chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; vaccines administered to a patient on 06/14/2023 after temperatue excursion; This spontaneous report has been received from a medical assistant and refers to a 4-month-old male patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 14-JUN-2023, the patient was vaccinated with improperly stored doses of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, 0.5 ml, administered in right thigh, lot #W039033 confirmed to be valid with expiration date: 01-OCT-2024 (dose number and route of administration were not reported), and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml orally, lot #1968385 confirmed to be valid with expiration date 22-MAY-2024 (dose number was not reported), both for prophylaxis.  The aformentioned vaccines underwent a temperature excursion of 49.1 degress Fahrenheit (F) for 34 minutes. There were two previous temperature excursions at 35.9 F for 2 minutes and again at 35.9 F for two minutes (product storage error). No adverse side effects were reported with the administration of the vaccines. User of the device was a healthcare professional and product was not available to obtain. ; Sender's Comments:  US-009507513-2307USA004472: US-009507513-2307USA005037:
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported with the administration of the vaccine; HCP called to report a TE for VAXNEUVANCE  which was also administered to a patient; This spontaneous report was received from a medical assistant and refers to a 16-month-old male patient. No information on patient's medical history, current conditions and concomitant medications was not provided.      On 21-JUN-2023 the patient was vaccinated with improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # W039033 and expiration date 01-OCT-2024, 0.5 milliliter in the left thigh for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).Temperature excursion was 49.1 degrees Fahrenheit (F) for 34 minutes with two previous excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes. ; Sender's Comments:  US-009507513-2307USA004472:
Age: 0.5
Sex: F
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE for VAXNEUVANCE/ and ROTATEQ/ which was also administered to a patient on 06/29/2023; This spontaneous report was received from the Medical Assistant, and refers to a 6-month-old female patient. Her medical history, concurrent conditions, and concomitant therapies were not provided.  On 29-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #W039033, expiration date: 01-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1968385, expiration date: 22-MAY-2024, administered orally for prophylaxis (strength was not provided). The vaccines were improperly stored: pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes), and rotavirus vaccine, live, oral, pentavalent (ROTATEQ): same excursion details (product storage error). No additional adverse event information was provided. ; Sender's Comments:  US-009507513-2307USA004472:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: No additional AE; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD.; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD.; This spontaneous report was received from a nurse and refers to a patient of an unspecified age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.   On 29-JUN-2023, the patient was vaccinated with the suspect vaccine measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD) subcutaneous injection that was administered as prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date was not provided), which was inadvertently reconstituted and administered to the patient that day with an expired sterile diluent (STERILE DILUENT) solution for injection/infusion, lot number: T029529, expiration date: 19-APR-2023 which was determined to be a valid lot number for sterile diluent (STERILE DILUENT) solution for injection/infusion (strength, dose, frequency, route of administration and anatomical location was not provided) (expired product administered, product preparation issue). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA004736: US-009507513-2307USA004745: US-009507513-2307USA004774:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: No additional AE; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD. No temperature excursion. No symptoms reported. STERILE DILUENT supported for 12 months post-expiry. Obtained consent to contact HCP. AEs Fil; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD. No temperature excursion. No symptoms reported. STERILE DILUENT supported for 12 months post-expiry. Obtained consent to contact HCP. AEs Fil; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-JUN-2023, the patient was administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dosage form, administered for prophylaxis (strength, dose, lot number, expiry date, anatomical location and route of administration were not provided) which was reconstituted with expired sterile diluent solution for injection/infusion (1 dosage form, lot #T029529, expiration date: 16-APR-2023, administered for prophylaxis, strength, and route of administration were not provided) (Expired product administered; Product preparation issue). No temperature excursion. No symptoms reported. No additional adverse event (AE) (No adverse event). Sterile diluent supported for 12 months post-expiry.