chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose abnormal, Diabetes mellitus inadequate control
Clinical narrative: Patient with diabetes received GARDASIL 9 and then had poorly controlled blood sugars; This spontaneous report has been received from a nurse, regarding to an 18-year-old female patient. The patient's concurrent conditions included Diabetes mellitus. Her pertinent medical history, concomitant medications, and previous drug reactions or allergies were unknown by reporter.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number and expiration date were not reported).  On an unspecified date in September 2022, the patient experienced had poorly controlled blood sugars (diabetes mellitus inadequate control). The outcome of blood glucose abnormal as well as the causal relationship between the event and the suspect vaccine were unknown. Additionally, it was reported that the patient's mother informed that the endocrinologist had told them not get with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because it could elevate blood sugars.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received VAQTA and PROQUAD that had undergone temperature excursion; No additional AE reported.; This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human Albumin (rHA) (PROQUAD) administered as prophylaxis, lot number W006584 with reported expiration date of 12-NOV-2022, however, upon internal review it was confirmed to be 23-AUG-2023 (dosage regimen and route of administration were not provided), and a dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis, lot number U026792 with expiration date 28-OCT-2022 (dosage regimen and route of administration were not provided). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human Albumin (rHA) (PROQUAD) vaccine underwent a temperature excursion of 76.1 degrees Fahrenheit (F) for 322 hours and 15 minutes, the Hepatitis A Vaccine, Inactivated (VAQTA) vaccine underwent a temperature excursion of 21.9 F for 147 hours. Both vaccines experienced previous temperature excursions (Product storage error). No additional adverse events were reported (No adverse event).
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Took only 3 out of 4 Vivotif capsules; A spontaneous report was received from a nurse on 08SEP2022. Additional information was received on 09SEP2022. It described a female patient (unknown age) who "took only 3 out of 4 Vivotif capsules" (PT: Incomplete course of vaccination). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient has only taken 3 of her 4 Vivotif capsules and has left her fourth dose of Vivotif in the refrigerator of the place that she had been visiting and for which she would not be driving back. Additionally, it was reported that her last dose of Vivotif was due on 05SEP2022. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took only 3 out of 4 Vivotif capsules (incomplete course of vaccination). Considering the case information, the causality of incomplete course of vaccination is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took only 3 out of 4 Vivotif capsules (incomplete course of vaccination). Considering the case information, the causality of incomplete course of vaccination is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took two doses of Vivotif in a row; A spontaneous report was received from the pharmacist on 09SEP2022. It described a 24-year-old adult male patient who "took two doses of Vivotif in a row" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient administered the first 2 doses of Vivotif on 08SEP2022 and 09SEP2022 mistakenly. Additionally, the patient did not experience any side effects. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took two doses of Vivotif in a row (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took two doses of Vivotif in a row (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Accidentally took her second Vivotif which was stored out of the refrigerator for about 48 hours; A spontaneous report was received from a pharmacist on 16SEP2022. It described a female patient (unknown age) who "accidentally took her second Vivotif which was stored out of the refrigerator for about 48 hours" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took the first dose of Vivotif which was stored correctly following which she left the product out of the refrigerator for about 48 hours and accidentally took her second Vivotif pill. Reportedly, the old pack of Vivotif was replaced with a new pack and she took her third dose which was stored at the correct temperature. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer accidentally took her second Vivotif which was stored out of the refrigerator for about 48 hours (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer accidentally took her second Vivotif which was stored out of the refrigerator for about 48 hours (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shingle vaccine and got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 21-SEP-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received shingles vaccine and experienced shingles. The reporter considered the events might had been to be related to shingles vaccine. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. .
