chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Vaccination site joint pain, Vaccination site pain
Clinical narrative: Hurting over the left shoulder and down the spine after booster; Hurting over the left shoulder and down the spine after booster; Left arm hurt after booster/Pain on left arm has has not improved after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (Hurting over the left shoulder and down the spine after booster), SPINAL PAIN (Hurting over the left shoulder and down the spine after booster) and VACCINATION SITE PAIN (Left arm hurt after booster/Pain on left arm has has not improved after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE JANSSEN (around 23MAR2021 to 15APR2021). Concurrent medical conditions included Fibroids (Cancerous Fibroids).    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced VACCINATION SITE PAIN (Left arm hurt after booster/Pain on left arm has has not improved after booster). On 28-Dec-2021, the patient experienced VACCINATION SITE JOINT PAIN (Hurting over the left shoulder and down the spine after booster). 28-Dec-2021, the patient experienced SPINAL PAIN (Hurting over the left shoulder and down the spine after booster). At the time of the report, VACCINATION SITE JOINT PAIN (Hurting over the left shoulder and down the spine after booster) and SPINAL PAIN (Hurting over the left shoulder and down the spine after booster) outcome was unknown and VACCINATION SITE PAIN (Left arm hurt after booster/Pain on left arm has has not improved after booster) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Insomnia, Myalgia
Clinical narrative: hasn't slept all night; temperature started coming on/temperature went to 102 Fahrenheit; whole body aches; headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hasn't slept all night), PYREXIA (temperature started coming on/temperature went to 102 Fahrenheit), MYALGIA (whole body aches), HEADACHE (headache) and NAUSEA (nausea) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 013M20A and 027L02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Hypertension (High blood pressure) and Hypercholesteraemia (High cholesterol).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced INSOMNIA (hasn't slept all night), PYREXIA (temperature started coming on/temperature went to 102 Fahrenheit), MYALGIA (whole body aches), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 30-Dec-2021, INSOMNIA (hasn't slept all night), PYREXIA (temperature started coming on/temperature went to 102 Fahrenheit), MYALGIA (whole body aches), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, Body temperature: 102 fahrenheit (High) 102 Fahrenheit.         Concomitant medication includes: Many medications The patient though of having COVID infection but realized that the events were common from the vaccine, later took medicine and was symptoms free.   This case was linked to MOD-2021-434890 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: hasn't slept all night; temperature started coming on/temperature went to 102 Fahrenheit; whole body aches; headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hasn't slept all night), PYREXIA (temperature started coming on/temperature went to 102 Fahrenheit), MYALGIA (whole body aches), HEADACHE (headache) and NAUSEA (nausea) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 013M20A and 027L02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Hypertension (High blood pressure) and Hypercholesteraemia (High cholesterol).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced INSOMNIA (hasn't slept all night), PYREXIA (temperature started coming on/temperature went to 102 Fahrenheit), MYALGIA (whole body aches), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 30-Dec-2021, INSOMNIA (hasn't slept all night), PYREXIA (temperature started coming on/temperature went to 102 Fahrenheit), MYALGIA (whole body aches), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, Body temperature: 102 fahrenheit (High) 102 Fahrenheit.         Concomitant medication includes: Many medications The patient though of having COVID infection but realized that the events were common from the vaccine, later took medicine and was symptoms free.   This case was linked to MOD-2021-434890 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: first case of Omicron; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (first case of Omicron) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukaemia.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (first case of Omicron). At the time of the report, COVID-19 (first case of Omicron) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced unexpected event of COVID-19 (AESI). The event occurred on an unknown date, it was reported that patient was fully vaccinated with mRNA-1273 vaccine. Vaccination dates were not disclosed. He said he didn't get that sick and it was real mild. Treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced unexpected event of COVID-19. The event occurred on an unknown date, it was reported that patient was fully vaccinated with mRNA-1273 vaccine. Vaccination dates were not disclosed. He said he didn't get that sick and it was real mild. Treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Lost vision (one eye); This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Lost vision (one eye)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (Lost vision (one eye)) (seriousness criteria hospitalization and medically significant). At the time of the report, BLINDNESS (Lost vision (one eye)) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  The patient knewpeople who had experienced same issue after 3-6 months of taking second vaccination. Lost vision (one eye).  Patient was hospitalized for couple of weeks and no doctors could point out the causes. They said they could do nothing and gave patient steroid and asked them to go home.  Company Comment: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the event was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-419388, MOD-2021-423102, MOD-2021-423139 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the event was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstruation irregular, Pregnancy test