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: HCP reports a patient who has previously completed the GARDASIL QUADRIVALENT series had a positive pap smear in 04/2023 for HPV 18 OR 45.  Physician is unsure which one the patient is testing positive for and no further details provided.  No other AE; This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's értinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient completed quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) series, for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.         On an unspecified date in April 2023, the patient had a positive smear for HPV 18 or 45 (smear cervix abnormal). The physician was unsure which one the patient was testing positive for and no further details provided. No other adverse event (AE) was reported. At the time of reporting, the outcome of the event was unknown.  The causality assessment between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; HBP reporting that VARIVAX was administered after it experienced a supported temperature excursion. No side effects reported from HBP.         ?    Names of vaccines involved (including lot/exp): VARIVAX, Lot: W025277, Expiration: 8/10/2024; This spontaneous report was received from an administrator refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with the first dose of improper storage varicella virus vaccine live (oka/merck)(VARIVAX) lot #W025277, expiration date: 10-AUG-2024, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis, dissolvent with sterile diluent.   Administered dose of vaccine was exposed to the temperature excursion of -8.6 degree Celsius for 51 minutes. The previous temperature excursion of -11.5 degree Celsius for 1 hour and 16 minutes (product storage error). There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; HBP reporting that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported from healthcare professional.         ?    Names of vaccines involved (including lot/exp): PROQUAD, Lot: W036940, Expiration: 4/15/2024; This spontaneous report was received from an administrator refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with the second dose of improper storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin), (PROQUAD) lot # W036940, expiration date: 19-MAY-2024, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis, dissolvent with sterile diluent.  Administered dose of vaccine was exposed to the temperature excursion of -8.6 degree Celsius for 51 minutes. The previous temperature excursion of -11.5 degree Celsius for 1 hour and 16 minutes (product storage error). There were no additional adverse events reported (no adverse event).
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Blood pressure abnormal, Dizziness, Skin discolouration, Syncope, Vomiting
Clinical narrative: Faint; Skin turned grey; Blood pressure was below 40; Vomited; Light headed; This spontaneous report has been received from a registered nurse, concerning an 11-year-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, administered intramuscularly (IM) as prophylaxis against anal, oropharyngeal and other head and neck cancers caused by Human Papilloma Virus (HPV) (lot number, expiration date, and anatomical location were not provided).  On the same day, the observation for 15 minutes after administration was not complete because the patient started running and moving around. He felt light-headed (Dizziness), faint (Syncope), and his skin turned grey (Skin discolouration). The patient's blood pressure was below 40 (units not provided) (Blood pressure abnormal) and he also vomited (Vomiting). For these events it was sought medical attention.  At the reporting time, the patient had recovered from the events.  The causal relationship between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event faint was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; A patient received an expired dose of the VARIVAX vaccine; This spontaneous report has been received from a medical assitant, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 13-JUL-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot number U020244 was verified to be valid, expiration date reported and confirmed as 28-JUN-2023), administered as prophylaxis (exact dose, route of administration, and anatomical location were not provided) (Expired product administered). No additional adverse event (AE) nor product quality complaint (PQC) were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Administration of VAQTA following a temperature excursion; This spontaneous report was received from a healthcare professional, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 13-JUL-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number 1989614 was verified to be valid, expiration date reported and confirmed as 23-AUG-2024), administered as prophylaxis (exact dose, route of administration, and anatomical location were not provided). The vaccine was administered following a temperature excursion (unspecified) (Product storage error). No further details, adverse events (AE), nor product quality complaints (PQC) were provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Obesity
