chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial septal defect, Cerebrovascular accident, May-Thurner syndrome
Clinical narrative: Patient developed acute onset confusion on 2/13/2022 with elevated BP and bradycardia, found to have CVA with bilateral thalamic infarcts documented on CT and MRI of head.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal cell carcinoma, Deafness, Malignant melanoma, Tinnitus
Clinical narrative: Sudden Hearing Loss- Tinnitus. This was the booster.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal cell carcinoma, Deafness, Malignant melanoma, SARS-CoV-2 test, Tinnitus
Clinical narrative: Sudden Hearing Loss- Tinnitus. This was the booster.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: Sudden Hearing Loss- Tinnitus. This was the booster.
Sex: M
Vaccine: HIBV, PPV
Symptoms: Antibody test abnormal, Gene sequencing, Hypergammaglobulinaemia, Inflammatory marker increased, Leukocytosis
Clinical narrative: poor antibody response; This literature marketed report has been received from the authors of a published literature article, entitled as stated below, and refers to an infant male patient. The patient had recurrent infections, which included oral candidiasis, influenza, otitis media, and presumed osteomyelitis and myositis without positive cultures, hypergammaglobulinemia, recurrent fever, leukocytosis, and elevated inflammatory markers.  On unknown dates, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) and pneumococcal vaccine (reported as Streptococcus pneumoniae vaccine) (doses, routes and sites of administration, lot numbers and expiration dates were not reported) for prophylaxis.  On an unknown date, the patient experienced a poor antibody response to haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) and pneumococcal vaccine (antibody test abnormal). On an unknown date, at the age of 9 months, he was referred to allergy/immunology due to poor antibody response to above mentioned vaccines, recurrent infections and hypergammaglobulinemia. Rheumatology was consulted due to recurrent fever, leukocytosis, and elevated inflammatory markers. Treatment with colchicine was initiated on an unknown date and his symptoms improved. He developed skin nodules, sparse hair, and conical teeth, raising concern for defects in the nuclear factor-k B essential modulator (NEMO) pathway. Whole exome sequencing was non-diagnostic. Deep sequencing of the IKBKG gene revealed a variant of uncertain significance in exon 7. Further evaluation at the Agency was planned. The authors reported that it was a challenging case with a working diagnosis of NEMO deficiency.  The outcome of antibody test abnormal was unknown. The authors considered antibody test abnormal to be related to suspected vaccines.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Sex: M
Vaccine: HIBV, PPV
Symptoms: Pyrexia, Skin mass
Clinical narrative: poor antibody response; This literature marketed report has been received from the authors of a published literature article, entitled as stated below, and refers to an infant male patient. The patient had recurrent infections, which included oral candidiasis, influenza, otitis media, and presumed osteomyelitis and myositis without positive cultures, hypergammaglobulinemia, recurrent fever, leukocytosis, and elevated inflammatory markers.  On unknown dates, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) and pneumococcal vaccine (reported as Streptococcus pneumoniae vaccine) (doses, routes and sites of administration, lot numbers and expiration dates were not reported) for prophylaxis.  On an unknown date, the patient experienced a poor antibody response to haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) and pneumococcal vaccine (antibody test abnormal). On an unknown date, at the age of 9 months, he was referred to allergy/immunology due to poor antibody response to above mentioned vaccines, recurrent infections and hypergammaglobulinemia. Rheumatology was consulted due to recurrent fever, leukocytosis, and elevated inflammatory markers. Treatment with colchicine was initiated on an unknown date and his symptoms improved. He developed skin nodules, sparse hair, and conical teeth, raising concern for defects in the nuclear factor-k B essential modulator (NEMO) pathway. Whole exome sequencing was non-diagnostic. Deep sequencing of the IKBKG gene revealed a variant of uncertain significance in exon 7. Further evaluation at the Agency was planned. The authors reported that it was a challenging case with a working diagnosis of NEMO deficiency.  The outcome of antibody test abnormal was unknown. The authors considered antibody test abnormal to be related to suspected vaccines.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; products experienced supported temperature excursion; This spontaneous report was received from medical assistant and referred to a patient with unknown gender and age. The patient's medical history, current condition, concomitant therapy, drug allergy or reaction was not provided.  On 21-MAR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) VIAL 2, administered 2mL/once, oral (strength not provided) (lot # 1742464 with expiry date 20-SEP-2022) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5mL/once (strength and route not provided) (lot # u014992 with expiry date 29-OCT-2023) after products experienced supported temperature excursion (Incorrect product storage). Both vaccines for prophylaxis. There was no additional adverse event.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; infant received an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to an infant of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 29-MAR-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #T034512, expiration date: 25-MAR-2022 (dose was not provided) administered orally for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other symptoms or other AE reported; doses of VARIVAX were given following temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On 18-MAR-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U022732, expiration date: 20-JUL-2023; strength, dose, and route were not reported) for prophylaxis (product storage error).    It was reported that the suspect vaccine was exposed to a temperature of 7.4 Fahrenheit (F) for a time frame of 10 minutes (on 01-MAR-2022). There were no previous temperature excursion. No other symptoms or other adverse event was reported.  This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2203USA010326:
