chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a reaction to it about a year and a half ago and they advised her that it was probable the PEG content that caused her reaction; had a reaction to it about a year and a half ago and they advised her that it was probable the PEG content that caused her reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 98-year-old female patient 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: IMMUNISATION REACTION (non-serious), REACTION TO EXCIPIENT (non-serious), outcome "unknown" and all described as "had a reaction to it about a year and a half ago and they advised her that it was probable the PEG content that caused her reaction".  Additional information: it was reported that the patient was  suggested not to take any more Pfizer Covid-19 Vaccine because she had a reaction to it about a year and a half ago and they advised her that it was probable the PEG (polyethylene glycol) content that caused her reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy,  swollen, red  area at injection site.  Covering area approximately  3?x 4?.  From 8pm 3/17/2021 to present and continuing through this report ( 3/18/2021 at noon).
Erythema multiforme- Itchy red rash all over body. Tx BENADRYL and cortisone ointment.
Severe tingling & numbness in feet, legs, hands - pain in extremities. Started about 2nd week of October 09. Went to DR on 10-20-09. Did Labs. Neuropathy continued - had brain and neck MRI. Went to neurologist did more labs and spinal tap. Now taking NEURONTIN. It's been 8 months and no better unless on medication.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that the vaccine was stored in freezer, and they take out one to two vials and place in fridge each day as needed.  No treatment medications were reported.
No additional adverse effects reports; one male patient was administered improperly stored RECOMBIVAX and ROTATEQ.; This spontaneous report was received from a vaccine coordinator referring to a 10 weeks old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 12-MAR-2020 the patient was vaccinated with improperly stored of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 5/0.5 microgram/milliliter (lot # R028529, expiration date 09-JUN-2021; dose, frequency and route were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1658255, expiration date 07-FEB-2021, orally; dose and frequency were not reported) for prophylaxis (product storage error).  The administered doses of the vaccines experienced a temperature/time frame at below 2 Degree Celsius (?). On 02-MAR-2020 it was 0.8 C for 5 hours and 9 minutes, on 04-MAR-2020 it was 0.9 C for 11 hours and on 05-MAR-2020 it was -1.3 C for 9 hours and 29 minutes. Previous temperature excursion was at above 9°C 9.3 C for 3 hours 33 minutes on 25-FEB-2020 and below 2°C (0.8 C) for 11 hours 39 minutes on 03-MAR-2020. The digital data logger was involved. No additional adverse effects were reported.
Patient's symptoms began 1 week prior to presentation and were worsening. She had associated wheezing, lower extremity edema, and intermittent cough. BNP was elevated. CXR showed bilateral interstitial pneumonia and she was found to be positive for Covid-19. Patient  was not hypoxic. She was started on IV diuresis which was increased.  Patient continued to diurese well and was transitioned to Bumex 2 mg p.o. B.i.d.  The day of discharge patient's hemoglobin was trending within a stable fashion as was her kidney function.  Patient is being discharged home on February 8, 2022 in stable condition.  Discharge  Diagnoses:   1. Acute on chronic Heart failure with preserved ejection fraction exacerbation 2. Severe pulmonary hypertension 3. COVID-19 pneumonia without hypoxia
fully vaccinated (moderna, 3/22/21, 4/19/21), onset of symptoms 8/3/21
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not reported. The patient had no Known allergies. There were no concomitant medications/No other medication in 2weeks. The following information was reported: 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: Unknown results, notes: COVID 19 Treatment; Positive, notes: still testing positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Adverse event: Covid symptoms came back a couple days after completing the paxlovid medication and still testing positive for Covid.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Initial report was received on 22 September 2010 from another manufacturer with Document Number 1110997 and Service Request Number 1-3683113970. The initial reporter was the patient's mother. A male patient was 8 months old, "more than 21 years ago" when he received an injection of DTP (manufacturer and lot number not reported). Five days after the vaccination, he experienced a grand mal seizure. He was examined by a neurologist and prescribed phenobarbital. The patient became neurologically impaired and stopped doing all activities. The patient's family history included, the mother's half brother who experienced a grand mal seizure after receiving an unspecified vaccination "many years ago." The patient's current status was not reported. Documents held by sender: None.
