chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13, PPV
Symptoms: Peripheral swelling, Product administered at inappropriate site, Vaccination site pain, Wrong product administered
Clinical narrative: wrong vaccine administered; Foggy feeling; Severe pain on her where the injection site was higher up on shoulder; Felt cold then felt hot then felt cold; arm was swollen and hard to touch; She had big red mark exact straight line right over bicep and back of triceps that encompassed half triceps and half bicep; Could feel cold feeling in back of arm like stuck there; felt weak and fatigued; felt weak and fatigued; had not a a pleasant reaction; arm was hard to touch; This spontaneous report was received from a consumer and refers to a 69-year-old female patient with osteoporosis, arthritis, bundle branch block left and asthma. The patient's medical history included pneumonia. Concomitant therapies included alprazolam (XANAX) and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). Historical vaccines included PFIZER BIONTECH COVID-19 VACCINE.  On 30-JUN-2023 the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W001100 and expiration date, 0.5 milliliter, intramuscularly in the left arm for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered).  On 30-JUN-2023, 6 hours after injection, the patient had not had a pleasant reaction (ill-defined disorder). First thing she felt was foggy feeling (feeling abnormal). Went to bed because she didn't feel comfortable moving about the house. Felt as if getting cold. Felt cold then hot then felt cold (feeling of body temperature change). Hot one second cold the next. Next thing was severe pain on her where the injection site was higher up on shoulder (vaccination site pain). Pain down top of rotator cuff and that pain was all on her upper arm and it was so painful she could not move her arm, she felt like neurological problem in a way. Pain was off the chart, and she could stand a lot of pain. Took 2 advil. Couldn't use or raise arm above straight out. This was caused by injection. Top of arm in front, not triceps, left of biceps it was hard and swollen, arm was swollen and hard to touch (Peripheral swelling) (Induration). Then more strangely she got like when you wear a t-shirt and get line from sunburn it's opposite that she had big red mark exact straight line right over biceps and back of triceps that encompassed half triceps and half bicep (Erythema). Could feel cold feeling in back of arm like stuck there (Peripheral coldness). Also felt weak and fatigued and like she had to go to bed and control (Asthenia) (Fatigue). The outcome of induration, ill-defined disorder, fatigue, asthenia, peripheral coldness, erythema, peripheral swelling, feeling of body temperature change, vaccination site pain and feeling abnormal was unknown. Action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding the events was not applicable.   The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Improperly stored vaccines administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 14-JUL-2023, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (lot # X004813, expiration date 28-JUL-2024; strength, dose, route were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) (lot # W017556, expiration date 07-JAN-2024; strength, dose, route were not reported) for prophylaxis. The temperature excursion was above 47 Fahrenheit degree (46.7 Fahrenheit degree) for 0 hours 25 minutes and 0 seconds (product storage error). There was no previous temperature excursion. No adverse event was reported.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No event; temperature excursion - vaccine not viable according to manufacturer; This spontaneous report was received from a physician and refers to an 8-week-old female patient.  The patient's medical history and concurrent conditions were not reported. The patient's historical vaccine included hepatitis B vaccine (basic series). Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and vitamin D.  On 05-JUN-2023, the patient received the first (also reported as booster series; conflicting information), improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # reported and upon internal validation confirmed as: 1968386, expiration date was reported and confirmed as: 23-MAY-2024, administered orally (exact dose was not provided) for prophylaxis, at private doctor's office/hospital, by the physician. No prescription drug treatment was required. Alarm believed to be due to sensory issues, monitoring temperatures with back up logger. Temperature in range, new data logger currently in use. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: No event; temperature excursion - vaccine not viable according to the manufacturer; ROTATEQ: basic series: 13-APR-2023/23-JUN-2023; This spontaneous report was received from a physician and refers to a 5-month-old male patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included hepatitis b vaccine (recombinant) (manufacturer unknown), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13).   