chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: ADMINISTRATION ERROR: SECOND  DOSE OF JANSSEN COVID-29 VACCINE  ADMINISTERED PRIOR TO LABEL  UPDATE FOR BOOSTER DOSING; OFF LABEL USE; This spontaneous report received from a patient 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 not reported, batch number: 212A21A, 212AZ1A expiry: 21-DEC-2021) dose was not reported, administered on 24-SEP-2021, and dose was not reported, administered on MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration error: second dose of janssen covid-29 vaccine administered prior to label update for booster dosing. On 24-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error: second dose of janssen covid-29 vaccine administered prior to label update for booster dosing and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Pain, Pyrexia
Clinical narrative: WAS IN BED; ACHES AND PAINS; LOW GRADE FEVER; 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, 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 an unspecified date, the patient experienced was in bed, aches and pains, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from was in bed, aches and pains, and low grade fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I know someone that got the Moderna booster & had these headaches, too.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I know someone that got the Moderna booster & had these headaches, too.) 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 16-Dec-2021, the patient experienced HEADACHE (I know someone that got the Moderna booster & had these headaches, too.). At the time of the report, HEADACHE (I know someone that got the Moderna booster & had these headaches, too.) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-172670 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: cousin died unexpectedly; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (cousin died unexpectedly) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 07-Dec-2021 The patient died on 07-Dec-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported Unknown primary series when agent asked. Caller could not confirm if cousin had Moderna or not for primary series. Caller knew her cousin was 50 years old but DOB she did not know and states she was not pregnant  Company comment: This case concerns a 50 year old female patient with no reported medical history, who experienced the serious unexpected event of Death, 6 days after receiving the third (booster) dose of mRNA 1273 Covid-19 vaccine. It is unknown if patient received mRNA 1273 vaccine for the primary series. Patient died unexpectedly and cause of death is unknown. It is unkown if an autopsy was performed.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 50 year old female patient with no reported medical history, who experienced the serious unexpected event of Death, 6 days after receiving the third (booster) dose of mRNA 1273 Covid-19 vaccine. It is unknown if patient received mRNA 1273 vaccine for the primary series. Patient died unexpectedly and cause of death is unknown. It is unkown if an autopsy was performed.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: psychosis episode after the 1st and 2nd dose of the Moderna COVID-; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (psychosis episode after the 1st and 2nd dose of the Moderna COVID-) in a 31-year-old male 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, 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 PSYCHOTIC DISORDER (psychosis episode after the 1st and 2nd dose of the Moderna COVID-). At the time of the report, PSYCHOTIC DISORDER (psychosis episode after the 1st and 2nd dose of the Moderna COVID-) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications  were not reported.   This case was linked to MOD-2021-416527 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Chest pain, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: Dizziness after the 3 weeks after the vaccine. Chest pain, shortage of breath, palpitations started on August 13th, 2021. They are getting better, but I still have all these symptoms from time to time.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: Dizziness after the 3 weeks after the vaccine. Chest pain, shortage of breath, palpitations started on August 13th, 2021. They are getting better, but I still have all these symptoms from time to time.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Increased upper airway secretion
Clinical narrative: I didn't feel the shot. It didn't feel like an IM shot. I asked the pharmacist if she was sure I got it. She said yes.  I left the pharmacy about 15 minutes later and went to downtown  for a celebratory walk and to look at Christmas decorations. Shortly thereafter I had mucus in my throat and I got that scary feeling of not being able to breathe. I returned to the pharmacy. They gave me Benadryl and water.  After about an hour, I was okay. Now though I'm worried I'm not protected against the Omicron variant. I'm a registered nurse and I worry I want be able to protect myself.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Chills, shaking uncontrollably. Than hot and sweaty with fever. Started about 30 hours after 2nd vaccination shot. Lasted about 17 hours. It felt like Montezuma?s Revenge
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Swelling
