chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss approximately two months after her second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 31-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Single), administration date: Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "hair loss approximately two months after her second vaccine". The event "hair loss approximately two months after her second vaccine" required physician office visit. Therapeutic measures were taken as a result of alopecia.  Additional information: Reporter reported that her daughter had been to an endocrinologist, a dermatologist who specializes in hair loss with a hair and scalp fellowship, and an immunological dermatologist, for the purpose of finding out what was going on with the hair loss. She stated that her daughter tried quite a few things, but nothing seems be working. She stated that her daughter tried vitamins and nutritional supplements mainly, and she took some iron supplements and B12 supplements. NDC/LOT/EXP: Unknown for the B12 and iron supplements that the patient took. She stated that she took those only after the hair loss for the purpose of trying to help the hair loss. She says she lives in a different state, so she doesn't know the dosage her daughter took, only that it was within recommended dosing. Reporter reported that her daughter started to notice the hair loss approximately two months after her second vaccine, and noticed it increased about two months after the third vaccination. She stated that it got worse after the third vaccination, and doesn't seem to have slowed much, between that it had waxed and waned.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "controlled high BP" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown that Other medication in 2weeks. Anti viral details product=COVID 19; Treatment start date was 27Apr2022, Treatment stop date was 02May2022, Lot number was FY5656.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: energy increase; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ENERGY INCREASED (non-serious), outcome "unknown", described as "energy increase".  Additional information: The reporter reports that after receiving all four doses of the Pfizer COVID 19 Vaccine he experienced an energy increase that lasted a day. reports that his neighbor also experienced an energy increase after his vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Vaccination site pain
Clinical narrative: Soreness at injection site about 5 hours after injection; Chills; joint aches; headache about 10 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 11:15 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa and ceftan based antibiotics" (unspecified if ongoing), notes: Known allergies: sulfa and ceftan based antibiotics. Concomitant medication(s) included: NASONEX; ESOMEPRAZOLE; LORAZEPAM; CENTRUM SILVER +50. Past drug history included: Sulfa and ceftan based antibiotics, reaction(s): "Known allergies: sulfa and ceftan based antibiotics", notes: Known allergies: sulfa and ceftan based antibiotics. Vaccination history included: Bnt162b2 (Dose 1, Lot No.: EL3247, Anatomical Location: Arm left), for COVID-19 immunization; Bnt162b2 (Dose 2, Lot No.: EP6955, Anatomical Location: Arm left), for COVID-19 immunization; Bnt162b2 (Dose 3, Lot No.: FH8027, Anatomical Location: Arm left), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 04May2022, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 04May2022, outcome "recovering", described as "Soreness at injection site about 5 hours after injection"; HEADACHE (non-serious) with onset 04May2022, outcome "recovering", described as "headache about 10 hours"; ARTHRALGIA (non-serious) with onset 04May2022, outcome "recovering", described as "joint aches". Therapeutic measures were not taken as a result of vaccination site pain, chills, arthralgia, headache. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received Nasonex, Esomeprazole, Lorazepam, Centrum Silver within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with Covid-19 and since the vaccination, the patient has not been tested for COVID-19.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (COMIRNATY), on 26Jan2021 at 12:00 as dose 1, single (Lot number: EN5318), on 16Feb2021 at 12:00 as dose 2, single (Lot number: EN5318), on 01Oct2021 at 09:30 as dose 3 (booster), single (Lot number: EW0217) and on 08Apr2022 at 15:15 as dose 4 (booster), single (Lot number: FH2048) at the age of 55 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05May2022 at 23:00, outcome "unknown", COVID-19 (medically significant) with onset 05May2022 at 23:00, outcome "recovering" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Negative, notes: Covid test type post vaccination: Nasal Swab; (05May2022) Positive, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical course includes the patient did not receive vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Diabetes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Negative; positive; Negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical Course: Received call from consumer who bought product from Pfizer Paxlovid for the COVID-19 virus. He got phone call from Pfizer and said Reference # He took Paxlovid for 5 days. Somebody called him back. He clarified that he had just left a message for medical information and had not completed a safety report before. He then stated his wife tested positive and took the pills also. Separate report completed for her. In Feb (year not provided), they got COVID-19 shots. They got Pfizer 2 shots and the booster and then everything was ok and then his wife went to away and they were tested when they get out of the plane and ship. She came back and got tested in withheld and came back to withheld. 4-5 days after that she felt funny and went to the drug store and bought a home testing kit. Hers was positive and his was negative. They don't know how she got it. He was surprised because they got the 2 shots and the booster. She wore the mask. He then asked what is the use of taking the shots. She took the 5 pills and wants to know what was the next step. He took them because he did not want to take any chances and thought it will not hurt him to take the Paxlovid. On his, it tested negative and the next day positive and the next day negative. He did not know what to make of it. He was an old man and doesn't have time to talk. He did not wish to complete report on himself or his wife and requested to be transferred to have his questions answered. No further details provided. The event of disconnection. Description of complaint: Took 2 Pfizer COVID vaccines and the booster and tested positive for COVID virus. On his, it tested negative and the next day positive and the next day negative. He did not know what to make of it. He did not wish to complete report. No further details provided. Product strength and count size dispensed: not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: Fm0698) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing), notes: other medical history: Crohn's. Concomitant medication(s) included: MERCAPTOPURINE, start date: 01Apr2017. Past drug history included: Cipro, reaction(s): "Allergy: Cipro", notes: known allergies: Cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (27Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Paxlovid rebound. Tested negative at end of course of drug. 3. Days later symptoms returned, stronger than initially and with a positive antigen test.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: 2 dose: pain in lungs for 24 hours after vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Lot number: EN6201) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seafood" (unspecified if ongoing), notes: Known allergies : Seafood, shellfish, pineapple; "shellfish" (unspecified if ongoing), notes: Known allergies : Seafood, shellfish, pineapple; "pineapple" (unspecified if ongoing), notes: Known allergies : Seafood, shellfish, pineapple. There were no concomitant medications. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: FK4175, Location of injection: Arm Left, tightness of chest and pain in lungs for 28 hours), administration date: Jan2021, when the patient was 23 years old, for COVID-19 Immunization, reaction(s): "tightness of chest"; Bnt162b2 (Dose Number: 1, Batch/Lot No: FK4175, Location of injection: Arm Left, tightness of chest and pain in lungs for 28 hours), administration date: Jan2021, when the patient was 23 years old, for COVID-19 Immunization, reaction(s): "pain in lungs".  The following information was reported: PULMONARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "2 dose: pain in lungs for 24 hours after vaccine".  Additional Information: No other medications in two weeks. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Illness
Clinical narrative: ST arthralgias; Sick; Cough; Fatigue; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, prev dose lot number: EL3247), administration date: 28Jan2021, when the patient was 39-year-old, for Covid-19 immunization; BNT162b2 (Dose: 02, prev dose lot number: EL3247), administration date: 18Feb2021, when the patient was 39-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 28Apr2022, outcome "unknown"; COUGH (non-serious) with onset 28Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 28Apr2022, outcome "unknown"; ARTHRALGIA (non-serious) with onset 28Apr2022, outcome "unknown", described as "ST arthralgias"; ILLNESS (non-serious) with onset 28Apr2022, outcome "unknown", described as "Sick". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of arthralgia, illness, cough, fatigue, chills.  Additional information: The patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: Unknown. Since the vaccination, the patient had been tested for COVID-19. COVID test post vaccination: covid test type post vaccination: Unknown. COVID test name post vaccination: Home Ag.