On 13-APR-2023, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (exact dose, lot #, expiration date were not provided) for prophylaxis. On 23-JUN-2023, the patient received the second dose (Inappropriate schedule of product administration) of improperly stored (Product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # reported and upon internal validation confirmed as: 1968385, expiration date was reported and confirmed as: 22-MAY-2024, administered orally (exact dose was not provided) for prophylaxis, at private doctor's office/hospital, by the physician. On the same day, the patient additionally received second doses of diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13). No prescription drug treatment was required. Alarm believed to be due to sensory issues, monitoring temperatures with back up logger. Temperature in range, new data logger currently in use. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improper storage of product in use; No additional AE; This spontaneous report was received from Other and refers to a 6-month-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).   On 22-JUN-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968385, expiration date: 22-MAY-2024, administered orally for prophylaxis (strength was not provided).  On an unknown date, the patient experienced Improper storage of product in use. Alarm believed to be due to sensory issues. Monitoring temperatures was with back up logger. Temperature in range. New data logger now in use. Return vaccine/waste in progress. No additional AE.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: ROTATEQ administered after temperature excursion; no additional AE; This spontaneous report was received from Physician and refers to a 2-month-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (manufacturer unknown), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13).   On 06-JUN-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968386, expiration date: 23-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced ROTATEQ administered after temperature excursion. Alarm believed to be due to sensory issues. Monitoring temperatures with back up logger. Temperature in range. New data logger now in use. Return vaccines/waste in progress. No adverse effects.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: termperature excursion-vaccine not viable according to manufacturer; no event; This spontaneous report was received from a nurse and refers to a 12-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 27-JUN-2023, the patient was vaccinated with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that was exposed to temperature excursion, in the left arm, lot number W011455 with expiration date 11-DEC-2024 (dose and route were not reported) for prophylaxis (product storage error). No event was reported.   This is one of several reports from the same source.; Sender's Comments:  US-009507513-2307USA009456: US-009507513-2306USA013096: US-009507513-2307USA009456: US-009507513-2307USA009680: US-009507513-2307USA009660: US-009507513-2307USA009636:
Sex: F
Vaccine: HPV9
Symptoms: Injury, Skin laceration, Syringe issue
Clinical narrative: a Nurse mildly cut herself on the finger from the VAXNEUVANCE syringe; her thumb slipped and cut against the broken finger flange; Nurse mildly cut herself on the finger from the syringe; This spontaneous report was received from a office manager and refers to a 32-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 14-JUL-2023, the nurse was performing vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # W026150 and expiration date 20-OCT-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) and the syringe broke (syringe issue).       On 14-JUL-2023, the patient experienced skin laceration and injury associated with device. The outcome of skin laceration and injury associated with device was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Poor quality device used, Syringe issue
Clinical narrative: No additional AE; Nurse administered PFS into deltoid of patient and while pushing against the plunger rod with her thumb to administer, her thumb slipped and cut against the broken finger flange causing a cut. Patient received full dose of vaccine with no side effect; her thumb slipped and cut against the broken finger flange; This spontaneous report was received from an office manager and refers to a 13-year-old male patient. No information on patient's medical history and current conditions was provided. Concomitant therapies included minocycline and ondansetron.         On 14-JUL-2023 the patient was vaccinated with poor quality device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # W026150 and expiration date 20-OCT-2024, intramuscular in the left deltoid for prophylaxis (exact dose and dose number were not provided) (poor quality device used, syringe issue and no adverse event).