Clinical narrative: Swollen right shoulder and right side of neck  after first vaccine; Sore right shoulder and right side of neck  after first vaccine; Sore right shoulder and right side of neck  after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen right shoulder and right side of neck  after first vaccine), NECK PAIN (Sore right shoulder and right side of neck  after first vaccine) and ARTHRALGIA (Sore right shoulder and right side of neck  after first vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced SWELLING (Swollen right shoulder and right side of neck  after first vaccine), NECK PAIN (Sore right shoulder and right side of neck  after first vaccine) and ARTHRALGIA (Sore right shoulder and right side of neck  after first vaccine). On 13-Jul-2021, SWELLING (Swollen right shoulder and right side of neck  after first vaccine), NECK PAIN (Sore right shoulder and right side of neck  after first vaccine) and ARTHRALGIA (Sore right shoulder and right side of neck  after first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got the first dose of the vaccine on the right shoulder.  Patient visited her doctor and blood works were done. The doctor told her that what she had was not an allergic reaction, and recommended to receive the second vaccine.  No concomitant medication information provided.  No treatment medication information provided.   This case was linked to MOD-2021-396388 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2021: Follow-up received on 19-Dec-2021 contains Non significant information: Patient demographic details added, On 19-Dec-2021: Follow-up received. New reporter information added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: Patient has received an expired booster on 13th November 2021; Sore left injection site arm after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm after booster dose) and EXPIRED PRODUCT ADMINISTERED (Patient has received an expired booster on 13th November 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 036B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient has received an expired booster on 13th November 2021). In November 2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm after booster dose). On 13-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient has received an expired booster on 13th November 2021) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm after booster dose) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient's DOB was mentioned as 30-Aug-2021. It was reported that patient took 3 doses through Shoulder Deltoid muscle. The patient originally contacted Moderna about an expiration date which had passed 2 days after she received the Moderna booster dose. There were no adverse events after first and second doses.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow-up received contains reporter details, route of administration of 3 doses and new event added. Patient age and date of booster dose administration updated.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Skin swelling, Urticaria
Clinical narrative: red rash covering a small area of the arm; maybe hive; the area is a tiny puffy; arm was itching terribly/very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash covering a small area of the arm), URTICARIA (maybe hive), SKIN SWELLING (the area is a tiny puffy) and PRURITUS (arm was itching terribly/very itchy) 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-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced RASH ERYTHEMATOUS (red rash covering a small area of the arm), URTICARIA (maybe hive), SKIN SWELLING (the area is a tiny puffy) and PRURITUS (arm was itching terribly/very itchy). At the time of the report, RASH ERYTHEMATOUS (red rash covering a small area of the arm), URTICARIA (maybe hive), SKIN SWELLING (the area is a tiny puffy) and PRURITUS (arm was itching terribly/very itchy) outcome was unknown.            Patient stated that after the first to doses they had nothing. No concomitant medication were provided. No treatment information were given.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Non-Significant Follow up- Updated contact information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Feeling exhausted; Real bad muscle aches one night / horrible pain in muscles; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling exhausted) and MYALGIA (Real bad muscle aches one night / horrible pain in muscles) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS.   On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received 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. In 2021, the patient experienced FATIGUE (Feeling exhausted) and MYALGIA (Real bad muscle aches one night / horrible pain in muscles). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. In December 2021, FATIGUE (Feeling exhausted) and MYALGIA (Real bad muscle aches one night / horrible pain in muscles) had resolved.            Concomitant medications included unknown Thyroid medication.  It was reported that the patient was fine after 5 days.   This case was linked to MOD-2021-404069, MOD-2021-404070 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow up information received included significant information events outcome updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: Vaccine not working(Lack of efficacy); This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Vaccine not working(Lack of efficacy)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    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 DRUG INEFFECTIVE (Vaccine not working(Lack of efficacy)). At the time of the report, DRUG INEFFECTIVE (Vaccine not working(Lack of efficacy)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter. Company comment: This is a spontaneous case concerning a 65-year-old female patient with a current history of multiple sclerosis, under OCRELIZUMAB as a treatment, who experienced the unexpected event of drug ineffective, reported as Vaccine not working (Lack of efficacy). It is unknow the number of doses received by this patient, also vaccination date and when the event lack of efficacy occurred. Concomitant medication of OCRELIZUMAB, could be a confounder. This case does not meet criteria for lack of efficacy; however, no further information was reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow up updated reporter type to consumer also concomitant medication added.; Sender's Comments: This is a spontaneous case concerning a 65-year-old female patient with a current history of multiple sclerosis, under OCRELIZUMAB as a treatment, who experienced the unexpected event of drug ineffective, reported as Vaccine not working (Lack of efficacy). It is unknow the number of doses received by this patient, also vaccination date and when the event lack of efficacy occurred. Concomitant medication of OCRELIZUMAB, could be a confounder. This case does not meet criteria for lack of efficacy; however, no further information was reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, Fatigue, Pain in extremity