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/30/2023 SEVERE OBESITY EQUIVALENT, BMI 39-39.9, ADULT W CO-MORBIDITY
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Pneumonia
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 5/3/2023 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 5/3/2023 ACUTE RESPIRATORY FAILURE
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Pneumothorax
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 ACUTE PNEUMOTHORAX R09.02 HYPOXIA 3/27/2023 ACUTE PNEUMOTHORAX J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 ACUTE PNEUMOTHORAX R09.02 HYPOXIA 3/27/2023 ACUTE PNEUMOTHORAX
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The 5 year old male was given both above vaccines above on the same day at the same time.  Currently no adverse effect.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: LOCAL ALLERGIC REACTION
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave an additional dose of Menquadfi secondary to a medication transcription error. No adverse reaction noted.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Condition aggravated, Eyelid pain, Herpes ophthalmic
Clinical narrative: Ocular herpes; blisters on eyelids; Inner lower eye lids with pain interior eye plus skin exterior in area; chills; fever; arm pain; rash on back; This serious case was reported by a consumer and described the occurrence of herpes ophthalmic in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 73XT7) for prophylaxis.   The patient's past medical history included herpes ophthalmic.   On 17-MAR-2023, the patient received Shingrix .5 ml. On 18-MAR-2023, 1 days after receiving Shingrix, the patient experienced herpes ophthalmic (Verbatim: Ocular herpes) (serious criteria GSK medically significant), blister (Verbatim: blisters on eyelids), eyelid pain (Verbatim: Inner lower eye lids with pain interior eye plus skin exterior in area), chills (Verbatim: chills), fever (Verbatim: fever), pain in arm (Verbatim: arm pain) and rash (Verbatim: rash on back). The patient was treated with fexofenadine hydrochloride (Allegra) and aciclovir (Acyclovir). The outcome of the herpes ophthalmic, blister, eyelid pain, chills, fever and pain in arm were not resolved and the outcome of the rash was resolved (duration 1 week).   It was unknown if the reporter considered the herpes ophthalmic, blister, eyelid pain, chills, fever, pain in arm and rash to be related to Shingrix.     It was unknown if the company considered the herpes ophthalmic, blister, eyelid pain, chills, fever, pain in arm and rash to be related to Shingrix.   Additional Information: GSK receipt date: 09-JUL-2023 It was reported that day after receiving Shingrix vaccine patient experienced fever, arm pain, chills day after, rash for 1 week on back, then blisters on eyelids, inner lower eye lids with pain interior eye plus skin exterior in area. Then went to left eye. The patient was treated with Allegra, Zyzal for allergy. The patient was treated with Acyclovir for Ocular herpes.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Ocular herpes; blisters on eyelids; Inner lower eye lids with pain interior eye plus skin exterior in area; chills; fever; arm pain; rash on back; This serious case was reported by a consumer and described the occurrence of herpes ophthalmic in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 73XT7) for prophylaxis.   The patient's past medical history included herpes ophthalmic.   On 17-MAR-2023, the patient received Shingrix .5 ml. On 18-MAR-2023, 1 days after receiving Shingrix, the patient experienced herpes ophthalmic (Verbatim: Ocular herpes) (serious criteria GSK medically significant), blister (Verbatim: blisters on eyelids), eyelid pain (Verbatim: Inner lower eye lids with pain interior eye plus skin exterior in area), chills (Verbatim: chills), fever (Verbatim: fever), pain in arm (Verbatim: arm pain) and rash (Verbatim: rash on back). The patient was treated with fexofenadine hydrochloride (Allegra) and aciclovir (Acyclovir). The outcome of the herpes ophthalmic, blister, eyelid pain, chills, fever and pain in arm were not resolved and the outcome of the rash was resolved (duration 1 week).   It was unknown if the reporter considered the herpes ophthalmic, blister, eyelid pain, chills, fever, pain in arm and rash to be related to Shingrix.     It was unknown if the company considered the herpes ophthalmic, blister, eyelid pain, chills, fever, pain in arm and rash to be related to Shingrix.   Additional Information: GSK receipt date: 09-JUL-2023 It was reported that day after receiving Shingrix vaccine patient experienced fever, arm pain, chills day after, rash for 1 week on back, then blisters on eyelids, inner lower eye lids with pain interior eye plus skin exterior in area. Then went to left eye. The patient was treated with Allegra, Zyzal for allergy. The patient was treated with Acyclovir for Ocular herpes.