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details; HCP reported that a single dose of VARIVAX: Lot X006979 Exp: 3/7/2025 was given to one patient; This spontaneous report was received from a registered nurse referring to a patient of 15-month child. The patient's medical history, Concomitant therapy included sterile diluent (lot #: W039703, expiry date: 15-AUG-2025), drug reactions, and allergies were not reported.  On 28-JUL-2023, the patient received a single dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose of 0.5mL/once (lot #: X006979, and expiry date: 07-MAR-2025, and anatomical location were not provided) for prophylaxis. On that day, the temperature excursion was 18.3 F for 35 minutes (product storage error). No further adverse event (AE) details.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No Ae; patient should have received QUADRACEL but was accidently given VAQTA.; Extra dose administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 06-OCT-2020 and 20-JUN-2021, the patient was vaccinated with the first and second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (dose, frequency, strength, lot #, expiry date, route of administration, anatomical location, and indication were not provided). On 31-JUL-2023, the patient should have received diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL), but was accidently given hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 mL (strength, lot #, expiry date, route of administration, anatomical location, and indication were not provided) (Wrong product administered) (Extra dose administered). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed that no symptomatic adverse events were reported; Inbound call from nurse calling to report temperature excursion. HCP states that MMR-II may have been administered to patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 31-JUL-2023, the patient was vaccinated with an improperly storage measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection, therapy type: rHA, 0.5 milliliter once, valid lot #W022640, expiration date: 15-APR-2024, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion occurred at 49.26 Fahrenheit (F) for 3 hours and 45 minutes. No previous temperature excursion was reported. No symptomatic adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; HBP called to report a T/E on PROQUAD that was improperly stored and administered. Confirmed no symptoms or side effects reported. See related AE cases 02441596 and 02441599. No additional AE/no PQC.         ?    Names of vaccines involved (includi; This spontaneous report was received from a vaccine administration via health business professional (HBP) and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 01-AUG-2023, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHa) (PROQUAD) 0.5 milliliter, administered once, lot # X007085, expiration date reported as 04-SEP-2024 (route of administraton and anatomical location were not provided) reconstituted with sterile diluent. Administered dose of vaccine experienced the temperature excursion of 17.8 degrees Fahrenheit for 1 hour and 30 minutes. No previous temperature excursion was reported. No additional adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Confidential called on behalf of HCP to report a rash after receiving ZOSTAVAX/ a unilateral zoster rash at different locations once a month for 3 years; This spontaneous report has been received from a physician, regarding to herself, an 80-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date (reported as many years ago), the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) subcutaneous injection, as prophylaxis (strength, dose scheme, route and anatomical location of administration, lot number and expiration date were not reported).  On an unreported date (reported as years ago), the patient experienced a unilateral zoster rash at different locations (Rash vesicular), which was reportedly treated with valaciclovir (VALTREX) if the rash was bothersome and it would go away, but that continued to appear once a month for 3 years.  By the time of the report the patient was recovered.   The causal relationship between rash vesicular and zoster vaccine live (ZOSTAVAX) was not reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received both doses of Shingrix in 2020, but observed and is treating a current shingles outbreak for this patient./Suspected vaccination failure; received both doses of Shingrix in 2020, but observed and is treating a current shingles outbreak for this patient.; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: received both doses of Shingrix in 2020, but observed and is treating a current shingles outbreak for this patient./Suspected vaccination failure) (serious criteria medically significant) and shingles (Verbatim: received both doses of Shingrix in 2020, but observed and is treating a current shingles outbreak for this patient.). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: Receipt date 7 August 2023: The physician reported that reported he/she saw a patient this morning in her 80's that received both doses of Shingrix in 2020, but observed and was treating a current shingles outbreak for this patient.  This case was considered as suspected vaccination failure since the details regarding time to onset, laboratory confirmation of shingles was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: caused me quite a lot of pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: caused me quite a lot of pain). The outcome of the pain was resolved (duration 1 week).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: Receipt Date: 01-AUG-2023 This case was reported by a patient via interactive digital media. The patient got very bad and it caused him/her quite a lot of pain for a whole week, he/she did not know if he/she would get the second dose of shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Sleep disorder
Clinical narrative: burning sensation in my leg is not going away; taking Tramadol, but just at night, so he/she could sleep, and during the day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced burning sensation (Verbatim: burning sensation in my leg is not going away) and sleep disorder (Verbatim: taking Tramadol, but just at night, so he/she could sleep, and during the day). The patient was treated with tramadol and gabapentin. The outcome of the burning sensation was not resolved and the outcome of the sleep disorder was not reported.   It was unknown if the reporter considered the burning sensation and sleep disorder to be related to Shingles vaccine.   It was unknown if the company considered the burning sensation and sleep disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-AUG-2023 This case was reported by a patient via interactive digital media. The patient got vaccinated shingles vaccine, after they gave him/her it he/she got a bit better, he/she could walk but the burning sensation in his/her leg was not going away.  The patient had everything done and he/she was taking Tramadol, but just at night, so he/she could sleep, and during the day, two Gabapentin after eating breakfast and another two, two hours before going to sleep.