vials were thawed directly from the freezer each time they needed to administer a dose; No adverse event; HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date), PRODUCT STORAGE ERROR (vials were thawed directly from the freezer each time they needed to administer a dose) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Patient had no known condition.     On 09-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were thawed directly from the freezer each time they needed to administer a dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date), PRODUCT STORAGE ERROR (vials were thawed directly from the freezer each time they needed to administer a dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date) and PRODUCT STORAGE ERROR (vials were thawed directly from the freezer each time they needed to administer a dose).    It was unknown if the patient received any othe vaccines in the 4 weeks prior to Covid-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial size was reported as 2.5 ml. Vial did not undergo any temperature excursions.  Treatment information was not provided.  This case contains information about patient 9th out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729345 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729345:Master case (patient 1)
Patient started having a reaction a few hours after getting the shot. Her arm swelled down to the elbow, was red and tender to the touch and she had fever, chills, headache, nausea and lightheadedness. Patient took TYLENOL and stayed in bed, symptoms mostly resolved without medical intervention 5 days later, patient's arm was still a little tender 1 week after getting the shot.
It was a runny nose and minor sore throat that started 4/13 and my wife also had symptoms and already tested positive. So I did a home test and tested positive. I really don't have any symptoms now so they lasted a couple of days at the most. Doctor put me on Paxlovid and I started that on 4/14/22.
Screaming, crying, fussy and left leg shaky after vaccines. Pt seen in our office 4/2/10.
Pt seen in ER with flu like symptoms (cough, runny nose, chills, nausea, vomiting, hyperactive bowel sounds). Came to ER at 10:55am following previous day vaccine injection.
Rash & difficulty breathing, treated by PMD with Epinephrine & BENADRYL.
On 9/6/11 around 7pm administered a BOOSTRIX shot to patient. He felt dizzy and almost fainted. I had the pharmacy technician call 911 while I continued to observe him. He felt better in a minute or two & ambulance took him to hospital. He was discharged at around 9PM.
He states that he began urinating every 2 hours at approximately 6 p.m. the day he received his second vaccine (approximately 4 hours after his vaccine) and this lasted until 8:00 a.m. the following morning (14 hours).   He had no other urinary complaints to suggest an infection.    He also had 3 episodes of diarrhea, fatigue, and joint pain following his second dose of vaccine.
FATIGUE WORSENED; HEADACHE; SORE MUSCLES OR MUSCLE ACHE; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. 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 not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced sore muscles or muscle ache. On 15-APR-2021, the subject experienced fatigue worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, and had not recovered from headache, sore muscles or muscle ache, and fatigue worsened. This report was non-serious.
seven days post vaccine pt developed pruritic rash on hands and within 12 hours had spread to whole body, improves with antihistamines but returns with any decrease. currently on three antihistamines daily to manage and still noting breakthrough episodes.
Induration 30mm X 50mm, redness, warm to touch, denies pain, feverish, body ache or HA
Swelling in injection area of arm; Redness in injection area of arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Swelling in injection area of arm) and VACCINATION SITE ERYTHEMA (Redness in injection area of arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN (ZOCOR), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], CINNAMON [CINNAMOMUM VERUM] and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling in injection area of arm) and VACCINATION SITE ERYTHEMA (Redness in injection area of arm). At the time of the report, VACCINATION SITE SWELLING (Swelling in injection area of arm) and VACCINATION SITE ERYTHEMA (Redness in injection area of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Reporter did not allow further contact; 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.
Consistent fever, lasting for 3 days.  Fever not helped by Motrin or acetaminophen.  Temperature ranged from 101.4 degrees F - 103.4 degrees F. On 1/19/2013 child woke with mild measle-like rash covering face, chest & stomach, and back.
Information has been received from a physician through a company representative concerning the physician's son who on 03/27/01 was vaccinated with varicella virus vaccine live. In 10/01, the pt broke out in"full blown chicken pox from his head to his toe". The physician reported that the break out was "so bad" the physician took the boy to a dermatologist to see if there would be scarring. It was reported that the child would not be scarred. The outcome of the event was unknown at the time of this report. Additional information has been requested.
Had a night terror; Woke up screaming and disoriented; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration on 31Mar2021 at 09:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Concomitant medication included OCP (oral contraceptive pills) from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 23:00, the patient had a night terror. The patient woke up screaming and disoriented. The patient ran out of the room and was screaming. The patient's mom had to "wake her up" even though it looked like the patient was awake. This had never happened before. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event night terror and woke up screaming and disoriented were resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Had Moderna COIV-19 Vaccine EUA.  About 12 hours later, woke up with fever, headache, sinus congestion, increased pain at injection site, pain in knee.  Fever (100-101.2 degrees) continued 30 hours;  headache, fatigue, sinus congestion and muscle achescontinued, although diminishing,  for an additional 30 hours.
