chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Dysgeusia, Pain, Vein disorder
Clinical narrative: STINGING; ODD METAL TASTE IN MY MOUTH; RAISED PROTRUSIONS ALONG A VEIN FROM MY ANKLE TO MY GROIN/ BLUISH PROTRUSIONS WENT FROM MY ANKLE TO MY KNEE; PRESSURE IN THIGH AND GROIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced stinging, odd metal taste in my mouth, raised protrusions along a vein from my ankle to my groin/ bluish protrusions went from my ankle to my knee, and pressure in thigh and groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stinging, odd metal taste in my mouth, raised protrusions along a vein from my ankle to my groin/ bluish protrusions went from my ankle to my knee and pressure in thigh and groin was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOGS IN LUNGS  AND ARMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clogs caught in lungs and arms, and was hospitalized for unspecified days. The patient was just released from the hospital (date unspecified). The patient was concerned that it was because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clogs in lungs and arms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210860637-covid-19 vaccine ad26.cov2.s- blood clogs in lungs and arms.This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: NO ADEQUATE PROTECTION FROM JOHNSON & JOHNSON COVID-19 VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reporter stated that she does not feel like she has adequate protection from Covid-19 after receiving Johnson & Johnson Covid-19 Vaccine and would not want a booster dose of the same vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no adequate protection from johnson & johnson covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210834826. This report was associated with product quality complaint.; Sender's Comments: V0. 20210860735-COVID-19 VACCINE AD26.COV2.S.- no adequate protection from johnson & johnson covid-19 vaccine. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Formication, Paraesthesia, Pruritus
Clinical narrative: UNUSUAL FEELING IN SKIN, ALL OVER BODY AND HEAD; FEELING LIKE CRAWLING; ITCH ALL OVER; FEELING LIKE TINGLING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced unusual feeling in skin, all over body and head. On AUG-2021, the patient experienced feeling like crawling. On AUG-2021, the patient experienced itch all over. On AUG-2021, the patient experienced feeling like tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unusual feeling in skin, all over body and head, feeling like tingling, feeling like crawling, and itch all over. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: MEDICATION ERROR; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Cold sweat, Injection site bruising, Injection site pain, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: COLD SWEAT; SINUS ISSUE; COLD LIKE SYMPTOMS; INJECTION SITE BRUISING; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 212 pounds, and height was 71 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: influenza vaccine ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 21-AUG-2021 for flu. No concomitant medications were reported.  On MAR-2021, the patient experienced injection site soreness. On 26-MAR-2021, the patient experienced injection site bruising. On 21-AUG-2021, the patient experienced cold like symptoms. On 21-AUG-2021, the patient experienced sinus issue. On an unspecified date, the patient experienced cold sweat. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bruising on 14-JUN-2021, cold like symptoms, and sinus issue on 23-AUG-2021, and injection site soreness on JUN-2021, and the outcome of cold sweat was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Sinus disorder
Clinical narrative: COLD SWEAT; SINUS ISSUE; COLD LIKE SYMPTOMS; INJECTION SITE BRUISING; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 212 pounds, and height was 71 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: influenza vaccine ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 21-AUG-2021 for flu. No concomitant medications were reported.  On MAR-2021, the patient experienced injection site soreness. On 26-MAR-2021, the patient experienced injection site bruising. On 21-AUG-2021, the patient experienced cold like symptoms. On 21-AUG-2021, the patient experienced sinus issue. On an unspecified date, the patient experienced cold sweat. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bruising on 14-JUN-2021, cold like symptoms, and sinus issue on 23-AUG-2021, and injection site soreness on JUN-2021, and the outcome of cold sweat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered the vaccine that undergone 2 temperature excursions; 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 (Patients were administered the vaccine that undergone 2 temperature excursions) 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 EXPIRED PRODUCT ADMINISTERED (Patients were administered the vaccine that undergone 2 temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered the vaccine that undergone 2 temperature excursions) 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 concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up report contain No New Information
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: very weird and annoying bumps at the back of her tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (very weird and annoying bumps at the back of her tongue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced TONGUE DISORDER (very weird and annoying bumps at the back of her tongue). At the time of the report, TONGUE DISORDER (very weird and annoying bumps at the back of her tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information provided.  Caller advised she went to an urgent care, but was not seen.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Euphoric mood, Fatigue, Headache
