chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: Got pretty sick with Covid like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got pretty sick with Covid like symptoms) 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 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced ILLNESS (Got pretty sick with Covid like symptoms). At the time of the report, ILLNESS (Got pretty sick with Covid like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test: negative (Negative) Tested negative on day 2 for COVID. On 26-Aug-2021, SARS-CoV-2 test: negative (Negative) Tested negative on day 9 for COVID.         No concomitant medications were reported. Treatment information was not provided. Patient reported that she had the second dose of Moderna 08FEB2021.  On 16AUG2021 patient got pretty sick with Covid like symptoms.  She tested negative on day 2 and day 9 for Covid.  Patient and his son were traveling together and he had the J&J vaccine.  He tested positive for Covid on his day 6.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Constant break through bleeding; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Constant break through bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM and TRAZODONE.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Constant break through bleeding). At the time of the report, HEAVY MENSTRUAL BLEEDING (Constant break through bleeding) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-316165 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster, Insomnia, Pain
Clinical narrative: received a Moderno vaccine my last shot was on the first I was just told by my position that I have a side effect which is shingles; I am in so much pain it is awful; I am very upset; I cannot sleep; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER, PAIN, FEELING ABNORMAL, and INSOMNIA 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 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 an unknown date, the patient experienced HERPES ZOSTER, PAIN, FEELING ABNORMAL, and INSOMNIA. At the time of the report, HERPES ZOSTER, PAIN, FEELING ABNORMAL, and INSOMNIA outcome was unknown.            No Treatment medications were provided No  Concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes On 11-Sep-2021 a Follow up received with updated events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 929901) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity reaction. Concurrent medical conditions included Latex allergy since 01-Jan-1994 and Urticaria.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with ADRENALINE [EPINEPHRINE] for Adverse event, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 11-Sep-2021 to 14-Sep-2021 for Adverse event, at a dose of every 4 hours and METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE [METHYLPREDNISOLONE ACETATE]) (oral) on 13-Sep-2021 for Adverse event, at a dose of 4 mg. On 13-Sep-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved.            Concomitant medications were not provided. Additional treatment included-oxygen. Company Comment:  This case concerns a 62-year-old female patient with relevant medical history of urticaria and hypersensitivity reaction who experienced serious expected event of anaphylactic reaction. The event occurred approximately one day after the second, most recent dose of Spikevax with first symptoms occurring within 24 hours.. Rechallenge was not applicable since the event occurred after the second dose of Spikevax. The event was consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received on 17-SEP-2021 and patient demographic updated, event were added, product tab information added,  medical history added and treatment medicines added.; Sender's Comments: This case concerns a 62-year-old female patient with relevant medical history of urticaria and hypersensitivity reaction who experienced serious expected event of anaphylactic reaction. The event occurred approximately one day after the second, most recent dose of Spikevax with first symptoms occurring within 24 hours.. Rechallenge was not applicable since the event occurred after the second dose of Spikevax. The event was consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine was administered to a 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was administered to a 15 year old) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was administered to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine was administered to a 15 year old) outcome was unknown.        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.   injection into the deltoid muscle. No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza, Malaise, Pyrexia
Clinical narrative: flu; feels really sick; fever 102.3 ºF; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), MALAISE (feels really sick) and PYREXIA (fever 102.3 ºF) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu), MALAISE (feels really sick) and PYREXIA (fever 102.3 ºF). At the time of the report, INFLUENZA (flu), MALAISE (feels really sick) and PYREXIA (fever 102.3 ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) fever 102.3 ºF..         No concomitant medication details were provided. No treatment medication details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Date refrigerated of suspect product was given as 13-APR-2021 and Temperature changes was 41F.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Severe migraine since having the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine since having the Moderna vaccine) 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 09-Sep-2021, the patient experienced MIGRAINE (Severe migraine since having the Moderna vaccine). At the time of the report, MIGRAINE (Severe migraine since having the Moderna vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.) outcome was unknown.            Patient had no known allergies.  Treatment also include Hot and cold compress and massage.  No concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain, Vaccination site pain
