chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Neuralgia, Pain
Clinical narrative: FEELS SKIN FLUSHING (IN BACK OF LEGS, ARMS, NECK AND CHEEKS AND GOES AWAY AND THEN COMES BACK BUT NOT GOT WORSE SINCE THEN); FEELS TINGLING (IN BACK OF LEGS, ARMS, NECK AND CHEEKS AND GOES AWAY AND THEN COMES BACK BUT NOT GOT WORSE SINCE THEN); NAUSEA; This spontaneous report received from a patient via a company representative concerned a 53 year old male. The patient's weight was 215 pounds, and height was 69 centimeters. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: The patient had not experienced any weakness and did not get sick or anything like that. The patient was taking allergy nose spray. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. Concomitant medications included quetiapine fumarate for drug used for unknown indication. On NOV-2021, the patient experienced nausea. On 09-NOV-2021, the patient experienced feels skin flushing (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then). On 09-NOV-2021, the patient experienced feels tingling (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels skin flushing (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then), and feels tingling (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then), and the outcome of nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20211124555.
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Weight, Weight increased
Clinical narrative: WEIGHT GAINED; This spontaneous report received from a patient concerned an elderly male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported. On an unspecified date, the patient experienced weight gained. Laboratory data (dates unspecified) included: Weight (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from weight gained. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received full dose of 0.5mL for his booster dose/ 0.5mL administered to patient instead of 0.25mL; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received full dose of 0.5mL for his booster dose/ 0.5mL administered to patient instead of 0.25mL) in a male 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 ACCIDENTAL OVERDOSE (Patient received full dose of 0.5mL for his booster dose/ 0.5mL administered to patient instead of 0.25mL). At the time of the report, ACCIDENTAL OVERDOSE (Patient received full dose of 0.5mL for his booster dose/ 0.5mL administered to patient instead of 0.25mL) had resolved.            No Treatment drugs were reported. No concomitants were reported.  Company Comment: This is a case of Accidental Overdose concerning a male patient of an unknown age with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a case of Accidental Overdose concerning a male patient of an unknown age with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-glomerular basement membrane disease
Clinical narrative: Anti-GBM; This literature-non-study case was reported in a literature article and describes the occurrence of ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (PRIVACY)    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 ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM) (seriousness criterion medically significant). The patient was treated with CYCLOPHOSPHAMIDE for Anti-GBM disease, at an unspecified dose and frequency. At the time of the report, ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM) to be possibly related.    No concomitant information were reported. Patient was also treated with Steroids and plasma exchange.  This is a literature case concerning a 60-year-old, female patient with no relevant history, who experienced the unexpected serious event of  ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (Anti-GBM).The event occurred after  a dose of mRNA-1273 Moderna vaccine ( doen´t clarify if it was 1st or 2nd dose). The rechallenge was not applicable.  The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-371317 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email received from team and contains new information. Event outcome and treatment medications were added.; Sender's Comments: This is a literature case concerning a 60-year-old, female patient with no relevant history, who experienced the unexpected serious event of anti-glomerular basement membrane disease (Anti-GBM). The event occurred after a dose of Moderna COVID-19 vaccine, dose number not provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain
Clinical narrative: Pain under the shoulder, the back and under the chest area,Pain from under right shoulder blade wrapping around; Pain under the shoulder, the back and under the chest area,right chest area.; Pain under the shoulder, the back and under the chest area; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain under the shoulder, the back and under the chest area,Pain from under right shoulder blade wrapping around), CHEST PAIN (Pain under the shoulder, the back and under the chest area,right chest area.) and ARTHRALGIA (Pain under the shoulder, the back and under the chest area) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu shot (likely more than 1 month prior). Concurrent medical conditions included Blood pressure high (within past 2 years) and High cholesterol (within past 2 years). Concomitant products included ATORVASTATIN for Coronary artery disease, VALSARTAN and HCTZ for an unknown indication.    On 20-Jan-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 BACK PAIN (Pain under the shoulder, the back and under the chest area,Pain from under right shoulder blade wrapping around), CHEST PAIN (Pain under the shoulder, the back and under the chest area,right chest area.) and ARTHRALGIA (Pain under the shoulder, the back and under the chest area). At the time of the report, BACK PAIN (Pain under the shoulder, the back and under the chest area,Pain from under right shoulder blade wrapping around), CHEST PAIN (Pain under the shoulder, the back and under the chest area,right chest area.) and ARTHRALGIA (Pain under the shoulder, the back and under the chest area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received 2nd dose on 17Feb2021 having lot no: 004M20A  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-369179 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received. Medical history, concomitant medication and patient race added.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered past the expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the expiry date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the expiry date). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the expiry date) 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.    Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received contains Significant information. Patient details updated. Product start date, expiry date were added.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cyanosis, Dyspnoea, Limb discomfort, Paraesthesia