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: No additional AE information; Customer calling to report MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient.; Customer calling to report MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient.; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.     On 30-MAR-2022, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (indication: prophylaxis; strength, dose, route, lot# and expiration date were not reported) that had been reconstituted with expired sterile diluent (strength, route, indication were not reported; 1 dose, lot # S025290, expiration date: 20-MAR-2022) had been inadvertently administered to the patient (expired product administered and product preparation error).  Vaccine was not expired and did not experience any temperature excursions. Sterile diluent had not experienced any temperature excursions. No additional adverse event information was reported.
Sex: U
Vaccine: HIBV, UNK
Symptoms: No adverse event, Product preparation error, Wrong product administered
Clinical narrative: when we went to mixthe powder with the liquid part of the vaccine we used sterile diluent rather than the liquid part of the vaccine; patient received a dose of HIB vaccine which contained sterile diluent patient received a dose of HIB vaccine which contained sterile diluent; No other AE; This spontaneous report was received from a medical assistant, referring to a 2-month-old patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# UJ589AAA, but upon internal validation established as non-valid, dose, strength, route and expiration date were not provided) for prophylaxis, which contained sterile diluent rather than the liquid part of the vaccine (product preparation error and wrong product administered). Other suspect therapies included sterile diluent. When the medicalt assistant went to mix the powder with the liquid part of the vaccine we used sterile diluent rather than the liquid part of the vaccine. No further information provided. No other adverse event.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: No additional AE information; MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient; MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 30-MAR-2022, the patient was vaccinated inadvertently with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot # and expiration date were not provided) that had been reconstituted with 1 dose of expired sterile diluent (lot #S025290, expiration date 20-MAR-2022) for prophylaxis (expired product administered, and product preparation error). The vaccine was not expired and did not experience any temperature excursions. The sterile diluent had not experienced any temperature excursions. No additional adverse event (AE) information.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Medical assistant called to report an AE.   The patient experienced fever, diarrhea and vomiting after receiving third dose of ROTATEQ (Lot 1742476   3/18/2023) .  The patient received the dose on 3/23/2022 and within 8 hours after the vaccination, t; Medical assistant called to report an AE.   The patient experienced fever, diarrhea and vomiting after receiving third dose of ROTATEQ (Lot 1742476   3/18/2023) .  The patient received the dose on 3/23/2022 and within 8 hours after the vaccination, t; Medical assistant called to report an AE.   The patient experienced fever, diarrhea and vomiting after receiving third dose of ROTATEQ (Lot 1742476   3/18/2023) .  The patient received the dose on 3/23/2022 and within 8 hours after the vaccination, t; This spontaneous report was received from a medical assistant referring to a 6-month-old female patient. Concomitant vaccines included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and influenza vaccine (reported as FLUZONE). The patient had no pertinent medical history and no drug reaction/allergy.  On 30-NOV-2021, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 24-JAN-2022, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Regard to both doses of vaccines, route: oral, indication: prophylaxis, strength, frequency, lot # and expiration date were not reported. The patient did not have any symptoms after receiving the first two doses. On 23-MAR-2022, the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742476 and expiration date 18-MAR-2023, strength and frequency were not reported) orally for prophylaxis.   On the same day within 8 hours after the vaccination, the patient experienced 15 vomiting episodes for 90 minutes. The patient went to an unspecified emergency room and was released without hospitalization. It was also reported, the patient experienced fever, diarrhea and vomiting on 23-MAR-2022. The patient received ondansetron (ZOFRAN) as treatment. The outcome of the evens was recovered. The causality of the events was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; The customer said an expired dose was administered to a patient.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 01-APR-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 1 dose expiration date 20-MAR-2022 (Expired product administered) (route of administration and lot number and expiration date were not provided) administered as prophylaxis.  No other adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported.; Caller stated PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a licensed practical nurse (L.P.N.), referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 18-MAR-2022, the patient was administered with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), dose 0.5 mL, lot number U014483, expiration date was not provided but upon internal validation established as 15-SEP-2023 (route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) reported (no adverse event). No additional information was provided.  There were reported temperature excursions of the administered vaccine of 35.1 degrees Fahrenheit (F) for 4 hours 40 minutes, 35.2 F for 54 hours and 35.3 F for 30 minutes. There were no previous temperature excursions. It was not provided if digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Cardiac disorder, Herpes zoster
