chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Neuropathy peripheral, Scan
Clinical narrative: ingrown toe nail; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 19Feb2021 at 09:15 as dose 1, single (Lot number: EL9267), in left arm, on 12Mar2021 at 09:15 as dose 2, single (Lot number: EN6207), in right arm and on 19Sep2021 as dose 3 (booster), single (Lot number: 7485) at the age of 82 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Lung cancer" (unspecified if ongoing), notes: She said she is a cancer patient and she said lung cancer for 8 years next month. Concomitant medication(s) included: TAGRISSO taken for lung neoplasm malignant. The following information was reported: INGROWING NAIL (non-serious), outcome "unknown", described as "ingrown toe nail". The event "ingrown toe nail" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: No. Prior Vaccinations(within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Vaccine Name: Manufacturer: Lot Number: Route, Anatomical Location: No. of Previous Doses: Date: No. AE(s) following prior vaccinations: None or Unknown Adverse Event: Onset Age: Vaccine/Brand Name: Vaccination Date: No; She don't go to the doctor except of scans every 3 months and if she goes to doctor is for something silly like an ingrown toe nail and goes to podiatrist. Family Medical History Relevant to AE(s): No.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Ingrowing nail
Clinical narrative: ingrown toe nail; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 19Feb2021 at 09:15 as dose 1, single (Lot number: EL9267), in left arm, on 12Mar2021 at 09:15 as dose 2, single (Lot number: EN6207), in right arm and on 19Sep2021 as dose 3 (booster), single (Lot number: 7485) at the age of 82 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Lung cancer" (unspecified if ongoing), notes: She said she is a cancer patient and she said lung cancer for 8 years next month. Concomitant medication(s) included: TAGRISSO taken for lung neoplasm malignant. The following information was reported: INGROWING NAIL (non-serious), outcome "unknown", described as "ingrown toe nail". The event "ingrown toe nail" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: No. Prior Vaccinations(within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Vaccine Name: Manufacturer: Lot Number: Route, Anatomical Location: No. of Previous Doses: Date: No. AE(s) following prior vaccinations: None or Unknown Adverse Event: Onset Age: Vaccine/Brand Name: Vaccination Date: No; She don't go to the doctor except of scans every 3 months and if she goes to doctor is for something silly like an ingrown toe nail and goes to podiatrist. Family Medical History Relevant to AE(s): No.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Continued injection site pain, fatigue, constant headache, body aches, and nausea
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Burning sensation, Electric shock sensation, Muscle contractions involuntary, Muscular weakness
Clinical narrative: First shot was in left arm. Within 2 days of first shot, I had what felt like bee stings/sharp, shooting pain in left axilla. I received second shot in the right arm. Within 2-3 days after second shot, I had severe left arm symptoms. These included severe pain in axilla, burning in upper arm, aching/weakness of whole arm, involuntary muscle contractions, and electrical, sharp, shooting pain. Symptoms were the worse in the first couple months. Over time, the symptoms lessoned. Over 4-6 months, I was much better. Currently, I am typically symptom free with rare 1-2 day mild flares of pain in left axilla and left arm weakness.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgic amyotrophy, Pain, Pain in extremity
Clinical narrative: First shot was in left arm. Within 2 days of first shot, I had what felt like bee stings/sharp, shooting pain in left axilla. I received second shot in the right arm. Within 2-3 days after second shot, I had severe left arm symptoms. These included severe pain in axilla, burning in upper arm, aching/weakness of whole arm, involuntary muscle contractions, and electrical, sharp, shooting pain. Symptoms were the worse in the first couple months. Over time, the symptoms lessoned. Over 4-6 months, I was much better. Currently, I am typically symptom free with rare 1-2 day mild flares of pain in left axilla and left arm weakness.