Sex: U
Vaccine: VARZOS
Symptoms: Gait inability, Herpes zoster, Vaccination failure
Clinical narrative: I had shingles / Suspected vaccination failure; I had shingles; got to were I couldn't walk; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had shingles) and unable to walk (Verbatim: got to were I couldn't walk). The outcome of the vaccination failure was unknown and the outcome of the shingles and unable to walk were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and unable to walk to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and unable to walk to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Jul-2023 This case was reported the patient via interactive digital media. The patient had already the shots. The patient had Shingles and got to were he/she could not walk. The patient asked to get the shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: shivering; This non-serious case was reported by a physician via sales rep and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shivering (Verbatim: shivering). The outcome of the shivering was not reported.   It was unknown if the reporter considered the shivering to be related to Shingrix.     It was unknown if the company considered the shivering to be related to Shingrix.   Additional Information: GSK Receipt date: 12-JUL-2023 The physician reported about a patient who received the first dose of Shingrix and experienced Shivering. The reporter was did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: another attack 3 years later/ Suspected vaccination failure; suffered another attack 3 years later; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (for three weeks) and shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: another attack 3 years later/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: suffered another attack 3 years later) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUL-2023 This case was reported by a patient via interactive digital media. The patient had pain for three weeks and it had hurt.  He/she got a shot for shingles after he/she healed, suffered another attack 3 years later. The reporter thanked God that it was less painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got Shingles shot/got shingles / Suspected vaccination failure; Got shingles; Painful blisters on the tummy; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got Shingles shot/got shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles), blister (Verbatim: Painful blisters on the tummy) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, blister and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-JUL-2023 This case was reported by a patient via interactive digital media. The patient stated that he/she got the original Shingles shot 6 years ago from reporting which eased some of the pain when he/she got shingles 2 years ago from reporting. The patient had painful blisters on the tummy but not as bad as it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the shots and still got them; painful,; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had the shots and still got them) and pain (Verbatim: painful,). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine shots and still got them. The patient states that his/her doctor said she had seen much worse, glad the patient got the shots. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: having gotten shingles even though she had previously taken Shingrix/ suspected vaccination failure; shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: having gotten shingles even though she had previously taken Shingrix/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). 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.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUL-2023 The patient took Shingrix shot to prevent shingles in the past and recently got shingles anyway.  This doctor was not her doctor at the time she got the Shingrix shot but he did comment the patient did report having gotten shingles even though she had previously taken Shingrix. The physician requested not to contact him/her.  He was her recent doctor and did not know the exact details of when she had Shingrix or how long of a time had elapsed before she got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule , time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My sister got the vaccine! And  still got Single/ Suspected vaccination failure; My sister got the vaccine! And  still got Single; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 vaccination failure (Verbatim: My sister got the vaccine! And  still got Single/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My sister got the vaccine! And  still got Single). 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 Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-JUL-2023 The case was received from the patient's sibling interactive digital media. The patient got the vaccine and still got shingle, it was bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a physician and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not reported.   The reporter considered the fever to be related to Shingrix.     The company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt date: 11-JUL-2023 The reporter did not consent to follow up.
Age: 90.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Anion gap, Blood culture, Blood culture negative, COVID-19, Cerebral atrophy
Clinical narrative: No adverse reaction to the vaccine itself, but patient presented with COVID & hemorrhagic stroke to the ED on 6/29/23.  Patient was transferred the same day to a local Medical Center where she expired on 7/9/23. Tests/labs conducted on 6/29/23: CBC, CMP, urinalysis, blood cultures, head & neck CT, EKG, chest x-ray (unremarkable). EKG: rate 86, sinus, left axis, normal int4rvasl, t wave inversion in lead III, V4, V5, V6, no acute ST elevation. T wave cahgnes in v4-v6 new when compared to 10/12/16 CT head: small acute left thalamic hemorrhage, chronic left thalamic lacunar infarct, age appropriate supratentorial and infratentorial atrophy, moderate chronic white matter microvascular ischemic disease  CT neck:  1.   No acute extracranial vascular abnormality identified.  2.   Nonspecific fluid distension of the midthoracic esophagus (reflux? distal  obstruction?)  Labs indicate a white count of 6.4, H&H 11.1 and 34 and platelets are 128.  Patient has no previous labs within the last year for comparison.  Patient also has a CMP with anion gap of 6.  Urinalysis without any acute evidence of infection.  Patient did have blood cultures obtained.
