chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest pain, Chills, Feeling cold, Headache
Clinical narrative: I was feeling fine until later in the evening. I got really cold with shivers that only a really warm ten minute shower helped. I started to have a massive headache and sharp random aches through my body. I took my temperature and it ranged between 99.9-101.7. I drank lots of water because I suddenly for so thirsty even though I?d already had 80+ ounces of water today. The center of my chest hurt briefly and it was hard to get comfy.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Thirst
Clinical narrative: I was feeling fine until later in the evening. I got really cold with shivers that only a really warm ten minute shower helped. I started to have a massive headache and sharp random aches through my body. I took my temperature and it ranged between 99.9-101.7. I drank lots of water because I suddenly for so thirsty even though I?d already had 80+ ounces of water today. The center of my chest hurt briefly and it was hard to get comfy.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives started on lower back and chest/neck, still persisting. It has been a month now. It has spread to lower stomach, thighs, eyes, full back, armpits and often flares-up in the evening. I used Benadryl one time, hives subdued but returned within 24 hours.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling, sometime burning in my hands and from the knee down to the bottoms of my feet. It has been increasing over the past month.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pollakiuria
Clinical narrative: Body aches starting around 9:00 pm. Severe chills starting at 11:00 pm lasting through night. Excessive urination starting at 12:00 am 12/29 every hour. Severe headache starting at 2:00 am (not able to control with Tylenol).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Peripheral swelling, Vaccination site paraesthesia
Clinical narrative: I felt tingling in my left arm at the injection site; it was swollen under arm.; I felt tired; had chills; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PARAESTHESIA (I felt tingling in my left arm at the injection site), PERIPHERAL SWELLING (it was swollen under arm.), FATIGUE (I felt tired) and CHILLS (had chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE PARAESTHESIA (I felt tingling in my left arm at the injection site), PERIPHERAL SWELLING (it was swollen under arm.), FATIGUE (I felt tired) and CHILLS (had chills). At the time of the report, VACCINATION SITE PARAESTHESIA (I felt tingling in my left arm at the injection site), PERIPHERAL SWELLING (it was swollen under arm.), FATIGUE (I felt tired) and CHILLS (had chills) 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 mediations were reported.    This case was linked to MOD-2021-403270, MOD-2021-403276 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: My arm was sore; I had a fever of 102F for 24hrs.; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (My arm was sore) and PYREXIA (I had a fever of 102F for 24hrs.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore) and PYREXIA (I had a fever of 102F for 24hrs.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (My arm was sore) and PYREXIA (I had a fever of 102F for 24hrs.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    This case was linked to MOD-2021-403035 (Patient Link).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: shots were not so hot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth 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 injection site warmth. On an unknown date, the outcome of the injection site warmth was unknown.   It was unknown if the reporter considered the injection site warmth to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The shots were not so hot.  For tolerance of 2nd dose, refer case US2021AMR263517. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR263517:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot, and then got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles 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 shot did not help.  The patient had the shot, and then got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I got one shot I didn't know it was supposed to be two shots; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient for himself/herself. The age at vaccination was not applicable for this report. The patient never had shingles, but patient got one shot patient did not know it was supposed to be two shots. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/recieved the shot, still got shingles; shingles, settled in his left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's father. The age at vaccination was not reported. The patient received a shingle shot and still got shingles. The reporter reported that they were horrible and they settled in his left eye. Shingles took several months for him to overcome. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (SHINGRIX) for prophylaxis. Previously administered products included SHINGRIX (1st dose received 2 years ago from reporting date).  On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient never got the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Repeat dose of Boostrix given 6 months apart; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3JS9E, expiry date 18th March 2024) for prophylaxis.   