chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerate
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity, Skin discolouration
Clinical narrative: Patient complains that after receiving vaccine he has pain in arm and back and also a brown spot of heel of foot. He states that all of these symptoms are related to the vaccine. He will be seeing a wound care doctor for heel and his regular doctor for back pain.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Glu like symptoms - tiredness, achiness
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Rash
Clinical narrative: Patient reported all over body itching that began on 12/11/23. She stated there is also a bumpy rash that has developed on her torso.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Back pain, Dyspnoea
Clinical narrative: SOB; Back Pain (right side); BP 161/93 at 11:40am & 152/83 at 11:50am
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Malaise, Syncope
Clinical narrative: Pt reported not feeling well day after vaccination. While standing in the school line he did have episode of vasovagal syncope and was caught by a teacher. Pt had no further issues noted and does have a history of vasovagal syncopal episodes.
Age: 64.0
Sex: M
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: Patient  presented to the pharmacy on 12/13/2023 and said he had previously received a flu shot from us and has had pain in his arm ever since. There was no discoloration, swelling, bruising or any other outward appearance different than a normal arm.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain, Sleep disorder, Swelling
Clinical narrative: Within first 10 minutes, I got a sharp pain at the top of my shoulder on the left side where the injection occurred.  Over the next few hours, it became consistent pain with a swelling like a small egg showing up on the top of my shoulder.  I took ibuprophen and it subsided somewhat but it is still noticeable.  The injection site pain was negligle but this shoulder pain would not allow me to sleep or lay on my left side.  After a week today, it is somewhat reduced (approximately 70%), but still noticeable and painful with movement.
Age: 1.75
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given wrong vaccine - Patient given Tdap (Boostrix) instead of Dtap (Infanrix) vaccine. Patient was at clinic 15 minutes after vaccine was given and had no side effect at that time. Patient's mom notived of the adverse event and will monitor patient for any side effects.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None reported or noted at time of event
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Back pain, Groin pain, Musculoskeletal pain, Myalgia
Clinical narrative: Muscle and joint pain in the lumbar region, hips, feet, groin, buttocks that may, hopefully, be abating.   ( Note: I had the h-p flu vaccine 0n 11/17 and had a low grade fever of 100 that night but was okay afterwards.  Also, I have not had a COVID shot since 11/2022, but did have the shingles series earllier this year w/ no adverse events.)
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Muscle and joint pain in the lumbar region, hips, feet, groin, buttocks that may, hopefully, be abating.   ( Note: I had the h-p flu vaccine 0n 11/17 and had a low grade fever of 100 that night but was okay afterwards.  Also, I have not had a COVID shot since 11/2022, but did have the shingles series earllier this year w/ no adverse events.)
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Differential white blood cell count, Full blood count, Metabolic function test, Muscle spasms
Clinical narrative: Received Boostrix in L deltoid around 4pm. Mom called the office back about 20 minutes later reporting tremors/spasms in pt's left arm/hand/fingers. Symptoms worsened and pt was taken to the ED, treated with Dexamethasone, Diazepam, Hydroxyzine, and Lorazepam. He was discharged with a referral to neurology.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Received Boostrix in L deltoid around 4pm. Mom called the office back about 20 minutes later reporting tremors/spasms in pt's left arm/hand/fingers. Symptoms worsened and pt was taken to the ED, treated with Dexamethasone, Diazepam, Hydroxyzine, and Lorazepam. He was discharged with a referral to neurology.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: HCP calling to report AE for administered supported TE's.  At time of call HCP did not have all of the AE info.  Case # given for callback to update.  Associated AE Case # 02515043, 02515525. No PQC. GARDASIL 9: LOT 1957404  Exp 10/5/2025 ABOVE 47°; This spontaneous report was received from a medical assistant 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 15-NOV-2023, the patient was vaccinated with an improperly dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1957404, expiration date 05-OCT-2025 (dose and route of administration not reported) for prophylaxis (product storage error).  The temperature excursion was of 47.44 degrees Fahrenheit for 10 minutes. No previous excursions were reported.