Age: 90.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Cerebral small vessel ischaemic disease, Chest X-ray normal, Computerised tomogram head abnormal, Computerised tomogram neck, Death
Clinical narrative: No adverse reaction to the vaccine itself, but patient presented with COVID & hemorrhagic stroke to the ED on 6/29/23.  Patient was transferred the same day to a local Medical Center where she expired on 7/9/23. Tests/labs conducted on 6/29/23: CBC, CMP, urinalysis, blood cultures, head & neck CT, EKG, chest x-ray (unremarkable). EKG: rate 86, sinus, left axis, normal int4rvasl, t wave inversion in lead III, V4, V5, V6, no acute ST elevation. T wave cahgnes in v4-v6 new when compared to 10/12/16 CT head: small acute left thalamic hemorrhage, chronic left thalamic lacunar infarct, age appropriate supratentorial and infratentorial atrophy, moderate chronic white matter microvascular ischemic disease  CT neck:  1.   No acute extracranial vascular abnormality identified.  2.   Nonspecific fluid distension of the midthoracic esophagus (reflux? distal  obstruction?)  Labs indicate a white count of 6.4, H&H 11.1 and 34 and platelets are 128.  Patient has no previous labs within the last year for comparison.  Patient also has a CMP with anion gap of 6.  Urinalysis without any acute evidence of infection.  Patient did have blood cultures obtained.
Age: 90.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Electrocardiogram T wave abnormal, Electrocardiogram T wave inversion, Full blood count normal, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: No adverse reaction to the vaccine itself, but patient presented with COVID & hemorrhagic stroke to the ED on 6/29/23.  Patient was transferred the same day to a local Medical Center where she expired on 7/9/23. Tests/labs conducted on 6/29/23: CBC, CMP, urinalysis, blood cultures, head & neck CT, EKG, chest x-ray (unremarkable). EKG: rate 86, sinus, left axis, normal int4rvasl, t wave inversion in lead III, V4, V5, V6, no acute ST elevation. T wave cahgnes in v4-v6 new when compared to 10/12/16 CT head: small acute left thalamic hemorrhage, chronic left thalamic lacunar infarct, age appropriate supratentorial and infratentorial atrophy, moderate chronic white matter microvascular ischemic disease  CT neck:  1.   No acute extracranial vascular abnormality identified.  2.   Nonspecific fluid distension of the midthoracic esophagus (reflux? distal  obstruction?)  Labs indicate a white count of 6.4, H&H 11.1 and 34 and platelets are 128.  Patient has no previous labs within the last year for comparison.  Patient also has a CMP with anion gap of 6.  Urinalysis without any acute evidence of infection.  Patient did have blood cultures obtained.
Age: 90.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Haemorrhagic stroke, Laboratory test normal, Lacunar infarction, Metabolic function test normal, Oesophageal disorder
Clinical narrative: No adverse reaction to the vaccine itself, but patient presented with COVID & hemorrhagic stroke to the ED on 6/29/23.  Patient was transferred the same day to a local Medical Center where she expired on 7/9/23. Tests/labs conducted on 6/29/23: CBC, CMP, urinalysis, blood cultures, head & neck CT, EKG, chest x-ray (unremarkable). EKG: rate 86, sinus, left axis, normal int4rvasl, t wave inversion in lead III, V4, V5, V6, no acute ST elevation. T wave cahgnes in v4-v6 new when compared to 10/12/16 CT head: small acute left thalamic hemorrhage, chronic left thalamic lacunar infarct, age appropriate supratentorial and infratentorial atrophy, moderate chronic white matter microvascular ischemic disease  CT neck:  1.   No acute extracranial vascular abnormality identified.  2.   Nonspecific fluid distension of the midthoracic esophagus (reflux? distal  obstruction?)  Labs indicate a white count of 6.4, H&H 11.1 and 34 and platelets are 128.  Patient has no previous labs within the last year for comparison.  Patient also has a CMP with anion gap of 6.  Urinalysis without any acute evidence of infection.  Patient did have blood cultures obtained.