Clinical narrative: vision loss; cardiac issues; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, cardiac issues and vision loss. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of herpes zoster, cardiac disorder and vision loss was not recovered. The reporter considered events to be related to zoster vaccine live (ZOSTAVAX). The lawyer assessed all events to be disabling.  Upon internal review, the event of vision loss was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Polyneuropathy, Post herpetic neuralgia
Clinical narrative: polyneuropathy; post herpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, polyneuropathy, and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of herpes zoster, polyneuropathy and post herpetic neuralgia was not recovered. The reporter considered events to be related to zoster vaccine live (ZOSTAVAX). The lawyer assessed all events to be disabling.  Upon internal review, the event of polyneuropathy was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered improperly stored VARIVAX at 8:30 AM on 04/04/2022; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-APR-2022 08:30, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # U008181, expiration date: 08-FEB-2023) for prophylaxis (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of minus 10 degree Celsius up to 8 degree Celsius (2.20 C (also reported as the max temperature reached to 2.20 C) for a time frame of 1 hour and 15 minutes. No additional adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE or PQC reported; PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a healthcare business professional referring to a patient of unknown age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  Temperature excursions of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) were registered as following: on 23-FEB-2022, it was exposed to a temperature 46.4 Fahrenheit (F) for a time frame of 1 hour; on 23-FEB-2022, it was exposed to a temperature 48.4 F for a time frame of 2 hours and 25 minutes; on 03-MAR-2022, it was exposed to a temperature 49.3 F for a time frame of 2 hours and 50 minutes; on 08-MAR-2022, it was exposed to a temperature 46 F for a time frame of 30 minutes; on 09-MAR-2022, it was exposed to a temperature 47.8 F for a time frame of 3 hours and 56 minutes. There was no previous temperature excursion.      On 15-MAR-2022, the patient was vaccinated with the improperly stored haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength and route were not reported; lot # T030711, expiration date: 15-APR-2023) 0.5 milliliter for prophylaxis (product storage error). No additional adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs were reported; improperly stored vaccine was administered; This spontaneous report was received from a licensed licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, patient's concurrent conditions and concomitant therapies were not reported.  On 17-MAR-2022, the patient was administered an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #U026217, expiration date: 02-NOV-2023 (formulation, strength, dose number, dose and route of administration were not provided) for prophylaxis (product storage error). No additional adverse events (AEs) were reported. Administered dose experienced a temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There were not previous temperature excursions.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 11-MAR-2022, the patient was vaccinated with improperly doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dosage form, lot numbers 1741817 and u026664, expiration dates 30-JUL-2022 and 24-FEB-2023 respectively and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 1 dosage form, lot number u026217, expiration date 02-NOV-2023 (routes of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccines underwnet a temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. No previous temperature excursions were detected.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001791:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 11-MAR-2022, the patient was vaccinated with improperly doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dosage form, oral, lot numbers 1741817 and u026664, expiration dates 30-JUL-2022 and 24-FEB-2023 respectively and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 1 dosage form, lot number u026217, expiration date 02-NOV-2023 (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccines underwent a temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. No previous temperature excursions were detected.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001821:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other issues or concerns noted; MMRII had a TE and had been administered; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On an unknown date, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced temperature excursion with 47 Fahrenheit degrees for 6 minutes and 50 seconds.   On 04-APR-2022, the patient was vaccinated with the improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # U013036, expiration date 23-APR-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported.