Sex: U
Vaccine: HEPA
Symptoms: Intercepted product storage error, Product storage error
Clinical narrative: temperature excursion/vaccine were still valid to use; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of intercepted product storage error in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient did not receive Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced intercepted product storage error (Verbatim: temperature excursion/vaccine were still valid to use). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 The reporter stated that he/she did not know how to say it, like a temperature excursion and what happened was his/her data logger quit reading but they noted it very next morning and it stop reading it at 4 o'clock pm the day prior.  It did not show any excursions or anything but, we just need to make sure that our vaccine were still valid to use. The first one was Havrix or the Hepatitis A. It was followed by option 3 with the timing 8am to7pm on Monday to Friday.  The reporter was informed about the role of Pfizer drug safety and when probed to proceed with question reporter hung up the call abruptly.  The further probing could not be done as reporter hung up the call abruptly.  Thus, product details expiry date and purchase details were unknown. Hence, limited information was available over the call. The temperature excursion had occurred to Havrix and asked vaccine were still valid to use, which led to intercepted product storage error.
Sex: F
Vaccine: MENB, UNK
Symptoms: Interchange of vaccine products
Clinical narrative: interchange/Pharmacist states that a Bexsero dose was originallyadministered and a month later patient gotTrumenba; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA (MENB VACCINE)) for prophylaxis.   In JUN-2023, the patient received Bexsero. On 24-JUL-2023, the patient received TRUMENBA (MENB VACCINE). On 24-JUL-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: interchange/Pharmacist states that a Bexsero dose was originallyadministered and a month later patient gotTrumenba). The outcome of the interchange of vaccine products 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: Receipt date 4 August 2023 The pharmacist stated that a Bexsero dose was originally administered to a patient and a month later patient got Trumenba. Trumenba was administered on 24-JUL-2023. No additional details regarding patient or product were available. The patient received Trumenba after bexsero vaccine which led to interchange of vaccine product.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after Shingrix). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date 31 Jul 2023 HCP was questioning the efficacy of Shingrix. He stated he had patient who return to him with shingles shortly after they got their Shingrix vaccination. He recognized the vaccine was not 100% effective however 2 patients returning with shingles was giving him hesitation. He wanted to know the data and also wanted to know more data.  This case has been linked with case  US2023106935 reported by same reporter.; Sender's Comments:  US-GSK-US2023106935:Same reporter, same product, different patients.
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: patient was given a dose of Infanrix in error instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: patient was given a dose of Infanrix in error instead of Boostrix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-AUG-2023 The reporter was a medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a patient was given a dose of Infanrix in error instead of Boostrix, which led to wrong vaccine administered.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Regurgitation, Underdose, Vomiting
Clinical narrative: Vomiting of dose; Vomitting of dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 732L4, expiry date 25-APR-2025) for prophylaxis.   On 03-AUG-2023, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On 03-AUG-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Vomiting of dose) and underdose (Verbatim: Vomitting of dose). The outcome of the regurgitation of medication and underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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: 3-Aug-2023 The nurse reported that the patient was administered a dose of Rotarix and afterwards vomited the dose back up. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose and vomited the dose back up, which led to underdose.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Exposed to a low temperature of 31.5 degrees Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   In JUN-2023, the patient received Bexsero. On 15-JUN-2023, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Exposed to a low temperature of 31.5 degrees Fahrenheit). 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: 03-AUG-2023 The reporter reported that on 15th June 2023 the Bexsero vaccines from the lot number 5AR2D was exposed to a low temperature of 31.5 Fahrenheit. The reporter stated that the vaccine was administered between 15th June 2023 to 21st June 2023. The reporter did not had specific date of vaccination for the patient. The reporter stated that at the time of reporting the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The Boostrix vaccine temperature was exposed to 31.5 degrees Fahrenheit, which led to incorrect storage of drug. The reporter did consent to follow up. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023105935:same reporter US-GSK-US2023105936:same reporter US-GSK-US2023105934:same reporter