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced sore arm for a couple of days no big deal. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLU4
Symptoms: Illness
Clinical narrative: Flulaval makes kids sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in an unspecified number of patients who received Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-SEP-2022 Reporter's comment: The reporter stated that the FluLaval Quadrivalent shots made kids sick. The reporter stated that GlaxoSmithKline need not to sold that product because it made kids sick. No additional details were provided. Additional Supportive Information: This case had been linked with case US2022134414, reported by the same reporter.; Sender's Comments:  US-GSK-US2022134414:Same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: 7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not have patient details at the time of call.  The reporter did not know dates of administration. The reporter had consent to follow up. Additional supportive information: Hiberix was reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This was one of the 7 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR136348:Same reporter. US-GSK-US2022AMR136361:Same reporter. US-GSK-US2022AMR136360:Same reporter. US-GSK-US2022AMR136363:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136365:Same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: 7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not had patient details at the time of reporting.  The reporter did not know dates of administration. The reporter consent to follow up. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This case is 1 of 7 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR136362:Same reporter. US-GSK-US2022AMR136361:Same reporter. US-GSK-US2022AMR136348:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136363:Same reporter US-GSK-US2022AMR136360:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot last Sep (1yr); This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2021).   On an unknown date, the patient did not receive 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: Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient did not realize that Shingrix was a two dose shot. The patients first shot was in last September (1 year). The patient to know what you recommended. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 1st dose on 29/08/2022, 2nd dose on 19/09/2022 (Rotarix/ Hiberix/ Pediarix); Hiberix and Pediarix 1st dose given at 3.6 months age; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HF4, expiry date 25th March 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number 335N9, expiry date 25th May 2023) for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 2339G, expiry date 16th February 2024) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) for prophylaxis.   Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX LYOPHILIZED FORMULATION).   On 19th September 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, the 2nd dose of Hiberix, the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 29th August 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On 29th August 2022, not applicable after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Hiberix, Rotarix lyophilized formulation and Rotarix Oral Applicator Device and unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Hiberix and ROTARIX LYOPHILIZED FORMULATION, the patient experienced inappropriate age at vaccine administration. On 19th September 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-SEP-2022 Reporters comment: The medical assistant reported the patient received Pediarix, Hiberix, Rotarix on 29th Aug 2022 then received the same vaccines early on 19th Sep 2022 at patient's 4-month checkup.  The medical assistant stated the patient was behind on vaccines and came in 29th Aug 2022 to catch up. The reporter did not consent to follow-up. Additional Supportive information: The patient received 1st dose of Hiberix and Pediarix at 3.6 months age, which led to inappropriate age at vaccine administration and received 2nd dose of Rotarix, Hiberix and Pediarix earlier than recommended time interval which led to shortening of vaccination schedule.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adult was given Infanrix; Adult was given Infanrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: The nurse practitioner reported that the patient accidentally received Infanrix instead of Boostrix. At the time of reporting, the health care professional did not had the date of birth or lot/expiry but did stated or confirmed it was an adult patient. The reporter did not want the information stored in GlaxoSmithKline database but agreed to follow up by safety.  The reporter consented to follow up by email. HCP's contact information emailed to safety. Additional Supportive Information: An adult patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix of 14July2018 confirmed; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th July 2018).   On an unknown date, the patient did not receive 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: 21-SEP-2022 Reporter's Comment: The case was self reported by the patient. The patient reported that he was unaware of whether they only received one or two doses, they only found the date for one dose. The reporter was also unsure of whether this was the first or second dose of Shingrix. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: THE JAB KILLED HER; This spontaneous report received from a patient via social media (J&J corporate) a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, dose 1 (01 total) administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died after taking vaccine from unknown cause of death. It was unknown if an autopsy was performed or not. The reporter reported that, "the jab killed her" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220948266, 20220946006 and 20220946018.; Sender's Comments: V0: 20220948144-COVID-19 VACCINE AD26.COV2.S- the jab killed her-The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: VACCINE ALMOST KILLED SON; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine almost killed son. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine almost killed son was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 47 year old white female. The patient's weight, height, and medical history were not reported. The patient was previously treated two doses of covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 205AZIA or 205A2LA (for first dose) and 18SS191 or 1882191 (for second dose), expiry: Unknown) dose was not reported, 1 total, first dose administered on 27-APR-2021 and second dose on 15-DEC-2021 for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with two doses of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, 1 total, administered on 10-MAY-2022 for covid-19 prophylaxis which was off label dosing frequency (The drug was associated with Off label use). Age at time of vaccination 47 years old. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vertigo
Clinical narrative: DIZZINESS; VERTIGOS; NAUSEAS; LIGHT HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 02-OCT-2021 for covid-19 prophylaxis. No concomitant medications were reported. On FEB-2022, the patient experienced dizziness, vertigos, nauseas, and light headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, light headaches, nauseas, and vertigos. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Diarrhoea, Dizziness, Headache
Clinical narrative: almost fainting; felt weak; Dizzy; terrible headache; unsteady; diarrhea; Rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (almost fainting), ASTHENIA (felt weak), DIZZINESS (Dizzy), HEADACHE (terrible headache) and BALANCE DISORDER (unsteady) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PRESYNCOPE (almost fainting), ASTHENIA (felt weak), DIZZINESS (Dizzy), HEADACHE (terrible headache), BALANCE DISORDER (unsteady), DIARRHOEA (diarrhea) and VACCINATION SITE RASH (Rash on her arm). At the time of the report, PRESYNCOPE (almost fainting), ASTHENIA (felt weak), DIZZINESS (Dizzy), HEADACHE (terrible headache), BALANCE DISORDER (unsteady), DIARRHOEA (diarrhea) and VACCINATION SITE RASH (Rash on her arm) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Upon internal review on 27-Sep-2022, non-significant correction was performed to update case level seriousness.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vaccination site rash
Clinical narrative: almost fainting; felt weak; Dizzy; terrible headache; unsteady; diarrhea; Rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (almost fainting), ASTHENIA (felt weak), DIZZINESS (Dizzy), HEADACHE (terrible headache) and BALANCE DISORDER (unsteady) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PRESYNCOPE (almost fainting), ASTHENIA (felt weak), DIZZINESS (Dizzy), HEADACHE (terrible headache), BALANCE DISORDER (unsteady), DIARRHOEA (diarrhea) and VACCINATION SITE RASH (Rash on her arm). At the time of the report, PRESYNCOPE (almost fainting), ASTHENIA (felt weak), DIZZINESS (Dizzy), HEADACHE (terrible headache), BALANCE DISORDER (unsteady), DIARRHOEA (diarrhea) and VACCINATION SITE RASH (Rash on her arm) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Upon internal review on 27-Sep-2022, non-significant correction was performed to update case level seriousness.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bleeding at the injection site (at the time of the injection),few drops of blood; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site (at the time of the injection),few drops of blood) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site (at the time of the injection),few drops of blood). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site (at the time of the injection),few drops of blood) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication was reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Upon internal review on 27-Sep-2022, Non-significant correction was performed to update case level seriousness.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Head ache; Body Ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head ache) and MYALGIA (Body Ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Head ache) and MYALGIA (Body Ache). At the time of the report, HEADACHE (Head ache) and MYALGIA (Body Ache) outcome was unknown.            All reported events occurred after the second dose of vaccine. No concomitant product was reported.  No treatment information was reported. Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable. Based o current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Upon internal review on 27-Sep-2022 case level seriousness was updated. On 20-May-2021: Follow up received on 20-May-2021:No new information was provided, FU declined.; Sender's Comments: Based o current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash morbilliform
