chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe allergic reaction with hives; Severe allergic reaction with hives / Allergic urticaria; This is a spontaneous report from a contactable consumer (patient) and physician. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration in the left arm on 16Jan2021 at 16:30 (Batch/Lot Number: BMG az nw pod, at the age of 32-year-old at vaccination) as a single dose for COVID-19 immunisation.  Medical history was reported as none. The patient has no known allergies. The patient did not receive any other vaccine within four weeks of the vaccination. There were no concomitant medications. Historical vaccine information included the patient received the first dose of BNT162B2 on 29Dec2020 at 16:30 PM (Batch/Lot number: BMG nw pod, at the age of 32-year-old at vaccination) as a single dose for COVID-19 immunisation. On 16Jan2021 at 16:30 the patient received the second dose of the BNT162B2 vaccine. On 29Jan2021 at 07:00, "right after" the vaccination, the patient developed a severe allergic reaction with hives. He went to 3 different allergist and it was not found to be a food allergy. The patient stated he has reason to believe the vaccine caused the reaction since it's a possible reaction. It has been 4 months and he was miserable. The antihistamines were not working. Steriods help 80% but he feels horrible from taking them. The event has resulted in doctor or other healthcare professional office/clinic visit. On 18Apr2021, the patient had a televisit follow up. On 18Apr2021, the patient had a food allergy lab test with unknown results. On 03May2021, the physician saw the patient for allergic urticaria. The physician saw the patient several months after the reaction. The physician reported discrepant therapy dates for the BNT162B2 vaccine (the first dose was received on 07Jan2021 and the second dose was received 21Jan2021). The patient has not tested positive for COVID-19 post vaccination. Post vaccination: PCR COVID-19 SARS-CoV-2 test was negative on 30May2021. The reporting physician considered that the causal effect to the adverse event with the BNT162B2 vaccine was possible. The outcome of the event severe allergic reaction with hives / allergic urticaria was not recovered.
MIGRAINE HEADACHES; CHILLS; FLUCTUATIONS IN HOT AND COLD FEELING; SNIFFLING AND RUNNY NOSE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type 1, and undisclosed autoimmune disorder.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced fluctuations in hot and cold feeling. On 20-MAR-2021, the subject experienced sniffling and runny nose. On 20-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced migraine headaches. Treatment medications (dates unspecified) included: sumatriptan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fluctuations in hot and cold feeling, sniffling and runny nose, and chills on 21-MAR-2021, and migraine headaches on APR-2021. This report was non-serious.
This spontaneous report was received from a consumer refers to his 66 year old wife (female patient) with penicillin allergy. No medical history was reported. On 25-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). Concomitant medications included some unspecified sleeping medication (manufacturer unknown). On 26-APR-2013, one day after getting the injection the patient suffered from a large red lump that was hard at the injection site. She also felt knocked out. She put ice on the site all day Friday and Saturday and was feeling much better by Saturday evening. No treatment was received. No laboratory diagnostic tests were performed. No medical attention was sought. The injection site was still red. The patient was recovering from the events. Additional information has been requested.
Injection site swelled up to size of tennis ball was hot and intensely itchy. Lasted for 4 days.Treatment was topical gel hydrocortisone, ice, and Sudafed. Outcomes were reduced itching, heat, and swelling when ice applied and topical hydrocortisone gel. Swelling, heat, and itching abated.
Night of injection I had chills around 12 am but next day fine. On the second day I started getting itchy on my right arm, I thought a mosquito had bit me. Went to check and noticed both arms were covered in red blotches. Went to store to get hydrocortisone cream and Benadryl. Got home and noticed more red spots on my legs and lower back. I?m currently on day 3. I have also taken Zyrtec and Claritin.
Per patient's mother:  "localized allergic reaction" in her right deltoid.  Mom states there is a two inch welt which is "red and hot."
Day and half of Dizziness, extreme fatigue, hard time walking  and getting up from laying down,  sharp pain in toes, headache and slight fever.
Chills/aches throughout body; nerve pain and numbness in both legs and feet; mygraine headaches
10/7/2009- paresthesias feet- last several days then resolved. 10/23/09-paresthesias L foot then bilateral feet, spread to hands, then face. Difficulty lifting left foot. 10/27/2009-  severe Shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. Then progression of severe lower extremity weakness, upper extremity weakness,  motor/ neurological motor processing difficulty, orthostatic hypotension and labile blood pressures, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynauds, insomnia, myalgias, slow speech, hypokalemia, abnormal balance/gait. severe sensitivity to sound, cholecystitis. Treatment- hospitalization, blood pressure meds, physical therapy, massage therapy.
