chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning, pain, sore muscle. heat, ice, Benadryl missed work of three days. Unable to move arm for three days and limited movement for a week. Area tender and itchy for three weeks.
Severe vertigo, with cold sweat, extreme nausea-went to ER-given cardiac, blood and CT tests. Symptoms going away. Will follow up with ENT
p/Hep B vax pt w/local swelling 8mm, no SOB, no chest pain, no diaphoresis; VS BP 110/60, P76, RR 16-20; ice pack applied to inject site; pt exp sore arm;
NAUSEA; BEDRIDDEN; MUSCLE ACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 08-APR-2021 15:00 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 08-APR-2021 23:00, the subject experienced chills. On 09-APR-2021, the subject experienced bedridden. On 09-APR-2021, the subject experienced muscle ache. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, muscle ache, fever, bedridden and nausea was not reported. This report was non-serious.
Pt received immunization in left deltoid and now entire arm feels "heavy".  Per pt it's very hard to move.  She also has severe pain at and surrounding injection site.
rash, welt, redness, warm to touch, 12 inches long, 4.5 inches wide, itchy
Patient complained of pounding headache 2/10, right lateral side, 15 mins after receiving first dose of the vaccine. She denied past medical history. She was assessed and monitored by NP, EMT, and paramedic. Initial BP - 135/90, HR - 80, O2 SAT - 98% on RA.
On the 9th night post 1st dose of vaccine, my right hand started feeling itchy and I noticed small hives by my thumb area. Later in the middle of the night, I got them on both palms and they were both itchy, though tolerable. By next morning, 10th day post vaccine, I had noticeable hives on both hands. They were itchy but manageable. I put some OTC hydrocortisone cream on both hands and that helped. By the next day, they were still there but not getting worse. Some hives were located on inner fingers, which made them swell. By the 3rd day of hives, they were subsiding and not worse. I did start feeling a bit of it on my feet, very minimal - maybe 2 or so per foot.
This spontaneous report was received from an office administrator refers to a 15 year old patient. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 03-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 (lot # M007764, expiry date: 30-JAN-2018) via intramuscular route. Reporter stated that the patient received their first and second dose of the vaccine (lot # L044475, expiry date: 12-MAY-2017 and lot # M005714, expiry date: 03-OCT-2017) on 25-MAR-2016 and 09-JUN-2016, respectively. The patient did not experience an adverse experience. Additional information has been requested.
PT EXPERIENCED SYNCOPE AND JOLTED HIS EXTREMITIS FOR FEW DECONDS BEFORE REGAINING CONSIOUSNESS. PATIENTS BP WAS 121 /78.
(Per mom) started like a "small knot"-turned red and redness spread to other side of arm. Fever of 101-102. Mom states that it started in the morning.
Diarrhea; This is a spontaneous report from a contactable consumer.This consumer reported similar events for 3 patients. This is 3rd of 3 reports.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were unknown. It was reported that patient's family members too also had a little diarrhea. On an unknown date, the patient experienced diarrhea.The outcome of the event was unknown.  Information on Lot/batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021124300 similar report from same reporter
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. Patient received the vaccination. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Patient medical history included Afib with known allergies to Sulfa drugs. Concomitant medication(s) included: ELIQUIS, start date: 09Nov2016, stop date: 11Jul2022; HYDROCHLOROTHIAZIDE, start date: 01Mar2017, stop date: 20Jul2022; CANDESARTAN CILEXETIL, start date: 08Feb2017, stop date: 20Jul2022. Other medications in 2 weeks included Eliquis with brand name Bristol myers squibb from 09Nov2016 to 11Jul2022, Hydrochlorothiazide with brand name Avet from 01Mar2017 to 20Jul2022 and Candesartan Cilexetil with brand name Mylan from 08Feb2017 to 20Jul2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Patient received Paxlovid from 11Jul2022 to 16Jul2022 for treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; LOSARTIN. 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: (26Sep2022) Negative; (27Sep2022) Positive, notes: Positive test today (negative yesterday). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment Paxlovid from 18Sep2022 to 22Sep2022 for covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Disoriented  Loss of motor skills (walking) Fever Vomiting Diarrhea Could not stand from seated position
It started after dinner just sitting on the couch, I started feeling pain at left abdomen under my lungs. It wasn't going away and was getting worse. I took TYLENOL PM. It wasn't gone in the morning. I was hoping it was gas. I ate lunch and it got worse. I couldn't walk after that. I noticed my whole abdomen was tender to the touch. I called my doctor office, they told me to go to the emergency room. I did go to the emergency and they took blood and urinalysis and an ultrasound. Dr. through she was seeing diverticulitis. I then had a CAT Scan and changed diagnosis to Omental Infarction. I lost blood supply to part of the Omentum. We were going to see if it would left heal. My internist did follow up blood work and one of the results came back questionable. The Protein S showed a little below the normal range. They aren't sure if it's significant so they're sending me to a hematologist. I'm on a cardiology event monitor for two weeks. I have an ECHO coming up to make sure my blood is flowing.
Administration Error: 12-Year-Old Female patient receives Bivalent Pfizer dose as first dose.