Clinical narrative: Pain in the left collar bone area.; pain and Inflamation in the Armpit; Pain at the site of the injection (upper left arm).; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in the left collar bone area.), INFLAMMATION (pain and Inflamation in the Armpit) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left arm).) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN (Pain in the left collar bone area.), INFLAMMATION (pain and Inflamation in the Armpit) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left arm).). At the time of the report, PAIN (Pain in the left collar bone area.), INFLAMMATION (pain and Inflamation in the Armpit) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left arm).) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: >35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-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 PRODUCT DOSE OMISSION ISSUE (>35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Experienced chills and arm pain 12 hours after the injection; Experienced chills and arm pain 12 hours after the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced chills and arm pain 12 hours after the injection) and CHILLS (Experienced chills and arm pain 12 hours after the injection) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Experienced chills and arm pain 12 hours after the injection) and CHILLS (Experienced chills and arm pain 12 hours after the injection). In August 2021, PAIN IN EXTREMITY (Experienced chills and arm pain 12 hours after the injection) and CHILLS (Experienced chills and arm pain 12 hours after the injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-316020.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered past the 30 day refrigeration time; Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.  First shot info was given that -Expiration date: 31-Oct-2021,Date refrigerated: 20-Apr-2021, Temperature changes (in F): 41.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-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 EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced COVID-19 (Got Covid 19). At the time of the report, COVID-19 (Got Covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.  It was reported that patient had Covid 19 after on 09/21 and Covid 19 results were positive and then again on 09/05 patient second dosage was schedule for 09/11.  Patient still COVID Positive as of today.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Sore throat; Fever; 17-year-old received the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna vaccine). On 07-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna vaccine) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received on 10-SEP-2021 and does not contain any new information On 13-Sep-2021: Follow up received on 13-SEP-2021 and does not contain any new information
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021 at 11:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine experienced excursion in the transport container / Excursion duration: 3-5 minutes) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Followup received: Patient details received
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: pain; fever of 101F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PYREXIA (fever of 101F), CHILLS (Chills) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced PAIN (pain), PYREXIA (fever of 101F), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain and Fever, at an unspecified dose and frequency. At the time of the report, PAIN (pain), PYREXIA (fever of 101F), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 101f (High) Fever of 101F.         No concomitant medications were provided
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose/ expired vaccine administered to 33 patients from Thursday, 09/Sep/2021 to Friday morning, 10/Sep/2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose/ expired vaccine administered to 33 patients from Thursday, 09/Sep/2021 to Friday morning, 10/Sep/2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) 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 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose/ expired vaccine administered to 33 patients from Thursday, 09/Sep/2021 to Friday morning, 10/Sep/2021). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose/ expired vaccine administered to 33 patients from Thursday, 09/Sep/2021 to Friday morning, 10/Sep/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Added onset date and stop date for the event.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: patient woke up finding himself having difficulty ambulating. It would take him approximately 20mins to walk towards the bathroom and with the help of a walker; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (patient woke up finding himself having difficulty ambulating. It would take him approximately 20mins to walk towards the bathroom and with the help of a walker) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (z-pack (azithromycin)). Concomitant products included METOPROLOL SUCCINATE (TOPROL), ROSUVASTATIN CALCIUM (CRESTOR), VITAMINS NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced GAIT DISTURBANCE (patient woke up finding himself having difficulty ambulating. It would take him approximately 20mins to walk towards the bathroom and with the help of a walker). At the time of the report, GAIT DISTURBANCE (patient woke up finding himself having difficulty ambulating. It would take him approximately 20mins to walk towards the bathroom and with the help of a walker) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications was not reported.   This case was linked to MOD-2021-316362 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: ambulating difficulty; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (ambulating difficulty) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to z-pack (azithromycin)). Concomitant products included METOPROLOL SUCCINATE (TOPROL), ROSUVASTATIN CALCIUM (CRESTOR), VITAMINS NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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, the patient experienced GAIT DISTURBANCE (ambulating difficulty). At the time of the report, GAIT DISTURBANCE (ambulating difficulty) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication use was not provided by the reporter   This case was linked to MOD-2021-316298 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cluster headache, Fatigue, Headache
Clinical narrative: cluster head aches; viscious head aches/Headaches after each dose; fatigue/ extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of CLUSTER HEADACHE (cluster head aches), HEADACHE (viscious head aches/Headaches after each dose) and FATIGUE (fatigue/ extremely tired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Stent placement. Concomitant products included LISINOPRIL, METOPROLOL and CLOPIDOGREL for an unknown indication.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CLUSTER HEADACHE (cluster head aches), HEADACHE (viscious head aches/Headaches after each dose) and FATIGUE (fatigue/ extremely tired). At the time of the report, CLUSTER HEADACHE (cluster head aches), HEADACHE (viscious head aches/Headaches after each dose) and FATIGUE (fatigue/ extremely tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had reported that he can only be mobile for 5 to 6 hours at a time.  No treatment medication was reported   This case was linked to MOD-2021-316382 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Boredom, Feeling abnormal
