provide more details upon follow up by safety team. The case was linked with US2024052728 via Linked Report considering the Same reporter and different patient.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient over 7 years received Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2227K, expiry date 17-JAN-2026) for prophylaxis.   On 05-APR-2024, the patient received the 1st dose of Pediarix. On 05-APR-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient over 7 years received Pediarix). 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: 24-APR-2024 It was reported that a patient was given Pediarix but aged out for that combo which led to inappropriate age at vaccine administration This was the 1st dose. She needed to be re vaccinated with separate vaccines in 4 weeks. Mother was aware of this.; Sender's Comments:  US-GSK-US2024043649:same reporter/ Different patient US-GSK-US2024043627:same reporter/ different patient
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17-FEB-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-APR-2024 The pharmacist received a box Shingrix vaccine from wholesaler, with expiration date 17 February 2024 the pharmacist want to know if he/she could use these vaccines or it was not good anymore, it had already two months passed since the expiration date, it was already administered. The pharmacist just got it on Monday and reported, he/she administered already, so he/she need to know what to do because the expiration date was two months prior. The pharmacist refused to provide patient's basic information because it was the whole box had been given. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Joint fluid drainage
Clinical narrative: experience knee pain (bilateral).; Both knees burn all the time; This non-serious case was reported by a consumer via call center representative and described the occurrence of knee pain in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included arthritis.   On 07-FEB-2024, the patient received Arexvy (right deltoid). In FEB-2024, between 2 and 3 weeks after receiving Arexvy, the patient experienced knee pain (Verbatim: experience knee pain (bilateral).) and burn of unspecified degree of knee (Verbatim: Both knees burn all the time). The outcome of the knee pain and burn of unspecified degree of knee were not resolved.   It was unknown if the reporter considered the knee pain and burn of unspecified degree of knee to be related to Arexvy.     It was unknown if the company considered the knee pain and burn of unspecified degree of knee to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-APR-2024 The reporter was the patient.  The patient received Arexvy in the upper right arm and about two and one-half weeks later, she began to experience severe knee pain (bilateral).  The left knee was worse than the right knee and had both knees burn all the time.  The patient had been to orthopedic doctors three times since receiving Arexvy. The fluid had been removed from the left knee and the patient had received steroid injections. The patient reported she never had problems from receiving any other vaccine or problems with her knees.  The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: did not receive 3rd dose of Pediarix prior to the seventh birthday; Inappropriate schedule of vaccine/ received 2 doses of Pediarix and 1 dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of product administration in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (received 1st dose at the of 5 year old on 04-MAY-2021 from batch number 2AJ32 with expiry date 02-SEP-2022) and Pediarix (received 2nd dose at the age of 6 year old on 17-MAR-2022 from batch number 5N259 with expiry date 05-OCT-2023).   On 25-SEP-2022, the patient received Kinrix. On an unknown date, the patient did not receive the 3rd dose of Pediarix. On 25-SEP-2022, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced inappropriate schedule of product administration (Verbatim: Inappropriate schedule of vaccine/ received 2 doses of Pediarix and 1 dose of Kinrix). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: did not receive 3rd dose of Pediarix prior to the seventh birthday). The outcome of the inappropriate schedule of product administration and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: SK Receipt Date: 25-APR-2024 Registered nurse (RN) requested data whether to administer Boostrix or Infanrix vaccine to a 7-year-old patient. The patient had received 2 doses of Pediarix and one dose of Kinrix, which led to an inappropriate schedule of product administration. Till the time of reporting, the patient did not receive 3rd dose of Pediarix prior to the 7th birthday, which led to an incomplete course of vaccination.  The reporter consent to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired dose applied; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15-APR-2024) for prophylaxis.   On 25-APR-2024, the patient received Pediarix. On 25-APR-2024, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired dose applied). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-APR-2024 The pharmacist reported that Pediarix vaccine that expired 15th April 2024 was applied to a patient, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose of vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 25-APR-2024, the patient received the 5th dose of Infanrix. On 25-APR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose of vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-APR-2024 The vaccine representative from GlaxoSmithKline reported on behalf of medical assistant that they had given dtap Infanrix to the patient on the day of reporting and it was showing on the box it expired 4 days ago (from the date of reporting), which led to an expired vaccine used. The reporter wanted to know what the course of action was.  The reporter consented to follow up.