chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Oxygen saturation decreased, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I received my second Pfizer COVID-19 booster on 7/15/2022. On 12/19/2022, I woke up with a heaviness in my body that was centered in my chest. I then took a home antigen test, and I got a positive result. My husband had tested positive two days prior, so I was expecting it. I felt unable to function, so I pretty much stayed in bed the whole time, except the times I would get up to fix food. I had a headache and disorientation. About 6 days in, I had an episode in which my oxygen level went down to 86. I became disoriented, so I had a lie down for about an hour. After about an hour, my oxygen level was normal again, so I got back up and went to the kitchen to do some work. When I went to the kitchen, I felt faint and disoriented again. Not only that, but my left thumb had turned blue! The area from the base of the thumb to the knuckle was purplish black, kind of like a bruise. There was no pain, though. I had another lie down, and I did not get back up. Thankfully, it didn't happen again after that. During my illness, I felt like I had congestion in the chest, but I couldn't cough it up. I avoided coughing, because I was afraid coughing would make it worse. I felt unable to function, because I had really intense fatigue. Despite my fatigue, though, I had trouble sleeping. Most nights, I would be awake until 4 AM. However, I was still able to eat; my senses of smell and taste were not affected by the virus. During my illness, I took echinacea tea, elderberry gummies, manuka honey, and ADVIL. I tested myself on day 8, day 12, and day 16, and it wasn't until day 16 that I got a negative result. At the time of this writing, I sort of still have some residual symptoms. I do my normal pre-COVID-19 activities (e.g. grocery shopping) every other day, and I'm always exhausted on the days in between. Prior to COVID-19, I would sometimes walk for a mile, but I have not been able to do that since getting sick.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Confusional state, Depersonalisation/derealisation disorder, Fatigue, Hyperhidrosis, Lethargy
Clinical narrative: Confusion x 3 days; Extreme sweating to the point I needed to change undershirt and underwear at night for 3 days; slight vertigo and depersonalization for 3 days. Heavy Fatigue/Lethargy for 3 days. Never experienced such symptoms from any vaccination nor booster. I have had COVID confirmed via a test months prior. Vaccination booster felt FAR FAR worse than COVID itself. I do not believe I wish to go through these symptoms from a vaccination again.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vertigo
Clinical narrative: Confusion x 3 days; Extreme sweating to the point I needed to change undershirt and underwear at night for 3 days; slight vertigo and depersonalization for 3 days. Heavy Fatigue/Lethargy for 3 days. Never experienced such symptoms from any vaccination nor booster. I have had COVID confirmed via a test months prior. Vaccination booster felt FAR FAR worse than COVID itself. I do not believe I wish to go through these symptoms from a vaccination again.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Dr. placed Hep A vaccine for patient. I discharge patient. Patient should get Hep A 0.5ml. But I got Hep A 1ml and administered to patient. Verified vaccine with Dr. before administer. Notified Dr. right away when error occurred. Dr. explained to patient's parents.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Chest X-ray normal, Chest pain, Chlamydia test negative, Echocardiogram normal
Clinical narrative: I woke up with extreme burning chest pain at 5:30 am on December 25, 2022.  Breathing was still normal, but the chest was hurting and the pain would not go away. Got driven to the Hospital and admitted into the ER.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Full blood count normal, Magnetic resonance imaging abnormal, Metabolic function test normal, Mycoplasma test negative
Clinical narrative: I woke up with extreme burning chest pain at 5:30 am on December 25, 2022.  Breathing was still normal, but the chest was hurting and the pain would not go away. Got driven to the Hospital and admitted into the ER.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Respiratory pathogen panel, SARS-CoV-2 test negative, Scan with contrast abnormal, Sleep disorder
Clinical narrative: I woke up with extreme burning chest pain at 5:30 am on December 25, 2022.  Breathing was still normal, but the chest was hurting and the pain would not go away. Got driven to the Hospital and admitted into the ER.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin, Troponin I increased
Clinical narrative: I woke up with extreme burning chest pain at 5:30 am on December 25, 2022.  Breathing was still normal, but the chest was hurting and the pain would not go away. Got driven to the Hospital and admitted into the ER.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bronchitis, Ear infection, Influenza virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: I had congestion that led to a sinus and ear and progressed to bronchitis. I was tested for COVID-19, influenza both came back negative. I was given antibiotic medication to help get rid of the sinus and ear infection. I am still battling the bronchitis.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: I had congestion that led to a sinus and ear and progressed to bronchitis. I was tested for COVID-19, influenza both came back negative. I was given antibiotic medication to help get rid of the sinus and ear infection. I am still battling the bronchitis.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pruritus, Rash, Rash papular, Rash pruritic
Clinical narrative: Received vaccine elsewhere on 12-22-22. Mother reports rash noted the next day on arms & legs. Itchy, scratching. Child seen at our clinic on 12-27-22. Rash on extremities tense, erythematous papules, generalized distribution, no drainage or tenderness. Talked w/ mom the next week. Rash almost completely gone.