Age: 17.0
Sex: F
Vaccine: COVID19, HEP, HEPA, HPV9, IPV, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: COVID 19 Pfizer dose given beyond use date.  There were no signs or symptoms of side effects.  There was no treatment necessary.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: COVID 19 Pfizer dose given beyond use date.  There were no signs or symptoms of side effects.  There was no treatment necessary.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chest X-ray normal, Chest pain, Dyspnoea, Fatigue
Clinical narrative: This is recounting my third shot which was my booster on 03/02/22. My first two Moderna shots had very few symptoms and I was fine within 24 hours. The booster done at pharmacy, I was also fine, until almost 2 weeks after, on Sunday I believe, I woke up with hives over 75% of my body. I never experienced hives before and they covered my arms, legs, stomach, neck, and so on. After a couple of hours, I had trouble breathing and went to the ER. It took a while to take me back despite feeling like scratching my skin off and once back they weren't much help. They took my vitals and gave me Prednisone and sent me on my way.   I felt little relief and the hives were so bad that I struggled that whole day. I finally fell asleep and was shocked to wake up with no improvements, in fact, my hands and neck were swollen and again I couldn't breathe. I went back to the ER and this time they took it a little more seriously by putting me on an IV drip, but again, I wasn't dying so they sent me home with some medication. I spent the next five days sleeping in a bathtub because that was the only place I could find relief. I was tired and itchy, my chest hurt, I had trouble breathing, etc.  A few days later I made my way to a dermatologist. I can't remember where, but they thought it could be an infectious disease. They said to follow up with this specialist and I didn't.  A few days after that I went to an allergist who asked me, when I got the booster, and I told him on the 2nd, and he said it was an allergic reaction to the booster. I didn't believe it. but soon I found groups of people with the exact same issues, occurring almost two weeks after the booster.  Now, fast forward to four months later and I still have daily hives. Even writing this my body is itchy. The only relief is a cold compress and Allegra. Thankfully it's not over 75% of my body anymore, and just small patches, but it is still there. And I've been losing a lot of hair.   The hives and chest pains were bothering me so I made an appointment with my primary doctor who had some chest x-rays done which didn't find anything. After a week the chest pains subsided, but the rash didn't.  What I do know is I felt incredible the week before March 2nd and although I am not nearly as severe, I am still stressed out and dealing with hives four months later and some on the internet said there symptoms went away after six months or more so I am hopeful this isn't permanent.. Now, I'm unfortunately completely against ever getting another booster again. I don't know why this happened, but I know there are enough people with the same symptoms as me. I hope my story helps in some way.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Stress, Swelling, Urticaria
Clinical narrative: This is recounting my third shot which was my booster on 03/02/22. My first two Moderna shots had very few symptoms and I was fine within 24 hours. The booster done at pharmacy, I was also fine, until almost 2 weeks after, on Sunday I believe, I woke up with hives over 75% of my body. I never experienced hives before and they covered my arms, legs, stomach, neck, and so on. After a couple of hours, I had trouble breathing and went to the ER. It took a while to take me back despite feeling like scratching my skin off and once back they weren't much help. They took my vitals and gave me Prednisone and sent me on my way.   I felt little relief and the hives were so bad that I struggled that whole day. I finally fell asleep and was shocked to wake up with no improvements, in fact, my hands and neck were swollen and again I couldn't breathe. I went back to the ER and this time they took it a little more seriously by putting me on an IV drip, but again, I wasn't dying so they sent me home with some medication. I spent the next five days sleeping in a bathtub because that was the only place I could find relief. I was tired and itchy, my chest hurt, I had trouble breathing, etc.  A few days later I made my way to a dermatologist. I can't remember where, but they thought it could be an infectious disease. They said to follow up with this specialist and I didn't.  A few days after that I went to an allergist who asked me, when I got the booster, and I told him on the 2nd, and he said it was an allergic reaction to the booster. I didn't believe it. but soon I found groups of people with the exact same issues, occurring almost two weeks after the booster.  Now, fast forward to four months later and I still have daily hives. Even writing this my body is itchy. The only relief is a cold compress and Allegra. Thankfully it's not over 75% of my body anymore, and just small patches, but it is still there. And I've been losing a lot of hair.   