Sex: F
Vaccine: HPV9, MMR
Symptoms: Inappropriate schedule of product administration, Mumps antibody test negative
Clinical narrative: blood titer shows no immunity for mumps; incomplete vaccine series for both GARDASIL 9 and MMR II; This spontaneous report was received from pharmacist and refers to a 37-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-MAR-2020, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 28-SEP-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate schedule of vaccine administered).  On unknown date, the blood titer showed no immunity for mumps (Mumps antibody test negative) but showed immunity for rubella. The outcome of the event was unknown.  The causal relationship between mumps antibody test negative and suspect vaccines was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; VARIVAX dose was stored improperly in refrigerator conditions since 10/9/2023 and the product was administered on 11/14/2023; This spontaneous report was received from Other Health Professional and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  Medical Assistant was calling to report that a varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection dose was stored improperly in refrigerator conditions since 09-OCT-2023 and the product was administered on 14-NOV-2023, at 0.5 ml / two dose series (lot # X011425 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) with expiry date of 19-APR-2025, strength and indication were not provided). The medical assistant confirmed the patient involved had not reported any medical concerns or symptoms related to the improperly stored and administered vaccine. No additional information was provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No additional AE; expired RECOMBIVAX HB that was administered to a patient on 01DEC2023; This spontaneous report was received from the physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-DEC-2023, the patient was vaccinated with expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #W016842, expiration date: 19-NOV-2023, administered for prophylaxis (anatomical location, strength, and route of administration were not provided) (expired product administered). No side effects reported. The vaccine had no previous temperature excursion. No other medical information known. Operator of Device was a Healthcare Professional.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Titers was low to pneumococcal vaccines (2/23 serotypes with protective responses); This literature marketed report has been received from the authors of a published literature article, concerning to a male patient of unknown age. The patient presented with very-early onset inflammatory bowel disease around 18 months of age with anemia, failure to thrive and biopsy consistent with celiac disease. He was hospitalized for 4.5 months with slow resolution of diarrhea with elimination of gluten, dairy, and eggs demonstrating improved growth. At 4 years, he presented with a diffuse papular rash initially on elbows, hairline, and ears that subsequently spread throughout the body. Steroid treatment was not effective and eventual skin biopsy revealed verruca plana. The same year, he was admitted for rotavirus infection for a few weeks. Abdominal imaging showed a splenic mass causing external pressure to the stomach and splenectomy with biopsy a benign vascular tumor. Following the splenectomy, he received prophylactic penicillin. At 6 years, he developed bouts of recurrent pancreatitis requiring an endoscopic retrograde cholangiopancreatography (ERCP) for bile stone removal and dilation of distal bile duct and intrahepatic strictures. There were no further episodes revealed of pancreatitis. The suspected diagnosis of primary sclerosis cholangitis was made. His previous drug reaction or allegories and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, anatomical site infection, lot #, expiry date, and route of administration were not provided).  On an unspecified date, immunology workup was initiated and showed that titers were low to pneumococcal vaccines (2/23 serotypes with protective responses) (antibody test negative). By the time of the report, the outcome of the event was not provided.   The reporter considered antibody test negative to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of two reports from the same literature.   A copy of the published article is attached as further documentation of the patient's experience.  Sender's Comments:  US-009507513-2312USA004091:
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: 23-valent pneumococcal vaccine onlyprotective for 10/23 tested serotypes; This literature marketed report has been received from the authors of a published literature article concerning to a male patient of unknown age. The patient developed symptoms shortly after birth with diffuse warts. Flat-topped pink papules and plaques started around his hairline and ears and subsequently spread most prominently in his inguinal region. A biopsy confirmed verruca plana. Imiquimod was trialed without improvement. At 4 years, initial immunologic work up showed mildly decreased T cells CD3 859 (normal 900-4500), CD4 388 (normal 500-2400), CD8 304 (normal 300-600) with normal B cell counts (497; normal 200-2100 cells/uL), and decreased NK cells (1; normal 100-1000 cells/uL). There was hypogammaglobulinemia with IgG 159 (normal 444-1187 mg/dL) and decreased class switching on B cell immunophenotyping. Vaccine titers showed protective diphtheria and tetanus titers. His previous drug reaction or allegories and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) injection, administered for prophylaxis (strength, dose, anatomical site infection, lot #, expiry date, and route of administration were not provided).  On an unspecified date, following pneumococcal vaccine, polyvalent (23-valent) was only protective for 10/23 tested serotypes (antibody test negative). By the time of the report, the outcome of the event was not provided.   The reporter considered antibody test negative to be related to pneumococcal vaccine, polyvalent (23-valent).  This is one of two reports from the same literature.    Sender's Comments:  US-009507513-2312USA002977:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AEs were reported; a patient received an expired PNEUMOVAX 23; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. Information regarding the patient's current condition, medical history and concomitant medication was not provided.     On 08-DEC-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # w021636, expiration date: 01-OCT-2023, 0.5 milliliter, once; route of administration was unknown) for prophylaxis (expired vaccine used). No additional adverse event (AE) (no adverse event).