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: ST arthralgias; Sick; Cough; Fatigue; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, prev dose lot number: EL3247), administration date: 28Jan2021, when the patient was 39-year-old, for Covid-19 immunization; BNT162b2 (Dose: 02, prev dose lot number: EL3247), administration date: 18Feb2021, when the patient was 39-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 28Apr2022, outcome "unknown"; COUGH (non-serious) with onset 28Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 28Apr2022, outcome "unknown"; ARTHRALGIA (non-serious) with onset 28Apr2022, outcome "unknown", described as "ST arthralgias"; ILLNESS (non-serious) with onset 28Apr2022, outcome "unknown", described as "Sick". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of arthralgia, illness, cough, fatigue, chills.  Additional information: The patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: Unknown. Since the vaccination, the patient had been tested for COVID-19. COVID test post vaccination: covid test type post vaccination: Unknown. COVID test name post vaccination: Home Ag.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Their mother died days after the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Their mother died days after the first shot". The date and cause of death for the patient were unknown.  Subject: Patient Assistance. Customer Verbatim: Is it ok for our children to get the COVID shot now that results show a high risk of serious side effects on children getting the shot? Their mother died days after the first shot. She was 30 yrs of age, healthy, energetic, great mom and wife. Now she is dead and the kids are motherless. Will the kids die too if the get the pfizer shot?.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Their mother died days after the first shot
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Injection site swelling, Nausea, Somnolence
Clinical narrative: Redness, swelling at injection site, immediate  15 x7 cms , 5days Nausea & light headedness ,sleepiness ,  next day x 36 hours Full recovery by 8th May
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation reaction
Clinical narrative: Suffered from more side effects with the booster than with the primary series; Experienced chills; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Suffered from more side effects with the booster than with the primary series) and CHILLS (Experienced chills) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Suffered from more side effects with the booster than with the primary series) and CHILLS (Experienced chills). At the time of the report, IMMUNISATION REACTION (Suffered from more side effects with the booster than with the primary series) and CHILLS (Experienced chills) outcome was unknown.            No concomitant medication was reported. No treatment medications was reported.   This case was linked to MOD-2022-560211 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Emotional distress, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: dry heaves; quite in distress; pain on right leg between the calf and shin; fever - 99.5F; Her whole body hurts and she's just lying on the couch; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), EMOTIONAL DISTRESS (quite in distress), PAIN IN EXTREMITY (pain on right leg between the calf and shin), PYREXIA (fever - 99.5F) and MYALGIA (Her whole body hurts and she's just lying on the couch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gastroesophageal reflux. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Gastroesophageal reflux.    On 05-May-2022 at 6:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced RETCHING (dry heaves), EMOTIONAL DISTRESS (quite in distress), PAIN IN EXTREMITY (pain on right leg between the calf and shin), PYREXIA (fever - 99.5F) and MYALGIA (Her whole body hurts and she's just lying on the couch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RETCHING (dry heaves), EMOTIONAL DISTRESS (quite in distress), PAIN IN EXTREMITY (pain on right leg between the calf and shin), PYREXIA (fever - 99.5F) and MYALGIA (Her whole body hurts and she's just lying on the couch) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2022, Body temperature: 99.5 (High) 99.5 F.         Caller reports that patient is feeling better after taking meds and having electrolytes.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: dry heaves; quite in distress; pain on right leg between the calf and shin; fever - 99.5F; Her whole body hurts and she's just lying on the couch; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), EMOTIONAL DISTRESS (quite in distress), PAIN IN EXTREMITY (pain on right leg between the calf and shin), PYREXIA (fever - 99.5F) and MYALGIA (Her whole body hurts and she's just lying on the couch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gastroesophageal reflux. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Gastroesophageal reflux.    