chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She felt sick, sore to the touch, had a fever and cannot relax. She also had to go to the bathroom often because she had dry heaves with her stomach and vomited. She still does not feel good as of 9-27-15.
She did poorly with 2nd Covid shot, she started passing out; light headed/dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 at early afternoon as dose 2, single (Lot number: E19269) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (ongoing), notes: takes medication as needed diagnosed as a kid, Continuing: True; "Labyrinthitis" (unspecified if ongoing), notes: takes Anitvert as neeed. Was diagnosed years ago.; "Slipped disc in back L4-L5" (unspecified if ongoing), notes: take Nabumetone; "Acid reflux sometimes will take something like Tums that is over the counter" (unspecified if ongoing), notes: Acid reflux sometimes will take something like Tums that is over the counter; "Lactose intolerant" (unspecified if ongoing), notes: Lactose intolerant will take a Lactaid pill before something with milk; "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Menopause" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Preventative for heart" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased (started years ago; 10mg daily) ; LEVOTHYROXINE taken for hypothyroidism (started years ago; 25mcg daily) ; PREMPRO oral taken for menopause (started years ago keeps her sane. she wasn't sleeping, concentrating she was shivering sweating, was a mess; 0.3mg/1.5mg three times a week orally); RAMIPRIL taken for hypertension (started years ago; 10mg once daily); ECOTRIN taken for cardiac disorder (started years ago; 81mg once a day); RESTASIS taken for dry eye (started years ago; 0.05% 1 drop each eye daily); FAMOTIDINE taken for reflux gastritis, NABUMETONE taken for pain, intervertebral disc protrusion. Vaccination history included: BNT162b2 (Dose: 1; lot: E13247), administration date: 22Jan2021, when the patient was 73-year-old, for Covid-19 immunization.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 12Feb2021, outcome "unknown", described as "She did poorly with 2nd Covid shot, she started passing out"; DIZZINESS (non-serious) with onset 12Feb2021, outcome "unknown", described as "light headed/dizzy".  Clinical summery: She did poorly with 2nd Covid shot, she started passing out. She had had to drive to beach for the shot and as soon as she got it she got light headed and dizzy. They asked if they needed to call EMS to look at her and she said no and put her head down and waited half hour and felt better was able to drive home.   No follow-up attempts are possible. No further information is expected.
CEREBROVASCULAR ACCIDENT R56.9 - Seizure (CMS/HCC)
sore arm, big welt, big knot,felt like, headache, body aches, bones aches, muscle spasms, kidney infection
102 fever Every lymph node in body sore and swollen  Chills Insomnia
Around 2-2 1/2 hours post injection, patient experienced a high pitched "ringing" predominantly in right ear but did exp. some ringing in left ear briefly.  Tinnitis continues to be constant in right ear. No relief as of this time. Dr. stated to patient if it continued she would refer her to a neurologist.
Pt recvd 3 doses of Engerix-B vax 13AUG90, 11SEP90 & 13FEB91 & was found to be a non-responder;
This prospective pregnancy report was initially received from a 25 year old female patient referring to herself and follow-up information was received from a registered nurse. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions, and allergies were not reported. On 23-JUN-2017, the patient was vaccinated with her first dose of GARDASIL 9 for human papillomavirus prevention (route, lot number, and expiration date were not reported). On an unspecified date in August 2017, the patient had her last menstrual period (LMP). On an unspecified date in 2017, the patient had pregnancy test and blood tests and on 16-SEP-2017, she found out that she was pregnant since an unspecified date (maternal exposure during pregnancy). On 25-SEP-2017, the patient received her second dose of GARDASIL 9 lot # N010497 and expiration date of 15-JAN-2020. On an unspecified date, the patient experienced ''normal pregnancy symptoms''. The nurse also stated that she did not have any information regarding the patient's pregnancy. The outcome of normal pregnancy symptoms and maternal exposure during pregnancy was unknown and no causality assessment was reported.
After receiving the second round of my Pfizer COVID vaccine, approximately an hour and a half later I received a rash on my right bicep and across my abdomen going slightly onto my back and I became itchy.
pt would throw arms out to side, body stiffen, arms shake, eyes stay forward facing, face bright pink, arms shaking, no crying poss holding breath, face bright pink lasting 5-7secs;
I RECEIVED MY SECOND SHOT OF JANSSEN WHILE I WAS ON A BUISNESS TRIP.  48 HOURS AFTER THE VACCINE I HAD A SEVERE REACTION WITH ACING MUSCLES AND FEVER WHICH TOOK ABOUT 12 HOURS - AFTER THAT I FELT FINE. 4 DAYS LATER I NOTICED A RASH ON MY LOWER THIGHS THAT WAS BURNING AND WAS PAINFULL. I WENT TO EMERGENCY ROOM LOCALLY  RIGHT AWAY AND LATER ON WAS DIAGNOSED WITH LEUKOCYTOCLASTIC VASCULITIS.
