chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: slightly tingling on his right hand/Pins and needles; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (slightly tingling on his right hand/Pins and needles) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 014M20A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (slightly tingling on his right hand/Pins and needles). At the time of the report, PARAESTHESIA (slightly tingling on his right hand/Pins and needles) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Very tired; Dose interval of 2 weeks/ doses were 2 weeks apart; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval of 2 weeks/ doses were 2 weeks apart) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic fatigue syndrome and Fibromyalgia. Concomitant products included NAPROXEN, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), ZOLPIDEM TARTRATE (AMBIEN) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval of 2 weeks/ doses were 2 weeks apart). In May 2021, the patient experienced FATIGUE (Very tired). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval of 2 weeks/ doses were 2 weeks apart) had resolved. At the time of the report, FATIGUE (Very tired) had not resolved.            No treatment information was provided.   This case was linked to MOD-2021-399093 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Dry mouth, Dyspnoea, Headache, Pain
Clinical narrative: not feeling very well, mild condition; woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad; having a weird dream; dry mouth; body aches; feeling feverish; feeling like starting to get a headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling very well, mild condition), DYSPNOEA (woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad), ABNORMAL DREAMS (having a weird dream), DRY MOUTH (dry mouth) and PAIN (body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 045B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (not feeling very well, mild condition), DYSPNOEA (woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad), ABNORMAL DREAMS (having a weird dream), DRY MOUTH (dry mouth), PAIN (body aches), PYREXIA (feeling feverish) and HEADACHE (feeling like starting to get a headache). At the time of the report, VACCINATION COMPLICATION (not feeling very well, mild condition), DYSPNOEA (woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad), ABNORMAL DREAMS (having a weird dream), DRY MOUTH (dry mouth), PAIN (body aches), PYREXIA (feeling feverish) and HEADACHE (feeling like starting to get a headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-399973.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: not feeling very well, mild condition; woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad; having a weird dream; dry mouth; body aches; feeling feverish; feeling like starting to get a headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling very well, mild condition), DYSPNOEA (woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad), ABNORMAL DREAMS (having a weird dream), DRY MOUTH (dry mouth) and PAIN (body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 045B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (not feeling very well, mild condition), DYSPNOEA (woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad), ABNORMAL DREAMS (having a weird dream), DRY MOUTH (dry mouth), PAIN (body aches), PYREXIA (feeling feverish) and HEADACHE (feeling like starting to get a headache). At the time of the report, VACCINATION COMPLICATION (not feeling very well, mild condition), DYSPNOEA (woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad), ABNORMAL DREAMS (having a weird dream), DRY MOUTH (dry mouth), PAIN (body aches), PYREXIA (feeling feverish) and HEADACHE (feeling like starting to get a headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-399973.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: First dose vaccination record says I have 1ml per dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (First dose vaccination record says I have 1ml per dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (First dose vaccination record says I have 1ml per dose). At the time of the report, ACCIDENTAL OVERDOSE (First dose vaccination record says I have 1ml per dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-399918 (Patient Link).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse experiences reported.; administration of an expired dose of MMR II; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 10-NOV-2021, the patient was vaccinated with an expired single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number 035356 was an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); lot number 035356 does not match any Company product as confirmed by Lot Verification team; expiration date was reported as 05-NOV-2021) (expired product administered). There was no previous temperature excursion reported. No adverse experiences were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: severe myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2021, the patient received Shingrix.On 22nd November 2021,4 days after receiving Shingrix, the patient experienced myalgia. On an unknown date,the outcome of the myalgia was not recovered/not resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were reported as follows: This case was reported by the physician for his wife. The physician stated his wife received the Shingrix vaccine on 18th November 2021 and then on the 22th November 2021 noted onset of myalgia and patient still had severe myalgia today,the 29th. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative (nurse) concerned a 51 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had no prior history of headaches or migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination (dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had really bad headache and was hospitalized on 29-NOV-2021 and the original reason for hospitalization was diagnosis with COVID-19 (confirmed covid-19 infection and confirmed clinical vaccination failure). Reporter stated that the patient still had headache on the day of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000204837.; Sender's Comments: V0:20211201634-COVID-19 VACCINE AD26.COV2.S-Confirmed covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211201634-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Illness, Lymphadenopathy, Neuralgia, Pain
