chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UrticariaPruritus Narrative: 12/19-12/21 hives to R wrist, chest, back, neck
Night of the shot Dec 1st.  Soreness where shot was given.  Chills, fever, headache, body aches.  Next day chills, soreness red rash with heat at shot spot, body aches. 2-3 days after shot sore arm and red rash with heat, itching.
Fever (T-max 100.4); headache; body aches; This is a spontaneous report from a contactable health care professional, the patient. A 29-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284) in the left arm on 07Jan2021  as a single dose, for COVID-19 vaccination.  The vaccine was administered at a Hospital.  Medical history included  Stiff-man syndrome, polycystic ovarian syndrome and known allergies to soy, sesame, and walnuts.  Concomitant medication included tramadol (TRAMADOL), gabapentin (GABAPENTIN), methocarbamol (ROBAXIN), dienogest, estradiol valerate (NATAZIA), insulin (INSULIN).  The patient previously experienced  drug hypersensitivity to Penicillin, Neosporin, and Levaquin. The patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), in the left arm on 17Dec2020 11:AM.  No other vaccines were given within 4 weeks except the first dose of BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 07Jan2021 17:30, the patient experienced fever (t-max 100.4), headache and body aches.  Lab data include body temperature: t-max 100.4 on 07Jan2021. No treatment was given for the events. The clinical outcome of the events fever (t-max 100.4), headache and body aches was recovering.
Patient started experiencing hives 3hrs after immunization. Also stated stomach bloating. Took patient to the Emergency Room. Prescribed topical steroid and Benadryl.
This spontaneous report as received from a pharmacist via Company Representative refers to a female patient of unknown age. On approximately 27-OCT-2014 "about 2 weeks ago" the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) in the arm (dosage and route not reported). The pharmacist reported that a patient experienced an injection-site infection after receiving ZOSTAVAX. The pharmacist reported that the patient sought medical attention at an unspecified urgent care clinic in an unspecified city. The pharmacist learned of the patient's adverse experience when he filled a prescription for an unspecified antibiotic for treatment of the injection-site infection on an unspecified date that the patient was given at the urgent care clinic. The representative states that the pharmacist did not specify whether or not the patient did or did not develop a rash. The representative did not know if the patient had notified her primary healthcare provider, and she did not have any additional information. The outcome of injection site infection was reported as recovering/resolving. Additional information has been requested.
Persistent itching and rash. First starting in general abdomen area. Now has spread to inner thighs, legs and forearms.
Patient developed fever, hallucinations, and mental status changes about 20 hours after receiving Menactra and Tdap.
Patient reported to the emergency department on 10/8/2010 with injection site pain and rash.
2-3 days of severe non-bloody diarrhea.  No vomiting, no fever, no dehydration. Mother reports painful cramping in infant, crying.
the metal part of the vial started leaking all over her hand, because it leaked out so much, the Pentacel vaccine was not able to be administered to the patient with no Ae; the metal part of the vial started leaking all over her hand, because it leaked out so much, the Pentacel vaccine was not able to be administered to the patient with no Ae; the metal part of the vial started leaking all over her hand, because it leaked out so much, the Pentacel vaccine was not able to be administered to the patient with no Ae; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient with an unknown demographic for whom it was reported that the metal part of the vial started leaking all over her hand, because it leaked out so much, the pentacel vaccine was not able to be administered to the patient (exposure via skin contact) (underdose) (syringe issue), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received at an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6257AA via unknown route in unknown administration site.  On an unknown date, it was reported that Nurse states that one of the Medical Assistants went to combine the ActHIB into the DTAP/Ipol vial and once they were combined and mixed together, the metal part of the vial started leaking all over her hand, because it leaked out so much, the Pentacel vaccine was not able to be administered to the patient (exposure via skin contact) (underdose) (syringe issue). The medical assistant had a gloved hand and was able to take off her gloves and wash her hands. According to the caller, she did not have any injuries as a result of this.  No lab data was provided.  Final diagnosis was not applicable the metal part of the vial started leaking all over her hand, because it leaked out so much, the pentacel vaccine was not able to be administered to the patient.   It was not reported if the patient received a corrective treatment.  It was not reported if patient had any adverse event.