On 05-May-2022 at 6:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced RETCHING (dry heaves), EMOTIONAL DISTRESS (quite in distress), PAIN IN EXTREMITY (pain on right leg between the calf and shin), PYREXIA (fever - 99.5F) and MYALGIA (Her whole body hurts and she's just lying on the couch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RETCHING (dry heaves), EMOTIONAL DISTRESS (quite in distress), PAIN IN EXTREMITY (pain on right leg between the calf and shin), PYREXIA (fever - 99.5F) and MYALGIA (Her whole body hurts and she's just lying on the couch) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2022, Body temperature: 99.5 (High) 99.5 F.         Caller reports that patient is feeling better after taking meds and having electrolytes.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: She had a huge welt on her arm.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She had a huge welt on her arm.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (She had a huge welt on her arm.). At the time of the report, URTICARIA (She had a huge welt on her arm.) had resolved.            No Concomitant Products were reported. Patient condition include Special needs Nonverbal. No Treatment information was reported.   This case was linked to MOD-2022-560539 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Non-significant follow up appended
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 046B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced PYREXIA (Fever of 101F). At the time of the report, PYREXIA (Fever of 101F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Body temperature: 101f (High) 101F.         No Concomitant Products were reported. Patient condition include Special needs Nonverbal. No Treatment information was reported.   This case was linked to MOD-2022-560526 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Urine odour abnormal
Clinical narrative: Pee smells like chemicals; This spontaneous case was reported by a consumer and describes the occurrence of URINE ODOUR ABNORMAL (Pee smells like chemicals) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINE ODOUR ABNORMAL (Pee smells like chemicals). At the time of the report, URINE ODOUR ABNORMAL (Pee smells like chemicals) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period; 10 Expired Doses Administered - date of administration on 22-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 Expired Doses Administered - date of administration on 22-Jan-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 Expired Doses Administered - date of administration on 22-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 Expired Doses Administered - date of administration on 22-Jan-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) 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 was reported. No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period; 1 Expired Doses Administered - date of administration on 24-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered - date of administration on 24-Mar-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered - date of administration on 24-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered - date of administration on 24-Mar-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. No treatment were reported.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test abnormal, Dyspnoea, Heart rate increased, Loss of consciousness, Supraventricular tachycardia
Clinical narrative: I started having issues breathing after my COVID shots.  I had blackouts that put me in the hospital I had Cardiology appointments and was diagnosed with supraventricular tachycardia. I'm being scheduled for an Ablation surgery.  All this started w/the covid shots!
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Fatigue, Head injury, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient reported vasovagal response during vaccine upon standing. Informed patient to stay seated after vaccine and not stand until feeling okay. Patient leanded head on counter, while I went to get water for patient fell and bumped head on ground.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient reported vasovagal response during vaccine upon standing. Informed patient to stay seated after vaccine and not stand until feeling okay. Patient leanded head on counter, while I went to get water for patient fell and bumped head on ground.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Pfizer 8/16/21  EW0173 dose 2 Pfizer 9/7/21  EW0183
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Dizziness, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: Hearth irregular palpitations ,lose feeling to left arm ,head ache body pain dizziness still have
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Palpitations
Clinical narrative: Hearth irregular palpitations ,lose feeling to left arm ,head ache body pain dizziness still have
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus in both ears