Clinical narrative: NEURALGIA; TENDER SORES (SCABBED OVER NOW); VERY ILL (FROM SHINGLES); SWOLLEN LYMPH NODES; SHINGLES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 23-OCT-2021, the patient experienced shingles. On an unspecified date, the patient experienced neuralgia, tender sores (scabbed over now), very ill (from shingles), and swollen lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shingles, and the outcome of neuralgia, swollen lymph nodes, very ill (from shingles) and tender sores (scabbed over now) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: MYOCARDITIS; This spontaneous report received from a consumer via a company representative via social media post concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, start therapy date were not reported. 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced myocarditis. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211203875 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Myocarditis. This event(s) is considered unassessable. 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).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for an unknown indication.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.  It was reported that offender were called back to the clinic and vital signs were taken and were normal.  No signs of any distress was present and when offender was asked if he had sign he denied any at that time.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow up received on 23-Nov-2021: Patient's date of birth and race were updated.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Fatigue, Magnetic resonance imaging
Clinical narrative: next morning he woke up deaf in his right ear./still cannot hear in his right ear; fatigued for a few hours after second shot; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (next morning he woke up deaf in his right ear./still cannot hear in his right ear) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigued for a few hours after second shot). On 13-Mar-2021, the patient experienced DEAFNESS UNILATERAL (next morning he woke up deaf in his right ear./still cannot hear in his right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (next morning he woke up deaf in his right ear./still cannot hear in his right ear) had not resolved and FATIGUE (fatigued for a few hours after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment This case concerns a 45-year-old male patient with no relevant medical history, who experienced serious unexpected event of deafness unilateral with another non-serious event. The event occurred the day after the second dose of the mRNA-1273. The rechallenge was not applicable as the events occurred following the second dose of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 45-year-old male patient with no relevant medical history, who experienced serious unexpected event of deafness unilateral with another non-serious event. The event occurred the day after the second dose of the mRNA-1273. The rechallenge was not applicable as the events occurred following the second dose of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Pain in extremity, Rhinorrhoea
Clinical narrative: running and stuff nose; arm sore; running and stuff nose; tired; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (running and stuff nose), PAIN IN EXTREMITY (arm sore), NASAL CONGESTION (running and stuff nose) and FATIGUE (tired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     No Medical History was provided by reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RHINORRHOEA (running and stuff nose) and NASAL CONGESTION (running and stuff nose). 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and FATIGUE (tired). On 31-Jan-2021, RHINORRHOEA (running and stuff nose), PAIN IN EXTREMITY (arm sore), NASAL CONGESTION (running and stuff nose) and FATIGUE (tired) had resolved.            No treatment information was reported by the reporter.   This case was linked to MOD-2021-397552, MOD-2021-397419 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: problems they have; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (problems they have) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 VACCINATION COMPLICATION (problems they have). At the time of the report, VACCINATION COMPLICATION (problems they have) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medication were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy, Pain
Clinical narrative: a little bit of painful; really uncomfortable thought the night; quite a bit of swelling area gland underneath her arm,like a knife swollen,; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little bit of painful), DISCOMFORT (really uncomfortable thought the night) and LYMPHADENOPATHY (quite a bit of swelling area gland underneath her arm,like a knife swollen,) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (a little bit of painful), DISCOMFORT (really uncomfortable thought the night) and LYMPHADENOPATHY (quite a bit of swelling area gland underneath her arm,like a knife swollen,). At the time of the report, PAIN (a little bit of painful), DISCOMFORT (really uncomfortable thought the night) and LYMPHADENOPATHY (quite a bit of swelling area gland underneath her arm,like a knife swollen,) outcome was unknown.            Concomitant and treatment medications was not provided by the reporter. Booster of the Moderna covid19 vaccine, quite a bit of swelling area gland underneath arm, like a knife swollen, a little bit of painful really uncomfortable thought the night, and her husband up to his neck, but had gone away on him, and didn't took anything, because she read that should take Advil or Tylenol.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Pain
