chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Felt like she had been hit by a truck; left arm swelled up; random hives (on her left arm, above thumb and crease of arm and sides); Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like she had been hit by a truck), PERIPHERAL SWELLING (left arm swelled up), URTICARIA (random hives (on her left arm, above thumb and crease of arm and sides)) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot on 13-Oct-2021. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included COPD, Drug allergy (prednisone injections) and Allergy (adhesives including band-aid adhesives). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD.   On 07-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) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like she had been hit by a truck), PERIPHERAL SWELLING (left arm swelled up), URTICARIA (random hives (on her left arm, above thumb and crease of arm and sides)) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Felt like she had been hit by a truck), PERIPHERAL SWELLING (left arm swelled up), URTICARIA (random hives (on her left arm, above thumb and crease of arm and sides)) and PYREXIA (Fever) outcome was unknown.            Patient  stated she was on a lot of medications and have been on them for many years but did not list the medication names.   This case was linked to MOD-2021-376927, MOD-2021-376967 (Patient Link).; Sender's Comments: This case concerns a 71-year-old, female patient with relevant medical history of drug (prednisone injections) and adhesive (Band-aid) allergies, who experienced the unexpected, non-serious events of feeling abnormal, peripheral swelling and urticaria, and the expected, non-serious event of pyrexia. The events occurred on the same day after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was positive for all events as these recurred after administration of the booster dose of the Moderna COVID-19 Vaccine. The medical history of drug and adhesive allergies remain as confounders for the peripheral swelling and urticaria. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Of note, the patient stated that she is 'on a lot of medications and have been on them for many years'. These may also be considered as confounders for the peripheral swelling and urticaria. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood testosterone, Vaccination site haemorrhage
Clinical narrative: Prolonged bleeding after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Prolonged bleeding after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 030M20A and 027A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included TESTOSTERONE and FISH OIL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-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) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE HAEMORRHAGE (Prolonged bleeding after booster). On 05-Nov-2021, VACCINATION SITE HAEMORRHAGE (Prolonged bleeding after booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood testosterone: low (Low) Low.         No treatment information was provided.  After vaccination, the patient was bleeding a little and placed a band-aid on the site.  On 05-Nov-2021 morning, patient took the band-aid off and had a lot of blood on the band-aid. The bleeding finally stopped. Patent self administer Testosterone shots weekly and had never bled that much except one time. When bled after Testosterone injection, testosterone lab levels were low. Because of the bleeding, the Testosterone injection did not work.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Paraesthesia, Pyrexia
Clinical narrative: Tingling in the right foot only; Fatigue; Body weakness; Morning after booster felt low grade fever chills body weakness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the right foot only), ASTHENIA (Body weakness), PYREXIA (Morning after booster felt low grade fever chills body weakness), CHILLS (Chills) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 032B21A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced ASTHENIA (Body weakness), PYREXIA (Morning after booster felt low grade fever chills body weakness) and CHILLS (Chills). On 05-Nov-2021, the patient experienced PARAESTHESIA (Tingling in the right foot only) and FATIGUE (Fatigue). At the time of the report, PARAESTHESIA (Tingling in the right foot only), ASTHENIA (Body weakness), PYREXIA (Morning after booster felt low grade fever chills body weakness), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient developing tingling in her right foot along with fever and fatigue. The symptoms were ongoing.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm was sore at the injection site for 3-4 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site for 3-4 weeks) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site for 3-4 weeks). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site for 3-4 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-377030, MOD-2021-377031 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Somnolence, Vaccination complication
Clinical narrative: sleepy; Bad reaction to the second dose; freezing cold; severe chills/teeth shattering chills; head ache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), VACCINATION COMPLICATION (Bad reaction to the second dose), FEELING COLD (freezing cold), CHILLS (severe chills/teeth shattering chills) and HEADACHE (head ache) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 SOMNOLENCE (sleepy), VACCINATION COMPLICATION (Bad reaction to the second dose), FEELING COLD (freezing cold), CHILLS (severe chills/teeth shattering chills) and HEADACHE (head ache). At the time of the report, SOMNOLENCE (sleepy), VACCINATION COMPLICATION (Bad reaction to the second dose), CHILLS (severe chills/teeth shattering chills) and HEADACHE (head ache) outcome was unknown and FEELING COLD (freezing cold) had resolved.            No concomitant medications were provided. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gait disturbance, Illness, Pain in extremity, Pyrexia