Previously administered products included Boostrix (received 1st dose on 2nd May 2011) and Boostrix (received 2nd dose over a 9 years later on 23rd June 2021).   On 22nd December 2021, the patient received the 3rd dose of Boostrix. On 22nd December 2021, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter stated that the patient received a repeat dose of Boostrix given 6 months apart, which led to extra dose administered. The health care professional had given consent for safety team to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a white, not Hispanic or Latino male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, 1 total administered on left arm on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021, the patient started having chills and fever up to 102 F, also complained of sore throat, head congestion and upset stomach that appeared a day after. On 26-DEC-2021, the patient went to see his Health Care Professional (HCP) on 26-DEC-2021, where he was evaluated and Polymerase chain reaction (PCR) was performed, resulting positive (confirmed covid-19 infection and confirmed clinical vaccination failure). Laboratory data included: Body temperature (NR: not provided) 102 F. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000208844.; Sender's Comments: V0 20211258412-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via social media concerned a 34 year old male of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered  for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  It was reported that, "neighbor's grandson (patient) died on day 8". The patient died from an unknown cause of death on an unspecified date (dose number in series was 1). It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event died was fatal. This report was serious (Death).; Sender's Comments: V0- 20211259188- covid-19 vaccine ad26.cov2.s -Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: A HUGE REACTION THAT LASTED OVER TWO WEEKS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: allergies, and other pre-existing medical conditions included: The patient experienced unspecified reaction due to unspecified medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a huge reaction that lasted over two weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a huge reaction that lasted over two weeks. This report was non-serious.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 patients received the booster after 12 hours of puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received the booster after 12 hours of puncture) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 040A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received the booster after 12 hours of puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received the booster after 12 hours of puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is taking other medication. No concomitant drugs were reported. No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 0.5mL administered for booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (0.5mL administered for booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (0.5mL administered for booster dose). On 30-Nov-2021, ACCIDENTAL OVERDOSE (0.5mL administered for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Patient took Moderna vaccine on 11-Nov-2021 at 9.11 am. No concomitant information was reported. No treatment information was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Vaccination site pain, Vomiting
Clinical narrative: Vomiting; On the lower back, on the side where she got the injection/hurts right now; Completely lost her appetite; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), VACCINATION SITE PAIN (On the lower back, on the side where she got the injection/hurts right now) and DECREASED APPETITE (Completely lost her appetite) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 045A21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, 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 VOMITING (Vomiting), VACCINATION SITE PAIN (On the lower back, on the side where she got the injection/hurts right now) and DECREASED APPETITE (Completely lost her appetite). At the time of the report, VOMITING (Vomiting), VACCINATION SITE PAIN (On the lower back, on the side where she got the injection/hurts right now) and DECREASED APPETITE (Completely lost her appetite) outcome was unknown.            