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Joint swelling, Sleep disorder
Clinical narrative: All joints in my body have swollen and causing pain, kept me up all night, sore left arm at injection site, headache
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Thalamic stroke
Clinical narrative: ACUTE STROKE OF THALAMUS, UNSPECIFIED TYPE AND ARTERY
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Rash, Rash erythematous, Skin swelling
Clinical narrative: Red bump rash all over chest and back within hours. Consequently the rash has now spread all over the body including the face. The bumps are slightly elevated and there is not itch or pain.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial ischaemia
Clinical narrative: DEMAND ISCHEMIA
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blindness transient, Headache, Hypoaesthesia, Metamorphopsia, Migraine
Clinical narrative: Migraine with black spots in eye on day vaccine was given  Since that day she has had daily headaches, vision problems to include black spots, waves in the eye and temporary blindness) and numbness in her limbs
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Visual impairment
Clinical narrative: Migraine with black spots in eye on day vaccine was given  Since that day she has had daily headaches, vision problems to include black spots, waves in the eye and temporary blindness) and numbness in her limbs
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   In JUN-2023, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023). 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: 03-AUG-2023 Nurse reported Bexsero vaccine exposed to a low temperature of 31.5 degrees Fahrenheit on 15June2023 was administered between 15Jun2023 and 21Jun2023. The reporter did not have specific date of administration for the patient. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The vaccine was kept out of the specified temperature which led product storage error. The reporter consented to follow up.  This case is one case among 4 linked case.; Sender's Comments: Nurse reports Bexsero vaccines from lot number 5AR2D exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023.  Reporter did not have specific date of administration for each patient.  At the time of reporting, the dose has not been repeated.  ~~~~~~~Consented to follow up. "The Vaccine Administration Facility is the same as Primary Reporter", Call Notes:Patient 3 of 4.  Reporter gave permission for follow-up. US-GSK-US2023105936:same reporter US-GSK-US2023105934:same reporter US-GSK-US2023105930:same reporter
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypoxia
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY HYPOXIA
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cough, Dyspnoea, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Presented w/ chest congestion, cough & SOB; COVID-19+ w/pna; tx w/ abx, steroids, VitD3, O2; dc'd home w/HHC & O2.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Presented with generalized weakness, nausea, and vomiting x 2 days; COVID-19+; tx w/abx, steroids, zinc, melatonin; did not require O2. dc home.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Palpitations, Ventricular arrhythmia
Clinical narrative: Presented to ED with palpitations, found to be in rapid ventricular response, likely due to symptomatic COVID-19 infection; tx w/O2, steroids, singulair, zinc; weaned to RA; dc'd to HHC.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dyspnoea, Dyspnoea exertional, SARS-CoV-2 test positive
Clinical narrative: Presented w/ 3 day history of worsening shortness of breath that has been progressive in nature; husband recently tested positive for COVID-19. Patient denies cough. She is markedly dyspnea with any type of mild exertion. Pt COVID-19+ w/pna; tx w/remdesivir, steroids, zinc, O2. Dc'd home on O2.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cough, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Presented w/fever, cough, and congestion x2 days; dx w/ COVID-19 pna; tx w/abx, zinc, Vit C, steroids; did not require O2. dc'd home.
Age: 71.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Asthenia, Blood glucose decreased, Cognitive disorder, Dysarthria, Muscle twitching
Clinical narrative: Covid vaccination history: Pfizer Monovalent on 3.17.21, 4.12.21, and 10.19.21. On 8.8.23 at 8am Resident receive Pfizer Covid Bivalent vaccine. On 8.8.23 at 8:15am, Resident began to have slurred speech, hand and facial twitching, weakness, and was unable to follow directions.  She was sent to a loval health care facility. Per hospital notes, Residents fasting blood sugar was 40. She was treated with glucagon and symptoms subsided and Resident was alert and oriented x 3. This Resident has no history of Diabetes. Hospital notes state concern for possible ingestion of sulfonylurea vs injection of insulin. Toxicology labs for sulfonylurea pending. Insulin was NOT administered in place of COVID vaccine.
