chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Heart rate increased, Lip swelling, Nausea
Clinical narrative: Anaphylaxis (raised heart rate, rash, nausea and vomiting, swollen lips and throat) difficulty breathing - anaphylaxis under control  Cause may be a salad Breathing still doesn?t feel normal
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash, Vomiting
Clinical narrative: Anaphylaxis (raised heart rate, rash, nausea and vomiting, swollen lips and throat) difficulty breathing - anaphylaxis under control  Cause may be a salad Breathing still doesn?t feel normal
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Dizziness, Palpitations
Clinical narrative: Pounding heart pain and dizziness. Lasted about 10 seconds, but happened on multiple occasions, sometimes multiple times a day.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling, Thrombosis, Ultrasound scan abnormal
Clinical narrative: Blood clot which was diagnosed via ultrasound on my top left calf on 06/07/21.   I began to experience swelling and pain on 06/03/21
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Hallucination, Thirst
Clinical narrative: Side effects began few hours after receiving the Covid-19 Janssen vaccine. Side effects included suddenly freezing followed by full body shivers, hallucinations, extreme thirst, woke up feeling extremely hot as if overheating but no sweating, confusion, headaches/migraines, nausea, and muscle tightness.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; incorrect product storage; This spontaneous report as received from a physician, concerning a 13 month old patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.   On 20-MAY-2021, temperature excursion occurred and on 24-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T037957 with expiration date 09-MAY-2021, first time dose (strength, frequency and route were not provided) for prophylaxis.  No signs or symptoms reported. No other adverse events reported.  The vaccine was stored at a temperature of 43.7 Fahrenheit with a time frame of 84 hours. It was not reported if digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; incorrect product storage; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided.  On 18-MAY-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot number was verified as T029532, expiry date 01-SEP-2022, dose 0.5 ml, (route of administration was not provided). There was no adverse events; it was also reported that the vaccine was "ok to use".   The reported stated that the vaccine was improperly stored (temperature 5.2 Fahrenheit (F) degrees for 24 minutes). Digital data logger involved. There was no previous temperature excursion.
Age: 25.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No reported or seen adverse reactions; The patient received VARIVAX that was exposed from  -10°C to 8°C for 528 hours; This spontaneous report was received from a nurse prescriber and  refers to a 25 year old patient of unknow gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.        On 12-MAY-2021, the nurse received a new shipment of varicella virus vaccine live (Oka/Merck)(VARIVAX) which was accidently placed in the refrigerator instead of the freezer and not discovered until 02-JUN-2021. Vaccines were back in recommended temperature range at this time. Temperature evaluation was done by the agent and vaccines were supported for use. On the same date 02-JUN-2021, one varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032320, expiration date 22-SEP-2022, 0.5 milliliter, subcutaneously for prophylaxis was given to the patient. The vaccine was exposed from -10 to 8 Celsius degrees (°C) (3.7°C) for 528 hours. There was no previous temperature excursion. The call was made due to "data logger".  The reported, also mentioned that the patient waited 15 minutes prior to leaving office and had no reported or seen adverse reactions.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer reporting administration of improperly stored ROTATEQ; This spontaneous report was received from an office manager, concerning an approximately 4 months old female patient. The patient's concurrent condition, concomitant medications and drug allergies were not reported, she presented for a physical examination without any concerns (well child visit). The patient had eczema at the time of vaccination (illness at vaccination).   On 06-APR-2021 (also reported as 27-APR-2021), the patient was vaccinated with the first dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally at the dose of 2 milliliter for prophylaxis, lot number 1742460 has been verified to be a valid lot number, expiration date reported and validated as 16-NOV-2021 (product storage error), however, the temperature was not reported.   It was stated that the patient did not received any treatment, it was confirmed that the operator was trained, and it was used according to the instruction leaflet. Previous temperature excursions were reported as yes, and digital data logger was involved. No adverse events were reported, nor product quality complain.  This is one of the several reports received from the same source.; Sender's Comments:  US-009507513-2105USA001739: US-009507513-2106USA002133: US-009507513-2106USA001659:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored product administered / temperature - 14C; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 05-MAY-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T021828, expiration date 25-JUN-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of the vaccine was stored in a temperature of -14 degrees Celsius (C) for 35 hours and 43 minutes. There was no previous temperature excursion reported. Digital data logger was involved.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2106USA001746: US-009507513-2106USA001739: US-009507513-2106USA001959: US-009507513-2106USA001941: US-009507513-2106USA001761:
Age: 0.17