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored MMR II. Strength, dose, route and lot number were not provided. MMR II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the MMR II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The MMR II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476 to 1405USA012480, 1405USA012482 and 1405USA004216). Additional information has been requested.
fever; chills; body aches; first dose february of 2020, has not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, chills, general body pain and incomplete course of vaccination. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The case was reported by patient herself. The patient experienced fever, chills and body aches which started the day after she was vaccinated and these symptoms resolved after a few days.  The patient did not receive the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The patient did not consent to follow up.
sore arm; body ache; Headache; cold chills and hot chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (body ache), HEADACHE (Headache) and CHILLS (cold chills and hot chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2019.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (body ache), HEADACHE (Headache) and CHILLS (cold chills and hot chills). On 17-Apr-2021, PAIN IN EXTREMITY (sore arm), MYALGIA (body ache), HEADACHE (Headache) and CHILLS (cold chills and hot chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
The patient developed "leg cramps" thighs and calves bilateral 7 days following Influenza vaccine. The pain was relieved by Darvocet, persists 1/18/01.
On 04/12/21 I awoke to pain to right arm swelling and redness to injection site..on 04/15/21 I awoke at 3am drenched in sweat with chills...weight gain of 6 lbs .. severely swollen right arm with pain and injection site looked like a bullseye....per my son COVID Arm .. my throat is blotchy and painful...in the evening I started experiencing headache which is constant...
Breakthrough case admission after 2 vaccines  Pfizer 2/9/21 Lot# EL9267;  Pfizer 3/2/21 lot# EN6205
LOCALIZED SWELLING, FIRMNESS TO AREA, REDNESS, WARM TO TOUCH. BEGAN 24 HRS. POST INJECTION WITH WORSENING 72 HRS. TREAT WITH TYLENOL, WARM COMPRESSES/WARM BATH
Day after vaccination patient had sore arm, days 2-4 patient had back pains, day 4-8 patient had migraines, day 8 patient woke up with swollen, itchy, and sore arm at the injection site. Patient tried norco and muscle relaxes. Recommended benadryl, and they patient also seen physician who prescribed cephalexin on day 8 after patient contacted pharmacy about adverse reactions
bad chest cold; some pain, at the injection site; lethargy; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargy), LOWER RESPIRATORY TRACT INFECTION (bad chest cold) and VACCINATION SITE PAIN (some pain, at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no known allergies. The patient was never been diagnosed with / tested positive for COVID-19. The patient did not have any chronic or long-standing health conditions.  Concomitant products included ASTRAGALUS MONGHOLICUS ROOT (ASTRAGALUS EXTRACT) for Immune enhancement therapy.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LETHARGY (lethargy) and VACCINATION SITE PAIN (some pain, at the injection site). On 25-Sep-2022, the patient experienced LOWER RESPIRATORY TRACT INFECTION (bad chest cold). On 07-Oct-2022, LOWER RESPIRATORY TRACT INFECTION (bad chest cold) had resolved. At the time of the report, LETHARGY (lethargy) and VACCINATION SITE PAIN (some pain, at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Negative) ran a couple of negative Covid tests.         The patient's weight was reported as 165 (unit not reported).  With the three previous injections, the patient experienced some pain, at the injection site, and lethargy the following day. The patient was not ill but could have felt better having recovered from a bad chest cold a week prior receiving bivalent booster dose. The patient did run a couple of negative Covid tests during the time he had cold.  No treatment details were reported.   This case was linked to (Patient Link).
Pt began with cough about 1 wk after receiving vaccine with SOB, chest pressure worsening, LE edema. Sent to hospital found to have acute heart failure. neg cath (10/30/23); CTA chest neg 10/27/23; cardiac MRI (10/31/23) - global hypokinesis Echo 11/2/23 - mild-mod mitral regurg
Fever of 104 1 F, chills, muscle arches, weakness, tired, headache - started within 12 hours of vaccine injection; still experiencing as of 18 hours post injection.