Age: 1.25
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; GARDASIL 9 was administered to 15 month old female patient on 12/22/22, along with MMR II, VARIVAX and HEPATITIS A vaccines.; This spontaneous report was received from a nurse prescriber via company representative and refers to a 15-month-old female patient (discrepancy, also reported as 3-month old).  The patient's medical history and concurrent conditions were not reported. The patient's concomitant medications included: Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), varicella virus vaccine live (Oka/Merck) (VARIVAX), Hepatitis A Vaccine, Inactivated (manufacturer unknown) (reported as hepatitis A vaccine), all administered on 22-DEC-2022 for prophylaxis.  On 22-DEC-2022, the patient was vaccinated also with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, administered once (strength, route of administration, vaccination site, dose number, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported.; administered a dose of PROQUAD via the intramuscular route instead of the subcutaneous route; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical histories, concomitant medications, concurrent conditions and  drug reaction/allergies were not reported.  On 04-JAN-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA), (PROQUAD) (dose considered as 1 dosage form, lot #W029548, expiration date: 14-MAR-2024, strength and anatomical site of administration were not provided) via the intramuscular route instead of the subcutaneous route for prophylaxis (incorrect route of product administration). No additional AE was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; PROQUAD was administered to a patient on 12/13/2022 after a supported temperature excursion that took place on 12/1/2022.; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's medical histories, concomitant medications, concurrent conditions and drug reaction/allergies were not reported.  On 13-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (0.5 milliliters, lot #W020552, expiration date: 26-DEC-2023, recombinant Human albumin [rHA] ) administrated for prophylaxis (strength, route of administration and anatomical site of administration were not provided), which supported temperature excursion occurred on 01-DEC-2022, the temperature was reported as 19.47 degree Fahrenheit (F) for 50 minutes (product storage error). The temperature excursion was not occurred previously. No additional adverse event  information was provided (no adverse event).
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: At this time patient is not experiencing any side effects/symptoms. No additional AE details available. No additional AE reported; Inbound call from nurse who reports 4th dose of GARDASIL 9 has been administered to a patient. Product was administered 1/9/2023. At this time patient is not experiencing any side effects/symptoms. No additional AE details available. No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unspecified age. Her concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 09-JAN-2023, the patient was vaccinated with 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis (Extra dose administered). It was reported the patient was not experiencing any side effects or symptoms. No additional adverse event details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot, still got shingles/suspected vaccination failure; Still got shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot and still got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccinated me 2 doses, get shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had experienced shingles before vaccination) and chickenpox.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 09-JAN-2023 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received the shingle vaccine and had a shingles. The patient stated that he/she had already shingles,before, they always vaccinated his/her 2 doses but always get shingles with later intervals, he/she thought  the vaccine should be before shingles appeared, the doctor told  it was because of having had chickenpox as a child.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Ophthalmic herpes zoster, Pain, Photophobia
Clinical narrative: Still very sensitive to light; Pain is horrendous; Headache every day; Had both vaccines prior Shingles/Suspected vaccination failure; Shingles in left eye; Got shingles on face; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced photophobia, pain and headache. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and headache were unknown and the outcome of the photophobia and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, photophobia, pain and headache to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received both the doses of Shingles vaccine. The patient stated that after received Shingles vaccine the patient experienced shingles on his/her face in his/her left eye. The patient reported that still very sensitive to the light and the pain was horrendous. The patient had a headache every day. The patient stated that it was terrible. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Still very sensitive to light; Pain is horrendous; Headache every day; Had both vaccines prior Shingles/Suspected vaccination failure; Shingles in left eye; Got shingles on face; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced photophobia, pain and headache. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and headache were unknown and the outcome of the photophobia and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, photophobia, pain and headache to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received both the doses of Shingles vaccine. The patient stated that after received Shingles vaccine the patient experienced shingles on his/her face in his/her left eye. The patient reported that still very sensitive to the light and the pain was horrendous. The patient had a headache every day. The patient stated that it was terrible. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site pain, Lethargy, Nausea, Pyrexia