Left thigh pain, redness, warm, rash since shot. No fluctuation. Dx cellulitis. Pt rx'd Keflex 125mg/5ml PO Q 6 hours x 1 wk.
Right arm painful, swollen, red, bruised. The next day had red blotches from shoulder to elbow..  Went to doctor, started on Bactrim, Benadryl, and Zantac.
PATIENT IS 17 YEARS OLD . MODERNA VACCINE HAS NOT BEEN APPROVED FOR INDIVIDUALS UNDER THE AGE OF18. PATIENT INADVERDENTLY RECEIVED HER FIRST DOSE OF MODERNA VACCINE.  NO KNOWN REPORTS OF COMPLICATIONS  FOLLOWING DOSE ADMINISTRATION
Patient complained of dizziness, coughing, and shortness of breath. She was alert, able to talk and was not wheezing. She was monitored for 30 minutes and symptoms subsided. Husband stated she has been coughing for a few days and was going to see her primary care doctor soon.
Pt came to clinic on 5/12/10 states (L) upper arm red & swollen & tender & painful. Injection site fine but below still warm, tender to palpation.
I am having really bad headaches which I thought was sinus infections. I was tested for COVID for was negative. Its a right sided headache that I have been experiencing for about 2 weeks. I could not determine the source of my pain. I saw the nurse practitioner for it on February 16. The provided treated me for a sinus infection but indicated that the symptoms typically are related to the omicron variant  but that was not my case. She gave me Augmentin for 10 days. I am still having some continuous symptoms and some off and on symptoms.
upon entry to Observation Area, patient reported that while vaccine was being injected he felt a "burning like fire" at the time of the shot and continues to have lesser burning 1.5 hour later. Left upper arm at injection site is if normal color, not swollen, not tender to palpation, and patient is able to move arm freely.
Pt received vaccine and stood next to mother waiting for sibling to receive vaccine. After about 2 -3 minutes, she felt faint and leaned heavily on her mother. She then reports momentarily blacking out during the time we helped her to sit in a chair across the room. She never appeared to lose consciousness but required assistance to cross the room to the open chair.  Once seated she said she felt dizzy and nauseous, like the room was spinning. He pulse and breathing were within normal range but she was flushed and sweating. She was given some water and sat for about 10 minutes and she started to feel better. She reports, no health conditions, allergies or needle phobias. Her mother reports that she had not had anything to eat since the night before. She walked on her own to the chair outside the immunization room with no issues. I asked her to stay for an additional 15 to 20 minutes be sure her episode resolved itself. After another 10 minutes she said the sick feeling was coming back and she felt very drained and unstable and she reported feeling nauseous and feeling pain in her stomach. It was at this point that we made the decision to call the ambulance. They arrived within 10 minutes and after evaluation took her to the hospital to be seen. Followed up with mother around 6:30pm - Mother reports she was evaluated and an EKG was preformed, everything cam back normal - they diagnosed it as a vasovagal reaction. no medications were prescribed and she is to follow up with her primary care MD at the earliest opportunity. Mother reports pt is still feeling tired even after almost 6 hours.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: Em9810), in left arm, on 08Mar2021 as dose 2, single (Lot number: En6202), in left arm and on 18Aug2021 as dose 3 (booster), single (Lot number: Ew0181) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Feb2022 as dose 4 (booster), single (Lot number: Dd7j21-2a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive; (Apr2022) Negative; (Apr2022) Positive, notes: retested positive in a rapid test again (day 14).Therapeutic measures were taken as a result of covid-19 with Anti-viral. Details of the treatment are as followed. Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 10Apr2022, Treatment stop date: 15Apr2022, Indication: Treatment of COVID-19.  Clinical course: Adverse event: Patient is also on Humira, got covid and started Pax and delayed my Humira until symptoms subsided. Patient took the Humira on day 4 of Pax, finished Pax, She felt a lot better, my tests went to negative. I continued to feel tired, though. But then she developed cold like symptoms and retested positive in a rapid test again (day 14). Adverse event country: Adverse event start date: 21Apr2022.  No follow-up attempts are possible. No further information is expected.
Right arm at injection site day of and right T10 dermatome distribution vesicular rash over next 3 days.
