chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose increased, Blood urea increased, Cellulitis, Electrocardiogram, Full blood count
Clinical narrative: Severe left arm pain with numbness/tingling lasting at least 8 weeks after vaccine administration requiring multiple medical visits, with pain starting 4-5 days after injection. 9/21/22 Urgent care visit: Provider noted injection seemed low on left arm. Negative left arm venous duplex ultrasound. Tylenol/naproxen for pain. 9/30/22 PCP visit: Empiric treatment for cellulitis with keflex. Trialed oxycodone but intolerable side effects, switched to gabapentin for pain management. 10/5/22 PCP visit: Reviewed labs, discontinued tylenol/naproxen based on labs, titrated gabapentin dose. 10/12/22 PCP visit: MRI ordered. Consideration of referral to rehabilitation medicine.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Magnetic resonance imaging normal, Metabolic function test, Pain in extremity, Paraesthesia
Clinical narrative: Severe left arm pain with numbness/tingling lasting at least 8 weeks after vaccine administration requiring multiple medical visits, with pain starting 4-5 days after injection. 9/21/22 Urgent care visit: Provider noted injection seemed low on left arm. Negative left arm venous duplex ultrasound. Tylenol/naproxen for pain. 9/30/22 PCP visit: Empiric treatment for cellulitis with keflex. Trialed oxycodone but intolerable side effects, switched to gabapentin for pain management. 10/5/22 PCP visit: Reviewed labs, discontinued tylenol/naproxen based on labs, titrated gabapentin dose. 10/12/22 PCP visit: MRI ordered. Consideration of referral to rehabilitation medicine.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered at inappropriate site, Renal function test abnormal, Ultrasound Doppler normal, X-ray limb
Clinical narrative: Severe left arm pain with numbness/tingling lasting at least 8 weeks after vaccine administration requiring multiple medical visits, with pain starting 4-5 days after injection. 9/21/22 Urgent care visit: Provider noted injection seemed low on left arm. Negative left arm venous duplex ultrasound. Tylenol/naproxen for pain. 9/30/22 PCP visit: Empiric treatment for cellulitis with keflex. Trialed oxycodone but intolerable side effects, switched to gabapentin for pain management. 10/5/22 PCP visit: Reviewed labs, discontinued tylenol/naproxen based on labs, titrated gabapentin dose. 10/12/22 PCP visit: MRI ordered. Consideration of referral to rehabilitation medicine.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Hypoaesthesia, Laboratory test, Limb discomfort, Lumbar puncture
Clinical narrative: Developed Guillain-Barre syndrome secondary to receiving the influenza vaccination with progressing paralysis.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Magnetic resonance imaging, Mobility decreased, Monoplegia, Muscle spasms, Muscular weakness
Clinical narrative: Developed Guillain-Barre syndrome secondary to receiving the influenza vaccination with progressing paralysis.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Myelitis transverse, Neurogenic bladder, Sensory loss, X-ray
Clinical narrative: Developed Guillain-Barre syndrome secondary to receiving the influenza vaccination with progressing paralysis.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Developed Guillain-Barre syndrome secondary to receiving the influenza vaccination with progressing paralysis.
Age: 64.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Skin reaction, Skin warm, Swelling
Clinical narrative: She got her vaccine, at first her arm was just a little sore.  When she woke up the next morning from where she got the shot about 1/2" up it was red, inflamed and hot to the touch and swelling out.  She went to her doctor on Monday and the swelling and inflammation had gone down to her elbow, and starting to wrap around her arm, like a shirt sleeve.  Her doctor she looked at it and gave her an antibiotic feeling that it was an infection she got when she received the vaccine.   She just started the antibiotics last night.  It is not as stiff today.  She has been very tired and light headed lately as well.  She was told to take the medicine and to come back on Wednesday and she had her nurse outline the redness and swelling on the arm and to put ice on it to take down the swelling.  The area is slowly spreading down her arm.  She has an appointment tomorrow to have it looked at again.
Age: 64.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: She got her vaccine, at first her arm was just a little sore.  When she woke up the next morning from where she got the shot about 1/2" up it was red, inflamed and hot to the touch and swelling out.  She went to her doctor on Monday and the swelling and inflammation had gone down to her elbow, and starting to wrap around her arm, like a shirt sleeve.  Her doctor she looked at it and gave her an antibiotic feeling that it was an infection she got when she received the vaccine.   She just started the antibiotics last night.  It is not as stiff today.  She has been very tired and light headed lately as well.  She was told to take the medicine and to come back on Wednesday and she had her nurse outline the redness and swelling on the arm and to put ice on it to take down the swelling.  The area is slowly spreading down her arm.  She has an appointment tomorrow to have it looked at again.
