chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 grandkids ages 16 and 17 almost 18, they have their 2 vaccinations; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 grandkids ages 16 and 17 almost 18, they have their 2 vaccinations) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 grandkids ages 16 and 17 almost 18, they have their 2 vaccinations). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 grandkids ages 16 and 17 almost 18, they have their 2 vaccinations) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-419804 (Patient Link).   Reporter did not allow further contact
Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lupus-like syndrome (She have LUPUS (pt thinks that is possible a different impact from covid shot in people with autoimmune disease).) and Surgery (She has a previous surgery, a plate in the neck.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Little sore arm). At the time of the report, PAIN IN EXTREMITY (Little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment information not provided.   This case was linked to MOD-2021-066882 (Patient Link).
I developed the following symptoms in less than 24 hrs:   Fever, severe headache, sinus congestion/pressure, aches & joint pains, fatique, extreme pain in my right arm which felt like it was on fire  to the point I couldn't lay on it.  These symptoms lasted for 3 days except for the joint pain which is still ongoing.   I developed the following symptoms within 48 hrs of the shot:   Diarrhea (this lasted for a few days after onset)   I developed the following symptoms within 2 weeks of the shot:   Shortness of breath & chest pain to the point I was struggling to breath going up and down the stairs and unable to exercise and do cardio.
Received booster dose Pfizer Covid 19 Vaccine and had a rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown. Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "Received booster dose Pfizer Covid 19 Vaccine and had a rash". Therapeutic measures were taken as a result of rash.  Additional information: The patient was seen by a dermatologist, however the rash has not gone away. The dermatologist prescribed medication, but the rash was still there. Caller had a rash and was prescribed Unknown medication by dermatologist but the rash had not gone away. Medication name was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
t013, pallor, "glassy eyes", urticarial eruption, ?arthralgia (difficulty walking-transient); Onset w/in 4 hrs post immun; Pred given & sx cleared w/in 24 hrs;
Burning, pruritis at injection site-self limited. Nausea, vomiting, diarrhea, rigors-began following trip to Florida. Symptoms slowly resolving.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=moderna,; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 19:00 as dose 6 (booster), single (Lot number: gj6739) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 5 (booster), single (Lot number: 048l2ia), 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Apr2022, outcome "unknown", described as "Vaccine brand other=moderna,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: re-emergence of COVID symptoms/positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of VARIVAX lot number M012990, expiration date 14-MAR-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided), were administered to an unspecified number of patients from 04-APR-2017 to 12-MAY-2017, for prophylaxis. It was reported that the vaccine was reconstituted with a sterile diluent (manufacturer unknown) lot number reported as N007760, expiration date reported as 31-JUN-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided), which was not improperly stored, also for prophylaxis. The vaccine was exposed to a temperature between - 14 and -10 Celsius degrees for 72 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007449:
PNEUMONIA; BLOOD CLOTS; This spontaneous report received from a consumer concerned an 89 year old male. Initial information was received on 13-APR-2021 and processed with additional information received on 15-APR-2021.  The patient's height, and weight were not reported. The patient's past medical history included congestive heart failure (ejection fraction 20%), large lower left groin hernia, atrial fibrillation, and dementia. No known drug allergies was reported. There was no history of blood clots.  The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. Batch number was not reported, will be requested. Concomitant medications included apixaban twice a day for atrial fibrillation.  On 11-MAR-2021, the patient was taken to Emergency Room (ER) and diagnosed with pneumonia. Patient was awake over 48 hours 'felt due to dementia and illness'.   On 14-MAR-2021, the patient was taken back to hospital and X-ray and CAT scan showed saddle pulmonary embolism.  On 15-MAR-2021, the patient was discharged to a home with hospice.  On 23-MAR-2021, the patient deceased. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Hospitalization Caused / Prolonged).; Sender's Comments: V0: An 89-year old man experienced fatal saddle pulmonary embolism 10 days after vaccine. Relevant medical history included congestive heart failure with ejection fraction 20%, atrial fibrillation (A Fib), and dementia. Relevant concomitant medication (others not reported) included Eliquis for A fib. The patient was diagnosed with pneumonia in the Emergency Department 7 days after vaccine, and 3 days later was brought back to the hospital and diagnosed with saddle pulmonary embolus. He was discharged home on hospice the next day and died 19 days after vaccine. There was no reported thrombocytopenia. The patient's age, concurrent pneumonia, and complicated past medical history are confounders. There is insufficient information to make a meaningful medical assessment. Additional information has been requested, including attempts to contact the patient's treating physicians.; Reported Cause(s) of Death: PNEUMONIA; BLOOD CLOTS
did not felt like eating; had a headache; was tired; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (did not felt like eating), HEADACHE (had a headache) and FATIGUE (was tired) in a 61-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (did not felt like eating), HEADACHE (had a headache) and FATIGUE (was tired). At the time of the report, DECREASED APPETITE (did not felt like eating), HEADACHE (had a headache) and FATIGUE (was tired) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant information were reported by the reporter. Patient was close to normal next day. No treatment information were reported by the reporter.   This case was linked to MOD-2022-587908, MOD-2022-587913, MOD-2022-587915, MOD-2022-587938 (Patient Link).
Signs= pt. had redness, tenderness & low grade fever with chills for 2 days (shots given Fri)- signs/symptoms sweat started fri night. Seen here mon am. Laboratory= vitals: afebrile P-68 BP 12/76. Left arm- 6-7 cm erythema tender to palpation around injection site. Prescription Medrol dose pt-7 day Dictoxallin 2 days qid, allergra 180 mg po for 6 days qd.