Clinical narrative: bored the next day; a little less perky; This spontaneous case was reported by a consumer and describes the occurrence of BOREDOM and FEELING ABNORMAL in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis flare up. Previously administered products included for Product used for unknown indication of Flu in 2020. Past adverse reactions to the above products included Swollen joints with Flu. Concurrent medical conditions included Arthritis.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BOREDOM and FEELING ABNORMAL. At the time of the report, BOREDOM and FEELING ABNORMAL outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  It was reported that patient has had received pneumonia shot in 2020 and had swollen joints. She stated after receiving the Moderna COVID-19 vaccination, she reported that it wasn't bad at all and she didn't have much going on after the injection.   Reporter did not allow further contact.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Pain in the arm; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm) and FATIGUE (Feeling tired) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm) and FATIGUE (Feeling tired). At the time of the report, VACCINATION SITE PAIN (Pain in the arm) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant include Steroids.  Treatment information was not reported.   This case was linked to MOD-2021-316580, MOD-2021-316581 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Laboratory test, Nasal congestion, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: pain in the arm on all doses/arm hurt for 2 days; slight grade fever; stuffy; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy), VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038CZ4A, 039K20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL CONGESTION (stuffy). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever). At the time of the report, NASAL CONGESTION (stuffy), VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Chest x-ray was clear.. On an unknown date, Laboratory test: normal (normal) normal. On an unknown date, SARS-CoV-2 test negative: negative (Negative) RT-PCR test - Negative. On an unknown date, SARS-CoV-2 test positive: positive (Positive) Antigen test(home) - Positive.         Concomitant medications reported includes, steroids.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-316515, MOD-2021-316581 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: pain in the arm on all doses/arm hurt for 2 days; slight grade fever; stuffy; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy), VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038CZ4A, 039K20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL CONGESTION (stuffy). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever). At the time of the report, NASAL CONGESTION (stuffy), VACCINATION SITE PAIN (pain in the arm on all doses/arm hurt for 2 days) and PYREXIA (slight grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Chest x-ray was clear.. On an unknown date, Laboratory test: normal (normal) normal. On an unknown date, SARS-CoV-2 test negative: negative (Negative) RT-PCR test - Negative. On an unknown date, SARS-CoV-2 test positive: positive (Positive) Antigen test(home) - Positive.         Concomitant medications reported includes, steroids.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-316515, MOD-2021-316581 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Off label use, Palpitations, Urticaria
Clinical narrative: not an immunocompromised patient; Hives; Stomach feels like burning and upset; Heart pumping occasionally; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), ABDOMINAL DISCOMFORT (Stomach feels like burning and upset), PALPITATIONS (Heart pumping occasionally) and OFF LABEL USE (not an immunocompromised patient) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 029L20A and 0251202A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced URTICARIA (Hives), ABDOMINAL DISCOMFORT (Stomach feels like burning and upset) and PALPITATIONS (Heart pumping occasionally). On an unknown date, the patient experienced OFF LABEL USE (not an immunocompromised patient). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date for Adverse event, at a dose of Every 6 hours. At the time of the report, URTICARIA (Hives), ABDOMINAL DISCOMFORT (Stomach feels like burning and upset) and PALPITATIONS (Heart pumping occasionally) outcome was unknown and OFF LABEL USE (not an immunocompromised patient) had resolved. Unknown          No Concomitant Medications were provided by the reporter
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: flu like symptoms; headache; shaking; weakness; fever; unbelievable fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-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 INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness), PYREXIA (fever), FATIGUE (unbelievable fatigue) and PAIN IN EXTREMITY (sore arm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness), PYREXIA (fever), FATIGUE (unbelievable fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          No treatment medications provided No Concomitant medications provided   This case was linked to MOD-2021-316889 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: flu like symptoms; headache; shaking; weakness; fever; unbelievable fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-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 INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness), PYREXIA (fever), FATIGUE (unbelievable fatigue) and PAIN IN EXTREMITY (sore arm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness), PYREXIA (fever), FATIGUE (unbelievable fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          No treatment medications provided No Concomitant medications provided   This case was linked to MOD-2021-316889 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chest pain, Chills, Myalgia
Clinical narrative: side effects after the second/ felt those were similar to the second shot reaction; night sweating/We felt those were similar to the second shot reaction; increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction; Chest pain on left side; Joint pain/We felt those were similar to the second shot reaction; aching everywhere/We felt those were similar to the second shot reaction; Fever/We felt those were similar to the second shot reaction; chills/We felt those were similar to the second shot reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after the second/ felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), CHEST PAIN (Chest pain on left side) and ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after the second/ felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), CHEST PAIN (Chest pain on left side), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction). At the time of the report, VACCINATION COMPLICATION (side effects after the second/ felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction) outcome was unknown and CHEST PAIN (Chest pain on left side) had resolved. Not Provided          No concomitant products were reported.  Physician suggested couple of Advil should eliminate any pain.   This case was linked to MOD-2021-312693, MOD-2021-317608 (Patient Link).