Age: 71.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Toxicologic test
Clinical narrative: Covid vaccination history: Pfizer Monovalent on 3.17.21, 4.12.21, and 10.19.21. On 8.8.23 at 8am Resident receive Pfizer Covid Bivalent vaccine. On 8.8.23 at 8:15am, Resident began to have slurred speech, hand and facial twitching, weakness, and was unable to follow directions.  She was sent to a loval health care facility. Per hospital notes, Residents fasting blood sugar was 40. She was treated with glucagon and symptoms subsided and Resident was alert and oriented x 3. This Resident has no history of Diabetes. Hospital notes state concern for possible ingestion of sulfonylurea vs injection of insulin. Toxicology labs for sulfonylurea pending. Insulin was NOT administered in place of COVID vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Death, Endotracheal intubation, Intensive care
Clinical narrative: Admitted for acute respiratory failure from covid 19 pna; tx w/remdesivir, Actemra, steroids, diuresis, and antibiotics. On 1/23 patient was transferred to ICU and placed on bipap with precedex gtt due to increase O2 demand.  1/24 patient intubated and prone therapy initiated. 1/26 continuous epoprostenol INH initiated.  1/27 ecmo referral initiated but patient was eventually denied by all facilities.  1/30 prone therapy completed.  1/31 epoprostenol and nimbex weaned off.  Despite all interventions patient continued to decline and palliative consulted. Pt subsequently expired.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Positive airway pressure therapy
Clinical narrative: Admitted for acute respiratory failure from covid 19 pna; tx w/remdesivir, Actemra, steroids, diuresis, and antibiotics. On 1/23 patient was transferred to ICU and placed on bipap with precedex gtt due to increase O2 demand.  1/24 patient intubated and prone therapy initiated. 1/26 continuous epoprostenol INH initiated.  1/27 ecmo referral initiated but patient was eventually denied by all facilities.  1/30 prone therapy completed.  1/31 epoprostenol and nimbex weaned off.  Despite all interventions patient continued to decline and palliative consulted. Pt subsequently expired.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, COVID-19, Endotracheal intubation, Gastrostomy, Influenza
Clinical narrative: Admitted with acute hypoxemic respiratory failure, symptomatic anemia.  Patient was found positive for COVID-19 and positive for influenza B. Treated w/O2 with need for intubation, abx, steroids, remdesivir, thiamine, Vit C, zinc. Post extubation pt failed multiple swallowing trials and Dobhoff placed d/t inability to place PEG. Pt dc'd to LTAC.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive, Swallow study abnormal
Clinical narrative: Admitted with acute hypoxemic respiratory failure, symptomatic anemia.  Patient was found positive for COVID-19 and positive for influenza B. Treated w/O2 with need for intubation, abx, steroids, remdesivir, thiamine, Vit C, zinc. Post extubation pt failed multiple swallowing trials and Dobhoff placed d/t inability to place PEG. Pt dc'd to LTAC.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: Admitted for pna d/t COVID-19; tx w/IV dexamethasone, zinc, steroid and O2.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fall, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Transfer from outside facility after a fall, concern for odontoid fracute .Fever, cough - covid was neg on admissionCOVID pos  01/11 Mild symptoms,zinc, singulair
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: presented to ER with COVID-19 test positivity and shortness of breath.steroids and ivermectin at home  nasal cannula,azithromycin and Rocephin, IV steroids, zinc /vitamin-C. D/C ohome on osygen
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Fatigue, Headache, SARS-CoV-2 test positive
Clinical narrative: Presents with SOB, fatigue and headache. Covid positive.Discahrged with PO decadron.Hospitalization
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Presented with COVID like symptoms.Tx w/ o Remdesevir,steroids, zinc sulfate, Singulair, vitamin D, supplemental oxygen.D/Chome on O2
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, COVID-19, COVID-19 pneumonia, Productive cough
Clinical narrative: Presents to ED Cough (Without SOB) covid + staff, 90% on RA, productive cough COVID 19 PNA and acute hypoxemic respiratory failure from it. Was managed with Remdesivir, systemic steroids, supplemental O2 and lovenox.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Presents to ED Cough (Without SOB) covid + staff, 90% on RA, productive cough COVID 19 PNA and acute hypoxemic respiratory failure from it. Was managed with Remdesivir, systemic steroids, supplemental O2 and lovenox.