weird rash welts on my body; My body is itchy; her legs, shoulders, back, forearm, neck and everywhere; Swell up on my breasts; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0161; Expiration Date: 31Jul2021) via intramuscular on 16Apr2021 at single dose for COVID-19 immunization at Pharmacy. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) at 400 mg, once a day (as needed tablet) for headache and muscle pain. Patient Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534; Expiration Date: 31Jul2021) first dose on 26Mar2021 for COVID-19 immunization. The patient reported that she received the Pfizer COVID vaccine recently and after the three weeks on Friday, 16Apr2021, she received second shot and she had very weird rash welts on her body like swelling on skin not at the injection site but on her legs, breasts, shoulders, back, right on her chest, forearm, neck and everywhere. My body was itchy. The patient reported that it did not seem normal, and they come and go. It was persistent throughout the day. It was not in the same spot during the day. It would get really hot like a normal itch. She reported that her body was itchy and when she scratch it little bit, it swell up. The patient reported that she took Diphenhydramine 25 mg, capsule, one per day. So, she took 2 pills for 2 days, one pill for one day and another for second day. The consumer stated that she had blood drawn probably on 31st January2021, no diabetes, cholesterol and everything was fine. It was a normal check for physical. She had to find the paperwork. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
13 weeks pregnant. Experienced severe nausea and vomitings with metallic after taste and heartburn.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 17-JUL-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician at a community health center for a blistering vesicular outbreak which was then diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Breakthrough case admission after 3 vaccines Moderna 8/14/21 Lot# 091D;  Moderna 9/11/21 lot# 052E21A;  Pfizer 1/1/23 Lot# GJ6739
Patient had reaction located on are inner arm away from injection site red, swollen, hot. patch on under arm of injection arm
back pain; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. A female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medication were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain". Took 0.5 Tylenol 250 mg for back pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
measles-like rash appeared 11 day p/MMR vax; PO was given DPh 12.5mg/tsp for itching;
This case was reported by a healthcare professional and described the occurrence of pain in right upper arm in a 32-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 October 2009 the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 19 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced pain in right upper arm. At the time of reporting the pain in right upper arm was unresolved. The nurse reported the subject had pain in upper right arm since receiving FLULAVAL. This is one of three cases reported by the nurse; see case A0816149A and A0816150A for subjects who had pain in upper right arm following vaccination with FLULAVAL.
Patient was given the Tdap vaccine in her left arm, at least 6 inches below the left deltoid triangle area it should have been administered in.  This was an error performed by our Medical Assistant.   She developed cellulitis and came to the office on November 11th and saw FNP-BC -she was given cephalexin 500mg qid x 7 days.  On 11/12/19 the patient reported that she felt it was getting worse and went to the ER (she has had a reaction to the flu shot in the past) and was discharged with Vaccine complication.  She was given Prednisone 20mg, 2 tablets by mouth daily for 5 days, and hydroxazine 25mg, tid as needed for itching.  She was seen again on 11/13/19 in our office and was reported to be doing better.  As of today, the patient states she is better - not 100% - but getting there.
Mixing error occurred, patient may have received only diluent. Patient scheduled to be revaccinated 05/07
10 hours after injection, increased pain and inflammation in area of limb that was 6 months post-op.  15 hours after injection, overall join pain and stiffness, fever, headache, and fatigue that persisted for 3 days. On day 2, swelling from injection site migrated to axillary lymph nodes and persisted for 2 days.
My husband has Covid right now; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My husband has Covid right now) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (My husband has Covid right now). At the time of the report, COVID-19 (My husband has Covid right now) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were not reported by reporter. Treatment information was not reported by reporter.
Terrible vertigo. Vomiting. Dizziness. Woke up with it have had it severely all day.
Within three or so hours after the vaccine (2nd Shingrix shot for shingles, administered about 11:30 or 11:45 a.m. on Sat. 2/29), Patient commented "every bone in my body aches" and after another hour, he was in bed.  He had chills, very cold, like 'the worse flu I ever had", extremely tired, felt 'horrible.'  He was bed bound for over 24 hours, after about  30 hours from the vaccine, he was able to lay  in a recliner, but still shivering despite a heavy blanket.   He still continued to what I describe as the flu,  and got a bit better by Monday 3/2, but was unable to go to his office job.  As of the submission of this report on 3/2 at 2:37, he is better, although reporting a headache and some aches.
Within 15 minutes of receiving vaccine patient was noted to have hives/redness to face, neck, chest, back and upper arms.  He was given 25mg of liquid benadryl. BP was slightly elevated at 140s/90s with pulse between 100 and 110. He was observed for 2 hours and then driven home by family.
The patient has been diagnosed with HPV after all doses of GARDASIL vaccines; This spontaneous report as received from a consumer via a product quality control employee refers to a 23 year old female patient. The patient did not have pertinent medical history or concurrent conditions. On an unknown date the patient was vaccinated with GARDASIL injection, the patient received all three doses on an unspecified dates (dose, application site, frequency and lot # were not reported). The patient was not receiving concomitant medications. On an unknown date the patient was diagnosed with HPV (Papilloma viral infection).    The outcome of papilloma viral infection was reported as not recovered. The patient did not seek medical attention, did not received any treatment, and labs were not performed. Additional information is not expected since the reporter denied further contact.
Day 1/ April 9, 2021/ Date of Vaccination:  Feel fine Day 2/ Day after shot:  Sore arm, achy, tired, headache Day 3/ Two days after shot:  Arm less sore, brain fog, burning and shocking sensation in feet- neuropathy, joint pain. Lymph nodes become tender and swollen in armpits sometime this week. Day 4:  Neuropathy in feet, fatigued, achy, menstrual spotting Day 5:   Symptoms continue Day 6:   Glands/ lymph nodes tender, headache Day 7:  Neuropathy/ burning and pins and needles sensation in hands and feet all night. Pain in old Shingles location on left back side of head. April 26, 2021:  Lymph nodes still tender and still very fatigued since vaccine dose #1. Symptoms persist for three weeks post-vaccination.