Clinical narrative: something odd happened/ some issues that don't happen all the time; pain in feet; a lot of difficulty walking; sick to stomach; gets very sick; suddenly get a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (something odd happened/ some issues that don't happen all the time), PAIN IN EXTREMITY (pain in feet), GAIT DISTURBANCE (a lot of difficulty walking), GASTRIC DISORDER (sick to stomach) and ILLNESS (gets very sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced VACCINATION COMPLICATION (something odd happened/ some issues that don't happen all the time), PAIN IN EXTREMITY (pain in feet), GAIT DISTURBANCE (a lot of difficulty walking), GASTRIC DISORDER (sick to stomach), ILLNESS (gets very sick) and PYREXIA (suddenly get a fever). At the time of the report, VACCINATION COMPLICATION (something odd happened/ some issues that don't happen all the time), PAIN IN EXTREMITY (pain in feet), GAIT DISTURBANCE (a lot of difficulty walking), GASTRIC DISORDER (sick to stomach) and PYREXIA (suddenly get a fever) outcome was unknown and ILLNESS (gets very sick) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: something odd happened/ some issues that don't happen all the time; pain in feet; a lot of difficulty walking; sick to stomach; gets very sick; suddenly get a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (something odd happened/ some issues that don't happen all the time), PAIN IN EXTREMITY (pain in feet), GAIT DISTURBANCE (a lot of difficulty walking), GASTRIC DISORDER (sick to stomach) and ILLNESS (gets very sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced VACCINATION COMPLICATION (something odd happened/ some issues that don't happen all the time), PAIN IN EXTREMITY (pain in feet), GAIT DISTURBANCE (a lot of difficulty walking), GASTRIC DISORDER (sick to stomach), ILLNESS (gets very sick) and PYREXIA (suddenly get a fever). At the time of the report, VACCINATION COMPLICATION (something odd happened/ some issues that don't happen all the time), PAIN IN EXTREMITY (pain in feet), GAIT DISTURBANCE (a lot of difficulty walking), GASTRIC DISORDER (sick to stomach) and PYREXIA (suddenly get a fever) outcome was unknown and ILLNESS (gets very sick) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Rash, Rash pruritic, Vaccination complication
Clinical narrative: Rash; some fatigue; some chills; covid arm (right arm) after second dose; Itchy Rash after 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm (right arm) after second dose), RASH PRURITIC (Itchy Rash after 2 days), RASH (Rash), FATIGUE (some fatigue) and CHILLS (some chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 012L20A and 062E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO), METFORMIN, METOPROLOL SUCCINATE and LEVOTHYROXINE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (covid arm (right arm) after second dose) and RASH PRURITIC (Itchy Rash after 2 days). On an unknown date, the patient experienced RASH (Rash), FATIGUE (some fatigue) and CHILLS (some chills). In March 2021, VACCINATION COMPLICATION (covid arm (right arm) after second dose) had resolved. At the time of the report, RASH PRURITIC (Itchy Rash after 2 days), FATIGUE (some fatigue) and CHILLS (some chills) outcome was unknown and RASH (Rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported.   This case was linked to MOD-2021-377027 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Additional events, Concomitant medication were updated.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Pop out came out; 19percent had the lymph nodes in the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Pop out came out) and LYMPHADENOPATHY (19percent had the lymph nodes in the arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 SWELLING (Pop out came out) and LYMPHADENOPATHY (19percent had the lymph nodes in the arm). At the time of the report, SWELLING (Pop out came out) and LYMPHADENOPATHY (19percent had the lymph nodes in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID 30 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (had COVID 30 days ago) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (had COVID 30 days ago). At the time of the report, COVID-19 (had COVID 30 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced the unexpected non - serious AESI event of COVID-19. The date of onset of the event was not reported, neither vaccination date. The event occurred after the second dose of mRNA-1273 Moderna vaccine. The rechallenge for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            no concomitant and treatment medications are provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: they feel very sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (they feel very sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (they feel very sick). At the time of the report, MALAISE (they feel very sick) 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.   No concomitants and treatment drugs are provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeding disorder, Parosmia, Taste disorder
Clinical narrative: Hard time eating  OR drinking something that she can withstand; Everything tastes like rot; Everything smells like rot; Metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), TASTE DISORDER (Everything tastes like rot), PAROSMIA (Everything smells like rot) and FEEDING DISORDER (Hard time eating  OR drinking something that she can withstand) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced DYSGEUSIA (Metallic taste). On 29-Oct-2021, the patient experienced TASTE DISORDER (Everything tastes like rot) and PAROSMIA (Everything smells like rot). On an unknown date, the patient experienced FEEDING DISORDER (Hard time eating  OR drinking something that she can withstand). At the time of the report, DYSGEUSIA (Metallic taste), TASTE DISORDER (Everything tastes like rot), PAROSMIA (Everything smells like rot) and FEEDING DISORDER (Hard time eating  OR drinking something that she can withstand) 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 stated that she called her doctor and she said that she doesn't deal with Moderna vaccine" also mentioned that pharmacy was also not able to help her. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD21-161833 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 138 doses administered after date of expiry/Dose administered after 30-day Use By Date or after manufacturer date of expiry; 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 (138 doses administered after date of expiry/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (138 doses administered after date of expiry/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (138 doses administered after date of expiry/Dose administered after 30-day Use By Date or after manufacturer date of expiry) 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 reported by the reporter.  Reporter estimated 138 doses have been administered from point of expiration which was 10-Oct2-021 until 4-Nov-2021.Reporter stated she only discovered that 14 vials were received from the Health Department and out of the 14 vials only 1 vial has not been punctured .Date the vial was initially stored in the refrigerator; HCP stated the vial was taken out on freezer each day of administration. 13 vials in total, approx. 138 expired doses have been administered from 10-Oct-2021 until 4-Nov-2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: It was reaction reported on a small percentage of people; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (It was reaction reported on a small percentage of people) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (It was reaction reported on a small percentage of people). At the time of the report, VACCINATION COMPLICATION (It was reaction reported on a small percentage of people) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Achiness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) 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 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achiness) and PYREXIA (Fever). At the time of the report, PAIN (Achiness) and PYREXIA (Fever) had resolved.            Concomitant medication include cholesterol medication and sinuses medication (allergies). No treatment medication reported.  For the first shot, patient did not had much going on.  For the second shot, patient experienced a little bit of a fever and achiness but it went away within 24 to 48 hours.   This case was linked to MOD-2021-377201 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Low grade fever; Soreness/Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), MYALGIA (Soreness/Sore arm) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever), MYALGIA (Soreness/Sore arm) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Low grade fever), MYALGIA (Soreness/Sore arm) and FATIGUE (Fatigue) outcome was unknown.            No concomitant drugs were reported. No tretament   drugs were reported   This case was linked to MOD-2021-377251.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Malaise, Nausea, Vomiting
Clinical narrative: Malaise; Nausea; Vomiting; Given a higher dose of the Moderna vaccine than the one required in error; 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 MALAISE (Malaise), NAUSEA (Nausea), VOMITING (Vomiting) and ACCIDENTAL OVERDOSE (Given a higher dose of the Moderna vaccine than the one required in error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 ml. On 06-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Given a higher dose of the Moderna vaccine than the one required in error). On an unknown date, the patient experienced MALAISE (Malaise), NAUSEA (Nausea) and VOMITING (Vomiting). On 06-Nov-2021, ACCIDENTAL OVERDOSE (Given a higher dose of the Moderna vaccine than the one required in error) had resolved. At the time of the report, MALAISE (Malaise), NAUSEA (Nausea) and VOMITING (Vomiting) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant mediation was reported.  Patient received booster dose 2.5ml dose of the Moderna vaccine instead of the 0.25ml. Events were mostly ok the last check up on 7Nov2021. No medication was prescribed to alleviate the symptoms. Patient was under care of a doctor.     Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Follow up received contained significant information reporter details, product details and new events were updated.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Illness, Nasopharyngitis, Nausea
Clinical narrative: sick; retching; sweating; cold; chills; fever of 102 F, went down to 101.6 F; vomiting; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), RETCHING (retching), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (cold) and CHILLS (chills) in a 44-year-old male 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 reported.  Concomitant products included LAMOTRIGINE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), RETCHING (retching), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (cold), CHILLS (chills), PYREXIA (fever of 102 F, went down to 101.6 F), VOMITING (vomiting) and NAUSEA (nauseous). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), RETCHING (retching), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (cold), CHILLS (chills), PYREXIA (fever of 102 F, went down to 101.6 F), VOMITING (vomiting) and NAUSEA (nauseous) outcome was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Retching, Vomiting