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Chills Nausea Headache muscle achy
Age: 12.0
Sex: M
Vaccine: COVID19, HPV9, MENB
Symptoms: Seizure
Clinical narrative: Seizures
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Injection site had redness, swelling, and blisters filled with fluid and patient complained of pain
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Store manager call pharmacy letting us know patient complain about adverse event from vaccine
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue
Clinical narrative: Hospitalized with fatigue and cough did not require any covid directed treatment
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection resulting in ED visit on 5/9/2022
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Back pain, Blood test abnormal, Joint stiffness
Clinical narrative: First: hip pain, right neck soreness. First days: Back and hip pain, Upper leg  pain and aches, Tightness around my knees.  Bilateral. Subsequent days and weeks: All of the above, but not always all at once.  Sometimes with increased intensity.  Sometimes with less intensity.  Sometimes accompanied by fleeting pain in different areas of my back, legs, and knees.  Some neck pain. Dr. discontinued Simvastin on April 18th.  Prescribed Cyclobenzaprine to take at bedtime to facilitate ability to sleep.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Ultrasound Doppler normal
Clinical narrative: First: hip pain, right neck soreness. First days: Back and hip pain, Upper leg  pain and aches, Tightness around my knees.  Bilateral. Subsequent days and weeks: All of the above, but not always all at once.  Sometimes with increased intensity.  Sometimes with less intensity.  Sometimes accompanied by fleeting pain in different areas of my back, legs, and knees.  Some neck pain. Dr. discontinued Simvastin on April 18th.  Prescribed Cyclobenzaprine to take at bedtime to facilitate ability to sleep.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Influenza A virus test, Influenza B virus test, SARS-CoV-2 test positive
Clinical narrative: COVID vaccine breakthrough case
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Dizziness, Dyspnoea, Echocardiogram, Feeling hot
Clinical narrative: I am a very healthy person, but after receiving my vaccine, I started to develop Acid Reflux and High Blood Pressure. I am now taking medication for the high blood pressure. I also experience pain and heat in my head. I'm experiencing numbness at the back of my head, a lot of dizziness, I'm short of breath and my ears are constantly ringing.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Headache, Hypertension, Hypoaesthesia, Tinnitus
Clinical narrative: I am a very healthy person, but after receiving my vaccine, I started to develop Acid Reflux and High Blood Pressure. I am now taking medication for the high blood pressure. I also experience pain and heat in my head. I'm experiencing numbness at the back of my head, a lot of dizziness, I'm short of breath and my ears are constantly ringing.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fall, Rhinorrhoea
Clinical narrative: Hospitalized with weakness and falls, non productive cough, rhinorrhea. Remdesivir 3 day course.  discharged to home.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and fever for about 6 hours overnight ; took 2 Tylenol and cold compress to forehead; chill and fever gone by 8 am
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Condition aggravated
Clinical narrative: I developed severe joint pain in my hips and knees. I had knee arthritis previously but it seemed to be exacerbated afterwards. I am unsure if its related but wanted to note it. Ankle pain was minimal.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Plantar fasciitis
Clinical narrative: planter fasietus on goingnone
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Vaccinated pt (per pt report) admitted with covid infection. No vaccine info available
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myeloid leukaemia, Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increased, Asthenia
Clinical narrative: 12/20/2021 - Came to ER with worsening Covid symptoms- c/o weakness/sore throat/diarrhea. Previous inpatient stay from 12/9 - 12/18, in with cellulitis and later became symptomatic with covid pneum - tested on 12/14 - treated with Remdesivir-5 days, antibiotics, and steroid. Still Thrombocytopenic and anemic with severe Leukocytosis. CRP 7. PaO2 of 70. Vitals WNL. On 2L O2 NC. New diagnosis of AML. Continuing Cefepimine and Doxy.  12/21 - WBC 65.4/Platelets 22. Received 2U platelets. Heparin held due to Thrombocytopenia.  12/22 - CT scan of lung concerning for consolidation. Still on 2LNC. Continuing antibiotic/steroid. Received 2 additional U platelets and 1 PRBC.  12/23 - Bone biopsy complete. Thrombocytopenia likely due to underlying Leukemia. Treatment pending result. Worsening hepatic dysfunction AST- from 138 on adm to 270, ALT from 76 to 200.  