Shingles in my eye and in my face , body aches, enlarged lymph nodes, tiredness
After each shot she started having palpitations; shortness of breath; she had an EKG but it showed normal sinus with multiple contractions.; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (After each shot she started having palpitations), DYSPNOEA (shortness of breath) and CARDIAC DISORDER (she had an EKG but it showed normal sinus with multiple contractions.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 079F21A, 004M20A and 011LZ014) for COVID-19 vaccination.     The patient's past medical history included Cardiomyopathy (Year before the COVID pandemic, with exercise she had palpitations when she was tired.). Concurrent medical conditions included Drug allergy, Allergy to animal and Allergy to chemicals.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PALPITATIONS (After each shot she started having palpitations), DYSPNOEA (shortness of breath) and CARDIAC DISORDER (she had an EKG but it showed normal sinus with multiple contractions.). At the time of the report, PALPITATIONS (After each shot she started having palpitations), DYSPNOEA (shortness of breath) and CARDIAC DISORDER (she had an EKG but it showed normal sinus with multiple contractions.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: showed multiple contractions It showed normal sinus with multiple contractions..         No Concomitant medication reported   Patient was unsure if First dose was an H or an A Patient was asking if her husband should receive the booster shot. Patient mentioned that she was not sure if she and her husband experienced side effects from the vaccine. Patient was calling to know if there were any reports about developing a body rash kind of systemic autoimmune rash that doesn't go away.  No Treatment medication reported   This case was linked to MOD-2022-503124 (Patient Link).
Child received immunization (sep sheet). 2 hours later, developed diarrhea which persisted till last time seen. 10/26/06 parents changed providers.
12 days after second dose, I woke up with headache, clogged left ear and vertigo.  Ear is still clogged 4 days later.  Used Claritin and Sudafed to treat.  Vertigo subsided.
Case number PHEH2012US017342 is an initial spontaneous report received from a nurse on 28 Aug 2012 with a follow up information received on 28 Aug 2012. This report refers to a male patient of unspecified age. He was vaccinated with MENVEO (batch number: M11082, expiry date: May 2014) 0.5 ml intramuscularly on 20 Aug 2012. On 21 Aug 2012, he experienced tenderness, redness and warmth at the injection site. The patient recovered from the events on 28 Aug 2012. No further information was available. Follow up information received on 28 Aug 2012: Reporter details updated.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L008665, exp. date: 10-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
18MAR97 diffuse pruritic rash on extremities & trunk;not reported until 24MAR97;tx w/Pred, Claritin, Motrin;pt exp serum sickness; pt & husband had infect which contributed to serum sickness;
Moderna COVID-19 Vaccine EUA. Fever, pain at the injection site, generalized malaise, headache
local rxn w/heat, pain, redness beginning day p/vax;PE warm & red 7x5mm are around inj site;
strokes; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is 2nd of 2 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization in a hospital. The patient's medical history was reported as none. Concomitant medications were not reported. The physician reported that there were two patients who came in with strokes with no underlying condition/health risks, but they had been recently vaccinated with the COVID vaccine on unspecified date. The outcome of the event was unknown. The event resulted in physician office visit. The event was assessed as serious (hospitalization).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of stroke, cannot be fully excluded. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021163467 same reporter, product, event; different patient
Lightheadedness; Body aches; Chills; Fever; Headache; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jul-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheadedness), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomited). At the time of the report, DIZZINESS (Lightheadedness), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 08-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 160 hours in which the highest recorded temperature was 59 degrees Fahrenheit (15 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning an approximately 15 months old child from a 20 year old female patient with asthma, migraines, depression, irregular heartbeat, high blood pressure, penicillin allergy and diphenhydramine allergy and a childhood history of anemia who on 22-FEB-2012 was vaccinated IM with her third dose of GARDASIL (lot # 670049/1261AA, EXP 11-NOV-2013). There was no concomitant medication. A pregnancy test was done on 22-FEB-2012 before the patient received dose 3 and it was negative. On 06-MAR-2012, the patient had a positive urine pregnancy test (MARRS case no. 1203USA01156). Her last menstrual period (LMP) was on 03-FEB-2012, and delivery date (EDD) was on 09-NOV-2012. The patient had sought medical attention by office visit. No treatment was given to the patient. On 11-FEB-2014, the baby was seen and was diagnosed with flu. The R.N. also noted in the baby's chart that the baby was experiencing behavior problems and was scheduled for an autism review once the baby reaches 18 months of age. The outcome of the events was unknown. This case is related to MARRS case no. 1203USA01156 (parent-child link). Additional information has been requested.
Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.   Additional details were provided as follows: The case was reported by the patient. Age at vaccination was not reported. The patient asked was a rash starting 3 days after your 2nd shot was common. No contact details were reported.