Clinical narrative: Extremely sore arm at injection site; Fever; Chills; Nausea; Lethargy; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (in approximately 1971). Concurrent medical conditions included hypothyroidism. Concomitant products included levothyroxine.   In September 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, fever, chills, nausea and lethargy. On an unknown date, the outcome of the injection site pain, fever, chills, nausea and lethargy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, nausea and lethargy to be related to Shingrix.     Linked case(s) involving the same patient:  US2023001647   Additional Information: GSK receipt date: 06-JAN-2023 Reporter's comment: The patient self-reported this case. The patient had her initial shingles vaccine in September 2022.  She had an extremely sore arm at injection site, fever, chills, nausea and lethargy for 24 hours.  The symptoms were not treated. The reporter consented to follow up. Additional Supportive information: For tolerance of 2nd dose refer case US2023001647, reported by same reporter.; Sender's Comments:  US-GSK-US2023001647:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Does shingles shots causes cramps; This case was reported by a consumer via call center representative and described the occurrence of cramp in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th January 2023, the patient received the 2nd dose of Shingles vaccine. On 6th January 2023, less than a day after receiving Shingles vaccine, the patient experienced cramp. On an unknown date, the outcome of the cramp was unknown.   It was unknown if the reporter considered the cramp to be related to Shingles vaccine.     Additional Information: GSK receipt date: 06-JAN-2023 Reporter's comment:  The patient self-reported this case. The patient reported that he/she received 2nd dose of Shingles shots and experienced cramp. The reporter wanted to know does Shingles shot causes cramp. The reporter did not consent to follow up.
Age: 0.42
Sex: M
Vaccine: PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: Temp. excursion lasted 13h-35.7°F, Vx administered; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7, expiry date 24th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (batch number FN5555, expiry date unknown) for prophylaxis.   Additional patient notes included None.   On 4th January 2023, the patient received Rotarix lyophilized formulation (oral), Rotarix Oral Applicator Device and the 2nd dose of PREVNAR 13 (intramuscular) .5 ml. On 4th January 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 06-JAN-2023 Reporter's comment: The reporter was certified MA (Medical assistant) called on behalf of facility. The reporter weight was 17 pounds, 14 ounces. The patient had no family medical history relevant to adverse event. The patient was not vaccinated with prior vaccinations (within 4 weeks). The reporter was reporting that they had given Rotarix and Prevnar 13 to patient after temperature excursion. The patient was administered with Prevnar 13 at appropriate age to get second dose. The temperature excursion lasted 13 hours and lowest temperature reached was 35.7 degrees Fahrenheit. The reporter clarified that 2 patients received the vaccines involved in the temperature excursion. Additional Vaccine administered on the same date of the Pfizer suspect. The patient was not required emergency room visit. The was not visited to physician office. Additional Supportive Information: The reporter was reporting that they had given Rotarix and Prevnar 13 to patient after temperature excursion, which led to incorrect storage of drug. The case had been linked to US2023AMR002404, reported by the same reporter, for a different patient. As clarification was raised to confirm the vaccination date and event onset date, the vaccination date and event onset date were captured 4th January 2023 from the narrative conservatively.; Sender's Comments:  US-GSK-US2023AMR002404:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Pain in extremity, Product supply issue