12/24 - One IV ripped and bled significantly. Patient unresponsive for 30 seconds trying to move from commode to bed. Rapid called. 2U PRBC and 2U platelets ordered HCT 26.2/HGB 7.8. Moved to CVICU. O2 at 98 on 4LNC.  GI consult indicates liver injury likely due to Covid liver, underlying sepsis, and potential drug induced from antibiotics. Indicates there is no specific treatment at this point for liver injury. Antibiotics continued for sepsis/pneumonia.  12/25 - Liver functions stable. Conservative management and supportive care contnued. Pulse 124, RR 29, all other vitals WNL. Transfusion support continued for AML. Biopsy report pending. 12/26 - NG tube attempted by nursing. Patient began to bleed and struggle. Attempted a 2nd time. Tip unable to be verified and left in place. Questionable blood aspiration. Developed fever overnight >104 - 103.2 - Tylenol given w/o relief. Transitioned to Palliative care for overall poor prognosis.  12/27 - Patient expired @2125
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy bone, C-reactive protein increased, COVID-19 pneumonia, Catheter site haemorrhage, Cellulitis
Clinical narrative: 12/20/2021 - Came to ER with worsening Covid symptoms- c/o weakness/sore throat/diarrhea. Previous inpatient stay from 12/9 - 12/18, in with cellulitis and later became symptomatic with covid pneum - tested on 12/14 - treated with Remdesivir-5 days, antibiotics, and steroid. Still Thrombocytopenic and anemic with severe Leukocytosis. CRP 7. PaO2 of 70. Vitals WNL. On 2L O2 NC. New diagnosis of AML. Continuing Cefepimine and Doxy.  12/21 - WBC 65.4/Platelets 22. Received 2U platelets. Heparin held due to Thrombocytopenia.  12/22 - CT scan of lung concerning for consolidation. Still on 2LNC. Continuing antibiotic/steroid. Received 2 additional U platelets and 1 PRBC.  12/23 - Bone biopsy complete. Thrombocytopenia likely due to underlying Leukemia. Treatment pending result. Worsening hepatic dysfunction AST- from 138 on adm to 270, ALT from 76 to 200.  12/24 - One IV ripped and bled significantly. Patient unresponsive for 30 seconds trying to move from commode to bed. Rapid called. 2U PRBC and 2U platelets ordered HCT 26.2/HGB 7.8. Moved to CVICU. O2 at 98 on 4LNC.  GI consult indicates liver injury likely due to Covid liver, underlying sepsis, and potential drug induced from antibiotics. Indicates there is no specific treatment at this point for liver injury. Antibiotics continued for sepsis/pneumonia.  12/25 - Liver functions stable. Conservative management and supportive care contnued. Pulse 124, RR 29, all other vitals WNL. Transfusion support continued for AML. Biopsy report pending. 12/26 - NG tube attempted by nursing. Patient began to bleed and struggle. Attempted a 2nd time. Tip unable to be verified and left in place. Questionable blood aspiration. Developed fever overnight >104 - 103.2 - Tylenol given w/o relief. Transitioned to Palliative care for overall poor prognosis.  12/27 - Patient expired @2125
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Death, Diarrhoea, Gastrointestinal tube insertion, Haematocrit decreased
Clinical narrative: 12/20/2021 - Came to ER with worsening Covid symptoms- c/o weakness/sore throat/diarrhea. Previous inpatient stay from 12/9 - 12/18, in with cellulitis and later became symptomatic with covid pneum - tested on 12/14 - treated with Remdesivir-5 days, antibiotics, and steroid. Still Thrombocytopenic and anemic with severe Leukocytosis. CRP 7. PaO2 of 70. Vitals WNL. On 2L O2 NC. New diagnosis of AML. Continuing Cefepimine and Doxy.  12/21 - WBC 65.4/Platelets 22. Received 2U platelets. Heparin held due to Thrombocytopenia.  12/22 - CT scan of lung concerning for consolidation. Still on 2LNC. Continuing antibiotic/steroid. Received 2 additional U platelets and 1 PRBC.  12/23 - Bone biopsy complete. Thrombocytopenia likely due to underlying Leukemia. Treatment pending result. Worsening hepatic dysfunction AST- from 138 on adm to 270, ALT from 76 to 200.  12/24 - One IV ripped and bled significantly. Patient unresponsive for 30 seconds trying to move from commode to bed. Rapid called. 2U PRBC and 2U platelets ordered HCT 26.2/HGB 7.8. Moved to CVICU. O2 at 98 on 4LNC.  GI consult indicates liver injury likely due to Covid liver, underlying sepsis, and potential drug induced from antibiotics. Indicates there is no specific treatment at this point for liver injury. Antibiotics continued for sepsis/pneumonia.  12/25 - Liver functions stable. Conservative management and supportive care contnued. Pulse 124, RR 29, all other vitals WNL. Transfusion support continued for AML. Biopsy report pending. 12/26 - NG tube attempted by nursing. Patient began to bleed and struggle. Attempted a 2nd time. Tip unable to be verified and left in place. Questionable blood aspiration. Developed fever overnight >104 - 103.2 - Tylenol given w/o relief. Transitioned to Palliative care for overall poor prognosis.  12/27 - Patient expired @2125