No Concomitants and Treatment medication were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (1st dose-big red blotches on her right arm where the injection went in) and VACCINATION SITE RASH (1st dose-big red blotches on her right arm where the injection went in) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (1st dose-big red blotches on her right arm where the injection went in) and VACCINATION SITE RASH (1st dose-big red blotches on her right arm where the injection went in). At the time of the report, VACCINATION SITE ERYTHEMA (1st dose-big red blotches on her right arm where the injection went in) and VACCINATION SITE RASH (1st dose-big red blotches on her right arm where the injection went in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-403034, MOD-2021-403065 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered  beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) 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 medication was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: felt achy; sore left injection site arm; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (felt tired) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C214 and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PAIN (felt achy), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (felt tired). At the time of the report, PAIN (felt achy), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (felt tired) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-428269 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness, dizziness lasted for 3 weeks, dizziness subsided; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness, dizziness lasted for 3 weeks, dizziness subsided) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness, dizziness lasted for 3 weeks, dizziness subsided). At the time of the report, DIZZINESS (dizziness, dizziness lasted for 3 weeks, dizziness subsided) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash; 4x4 inches red area; Delayed right arm swelling 5-7 days after the dose; Raised with swelling; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (Rash), VACCINATION SITE ERYTHEMA (4x4 inches red area), VACCINATION SITE SWELLING (Delayed right arm swelling 5-7 days after the dose) and VACCINATION SITE RASH (Raised with swelling) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (4x4 inches red area), VACCINATION SITE SWELLING (Delayed right arm swelling 5-7 days after the dose) and VACCINATION SITE RASH (Raised with swelling). On an unknown date, the patient experienced RASH (Rash). On 07-Feb-2021, VACCINATION SITE SWELLING (Delayed right arm swelling 5-7 days after the dose) had resolved. At the time of the report, RASH (Rash), VACCINATION SITE ERYTHEMA (4x4 inches red area) and VACCINATION SITE RASH (Raised with swelling) 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.   Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient received second dose of vaccine on an unknown date.   This case was linked to MOD-2021-255428 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant follow up received on 12 Jul 2021, event rash and second dose details updated.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Vaccination site pain, vaccination site erythema and vaccination site swelling are consistent with the known safety profile of mRNA-1273.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Chills, Diarrhoea, Headache
Clinical narrative: Pain in the bones; Headache; A lot of chills; Fever; Nausea; Diarrhea; Stomachache; J&J Covid-19 vaccine as primary vaccination series (in March).; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache), BONE PAIN (Pain in the bones), HEADACHE (Headache) and NAUSEA (Nausea) in a 50-year-old male patient 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 was provided by the reporter.  Previously administered products included for COVID-19 vaccination: J&J Covid-19 vaccine in March 2021. Past adverse reactions to the above products included No adverse reaction with J&J Covid-19 vaccine. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and LOSARTAN for an unknown indication.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (J&J Covid-19 vaccine as primary vaccination series (in March).). In November 2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and NAUSEA (Nausea). On 27-Nov-2021, the patient experienced BONE PAIN (Pain in the bones), HEADACHE (Headache), CHILLS (A lot of chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (J&J Covid-19 vaccine as primary vaccination series (in March).) had resolved. On 28-Nov-2021, BONE PAIN (Pain in the bones), CHILLS (A lot of chills) and PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.            Concomitant drugs included  diabetes medication and anxiety medications.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea, Pyrexia
Clinical narrative: Pain in the bones; Headache; A lot of chills; Fever; Nausea; Diarrhea; Stomachache; J&J Covid-19 vaccine as primary vaccination series (in March).; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache), BONE PAIN (Pain in the bones), HEADACHE (Headache) and NAUSEA (Nausea) in a 50-year-old male patient 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 was provided by the reporter.  Previously administered products included for COVID-19 vaccination: J&J Covid-19 vaccine in March 2021. Past adverse reactions to the above products included No adverse reaction with J&J Covid-19 vaccine. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and LOSARTAN for an unknown indication.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (J&J Covid-19 vaccine as primary vaccination series (in March).). In November 2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and NAUSEA (Nausea). On 27-Nov-2021, the patient experienced BONE PAIN (Pain in the bones), HEADACHE (Headache), CHILLS (A lot of chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (J&J Covid-19 vaccine as primary vaccination series (in March).) had resolved. On 28-Nov-2021, BONE PAIN (Pain in the bones), CHILLS (A lot of chills) and PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.            