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Email received in the Contact Center mailbox on 08DEC2023 at 2147ET with the subject line,"  DPOC case requires your attention." Many fields are marked as unknown as they were unable to be asked. Company awareness date reflects the da; No Adverse Event; This spontaneous report was received from a pharmacist refers to a 70-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot# was reported as: W0077035, and expired dose was reported as: 20-OCT-2023, in the right arm (exact dose and route of administration were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).  Lot number W0077035 has been verified to be a non-valid lot number for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and does not match any Company product.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Polymyalgia rheumatica
Clinical narrative: patient developed PMR 2 weeks after the first shot; This serious case was reported by a nurse via sales rep and described the occurrence of polymyalgia rheumatica in a 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, 2 weeks after receiving Shingrix, the patient experienced polymyalgia rheumatica (Verbatim: patient developed PMR 2 weeks after the first shot) (serious criteria GSK medically significant). The outcome of the polymyalgia rheumatica was not reported.   It was unknown if the reporter considered the polymyalgia rheumatica to be related to Shingrix.     It was unknown if the company considered the polymyalgia rheumatica to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-DEC-2023 The nurse reported that she developed polymyalgia rheumatica 2 weeks after the first shot. The patient never got the second shot. The reporter denied to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Pain, Pyrexia, Swelling
Clinical narrative: Fever; Fatigue; Pain; Swelling; Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever (Verbatim: Fever), fatigue (Verbatim: Fatigue), pain (Verbatim: Pain), swelling (Verbatim: Swelling) and headache (Verbatim: Headache). The outcome of the fever, fatigue, pain, swelling and headache were not reported.   It was unknown if the reporter considered the fever, fatigue, pain, swelling and headache to be related to Arexvy.     It was unknown if the company considered the fever, fatigue, pain, swelling and headache to be related to Arexvy.   Additional Information: GSK receipt date: 05-DEC-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient had a fever, fatigue, pain, swelling headache badly.
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: he is aware the vaccine doesn't have an approval at this age but said they were high risk.She is aware the vaccine doesn't have an approval at this age but said they were high risk.; This non-serious case was reported by a physician via sales rep and described the occurrence of off label use in unapproved age group in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero .5 ml. On an unknown date, an unknown time after receiving Bexsero, the patient experienced off label use in unapproved age group (Verbatim: he is aware the vaccine doesn't have an approval at this age but said they were high risk.She is aware the vaccine doesn't have an approval at this age but said they were high risk.). The outcome of the off label use in unapproved age group 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: 05-Dec-2023 The reporter reported that she administered Bexsero vaccine in 2 to 3 patients of less than 10 years of age. The reporter was aware the vaccine does not had an approval at this age but stated that they were on high risk, which led to off label use in unapproved age group. The reporter was aware of the data in this age group. The reporter did not report any incident following administration. The reporter did not had any patient or administration data on hand at the time of reporting. The reporter did not consent to follow up
Sex: U
Vaccine: TDAP
Symptoms: Product preparation issue
Clinical narrative: The pharmacist did not shake the syringes vigorously to resuspend the vaccine component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 25A2F, expiry date 19-JAN-2026) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate reconstitution technique (Verbatim: The pharmacist did not shake the syringes vigorously to resuspend the vaccine component). The outcome of the inappropriate reconstitution technique 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 :30-NOV-2023 The pharmacist reported that she had 3 Boostrix prefilled syringes that were clear with a white cloudy substance at the bottom.  Upon reviewing the product information description and preparation for administration sections with the pharmacist, the pharmacist did not shake the syringes vigorously to resuspend the vaccine component which led to Inappropriate reconstitution technique. No PQC associated with this case.  No patient involvement. The reporter consented to follow up.