Age: 61.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; patient received GARDASIL 9 at 61 years of age; This spontaneous report was received from a pharmacist and refers to a 61 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  In October 2021, the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose number, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events was reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: ROTATEQ had a TE and then was administered; This spontaneous report was received from a medical assistant, referring to a 10 weeks old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # U021367, expiration date 07-MAR-2023, dose, and strength were not provided) had a temperature excursion. Then, on 04-APR-2022, was administered to the patient orally for prophylaxis (product storage error). The vaccine experienced temperature excursion of 47 Degree Fahrenheit for 6 minutes and 50 seconds. No other issue or concerns noted.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 62-year-old 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, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060954   Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The patient received dose of Shingrix vaccine two months ago from the date of reporting and experienced normal soreness in arm. The patient received 2nd dose of Shingrix on 01st April 2022. Additional supportive information: The patient self-reported this case via interactive digital media. For the tolerance of 2nd dose of Shingrix, refer linked case US2022AMR060954. The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060954:Same patient/reporter
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Headache, IVth nerve paralysis, Pain in extremity, Pain of skin
Clinical narrative: right eye IV nerve palsy; vertical diplopia/double vision; soreness in arm; scalp tenderness; headache; pain and soreness in the area of the right superior nasal orbital rim; This case was reported by a consumer and described the occurrence of ivth nerve palsy in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose 2 months ago and had about the normal soreness in his arm, refer case US2022AMR060953).   On 1st April 2022, the patient received the 2nd dose of Shingrix. On 2nd April 2022, 1 days after receiving Shingrix, the patient experienced ivth nerve palsy (serious criteria GSK medically significant) and double vision. In April 2022, the patient experienced pain in arm, scalp tenderness, headache and nasal pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the ivth nerve palsy, double vision, pain in arm, scalp tenderness, headache and nasal pain were unknown.   It was unknown if the reporter considered the ivth nerve palsy, double vision, pain in arm, scalp tenderness, headache and nasal pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060953   Additional Information: GSK receipt date: 05-Apr-2022 Reporter's comment: The patient received a dose of Shingrix and 1 day after vaccination, the patient woke up with double vision.  The reporter's wife was a licensed OD and she was able to determine that he had vertical diplopia from a right eye IV nerve palsy. Less than a week, after receiving the vaccination, the patient also experienced some right sided scalp tenderness, a headache, as well as pain and soreness in the area of the right superior nasal orbital rim. The patient asked if a fourth nerve palsy been reported as an adverse side effect after any other Shingrix vaccinations. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060953:Same patient/reporter
Sex: M
Vaccine: VARZOS
Symptoms: Rhinalgia
Clinical narrative: right eye IV nerve palsy; vertical diplopia/double vision; soreness in arm; scalp tenderness; headache; pain and soreness in the area of the right superior nasal orbital rim; This case was reported by a consumer and described the occurrence of ivth nerve palsy in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose 2 months ago and had about the normal soreness in his arm, refer case US2022AMR060953).   On 1st April 2022, the patient received the 2nd dose of Shingrix. On 2nd April 2022, 1 days after receiving Shingrix, the patient experienced ivth nerve palsy (serious criteria GSK medically significant) and double vision. In April 2022, the patient experienced pain in arm, scalp tenderness, headache and nasal pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the ivth nerve palsy, double vision, pain in arm, scalp tenderness, headache and nasal pain were unknown.   It was unknown if the reporter considered the ivth nerve palsy, double vision, pain in arm, scalp tenderness, headache and nasal pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060953   Additional Information: GSK receipt date: 05-Apr-2022 Reporter's comment: The patient received a dose of Shingrix and 1 day after vaccination, the patient woke up with double vision.  The reporter's wife was a licensed OD and she was able to determine that he had vertical diplopia from a right eye IV nerve palsy. Less than a week, after receiving the vaccination, the patient also experienced some right sided scalp tenderness, a headache, as well as pain and soreness in the area of the right superior nasal orbital rim. The patient asked if a fourth nerve palsy been reported as an adverse side effect after any other Shingrix vaccinations. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060953:Same patient/reporter
