chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temp of 103 F; chills; body aches; This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. A patient (medical director) of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2 (lot/ batch number and expiry date were unknown) on an unspecified date at a single dose for COVID-19 immunization and had no adverse effect. The patient had the second shot and spent Wednesday in bed with a temperature of 103F, chills, and body aches on an unspecified date. Outcome of the events was unknown.    Information about lot/batch number has been requested.
Pt fainted within 5 minutes of vaccine administration. Pt ran a fever no higher than 102.1F for 3 consecutive days. The pt maintained a sore throat for 3 consecutive days and experienced stomach irritation.
Swollen lymph nodes; Injection site pain; Tiredness; Insomnia; Double vision; Joint pain; Muscle pain; Nausea; Chills; Sweating; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization (at the age of 35-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on an unspecified date, as single dose for COVID-19 immunization and experienced injection site pain, tiredness, insomnia, headache within the first 4 hours, muscle and joint pain, nausea, feeling unwell, cough for the first 30 minutes, accelerated heartbeat for the first 30 minutes but did not last, dizziness and weakness for the first 4hous. It was reported that after receiving the second dose of vaccine on an unspecified the patient experienced injection site pain, tiredness, insomnia, muscle pain, joint pain chills, nausea, swollen lymph nodes, double vision and dizziness within the first 4 hrs and also experienced sweating. Caller mentioned that she had side effects after getting the first and second dose of the vaccine and stated that she had experienced way more severe and longer than usual side effects during the first dose compared to that of the second dose. Caller would like to know if there are currently any antibody test used for detecting the COVID19 virus accurately post vaccination that might not give a false positive result. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Felt like tendinitis; Skin burning on legs for a couple hours; Still has slight pain in arm where he had surgery; Fatigue; Severe joint and bone ache; Severe joint and bone ache; Slight headache; Minor nausea; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Felt like tendinitis), SKIN BURNING SENSATION (Skin burning on legs for a couple hours), PAIN IN EXTREMITY (Still has slight pain in arm where he had surgery), FATIGUE (Fatigue) and MYALGIA (Severe joint and bone ache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDONITIS (Felt like tendinitis), SKIN BURNING SENSATION (Skin burning on legs for a couple hours), PAIN IN EXTREMITY (Still has slight pain in arm where he had surgery), FATIGUE (Fatigue), MYALGIA (Severe joint and bone ache), ARTHRALGIA (Severe joint and bone ache), HEADACHE (Slight headache) and NAUSEA (Minor nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TENDONITIS (Felt like tendinitis), SKIN BURNING SENSATION (Skin burning on legs for a couple hours), PAIN IN EXTREMITY (Still has slight pain in arm where he had surgery), FATIGUE (Fatigue), MYALGIA (Severe joint and bone ache), ARTHRALGIA (Severe joint and bone ache), HEADACHE (Slight headache) and NAUSEA (Minor nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included cholesterol medicine, over the counter sinus medicine and EMTRICITABINE, for an unknown indication.   This case was linked to MOD-2021-059685 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021. Reported email ID has been updated.; Sender's Comments:  MOD-2021-059685:First Dose Case
COVID-19; COVID-19; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4510288-00.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 04May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. The patient's concomitant medications were not reported. No known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: On 23Jun2022, the patient experienced Covid. In 2022, the COVID resolved. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The patient was treated with Paxlovid and Cortisone. The reporter's causality for the event of Covid with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event of Covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Possible.  The reporter considered "covid-19" related to BNT162b2.  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 known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
A report has been received from a Physician concerning a 15 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The patient received FLUMIST on 10-Dec-2013 that expired on 09-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 031B21A) for COVID-19 vaccination. 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that there are 4 days temperature data (between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit. Treatment information was not reported.
Severe body aches, fever, chills, severe headache 3 days now, nausea, exhaustion
PAIN AT RIGHT SIDE-FLANK AREA AND  BEHIND RIGHT KNEE Narrative:   Other Relevant History:
Tingling at site within a few hours of injection. Large red hard warm circular rash at site of injection the following morning. Itching speckled rash on the arm around the redness.
This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of GARDASIL (dose, route, lot and expiration date were not reported), exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second all was reported that no doses of VAQTA where involved in this excursion. This is the one of two reports from the same source. Additional information has been requested.