Age: 90.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Platelet count decreased, Thalamic infarction, Thalamus haemorrhage, Urine analysis normal, White blood cell count normal
Clinical narrative: No adverse reaction to the vaccine itself, but patient presented with COVID & hemorrhagic stroke to the ED on 6/29/23.  Patient was transferred the same day to a local Medical Center where she expired on 7/9/23. Tests/labs conducted on 6/29/23: CBC, CMP, urinalysis, blood cultures, head & neck CT, EKG, chest x-ray (unremarkable). EKG: rate 86, sinus, left axis, normal int4rvasl, t wave inversion in lead III, V4, V5, V6, no acute ST elevation. T wave cahgnes in v4-v6 new when compared to 10/12/16 CT head: small acute left thalamic hemorrhage, chronic left thalamic lacunar infarct, age appropriate supratentorial and infratentorial atrophy, moderate chronic white matter microvascular ischemic disease  CT neck:  1.   No acute extracranial vascular abnormality identified.  2.   Nonspecific fluid distension of the midthoracic esophagus (reflux? distal  obstruction?)  Labs indicate a white count of 6.4, H&H 11.1 and 34 and platelets are 128.  Patient has no previous labs within the last year for comparison.  Patient also has a CMP with anion gap of 6.  Urinalysis without any acute evidence of infection.  Patient did have blood cultures obtained.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Mastitis, Skin discolouration
Clinical narrative: Patient reported severe right breast infection including streaking 2 days after vaccination with the Shingrix vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen hot itchy area all around my left bicep ( injection site)
Age: 51.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Salivary hypersecretion
Clinical narrative: About two months after I took both the first vaccine of Covid and the booster shot, I start experiencing Hypersalivation where my glands producing salivae have been producing saliva in excess and my mouth will be filled with salivae to the point I need to constantly spit ...
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Computerised tomogram abdomen abnormal, Magnetic resonance imaging, Nausea
Clinical narrative: Extreme abdominal pain on left side all day on June 28th, nausea, vomiting, fever.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal infarct, Renal necrosis, Thrombosis, Ultrasound scan
Clinical narrative: Extreme abdominal pain on left side all day on June 28th, nausea, vomiting, fever.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Extreme abdominal pain on left side all day on June 28th, nausea, vomiting, fever.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Arthralgia, Asthenia, Back pain, Chills
Clinical narrative: severe headache, severe generalized joint pain, moderate abdominal pain, moderate back pain, hypotension with BPs of <90mmHg, chilling/low grade fever, fatigue. Sx onset at 24hrs post dose with fatigue/weakness/exercise intolerance. Rapid escalation of other sx by 36hrs post dose. Chilling persisted over 24hrs.  Symptomatic orthostatic hypotension persisted through 72hrs. Arthralgias/abdominal pain persisted through 72 hours.  Home selfcare c/o bed rest, po fluids, ibuprofen, diphenhydramine.  No injection site reaction or urticaria/rash is seen.  There have been no adverse reactions to any prior COVID vaccine dose including Moderna and Pfizer.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Exercise tolerance decreased, Fatigue, Headache, Hypotension, Orthostatic hypotension
Clinical narrative: severe headache, severe generalized joint pain, moderate abdominal pain, moderate back pain, hypotension with BPs of <90mmHg, chilling/low grade fever, fatigue. Sx onset at 24hrs post dose with fatigue/weakness/exercise intolerance. Rapid escalation of other sx by 36hrs post dose. Chilling persisted over 24hrs.  Symptomatic orthostatic hypotension persisted through 72hrs. Arthralgias/abdominal pain persisted through 72 hours.  Home selfcare c/o bed rest, po fluids, ibuprofen, diphenhydramine.  No injection site reaction or urticaria/rash is seen.  There have been no adverse reactions to any prior COVID vaccine dose including Moderna and Pfizer.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: severe headache, severe generalized joint pain, moderate abdominal pain, moderate back pain, hypotension with BPs of <90mmHg, chilling/low grade fever, fatigue. Sx onset at 24hrs post dose with fatigue/weakness/exercise intolerance. Rapid escalation of other sx by 36hrs post dose. Chilling persisted over 24hrs.  Symptomatic orthostatic hypotension persisted through 72hrs. Arthralgias/abdominal pain persisted through 72 hours.  Home selfcare c/o bed rest, po fluids, ibuprofen, diphenhydramine.  No injection site reaction or urticaria/rash is seen.  There have been no adverse reactions to any prior COVID vaccine dose including Moderna and Pfizer.