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer reporting administration of improperly stored PEDVAX HIB and ROTATEQ; This spontaneous report was received from an office manager, concerning 10-week-old female patient. The patient's concurrent condition, concomitant medications and drug allergies were not reported, she presented for a physical examination without any concerns (well child visit) at the time of vaccination.   On 07-APR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally at the dose of 2 milliliter (ml), lot number 1687012 has been verified to be a valid lot number, expiration date reported and validated as 08-JUL-2021 (strength was not provided) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), at the dose of 0.5ml, intramuscular, lot # T001206 has been verified to be a valid lot number with an expiration date reported and validated as 03-JUN-2022 (anatomical location was not provided), both vaccines for prophylaxis (product storage error), however, the temperature was not reported.   It was stated that the patient did not received any treatment, it was confirmed that the operator was trained, and it was used according to the instruction leaflet. Previous temperature excursions were reported as yes, and digital data logger was involved. No adverse events were reported, nor product quality complain.   The reporter considered product storage error to be not related to haemophilus b Conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) because it was attributable to other factors (not specified).  This is one of the several reports received from the same source.; Sender's Comments:  US-009507513-2105USA001739: US-009507513-2106USA001370: US-009507513-2106USA001659:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE occurred; Patient received a dose of VAQTA after it was stored outside of the recommended storage range.; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication, drug allergies and reactions were not reported.   07-JUN-2021, the patient was vaccinated with an improperly storage dose of hepatitis a vaccine, inactivated (VAQTA) lot # T035721, expiration date was reported as 15-APR-2022 (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature of 51 °F for 1 hours. No previous temperature excursion was reported. No adverse effect was reported. The report was received due to a data logger. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035721; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PROQAD was inadvertently administered to a 49 year old patient; No additional AEs; This spontaneous report was received from a consumer and refers to a 49-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, strength, dose, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). The reporter did not have any additional information as she stated that the administration did not occur in their clinic. No additional adverse events reported. The outcome of the event was unknown.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other adverse events; temperature excursion/ administered; This spontaneous report was received from a pharmacist and refers to a 12-month-old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 09-JUN-2021, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) dose reported as 1 time dosage, lot # T022312, expiration date 30-JUN-2022) (route of administration was not reported) for prophylaxis. No signs or symptoms was reported.  On an unknown date, the temperature excursion was 15 degrees Celsius, for a time frame of 5 hours. There was no previous temperature excursion. The digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AEs reported; expired dose of proquad was inadvertantly; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 10-JUN-2021, the patient was inadvertently vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 injection lot # S038145, expiration date 25-MAY-2021 (exact dose and route of administration were nor provided) for prophylaxis. The nurse requested post-expiry viability data. No further information was provided and no other adverse events (AEs) were reported. The action taken was not applicable.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no other adverse events; temperature excursion/ 15 C; This spontaneous report was received from a pharmacist and refers to a 4-year-old patient of an unspecified gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 09-JUN-2021, the patient was vaccinated with improperly stored 1 time dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # T027114, expiration date was reported and also validated as 07-FEB-2022 (exact dose, strength, route of administration, anatomical location were not provided) for prophylaxis. The data logger registered, that the vaccine prior to administration was stored at the temperature of 15 degree Celsius (C) for 5 hours (product storage error temperature too high). No previous temperature excursion was detected. No other adverse event or product quality complaints were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003417: US-009507513-2106USA003447: US-009507513-2106USA003425:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; Administration of improperly stored vaccine / temperature 47 F; This spontaneous report was received from a medical assistant and refers to a 6 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 10-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose unspecified, orally, lot # T033812, expiration date 29-DEC-2021 for prophylaxis. The administered dose of the vaccine was stored in a temperature of 47 degrees Fahrenheit (F) for 1 hour. There was no previous temperature excursion reported. Digital data logger was not involved. No adverse event (AE) was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2106USA003944: US-009507513-2106USA004039: US-009507513-2106USA004087: US-009507513-2106USA003971: US-009507513-2106USA004335:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; temperature excursion (TE)/ administered on 07-JUN-2021; This spontaneous report was received from a medical assistant and refers to a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 07-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA, dose: 0.5 ml, intramuscularly (IM), lot # T001212, expiration date was reported and also validated as 12-JAN-2022, for prophylaxis (strength and anatomical location were not reported) (improper storage of product in use).  The digital data logger registered, that on 07-MAY-2021, unsupported temperature excursion (TE) occurred and the vaccine was stored at the temperature of 54 degree Fahrenheit (F) for 10 hours. No previous TE was detected. The vaccine was not removed from the inventory and was administered to the patient. No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received an expired VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 15-JUN-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA), 1 ml, lot # S025258 with expiration date 05-NOV-2020 (route and anatomical location were not reported) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 21.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: no additional AE; Adult patient was administered a pediatric dose; This spontaneous report as received from a registered nurse referring to a 21-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.    On 08-JUN-2021, the patient was inadvertently vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 milliliter for prophylaxis (lot# T022333 has been verified to be valid, expiration date reported and validated as 11-DEC-2021) (dose number, route of administration, anatomical location site, and vaccination scheme were not provided) (incorrect dose administered). No additional adverse event (AE) reported.