Clinical narrative: pins & needles in her muscles; sometimes her legs would give way; shortness of breath; blue lips; loss of balance; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (pins & needles in her muscles), LIMB DISCOMFORT (sometimes her legs would give way), DYSPNOEA (shortness of breath), CYANOSIS (blue lips) and BALANCE DISORDER (loss of balance) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-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 PARAESTHESIA (pins & needles in her muscles), LIMB DISCOMFORT (sometimes her legs would give way), DYSPNOEA (shortness of breath), CYANOSIS (blue lips) and BALANCE DISORDER (loss of balance). At the time of the report, PARAESTHESIA (pins & needles in her muscles), LIMB DISCOMFORT (sometimes her legs would give way), DYSPNOEA (shortness of breath), CYANOSIS (blue lips) and BALANCE DISORDER (loss of balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to her cardiologist & had a stress test & echocardiogram and they said her side effects could possibly be due to the vaccine. The patient is wondering whether or not to get her 2nd dose & wants to know if loss of balance is a normal, common side effect of the vaccine. Before providing more information on the shortness of breath (the myo/pericarditis questions)  Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was stored in the refrigerator for 30 days and expired on 10/29/21. However a dose was given on 11/1.; 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 (The vaccine was stored in the refrigerator for 30 days and expired on 10/29/21. However a dose was given on 11/1.) 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 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator for 30 days and expired on 10/29/21. However a dose was given on 11/1.). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in the refrigerator for 30 days and expired on 10/29/21. However a dose was given on 11/1.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: Feeling weird; Laying down with Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling weird) and CHILLS (Laying down with Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and HYDROXYZINE for an unknown indication.   On 02-Nov-2021 at 7:30 PM, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Laying down with Chills). On 03-Nov-2021 at 9:30 AM, the patient experienced FEELING ABNORMAL (Feeling weird). On 04-Nov-2021 at 6:30 AM, FEELING ABNORMAL (Feeling weird) and CHILLS (Laying down with Chills) had resolved.            The patient stated didn't feel normal until Thursday morning 6:30 am. No treatment medication reported by reporter.   This case was linked to MOD-2021-375327, MOD-2021-375339, MOD-2021-375342 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up information received on 08/Nov/2021: Added patient race and demographics. Added concomitant products.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: Feeling weird, didn't feel normal until morning 6:30AM; Laying down with chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling weird, didn't feel normal until morning 6:30AM) and CHILLS (Laying down with chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced CHILLS (Laying down with chills). On 03-Nov-2021 at 9:30 AM, the patient experienced FEELING ABNORMAL (Feeling weird, didn't feel normal until morning 6:30AM). On 04-Nov-2021, FEELING ABNORMAL (Feeling weird, didn't feel normal until morning 6:30AM) and CHILLS (Laying down with chills) had resolved. Not Provided          No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-375339, MOD-2021-375333 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up contains outcome and end date of the event (Chills) and  Reporter Causality
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Loss of appetite after the 2nd shot; Slight temperature after the 2nd shot; Fatigue after the 2nd shot; Chills after the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite after the 2nd shot), PYREXIA (Slight temperature after the 2nd shot), FATIGUE (Fatigue after the 2nd shot) and CHILLS (Chills after the 2nd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-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 DECREASED APPETITE (Loss of appetite after the 2nd shot), PYREXIA (Slight temperature after the 2nd shot), FATIGUE (Fatigue after the 2nd shot) and CHILLS (Chills after the 2nd shot). At the time of the report, DECREASED APPETITE (Loss of appetite after the 2nd shot), PYREXIA (Slight temperature after the 2nd shot), FATIGUE (Fatigue after the 2nd shot) and CHILLS (Chills after the 2nd shot) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  After the 2nd shot, the patient experienced fatigue, chills, a slight temperature and loss of appetite.   This case was linked to MOD-2021-375387, MOD-2021-375404 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 2 patients got full dose instead of booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (2 patients got full dose instead of booster dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (2 patients got full dose instead of booster dose). On 02-Nov-2021, ACCIDENTAL OVERDOSE (2 patients got full dose instead of booster dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Punctured the vial stopper of the vial today 22 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Punctured the vial stopper of the vial today 22 times) 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 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Punctured the vial stopper of the vial today 22 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (Punctured the vial stopper of the vial today 22 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red swollen arm; Red swollen arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Red swollen arm), VACCINATION SITE ERYTHEMA (Red swollen arm) and PYREXIA (Fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE SWELLING (Red swollen arm), VACCINATION SITE ERYTHEMA (Red swollen arm) and PYREXIA (Fever). At the time of the report, VACCINATION SITE SWELLING (Red swollen arm), VACCINATION SITE ERYTHEMA (Red swollen arm) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-375565 (Patient Link).