The hives and chest pains were bothering me so I made an appointment with my primary doctor who had some chest x-rays done which didn't find anything. After a week the chest pains subsided, but the rash didn't.  What I do know is I felt incredible the week before March 2nd and although I am not nearly as severe, I am still stressed out and dealing with hives four months later and some on the internet said there symptoms went away after six months or more so I am hopeful this isn't permanent.. Now, I'm unfortunately completely against ever getting another booster again. I don't know why this happened, but I know there are enough people with the same symptoms as me. I hope my story helps in some way.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: COVID 19 Pfizer dose given beyond use date.  There were no signs or symptoms of side effects.  There was no treatment necessary.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Immediate severe right shoulder pain, concern for vaccine injected into joint space. 1 to 2 days after vaccine develop diarrhea and mild fatigue/aches. Seven days after vaccine started having increased fatigue, severe headache, bodyaches, diarrhea, nausea.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Pain
Clinical narrative: Immediate severe right shoulder pain, concern for vaccine injected into joint space. 1 to 2 days after vaccine develop diarrhea and mild fatigue/aches. Seven days after vaccine started having increased fatigue, severe headache, bodyaches, diarrhea, nausea.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Pain, Pyrexia
Clinical narrative: Fever,  body aches, loss of appetite.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Nurse calling for TE evaluation on frozen products states products have been administered.     Names of vaccines involved (including lot/exp) PROQUAD   W004029   8/1/2023        ?    Temperature 6°F up to 14°F (8F) for 0 hours 18 minutes 0 second; No additional AE details; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, or drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with improperly stored (reported as "frozen products stated products have been administered") measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W004029, expiration date: reported as 01-AUG-2023, however upon internal validation it was established as 02-AUG-2023, administered for prophylaxis (strength, site and route of administration were not provided) (product storage issue). It was reported that the temperature of excursion was 6 degrees Fahrenheit (F) up to 14 degrees F for 18 minutes and then 14 degrees F to 46 degrees F for 45 minutes. There was no previous temperature excursion. The vaccine was administered with a sterile diluent (which was considered to be a concomitant therapy). No additional adverse events were reported.; Sender's Comments:  US-009507513-2206USA002264: US-009507513-2206USA002231:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE details; Inbound call from HCP stating a dose of MMR-II was inadvertently given after it's expiration date.; This spontaneous report was received from a health care professional referring to patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent.  On 13-JUN-2022, the patient was inadvertently vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live rHA (M-M-R II) (valid lot #T016195, upon internal revision expiration date was: 11-JUN-2022 (but reported as 11-MAY-2022)) (Expired product administered) (strength, route of administration and anatomical location were not provided) for prophylaxis.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported.; Caller reported VARIVAX administered after temperature excursion.; This spontaneous information has been received from an administrator, concerning a male patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 16-MAY-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection at dose of 0.5 milliliter (ml) subcutaneously (SQ), with lot number U022321 and expiration date 15-JUL-2023, for prophylaxis (vaccination scheme frequency and anatomical location was not provided). This administration was performed after a temperature excursion (product storage error), with a temperature of 6 degrees Fahrenheit (F), time frame 30 minutes; it was reported that there was no previous temperature excursion. No adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; Caller reports that doses of improperly stored vaccines were administered to patients.; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and geneder. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-JUN-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) oral liquid, 1 dosage form, lot #1742084, expiration date: 05-OCT-2022, administered orally for prophylaxis (dose number and strength was not provided). No other adverse events reported.; Sender's Comments:  US-009507513-2206USA006019: US-009507513-2206USA006096: US-009507513-2206USA006141: US-009507513-2206USA006272:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; expired doses of VAQTA; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUN-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, once, lot #T031201, expiration date: 14-JUN-2022 (expired product administered) (route of administration and injection site were not provided) for prophylaxis. Hepatitis a vaccine, inactivated (VAQTA) did not have any prior temperature excursions. Patient had no adverse effects or symptoms from this dose.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA007065: US-009507513-2206USA007033: US-009507513-2206USA006941: US-009507513-2206USA006955: US-009507513-2206USA006951:
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Caller reports no adverse effects to patient; VARIVAX administered IM rather than SQ; This spontaneous report was received from a medical assistant and refers to a 42-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JUN-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml/once (anatomical location, lot #, and expiry date were not provided) intramuscularly rather than subcutaneously (incorrect route of product administration). No adverse effects were reported. The reporter inquired if re-dosing was necessary.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion; This spontaneous report was received from a certified medical assistant and refers to 11-year-old male patient. There was no information about the patient's concurrent conditions or medical history provided. Concomitant medications included meningococcal vaccine (MENINGOCOCCAL VACCINE) (lot # U7191AA, expiration date 18-JAN-2023, intramuscular, left deltoid) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (lot # U6900AA, expiration date 18-NOV-2022, intramuscular, right deltoid).  On 24-MAR-2022, the patient was vaccinated with the first dose (previous dose reported as 0) of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T036812, expiration date 28-APR-2023 (also reported as 23-APR-2023), intramuscular, left deltoid (dose and route of administration were not reported) for prophylaxis, which were involved in a temperature excursion of 0.39 degrees Celsius for 80 hours and 11.2 degrees Celsius for 80 hours (product storage error). This temperature excursion was found out on 31-MAR-2022. The medication error occurred in the process of storage in clinical practice. The operator of vaccine/vaccine-device was healthcare professional who was trained. The vaccine/vaccine-device was used according to the instruction leaflet. The patient wanted to repeat dose on 24-SEP-2022. There was no additional adverse event or product quality complaint reported. No information about previous excursions reported.  This is one of cases from same reporter. ; Sender's Comments:  US-009507513-2204USA005218: US-009507513-2207USA000783: US-009507513-2207USA000784: US-009507513-2207USA000785:
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion for GARDASIL 9 and M-M-R II; No additional AE reported; This spontaneous report was received from a certified medical assistant and refers to 20-year-old female patient. There was no information about the patient's concurrent conditions, concomitant medications or medical history provided.  On 21-JAN-2022, the patient was vaccinated with the first dose (previous dose reported as 0) of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T030746, expiration date 16-MAR-2023, intramuscular, right deltoid  (dose and route of administration were not reported) for prophylaxis, which were involved in a temperature excursion of 0.39 degrees Celsius for 80 hours and 11.2 degrees Celsius for 80 hours (product storage error). This temperature excursion was from 17-JAN-2022 to 31-MAR-2022. The medication error occurred in the process of storage in clinical practice. The operator of vaccine/vaccine-device was healthcare professional who was trained. The vaccine/vaccine-device was used according to the instruction leaflet. The patient wanted to repeat dose on 11-JUL-2022. There was no additional adverse event or product quality complaint reported. No information about previous excursions reported.  This is one of cases from same reporter. ; Sender's Comments:  US-009507513-2207USA000782: US-009507513-2204USA005218: US-009507513-2207USA000784: US-009507513-2207USA000785:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to 13-year-old female patient. There was no information about the patient's concurrent conditions, concomitant medications or medical history provided. On 24-MAR-2022, the patient was vaccinated with the second dose (previous dose reported as 1) of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T036812, expiration date 28-APR-2023, intramuscular, left deltoid  (dose and route of administration were not reported) for prophylaxis, which were involved in a temperature excursion of 0.39 degrees Celsius for 80 hours and 11.2 degrees Celsius for 80 hours (product storage error). This temperature excursion was from 17-JAN-2022 to 31-MAR-2022. The medication error occurred in the process of storage in clinical practice. The operator of vaccine/vaccine-device was healthcare professional who was trained. The vaccine/vaccine-device was used according to the instruction leaflet. The patient wanted to repeat dose on September 2022. There was no additional adverse event or product quality complaint reported. No information about previous excursions reported.  This is one of cases from same reporter. ; Sender's Comments:  US-009507513-2204USA005218: US-009507513-2207USA000782: US-009507513-2207USA000783: US-009507513-2207USA000785:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported; temperature excursion; This spontaneous report was received from a certified medical assistant and refers to 15-year-old male patient. There was no information about the patient's concurrent conditions, concomitant medications or medical history provided.  