Went home from office and slept for four hours. Woke up screaming, had temp of 101.4. Had a bad poopy diaper so was put in the bath for about 1 min was then given Tylenol and dressed. About an hour later her hands and lips were blue. Lips quivered, then pale and limp. 911 was called and pt transferred to hospital.  5/16/08 Case closed w/medical records that accompanied report. FINAL DX: apparent life threatening event. Hospital records of 5/8-5/9/2008 reveal patient experienced an episode of unresponsiveness, purple hands, lip quivering then pale & limp.  Cold s/s x 1 day w/rhinorrhea, nasal congestion & sneezing.  Developed fever after vaccinations.  Parent provided rescue breaths & patient responded.  Parent & sibling w/viral illness & ear infection.  No further episodes while hospitalized & d/c to home w/pcp f/u.
This spontaneous report was received from a health care worker referring to multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL 9 which had lot # L024993, expiry date: 17-OCT-2017 (strength, dose and route not reported). No adverse effects reported. No product quality complaint (PQC) involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Injection site: welt and hard lump , itchy, sore arm, elbow had sharp pain on movement to pick things up, could not bear weight., and lack of strength. Headache, fever 100.5, nauseous,  profoundly weak,  greatly fatigued, body aches, joint pain, chills, lack of Appetite and , motivation
shortness of breath has gotten to the point of her gasping for air"; appetite is gone; bad cough; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number/Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number/Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. it was reported that patient experiencing shortness of breath that lasted a few days after receiving both doses. Caller states her shortness of breath has gotten to the point of her gasping for air. Caller states her appetite is gone and she has a bad cough. The outcome of the event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.  .
patient 01Sep2022 when manufacture date on bottle was Sep2021. One day after expiration date; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID: (005570).  A 7-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 3 (booster), single (Lot number: FL8094, Expiration Date: Sep2021) at the age of 7 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 11Nov2021, when the patient was 6-year-old, for COVID-19 immunisation, reaction(s): "AE(s) following prior vaccinations: None"; BNT162b2 (DOSE 2, SINGLE), administration date: 03Dec2021, when the patient was 6-year-old, for COVID-19 immunisation, reaction(s): "AE(s) following prior vaccinations: None". The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 01Sep2022, outcome "unknown", described as "patient 01Sep2022 when manufacture date on bottle was Sep2021. One day after expiration date".  Additional information: NDC number of Covid-19 monovalent 5 to 11 vaccine: 59267-1055-4. rIt was reported that Pfizer covid vaccine (orange cap) with the manufacture date Sep2021. Technically, was given 1 day past expiration that was given. No relevant tests was conducted. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with any AE(s). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Patient complained of warmness to the touch at the site on 10/15/13 in the evening. Patient also indicated a welt below the site of injection on 10/15/13 and called the pharmacy on 10/16/13 @ 5PM. Patient took Benadryl and will apply ice to the area.
Red & itchy at the injection site. Vaccine given on 2/4/19, started on 2/6/19; almost cleared on 2/7/19; patient did not take any medications for the rash.
pain; persistent pain that interfered with daily activities; This case was reported by a pharmacist via sales rep and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and activities of daily living impaired. On an unknown date, the outcome of the pain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient was vaccinated with 3 vaccines on the same arm by pharmacist of which one of the vaccines was Shingrix.  The patient returned to the pharmacy later complaining of persistent pain that interfered with daily activities.
Pain in injection site; A spontaneous report was received from a consumer, concerning a 22 year-old female patient, who received Moderna's COVID-19 vaccine and experienced pain in injection site.  There were no medical history and concomitant medications provided.  On 28-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28-Dec-2020 the patient developed pain in the injection site. It was confirmed that she was not pregnant and did not have any other side effects.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, experienced pain in injection site was unknown.; Reporter's Comments: This case concerns a 22-year old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown) and experienced an expected non-serious event of Injection site pain. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
pt recv vax 16MAY97 & 4hr post vax pt became lethargic & had mild redness @ the inj  site;
05/23/2022 Vaccination  06/10/2022 Started to experience sore throat, mild.  06/11/20232 HA, cough. Took at home COVID test, negative 06/13/2022 Rapid COVID; Positive  06/14/2022 PCR; I did not get the results till late on 06/15/2022. I had called the pharmacy as it was not posted and it was 48 hours since I took the test. The pharmacy mentioned it 'could be due the store losing power'. I felt that it took a long time to get the results, even though I was taking the necessary precautions to isolate. The  health department didn't provide enough information on how to protect my family other then using a different sink when washing hands. I was not given any guidelines on how many days I was contagious, etc. I would have benefited from having that information up front when testing positive.  06/20/2022 COVID- *bronchitis and touch of pneumonia. Still have not recovered from COVID
Patient went home and started to experience tingling and numbness in legs and feet. Then she began to feel tightness in her throat. She took Benadryl and symptoms improved. Tingling sensation persisted for several days after. Patient informed to follow up with PCP
Random pins and needles/tingling sensations all over my body: legs, feet, head, back. They come and go and aren't severe. Some times I don't notice it, some times I do.