Age: 25.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: No additional AEs reported; a patient due for her second dose of VARlVAX and was accidently administered PROQUAD instead of VARlVAX; This spontaneous report was received from a medical assistant referring to a 25-year-old female. Information regarding the patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-JUN-2021, the patient was due for her second dose of varicella virus vaccine live (Oka/Merck) (VARlVAX) for prophylaxis (dose, vaccination scheme, route of administration, anatomical injection site, lot number and expiration date not reported) and was accidently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter for prophylaxis (lot # T021301 has been verified to be valid, expiration date reported and validated as 19-DEC-2021) for prophylaxis (dose number, route of administration, anatomical injection site and vaccination scheme were not reported)  instead (wrong product administered). No additional adverse events (AEs) reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Poor quality product administered, Product distribution issue, Product storage error
Clinical narrative: No additional AEs; 5 bad doses were given and 6 potential patients were involved; 5 bad doses were given and 6 potential patients were involved; back in April we had a delivery of GARDASIL 9 that did not arrive for more than 5 days; This spontaneous report was received from an office manager referring to a patient of unknown age and gender.  Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided.  On an unspecified date in April 2021, the reporter had a delivery of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days (product distribution issue), when the product was received it was supposed to be returned to the wholesaler, instead it was placed in the refrigerator. Information about the temperature storage or a time frame was unknown by the reporter. There wasn't a previous temperature excursion.  On 15-JUN-2021, the patient was vaccinated with a bad dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, 1 time dose as prophylaxis (with lot number T026168 and expiration date 04-DEC-2022, both verified as valid; vaccination scheme frequency, route and anatomical location of administration were not provided) (product storage error) (poor quality product administered). No additional adverse events occurred.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA005004: US-009507513-2106USA005001: US-009507513-2106USA005150: US-009507513-2106USA005081: US-009507513-2106USA005047:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: No additional information was provided; back in April we had a delivery of GARDASIL 9 that did not arrive for more than 5 days, when the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported.     Back in April 2021 the reporter had a delivery of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days. When the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator. It was discovered on 16-JUN-2021 that 5 bad doses were given, and 6 potential patients were involved, including that on 13-MAY-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (one time dose; lot # T026168, expiration date 04-DEC-2022; route and strength unknown) for prophylaxis (product storage error). The reporter could not confirm if this was a valid dose or bad dose. No additional adverse event. The temperature and time frame of the vaccine was unknown. There was no previous temperature excursion. The call was not because of a data logger.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA005004: US-009507513-2106USA005001: US-009507513-2106USA005005: US-009507513-2106USA005047: US-009507513-2106USA005150:
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: with in several hours the patient had fever, chills, and body aches, and has resolved 48 hours later; with in several hours the patient had fever, chills, and body aches, and has resolved 48 hours later; with in several hours the patient had fever, chills, and body aches, and has resolved 48 hours later; This spontaneous report was received from a nurse via a company representative and refers to a 22-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 15-JUN-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 time dose (site and route of administration, lot# and expiration date were not reported) for prophylaxis. The same day within several hours after the vaccination, the patient experienced fever, chills and body aches. The events had resolved 48 hours later, on 17-JUN-2021.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; mishandling of the product; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  In April 2021, there was a delivery of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  that did not arrive for more than 5 days, when the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator. On 28-MAY-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T026168, expiration date was reported as 04-DEC-2022; site and route of administration were not reported) for prophylaxis. There was no previous temperature excursion/ No digital data logger was involved. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA005004: US-009507513-2106USA005005: US-009507513-2106USA005001:
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details are available; a dose of MMR II which expired on 5/30/2021 was administered to a patient on 6/17/2021; This spontaneous report was received from a medical assistant and refers to a 11-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was not provided.  On 17-JUN-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, dose: 0.5 milliliter, lot # S016676, expiration date: 30-MAY-2021 (dose number, route of administration and anatomical location were not reported) for an unknown indication established as prophylaxis. The expired dose of vaccine had no temperature excursions. No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 12 month old was inadvertently administered the PNEUMOVAX 23 vaccine; No additional AE; This spontaneous report was received from a pharmacist referring to a 12-month-old patient of unknown gender.   Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided.  On an unknown date, the 12-month-old patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (route and anatomical location of administration were not provided; dose, vaccination scheme frequency, lot number and expiration date were unknown by the reporter) for prophylaxis (product administered to patient of inappropriate age).