Immense pain in arm unable to lift. Worse than 3 previous by far.  Also I recently caught covid (6/19) and that arm swelled and a bruise the size of a softball appeared.  As of July 11th the arm is still sore and swollen but it's better than when infected. Bruise is no longer visible. I've pointed this out to my gp. Not sure if this is related but my neck on the same side has been stiff as well.
Patient's eyes are swollen, upper and lower lids, and significant watering. Patient states that she had not had that prior to immunization. Additionally she had pain and swelling at injection site. She has seen her ophthalmogist and her regular physician regarding her eyes. No diagnosis.
THE PATIENT HAD A SORE ARM AFTER THE IMMUNIZATION FOR SEVERAL MONTHS.
L sided HA, severe pain and photophobia, nausea, dizziness/vertigo. IMITREX 25 mg given. TYLENOL, ALEVE taken prior to presentation in clinic. Meclizine 12.5 mg given in clinic.
Moderna COVID-19 Vaccine EUA - within 30 minutes - high blood pressure, dizzy, nauseous, within one hour - fever, joint pain, chills, fatigue - resolved within 24 hours. Arm pain lasted 3 days.  On 1/23 - arm pain returned with a rash
Increasing difficulty swallowing - described as a "large peach pit in throat" achy, fatique, malaise.
Severe arm pain, body aches, fever, chills, headache, lasting 3 days.
Dizziness:  within an hour of infection Pain at injection site; low-grade fever; tiredness, headache; muscle & joint pain began about 12-1 am on 03/23/21 Took 2 Aleve about 7 am (no help) then 2 Extra-Strength Tylenol (a little relief) about 11 am.  And finally 2 Advil at 7 pm (gave most relief) on 3/23/21.   All symptoms lasted until about 9 pm on 03/23/21
It looks like he is suffering from a headache. He holds his head a lot; he is in general discomfort; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (It looks like he is suffering from a headache. He holds his head a lot) and DISCOMFORT (he is in general discomfort) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Brain damage.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (It looks like he is suffering from a headache. He holds his head a lot) and DISCOMFORT (he is in general discomfort). At the time of the report, HEADACHE (It looks like he is suffering from a headache. He holds his head a lot) and DISCOMFORT (he is in general discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Tylenol. No concomitant medications were provided by reporter.   Reporter did not allow further contact
weakness; high fever (103-104) for six days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and PYREXIA (high fever (103-104) for six days) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ASTHENIA (weakness) and PYREXIA (high fever (103-104) for six days). At the time of the report, ASTHENIA (weakness) and PYREXIA (high fever (103-104) for six days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to an unknown age.
Mom states 24 hrs after imm. Pt had raised white papules with erythema around, on chest, legs that resolved with BENADRYL then reappeared in more areas the next day. With itching.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 13:30 as dose 1, single (Lot number: EL3246), in left arm, on 09Feb2021 at 13:30 as dose 2, single (Lot number: EL9265), in left arm, on 27Sep2021 at 16:15 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 04Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FK98933579) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "EBV" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Hyperlipemmia" (unspecified if ongoing); "Diverticulosis with Bowel resection" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Demerol, reaction(s): "known allergies"; Erythromycin, reaction(s): "known allergies"; Gabapentin, reaction(s): "known allergies"; Statins, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 9 days after the suspect product(s) administration, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: Body temperature: (30Jul2022) 104 Centigrade, notes: Day 0 temp104degree, High; (31Jul2022) 103 Centigrade, notes: Day 1 Temp 103degree, High; (08Aug2022) 101.4 Centigrade, notes: Day 9 rebound temp101.4degree, High; SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Paxlovid was used from 30Jul2022 to 03Aug2022 for the treatment of COVID-19. Adverse event: Day 0 temp 104degree, chills, severe Headache, eye ache. Muscle and joint pain Bronchitis type cough mild SOB with exertion (Hx Asthma), phlegm clear the yellow malaise. Day 1 Temp 103degree. Afebrile with Tylenol. Continued cough, malaise, joint and muscle pain. Day2 slight improvement. No loss of taste/ smell continued cough some nausea with paxlovid. Symbicourt increased to 2 puffs bid, Albuterol q8degree. Day 9 rebound temp101.4degree severe HA, body/joint pain eye ache cold symptoms runny nose, sneezing loss taste/smell test Pos. Adverse event start date: 08Aug2022 12:00AM. Patient was not recovered and no treatment was received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201053725 Same patient, different product and event;
Maderna COVID19 Vaccine EUA   Resulted in mild sore left arm only.