Age: 64.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: She got her vaccine, at first her arm was just a little sore.  When she woke up the next morning from where she got the shot about 1/2" up it was red, inflamed and hot to the touch and swelling out.  She went to her doctor on Monday and the swelling and inflammation had gone down to her elbow, and starting to wrap around her arm, like a shirt sleeve.  Her doctor she looked at it and gave her an antibiotic feeling that it was an infection she got when she received the vaccine.   She just started the antibiotics last night.  It is not as stiff today.  She has been very tired and light headed lately as well.  She was told to take the medicine and to come back on Wednesday and she had her nurse outline the redness and swelling on the arm and to put ice on it to take down the swelling.  The area is slowly spreading down her arm.  She has an appointment tomorrow to have it looked at again.
Age: 59.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injection site rash, Injection site swelling, Muscle twitching
Clinical narrative: Pain, muscle twitching, lump, deep red rash, swelling all in bicep area below where injection was given. Swollen left lymph node in neck. The reaction began approximately 15-20 minutes after injection.
Age: 59.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Lymphadenopathy, Muscle mass, Muscle twitching, Myalgia, Rash
Clinical narrative: Pain, muscle twitching, lump, deep red rash, swelling all in bicep area below where injection was given. Swollen left lymph node in neck. The reaction began approximately 15-20 minutes after injection.
Age: 59.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Rash erythematous
Clinical narrative: Pain, muscle twitching, lump, deep red rash, swelling all in bicep area below where injection was given. Swollen left lymph node in neck. The reaction began approximately 15-20 minutes after injection.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered Improperly Stored, Separate PROQUAD; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 12-OCT-2022, improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status: recombinant human albumin (rHA), lot #W002785, expiration date: 24-JUL-2023 (dose, route of administration and anatomical location were not provided) were administered to patient for prophylaxis. The vaccine experienced a temperature excursion of 70.65 degree Fahrenheit for 4 hour and 15 minutes on 09-OCT-2022 (product storage error). There was previous temperature excursion of 14 degree Fahrenheit up to 46 degree Fahrenheit for 2 hours and 47 degree Fahrenheit to 77 degree Fahrenheit (68.9 degree Fahrenheit) for 2 hours on 23-SEP-2022. No additional adverse event was reported.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: No AE; patient received a dose of PEDVAXHIB that was mixed with STERILE DILUENT; 1ml was administered intramuscularly to the patient; This spontaneous report was received from a nurse and refers to a 2-month-old infant.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2022, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 milliliter, lot # U093351, expiry date 22-JUN-2024 (strength was not provided) mixed with sterile diluent, solution for injection/infusion, 0.5 milliliter, lot #U024490, expiration date: 02-NOV-2023, administered intramuscularly in their left upper thigh for prophylaxis (strength and indication were not provided) (product preparation error, overdose).  Lot number U093351 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB).  No additional adverse events were reported.
Age: 37.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; dose of PROQUAD [LOT/EXP unknown by reporter] was administered 37 year old postpartum female patient on 20OCT2022 instead of MMR II; This spontaneous report was received from a pharmacist and refers to a 37-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose reported as 1 (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis, instead of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (wrong vaccine administered. There was no additional adverse event reported.