This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported. On 29-NOV-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (Lot# U002530 and expiration date 24-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 42 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
pt recvd Hep B vax approx DEC91; approx 1 mo p/vax devel serum sickness synd; lymphadenopathy, sore throat, malaise, myalgia, photophobia, fatigue; also devel pain in feet described by MD as fascitis; t102, WBC 11,000 w/atypical lymphocyte;
The injection site is 4 inches and half and it is like cellulitis; First felt like a bruise and the bruise went away; It's very warm to the touch; It started Itching; Rash on the arm; First felt like a pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (The injection site is 4 inches and half and it is like cellulitis) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical events.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NAUSEA (Nausea). On 27-Mar-2021, the patient experienced CELLULITIS (The injection site is 4 inches and half and it is like cellulitis) (seriousness criterion medically significant), VACCINATION SITE BRUISING (First felt like a bruise and the bruise went away), VACCINATION SITE WARMTH (It's very warm to the touch), VACCINATION SITE PRURITUS (It started Itching), VACCINATION SITE RASH (Rash on the arm) and VACCINATION SITE PAIN (First felt like a pain). At the time of the report, CELLULITIS (The injection site is 4 inches and half and it is like cellulitis), VACCINATION SITE WARMTH (It's very warm to the touch), VACCINATION SITE PRURITUS (It started Itching), NAUSEA (Nausea), VACCINATION SITE RASH (Rash on the arm) and VACCINATION SITE PAIN (First felt like a pain) outcome was unknown and VACCINATION SITE BRUISING (First felt like a bruise and the bruise went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  No treatment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specified information. At the first facility they might have administered VAQTA, RECOMBIVAX HP, and GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been administered to patients. The first set of vaccines were RECOMBIVAX HB, COMVAX, GARDASIL, ROTATEQ which were exposed to 30F for 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported.  The second set of vaccines for this facility were COMVAX and GARDASIL which were exposed to 30F for 221 hours and 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source (same reporter link: 1406USA000768, 1406USA007003, 1406USA007004, 1406USA007006). Additional information has been requested.
Gave the patient Fluzone Quad IM in the Left Arm about 75% of the vaccine went into the patient's arm but the last 25% came out the back of the syringe at the plunger.
DIZZINESS; ACHY FEELING; NAUSEA; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, non alcohol, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced achy feeling. On 06-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, achy feeling, and nausea on 06-APR-2021. This report was non-serious.
Swollen eyes (started on the morning third day post injection); lymph nodes in right armpit, mild swelling in neck region.
Presented to clinic next day, 10/20/10 with pain/swelling at injection site. Treated with antihistamine, NSAID. ADR - not reported to HD until this form was completed.
Shingles on right shoulder and back after receiving "Flu Shot"; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting Valacyclovir, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and tramadol. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that she had a shingles on right shoulder and back after receiving Flu shot in left arm. The reporter did not know the name of the flu vaccine. The patient was prescribed Valacyclovir and Tramadol to treat shingles. The reporter did not consent to follow up.
Left sided Bell's palsy 3 days after vaccine administration.  Was resolving at time of examination 21 days later.  No treatment was required at that point in time.  5/23/08 Reviewed PCP medical records & vax records. FINAL DX: left Bell's palsy. Records reveal patient experienced prior casted arm fracture & was referred to ortho. Also experienced vision deficits & referred to ophthal.  Returned to PCP 2/25/08 w/left facial weakness & cough that had started 2/4/08.  Family noticed w/talking. No treatment provided as was resolving spontaneously.  Labs revealed impaired glucose metabolism & referred for further w/u.
Very painful left arm full arm right after injection and pain all night long into the next morning. Left leg pain down entire left leg the first night and next day after vaccine. Headache mild possibly migraine I do get migraines. Fatigue moderate next day.
Pt was very anxious about receiving vaccines. RN administered a Tdap IM in the deltoid of her left arm. Pt stated that it hurt. RN then administered an HPV an inch lower in the same arm. Pt stated that it didn't hurt, it just felt weird. Pt then became very pale and stated that she was going to pass out. She was sitting upright in a chair. RN had her slide down and rest her head on the back of the chair. Pt then just turned her head and fainted for about 2 seconds. During this time her legs and arms straightend out. Her mom got a cool cloth. We assisted her to the floor where she laid for about 10 minutes. She then sat in the chair for another 5 minutes. Her color came back and she stated she felt exhausted, but fine. RN gave her cell phone number and instructions to go to the ER if any concerns. RN gave info on the imms given and where they where given. RN text pt the next morning and she stated that she had just finished basketball pracitce and was feeling fine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Age of patient was reported as 29.99  On 15-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 06-Apr-2021 and beyond use date was 05-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
About 24 hours after receiving vaccine, I developed myalgias, severe headache, stomach bloating, nausea, dizziness, and extreme fatigue and hypersomnia.  I fell asleep suddenly for hours at a time. The symptoms lasted for six days after receiving the vaccine, with fatigue and hypersomnia lasting the longest.  I missed work due to the symptoms.
Experienced nausea and upset stomach. Vomited approximately 2 hours after initial symptoms with stomach cramps and diarrhea following into the next day.
NEUROPATHY 2/20/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC NEUROPATHY 2/20/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC
This patient came in to the clinic today for vaccine administration. As we compared with the Yellow immunization card and records, child needed MMR and Varicella vaccine. Medical assistant administered PROQUAD instead of MMR vaccine without realizing that it is a combo vaccination and also administered varicella vaccine separately. Child received 2 varicella vaccine. Child does not have any adverse reaction so far and we informed the mother and requested her to come back to clinic if any concerns arise.