Recvd Prevnar 13 #3 and Pediarix #3 at 6 month physical 10/7/2014.  Per parent report was fine the rest of the day. rash noted in office had resolved. Had given Tylenol 'just in case' when they got home.   Slept well.  At 3.40am woke up with 'desperate' crying - when picked her up felt hot. Gave her 1.25ml of Tylenol. And ~10 minutes later head rolled back, eyes rolled back. Arms became stiff with jerking movements as well as right leg. Was moaning. Breathing became a concerned and her face turned blue for 5 minutes.  took "20 minutes" for jerking movements to resolve. Call 911 - EMS temp axillary and otic was "around 100F". She was sleepy afterwards.  Movements had resolved prior to EMS per dad - Checked temp 100.4F axillary afterwards - no Tylenol given.  Were told it was a febile seizure.
Bruised, swollen arm and sore arm. Went to Dr to check her arm, Dr did a venous doppler to check for blood clot and no blood clot.
Initial unsolicited report received from a nurse on 13-Jul-2018. This case involves a 20-year-old female patient who received an expired dose of 0.5 ml MENACTRA lot number: U5523AA, expiration date: not reported via intramuscular route in the right deltoid on 12-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was not known whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient states when she received the vaccine she bled at site of injection and immediately bad pain. The next day her arm was swollen, black & blue and warm to the touch. She states that the swelling has gone down, but it is still warm and very painful. She says her whole arm hurts. She has contacted her primary physician and was told it might be a hematoma, but has not yet been seen by the physician.
Information has been received through the Merck pregnancy registry from a nurse concerning a female with no pertinent medical history and no history of drug reactions or allergies on prior pregnancies who between January and April 2008 received at least 2 doses of GARDASIL at a different facility.  There was no concomitant medication.  The patient was pregnant.  Her last menstrual period was approximately 26-DEC-2007.  The estimated due date is 02-OCT-2008.  The patient was seen in the reporter's office in April 2008 for obstetric care.  On 23-APR-2008, the patient had a normal ultrasound and negative serum alpha-fetoprotein test.  On approximately 26-MAY-2008, the patient developed vaginal bleeding.  On 25-MAY-2008, an ultrasound was performed and was normal.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Within 5 minutes of influenza vaccination, Pt came in itching + had facial Flushing. Pt has an allergy to chickens but stated she has never had any trouble with Flu vaccinations.
Ehlers-Danlos syndrome; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: EHLERS-DANLOS SYNDROME (non-serious), outcome "unknown".  Additional information : This nurse below reported to her today that she developed Ehlers-Danlos syndrome subsequent to receiving Pfizer's Covid vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Late afternoon of June 28th, 2021, I became aware of numbness, painful tingling and burning sensation extending from between my eyebrows down nose and mouth. This extended  horizontally from the center of my face in a widening arc to include my right eye and right cheeks, down to my throat. It also included a small patch, about the size and shape of an almond , to  the tip of my right index finger.   This caused me to feel as if there were spider webs in my mouth, caused me to drool and presented dryness, intense pressure to my right eye. I went to bed and expected it to be resolved by the time I awoke.   The next morning these symptoms were unchanged. I called a telehealth Urgent Care for a visit, who urged me to go to the emergency room.  Due to the very strange feeling of burning and tingling I thought it may be a herpetic type reaction, but the online provider wanted to rule out stroke. I did go the the Emergency room that day. Neuro workup did not indicate stroke, nor Shingles, though provider did give me an antiviral for good measure, that seemed to have neither helped or hurt. The symptoms did lessen over the next week. I still have numbness to tip of my nose, half of my lips and tip and right side of my tongue, and right finger as well.
