chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm soreness; mild to moderate headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient was 5 months pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; HEADACHE (non-serious), outcome "unknown", described as "mild to moderate headache".  This (Age: 34; Unit: Unknown) female consumer reported for herself. 24 hours following receipt of the second dose of Pfizer's COVID-19 vaccine, patient experienced arm soreness and mild to moderate headache. Patient is in month 5 of pregnancy and elected to receive. Patient in month 5 of pregnancy and elected to receive vaccine after discussion with doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Cough, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: The first series caused a day off school each time due to fatigue and muscle pain, but recovery was speedy. The booster shot has caused headaches daily (mild to moderate) that doesn't go away, Nausea and vomiting (mild), dizziness (severe and causes falls and inability to walk during the day/night), muscle and joint pain over the entire body except for the left arm (moderate to severe), slightly decreased appetite, cough and shortness of breath, sinuses are stuffy and won't clear up
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Sinus disorder
Clinical narrative: The first series caused a day off school each time due to fatigue and muscle pain, but recovery was speedy. The booster shot has caused headaches daily (mild to moderate) that doesn't go away, Nausea and vomiting (mild), dizziness (severe and causes falls and inability to walk during the day/night), muscle and joint pain over the entire body except for the left arm (moderate to severe), slightly decreased appetite, cough and shortness of breath, sinuses are stuffy and won't clear up
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: The first series caused a day off school each time due to fatigue and muscle pain, but recovery was speedy. The booster shot has caused headaches daily (mild to moderate) that doesn't go away, Nausea and vomiting (mild), dizziness (severe and causes falls and inability to walk during the day/night), muscle and joint pain over the entire body except for the left arm (moderate to severe), slightly decreased appetite, cough and shortness of breath, sinuses are stuffy and won't clear up
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Cough, Dizziness, Dyspnoea
Clinical narrative: The first series caused a day off school each time due to fatigue and muscle pain, but recovery was speedy. The booster shot has caused headaches daily (mild to moderate) that doesn't go away, Nausea and vomiting (mild), dizziness (severe and causes falls and inability to walk during the day/night), muscle and joint pain over the entire body except for the left arm (moderate to severe), slightly decreased appetite, cough and shortness of breath, sinuses are stuffy and won't clear up
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: The first series caused a day off school each time due to fatigue and muscle pain, but recovery was speedy. The booster shot has caused headaches daily (mild to moderate) that doesn't go away, Nausea and vomiting (mild), dizziness (severe and causes falls and inability to walk during the day/night), muscle and joint pain over the entire body except for the left arm (moderate to severe), slightly decreased appetite, cough and shortness of breath, sinuses are stuffy and won't clear up
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare business professional concerning a patient of unknown age. No information about the current condition, medical history or concomitant therapy was reported. There was previous temperature excursion of varicella virus vaccine live (oka/merck)(VARIVAX) and it was noted from 6 F to 14 F (5.7 F) for 11 minutes on 19-DEC-2021. On 20-DEC-2021, varicella virus vaccine live (oka/merck)(VARIVAX) was stored at 5.9 F for 13 minutes. On 21-DEC-2021, the patient was administered improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose and route were not reported; lot # U020244, expiry date: 28-JUN-2023) as prophylaxis (product storage error). The patient did not experience any adverse effects after this vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pericarditis, Pleurisy
Clinical narrative: pericarditis; pleurisy; This case was reported by a consumer and described the occurrence of pericarditis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant) and pleurisy. On an unknown date, the outcome of the pericarditis and pleurisy were not recovered/not resolved.   It was unknown if the reporter considered the pericarditis and pleurisy to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix and developed  pericarditis and pleurisy 3 days after injection. The patient reported that it was now 8 months and he/she still suffering.  The patient also stated that he/she also reported this information after a couple days of symptoms and a diagnosis, and asked for update on the same. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Death, Herpes zoster