Clinical narrative: sick; retching; sweating; cold; chills; fever of 102 F, went down to 101.6 F; vomiting; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), RETCHING (retching), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (cold) and CHILLS (chills) in a 44-year-old male 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 reported.  Concomitant products included LAMOTRIGINE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), RETCHING (retching), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (cold), CHILLS (chills), PYREXIA (fever of 102 F, went down to 101.6 F), VOMITING (vomiting) and NAUSEA (nauseous). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), RETCHING (retching), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (cold), CHILLS (chills), PYREXIA (fever of 102 F, went down to 101.6 F), VOMITING (vomiting) and NAUSEA (nauseous) outcome was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: loads of itching, like she had a bunch of insect bites/It didn't start until the middle of the night. She woke up with lots of itching,; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (loads of itching, like she had a bunch of insect bites/It didn't start until the middle of the night. She woke up with lots of itching,) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced PRURITUS (loads of itching, like she had a bunch of insect bites/It didn't start until the middle of the night. She woke up with lots of itching,). On 05-Nov-2021, PRURITUS (loads of itching, like she had a bunch of insect bites/It didn't start until the middle of the night. She woke up with lots of itching,) had resolved.            No concomitant and treatment medication information was reported. The patient had loads of itching, like had a bunch of insect bites. It didn't start until the middle of the night. She woke up with lots of itching, and it kept lasting until yesterday 04-Nov-2021. It was finally going away today 05-Nov-2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Headache, Hyperhidrosis, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of burning sensation (burning up), dyspnea (she can't breathe), hyperhidrosis (sweating), pain (her body hurts) and headache (her head hurts) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 035C21A and 035C21A) for COVID-19 immunization. No medical history reported. On Oct 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Nov 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 4, 2021, patient experienced burning sensation (burning up), dyspnea (she can't breathe), hyperhidrosis (sweating), pain (her body hurts) and headache (her head hurts). At the time of the report, burning sensation (burning up), dyspnea (she can't breathe), hyperhidrosis (sweating), pain (her body hurts) and headache  (her head hurts) outcome: unknown. Concomitant medications and treatment information not reported. On the Nov 4, 2021, she got her second dose with lot number 035C21A. 6 hours later, she felt like she had COVID-19 all over. She experienced: burning up, she can't breathe, sweating, her body hurts and her head hurts. This case linked to MOD-2021-377556 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lung disorder, Memory impairment
Clinical narrative: she has very bad lungs.; sitting down at the moment because she is very sick.; can't remember words because the chemo knocked it out of her brain; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (she has very bad lungs.), ILLNESS (sitting down at the moment because she is very sick.) and MEMORY IMPAIRMENT (can't remember words because the chemo knocked it out of her brain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 010M20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy since an unknown date. Concurrent medical conditions included Cancer (for a long time) and Chemo brain.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 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 LUNG DISORDER (she has very bad lungs.), ILLNESS (sitting down at the moment because she is very sick.) and MEMORY IMPAIRMENT (can't remember words because the chemo knocked it out of her brain). At the time of the report, LUNG DISORDER (she has very bad lungs.), ILLNESS (sitting down at the moment because she is very sick.) and MEMORY IMPAIRMENT (can't remember words because the chemo knocked it out of her brain) outcome was unknown.            Patient got tested and there were no antibodies. No treatment details provided and No concomitant medications provided. Patient stated that she had she had "chemo brain" , she had cancer for a long time, she did chemotherapy, and she can't remember words because the chemo knocked it out of her brain. She had chemotherapy way before the vaccination with the Moderna Covid19 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an 80-year-old female patient 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 (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      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.  Patient year of birth was provided as .
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly female patient 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 (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) 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 medications were provided.  No treatment medications were provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Underdose
Clinical narrative: Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 1:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  On 29-Oct-2021, the patient received first dose of Sanofi Pasteur (Intramuscular) (Left Arm).1 dosage form (batch no. W731AB).  The patient had no reaction post vaccination.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients administered vaccine past the beyond use date/ vial that had been punctured on 04NOV2021 and is now past the 12 hour beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date/ vial that had been punctured on 04NOV2021 and is now past the 12 hour beyond use date) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date/ vial that had been punctured on 04NOV2021 and is now past the 12 hour beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date/ vial that had been punctured on 04NOV2021 and is now past the 12 hour beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the 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 information was reported.  It was reported that, the Pharmacist administered some vaccinations this morning from a Moderna COVID-19 vial that had been punctured on 04-NOV-2021 and was now past the 12 hours beyond use date and 10 patients received vaccine from this vial.