Clinical narrative: Period still has not come per the patient,Irregular period; Did not get the period after receiving the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Period still has not come per the patient,Irregular period) and AMENORRHOEA (Did not get the period after receiving the moderna vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced MENSTRUATION IRREGULAR (Period still has not come per the patient,Irregular period) and AMENORRHOEA (Did not get the period after receiving the moderna vaccine). At the time of the report, MENSTRUATION IRREGULAR (Period still has not come per the patient,Irregular period) and AMENORRHOEA (Did not get the period after receiving the moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that her last menstrual cycle period was on 21-Nov-2021 before the vaccine and her period usually lasts 10 days at the latest. Now it is 29-Dec-2021, the still not get the period after the vaccine. patient went to ER and done the HPT for the pregnancy test and it was negative that the patient was not pregnant. The patient stated that her period should have come by 21-Dec-2021 and has not gotten her period yet  No concomitant medications reported.  No treatment medications were reported.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15-year-old  received a Moderna booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old  received a Moderna booster shot) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old  received a Moderna booster shot). On 28-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year-old  received a Moderna booster shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (tested positive). At the time of the report, COVID-19 (tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.  This is a spontaneous case concerning  a  patient of unknown gender and age with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The events occurred approximately 9 days after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Sender's Comments: This is a spontaneous case concerning  a  patient of unknown gender and age with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The events occurred approximately 9 days after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: twelve-year-old patient got vaccinated with Moderna Vaccine for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (twelve-year-old patient got vaccinated with Moderna Vaccine for COVID-19) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (twelve-year-old patient got vaccinated with Moderna Vaccine for COVID-19). On 01-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (twelve-year-old patient got vaccinated with Moderna Vaccine for COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17yo male came to the office for a Pfizer Covid-19 booster. He received a Moderna Covid-19 booster instead.) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination. No Medical History information was reported.On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17yo male came to the office for a Pfizer Covid-19 booster. He received a Moderna Covid-19 booster instead.). On 28-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17yo male came to the office for a Pfizer Covid-19 booster. He received a Moderna Covid-19 booster instead.) had resolved.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. Patient was doing fine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Headache, Hypoaesthesia, Nausea
Clinical narrative: It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting; My fingertips and my fingers are like tingling; It is very uncomfortable; Her hand is numb; Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain; This time it is unbearably sore; She is also feeling a little nauseous; She is having headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting), PARAESTHESIA (My fingertips and my fingers are like tingling), DISCOMFORT (It is very uncomfortable), HYPOAESTHESIA (Her hand is numb) and ARTHRALGIA (Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN IN EXTREMITY (It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting), PARAESTHESIA (My fingertips and my fingers are like tingling), DISCOMFORT (It is very uncomfortable), HYPOAESTHESIA (Her hand is numb), ARTHRALGIA (Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain), VACCINATION SITE PAIN (This time it is unbearably sore), NAUSEA (She is also feeling a little nauseous) and HEADACHE (She is having headache). At the time of the report, PAIN IN EXTREMITY (It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting), PARAESTHESIA (My fingertips and my fingers are like tingling), DISCOMFORT (It is very uncomfortable), HYPOAESTHESIA (Her hand is numb), ARTHRALGIA (Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain), VACCINATION SITE PAIN (This time it is unbearably sore), NAUSEA (She is also feeling a little nauseous) and HEADACHE (She is having headache) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-435151, MOD-2021-435156 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting; My fingertips and my fingers are like tingling; It is very uncomfortable; Her hand is numb; Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain; This time it is unbearably sore; She is also feeling a little nauseous; She is having headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting), PARAESTHESIA (My fingertips and my fingers are like tingling), DISCOMFORT (It is very uncomfortable), HYPOAESTHESIA (Her hand is numb) and ARTHRALGIA (Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN IN EXTREMITY (It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting), PARAESTHESIA (My fingertips and my fingers are like tingling), DISCOMFORT (It is very uncomfortable), HYPOAESTHESIA (Her hand is numb), ARTHRALGIA (Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain), VACCINATION SITE PAIN (This time it is unbearably sore), NAUSEA (She is also