PATIENT HAD COVID-19 VACCINE ON Dose 1 date: 12/21/2020,  Dose 2 date: 01/11/2021 AND TESTED POSITIVE TO COVID ON 9/3/21
Headache, Myalgia, Arthralgia, Fever, Sore Arm, Narrative:  Other Relevant History:
Within 5 mins of vaccines being given, baby had red blotched areas on thighs then face and stomach and legs. Never had SOB or any other signs of distress. Skin only was red about 5-10 mins. Areas started to fade and was back to normal appearance within about 10-15 mins.
arm was warm to touch; Itchiness; 2 inch hard welt; redness; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was warm to touch), VACCINATION SITE PAIN (pain), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE INDURATION (2 inch hard welt) and VACCINATION SITE ERYTHEMA (redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm was warm to touch), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE INDURATION (2 inch hard welt) and VACCINATION SITE ERYTHEMA (redness). On 14-Mar-2021, VACCINATION SITE WARMTH (arm was warm to touch), VACCINATION SITE PAIN (pain), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE INDURATION (2 inch hard welt) and VACCINATION SITE ERYTHEMA (redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Pt recvd vax 30AUG91; On 5SEP91 t104.5, sponge baths & APAP & temp controlled @ 101 x 2 days; On the eight day post vax, t100 & generalized rash appeared; Pt visited MD following day w/sl tonsillitis noted; c/o flu-like sx;
10 days post vax the pt experienced a mild chickenpox rash on her neck, back and abdomen.
her blood sugar and blood pressure is also up; her blood sugar and blood pressure is also up; Her arm is still sore where they put the shot in all the way down to the elbow; This is a spontaneous report from a contactable consumer.   A 81-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm on 01Feb2021 09:00 as 1st DOSE, SINGLE DOSE for an unspecified indication. The patient medical history and concomitant medications were not reported. On Feb2021 the patient experienced her arm was still sore where they put the shot in all the way down to the elbow, her blood sugar and blood pressure was also up and her blood sugar and blood pressure was also up. The patient underwent lab tests and procedures which included blood glucose: up, blood pressure measurement: up. Outcome of event injection site pain not recovered, and blood glucose increased, blood pressure increased was unknown. Follow-up (05Feb2021): This is a Follow-up spontaneous report from a contactable consumer. This Consumer reporter for a 81-year-old female patient added. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
3 DAYS AFTER ADMINISTRATION OF HEPATITIS A VACCINE (LATERAL RT THIGH) LOCAL ERYTHEMA REACTION WAS NOTED AROUND THE VACCINATION SITE WHICH SPEAD INTO MACULAR RASH TO THE LOWER AND ALSO THE OPPOSITE EXTREMITY.
My arms is swollen the size of a avocado  seed; It is itching the spot where they injected me is warm, swollen and red; It is itching the spot where they injected me is warm, swollen and red; It is itching the spot where they injected me is warm, swollen and red; It is itching the spot where they injected me is warm, swollen and red; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) at the age of 40 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Known allergies: Chocolate" (unspecified if ongoing), notes: known allergies: chocolate. The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "known allergies: Benadryl", notes: known allergies: Benadryl. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset May2021, outcome "unknown", described as "My arms is swollen the size of a avocado  seed"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset May2021, outcome "unknown" and all described as "It is itching the spot where they injected me is warm, swollen and red".  Additional information: The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks The patient did not had COVID prior vaccination and since vaccination, patient had not tested with covid 19.Device Date mentioned as 19May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: Patient received one dose of the covid vaccine. Patient died approx. one month after first dose. Cause of death noted to be end stage dementia and failure to thrive. Reporting per instruction.
Lower eyelid edema with internal lesions resembling styes.  Bilateral, chronic, and/or recurring with a minimum of 4 instances.
Pain at injection site; Swelling at injection site; Rash around injection site; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 26Jun2021 at 16:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety disorder. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jun2021 at 00:00, the patient experienced pain at injection site, swelling at injection site and rash around injection site. Therapeutic measures were taken as a result of the events which included treatment with BENADRYL and ibuprofen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the events of pain at injection site, swelling at injection site and rash around injection site was not resolved at the time of this report.