Clinical narrative: Death NOS; Shingle within the same week, permanent until he died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and shingles. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the shingles was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's relative.  The age at vaccination was not reported. The patient received Shingles vaccine when it first came out. Less than a week after receiving Shingles vaccine, the patient got a full-blown shingles breakout within the same week. The patient had permanent shingles until the day he died. This case had been linked with case US2021AMR201151, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201151:Same reporter.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid portion; administered only the liquid portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 5th January 2022, the patient received Menveo. On 5th January 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the day before reporting, she administered only the liquid portion of Menveo to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have any patient or vaccine lot, expiration date information at the time of the call as she was not at work. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 DEC-2021, the patient experienced positive covid test. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine was not applicable. The outcome of positive covid test was not reported. This report was non-serious. This case, from the same reporter is linked to 20220104898.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed along with the additional information received on 05-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 08-AUG-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total administered to left arm for prophylactic vaccination. It was unspecified whether patient had experienced any adverse events following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: unknown) dose was not reported, 1 total administered to left arm on 06-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JAN-2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced fever of 99.8 F, aches, fatigue and cough (coded as suspected covid-19 infection). Laboratory data included: covid-19 rapid diagnostic test (NR: not provided) positive (coded as suspected clinical vaccination failure). It was reported that the symptoms went away on 02-JAN-2022. The patient currently had scratchy throat and fatigue. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000210193.; Sender's Comments: V0: 20220104880-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number: unknown, expiry: unknown) dose not reported, dose number in series 1, 01 in total administered, start therapy date were not reported 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.  It was reported that "reporter had a relative that lost both of his parents within 2 days of the jab. On an unspecified date, the patient was died from an unknown cause of death. They were among the official death counts attributed to the jab". (dose number in series was 1). It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220112752.; Sender's Comments: V0: 20220112398-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: COULD NOT SLEEP ON EITHER SIDE; BOTH ARMS SORE; This spontaneous report received from a consumer via a company representative concerned a 40 year old of unspecified 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. 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 could not sleep on either side, and both arms sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not sleep on either side and both arms sore was not reported. This report was non-serious. This case, from the same reporter is linked to 20220113961, 20220114079 and 20220114182.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of vaccination site pruritus (red swelling itchy at site), vaccination site erythema (red swelling itchy at site) and vaccination site swelling (red swelling itchy at site) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pruritus (red swelling itchy at site), vaccination site erythema (red swelling itchy at site) and vaccination site swelling (red swelling itchy at site). At the time of the report, vaccination site pruritus (red swelling itchy at site), vaccination site erythema (red swelling itchy at site) and vaccination site swelling (red swelling itchy at site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter did not allow further contact.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, General physical health deterioration, Myalgia, Vaccination complication
Clinical narrative: 40 minutes after she had a bad reaction/ other reactions; Cannot do physical labor; muscle aches; She could only work 3 hours a day because one of the symptom is extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (40 minutes after she had a bad reaction/ other reactions), GENERAL PHYSICAL HEALTH DETERIORATION (Cannot do physical labor), MYALGIA (muscle aches) and FATIGUE (She could only work 3 hours a day because one of the symptom is extreme tiredness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (40 minutes after she had a bad reaction/ other reactions). an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Cannot do physical labor), MYALGIA (muscle aches) and FATIGUE (She could only work 3 hours a day because one of the symptom is extreme tiredness). At the time of the report, VACCINATION COMPLICATION (40 minutes after she had a bad reaction/ other reactions), GENERAL PHYSICAL HEALTH DETERIORATION (Cannot do physical labor), MYALGIA (muscle aches) and FATIGUE (She could only work 3 hours a day because one of the symptom is extreme tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Reporter stated that patient only took one shot of Moderna two years ago (exact date is unknown) and had other reactions and its been two years. Patient went to 19 doctors and no one could help her.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Headache, Migraine, Nausea
