chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia, Product dose omission issue
Clinical narrative: 1st dose on 3/16/21 and was told not to take 2nd dose; Had pneumonia; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (Had pneumonia) 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.     Concomitant products included PREDNISOLONE for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PNEUMONIA (Had pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (1st dose on 3/16/21 and was told not to take 2nd dose). At the time of the report, PNEUMONIA (Had pneumonia) outcome was unknown and INTENTIONAL DOSE OMISSION (1st dose on 3/16/21 and was told not to take 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   The patient had pneumonia and didn't know it ended up keeping the pneumonia for months and was told not to get the 2nd dose. patient was now finishing up a 90 prescription of antibiotics and Patient was on Prednisolone drops for one eye and wanted to know if could take 2 dose or need to start over. Company comment: This is a spontaneous case concerning unknown age and gender patient with no medical history reported, who experienced the serious unexpected , according Agency,  event of pneumonia. The event occurred after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable. The case was assessed as serious due to Important medical event, patient reported keeping the pneumonia for months and a 90 prescription of antibiotics per treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning unknown age and gender patient with no medical history reported, who experienced the serious unexpected , according Agency,  event of pneumonia. The event occurred after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable. The case was assessed as serious due to Important medical event, patient reported keeping the pneumonia for months and a 90 prescription of antibiotics per treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: Covid positive after full vaccination series; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after full vaccination series) in a 100-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 03-Jan-2021, the patient experienced COVID-19 (Covid positive after full vaccination series). At the time of the report, COVID-19 (Covid positive after full vaccination series) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: positive (Positive) Tested positive.   No concomitant medications were provided by reporter.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 100 year-old, female patient with no reported medical history, who experienced the non-serious unexpected, according CCDS, AESI of COVID-19. The event occurred after the second dose of mRNA-1273 vaccine, dose date and events date not provided. The outcome of the event was reported as unknown. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 100 year-old, female patient with no reported medical history, who experienced the non-serious unexpected, according CCDS, AESI of COVID-19. The event occurred after the second dose of mRNA-1273 vaccine, dose date and events date not provided. The outcome of the event was reported as unknown. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: Went blind on right eye for 5 minutes; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Went blind on right eye for 5 minutes) 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 UNILATERAL (Went blind on right eye for 5 minutes) (seriousness criterion medically significant). At the time of the report, BLINDNESS UNILATERAL (Went blind on right eye for 5 minutes) had resolved.            No concomitant details were provided by reporter. No treatment details were provided by reporter.  Patient got her sight back about after 5 minutes.  This is a spontaneous case concerning  a female patient of unknown age with no relevant medical history, who experienced the unexpected serious event of Unilateral Blindness. The event occurred approximately on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-439924, US-MODERNATX, INC.-MOD-2022-440018, US-MODERNATX, INC.-MOD-2022-440019 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age with no relevant medical history, who experienced the unexpected serious event of Unilateral Blindness. The event occurred approximately on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. US-MODERNATX, INC.-MOD-2022-439924:MOD22-000708(Reporter first dose)/same reporter different patient US-MODERNATX, INC.-MOD-2022-440018:MOD22-000708(Reporter second dose)/same reporter different patient US-MODERNATX, INC.-MOD-2022-440019:MOD22-000708(Reporter booster dose)/same reporter different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contract Covid after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (contract Covid after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced COVID-19 (contract Covid after vaccination). At the time of the report, COVID-19 (contract Covid after vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported Patient was asking if they can get a booster dose of vaccine as they had contracted COVID-19 earlier.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. The event occurred approximately 7 months after the second dose of mRNA-1273 vaccine, exact date of vaccination not provided. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. The event occurred approximately 7 months after the second dose of mRNA-1273 vaccine, exact date of vaccination not provided. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: tested positive for covid; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032141A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (Patient had received one Johnson&Johnson COVID-19 vaccine dose). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26 (JNJ 78436735).    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 05-Jan-2022, the patient experienced COVID-19 (tested positive for covid). On 31-Dec-2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. At the time of the report, COVID-19 (tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: tested positive for covid (Positive) tested positive for covid.         Concomitant information was not provided. Treatment information was not provided. The patient reported that she feels ok.  State was reported.  Company comment: This is a spontaneous case concerning a 56 year-old, female patient with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. Additionally, interchange of vaccine products was reported in this case since the patient received a dose of Janssen COVID-19 vaccine on an unknown date. The event occurred approximately 5 days after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 56 year-old, female patient with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. Additionally, interchange of vaccine products was reported in this case since the patient received a dose of Janssen COVID-19 vaccine on an unknown date. The event occurred approximately 5 days after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced COVID-19 (I had Covid). At the time of the report, COVID-19 (I had Covid) outcome was unknown. No concomitant medications were reported. No treatment drugs were reported. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. The event occurred approximately 8 months after the second dose of mRNA-1273 vaccine, exact date of vaccination not provided. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. The event occurred approximately 8 months after the second dose of mRNA-1273 vaccine, exact date of vaccination not provided. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: has covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (has covid) 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, 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 (has covid). At the time of the report, COVID-19 (has covid) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.  Company comment: This is a spontaneous case concerning a female patient of unknown age, no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Additional information received included No new information.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age, no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 immunisation.     The patient's past medical history included Recreational drug use and Ectopic pregnancy (one past pregnancy). Concurrent medical conditions included Multigravida, Attention deficit hyperactivity disorder, Type 2 diabetes mellitus, Blood pressure high, Hyperthyroidism and Polycystic ovarian syndrome. Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 immunisation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), LEVOTHYROXINE from 19-Feb-2021 to an unknown date, METFORMIN from 19-Feb-2021 to an unknown date, ATENOLOL from 05-Apr-2021 to an unknown date, BUPROPION HYDROCHLORIDE (BUPROPION HCL ER) from 19-Feb-2021 to an unknown date and ACETYLSALICYLIC ACID (ASPIRIN LOW) from 12-Mar-2021 to an unknown date for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 19-Feb-2021 and the estimated date of delivery was 26-Nov-2021. On 25-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 25-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body mass index: increased (High) increased.         Treatment  medication was not reported. The patient had been pregnant before.   Reporter did not allow further contact
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: He waited more than 36 days between doses; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited more than 36 days between doses) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 047E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HERPES ZOSTER (Shingles). On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited more than 36 days between doses). On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited more than 36 days between doses) had resolved. At the time of the report, HERPES ZOSTER (Shingles) had resolved.            No concomitant medication reported. Patent family doctor gave him medication for the shingles. Patient reported to the Health Department as well.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (restart vaccination series Dose 1: Aug 9 2021, Restart: Dec 16 2021) and OFF LABEL USE (My doctor wanted me to start all over again, I restarted on Dec 16 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069HZ1A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes, PIROXICAM (PAXIL [PIROXICAM]) and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE; PARACETAMOL]) for an unknown indication. On 16-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (restart vaccination series Dose 1: Aug 9 2021, Restart: Dec 16 2021) and OFF LABEL USE (My doctor wanted me to start all over again, I restarted on Dec 16 2021). On 16-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (restart vaccination series Dose 1: Aug 9 2021, Restart: Dec 16 2021) and OFF LABEL USE (My doctor wanted me to start all over again, I restarted on Dec 16 2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information mentioned. Patient could not remember other medications. The patient got her Moderna shot on 9-Aug-2021, after that she had a heart attack. She could not got her second dose, as she was in hospital in coma. Her doctor wanted her to start all over again, she restarted on 16-Dec-2021. This case was linked to MOD-2022-447503 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness). In 2021, PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant product use was reported. The patient after receiving the second dose experienced a sore arm and a little weakness that went away quickly. No treatment information was provided. This case was linked to MOD-2022-448394, MOD-2022-448414 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder pain, Dysphagia, Myalgia, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (He couldn't swallow anything), BLADDER PAIN (His bladder was hurting), URTICARIA (Developed hives all over his body/ hives started on his scalp, thighs and just went everywhere/ hives were getting worse) and MYALGIA (Muscles also started hurting) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination. No Medical History information was reported. On 17-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 DYSPHAGIA (He couldn't swallow anything), URTICARIA (Developed hives all over his body/ hives started on his scalp, thighs and just went everywhere/ hives were getting worse) and MYALGIA (Muscles also started hurting). On 01-Jan-2022, the patient experienced BLADDER PAIN (His bladder was hurting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Dec-2021 for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Dec-2021 for Adverse event, at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) on 01-Jan-2022 for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (He couldn't swallow anything), BLADDER PAIN (His bladder was hurting) and MYALGIA (Muscles also started hurting) outcome was unknown and URTICARIA (Developed hives all over his body/ hives started on his scalp, thighs and just went everywhere/ hives were getting worse) was resolving. No concomitant medications were provided. Treatment medications also included Steroid injection in his butt. On 29-DEC-2021 the patient went to Urgent Care. He conveyed that the hives were getting worse and his bladder was hurting so he went to the Emergency on 01-JAN-2022. The patient stated that Xyzal helped him more and the hives are improving.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (has gotten a full third dose after the first trimester of second pregnancy) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Pregnancy (At 18 weeks pregnant, the baby had to be medically aborted). Concurrent medical conditions included Pregnancy (now past 18 weeks of pregnancy). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-May-2022. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (has gotten a full third dose after the first trimester of second pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (has gotten a full third dose after the first trimester of second pregnancy) had resolved. Not Provided. The patient was previously pregnant when first dose was taken, which resulted in medical abortion at 18 weeks pregnancy. The patient went in for anatomical study late Aug-2021 and the next day, had the medical abortion. A week before everything was fine. The daughter had a different ultrasound a week prior and everything was fine. It happened suddenly that the baby's brain was surrounded in fluid and baby was brain dead. The patient went in for the study and baby was surrounded in fluid. The fetus had a chamber at base of neck that didn't close. Baby's due date was mid Nov-2021. The patient now has gotten a full third dose after the first trimester of second pregnancy and experienced depression after abortion but was now doing okay. The patient is now on an unspecified antidepressant and undergoing psychotherapy. This case was linked to MOD-2021-042890 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: felt achy; chills; feverish to the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy), CHILLS (chills) and PYREXIA (feverish to the second shot.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (felt achy), CHILLS (chills) and PYREXIA (feverish to the second shot.). In 2021, PAIN (felt achy), CHILLS (chills) and PYREXIA (feverish to the second shot.) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Malaise
Clinical narrative: She also had no appetite; didn't feel really good; diarrhea; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (She also had no appetite), MALAISE (didn't feel really good), DIARRHOEA (diarrhea) and DIZZINESS (dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (She had heart problems for several years.). Concomitant products included PROPAFENONE, AMLODIPINE and ESTRADIOL (ESTROGEN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DECREASED APPETITE (She also had no appetite), MALAISE (didn't feel really good), DIARRHOEA (diarrhea) and DIZZINESS (dizzy). In February 2021, MALAISE (didn't feel really good), DIARRHOEA (diarrhea) and DIZZINESS (dizzy) had resolved. At the time of the report, DECREASED APPETITE (She also had no appetite) outcome was unknown.        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 mentioned that she doesn't have her female parts which have been going on for several years. Concomitant medications include anti-depressant medications. For dizziness she just laid down. No treatment medications were provided by the reporter.   This case was linked to MOD-2022-448789 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: She also had no appetite; didn't feel really good; diarrhea; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (She also had no appetite), MALAISE (didn't feel really good), DIARRHOEA (diarrhea) and DIZZINESS (dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (She had heart problems for several years.). Concomitant products included PROPAFENONE, AMLODIPINE and ESTRADIOL (ESTROGEN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DECREASED APPETITE (She also had no appetite), MALAISE (didn't feel really good), DIARRHOEA (diarrhea) and DIZZINESS (dizzy). In February 2021, MALAISE (didn't feel really good), DIARRHOEA (diarrhea) and DIZZINESS (dizzy) had resolved. At the time of the report, DECREASED APPETITE (She also had no appetite) outcome was unknown.        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 mentioned that she doesn't have her female parts which have been going on for several years. Concomitant medications include anti-depressant medications. For dizziness she just laid down. No treatment medications were provided by the reporter.   This case was linked to MOD-2022-448789 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Malaise
Clinical narrative: No appetite; Did not feel really good; Diarrhea; Dizzy; Bad stomach problems and that she felt crummy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Bad stomach problems and that she felt crummy), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Did not feel really good), DIARRHOEA (Diarrhea) and DIZZINESS (Dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (going on for several years). Concomitant products included PROPAFENONE and AMLODIPINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (Bad stomach problems and that she felt crummy). On an unknown date, the patient experienced DECREASED APPETITE (No appetite), FEELING ABNORMAL (Did not feel really good), DIARRHOEA (Diarrhea) and DIZZINESS (Dizzy). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) ongoing since an unknown date for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Bad stomach problems and that she felt crummy) had not resolved and DECREASED APPETITE (No appetite), FEELING ABNORMAL (Did not feel really good), DIARRHOEA (Diarrhea) and DIZZINESS (Dizzy) outcome was unknown.            Patient was taking anti depressant medication and low dose estrogen as concomitant medications.  Patient mentioned that she does not have her female parts.For dizziness patient just laid down.   This case was linked to MOD-2022-448767 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: No appetite; Did not feel really good; Diarrhea; Dizzy; Bad stomach problems and that she felt crummy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Bad stomach problems and that she felt crummy), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Did not feel really good), DIARRHOEA (Diarrhea) and DIZZINESS (Dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (going on for several years). Concomitant products included PROPAFENONE and AMLODIPINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (Bad stomach problems and that she felt crummy). On an unknown date, the patient experienced DECREASED APPETITE (No appetite), FEELING ABNORMAL (Did not feel really good), DIARRHOEA (Diarrhea) and DIZZINESS (Dizzy). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) ongoing since an unknown date for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Bad stomach problems and that she felt crummy) had not resolved and DECREASED APPETITE (No appetite), FEELING ABNORMAL (Did not feel really good), DIARRHOEA (Diarrhea) and DIZZINESS (Dizzy) outcome was unknown.            Patient was taking anti depressant medication and low dose estrogen as concomitant medications.  Patient mentioned that she does not have her female parts.For dizziness patient just laid down.   This case was linked to MOD-2022-448767 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: arm soreness; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and FATIGUE (fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Dust allergy, Seasonal allergy, Hypothyroidism and Acne. Concomitant products included SPIRONOLACTONE from 2019 to an unknown date for Acne, LEVOTHYROXINE SODIUM (SYNTHYROID) from 2012 to an unknown date for Hypothyroidism.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2022-445194 (Patient Link).