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old received a Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   On 22nd February 2022, the patient received Boostrix. On 22nd February 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's Comments: The 2 years old patient received a Boostrix dose, which led to Inappropriate age at vaccine administration. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose January 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2021, batch number 9Y92A, expiry date 2nd June 2023).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-APR-2022 Reporter's Comments: The reporter reported that patient wanted to get their second dose on reporting date. The reporter consented to follow-up. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injections site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060904   Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced pain at the injections site. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060904:Same patient/reporter
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: administered less than half a dose, some volume was lost; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult female patient who received Herpes zoster (Shingrix) (batch number 7P2PS, expiry date 2nd July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 06-Apr-2022 Reporter's Comment: The nurse from her facility administered less than half a dose of Shingrix to a patient, because the patient pull the arm out during the administration, and some volume was lost. The reporter consented to follow up. Additional Supportive Information: The patient did receive less than half dose of Shingrix, which led to accidental underdose.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Asthma, Vitamin D deficiency and Allergy to antibiotic (Allergic to ciprofloxacin). On 06-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The HCP stated that patient took second booster dose on 06-Apr-2022 and no side effect experienced. HCP explained vaccine was expired 2 days ago. No treatment details were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered to patient post expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient post expiry) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient post expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient post expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported.  The patient had received the additional dose. The vial was initially stored in refrigerator on 31-Aug-2021. The vial did not undergone any temperature excursions.   In follow up, the reporter wanted to make an update regarding some additional information reporter sent on 06-Apr-2022. Reporter wanted to clarify that the information provided by email was from new patients different than previous patients which was reported on 31-Mar-2022, and that some of these new patients belongs to different clinics, but all of them pertained to the same community clinic.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received and narrative was updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was refrigerated on 31-Aug-2021, expired on 22-Sep-2021 and was administered on 24-Sep-2021.; doses that were expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses that were expired) and PRODUCT STORAGE ERROR (Vaccine was refrigerated on 31-Aug-2021, expired on 22-Sep-2021 and was administered on 24-Sep-2021.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses that were expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was refrigerated on 31-Aug-2021, expired on 22-Sep-2021 and was administered on 24-Sep-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses that were expired) and PRODUCT STORAGE ERROR (Vaccine was refrigerated on 31-Aug-2021, expired on 22-Sep-2021 and was administered on 24-Sep-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 31-Aug-2021. The vial did not undergo any temperature excursions.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2022-534284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received contains non significant information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received some Moderna COVID19 doses that were expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  On 31 Aug 2021, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursion.  No Treatment medication reported.   This case was linked to MOD-2022-534284.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Non significant information received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received some Moderna COVID19 doses that were expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 31 Aug 2021 vials were initially stored in refrigerator, it mentioned that the vials didn't undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-534284.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Non-significant follow up appended.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. The vial was initially stored in the refrigerator on 31 Aug 2021. The vial did not undergo any temperature excursions. Upon follow up, the reporter clarified that information provided by email was from new patients different than previous patients reported by her colleague on 31-Mar-2022 and that some of these new patients belongs to different clinics, but all of them pertained to the same community clinic. No treatment medication were provided. This case was linked to MOD-2022-534284 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Significant Follow up - Narrative updated.