feeling a little nauseous) and HEADACHE (She is having headache). At the time of the report, PAIN IN EXTREMITY (It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting), PARAESTHESIA (My fingertips and my fingers are like tingling), DISCOMFORT (It is very uncomfortable), HYPOAESTHESIA (Her hand is numb), ARTHRALGIA (Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain), VACCINATION SITE PAIN (This time it is unbearably sore), NAUSEA (She is also feeling a little nauseous) and HEADACHE (She is having headache) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-435151, MOD-2021-435156 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: patient broke out in hives from head to toe; a breakthrough itching; red marks on skin; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (patient broke out in hives from head to toe), PRURITUS (a breakthrough itching) and ERYTHEMA (red marks on skin) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 034C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (patient broke out in hives from head to toe), PRURITUS (a breakthrough itching) and ERYTHEMA (red marks on skin). At the time of the report, URTICARIA (patient broke out in hives from head to toe), PRURITUS (a breakthrough itching) and ERYTHEMA (red marks on skin) had not resolved.            No concomitant medications were reported. Treatment medication included Antihistamines daily. 10 days after vaccination events were started.   This case was linked to MOD-2021-435530, MOD-2021-435507 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain, Vaccination site reaction
Clinical narrative: Poison Ivy like sensation on injection site comes & goes after first shot; Diarrhea after first shot; Burning sensation on injection site comes & goes after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Poison Ivy like sensation on injection site comes & goes after first shot), DIARRHOEA (Diarrhea after first shot) and VACCINATION SITE PAIN (Burning sensation on injection site comes & goes after first shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE REACTION (Poison Ivy like sensation on injection site comes & goes after first shot), DIARRHOEA (Diarrhea after first shot) and VACCINATION SITE PAIN (Burning sensation on injection site comes & goes after first shot). On 30-Dec-2021, VACCINATION SITE REACTION (Poison Ivy like sensation on injection site comes & goes after first shot) and VACCINATION SITE PAIN (Burning sensation on injection site comes & goes after first shot) had resolved. At the time of the report, DIARRHOEA (Diarrhea after first shot) had not 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.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-435888 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Vaccination complication
Clinical narrative: same reaction as the initial reporter; spasms in the chest; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (same reaction as the initial reporter) and MUSCLE SPASMS (spasms in the chest) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (same reaction as the initial reporter) and MUSCLE SPASMS (spasms in the chest). At the time of the report, VACCINATION COMPLICATION (same reaction as the initial reporter) and MUSCLE SPASMS (spasms in the chest) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.  Caller stated that he joined a social media group called 'Chronic Spontaneous Urticaria after COVID- 19 vaccine Support Group' where there are group of people with the same type of reactions. Reporter stated that a doctor he knows had a same reaction and spasms in the chest after the 2nd dose in a similar time frame as he did (10-14 days).
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Hepatic failure
Clinical narrative: liver failure; receiving two shots of the booster.; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC FAILURE (liver failure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic liver disease (chronic liver disease).   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC FAILURE (liver failure) (seriousness criteria death, hospitalization and medically significant) and EXTRA DOSE ADMINISTERED (receiving two shots of the booster.). The patient died on an unknown date. The reported cause of death was Liver failure. It is unknown if an autopsy was performed. At the time of death, EXTRA DOSE ADMINISTERED (receiving two shots of the booster.) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment medication information was not provided by the reporter.  Reporter stated that a girl with chronic liver disease went into liver failure and had jaundice and also died in hospital after receiving two shots of the booster.  Company comment: This is a  spontaneous case concerning a  female patient of an unknown age  with concurrent medical condition of Chronic liver disease who experienced serious, unexpected event of hepatic failure. Vaccination dates and start date of the event were not provided. Reporter stated that a girl with chronic liver disease went into liver failure and had jaundice and also died in hospital after receiving two shots of the booster. Date of death was not disclosed. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested. Concurrent medical condition of Chronic liver disease remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a  spontaneous case concerning a  female patient of an unknown age  with concurrent medical condition of Chronic liver disease who experienced serious, unexpected event of hepatic failure. Vaccination dates and start date of the event were not provided. Reporter stated that a girl with chronic liver disease went into liver failure and had jaundice and also died in hospital after receiving two shots of the booster. Date of death was not disclosed. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested. Concurrent medical condition of Chronic liver disease remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Liver failure
Sex: U
Vaccine: COVID19
Symptoms: Rash, Tinnitus