Sex: U
Vaccine: SMALLMNK
Symptoms: Monkeypox
Clinical narrative: Monkeypox despite the completion of Jynneos vaccination; Case reference number US-BN-2022-004174 is a spontaneous case report initially received on 21-Oct-22 from physician via Bavarian Nordic (reference: BN_2022_02594) and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, as reported in August, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose reported as 'first full dose', through unknown route of administration, at unknown anatomical location, for unknown indication.  On an unspecified date, as reported in September, the patient was vaccinated with a second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose reported as 'second microdose', through unknown route of administration, at unknown anatomical location, for unknown indication.  On an unspecified date, the patient developed monkeypox despite completion of Jynneos vaccination.  As reported, the patient developed more severe symptoms.  The reporter did not provide a seriousness criteria or a causality assessment.  This case is linked with the case US-BN-2022-004175 (same reporter).  No further information was provided.; Reporter's Comments: A patient of unknown age and gender developed monkeypox (patient developed more severe symptoms) despite completion of Jynneos vaccination. Monkeypox are unlisted and unexpected according to CCDS v1 and USPI. Vaccination with Jynneos may not protect all recipients and may not result in protection in all cases. The outcome was unknown. The patient's medical history and concomitant medications details were not provided. Causality is therefore assessed as not related to suspect product but to environmental factors. The case is serious due to medical significance.; Sender's Comments: A patient of unknown age and gender developed monkeypox (patient developed more severe symptoms) despite completion of Jynneos vaccination. Monkeypox are unlisted and unexpected according to CCDS v1 and USPI. Vaccination with Jynneos may not protect all recipients and may not result in protection in all cases. The outcome was unknown. The patient's medical history and concomitant medications details were not provided. Causality is therefore assessed as not related to suspect product but to environmental factors. The case is serious due to medical significance.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hip surgery, Vaccination failure
Clinical narrative: shingles, still get them, got both vaccines/ Suspected vaccination failure; shingles, still get them; hip surgery; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 1st dose of Shingles vaccine and the 2nd 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), shingles and hip surgery. On an unknown date, the outcome of the vaccination failure, shingles and hip surgery were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and hip surgery to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got both vaccines for shingles and they had not helped him.  The patient still got them.  The patient had a terrible case of shingles after his hip surgery.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact detail were available. This case was linked with case US2022AMR140020, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR140020:Same reporter
Age: 51.0
Sex: F
Vaccine: COVID19, PPV, VARZOS
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: 1st dose around late summer, 2nd in September; Sick the next day; This case was reported by a consumer and described the occurrence of sickness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, COVID-19 VACCINE for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   The patient's past medical history included morbid obesity, tennis elbow, fibromyalgia, shingles (On 28th May 2021, the patient was diagnosed with shingles) and pain. Previously administered products included Valcyclovir, Prednisone and codeine.   In September 2022, the patient received the 2nd dose of Shingrix. In August 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received COVID-19 VACCINE and PNEUMONIA VACCINE. In August 2022, not applicable after receiving Shingrix and 1 day after receiving Shingrix, the patient experienced sickness. In September 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.   Additional Information: Receipt Date: 28-OCT-2022 Reporter is Comment: During an onboarding call with the Shingrix team, shared that she had received her Shingrix vaccine. The only side effect she experienced was during her first dose of Shingrix with the Covid booster and vaccine for Pneumonia. She was sick for the next day but she did not experience any reaction after the second dose. Additionally, shared that she was currently being administered hormones and was prescribed a weight loss medicine. She was previously in pain when she was prescribed additional hormones years ago, but now had more energy and was more active since being on the weight loss drug. She did not clarify the type of hormone or weight loss drug name. It was unknown if the reporter considered the sickness to be related to Covid-19 vaccine and Pneumonia vaccine. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Armpit swelling; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling 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 local swelling. On an unknown date, the outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and asked could the Shingles vaccine cause armpit to swell. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness 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 dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that after received Shingles vaccine he/she experienced dizzy. The patient wanted to know why he/she experienced dizzy after received Shingles vaccine shot. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose today, 1st dose about a year ago; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose about a year ago ).   On 28th October 2022, the patient received the 2nd dose of Shingrix. On 28th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient asked that since the recommended separation was 4 to 6 months, did he/she need to get a third vaccine in April. Additional supportive information: The patient received the second dose later the recommended interval, which led to lengthening of vaccine schedule.  The follow-up could be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash today, vaccination yesterday; Shingles rash today, vaccination yesterday; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th October 2022, the patient received Shingles vaccine. On 28th October 2022, 1 days after receiving Shingles vaccine, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022. Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he/she had got the shingles rash on the reporting day and after receiving the vaccine the day before reporting. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: FLUX, UNK