Concomitant drugs included  diabetes medication and anxiety medications.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: dose administered following potential temperature excursion; expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered following potential temperature excursion) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose administered following potential temperature excursion) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, PRODUCT STORAGE ERROR (dose administered following potential temperature excursion) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist calls to report they have some Moderna vaccines that went out of range on 01DEC2021. Pharmacist says he did administer 3 doses to 3 patients from the vials but was not sure if it was at the time of the excursion. Pharmacist was not at the pharmacy at the time of their call and did not have details to provide at the time of the call for a temperature excursion escalation. Pharmacist took case number and temperature excursion tool and depending on the response from the tool will collect additional information
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Chest pain, Chills
Clinical narrative: Severe pain under the left arm in the armpit. Pain is radiating down left arm close to the elbow as well as the upper left back and left chest area. Limited movement in left arm.    Fever Chills  Body aches
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: Severe pain under the left arm in the armpit. Pain is radiating down left arm close to the elbow as well as the upper left back and left chest area. Limited movement in left arm.    Fever Chills  Body aches
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Daily headaches since booster shot. Over two weeks of headaches since being boosted. All other ?typical? symptoms lasted a few days and went away. Headaches have persisted.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Dyspnoea
Clinical narrative: Weakness, body aches, feverish, headache, chills, bronchial cough, severe sore throat, short breath, severe congestion. Treatment: OTC Mucinex, vicks vapor rub, lozenges, antibiotics, steroids, inhaler. Also taking home remedy: ginger, garlic, cayenne pepper, turmeric, thyme, honey, lemon concoction. Symptoms timeline:  12/17: too tired, 12/18: just off, 12/19: headache, 12/20: mild cold symptoms, 12/21-22-23: body ache, feverish, chills, 12/24-28: severe sore throat, congestion, cough. Rx meds started 12/28
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Nasopharyngitis, Oropharyngeal pain, Pain
Clinical narrative: Weakness, body aches, feverish, headache, chills, bronchial cough, severe sore throat, short breath, severe congestion. Treatment: OTC Mucinex, vicks vapor rub, lozenges, antibiotics, steroids, inhaler. Also taking home remedy: ginger, garlic, cayenne pepper, turmeric, thyme, honey, lemon concoction. Symptoms timeline:  12/17: too tired, 12/18: just off, 12/19: headache, 12/20: mild cold symptoms, 12/21-22-23: body ache, feverish, chills, 12/24-28: severe sore throat, congestion, cough. Rx meds started 12/28
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Weakness, body aches, feverish, headache, chills, bronchial cough, severe sore throat, short breath, severe congestion. Treatment: OTC Mucinex, vicks vapor rub, lozenges, antibiotics, steroids, inhaler. Also taking home remedy: ginger, garlic, cayenne pepper, turmeric, thyme, honey, lemon concoction. Symptoms timeline:  12/17: too tired, 12/18: just off, 12/19: headache, 12/20: mild cold symptoms, 12/21-22-23: body ache, feverish, chills, 12/24-28: severe sore throat, congestion, cough. Rx meds started 12/28
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reported feeling that he was going to faint, had anxiety, and was sweating.  Rescue called and he was evaluated. All vitals ok and patient recovered.  He left with his father.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reported feeling that he was going to faint, had anxiety, and was sweating.  Rescue called and he was evaluated. All vitals ok and patient recovered.  He left with his father.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Syringe issue
Clinical narrative: Systemic: Patient given vaccine with ml/25G x 1inch safety needle. During administration, needle detached from syringe, some vaccine leaked out of syringe, Mild, Additional Details: Alerted NP who spoke with collaborating physician. Advised to not administer anymore vaccine today & schedule for second dose. Patient aware and agreed with decision made.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: face swell up; throat swell up; dizzied; kind of weak; couldn't breath; felt super super estrange , cant describe how weird it was,he didn't felt good,but was stabilized, but felt like crap; later that night chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swell up), PHARYNGEAL SWELLING (throat swell up), DIZZINESS (dizzied), ASTHENIA (kind of weak) and DYSPNOEA (couldn't breath) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concomitant products included IRBESARTAN for Blood pressure.