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: the mother of the patient requested meningitis and the technician mistakenly entered mmr.  the error wasnt noticed till the mom gave the school the shot record and they said it was not the vaccine she needed.  the mom called when she found out it was wrong, 2 days later.  she said her daughter didnt experice any ill effects from getting the mmr but she still needed the meningitis vaccine.  they came back that afternoon, on 7/13/2023, and recieved the correct vaccine.  I contacted the local poison control to see if there were any known adverse events from getting this vaccine again for this patient.  They said the only effects they should expect were the usual possible pain at injection site and redness.  I passed this information on to mom at the time of giving the menveo.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Skin lesion
Clinical narrative: The morning after the last shot my arms, face and head were red like a sun burn. I continue to have deep sores on my arms, face ears and scalp.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Developed red, warm, tender area ~8x6cm outer left upper arm - indurated 6 days following vaccine administration
Age: 49.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site bruising, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Bruising, pain, and hard lump approximately the size of a large marble at site of injection. Still present on 7/7/23 - nearly 2 weeks post injection. Lump size has not decreased, nor has pain or bruising decreased.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: Dx with Plaque Psoriasis by dermatologist, is continuing treatment with That  clinic.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Deafness, Visual impairment
Clinical narrative: Approximately 2 mins after injections, mom came out of room saying patient could not hear or see. Lead MA and supervising provider came in obtained vitals, laid pt. down, applied cold wet cloth, elevated legs, Provider eval. Pt. Pt. admits to having nothing to eat. Juice given & observed til discharged with stable vitals, feeling better.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 3/31/21 047A21A, 4/28/21 040B21A 10/14/21 017F21A and 8/16/22 013B22A
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Patient inadvertently received both PROQUAD and VARIVAX on 07/06/2023.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's medical history and concurrent conditions was not reported. The patient's concomitant medications included sterile diluent.     On 07-JUN-2023 , the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (valid lot number w038809 with expiration date 04-JUN-2024) and varicella virus vaccine live (oka/merck)( VARIVAX) (lot number w024912 is an invalid lot number for varicella virus vaccine live (oka/merck)( VARIVAX)), both vaccines were diluted with they respective sterile diluents (strength, dose, route of administration and anatomical location were not provided for any vaccine) (inappropriate schedule of product administration).   No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: Caller reports that they had a temperature excursion 3/31/2023 which they called into the regulatory agency; the products were labeled but still accidentally administered after the new short dated expiration date.; The vaccines were "short dated" and a new expiration date of 6/30/2023 was given.; This spontaneous report was received from an office manager and refers to a patient of no reported age or gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-JUL-2023, the patient was vaccinated with an expired and improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliters, lot # W031816, expiration date: 16-NOV-2022, administered as prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) following a temperature excursion of 6 degree Fahrenheit (F) up to 14 F 4 hours 0 minutes; 14 F up to 46 F 4 hours 0 minutes; 47 F to 77 F (50 F) 3 hours 57 minutes (TOTAL: 11 hours 57 minutes)  (Improper storage of product in use, expired product administered). The vaccine was short-dated, and a new expiration date of 30-JUN-2023 was given, it was mentioned that the vaccine was labeled but still accidentally administered after the new short-dated expiration date (product expiration date issue).  This is one of several cases from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE and no PQC; Healthcare professional calling to report an administration of ROTATEQ following a temperature excursion.; This spontaneous report has been received from a nurse, regarding a patent of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported  On 16-MAY-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (lot number: 1932216, which was determined to be valid, with an expiration date on 12-APR-2024) (strength, dose, scheme, and route of administration were not reported).  The administered dose underwent a temperature excursion during unreported date on unreported temperature. There was a no previous temperature excursion reported. No additional adverse effect was reported.