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Exposed to a low temperature of 31.5 degrees; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   In JUN-2023, the patient received Bexsero. On 15-JUN-2023, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Exposed to a low temperature of 31.5 degrees). The outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 03-AUG-2023 The reporter reported that on 15th June 2023 the Bexsero vaccines from the lot number 5AR2D was exposed to a low temperature of 31.5 Fahrenheit. The reporter stated that the vaccine was administered between 15th June 2023 to 21st June 2023. The reporter did not had specific date of vaccination for the patient. The reporter stated that at the time of reporting the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The Boostrix vaccine temperature was exposed to 31.5 degrees Fahrenheit, which led to incorrect storage of drug. The reporter did consent to follow up. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023105930:same reporter US-GSK-US2023105935:same reporter US-GSK-US2023105934:same reporter
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: OBSTRUCTIVE SLEEP APNEA HYPOTENSION 2/18/2023  &  2/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, SARS-CoV-2 test positive
Clinical narrative: Presented to the ED with complaints of shortness of breath, fatigue and nonproductive cough.COVID-19 positiVE, admitted, tx w/ Decadron  oral doxycycline  , supplemental O2
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Presents to ER for hypoxia and shortness of breath. COVID psotivie, admitted. Remdesivir, steroids, Vitamin suplementsSupplemental O2. D/C home on O2
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: Presents to ED from Nursing home with shortness of breath, found to be COVID postive.Placed on supplementaL O2, BIPAP, Dexamethasone, Remdesivir,Actemra, empiric antibiotics
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Sepsis
Clinical narrative: Admitted from nursing home,  with Sepsis due to Covid19.1. Tx with solumedrol and remdesivir
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Lacunar stroke
Clinical narrative: ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Hypoxia, Pneumonia
Clinical narrative: COVID 19 on present on admission:  Diagnosed  1/6/22 at Nursing home:  Pneumonia with acute respiratory failure and hypoxia.Tx w/prednisone,doxycycline,Oxygen
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Cough, Dyspnoea
Clinical narrative: Patient presents with:Covid Like Symptoms: tested positive on 12/29 was given hydrochloroquin. increase in cough, sob, tachypnea.COVID 19 Pneumonia, acute resp failure with hypoxia,cefepime and azithromycin,IV steroids, zinc, vitamin-C/D.Remdesivir and baricitinib. Supplemental Oxygen.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive, Tachypnoea
Clinical narrative: Patient presents with:Covid Like Symptoms: tested positive on 12/29 was given hydrochloroquin. increase in cough, sob, tachypnea.COVID 19 Pneumonia, acute resp failure with hypoxia,cefepime and azithromycin,IV steroids, zinc, vitamin-C/D.Remdesivir and baricitinib. Supplemental Oxygen.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Dyspnoea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Presented to the emergency department from group home for evaluation fever, sleepiness and shortness of breath , COVID positive, COVID Pneumonia Tx, w/. Zinc. IV remdesivir
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Presented to the emergency department from group home for evaluation fever, sleepiness and shortness of breath , COVID positive, COVID Pneumonia Tx, w/. Zinc. IV remdesivir
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiogenic shock
Clinical narrative: CARDIOGENIC SHOCK
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cough, Dyspnoea, Exposure to SARS-CoV-2, Hypoxia
Clinical narrative: Presents to the ED with C/O SOB, Cough, and Congestion for the last 3-4 days, exposed to COVID.Admitted for Acute Respiratory Distress with Hypoxia, Covid Pneumonia, Hypoxia, and SOB and Cough.  Tx W/ IV Decadron,Rocephin and azithromycin , Zinc,Vitamin-C, zinc, vitamin D3 replacement. Supplemental Oxygen. Remdesivir. D/C home /HHC