Clinical narrative: Nausea; Feeling warm, but not a significant fever; Little achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling warm, but not a significant fever), PAIN (Little achy) and NAUSEA (Nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 014C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FEELING HOT (Feeling warm, but not a significant fever) and PAIN (Little achy). On 27-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) on 27-Nov-2021 for Nausea, at a dose of 2 dosage form. At the time of the report, FEELING HOT (Feeling warm, but not a significant fever) and PAIN (Little achy) outcome was unknown and NAUSEA (Nausea) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use included medications for pain taking occasionally.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness for about a week; Fatigue for almost a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness for about a week) and FATIGUE (Fatigue for almost a week) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042120A and 020120A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, 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 experienced PAIN IN EXTREMITY (Arm soreness for about a week) and FATIGUE (Fatigue for almost a week). At the time of the report, PAIN IN EXTREMITY (Arm soreness for about a week) and FATIGUE (Fatigue for almost a week) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Patient experienced no adverse event for First dose.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Felt sick when he got the first 2 dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick when he got the first 2 dose) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was 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 ILLNESS (Felt sick when he got the first 2 dose). At the time of the report, ILLNESS (Felt sick when he got the first 2 dose) 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.   This case was linked to MOD-2021-398917, MOD-2021-398877 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021 at 8:20 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Reporter stated that there were some unpunctured Moderna COVID-19 vaccine vials at her facility that were stored in the refrigerator. Per her records, the vials use by date was 28 Nov 2021.The patient has not reported any adverse reactions to the dose so far.
Sex: U
Vaccine: COVID19
Symptoms: Neutrophil count, Rash, White blood cell count
Clinical narrative: got terrible rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (got terrible rashes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-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 RASH (got terrible rashes). At the time of the report, RASH (got terrible rashes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Neutrophil count: low (Low) low. On an unknown date, White blood cell count: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-399806 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pyrexia
Clinical narrative: Dizziness; excessive tiredness; fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (excessive tiredness) and PYREXIA (fever of 101F) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (excessive tiredness) and PYREXIA (fever of 101F). On 28-Nov-2021, DIZZINESS (Dizziness), FATIGUE (excessive tiredness) and PYREXIA (fever of 101F) had resolved.            No concomitant medications were reported.  Treatment information was not provided. The onset of symptoms was around 07:00 AM in the morning. Patient had a fever of 101 degree Fahrenheit.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Moderna COVID-19 vaccine on 03Mar2021 and the second on 23Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 03Mar2021 and the second on 23Mar2021) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0211321A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 03Mar2021 and the second on 23Mar2021). On 23-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna COVID-19 vaccine on 03Mar2021 and the second on 23Mar2021) had resolved.            Concomitant products included a lot of unspecified pills for unknown indication. No treatment medications were reported.   This case was linked to MOD-2021-032507, MOD-2021-400008 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered beyond expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. The vaccine was removed from the freezer and placed in the refrigerator on 11/17/21.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea, Night sweats
Clinical narrative: night sweets; felt sick all the time; left arm hurts and feels sore; fever; chills; exhausted; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweets), MALAISE (felt sick all the time), VACCINATION SITE PAIN (left arm hurts and feels sore), PYREXIA (fever) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fruit allergy (orange) and Drug allergy (Codeine).   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, 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 experienced NIGHT SWEATS (night sweets), MALAISE (felt sick all the time), VACCINATION SITE PAIN (left arm hurts and feels sore), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and NAUSEA (nausea). At the time of the report, NIGHT SWEATS (night sweets), MALAISE (felt sick all the time), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and NAUSEA (nausea) had resolved and VACCINATION SITE PAIN (left arm hurts and feels sore) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  At the time of reporting patient's left arm was not red. Patient had a virtual meeting with HCP.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: night sweets; felt sick all the time; left arm hurts and feels sore; fever; chills; exhausted; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweets), MALAISE (felt sick all the time), VACCINATION SITE PAIN (left arm hurts and feels sore), PYREXIA (fever) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fruit allergy (orange) and Drug allergy (Codeine).   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, 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 experienced NIGHT SWEATS (night sweets), MALAISE (felt sick all the time), VACCINATION SITE PAIN (left arm hurts and feels sore), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and NAUSEA (nausea). At the time of the report, NIGHT SWEATS (night sweets), MALAISE (felt sick all the time), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and NAUSEA (nausea) had resolved and VACCINATION SITE PAIN (left arm hurts and feels sore) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  At the time of reporting patient's left arm was not red. Patient had a virtual meeting with HCP.