Clinical narrative: Rash over torso looks like measles; Slight itching; This spontaneous case was reported by a patient and describes the occurrence of RASH MORBILLIFORM (Rash over torso looks like measles) and PRURITUS (Slight itching) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal (On blood pressure medication).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RASH MORBILLIFORM (Rash over torso looks like measles) and PRURITUS (Slight itching). At the time of the report, RASH MORBILLIFORM (Rash over torso looks like measles) was resolving and PRURITUS (Slight itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medication was reported.  Company comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Upon internal review on 27-Sep-2022, Non-significant correction was performed to update case level seriousness.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Meniere's disease
Clinical narrative: Acute left sided sensorineural hearing loss, tinnitus, vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENIERE'S DISEASE (Acute left sided sensorineural hearing loss, tinnitus, vertigo) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine and Allergy to vaccine. Concomitant products included NORETHISTERONE ACETATE (NORETHISTERONE ACETATE & ethinyl estra) for Birth control.   On 10-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced MENIERE'S DISEASE (Acute left sided sensorineural hearing loss, tinnitus, vertigo) (seriousness criterion medically significant). At the time of the report, MENIERE'S DISEASE (Acute left sided sensorineural hearing loss, tinnitus, vertigo) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Acoustic stimulation tests: Possible Meniere's Disease. On 30-Mar-2021, Acoustic stimulation tests: acute left sided sensorineural hearing loss.. On 19-Apr-2021, Acoustic stimulation tests: no hearing improvement on left side.         Treatment included  was prednisone oral, 1 dexamethasone injection in the left ear, sodium restricted diet, and Potassium sparing diuretics.  The patient was diagnosed with Meniere's Disease and was given potassium spring diuretics but no improvement of symptom. The patient reported mild hypotensive episode and stopped the diuretic. ENT prescribed oral prednisone but with no improvements in symptoms, the patient is now scheduled for MRI.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Follow-up included suspect product start time, patient race and ethnicity, allergies, concomitant medications and diagnosis, and outcome of the events. On 25-Apr-2021: Upon internal review on 27-Sep-2022, non-significant correction was performed to update case received from field to blank.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  Critical details such as the medical history and diagnostic report is lacking. The patient was diagnosed with Meniere's disease which confounds the causality.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paralysis, Seizure
Clinical narrative: Paralyzed; seizures; Head throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralyzed) and SEIZURE (seizures) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (Paralyzed) (seriousness criteria disability and medically significant), SEIZURE (seizures) (seriousness criterion medically significant) and HEADACHE (Head throbbing). At the time of the report, PARALYSIS (Paralyzed), SEIZURE (seizures) and HEADACHE (Head throbbing) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No relevant concomitant medications were reported  No treatment information was provided.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information is not expected as the reporter did not allow further contact.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Upon internal review on 22-SEP-2022, non-significant corrections performed to update case received from field.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information is not expected as the reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Feel only pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Feel only pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Feel only pain). At the time of the report, MYALGIA (Feel only pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.   This case was linked to MOD-2021-620512 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Upon internal review on 29-Sep-2022, significant correction was performed to update the suspect product coding. Invalid classification was removed.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Sweat; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweat) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweat) and CHILLS (Chills) outcome was unknown.    No concomitant medications was reported. No treatment drug details was reported. This case was linked to US-MODERNATX, INC.-MOD-2022-647572, US-MODERNATX, INC.-MOD-2022-647571 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647572:case for patient-1 US-MODERNATX, INC.-MOD-2022-647571:Patient No 2 case
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date), PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thawdate). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thawdate), PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date) and PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date).    No concomitant medications were reported. On 09-Aug-2022, the vial was thawed. Patient received vaccine after it had been stored more than 30 days past the initial thaw date.  Patient received primary series doses of the 6m-5y presentation of the Moderna COVID-19 vaccine(lot number AS1414B, expiration date unknown). All patients have not reported any symptoms.  Patient did not receive any additional doses, medications or treatments to the knowledge of the vaccination provider. No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-649988, MODERNATX, INC.-MOD-2022-650293 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-650293: MODERNATX, INC.-MOD-2022-649988:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 041L20A and 041L20A) for COVID-19 vaccination.     Patient had no allergies.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2022-649971 (Patient Link).