Clinical narrative: Tinnitus; rash; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and RASH (rash) 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 TINNITUS (Tinnitus) and RASH (rash). At the time of the report, TINNITUS (Tinnitus) outcome was unknown and RASH (rash) had not resolved.            It was reported that About 2 weeks after the booster rash appeared (still have) and Tinnitus as well. No treatment medication was reported. No Concomitant medication was reported.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves male patient of unknown age who experienced got the flu shot and got the flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "got the flu shot and got the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got the flu shot and got the flu). At time of reporting, the outcome was Unknown for the event got the flu shot and got the flu.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing on my ears
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Cardiac monitoring abnormal, Chills, Computerised tomogram thorax, Coronary artery occlusion
Clinical narrative: 8 Jun 2021 started with chills and fever at 1600hrs, Shortness of breath and elevated heart rate 2100hrs, arrived at Emergency Room approx 2145hrs. Heart rate @ 180bpm, Fever, prescribed antibody's, Antibiotics, Had a Chest CT scan. Kept overnight until heart rate was <100bpm. I then noticed shortness of breath and walking became an effort and had to pause to catch my breath. Scheduled appointment with Family Doctor at a local Clinic on 22 Jun 2021.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Gait disturbance, Heart rate increased
Clinical narrative: 8 Jun 2021 started with chills and fever at 1600hrs, Shortness of breath and elevated heart rate 2100hrs, arrived at Emergency Room approx 2145hrs. Heart rate @ 180bpm, Fever, prescribed antibody's, Antibiotics, Had a Chest CT scan. Kept overnight until heart rate was <100bpm. I then noticed shortness of breath and walking became an effort and had to pause to catch my breath. Scheduled appointment with Family Doctor at a local Clinic on 22 Jun 2021.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: 8 Jun 2021 started with chills and fever at 1600hrs, Shortness of breath and elevated heart rate 2100hrs, arrived at Emergency Room approx 2145hrs. Heart rate @ 180bpm, Fever, prescribed antibody's, Antibiotics, Had a Chest CT scan. Kept overnight until heart rate was <100bpm. I then noticed shortness of breath and walking became an effort and had to pause to catch my breath. Scheduled appointment with Family Doctor at a local Clinic on 22 Jun 2021.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin E, Blood thyroid stimulating hormone, C-reactive protein normal, Full blood count normal, Pruritus
Clinical narrative: pt developed severe itching 1 week after #3 covid vaccine and lasted over one week and did not respond to antihistamines
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: pt developed severe itching 1 week after #3 covid vaccine and lasted over one week and did not respond to antihistamines
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Myalgia
Clinical narrative: Muscle pain below the chest, difficulty breathing and pressure in the ribs. Wrist pain that returned to pain after three days after vaccination.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Inflammation, Muscle spasms
Clinical narrative: spine inflammation. started as if was only a back right shoulder spasm, but kept gradually increasing pain intensity thru next days. realized the pain really comes from the one location in spine reflecting on all shoulder area. now it feels on another spine. Its extremlly uncomfortable to be seated or standing, have to lay on an angle. if standing and hurting, I touch spine area and pain from shoulder decreases. Being resting but no improvement.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular, Pharyngeal swelling, Throat tightness
Clinical narrative: Rapid/ irregular heart beat now almost daily and constriction of throat when swallowing feels swollen
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Administered an expired dose of Rotateq; This spontaneous report as received from a consumer (office manager) refers to a 6 month old patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided.  On 15-DEC-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Lot No. 1691302 has been verified to be a valid lot number for [Rotavirus Vaccine, Live, Oral, Pentavalent], expiration date reported as 12-DEC-2021, but upon internal validation established as 23-JAN-2022), orally as prophylaxis (anatomical location was not provided) (expired product administered).  No additional adverse event reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; The patient was administered an expired dose of ROTATEQ; This spontaneous report received from an office manager and refers to a 06-months old patient of unknown gender. The information about patient's pertinent medical history and drug reaction and allergy, and concomitant medications were not reported.  On 15-DEC-2021, the patient was vaccinated with expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (Lot No. 1691302 has been verified to be a valid lot number for [Rotavirus Vaccine, Live, Oral, Pentavalent], expiration date reported as 12-DEC-2021, but upon internal validation established as 23-JAN-2022) (frequency and exact dose were not reported,) as prophylaxis (Expired product administered). No additional AE reported. No PQC reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report received from a pharmacist and refers to a patient of unknown age and gender. The information about patient's pertinent medical history and drug reaction and allergy, and concomitant medications were not reported. On 28-DEC-2021, the patient was vaccinated with expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter lot# S036662 and expiration date 14-NOV-2021 (frequency, route of administration and anatomical site of vaccination,) as prophylaxis (Expired product administered). The reporter stated that, the vaccine did not experience temperature excursion. No additional AE reported. No PQC reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additiona AE; A patient was inadvertently administered expired dose of ROTATEQ; This spontaneous report received from a medical assistance and refers to a patient of unknown age and gender. The information about patient's pertinent medical history and drug reaction and allergy, and concomitant medications were not reported.  