Age: 28.0
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 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 antibody test positive on 22-Jul-2021.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitants were reported. No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered beyond 12 hours after first puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The injection was warm to touch; The injection site swell up; Hurt for 3 to 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The injection was warm to touch), VACCINATION SITE SWELLING (The injection site swell up) and VACCINATION SITE PAIN (Hurt for 3 to 4 days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 930904, 030L20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced VACCINATION SITE WARMTH (The injection was warm to touch), VACCINATION SITE SWELLING (The injection site swell up) and VACCINATION SITE PAIN (Hurt for 3 to 4 days). At the time of the report, VACCINATION SITE WARMTH (The injection was warm to touch), VACCINATION SITE SWELLING (The injection site swell up) and VACCINATION SITE PAIN (Hurt for 3 to 4 days) had resolved.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter. After receiving the booster at the injection, it swell up and was warm to the touch and hurt for about 3 or 4 days  Patient was taking other medication. HCP  was aware side of the effects.   This case was linked to MOD-2021-376348 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: a shroud was lifted; She continues to have tinnitus at this time.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (a shroud was lifted) and TINNITUS (She continues to have tinnitus at this time.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Long haulers COVID-19) in April 2020. Concomitant products included VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (a shroud was lifted) and TINNITUS (She continues to have tinnitus at this time.). At the time of the report, FEELING ABNORMAL (a shroud was lifted) was resolving and TINNITUS (She continues to have tinnitus at this time.) had not resolved.            Patient had reported that in April 2020, she had experienced headache, tinnitus really loud, cough, fever, exhaustion, brain fog, and respiratory distress. These got worse for 29 days before improving but never went away. She felt as if something had entered her body for 29 days.  Patient also thinks she had a cytokine storm for 5 weeks sometime in 2020. In February 2021 she had another respiratory thing, felt horrible, could not walk more than a few miles, and continued to have fevers, tinnitus, brain fog, and exhaustion. She had covid-19 tests within 48 hours and 60 days of first experiencing symptoms.   Patient reported of taking CoQ 10, zinc, vitamin D, Claritin, and ecstasy for her symptoms. The only thing that seemed to have helped was electrolytes, which would seem to help the next day which she liked to consume through a coconut water protein drink. .She started to exercise but without repercussions.    This case was linked to MOD-2021-376668 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Re-dosing of moderna vaccine; Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication as provided No treatment received ed by the patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm is sore; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) and HEADACHE (bad headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (arm is sore) and HEADACHE (bad headache). At the time of the report, PAIN IN EXTREMITY (arm is sore) and HEADACHE (bad headache) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Vaccination site pruritus
Clinical narrative: Tiredness; Itching is not constant, "like an itch you cannot get under your foot"; Itching of left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching is not constant, "like an itch you cannot get under your foot"), VACCINATION SITE PRURITUS (Itching of left arm injection site) and FATIGUE (Tiredness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 026L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced PRURITUS (Itching is not constant, "like an itch you cannot get under your foot") and VACCINATION SITE PRURITUS (Itching of left arm injection site). On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, PRURITUS (Itching is not constant, "like an itch you cannot get under your foot"), VACCINATION SITE PRURITUS (Itching of left arm injection site) and FATIGUE (Tiredness) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-376919 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Vaccination site pain, Vaccination site reaction
Clinical narrative: After first dose sore arm; Muscle spasms; Fingers stiff and curled; Spot has been there for 2 to 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After first dose sore arm), MUSCLE SPASMS (Muscle spasms), MUSCULOSKELETAL STIFFNESS (Fingers stiff and curled) and VACCINATION SITE REACTION (Spot has been there for 2 to 3 weeks) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (After first dose sore arm), MUSCLE SPASMS (Muscle spasms), MUSCULOSKELETAL STIFFNESS (Fingers stiff and curled) and VACCINATION SITE REACTION (Spot has been there for 2 to 3 weeks). At the time of the report, VACCINATION SITE PAIN (After first dose sore arm), MUSCLE SPASMS (Muscle spasms) and MUSCULOSKELETAL STIFFNESS (Fingers stiff and curled) outcome was unknown and VACCINATION SITE REACTION (Spot has been there for 2 to 3 weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information includes Vitamin C   This case was linked to MOD-2021-376923 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Eye pain, Ocular hyperaemia, Swelling of eyelid, Vomiting