Clinical narrative: felt drugged-out; it feels like she is coming down with flu; sore throat; joint aches; headache/severe headaches; chills; body aches/more body aches; feeling tired/tired/extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint aches) and HEADACHE (headache/severe headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced FATIGUE (feeling tired/tired/extremely fatigued). On 09-Aug-2021, the patient experienced MYALGIA (body aches/more body aches). On 10-Aug-2021, the patient experienced CHILLS (chills). On 11-Aug-2021, the patient experienced HEADACHE (headache/severe headaches). On an unknown date, the patient experienced EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat) and ARTHRALGIA (joint aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 13-Aug-2021, CHILLS (chills), MYALGIA (body aches/more body aches) and FATIGUE (feeling tired/tired/extremely fatigued) had resolved. At the time of the report, EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint aches) and HEADACHE (headache/severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  On 09-Aug-2021, the patient felt extremely fatigued and tired. On 10-Aug-2021, the patient had more body aches. The patient received her vaccination in her right arm shoulder deltoid muscle.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: New reporter demographic details; date of birth of the patient; vaccination date, route and anatomical location; corrective treatment and new events were added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Oropharyngeal pain
Clinical narrative: felt drugged-out; it feels like she is coming down with flu; sore throat; joint aches; headache/severe headaches; chills; body aches/more body aches; feeling tired/tired/extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint aches) and HEADACHE (headache/severe headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced FATIGUE (feeling tired/tired/extremely fatigued). On 09-Aug-2021, the patient experienced MYALGIA (body aches/more body aches). On 10-Aug-2021, the patient experienced CHILLS (chills). On 11-Aug-2021, the patient experienced HEADACHE (headache/severe headaches). On an unknown date, the patient experienced EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat) and ARTHRALGIA (joint aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 13-Aug-2021, CHILLS (chills), MYALGIA (body aches/more body aches) and FATIGUE (feeling tired/tired/extremely fatigued) had resolved. At the time of the report, EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint aches) and HEADACHE (headache/severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  On 09-Aug-2021, the patient felt extremely fatigued and tired. On 10-Aug-2021, the patient had more body aches. The patient received her vaccination in her right arm shoulder deltoid muscle.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: New reporter demographic details; date of birth of the patient; vaccination date, route and anatomical location; corrective treatment and new events were added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: She had a cough during the call; headaches; fatigue; Thought she had fever but does not know if she had; difficulty breathing; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), DIZZINESS, COUGH, HEADACHE, and FATIGUE in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced DYSPNOEA (difficulty breathing), DIZZINESS (dizziness), HEADACHE, FATIGUE, and PYREXIA. On an unknown date, the patient experienced COUGH. At the time of the report, DYSPNOEA, DIZZINESS, HEADACHE, and FATIGUE had not resolved and COUGH and PYREXIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and no treatment medications were reported.  Patient query was how to treat symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She had a cough during the call; headaches; fatigue; Thought she had fever but does not know if she had; difficulty breathing; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), DIZZINESS, COUGH, HEADACHE, and FATIGUE in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced DYSPNOEA (difficulty breathing), DIZZINESS (dizziness), HEADACHE, FATIGUE, and PYREXIA. On an unknown date, the patient experienced COUGH. At the time of the report, DYSPNOEA, DIZZINESS, HEADACHE, and FATIGUE had not resolved and COUGH and PYREXIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and no treatment medications were reported.  Patient query was how to treat symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Myalgia, Pyrexia
Clinical narrative: In bed sick; Runny nose; Fever; Aches; Headache; Fatigue; 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 ILLNESS (In bed sick), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Aches) and HEADACHE (Headache) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced ILLNESS (In bed sick), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ILLNESS (In bed sick), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        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.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: In bed sick; Runny nose; Fever; Aches; Headache; Fatigue; 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 ILLNESS (In bed sick), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Aches) and HEADACHE (Headache) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced ILLNESS (In bed sick), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ILLNESS (In bed sick), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        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.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Vaccination complication
Clinical narrative: Felt lousy; Minor symptoms; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt lousy), VACCINATION COMPLICATION (Minor symptoms) and ARTHRALGIA (Shoulder pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart attack (Reported as heart condition and he had two heart attacks and a stent placed.) and Diabetic.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced MALAISE (Felt lousy), VACCINATION COMPLICATION (Minor symptoms) and ARTHRALGIA (Shoulder pain). At the time of the report, MALAISE (Felt lousy), VACCINATION COMPLICATION (Minor symptoms) and ARTHRALGIA (Shoulder pain) outcome was unknown.            It was reported that the patient had two heart attacks and a stent placed. No concomitant medications information were reported. No treatment medications were provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Illness, Pyrexia, Suppressed lactation