On 28-DEC-2021, the patient was inadvertently vaccinated with expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally lot# 1691303 and expiration date 21-DEC-2021 (frequency was not reported,) as prophylaxis (Expired product administered).   No additional AE reported. No PQC reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced blister and pain. On an unknown date, the outcome of the blister was unknown and the outcome of the pain was recovering/resolving. It was unknown if the reporter considered the blister and pain to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter said odd this popped up everything but all the blisters so blessed the patient had the shot or could had been worse. The patient do still had pain but was getting better. The patient said get your shingles shot if you had not. The patient would be getting a booster. Note: as shingles vaccine did not require booster,so here booster indicate to 2nd dose. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain
Clinical narrative: Sick; Sore; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date and was okay with the 1st dose).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and pain. On an unknown date, the outcome of the sickness and pain were unknown.   It was unknown if the reporter considered the sickness and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she was sick and had soreness from the 2nd dose. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got sick; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's dad suffered terribly with shingles).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt sick from it. The patient stated that so much so that he/she was dreaded the second one. The patient also stated that he/she watched his/her dad was suffered terribly with shingles. Nope, did not want to go there if he/she could prevent. The follow-up would not possible as no contact details were available. For 2nd dose tolerance, refer linked case US2021AMR266347, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266347:Different dose
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Dyspnoea, Eye pain, Fatigue
Clinical narrative: pain in the arm; Headache; eye pain; Shortness of breath; Cough; Chills; Flu-like symptoms; Fatigue; Body aches; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix.   On 21st December 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 21st December 2021, 8 hrs after receiving Shingrix, the patient experienced fatigue, general body pain, eye pain, shortness of breath, cough, chills and influenza-like symptoms. On 26th December 2021, the patient experienced headache. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the fatigue, general body pain, eye pain, shortness of breath, cough, chills and influenza-like symptoms were not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the fatigue, general body pain, headache, eye pain, shortness of breath, cough, chills, influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by consumer itself. The patient reported that received second dose of Shingrix  on his right arm. On 26th December 2021, 5 days after vaccination the patient experienced headache. The reporter consented to follow up. .; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR264178:same reporter
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: pain in the arm; Headache; eye pain; Shortness of breath; Cough; Chills; Flu-like symptoms; Fatigue; Body aches; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix.   On 21st December 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 21st December 2021, 8 hrs after receiving Shingrix, the patient experienced fatigue, general body pain, eye pain, shortness of breath, cough, chills and influenza-like symptoms. On 26th December 2021, the patient experienced headache. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the fatigue, general body pain, eye pain, shortness of breath, cough, chills and influenza-like symptoms were not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the fatigue, general body pain, headache, eye pain, shortness of breath, cough, chills, influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by consumer itself. The patient reported that received second dose of Shingrix  on his right arm. On 26th December 2021, 5 days after vaccination the patient experienced headache. The reporter consented to follow up. .; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR264178:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Blood test, Depression, Dermatitis atopic, Dry skin
Clinical narrative: A LITTLE BIT DEPRESSED; PAINFUL SKIN; HAS NOT HAD GOOD SLEEP AT NIGHT; ATOPIC DERMATITIS; ITCHY LIKE CRAZY; DRY SKIN PATCHES; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure, and propranolol for blood pressure.  On APR-2021, the patient experienced atopic dermatitis. On APR-2021, the patient experienced itchy like crazy. On APR-2021, the patient experienced dry skin patches. Laboratory data included: Blood test (NR: not provided) Normal, and Skin biopsy (NR: not provided) atopic dermatitis. On MAY-2021, the patient experienced has not had good sleep at night, and painful skin. On an unspecified date, the patient experienced a little bit depressed. Treatment medications (dates unspecified) included: triamcinolone, diphenhydramine hydrochloride, pramocaine hydrochloride, prednisone, dupilumab, and hydroxyzine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from atopic dermatitis, itchy like crazy, dry skin patches, painful skin, and a little bit depressed, and the outcome of has not had good sleep at night was not reported. This report was non-serious.