Age: 33.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: an expired Twinrix vaccine was administered to a female; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 02-DEC-2023, the patient received Twinrix adult (intramuscular, right deltoid). On 02-DEC-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: an expired Twinrix vaccine was administered to a female). 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:04-DEC-2023  The pharmacist reported that an expired Twinrix vaccine was administered to a patient, which led to expired vaccine used. No additional information was provided. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: medical assistant called to inform that earlier that day, a patient who had already received a dose of FluLaval in September received another dose of FluLaval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 59-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number E5MN5) for prophylaxis.   Concomitant products included Influenza vaccine inact split 4v (Flulaval quadrivalent).   On 04-DEC-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 04-DEC-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: medical assistant called to inform that earlier that day, a patient who had already received a dose of FluLaval in September received another dose of FluLaval). The outcome of the extra dose 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: 04-DEC-2023 The reporter was a medical assistant called to inform that earlier that day, a patient who had already received a dose of FluLaval in September received another dose of FluLaval, which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: maladministration of only the diluent of Shingrix to a patient; maladministration of only the diluent of Shingrix to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number B9J49, expiry date 30-SEP-2025) for prophylaxis.   On 04-DEC-2023, the patient received Shingrix. On 04-DEC-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: maladministration of only the diluent of Shingrix to a patient) and inappropriate preparation of medication (Verbatim: maladministration of only the diluent of Shingrix to a patient). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 04-DEC-2023 Pharmacist called to inform about the maladministration of only the diluent of Shingrix to a patient (without the powder component), which led to  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered just the adjuvant portion of Shingrix to a patient; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 7373X, expiry date 18-JUN-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered just the adjuvant portion of Shingrix to a patient) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-DEC-2023 The registered nurse reported she administered just the adjuvant portion of Shingrix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a female patient received Kinrix in error since she is 5 month old; 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 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included Dtap (patient previously received just one dose of Dtap).   On 04-DEC-2023, the patient received Kinrix. On 04-DEC-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a female patient received Kinrix in error since she is 5 month old). 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: 05-DEC-2023 The medical assistant reported that a patient received kinrix in error since she was 5 month old, which led to inappropriate age at vaccine administration. The patient was following the catch up administration. The vaccine administration facility was the same as primary reporter The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: underdose; adult patient inadvertently received a pediatric dose of Engerix-B.; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number Y42R3, expiry date 12-MAY-2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: underdose) and adult use of a child product (Verbatim: adult patient inadvertently received a pediatric dose of Engerix-B.). The outcome of the accidental underdose and adult use of a child product 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: 05-DEC-2023 The nurse practitioner reported an adult patient inadvertently received a pediatric dose of Engerix-B, which led accidental underdose and adult use of child product. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: RECEIVED THE FIRST DOSE OF SHINGRIX BUT FAILED TO RETURN FOR SECOND DOSE. IT HAS BEEN OVER 6 MONTHS; This non-serious case was reported by a pharmacist 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 (on an unknown date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: RECEIVED THE FIRST DOSE OF SHINGRIX BUT FAILED TO RETURN FOR SECOND DOSE. IT HAS BEEN OVER 6 MONTHS). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 05-DEC-2023 The patient received the first dose of Shingrix but failed to return for second dose.  It has been over 6 months since the first dose.  The reporter asked the way to proceed there, if needed to just administered 2nd dose asap or start over with series of 2 doses. The vaccine administration facility was the same as primary reporter. Till the date of reporting the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: FLUX, RSV
Symptoms: Pain, Swelling