Clinical narrative: Ouchiest arm ever; Scarcity made #2 a year out; Annoyingly got 3 shots; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced pain in arm, product supply issue and extra dose administered. On an unknown date, the outcome of the pain in arm, product supply issue and extra dose administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Jan-2023. Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that annoyingly, got three and first then scarcity made 2 a year out.  The pharmacist said start over so the patient did. The reporter stated that ouchiest arm ever for a vaccination and got 2 more all good. Additional supportive information: The reporter stated that scarcity made 2 a year out which lead to Product supply issue. The patient annoyingly got 3 shots which leads to extra dose administered. The follow up would not possible, as no contact details were available. Note: Due to insufficient information for pain in arm hence link with all three suspect.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Keloid scar, Rash
Clinical narrative: Looks like keloids; Rash on fingers and knuckles; Blisters on fingers and knuckles; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2022, the patient received the 1st dose of Shingrix. In December 2022, 1 week after receiving Shingrix, the patient experienced rash and blister. In January 2023, the patient experienced keloid. On an unknown date, the outcome of the rash and blister were unknown and the outcome of the keloid was not recovered/not resolved.   It was unknown if the reporter considered the rash, blister and keloid to be related to Shingrix.     Additional Information: GSK receipt date: 06-JAN-2023 Reporters comment:  This case was reported by a patient via interactive digital media. The patient developed a rash and blisters on fingers and knuckles a week after Shingrix. At the time of reporting had what looks like keloids in those areas. The reporter asked should get a 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities
Clinical narrative: Was in bed all day; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that he/she just got his/her shingles vaccine. The patient stated that did not plan anything for the day after the shingles shot. The patient was in bed all day. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurts horrible; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccines with an associated reaction of pain in extremity (received Covid vaccine on an unknown date in an unknown arm).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had received the first dose in an unknown arm. The reporter stated that his/her arm hurts horrible with the vaccine, it hurt just as much with the covid vaccines. The reporter was going for the second dose. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: RV1
Symptoms: Product storage error
Clinical narrative: Temp. excursion lasted 13h, 35.7°F, Vx administered; This case was reported by a other health professional via other manufacturer and described the occurrence of intercepted product storage error in a patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7, expiry date 24th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 3rd January 2023, the patient did not receive Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 3rd January 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JAN-2023, 11-JAN-2023 Reporter's comment: The reporter was certified MA (Medical assistant) called on behalf of facility. The temperature excursion lasted 13 hours and lowest temperature reached was 35.7 degrees Fahrenheit. The reporter clarified that patient did not receive the vaccine involved in the temperature excursion. Additional Supportive Information: The reporter was reporting that patient did not receive Rotarix after temperature excursion, which led to intercepted product storage error.; Sender's Comments:  US-GSK-US2023AMR001933:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Administered it through the wrong route; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The reporter asked that any information on administering in the wrong route and what the next steps were or they should revaccinate or there were any adverse events they should be aware of. Additional supportive information; The patient received  dose of Tdap through the wrong route, which led to intramuscular formulation administered by other route. The follow-up could not be possible as no contact details were available. The suspect was coded as per reported information.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 17months ago, 2nd not yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (17 months ago received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient forgot to get the 2nd shot. The reporter wanted to know if it was too late to get the 2nd one now and need to start over with the 1st shot. The follow-up could not be possible as no contact details were available. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix administered to a 12 years-old; Received Infanrix instead of Menveo; recreived Infanrix and Boostrix on the same day; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 10th August 2022, the patient received Infanrix, Infanrix Pre-Filled Syringe Device and Boostrix. On 10th August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving Boostrix, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and overdose were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Jan-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Additional supportive information: The patient received both Infanrix and Boostrix on the same day, but was supposed to get Boostrix and Menveo, which led to wrong vaccine administered and overdose. The patient received the Infanrix vaccine at an inappropriate age, which led inappropriate age at vaccine administration.