Sex: M
Vaccine: HEP
Symptoms: Incorrect product formulation administered
Clinical narrative: administering 2 doses of pediatric RECOMBIVAX HB to a 22 year old man for his first dose of hepatitis b, rather than giving the adult RECOMBIVAX HB.; Caller states customer is considering administering 2 doses of pediatric RECOMBIVAX HB to a 22 year old man / Doses have not yet been administered.; No additional AE; This spontaneous report was received from a healthcare office manager referring to a 22-year-old male patient. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not provided.  On an unspecified date, the patient considered to get vaccinated with two doses of pediatric formulation of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (concentration, dose number, vaccination scheme frequency, route of administration, anatomical site of vaccination were not reported;  lot number and expiration date were unknown by the reporter) for prophylaxis. He did not consider getting vaccinated with the adult formulation of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (circumstance or information capable of leading to medication error), (incorrect product formulation administered) since the adult formulation of the vaccine was not in stock. No additional adverse event was reported.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: patient is currently pregnant at this time and received the GARDASIL 9 vaccine inadvertently today; no additional adverse events have been reported; This spontaneous prospective pregnancy report as received from a registered nurse concerning a 28-year-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 14-JUN-2021,  the patient was vaccinated with a first dose reported as single dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe,  lot # T026168, expiration date reported : 04-DEC-2022,  dose:0 .5 milliliter, intramuscularly,  for prophylaxis (anatomical location was not reported), inadvertently.  On an unknown date, the patient became pregnant. At the time of vaccination the patient was currently pregnant and no additional adverse events had been reported by the patient as a result of receiving the vaccine. The mother's last menstrual period, estimated due date, prenatal tests and results were not reported.The trimester of exposure was unspecified. The pregnancy outcome was outcome pending. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: no adverse events; Dose of PNEUMOVAX23  had expired on 06/12/2021 and was administered on 06/21/2021; This spontaneous report was received from a medical sassistant, referring to a 68 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 21-JUN-2021, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5ml, lot# S029916, expiration date 12-JUN-2021, for prophylaxis (strength, dose, route and frequency were not reported). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; PNEUMOVAX23 was administered to a patient on 16JUN2021 after experiencing a temperature excursion; This spontaneous report was received from a vaccine coordinator, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 16-JUN-2021, the patient was vaccinated with an improper stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot# T033369, expiration date 26-MAY-2022, for prophylaxis (strength, dose, route and frequency were not reported).   The temperature excursion was of -40.0 Centigrade degrees (°C), during 45 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033369; expirationdate: 26-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; Patient was inadvertently administered expired GARDASIL 9 by unknown nurse; This spontaneous report as received from a Healthcare Business Professional, referring to a 24 year old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      On 22-JUN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), with lot # R028762 and expiration date on 21-JUN-2021 (route, strength, and dose were not provided) for prophylaxis. The vaccine had not been involved in any previous temperature excursion. No additional adverse events were reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no adverse event; administration of an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a 2 month old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUN-2021, the patient was vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1684157, expiring on 26-JUN-2021, 2 milliliter, oral, for prophylaxis.  The administered dose of the vaccine experienced a temperature excursion of 8.6 degrees Celsius for 4hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-OCT-2014, the pt was administered the zoster vaccine live (ZOSTAVAX) (route, dose, lot number and expiration date were not reported) by a healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dizziness, Fatigue, Gait inability