Clinical narrative: sore arm for 6 months; fatigue; got coronavirus after vaccination; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got coronavirus after vaccination), DRUG INEFFECTIVE (Lack of drug effect), PAIN IN EXTREMITY (sore arm for 6 months) and FATIGUE (fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised (Patient reported she has a bad immune system because of this.). Concomitant products included ZINC, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), VIT D [VITAMIN D NOS], ETANERCEPT (ENBREL), ASCORBIC ACID (VITAMIN C ACID), MULTIVITAMIN [VITAMINS NOS], FLUOXETINE HYDROCHLORIDE (PROZAC) and PREDNISONE for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (got coronavirus after vaccination) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for 6 months) and FATIGUE (fatigue). At the time of the report, COVID-19 (got coronavirus after vaccination) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and PAIN IN EXTREMITY (sore arm for 6 months) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 128 (High) Patient reported she has very high antibodies,especially considering she does not have a good immune system..         Treatment information was not provided.   This case was linked to MOD-2021-406306 (Patient Link).; Sender's Comments: This is a spontaneous, lack of efficacy case concerning a 64-year-old, female patient with current medical history of Rheumatoid arthritis, who experienced the unexpected adverse event of special interest of COVID-19. The event occurred approximately 5 months after the second dose. Immunosuppression due to current medical history of Rheumatoid arthritis, is a confounder for the event  lack of efficacy. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Postmenopausal haemorrhage
Clinical narrative: arm sore; feel tired; chills; menstruation when already menopause; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (menstruation when already menopause) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 030B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (menstruation when already menopause) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore), FATIGUE (feel tired) and CHILLS (chills). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (menstruation when already menopause), PAIN IN EXTREMITY (arm sore), FATIGUE (feel tired) and CHILLS (chills) outcome was unknown.            No treatment medications were reported. Patient did not take any OTC medications for symptom relief.  Company comment: This Spontaneous case concerns a 52-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) event of Postmenopausal bleeding. The patient experienced menstruation when she was already menopause 1 day after receiving the third dose number of mRNA-1273 vaccine. The rechallenge is not applicable, as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-406646, MOD-2021-406538 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 52-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) event of Postmenopausal bleeding. The patient experienced menstruation when she was already menopause 1 day after receiving the third dose number of mRNA-1273 vaccine. The rechallenge is not applicable, as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: The rash was really red; The rash was really itchy; I started developing hives on that evening and it was also itching; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (The rash was really red), RASH PRURITIC (The rash was really itchy), PAIN IN EXTREMITY (sore arm) and URTICARIA (I started developing hives on that evening and it was also itching) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 06-Dec-2021, the patient experienced URTICARIA (I started developing hives on that evening and it was also itching). On 09-Dec-2021, the patient experienced RASH ERYTHEMATOUS (The rash was really red) and RASH PRURITIC (The rash was really itchy). The patient was treated with PREDNISONE on 07-Dec-2021 for Adverse event, at a dose of 20 mg; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 08-Dec-2021 for Adverse event, at a dose of UNK, qd (1 daily) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 09-Dec-2021 for Hives, at a dose of 25 mg three times a day. At the time of the report, RASH ERYTHEMATOUS (The rash was really red), RASH PRURITIC (The rash was really itchy), PAIN IN EXTREMITY (sore arm) and URTICARIA (I started developing hives on that evening and it was also itching) outcome was unknown.            Concomitant medications were not provided Patient also experienced itching and rash was really red On 07Dec2021, Patient was worse that morning. She went to the emergency room. The Dr thought it might be food related. They gave her Prednisone 20mg in the emergency room. They also prescribed Zyrtec 1 daily. On 08Dec2021 Patient started taking Zyrtec 1 daily. On 09Dc20211, the rash was really red & itchy. She went to the emergency room at 9:30a.m The Dr thought there may be a connection to the booster dose. They gave her 2 Benadryl 25mg & 2 Prednisone 20mg, while in the emergency room. They also prescribed Benadryl 25mg 3 times/day until the hives are gone. The hives are typically bad in the mornings.   This case was linked to MOD-2021-407222, MOD-2021-407223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow-up received on 09-Dec-2021. It contains No New Information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Pain in extremity