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old was given a moderna shot by mistake; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old was given a moderna shot by mistake) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old was given a moderna shot by mistake). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old was given a moderna shot by mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Insomnia, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), ERYTHEMA (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red.), PRURITUS (It started on my arm first. Swollen, red and itchy), INSOMNIA (No sleep at night) and RASH (Rashes are all over my body, on and off) 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 16-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 PERIPHERAL SWELLING (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), ERYTHEMA (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), PRURITUS (It started on my arm first. Swollen, red and itchy), INSOMNIA (No sleep at night), RASH (Rashes are all over my body, on and off) and HYPERSENSITIVITY (allergy symptoms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of Three times a day and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Itching, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), ERYTHEMA (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), INSOMNIA (No sleep at night), RASH (Rashes are all over my body, on and off) and HYPERSENSITIVITY (allergy symptoms) outcome was unknown and PRURITUS (It started on my arm first. Swollen, red and itchy) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After the [patient took booster shot, the patient had allergy symptoms. It started on my arm first swollen, red and itchy. After 2 weeks rashes are all over body on and off first and recently finger and feet toes are swollen and red. The patient never seen this continuing rash on body on and off in life and since the first Moderna vaccine the patient had itchy and red arm on the injected site after 7 days for first shot. The patient took Benadryl three times a day when the itchiness made no sleep at night and tried cetirizine, still itchy. Benadryl works better but it makes drowsy and need to take it 3 times a day to ease the itchy feeling. This case was linked to MOD-2022-449535 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Follow Up received and added events, Suspect drug start date, and treatment medications.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), ERYTHEMA (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red.), PRURITUS (It started on my arm first. Swollen, red and itchy), INSOMNIA (No sleep at night) and RASH (Rashes are all over my body, on and off) 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 16-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 PERIPHERAL SWELLING (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), ERYTHEMA (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), PRURITUS (It started on my arm first. Swollen, red and itchy), INSOMNIA (No sleep at night), RASH (Rashes are all over my body, on and off) and HYPERSENSITIVITY (allergy symptoms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of Three times a day and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Itching, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), ERYTHEMA (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), INSOMNIA (No sleep at night), RASH (Rashes are all over my body, on and off) and HYPERSENSITIVITY (allergy symptoms) outcome was unknown and PRURITUS (It started on my arm first. Swollen, red and itchy) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After the [patient took booster shot, the patient had allergy symptoms. It started on my arm first swollen, red and itchy. After 2 weeks rashes are all over body on and off first and recently finger and feet toes are swollen and red. The patient never seen this continuing rash on body on and off in life and since the first Moderna vaccine the patient had itchy and red arm on the injected site after 7 days for first shot. The patient took Benadryl three times a day when the itchiness made no sleep at night and tried cetirizine, still itchy. Benadryl works better but it makes drowsy and need to take it 3 times a day to ease the itchy feeling. This case was linked to MOD-2022-449535 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Follow Up received and added events, Suspect drug start date, and treatment medications.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (side affects after the booster shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side affects after the booster shot). At the time of the report, VACCINATION COMPLICATION (side affects after the booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 11 Doses administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the Moderna vaccine put out of the freezer on 01-DEC-2021 and placed in the refrigerator, so it was not supposed to be used beyond 31-DEC-2021 but 11 doses were administered on 05-JAN-2022. And also stated that the vial did not undergo any temperature excursions.  Concomitant medication information was not reported Treatment information was not reported
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 11 Doses administered after 30 day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30 day Use By Date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30 day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30 day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. It was reported that the Moderna vaccine put out of the freezer on 01-Dec-2021and placed in the refrigerator, so it was not supposed to be used beyond 31-Dec-2021 but 11 doses were administered on 05-Jan-2022.