Clinical narrative: Syncope; Diarrhoea; Dizziness; Fatigue; Gait inability; Pallor; Skin discolouration; Pyrexia; Vomiting; This case was received via Regulatory Authority on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), FATIGUE (Fatigue), GAIT INABILITY (Gait inability), PALLOR (Pallor), SKIN DISCOLOURATION (Skin discolouration), PYREXIA (Pyrexia) and VOMITING (Vomiting) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced SYNCOPE (Syncope) (seriousness criteria medically significant and congenital anomaly), DIARRHOEA (Diarrhoea) (seriousness criterion congenital anomaly), DIZZINESS (Dizziness) (seriousness criterion congenital anomaly), FATIGUE (Fatigue) (seriousness criterion congenital anomaly), GAIT INABILITY (Gait inability) (seriousness criterion congenital anomaly), PALLOR (Pallor) (seriousness criterion congenital anomaly), SKIN DISCOLOURATION (Skin discolouration) (seriousness criterion congenital anomaly), PYREXIA (Pyrexia) (seriousness criterion congenital anomaly) and VOMITING (Vomiting) (seriousness criterion congenital anomaly). At the time of the report, SYNCOPE (Syncope), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), FATIGUE (Fatigue), GAIT INABILITY (Gait inability), PALLOR (Pallor), SKIN DISCOLOURATION (Skin discolouration), PYREXIA (Pyrexia) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.2 (High) 103.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported.  Action taken with the mRNA-1273 in response to the event is not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Pyrexia, Skin discolouration, Syncope, Vomiting
Clinical narrative: Syncope; Diarrhoea; Dizziness; Fatigue; Gait inability; Pallor; Skin discolouration; Pyrexia; Vomiting; This case was received via Regulatory Authority on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), FATIGUE (Fatigue), GAIT INABILITY (Gait inability), PALLOR (Pallor), SKIN DISCOLOURATION (Skin discolouration), PYREXIA (Pyrexia) and VOMITING (Vomiting) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced SYNCOPE (Syncope) (seriousness criteria medically significant and congenital anomaly), DIARRHOEA (Diarrhoea) (seriousness criterion congenital anomaly), DIZZINESS (Dizziness) (seriousness criterion congenital anomaly), FATIGUE (Fatigue) (seriousness criterion congenital anomaly), GAIT INABILITY (Gait inability) (seriousness criterion congenital anomaly), PALLOR (Pallor) (seriousness criterion congenital anomaly), SKIN DISCOLOURATION (Skin discolouration) (seriousness criterion congenital anomaly), PYREXIA (Pyrexia) (seriousness criterion congenital anomaly) and VOMITING (Vomiting) (seriousness criterion congenital anomaly). At the time of the report, SYNCOPE (Syncope), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), FATIGUE (Fatigue), GAIT INABILITY (Gait inability), PALLOR (Pallor), SKIN DISCOLOURATION (Skin discolouration), PYREXIA (Pyrexia) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.2 (High) 103.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported.  Action taken with the mRNA-1273 in response to the event is not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Pulmonary embolism, Thrombosis
Clinical narrative: Pulmonary embolism; Thrombosis; This case was received via  VAERS (Reference number: 1350684) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and THROMBOSIS (Thrombosis) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome and Glucose tolerance impaired. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization, medically significant and life threatening) and THROMBOSIS (Thrombosis) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and THROMBOSIS (Thrombosis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Angiogram: abnormal (abnormal) Angiogram peripheral abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was seen in emergency room (ER) with left lower extremity blood clot. No treatment information provided. Action taken with mRNA-1273 was not applicable.  Company comment Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diabetes mellitus, Facial paralysis, Hypertension, Ischaemic stroke
Clinical narrative: Confusional state; Diabetes mellitus; Facial paralysis; Hypertension; Ischaemic stroke; This case was received via  VAERS (Reference number: 1358541) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (Confusional state) (seriousness criteria hospitalization and disability), DIABETES MELLITUS (Diabetes mellitus) (seriousness criteria hospitalization, disability and medically significant), FACIAL PARALYSIS (Facial paralysis) (seriousness criteria hospitalization, disability and medically significant), HYPERTENSION (Hypertension) (seriousness criteria hospitalization and disability) and ISCHAEMIC STROKE (Ischaemic stroke) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized on 05-May-2021 due to CONFUSIONAL STATE, DIABETES MELLITUS, FACIAL PARALYSIS, HYPERTENSION and ISCHAEMIC STROKE. At the time of the report, CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  Patient received first dose of vaccine on 5/3/21. On 5/5, presented to urgent care clinic and was transferred to hospital with confusion, and facial droop. Patient was Diagnosed with acute ischemic stroke, new diagnosis hypertension and diabetes mellitus.    Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.