Clinical narrative: Diarrhea; Headache/ it was really bad, she couldn't get rid of the headache; Nauseated; Vomit; coughing; sore throat; Next day she had migraine; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Next day she had migraine), COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (Sore arm) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Dec-2021, the patient experienced MIGRAINE (Next day she had migraine). On an unknown date, the patient experienced COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (Diarrhea), HEADACHE (Headache/ it was really bad, she couldn't get rid of the headache), NAUSEA (Nauseated) and VOMITING (Vomit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Next day she had migraine), COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), NAUSEA (Nauseated) and VOMITING (Vomit) outcome was unknown and HEADACHE (Headache/ it was really bad, she couldn't get rid of the headache) had not resolved.            No Concomitant drug reported.   The first day after the booster it was normal. Then she had a headache and the next day she had migraine, she was nauseated, vomit, diarrhea. She took her migraine pill, it kind of helped her. The next day she felt much better and has been working since. Sometimes she would get a light headache but it did not get worse until 05 Jan 2022, it was really bad, she couldn't get rid of the headache, she took Tylenol and ended up having migraine medication again.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Vomiting
Clinical narrative: Diarrhea; Headache/ it was really bad, she couldn't get rid of the headache; Nauseated; Vomit; coughing; sore throat; Next day she had migraine; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Next day she had migraine), COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (Sore arm) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Dec-2021, the patient experienced MIGRAINE (Next day she had migraine). On an unknown date, the patient experienced COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (Diarrhea), HEADACHE (Headache/ it was really bad, she couldn't get rid of the headache), NAUSEA (Nauseated) and VOMITING (Vomit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Next day she had migraine), COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), NAUSEA (Nauseated) and VOMITING (Vomit) outcome was unknown and HEADACHE (Headache/ it was really bad, she couldn't get rid of the headache) had not resolved.            No Concomitant drug reported.   The first day after the booster it was normal. Then she had a headache and the next day she had migraine, she was nauseated, vomit, diarrhea. She took her migraine pill, it kind of helped her. The next day she felt much better and has been working since. Sometimes she would get a light headache but it did not get worse until 05 Jan 2022, it was really bad, she couldn't get rid of the headache, she took Tylenol and ended up having migraine medication again.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: patient received Pfizer as a second dose; 15 YO patient received Moderna as a 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 YO patient received Moderna as a 1st dose) and INTERCHANGE OF VACCINE PRODUCTS (patient received Pfizer as a second dose) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 YO patient received Moderna as a 1st dose). On 06-Jan-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received Pfizer as a second dose). On 08-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 YO patient received Moderna as a 1st dose) had resolved. On 06-Jan-2022, INTERCHANGE OF VACCINE PRODUCTS (patient received Pfizer as a second dose) 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 reported.  No treatment reported
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Vaccination complication
Clinical narrative: aches; adverse reactions; Chills; muscle soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (aches), VACCINATION COMPLICATION (adverse reactions), CHILLS (Chills) and MYALGIA (muscle soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), VACCINATION COMPLICATION (adverse reactions), CHILLS (Chills) and MYALGIA (muscle soreness). At the time of the report, PAIN (aches), VACCINATION COMPLICATION (adverse reactions), CHILLS (Chills) and MYALGIA (muscle soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain on Injection area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on Injection area) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain on Injection area). At the time of the report, VACCINATION SITE PAIN (Pain on Injection area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information provided.  It was reported that the patient use Moderna vaccine when complete 2 hours and had pain on Injection area and was carrying because very hard pain in injection area.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: itching all body; rashes all body; After 5-6 days of my booster dose, my body reacted with alergy reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching all body), RASH (rashes all body) and HYPERSENSITIVITY (After 5-6 days of my booster dose, my body reacted with alergy 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching all body), RASH (rashes all body) and HYPERSENSITIVITY (After 5-6 days of my booster dose, my body reacted with alergy reaction). At the time of the report, PRURITUS (itching all body), RASH (rashes all body) and HYPERSENSITIVITY (After 5-6 days of my booster dose, my body reacted with alergy reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: sly chest pain  like in his breast bone on the top of his chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (sly chest pain  like in his breast bone on the top of his chest) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (sly chest pain  like in his breast bone on the top of his chest). At the time of the report, CHEST PAIN (sly chest pain  like in his breast bone on the top of his chest) had not resolved.            No concomitant medications reported. No treatment medications reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had second dose several months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had second dose several months after the first dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had second dose several months after the first dose). On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had second dose several months after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug were reported.   No concomitant medication were reported. Patient inquires if they should get the booster in a month. Patient inquires if these 2 doses they received, with several months in between, render them fully vaccinated.     This case was linked to MOD-2022-445409 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Myalgia, Vaccination site pain