Patient developed hives the day after receiveing vaccinations. Began on lower extremeities and spread to her upper chest. Afebrile. Otherwise feeling fine. Benedryl provided relief. Symptoms had improved after 4 days, althou some hives were still present. Patient was adopted from another country, childhood immnuizations were documented as being received, but when titers were drawn, pt was found not immune, therfore repeat vaccinations are being provided per pediatricians recommendations.
My arm started twitching the day  I received the shot. It has been twitching on a daily basis for about 2-3 seconds intermittently ever since that day. The twitching seems to be getting stronger.
Parents reported today as child's first COVID-19 vaccine to registration and to administering nurse.  Parent completed registration form and signed checking moderna, 1st vaccine, and NO - on history of previous COVID-19 vaccination.   Patient was not found on initial search of CVMS during registration using name and DOB.  After vaccine administration, clinical team attempted to enter vaccine information into CVMS and saw that patient had in fact received a two dose series of Pfizer vaccines in Nov and Dec 2021.  I called and spoke to patient's mother who had difficulty recalling his COVID-19 vaccinations in 2021.   She reported thinking that she needed this vaccine today because the "news said to get it."  I discussed the current recommendations for booster for her age in detail with her and explained the process for reporting the incident.  Also discovered patient's DOB was entered incorrectly into CVMS during the 2021 entry.  Patient's mother expressed verbal understanding and had the opportunity to ask questions and had none.
5/28/13: 12-month vaccines --> MMR to right thigh. 5/29/13: Phone call reporting "red bump" to right thigh. 6/05/13: Office visit for rash, clumsiness --> sterile abscess, right thigh --> 1 cm area of petechiae to sternum, o/w no rash --> uncertain ataxia with gait weak, right side. 6/07/13: Follow-up office visit --> rash, (+) ataxic gait --> admission hospital Dx "Acute cerebellar ataxia."
Shingles; Outbreak back & right breast with intense pain over 48 hrs; Outbreak back & right breast with intense pain over 48 hrs; itching & pain within 24 hrs; itching & pain within 24 hrs; tingling in chest right side; Blisters; Scars on back; nerve pain; This is a spontaneous report from a contactable consumer (Patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 27Jan2021 at 14:30 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. The most recent facility where the COVID-19 vaccine was administered was reported as other. Medical history included arthritis, IBS, dermatitis and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID) and ibuprofen, both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to vaccination or on the same day of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that patient does not had any previous shingles before vaccination. On 27Jan2021 at 15:45 (minutes after vaccination), patient experienced tingling in chest right side, blisters, scars on back and nerve pain. On 28Jan2021, patient had itching & pain within 24 hrs. On 29Jan2021, patient experienced an outbreak back & right breast with intense pain over 48 hrs. The patient had tried to call doctor, who was unable to see patient till Tuesday (reported as 02Jan), and on an unspecified date in Feb2021, patient was diagnosed with Shingles. However, it was too late to administer any medication that would help clear up quickly. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were assessed as Serious (Disability/Incapacitating/permanent damage). The blisters took over 10 weeks to clear and the event nerve pain was continuing at the time of report (27Jun2021). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures included gamapentin for pain. The outcome all the events except nerve pain was recovered with sequel. The event nerve pain was not recovered.
pt recv vax & was again vaccinated w/MMR in 1994 & failed to seroconvert;
Evening of 12/27 she noticed redness, swelling to inner and outer upper arm. She reported pain to touch, warm to touch. Pt tried ice packs. OTC allergy meds, anti-inflammatory with no relief.
After my 2nd dose about 2 weeks post-injection  I started to experience extreme vestibular problems.  Head pressure, dizziness, vertigo, ear pain, and plugged ears. I've never experienced something like this before. It has affected me so severely I was practically disabled until probably September it started to let up.  I still experience problems today but it is very manageable now.  I did get my booster even though I was very scared to retrigger this but so far it has not worsened and it's been a few weeks.
pt recvd vax & later in day exp palpitations, dizziness & was jittery; recovered in 2 days;
Swollen lymph node in left armpit; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730), via an unspecified route of administration on the left arm on 04Jan2021 at 15:45 at a single dose for COVID-19 immunization. The patient has no medical history and no known allergies. The patient's concomitant medications were not reported.  The patient experienced swollen lymph node in left armpit on 05Jan2021 at 16:00. No treatment administered for the event. The patient did not have other vaccine in four weeks or other medications in two weeks. The patient also did not have Covid prior vaccination and had not tested for Covid post vaccination. The event was resolving.