Clinical narrative: a very sore arm; brain fog/just didn't feel sharp, mentally; had a strange pressure in my head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a very sore arm), FEELING ABNORMAL (brain fog/just didn't feel sharp, mentally) and HEAD DISCOMFORT (had a strange pressure in my head) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (a very sore arm), FEELING ABNORMAL (brain fog/just didn't feel sharp, mentally) and HEAD DISCOMFORT (had a strange pressure in my head). At the time of the report, PAIN IN EXTREMITY (a very sore arm), FEELING ABNORMAL (brain fog/just didn't feel sharp, mentally) and HEAD DISCOMFORT (had a strange pressure in my head) outcome was unknown.            No Concomitant medication details were provided. No Treatment medication details were provided.   This case was linked to MOD-2021-407181, MOD-2021-407223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow-up received 09-Nov-2021 and does not contain any new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Pain in extremity
Clinical narrative: Patient arm was very sore; sick to patient stomach; Patient was nauseated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient arm was very sore), ABDOMINAL DISCOMFORT (sick to patient stomach) and NAUSEA (Patient was nauseated) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Patient arm was very sore), ABDOMINAL DISCOMFORT (sick to patient stomach) and NAUSEA (Patient was nauseated). At the time of the report, PAIN IN EXTREMITY (Patient arm was very sore), ABDOMINAL DISCOMFORT (sick to patient stomach) and NAUSEA (Patient was nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication details were provided. No Treatment medication details were provided.   This case was linked to MOD-2021-407181, MOD-2021-407222 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow-up received on 09 Dec 2021 and does not contain any new information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Feeling abnormal, Palpitations
Clinical narrative: Arrhythmia; Palpitations; Feels like something is not ok//like heart does something and then she doesn't feel it anymore; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia), PALPITATIONS (Palpitations) and FEELING ABNORMAL (Feels like something is not ok//like heart does something and then she doesn't feel it anymore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 045A21A and 029A21A) 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 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ARRHYTHMIA (Arrhythmia), PALPITATIONS (Palpitations) and FEELING ABNORMAL (Feels like something is not ok//like heart does something and then she doesn't feel it anymore). At the time of the report, ARRHYTHMIA (Arrhythmia), PALPITATIONS (Palpitations) and FEELING ABNORMAL (Feels like something is not ok//like heart does something and then she doesn't feel it anymore) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Also it was stated that patient doesn't have any history of Myocarditis/pericarditis and COVID-19 infection.  Company comment: This  spontaneous case concerns a 36-year-old female patient with no medical history reported, who experienced the unexpected non serious event/AESI of Arrhythmia after mRNA- 1273 Moderna vaccine. The onset of the event occurred 2 to 4 days after the booster dose of mRNA- 1273 vaccine. Patient experienced palpitations, but medical consultation was not done.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This  spontaneous case concerns a 36-year-old female patient with no medical history reported, who experienced the unexpected non serious event/AESI of Arrhythmia after mRNA- 1273 Moderna vaccine. The onset of the event occurred 2 to 4 days after the booster dose of mRNA- 1273 vaccine. Patient experienced palpitations, but medical consultation was not done.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian vein thrombosis
Clinical narrative: Blood clot in right ovarian vein; This spontaneous case was reported by a nurse and describes the occurrence of OVARIAN VEIN THROMBOSIS (Blood clot in right ovarian vein) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OVARIAN VEIN THROMBOSIS (Blood clot in right ovarian vein) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) from 01-May-2021 to 01-Nov-2021 for Adverse event, at a dose of 20 mg once a day. At the time of the report, OVARIAN VEIN THROMBOSIS (Blood clot in right ovarian vein) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that after second dose patient had a blood clot in right ovarian vein. Patient was concerned about booster.  Company comment: This case concerns a 60 year old female patient with no reported medical history, who experienced the serious unexpected event of ovarian vein thrombosis on an unknown date after the second dose of mRNA 1273 Covid-19 vaccine. Information on clinical course was not provided, the patient was treated with Rivaroxaban. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 60 year old female patient with no reported medical history, who experienced the serious unexpected event of ovarian vein thrombosis on an unknown date after the second dose of mRNA 1273 Covid-19 vaccine. Information on clinical course was not provided, the patient was treated with Rivaroxaban. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cancer
Clinical narrative: Ovarian cancer; This spontaneous case was reported by a consumer and describes the occurrence of OVARIAN CANCER (Ovarian cancer) 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 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced OVARIAN CANCER (Ovarian cancer) (seriousness criterion medically significant). At the time of the report, OVARIAN CANCER (Ovarian cancer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were given. No treatment information were given. Caller reports that their sister got diagnosed with ovarian cancer 6 to 8 months after receiving the Moderna Covid-19 Vaccine.  Company comment: This case concerns a female patient, unknown age, with no reported medical history who experienced the serious, unexpected event of ovarian cancer 6-8 months after unspecified dose of mRNA 1273 vaccine. Information on clinical course was not provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no reported medical history who experienced the serious, unexpected event of ovarian cancer 6-8 months after unspecified dose of mRNA 1273 vaccine. Information on clinical course was not provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccine breakthrough infection