Clinical narrative: Several months later after the second dose, hair was falling out of the top of his forearms/hair falling out of the back of his hands/hair falling off of legs.; muscle aches; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Several months later after the second dose, hair was falling out of the top of his forearms/hair falling out of the back of his hands/hair falling off of legs.), MYALGIA (muscle aches) and VACCINATION SITE PAIN (soreness at the injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (muscle aches) and VACCINATION SITE PAIN (soreness at the injection site). In September 2021, the patient experienced ALOPECIA (Several months later after the second dose, hair was falling out of the top of his forearms/hair falling out of the back of his hands/hair falling off of legs.). At the time of the report, ALOPECIA (Several months later after the second dose, hair was falling out of the top of his forearms/hair falling out of the back of his hands/hair falling off of legs.), MYALGIA (muscle aches) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-445521 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received a booster dose in error instead of a 3rd additional dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received a booster dose in error instead of a 3rd additional dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown, Unknown and Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   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 INCORRECT DOSE ADMINISTERED (Received a booster dose in error instead of a 3rd additional dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Received a booster dose in error instead of a 3rd additional dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The caller reported that the patient is immunosuppressed and received dose 1and 2 at the 28 day interval and 6 months later he received a booster dose in error instead of a 3rd additional dose.  No treatment medication was reported.  No Concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had some very strong reactions to the first two doses of Moderna.; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Had some very strong reactions to the first two doses of Moderna.) 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 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had some very strong reactions to the first two doses of Moderna.). At the time of the report, VACCINATION COMPLICATION (Had some very strong reactions to the first two doses of Moderna.) 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.   Concomitant medications were not reported.  Treatment details were not provided.   This case was linked to MOD-2022-445722 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: Had some very strong reactions to the first two doses of Moderna.; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Had some very strong reactions to the first two doses of Moderna.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VACCINATION COMPLICATION (Had some very strong reactions to the first two doses of Moderna.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION COMPLICATION (Had some very strong reactions to the first two doses of Moderna.) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. This case was linked to MOD-2022-445709 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Rash, Vertigo
Clinical narrative: Chest tightness; Chest stabbing pain/weird chest overall pain which are getting worse; Extreme vertigo; Crocodile skin rash; This spontaneous case was reported by a non-health professional and describes the occurrence of CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest stabbing pain/weird chest overall pain which are getting worse), VERTIGO (Extreme vertigo) and RASH (Crocodile skin rash) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest stabbing pain/weird chest overall pain which are getting worse), VERTIGO (Extreme vertigo) and RASH (Crocodile skin rash). At the time of the report, CHEST DISCOMFORT (Chest tightness), VERTIGO (Extreme vertigo) and RASH (Crocodile skin rash) outcome was unknown and CHEST PAIN (Chest stabbing pain/weird chest overall pain which are getting worse) had not resolved.            No concomitant medication information was provided.  No treatment medication were provided.  The patient was concerned whether kids would also experience events which were experienced by him after vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain assessment
Clinical narrative: Headache; constant ache, doesn't stop. Not severe but not pleasant.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 12:30 (Lot number: EW0169) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (administration time=12:00 PM,, dose number=1,, vaccine location=Left arm}], lot number=EP6955,), administration date: 31Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 29Apr2021 09:00, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 29Apr2021 09:00, outcome "not recovered", described as "constant ache, doesn't stop. Not severe but not pleasant.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain.  Additional Information: Headache, started the next day. All over, constant ache, doesn't stop. Not severe but not pleasant. 10Apr on the pain scale. Nothing helps, tried ASA, APAP, naproxen, ibuprofen. Patient has been vaccinated within 4 weeks of the vaccination. Patient tested positive with COVID-19 test prior to COVID-19 vaccination. Patient has not been tested for COVID-19 test post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site discolouration, Vaccination site pain, Vaccination site swelling