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives; a rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and RASH (a rash all over the body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced URTICARIA (hives) and RASH (a rash all over the body). At the time of the report, URTICARIA (hives) and RASH (a rash all over the body) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Feeling extremely cold; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Feeling extremely cold) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced FEELING COLD (Feeling extremely cold). At the time of the report, FEELING COLD (Feeling extremely cold) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: 4 weeks after the second dose she started to have dizziness; 4 weeks after the second dose she started to have a couple episodes of vertigo which has continued to today.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (4 weeks after the second dose she started to have dizziness) and VERTIGO (4 weeks after the second dose she started to have a couple episodes of vertigo which has continued to today.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 017A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (4 weeks after the second dose she started to have dizziness) and VERTIGO (4 weeks after the second dose she started to have a couple episodes of vertigo which has continued to today.). At the time of the report, DIZZINESS (4 weeks after the second dose she started to have dizziness) and VERTIGO (4 weeks after the last dose she started to have a couple episodes of vertigo which has continued to today.) had not resolved.            No concomitant medications were reported No treatment medications were reported  Symptoms: It was reported that 4 weeks post second dose vaccination, patient started experiencing dizziness and vertigo episodes, which was aggravated by actions like standing up, thrown her head back to take medicines and when her eyes were closed, she tried to slow her actions and became deliberate which helped some level.She has spoken to a doctor regarding her dizziness, who encouraged her to wait it out.   This case was linked to MOD-2021-399922 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: second dose vaccination record says  have 1ml per dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (second dose vaccination record says  have 1ml per dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (second dose vaccination record says  have 1ml per dose). At the time of the report, ACCIDENTAL OVERDOSE (second dose vaccination record says  have 1ml per dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.   This case was linked to MOD-2021-399913 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 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 PAIN IN EXTREMITY (pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula). At the time of the report, PAIN IN EXTREMITY (pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-399933 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Illness, Influenza
Clinical narrative: Has been having a weak stomach; Flu symptoms; Has been sick ever since; she was really sick; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Has been having a weak stomach), INFLUENZA (Flu symptoms), ILLNESS (Has been sick ever since; she was really sick) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 001B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced HEADACHE (Headache). On 25-Nov-2021, the patient experienced INFLUENZA (Flu symptoms) and ILLNESS (Has been sick ever since; she was really sick). On 26-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (Has been having a weak stomach). The patient was treated with Manual therapy (Pressing on temples) for Headache. On 25-Nov-2021, INFLUENZA (Flu symptoms) and ILLNESS (Has been sick ever since; she was really sick) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Has been having a weak stomach) and HEADACHE (Headache) had not resolved.            No concomitant medication was reported.  No treatment medication use was reported.  It has been a week and patient was not feeling right.   This case was linked to MOD-2021-399935 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Pyrexia
Clinical narrative: Chills; 101.4 Fever; Soreness in every joint of her body; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (101.4 Fever) and ARTHRALGIA (Soreness in every joint of her body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (Patient uses insulin.) and Heart disorder. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), VITAMIN C [ASCORBIC ACID], VITAMIN E [VITAMIN E NOS], VITAMIN B3, VITAMIN B12 [VITAMIN B12 NOS], MULTIVITAMIN [VITAMINS NOS], CALCIUM and FISH OIL for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced CHILLS (Chills), PYREXIA (101.4 Fever) and ARTHRALGIA (Soreness in every joint of her body). At the time of the report, CHILLS (Chills), PYREXIA (101.4 Fever) and ARTHRALGIA (Soreness in every joint of her body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, Body temperature: 101.4 (High) 101.4.         Relevant concomitant medications included Rismol (heart medication), Hidrocloric-Iosin and Cobutane.  No treatment information was provided.  Patient did not experience reaction for the first two vaccines.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula). At the time of the report, PAIN IN EXTREMITY (Pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula) outcome was unknown.      No relevant concomitant medications was reported. Treatment information was not provided.  This case was linked to MOD-2021-399919 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: for 12 hours the flu-symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (for 12 hours the flu-symptoms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (for 12 hours the flu-symptoms). In April 2021, INFLUENZA LIKE ILLNESS (for 12 hours the flu-symptoms) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-399927 (Patient Link).