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced SWELLING FACE (face swell up), PHARYNGEAL SWELLING (throat swell up), DIZZINESS (dizzied), ASTHENIA (kind of weak), DYSPNOEA (couldn't breath), FEELING ABNORMAL (felt super super estrange , cant describe how weird it was,he didn't felt good,but was stabilized, but felt like crap), CHILLS (later that night chills) and HEADACHE (headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 19-Nov-2021, CHILLS (later that night chills) and HEADACHE (headaches) had resolved. At the time of the report, SWELLING FACE (face swell up), PHARYNGEAL SWELLING (throat swell up), DIZZINESS (dizzied), ASTHENIA (kind of weak), DYSPNOEA (couldn't breath) and FEELING ABNORMAL (felt super super estrange , cant describe how weird it was,he didn't felt good,but was stabilized, but felt like crap) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, Heart rate increased: high (High) fast heart beat. On an unknown date, SARS-CoV-2 test: positive (Positive) got covid19..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant includes blood pressure medicine.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Non significant follow up received; Sender's Comments: Case routed out of MR workflow as medical review is not required per new CMOP process for non serious cases which are not AESI and LOE
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Pharyngeal swelling, SARS-CoV-2 test, Swelling face
Clinical narrative: face swell up; throat swell up; dizzied; kind of weak; couldn't breath; felt super super estrange , cant describe how weird it was,he didn't felt good,but was stabilized, but felt like crap; later that night chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swell up), PHARYNGEAL SWELLING (throat swell up), DIZZINESS (dizzied), ASTHENIA (kind of weak) and DYSPNOEA (couldn't breath) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concomitant products included IRBESARTAN for Blood pressure.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced SWELLING FACE (face swell up), PHARYNGEAL SWELLING (throat swell up), DIZZINESS (dizzied), ASTHENIA (kind of weak), DYSPNOEA (couldn't breath), FEELING ABNORMAL (felt super super estrange , cant describe how weird it was,he didn't felt good,but was stabilized, but felt like crap), CHILLS (later that night chills) and HEADACHE (headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 19-Nov-2021, CHILLS (later that night chills) and HEADACHE (headaches) had resolved. At the time of the report, SWELLING FACE (face swell up), PHARYNGEAL SWELLING (throat swell up), DIZZINESS (dizzied), ASTHENIA (kind of weak), DYSPNOEA (couldn't breath) and FEELING ABNORMAL (felt super super estrange , cant describe how weird it was,he didn't felt good,but was stabilized, but felt like crap) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, Heart rate increased: high (High) fast heart beat. On an unknown date, SARS-CoV-2 test: positive (Positive) got covid19..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant includes blood pressure medicine.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Non significant follow up received; Sender's Comments: Case routed out of MR workflow as medical review is not required per new CMOP process for non serious cases which are not AESI and LOE
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Lymph node pain, Lymphadenopathy, Tenderness
Clinical narrative: tenderness in the armpit; tenderness in the side of my breast where lymph nodes are; lymph node reaction after 2 months post 2nd dose,swollen lymph nodes; the lymph nodes under her right arm have been tender & a tiny bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness in the armpit), BREAST TENDERNESS (tenderness in the side of my breast where lymph nodes are), LYMPHADENOPATHY (lymph node reaction after 2 months post 2nd dose,swollen lymph nodes) and LYMPH NODE PAIN (the lymph nodes under her right arm have been tender & a tiny bit swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 026D21A) for COVID-19 vaccination.     Family history included Cancer since an unknown date.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-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 TENDERNESS (tenderness in the armpit), BREAST TENDERNESS (tenderness in the side of my breast where lymph nodes are), LYMPHADENOPATHY (lymph node reaction after 2 months post 2nd dose,swollen lymph nodes) and LYMPH NODE PAIN (the lymph nodes under her right arm have been tender & a tiny bit swollen). At the time of the report, TENDERNESS (tenderness in the armpit), BREAST TENDERNESS (tenderness in the side of my breast where lymph nodes are) and LYMPHADENOPATHY (lymph node reaction after 2 months post 2nd dose,swollen lymph nodes) had not resolved and LYMPH NODE PAIN (the lymph nodes under her right arm have been tender & a tiny bit swollen) outcome was unknown.            No concomitant product and treatment medications was reported. It was reported that patient had mammogram & a doctors appointment scheduled for next week.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow-up information contains additional event Lymph node pain, updated medical history and drug dosage information.; Sender's Comments: Case routed out of MR workflow as medical review is not required per new investigative process for non serious cases which are not AESI and LOE