Pt was given vaccine and immediately c/o SOB and numb tongue.  Called emergency number.
swelling; itching on arm; injection site redness and itching; Itching and burning; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Itching and burning), VACCINATION SITE ERYTHEMA (injection site redness), SWELLING (swelling), PRURITUS (itching on arm) and VACCINATION SITE PRURITUS (injection site redness and itching) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced BURNING SENSATION (Itching and burning) and VACCINATION SITE ERYTHEMA (injection site redness). On an unknown date, the patient experienced SWELLING (swelling), PRURITUS (itching on arm) and VACCINATION SITE PRURITUS (injection site redness and itching). At the time of the report, BURNING SENSATION (Itching and burning), VACCINATION SITE ERYTHEMA (injection site redness), SWELLING (swelling), PRURITUS (itching on arm) and VACCINATION SITE PRURITUS (injection site redness and itching) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications not provided.  Treatment not provided.
2-12-10 Swollen left upper arm from shoulder to elbow no pain. Itchy. 2-13-10 Spotty fine rash on tummy and hips, itchy tx with Benadryl orally by mouth. 2-15-10 rash, itchy resolved as well as swelling arm.
Next day following vaccine, site was sensitive to touch, red, and inflamed.  The site would decrease in size when ibuprofen was taken and when effects of drug decreased, the site would grow in size again. Left arm was sore to raise and site felt tight when lifting arm.  Inflammation, redness, and soreness continued for 4 days post vaccine.
Patient reported loss of hearing and sight about 5 minutes after the injection.  Was in car with mother, who laid patient's passenger seat back, patient pass out for a few seconds, then went she came to, felt fine.
Fever 103 w/delerium began evening of inject & 2 days following inject; In AM pt tired but no temp;
Pfizer-BioNTech COVID-19 Vaccine Nausea, diarrhea, myalgias, cephalgia
Headache, Myalgia, Arthralgia, Fever CHILLS Narrative:
COULD NOT WALK; LEGS HURT SO BAD FOR 3 DAYS; This spontaneous report received from a patient via a company representative from social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal arteriovenous malformation. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. On an unspecified date, the patient experienced could not walk, and legs hurt so bad for 3 days (dose number in series: 1). The patient recovered from legs hurt so bad for 3 days and outcome of couldn't walk was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced could not walk, and legs hurt so bad for 3 days (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from legs hurt so bad for 3 days, and the outcome of could not walk was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 3) (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced could not walk, and legs hurt so bad for 3 days (dose number in series: 3). This report was non-serious.  This case, involving the same patient is linked to 20220220578 (dose number in series: 1) and 20220222831 (dose number in series: 3).
I developed Shingles on 3/16 left side of my face. It started off as small cluster blisters contained to that one side of my face spreaded back of my neck accompanied by TJ symptoms. I had a TeleHealth visit was prescribed Antiviral medication and was told vaccine might have triggered my immune system. I have been on the medication for a week now symptoms had subsided.
Soreness at injection site after 2 hours; Headaches and chills with fever up to 100.4F starting about 9 hours after injection and lasting over 12 hours.
Nervous system shot . Profound non stop headaches . Profound body ache on spine , knees , nerves . Blisters that burn and cause nerves to hurt
Heart rate shot up to 130 a hour after shot. It?s been doing this ever since. I?ve been in the er 3 times for a high heart rate. I?ve been to my doctor and she recently put me on a beta blocker to calm my heart, she also put a stat referral to see a cardiologist.
At the site of the injection, several skin colored bumps appeared after 2 days.  Then, four days later, on 8/21/11, child began first mensturation.  Didn't know if the Gardasil injection was related to the onset of the menstruation although it is most probably related to the 30 or so, bumps.
Immediately when imm given burning sensation followed by soreness to (LT) deltoid. Ibuprofen taken for several days following imm. ALEVE is taken every night so she can sleep on that arm. Continues extreme soreness to deltoid (lt).