Clinical narrative: sick again; pain in her bones; didn't have milk for 4 weeks/was so dry/every other day, she is able to pump 1 teaspoon of breast milk; fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (pain in her bones), ILLNESS (sick again), SUPPRESSED LACTATION (didn't have milk for 4 weeks/was so dry/every other day, she is able to pump 1 teaspoon of breast milk), POOR FEEDING INFANT (her son still doesn't want to touch it or eat any of it) and PYREXIA (fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q36B21A and Q3AA21A) for COVID-19 vaccination.     medical history not provided.  Concurrent medical conditions included Breast feeding.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 BONE PAIN (pain in her bones), ILLNESS (sick again), SUPPRESSED LACTATION (didn't have milk for 4 weeks/was so dry/every other day, she is able to pump 1 teaspoon of breast milk), POOR FEEDING INFANT (her son still doesn't want to touch it or eat any of it) and PYREXIA (fever). At the time of the report, BONE PAIN (pain in her bones), ILLNESS (sick again) and PYREXIA (fever) outcome was unknown, SUPPRESSED LACTATION (didn't have milk for 4 weeks/was so dry/every other day, she is able to pump 1 teaspoon of breast milk) had resolved and POOR FEEDING INFANT (her son still doesn't want to touch it or eat any of it) had not resolved.            Concomitant medications include iron supplements and vitamins for women. No treatment medication information provided. patient  doctor gave her some hormone and did bloodwork which didn't show any issues.   This case was linked to MOD-2021-285020 (Parent-Child Link). This case was linked to MOD-2021-284994 (Patient Link).   See case MOD-2021-285020 for details regarding the child case.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Illness, Nausea, Pain
Clinical narrative: Very ill; Extremely achy; Tired; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill), PAIN (Extremely achy), FATIGUE (Tired), VOMITING (Vomiting) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0303L20A and 028L(I)20A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Lupus).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-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 ILLNESS (Very ill), PAIN (Extremely achy), FATIGUE (Tired), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, ILLNESS (Very ill), PAIN (Extremely achy), FATIGUE (Tired), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure went very high and normal (normal) Blood pressure went  back to normal.         No concomitant medications were reported.   Treatment included blood pressure medication since the blood pressure went very high which required an adjustment in blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up information includes no new information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very ill; Extremely achy; Tired; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill), PAIN (Extremely achy), FATIGUE (Tired), VOMITING (Vomiting) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0303L20A and 028L(I)20A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Lupus).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-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 ILLNESS (Very ill), PAIN (Extremely achy), FATIGUE (Tired), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, ILLNESS (Very ill), PAIN (Extremely achy), FATIGUE (Tired), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure went very high and normal (normal) Blood pressure went  back to normal.         No concomitant medications were reported.   Treatment included blood pressure medication since the blood pressure went very high which required an adjustment in blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up information includes no new information
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) 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 02-Apr-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 (more than 36 days from first vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (chills) and PYREXIA (fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) 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 concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia
Clinical narrative: loss of voice; hoarseness; 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 APHONIA (loss of voice) and DYSPHONIA (hoarseness) 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 APHONIA (loss of voice) and DYSPHONIA (hoarseness). At the time of the report, APHONIA (loss of voice) and DYSPHONIA (hoarseness) 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 Concomitant drugs were reported.  No Treatment medications were reported.   Reporter did not allow further contact
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator; received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history and laboratory data was provided by the reporter.     On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator) 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.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: immediate mild allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (immediate mild allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (immediate mild allergic reaction). At the time of the report, HYPERSENSITIVITY (immediate mild allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Cough; Redness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) 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 COUGH (Cough), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, COUGH (Cough), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the Patient had Vaccine 2 days ago.  No concomitant medications were reported.  No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain, Vaccination site scar
Clinical narrative: scar tissue on the muscle where received the vaccine; received both doses at the end of December; arm pain where received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR (scar tissue on the muscle where received the vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received both doses at the end of December) and VACCINATION SITE PAIN (arm pain where received the vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included MELATONIN and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 VACCINATION SITE SCAR (scar tissue on the muscle where received the vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received both doses at the end of December) and VACCINATION SITE PAIN (arm pain where received the vaccine). At the time of the report, VACCINATION SITE SCAR (scar tissue on the muscle where received the vaccine) and VACCINATION SITE PAIN (arm pain where received the vaccine) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received both doses at the end of December) had resolved.            No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Ear infection, Headache, Influenza