On 07-FEB-2022, the patient was vaccinated with the second dose (previous dose reported as 1) of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T030746, expiration date 16-MAR-2023, intramuscular, right deltoid  (dose and route of administration were not reported) for prophylaxis, which were involved in a temperature excursion of 0.39 degrees Celsius for 80 hours and 11.2 degrees Celsius for 80 hours (product storage error). This temperature excursion was from 17-JAN-2022 to 31-MAR-2022. The medication error occurred in the process of storage in clinical practice. The operator of vaccine/vaccine-device was healthcare professional who was trained. The vaccine/vaccine-device was used according to the instruction leaflet. The patient wanted to repeat dose in August 2022. There was no additional adverse event or product quality complaint reported. No information about previous excursions reported.  This is one of cases from same reporter. ; Sender's Comments:  US-009507513-2207USA000782: US-009507513-2207USA000783: US-009507513-2207USA000784: US-009507513-2204USA005218:
Age: 23.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired VAQTA was administered to a patient today (05Jul2022.); This spontaneous report was received from a registered nurse and refers to a 23-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-JUL-2022, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #T035721, expiration date: 15-APR-2022, administered for prophylaxis (dose, strength, and route of administration were not provided) (expired product administered). No additional adverse event reported. Vaccine was not part of a temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any other AE; caller said the patient received a dose after a temperature excursion occurred.; This spontaneous report was received from medical assistant, referring to patient of unknown date and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JUN-2022, the patient was vaccinated with one dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1858935 has been verified to be a valid lot, expiration date: 25-MAR-2023), administered orally for prophylaxis (strength, route of administration and anatomical location was not provided).   Additionally, it was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent to a temperature excursion of 9.8 degree Celsius (°C) for 47 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red around injection site; warm around injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th June 2022, the patient received the 1st dose of Shingles vaccine. On 29th June 2022, 5 days after receiving Shingles vaccine, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient received 1st shot on unknown arm at doctor's office last Friday and on in the morning of reporting day, he/she noticed that the arm was red and warm around injection site. The patient asked if this was normal. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received the adjuvant prior to mixing; only received the adjuvant prior to mixing; This case was reported by a other health professional via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-Jun-2022 Reporters comment: This case was reported via interactive digital media. For Shingrix, reporter had a patient that had only received the adjuvant prior to mixing.  The reporter wanted to know that was there a time frame we must wait to start the series over. Additional Supportive Information: The patient received only the adjuvant prior to mixing which led to the inappropriate preparation of medication and inappropriate dose of vaccine administered. Follow up was not possible as no contact details available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received one dose of Shingrix in 9.2020; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: This case was received from other healthcare professional via interactive digital media. The patient was there to get Shingrix again and the question was that she had to get a second dose after (2-6months) after receiving the dose on the date of reporting.  The follow-up would not possible as no contact details were available. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingirx which led to incomplete course of vaccination.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: initial dose on 6/14/2022, second on 6/30/2022 / 2nd dose was given 2-weeks after the 1st; This case was reported by a other health professional via other manufacturer and described the occurrence of drug dose administration interval too short in a 44-year-old female patient who received HBV (Engerix B adult) (batch number 333m4, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B adult).   On 30th June 2022, the patient received the 2nd dose of Engerix B adult (intramuscular) and Engerix B Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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-JUN-2022 Reporter's Comments: The patient was given their second dose of Engerix-B 2-weeks early. The second dose was given 2-weeks after the first versus the recommended 4-weeks. The reporter gave consent to follow up. Additional Supportive Information: The second dose was given 2-weeks after the first dose which led to shortening of vaccinations schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Rash, Rash erythematous, Swelling