Clinical narrative: her eye got more and more inflame through the day; her eye lid is swollen; her eye is red and painful; her eye is red and painful; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (her eye got more and more inflame through the day), SWELLING OF EYELID (her eye lid is swollen), OCULAR HYPERAEMIA (her eye is red and painful), EYE PAIN (her eye is red and painful) and VOMITING (throwing up) 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 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced VOMITING (throwing up). On an unknown date, the patient experienced EYE INFLAMMATION (her eye got more and more inflame through the day), SWELLING OF EYELID (her eye lid is swollen), OCULAR HYPERAEMIA (her eye is red and painful) and EYE PAIN (her eye is red and painful). At the time of the report, EYE INFLAMMATION (her eye got more and more inflame through the day), SWELLING OF EYELID (her eye lid is swollen), OCULAR HYPERAEMIA (her eye is red and painful), EYE PAIN (her eye is red and painful) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Very hot injection site; Swollen injection site; Painful injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Very hot injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE PAIN (Painful injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 001BZ1A and 028A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pneumonia (Years ago). Past adverse reactions to the above products included Adverse reaction with pneumonia.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Nov-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021 at 12:00 PM, the patient experienced VACCINATION SITE WARMTH (Very hot injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE PAIN (Painful injection site). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Very hot injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE PAIN (Painful injection site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: high (High) Body temperature is 98.1.         No concomitant medication details were provided. Pain is really bad Treatment included ice pack, symptoms turned down little bit.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Up all night; Arm was sore; Chills/chilling; Temperature went up a little bit; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Up all night), PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills/chilling) and PYREXIA (Temperature went up a little bit) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression and Blood pressure.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INSOMNIA (Up all night), PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills/chilling) and PYREXIA (Temperature went up a little bit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Up all night), PAIN IN EXTREMITY (Arm was sore) and CHILLS (Chills/chilling) outcome was unknown and PYREXIA (Temperature went up a little bit) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 100.3 (High) The temperature is still up (100.3 F)..         Patient medical history include blood pressure  Concomitant medication include blood pressure medicine, depression medicine and other medicines.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received booster dose in less than 6 months after their primary series; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received booster dose in less than 6 months after their primary series) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 035C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received booster dose in less than 6 months after their primary series). On 06-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received booster dose in less than 6 months after their primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Infection
Clinical narrative: absolute monocytes went from 551 to 1053/ leukemia levels; his body is fighting an infection; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MONOCYTE COUNT INCREASED (absolute monocytes went from 551 to 1053/ leukemia levels), INFECTION (his body is fighting an infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.    No medical history was provided by the reporter.  Concomitant products included CITALOPRAM, LORATADINE, MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS, CALCIUM and VITAMINS NOS for an unknown indication.   On 25-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced MONOCYTE COUNT INCREASED (absolute monocytes went from 551 to 1053/ leukemia levels) and INFECTION (his body is fighting an infection). On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, MONOCYTE COUNT INCREASED (absolute monocytes went from 551 to 1053/ leukemia levels) and INFECTION (his body is fighting an infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Monocyte count: 1053 (High) absolute monocytes went from 551 to 1053 which are leukemia levels..         No treatment medications was provided by the reporter.  Patient received the booster dose and about 3 days later, on ??-NOV-2021, patient had blood test and monocyte count was increased which are leukemia levels. Patient levels show his body was fighting an infection.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance
Clinical narrative: "woozy like on a boat and unsteady/ I walked into a walk heading into the bathroom"; woozy like on a boat and unsteady; This spontaneous case was reported by an other health care professional and describes the occurrence of GAIT DISTURBANCE ("woozy like on a boat and unsteady/ I walked into a walk heading into the bathroom") and DIZZINESS (woozy like on a boat and unsteady) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Concurrent medical conditions included Peripheral neuropathy. Concomitant products included GABAPENTIN for Peripheral neuropathy, LEVOTHYROXINE and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced GAIT DISTURBANCE ("woozy like on a boat and unsteady/ I walked into a walk heading into the bathroom") and DIZZINESS (woozy like on a boat and unsteady). At the time of the report, GAIT DISTURBANCE ("woozy like on a boat and unsteady/ I walked into a walk heading into the bathroom") and DIZZINESS (woozy like on a boat and unsteady) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took 1st dose on 01Feb2021 having lot number 028L20A and 2nd dose on 01Mar2021 having lot number 011A21A No treatment information were reported by the reporter