Clinical narrative: patch with a circumference of about 2 inches; painful to the touch; swelled up; left a bruise like mark; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced a patch with a circumference of about 2 inches, painful to the touch, swelled up and left a bruise like a mark. The clinical course was reported as follows: Above the injection sight of the second dose there was a patch with a circumference of about 2 inches, give or take that got swelled up. It was painful to the touch for about 2-3 days and once the swelling went down it left a bruise like mark in the same spot. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. The clinical outcome of the events patch with a circumference of about 2 inches, painful to the touch, swelled up and left a bruise like a mark was resolved with sequelae at the time of the report.  No follow-up attempts are possible; information about the lot number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended patient data.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 25Feb2021 14:15 (Lot number: EN6202, Expiration Date: Jun2021) at the age of 82 years as dose 2 single for covid-19 immunisation. Relevant medical history included: "COPD", start date: 1965 (unspecified if ongoing), notes: Stop date: Ongoing; "Removal of cancerous from lung", start date: Aug2006 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 04Feb2021, Time: 12:30 P, Anatomical Site of injection: arm, Route of administration: Intramuscular, Lot#EL9262 (Exp. May2021)), administration date: 04Feb2021, for COVID-19 Immunisation, reaction(s): "Headache"; Bnt162b2 (Dose: 1st), for COVID-19 Immunisation, reaction(s): "Tired", "Sweating", "General malaise", "Muscle aches", "Fever". The following information was reported: HEADACHE (non-serious) with onset 26Feb2021, outcome "recovered" (2021), described as "Headache".  Additional information: Headache the next day- lasted several hours and was gone. No other side effects.Prior vaccination (within 4 weeks): None.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, Arthritis, Behcet's syndrome
Clinical narrative: Since the administration of the vaccine, persistent headaches, non-erosive polyarthralgias, recurrent oral and genital ulcers, anterior uveitis of repetition have appeared, everything points to having developed behcet's disease after vaccination, currently under follow-up by rheumatology.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Blood fibrinogen increased, Blood test abnormal, C-reactive protein increased, Condition aggravated, Genital ulceration
Clinical narrative: Since the administration of the vaccine, persistent headaches, non-erosive polyarthralgias, recurrent oral and genital ulcers, anterior uveitis of repetition have appeared, everything points to having developed behcet's disease after vaccination, currently under follow-up by rheumatology.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Iridocyclitis, Magnetic resonance imaging head abnormal, Magnetic resonance imaging joint, Mouth ulceration
Clinical narrative: Since the administration of the vaccine, persistent headaches, non-erosive polyarthralgias, recurrent oral and genital ulcers, anterior uveitis of repetition have appeared, everything points to having developed behcet's disease after vaccination, currently under follow-up by rheumatology.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Spinal X-ray abnormal, White matter lesion, X-ray limb abnormal
Clinical narrative: Since the administration of the vaccine, persistent headaches, non-erosive polyarthralgias, recurrent oral and genital ulcers, anterior uveitis of repetition have appeared, everything points to having developed behcet's disease after vaccination, currently under follow-up by rheumatology.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: My right hand went partially numb and tingled for 2 days after getting my booster.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Urticaria
Clinical narrative: 2 weeks after had swelling in eyelids - resolved after several days 3 weeks after had localized hives on neck and face - taking Zyrtec
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Immunisation
Clinical narrative: Development of Deep Venous Thrombosis Right lower extremity; Booster; This is a spontaneous report received from contactable Consumer. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Oct2021 (Lot number: FF2590) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Lot EL9269. NDC: 59267 100001, Location of injection: Arm Left), administration date: 20Feb2021, when the patient was 71 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Lot EL9269  NDC: 59267 10001, Location of injection: Arm Left), administration date: 30Dec2020, when the patient was 71 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant,hospitalization, disability, life threatening) with onset 16Oct2021, outcome "unknown", described as "Booster"; DEEP VEIN THROMBOSIS (medically significant,hospitalization, disability, life threatening) with onset 18Oct2021 15:00, outcome "recovering", described as "Development of Deep Venous Thrombosis Right lower extremity". The events "booster" and "development of deep venous thrombosis right lower extremity" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis with Rx for Eliquis. Clinical course: the patient had no Covid prior vaccination, the patient was not tested for Covid post vaccination. Patient had no known allergies. No other vaccine in four weeks.