Age: 0.33
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose given to a 18 weeks-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 18-week-old male patient who received Hepatitis B vaccine for prophylaxis.   On 10th September 2009, the patient received the 3rd dose of Hepatitis B vaccine. On 10th September 2009, unknown after receiving Hepatitis B vaccine, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional Information: GSK Receipt Date: 6-JAN-2023 Reporter's Comment: At the time of reporting, the patient age was 13 years old. The medical assistant reported that the patient received third dose of Hepatitis B vaccine when he was 18 weeks old. The reporter wished to know if the patient required a booster shot and if the third dose was valid. Very basic information was given by the reporter. The reporter had no information about the previous vaccines nor patient other than age and sex. The reporter did not consent to follow up. Additional Supportive Information: The patient received the third dose of Hepatitis B vaccine at 18 weeks, which led to inappropriate schedule of vaccine administered. Conservatively inappropriate schedule of vaccine administered event was captured as there was no information regarding previous vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Pain in extremity
Clinical narrative: Soreness of right arm; Partial administration, got some of the dose; Medicine ran down the arm; Medicine ran down the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2023, the patient received the 2nd dose of Shingrix. On 5th January 2023, less than a day after receiving Shingrix, the patient experienced pain in arm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: The patient reported that when the Shingrix dose was being administered in her right arm, the patient pulled away and caused partial administration of the shingles vaccine (adverse event filed). The patient reported some Shingrix medicine ran down her arm after she pulled away (adverse event filed). The patient reported soreness of her right arm since she received the Shingrix dose and reported that the administrating pharmacist said she got some of the Shingrix dose. The patient declined to give full address. The patient unable to provide lot number or expiration date of the Shingrix she received. The patient declined to provide consent for health care professional. Additional Supportive Information: The patient reported some Shingrix medicine ran down her arm after she pulled away and caused partial administration of vaccine, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Incapacitating myalgia; Fever; This case was reported by a other health professional via call center representative and described the occurrence of myalgia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and fever. On an unknown date, the outcome of the myalgia and fever were unknown.   It was unknown if the reporter considered the myalgia and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Jan-2023. Reporter's Comments: The reporter stated that the patient had severe symptoms after the patient had received the first dose of Shingrix approximately 4 months ago from reporting.  The patient seemed to have had presented incapacitating myalgia and fever.  No information about the vaccine or more information about the patient was disclosed. The reporter gave consent to follow up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: administered 1.0 ml dose to a 19 y/o; administered 1.0 ml dose to a 19 y/o; 4th dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B) (batch number K9HS5, expiry date 18th March 2024) for prophylaxis.   On 6th January 2023, the patient received the 4th dose of Engerix B 1 ml. On 6th January 2023, unknown after receiving Engerix B, the patient experienced overdose, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the overdose, inappropriate age at vaccine administration and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: The reporter consented to follow up. Additional Supportive Information: The patient received 4th dose of Engerix-B, the dose administered was 1.0 mL dose instead of the 0.5 mL dose, which led to overdose, inappropriate age at vaccine administration and extra dose administered.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient was inadvertently given an expired dose of Twinrix on 09Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The patient was inadvertently given an expired dose of Twinrix. No further details provided. The reporter consented to follow up. Additional supportive information: The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Jan-2023 Reporter's comment: The specialist requested initials and date of birth, but only gender was provided at the time of call. The reporter consented to follow-up from safety. Additional supportive information: The patient received an expired dose of Twinirx, which led to expired vaccine used.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid component; Administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA748A, expiry date 13th September 2024) for prophylaxis.   On 25th November 2022, the patient received Menveo. On 25th November 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 09-JAN-2023 Reporter's comment: A pharmacy manager asked for information about the administration of only the liquid component MenCYW-135 Liquid Conjugate of Menveo The pharmacy manager asked for safety information and if patients had to be revaccinated. The reporter consented to follow-up. This is 1 of 2 linked cases reported by same reporter. Additional supportive information: The patient only received the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023002246:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2 years since patient received 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The reporter reported that what if it had been 2 years since patient received first dose of Shingrix. The health care professional disconnected the chat after reporter asked for their demographics.  No additional information was available. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 59.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose was given to an adult; pediatric dose was given to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 41-year-old female patient who received HBV (Engerix B pediatric) (batch number unknown, expiry date 7th December 2023) for prophylaxis.   On 10th January 2023, the patient received Engerix B pediatric. On 10th January 2023, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.      Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: A nurse reported that an adult patient was given a pediatric dose of Engerix B. No symptoms were reported. The reporter consented to follow-up. Additional supportive information: The adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.