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Soreness in arm; Dizziness; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 66-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included lenvatinib mesilate (Lenvima) for renal cell cancer.   The patient's past medical history included stomach pain, cough and vomiting. Concurrent medical conditions included renal cell cancer.   On 5th October 2022, the patient received Flu vaccine. In April 2022, the patient started Lenvima (oral) 10 mg once daily (10 mg daily). On 5th October 2022, less than a day after receiving Flu vaccine, the patient experienced pain in arm and dizziness. The action taken with Lenvima was unknown. On an unknown date, the outcome of the pain in arm and dizziness were recovering/resolving.   It was unknown if the reporter considered the pain in arm and dizziness to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: The reporter reported that the patient received Flu vaccine after received flu vaccine the patient experienced soreness in arm and some dizziness that was getting better. The reporter was unknown if MD was aware. The reporter stated that the patient was also on therapy Lenvima drug and also about 5 days last week he was experienced stomach ache, coughing and vomited this are resolved. It was unknown if the reporter considered the pain in arm and dizziness to be Lenvima  Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe 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: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157002:Same reporter US-GSK-US2022AMR157003:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157008:Same reporter
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe 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: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157003:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157008:Same reporter
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe 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: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157002:Same reporter US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157008:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Relieve of nerve pains in hands and feet/happened agains on my 2nd shot and again was short lived/ still suffer from the constand nerve pain like shards of glass; This case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of therapeutic response unexpected (received 1st dose in 2019 or 2020 and after receiving Shingles vaccine, almost instantly relieved of nerve pains in hands and feet and nerve damage and associated pain dramatically improved, refer case US2022156236). Concurrent medical conditions included nerve damage and nerve pain.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022156236   Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. Prior to receiving vaccine, the patient suffered from severe nerve damage and pain from a cervical injury a couple years after the accident.  The patient received the Shingles vaccine in either 2019 or 2020 and it changed his life. Although it was short lived for about a week. The patient thought it was a new him, this happened again with the 2nd shot and again was short lived. The physician could not able to explain why this occurred.  The patient still suffer from the constant nerve pain like shards of glass throughout his body daily.  The patient prayed that he never get shingles but he did not thought it could get worse. No additional details were provided by the reporter. Additional supportive information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022156236:Same reporter
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe 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: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157003:Same reporter US-GSK-US2022AMR157002:Same reporter US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157008:Same reporter
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe 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: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR157003:Same reporter US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157002:Same reporter US-GSK-US2022AMR157008:Same reporter
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe 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: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR157003:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157001:Same reporter US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157002:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: subcutaneous injection for 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine (subcutaneous). On an unknown date, unknown after receiving Shingles 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: 28-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. Additional supportive information: The patient got 1st dose subcutaneous injection, which led to intramuscular formulation administered by other route. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Dizziness
Clinical narrative: dizzy for 3 days; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine and Influenza vaccine.     Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's Comments: The patient self-reported this case. The patient stated that after getting the Flu shot and Shingle shot, he/she had been dizzy for 3 days and wanted to know what should be done and why he/she was dizzy after healing shingle shot. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling increased, Do I have cellulitis; Arm hotter; arm redder/redness; Arm pain; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, extremities hot feeling of, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, erythema of extremities and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, extremities hot feeling of, erythema of extremities and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's comment:  The patient received dose of Shingrix vaccine 5 days ago from the date of reporting and experienced all the common side effects.  After a couple days from the vaccination his/her arm started feeling better but today (on the day of reporting) the swelling increased, and it was hotter and redder than it was before. The patient asked did he/she have cellulitis. The patient also asked how long did arm pain, redness and heat last. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 8th October 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 19th October 2022, unknown after receiving Boostrix and Boostrix 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: 28-Oct-2022 Reporter's comment: The reporter did not had access to lot number. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
Age: 72.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 72-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 27th October 2022, unknown after receiving Bexsero and Bexsero 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: 28-Oct-2022 Reporter's comment: The adverse event contains all reported information. The reporter consented to safety team follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: meant to receive varicella vaccine, received Shingrix; Shingrix administered to 42-year-old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE LIVE (VARICELLA VACCINE).   On 28th October 2022, the patient received the 2nd dose of Shingrix. On 28th October 2022, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: Nurse reported that on the day of reporting, the patient meant to receive a second dose for varicella vaccine received shingrix by mistake. The reporter was asked for batch number and expiration date, but the response was that she did not had them. The reporter said first dose of varicella vaccine was 2 months ago but did not had an exact date. The reporter said that was unknown if patient was immunocompromised or immunocompetent. The reporter consented to follow-up. Additional supportive information: The patient received Shingrix mistakenly instead of Varicella at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The case US2022156206 was identified as duplicate of US2022156205. The case US2022156206 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.