Clinical narrative: feeling like flu; Pulsatile Tinnitus/throbbing in the right ear; ear infection/something wrong with her ear; sore arm; reaction was much worse; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (feeling like flu), TINNITUS (Pulsatile Tinnitus/throbbing in the right ear), EAR INFECTION (ear infection/something wrong with her ear), PAIN IN EXTREMITY (sore arm) and CONDITION AGGRAVATED (reaction was much worse) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medication history was provided by the reporter.  Concomitant products included CALCIUM, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, SODIUM (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE;SODIUM]), PARACETAMOL (TYLENOL) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-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 INFLUENZA (feeling like flu), TINNITUS (Pulsatile Tinnitus/throbbing in the right ear), EAR INFECTION (ear infection/something wrong with her ear), PAIN IN EXTREMITY (sore arm), CONDITION AGGRAVATED (reaction was much worse), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). At the time of the report, INFLUENZA (feeling like flu), TINNITUS (Pulsatile Tinnitus/throbbing in the right ear), EAR INFECTION (ear infection/something wrong with her ear), PAIN IN EXTREMITY (sore arm), CONDITION AGGRAVATED (reaction was much worse), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            The treatment information was not provided.   This case was linked to MOD-2021-288121 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: feeling like flu; Pulsatile Tinnitus/throbbing in the right ear; ear infection/something wrong with her ear; sore arm; reaction was much worse; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (feeling like flu), TINNITUS (Pulsatile Tinnitus/throbbing in the right ear), EAR INFECTION (ear infection/something wrong with her ear), PAIN IN EXTREMITY (sore arm) and CONDITION AGGRAVATED (reaction was much worse) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medication history was provided by the reporter.  Concomitant products included CALCIUM, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, SODIUM (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE;SODIUM]), PARACETAMOL (TYLENOL) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-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 INFLUENZA (feeling like flu), TINNITUS (Pulsatile Tinnitus/throbbing in the right ear), EAR INFECTION (ear infection/something wrong with her ear), PAIN IN EXTREMITY (sore arm), CONDITION AGGRAVATED (reaction was much worse), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). At the time of the report, INFLUENZA (feeling like flu), TINNITUS (Pulsatile Tinnitus/throbbing in the right ear), EAR INFECTION (ear infection/something wrong with her ear), PAIN IN EXTREMITY (sore arm), CONDITION AGGRAVATED (reaction was much worse), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            The treatment information was not provided.   This case was linked to MOD-2021-288121 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: haven't felt great since first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (haven't felt great since first vaccination) 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 16-Aug-2021, the patient experienced MALAISE (haven't felt great since first vaccination). At the time of the report, MALAISE (haven't felt great since first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitent drugs were provided.  No Treatment drugs were provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Side effect with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effect with the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Side effect with the first dose). At the time of the report, ADVERSE REACTION (Side effect with the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medication information was provided.   Reporter did not allow further contact
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: After getting the second shot they had the typical feeling under the weather for about 24 hours.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After getting the second shot they had the typical feeling under the weather for about 24 hours.) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 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 (After getting the second shot they had the typical feeling under the weather for about 24 hours.). At the time of the report, VACCINATION COMPLICATION (After getting the second shot they had the typical feeling under the weather for about 24 hours.) outcome was unknown.            No concomitant medication were given by the reporter. No Treatment information were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Daughter in law got   moderna shots in april. they now hav e been told they have the covid virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Daughter in law got   moderna shots in april. they now hav e been told they have the covid virus) 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 April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Daughter in law got   moderna shots in april. they now hav e been told they have the covid virus). At the time of the report, COVID-19 (Daughter in law got   moderna shots in april. they now hav e been told they have the covid virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications details were provided. No Treatment Medications details were provided.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dizziness, Erythema, Feeling hot, Pain
Clinical narrative: Covid arm 7 days after each dose/Localized allergic reaction; Very hot; Red; Throbbing; Localized allergic reaction; A little bit lightheaded; Rash; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing) and ALLERGY TO VACCINE (Localized allergic reaction) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 24-Dec-2020, 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 COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing), ALLERGY TO VACCINE (Localized allergic reaction), DIZZINESS (A little bit lightheaded) and RASH (Rash). The patient was treated with Manual therapy for Pain. At the time of the report, VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing), ALLERGY TO VACCINE (Localized allergic reaction), DIZZINESS (A little bit lightheaded) and RASH (Rash) 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.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-288404 (Patient Link).