pt recv vax & 3months later was found to be thrombocytopenic; This discovery was made on routine blood test; pt seen by MD; all other lab values are nl; bone marrow biopsy indicated pt had ITP;
was in so much pain she was crying; Right ankle and foot was swollen and shiny/wrist was swollen and shiny/knee was swollen and shiny; knee was shiny with a lump she did not have before; arm, hand was swollen and shiny/foot was swollen; right elbow is messed up/its swollen and stiff; right elbow is messed up/its swollen and stiff; This is a spontaneous report from a contactable consumer.   An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), first dose on 28Jan2021 at 12:30 then second dose at 18Feb2021 at 11:25, both via an unspecified route of administration at a single dose on left arm for COVID-19 immunisation. Medical history included diabetes mellitus (diagnosed 40 years ago) and a heart condition (had 5 stents, angioplasty, open heart surgery, clarified as triple bypass, in 98, 7 heart caths- 2 of them in one day, a stroke and a heart attack) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the vaccine, the second one on 18Feb2021, last Thursday. She was in the hospital yesterday. On 21Feb2021,  the patient experienced her right ankle and foot was swollen and shiny, her knee was swollen and shiny and knee was shiny with a lump she did not have before, arm, hand and wrist were swollen and shiny and her shoulder, and her right elbow was messed up. The doctor is the current county health advisor, he said to report all these things. On 21Feb2021, the patient was in so much pain she was crying. She went to the emergency room because it hurt so bad and then was admitted and kept overnight. The patient was put on prednisone to help with swelling. The patient's right elbow being messed up is improved and persisting, its swollen and stiff. The outcome of the events knee was shiny with a lump she did not have before and pain was recovering, right elbow messed up was not recovered, while of the rest was unknown.  Information on the lot/ batch number has been requested.
Fever, 3 cysts (inguinal, under arm and behind ear) inflammation-pain, tx CIPRO, BACTROBAN and MOTRIN by Dr.
24 hours after the 3rd booster.  Injection site was painful and red for 2 weeks. fever, chills and body ache, upset stomach and could not eat and nausea. After a month went to doctor  on 7Jan2022, Given antibiotics.
Started with a slight fever and fatigue, evolved to intense chills and feeling very cold, got a 102.5 fever from midnight ~ 8am, milder fever until ~7pm day after vaccination. At the same time as the fever an intense headache started and lasted until ~ 10am. In that afternoon pain in the joints and muscles of the legs started and lasted all afternoon and early evening. Fatigue lasted until ~ 48h after vaccination. Muscle pain at the injection site started directly after vaccination and is still ongoing.
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patient was vaccinated with GARDASIL (dosing details unspecified). On an unknown date, unspecified time after vaccination, the patient fainted. No Product Quality Complaint (PQC) was involved. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with the suspect therapy. Additional information has been requested.
Fever, dizzy spells approx 24 hours after receiving pneumonia and Hep A vaccine injections and 1st oral typhoid pill.
patient was already vaccinated with the flu vaccine on 9/15/23 and received another one on 11/3/23 by error
Pt received vaccine at 1245. Pt began experiencing numbness in tongue, light-headedness and a scratch in her throat at 1251.  Pt was given Benadryl 50 mg PO at 1258. Provider evaluated pt at 1315 lungs were clear and did not find any significant swelling. Tylenol 650 mg was given at 1354. At 1358 swelling on the L side had subsided, but tingling tongued throughout mouth and throat, with a "pounding" headache on the R side of her head. Benadryl 25 mg was administered at 1358.  BP at 1315- 136/81, 1319- 119/71, 1344- 117/79, 1400- 130/82
Patient became very pale, reported feeling dizzy and having blurry vision after immunization, patient was given a cold pack to apply to neck and gradually felt better, patient remained at pharmacy for 30 minutes for monitoring
She received 4th dose by mistake on 10/29/2021. She received her third dose on 10/14/2021.
This spontaneous report as received from a pharmacist via a company representative concerns a female patient of unknown age, who on an unknown date, was vaccinated with ZOSTAVAX "one shot/ once" (dosage and lot number not provided) by subcutaneous injection. No information was provided regarding concomitant medications or the patient's medical history. On an unknown date, after getting the ZOSTAVAX), the patient experienced a rash which was diagnosed as shingles. The shingles were on her shoulders and chest. It was unknown if the patient received any treatment. The outcome of the rash which was diagnosed as shingles is unknown. Additional information has been requested.
Joint pains/aches since vaccine given. Shoulder/armits aching - elbow/arms stiffening. Received affected Lot GARDASIL (J007354) on 10/04/2013 No Complaints at that time.
Child developed a large area of pink/redness over the upper arm.  This was also warm to the touch.  Dr. advised family to ice the area, and if necessary they could apply Hydrocortisone cream over the area.  They did not contact the office again, so we assume resolution to symptoms.