Clinical narrative: swelling under my arm; Pain, Pain under the arm; rash lower chest; Small red patch under arm; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced swelling, axillary pain, rash and red rash. On an unknown date, the outcome of the swelling was unknown and the outcome of the axillary pain and red rash were not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the swelling, axillary pain, rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received a first dose of Shingrix 3 three days ago (the day before reporting) and experienced swelling under arm, pain, also got a rash on the lower area of chest. The rash had subsided but there was a small red patch and pain under the arm. The patient asked was this normal. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inadvertently administered the Menveo diluent component without the powder component to a patient; Inadvertently administered the Menveo diluent component without the powder component to a patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 30th June 2023) for prophylaxis.   On 21st June 2022, the patient received Menveo. On 21st June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-JUNE-2022 This case was reported by the other healthcare professional. Reporter reported patient was inadvertently administered the Menveo diluent component without the powder component. Additional supportive information: As administered the Menveo diluent component without the powder component to a patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Gave a dose that was 9 days expired. The child is not experiencing any symptoms.; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 23-month-old female patient who received HAV (Havrix pediatric) (batch number ce74n, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2022, the patient received the 1st dose of Havrix pediatric (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The reporter stated that a patient was administered a dose of Havrix in the left thigh, that was 9 days expired. The patient was not experiencing any symptoms at the time of reporting. The reporter consented to follow up.  Additional Supportive Information: The patient was administered dose of Havrix vaccine, which was already expired in 19th June 2022, which led to expired vaccine used.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Nurse gave an expired vaccine to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E525, expiry date 21st June 2022) for prophylaxis.   On 28th June 2022, the patient received Boostrix. On 28th June 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: On 28th June 2022, a nurse gave a Boostrix vaccine to adult patient. The reporter consented to follow up via email. Additional Supportive Information: The patient was administered an expired dose of Boostrix vaccine, which led to expired vaccine used.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Tendernessand pain  at injection site; Redness about the size of a golf ball around injection site; area was warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (outbreak of Shingles in 2005) and shingles (outbreak of Shingles in April 2021). Previously administered products included Shingrix (received 1st dose in December 2021).   On 25th June 2022, the patient received the 2nd dose of Shingrix. In June 2022, 24 hrs after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On 25th June 2022, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness, injection site erythema and injection site warmth to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient reported developing large area of redness about the size of a golf ball around the injection site approximately 24 hours after receiving second dose of Shingrix. The patient also experienced tenderness and pain at the injection site immediately after receiving dose. The patient noticed the area was warm to the touch approximately 24 hours after receiving dose. The reporter wondered if previously experiencing two outbreaks of Shingles (in 2005 and April of 2021) had anything to do with his reaction to the second dose of Shingrix, as he typically had no reaction to vaccines. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Rash, Rash macular
Clinical narrative: swelling or puffiness of lip; some numbness; Itchy rash/itchy blotches; Rash; red itchy blotches/spots in upper chest and neck; This case was reported by a consumer via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown for product used for unknown indication.   On 27th June 2022 10:00, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Nucala at an unknown dose and frequency. On 27th June 2022, less than a day after receiving Shingrix and unknown after starting Nucala, the patient experienced rash, red blotches and itchy rash. On 28th June 2022, the patient experienced lip swelling and numbness. The action taken with Nucala was unknown. On an unknown date, the outcome of the rash, red blotches, lip swelling and numbness were not recovered/not resolved and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the rash, red blotches, lip swelling, numbness and itchy rash to be related to Shingrix and Nucala.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The case was reported by the patient. The reporter who called to report side effects of Shingrix.  She stated that, 1-2 hours after vaccination she noted a rash which she described as red itchy blotches/spots in the upper chest and neck area.  At the time of reporting, she noted some swelling or puffiness to the corner of her lip and some numbness. The symptoms had not yet resolved.  The patient stated that, she also recently was started on Nucala.  The reporter provided medical advice disclaimer and referred to healthcare professional. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash pruritic, Swelling face