Clinical narrative: flu like symptoms for half a day; I had a breakthrough COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (I had a breakthrough COVID-19 infection) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LOSARTAN and ATORVASTATIN for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced VACCINE BREAKTHROUGH INFECTION (I had a breakthrough COVID-19 infection) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms for half a day). At the time of the report, VACCINE BREAKTHROUGH INFECTION (I had a breakthrough COVID-19 infection) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms for half a day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications was provided as Monoclonal Antibodies. The patient experienced flu like symptoms for half a day which was resolved and tested negative on 20-SEP-2021.; Sender's Comments: This case concerns a 60-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected event of vaccine breakthrough infection and a non-serious event of Influenza like illness. The event occurred 6 months 9 days after the 2nd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Head discomfort, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: SOB; pulse ox of 91%; diarrhea; full head; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (SOB) and OXYGEN SATURATION DECREASED (pulse ox of 91%) 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 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (SOB) (seriousness criterion medically significant), OXYGEN SATURATION DECREASED (pulse ox of 91%) (seriousness criterion medically significant), DIARRHOEA (diarrhea) and HEAD DISCOMFORT (full head). At the time of the report, DYSPNOEA (SOB), OXYGEN SATURATION DECREASED (pulse ox of 91%), DIARRHOEA (diarrhea) and HEAD DISCOMFORT (full head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 91% (Low) 91%.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. I had the covid booster 8 days ago. Now I am SOB with a pulse ox of 91%, diarrhea and full head. Could this be a reaction to the booster?   Treatment information was not provided.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) events of Dyspnoea and Oxygen saturation decreased after mRNA- 1273 Moderna vaccine. The events occurred approximately 8 days after the booster dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course and medical assessment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) events of Dyspnoea and Oxygen saturation decreased after mRNA- 1273 Moderna vaccine. The events occurred approximately 8 days after the booster dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course and medical assessment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: husband also got the vaccine on same day and was positive for COVID-19 but became very sick; husband also got the vaccine on same day and was positive for COVID-19 but became very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) and COVID-19 (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) (seriousness criterion hospitalization) and COVID-19 (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) (seriousness criterion hospitalization). At the time of the report, ILLNESS (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) and COVID-19 (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information  was reported. No treatment medication was reported.  Company Comment This case concerns a male patient of an unknown age with no medical history, who experienced the serious unexpected, event of Illness and the AESI of COVID-19. The events occurred on an unknown date after the first dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-409280 (Patient Link).; Sender's Comments: This case concerns a male patient of an unknown age with no medical history, who experienced the serious unexpected, event of Illness and the AESI of COVID-19. The events occurred on an unknown date after the first dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt fatigued after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt fatigued after the first dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-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 FATIGUE (felt fatigued after the first dose). At the time of the report, FATIGUE (felt fatigued after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-409612 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory symptom, Sinusitis
Clinical narrative: Sinus infection; Upper respiratory illness; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) and RESPIRATORY SYMPTOM (Upper respiratory illness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since September 2018, Insulin resistance (due to PCOS) since 2011 and Polycystic ovarian syndrome since 2011. Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) from September 2021 to an unknown date for Birth control pill, LOSARTAN from September 2018 to an unknown date for Blood pressure high, METFORMIN HYDROCHLORIDE (GLUCOPHAGE) from 2011 to an unknown date for Insulin resistance, MULTIVITAMIN FOR WOMEN from September 2019 to an unknown date for Vitamin supplementation, FISH OIL from September 2019 to an unknown date for an unknown indication.   On 21-Apr-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced SINUSITIS (Sinus infection) and RESPIRATORY SYMPTOM (Upper respiratory illness). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) on 11-Jun-2021 at an unspecified dose and frequency. On 11-Oct-2021, SINUSITIS (Sinus infection) and RESPIRATORY SYMPTOM (Upper respiratory illness) had resolved.            Other Concomitant includes Probiotic started  since Sep-2019 and still continuing.   This case was linked to MOD-2021-406383, MOD-2021-410582 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 09-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  No treatment information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Significant Follow up-patient demographics added, report type changed from Invalid to spontaneous. suspect product start date, suspect product expire date, lot number has been updated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.