Clinical narrative: Pain on side of body where Arexvy administered; Swelling on side of body where Arexvy administered; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in a 65-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received Arexvy and Influenza vaccine. On an unknown date, 3 days after receiving Arexvy, the patient experienced pain (Verbatim: Pain on side of body where Arexvy administered) and swelling (Verbatim: Swelling on side of body where Arexvy administered). The outcome of the pain and swelling were resolved (duration 1 week).   It was unknown if the reporter considered the pain and swelling to be related to Arexvy.     It was unknown if the company considered the pain and swelling to be related to Arexvy.   Additional Information: GSK Receipt date: 06-DEC-2023 A physician reported that a patient following the Arexvy vaccine. Patient experienced pain and swelling on same side of body where Arexvy vaccine was administered 3-4 days after Arexvy vaccine. Patient was also administered flu vaccine for 65 and over on the same side.  Doctor was not sure which vaccine caused the pain and swelling. Pain and swelling went away after 1 week. It was unknown if the reporter considered the pain and swelling to be related to Flu vaccine.  The reporter did not consent to follow-up.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Gait disturbance, Joint effusion, Ultrasound joint abnormal
Clinical narrative: I received the vaccine on a Friday and by the next Friday Dec. 1st while I was working I noticed that my left knee was beginning to hurt. I ended up wrapping it with an ace wrap and it did help the discomfort. I went to bed that night and both my knees were hurting me and by Saturday I could barely walk. I ended up going to the ER where it was found that I had fluid on both my knees worse on the left than the right. I was told to take some NSAIDS, rest, ice and elevate. I did all those things but it did not get better. I ended up doing some research on side effects of the COVID vaccine after I received my infusion for my MS and recieved Solumedrol as a pre-medication and by the next day by knees felt better but still not great. In this research I found that there were other pts who also had this issue and steroids helped them. I was able to get some decadron PO which I have started 12/12/2023 and my knees are feeling better but still not normal.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Past Shelf life
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Past shelf life
Age: 100.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Facility verified with PCP that dose should be given, then contacted pharmacy to administer dose. Pharmacy went to facility and administered dose (with signed consent form). When billing pharmacy discovered patient had completed series on 11/4/20. Facility notified family and PCP.  No symptoms reported.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient reports rash, itchiness the day following his vaccination. Two days later he states it is getting better but is still there.
Sex: M
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: recommendation to get vaccinated was from his doctor; patient 48 years of age received the first dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient was immunocompetent with history of having shingles).   In OCT-2023, the patient received the 1st dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient 48 years of age received the first dose of Shingrix in a different facility (pharmacy) on October 2023 and wants to received the 2nd dose in the pharmacy. 2nd dose was not administered at the moment). On an unknown date, the patient experienced off label use (Verbatim: recommendation to get vaccinated was from his doctor). The outcome of the inappropriate age at vaccine administration and off label use were unknown.   Additional Information: GSK receipt date 6 Dec 2023: Pharmacist reported on 6rh December 2023 that patient 48 years of age received the first dose of Shingrix in a different facility on October 2023 and wanted to received the 2nd dose in the pharmacy. 2nd dose was not administered at the moment, patient was immunocompetent with history of having shingles and the recommendation to get vaccinated was from his doctor. The reporter did not consent to follow-up. 48 year old immunocompetent with history of having shingles and the recommendation to get vaccinated was from his doctor received 1st dose of shingrxi which led to inappropriate age at vaccine administration and off label.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th December 2021, batch number:5X992 and expiry date:23-JAN-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not yet received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2023 The patient had not yet received second dose of Shingrix.  The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: feeling burning on right side of body from side to umbilicus; feeling stinging and painful on right side of body from side to umbilicus; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2021, the patient received Shingrix. In NOV-2023, more than a year after receiving Shingrix, the patient experienced burning sensation (Verbatim: feeling burning on right side of body from side to umbilicus) and pain (Verbatim: feeling stinging and painful on right side of body from side to umbilicus). The outcome of the burning sensation and pain were not resolved.   It was unknown if the reporter considered the burning sensation and pain to be related to Shingrix.     It was unknown if the company considered the burning sensation and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-DEC-2023 The patient self-reported this case. The patient received Shingrix vaccine on November 2 years ago from reporting. She did not remember if she got 2 or 1 dose only. She stated about 2 weeks ago from reporting she was feeling stinging, burning, and painful on right side of body, from side to umbilicus. She stated no rash or redness. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: yesterday an adult patient received a pediatric dose of Engerix-B.; adult use of child product; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 27-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 05-DEC-2023, the patient received Engerix B pediatric. On 05-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: yesterday an adult patient received a pediatric dose of Engerix-B.) and adult use of a child product (Verbatim: adult use of child product). The outcome of the underdose and adult use of a child product 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: 06-DEC-2023 The pharmacist stated that yesterday an adult patient received a pediatric dose of Engerix-B which led to underdose and adult use of a child product. The reporter did not consent to follow-up.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: a patient who received only the adjuvant portion of the Shingrix; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number N425G, expiry date 07-DEC-2025) for prophylaxis.   On 05-DEC-2023, the patient received the 1st dose of Shingrix. On 05-DEC-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: a patient who received only the adjuvant portion of the Shingrix ) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-DEC-2023 The regular nurse requested data on the revaccination of a patient who received only the adjuvant portion of the Shingrix vaccine. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; patients has a case of shingles; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 01-DEC-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: patients has a case of shingles). 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 Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 08-DEC-2023 The pharmacist reporting that one of her female patient had a case of shingles and had not resolved.  The patient said she had a couple spots, unknown location on her body.  The reporter reported that the patient stated she had both doses of Shingrix in 2020.  This case was considered as suspected vaccination failure as details regarding completion laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Headache, Malaise, Pain
Clinical narrative: COVID-19; Arm had swollen as big as a basketball; Generally Feeling unwell; Pain until fingertips; Headache; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), PERIPHERAL SWELLING (Arm had swollen as big as a basketball), MALAISE (Generally Feeling unwell), PAIN (Pain until fingertips) and HEADACHE (Headache) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 020H22H, 032F21V, 013A21 and 029L20A) for COVID-19 prophylaxis.     The patient's past medical history included Broken bones (Legs broken.), Flu (Flu that lasted for 16-17 days, experienced twice in last year), Hip replacement and Shoulder replacement. Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL and VERAPAMIL for Hypertension.   On 02-Jan-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (Arm had swollen as big as a basketball), MALAISE (Generally Feeling unwell), PAIN (Pain until fingertips) and HEADACHE (Headache). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), PERIPHERAL SWELLING (Arm had swollen as big as a basketball), MALAISE (Generally Feeling unwell), PAIN (Pain until fingertips) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Formal blood pressure was 118-120 and at night it raises up to 186-204.. On an unknown date, SARS-CoV-2 test: (Positive) Tuesday and (Negative) Monday.         Patient received Paxlovid and experienced Diarrhea 10 days after, headache as well as body pain and also increase in blood pressure specifically at night, blister in mouth for 3 to 4. Patient experienced diarrhea 12 to 15 times a day however it slows down to 3 to 4 times a day. He had some sinus problems, congestion, green phlegm and coughing. He had ache and pain in hips and shoulders. Patient took many COVID tests.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test
Clinical narrative: COVID-19; Arm had swollen as big as a basketball; Generally Feeling unwell; Pain until fingertips; Headache; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), PERIPHERAL SWELLING (Arm had swollen as big as a basketball), MALAISE (Generally Feeling unwell), PAIN (Pain until fingertips) and HEADACHE (Headache) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 020H22H, 032F21V, 013A21 and 029L20A) for COVID-19 prophylaxis.     The patient's past medical history included Broken bones (Legs broken.), Flu (Flu that lasted for 16-17 days, experienced twice in last year), Hip replacement and Shoulder replacement. Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL and VERAPAMIL for Hypertension.   On 02-Jan-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (Arm had swollen as big as a basketball), MALAISE (Generally Feeling unwell), PAIN (Pain until fingertips) and HEADACHE (Headache). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), PERIPHERAL SWELLING (Arm had swollen as big as a basketball), MALAISE (Generally Feeling unwell), PAIN (Pain until fingertips) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Formal blood pressure was 118-120 and at night it raises up to 186-204.. On an unknown date, SARS-CoV-2 test: (Positive) Tuesday and (Negative) Monday.         Patient received Paxlovid and experienced Diarrhea 10 days after, headache as well as body pain and also increase in blood pressure specifically at night, blister in mouth for 3 to 4. Patient experienced diarrhea 12 to 15 times a day however it slows down to 3 to 4 times a day. He had some sinus problems, congestion, green phlegm and coughing. He had ache and pain in hips and shoulders. Patient took many COVID tests.