Clinical narrative: swelling or puffiness of lip; some numbness; Itchy rash/itchy blotches; Rash; red itchy blotches/spots in upper chest and neck; This case was reported by a consumer via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown for product used for unknown indication.   On 27th June 2022 10:00, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Nucala at an unknown dose and frequency. On 27th June 2022, less than a day after receiving Shingrix and unknown after starting Nucala, the patient experienced rash, red blotches and itchy rash. On 28th June 2022, the patient experienced lip swelling and numbness. The action taken with Nucala was unknown. On an unknown date, the outcome of the rash, red blotches, lip swelling and numbness were not recovered/not resolved and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the rash, red blotches, lip swelling, numbness and itchy rash to be related to Shingrix and Nucala.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The case was reported by the patient. The reporter who called to report side effects of Shingrix.  She stated that, 1-2 hours after vaccination she noted a rash which she described as red itchy blotches/spots in the upper chest and neck area.  At the time of reporting, she noted some swelling or puffiness to the corner of her lip and some numbness. The symptoms had not yet resolved.  The patient stated that, she also recently was started on Nucala.  The reporter provided medical advice disclaimer and referred to healthcare professional. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: extra dose of DTAP AND IPV; extra dose of DTAP AND IPV, IPOL received on Nov 29th 2021, Kinrix received on June 28th 2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included PEDIARIX (received 1st dose on 10th October 2017), PEDIARIX (received 2nd dose on 18th December 2017), PEDIARIX (received 3rd dose on 20th February 2018), Infanrix (received 1st dose on 4th December 2018), Infanrix (received 2nd dose 29th November 2018) and IPOL (received on 29th November 2021).   On 28th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered 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: 28-JUN-2022 Reporter's Comment: The patient received a 1st dose of Kinrix in 28th June 2022. The reporter reported that patient got an extra dose of DTAP AND IPV. The reporter consented to follow up. Additional Supportive Information: The patient received 1st dose Kinrix after receiving 3 doses of Pediarix, 2 doses of Infanrix, 1 dose of IPOL, which led to extra dose administered and wrong vaccine administered.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gait disturbance, Hyperhidrosis
Clinical narrative: Tiredness; Shivering; Sweating/profuse sweating; Unable to move legs/she could not walk; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included nerve damage (Nerve Damage back lower extremities), arthritis, low back pain (Chronic pelvic low back pain), osteoporosis (Osteoporosis of hip and spine), intervertebral disc protrusion and vertigo. Concurrent medical conditions included mobility decreased.   On 7th June 2022, the patient received the 2nd dose of Shingrix. On 8th June 2022, 1 days after receiving Shingrix, the patient experienced tiredness, shivering and sweating. In June 2022, the patient experienced walking difficulty. In June 2022, the outcome of the tiredness, shivering and sweating were recovered/resolved. On an unknown date, the outcome of the walking difficulty was recovering/resolving.   It was unknown if the reporter considered the tiredness, shivering, sweating and walking difficulty to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's comments: This case was reported by the patient herself. The reporter stated that after a couple of days of receiving her second Shingrix dose, she could not walk, she could not move her legs. Gradually, she was improving over the next couple of weeks. The reporter stated that she had an appointment with her neurologist yesterday (day before reporting), but when she got up she could not move her legs again and had to cancel her appointment. The reporter stated that she was better today (on day of reporting) than she was a day before. The reporter stated that she also had experienced profuse sweating, shivering, and tiredness the day after her Shingrix shot, all of which have resolved. The reporter stated that she was highly sensitive to medications. The reporter consented to follow up and gave consent to follow up with healthcare professional.