Light-headedness started a few days after first dose and continues to present day. First Tachycardia event  April 30. Heart rate at rest was 140 bpm for 45 minutes, Intermittent tachycardia persists to present day. First A-fib event was May 4th.  Second A-fib event was May 18. Tachycardia and A-fib events were measure by my Apple Watch. Heart rhythm irregularities continue to present day.
Ringing in my ears and nausea, started in the first two hours after getting the shot.
never went back for 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (received 1st dose 2 years before the date of reporting and had bad reaction) and Shingles vaccine (Original shingles shot received many years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient never went back for 2nd dose of Shingrix, which led to incomplete course of vaccinations. The reporter asked if it was too late at the time of reporting and if the patient needs to start over.; Reporter's Comments: This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.
102 fever, severe  body aches- 600 mg Advil every 5 hours for two days arm rash and swollen- Benadryl for 1 day  tired
Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 17-DEC-2010 as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster (onset not reported). On or about 26-OCT-2011, patient was treated for ongoing painful rash and persistent nerve pain which was then diagnosed as shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Patient received 2 vaccines - GARDASIL and VAQTA. He felt dizzy after receiving the vaccines and passed out few minutes later. He was passed out for about 38 seconds. Drank water, few minutes later he threw up. He told us that he had passed out last year during blood draw.
Still having headache, nausea , fatigue, have some kind of sore inside left nostril, feel not normal still on 7 th day. Hands feel numb also
pt recvd flu vax & exp arm pain in same arm that vax was given; pt sill c/o arm pain;
Patient first developed itchy eyes on 12/17/20 at 10pm.  She took Robitussin because she didn't have any Benadryl.  She woke up at 6am on 12/18/20 with a swollen face.  Her hands were also swollen and her eyes were still itching.   The swelling was gone by 12/19/20 but then she developed generalized hives on 12/21/20 which have continued through today.  On 12/29/20 her face swelled again.  She is now taking Benadryl and Xyzal to control the hives and swelling.
Chest pain on my left side just left of my sternum started shooting pain 4 days after the shot. The shooting pain lasted for 1-2 seconds comes every 15-40 mins lasted total of couple of hours. Then the shooting pain stopped, but the burning pain sustained and got worse. So went to ER and had some tests done as inpatient. Had one time V tach on heart monitor. ECG, Echo, Troponin were normal, has some trace pericardial effusion which doctor think it?s not from this time as my ESR and CRP were normal. Discharged with heart monitor for a month and now still has pain which is a month later. The pain is like burning pain, mostly just on the left side of the chest .
Menstrual spotting although patient has Mirena IUD and has been without menses. Spotting began about 24 hrs after injection and ended within 8 hrs.  Heart palpitations began roughly 24 hrs after vaccine and continued sporadically for the next several days. They persist 5 days after receiving the vaccine.   Significant swelling in left lymph nodes in arm pit. Swelling went down after about 4 days.
On 12/2/99, the pt experienced and excoriated rash of mild varicella on the trunk, wrist, ankles, and scalp. There was not fever. She had approximately 50 lesions in various stages of development. Subsequently, the pt recovered. No further information is available.
Notified by patient that she had "an allergic reaction" to her first dose of the vaccine. "It happened a day later, but I don't know if it was the shrimp I had that day. I was flushed and I got welts, so I went to the urgent care. I was prescribed an Epi-pen by my allergist after following up with them. I feel comfortable getting the second dose." Pharmacist and vaccine clinic lead notified. 30 min after dose given, pt states, "My ears are feeling a little itchy." Vital signs @ 1002: BP 175/80 P 69 O2 97% Temp 98.3 F R 12. VS @ 1007: BP 165/79 P 64 O2 98% Temp 98.4 F R 14. 1015 Pt states, "I'm feeling better and my husband is at home to watch me. I think I was just nervous." Pt declines dizziness/lightheadedness upon standing and declines any itching after second set of VS. Educated pt on strict ER precautions. Pt verbalized understanding and was appreciative for visit.
pt recvd vax & exp swelling, redness & itch @ site of inject;
On 4/20/00, the pt received his 3rd dose of Lymerix and subsequently, he experienced bilateral biceps and shoulder pain. No treatment was given. The most recent information, received on 6/21/00, reports the outcome of the event as unresolved.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V deficiency. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN [METFORMIN HYDROCHLORIDE]), LOSARTAN, LEVOTHYROXINE, SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications were not provided by reporter.   This case was linked to MOD-2021-290159 (Patient Link).
Patient told me on 4/17/18 that a couple of days after her vaccination, she gradually started to get pain and swelling on the back of her foot and ankles. It happened to both feet, but the left foot is worse than the right. She said the swelling was pain and it made it hard to walk for a few days. Today she said it was feeling a bit better and was taking ibuprofen for it. I told her to continue the ibuprofen and ice the areas. Told her to give me and update and call her doctor if it gets any worse.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 13-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Initial report received from a non health care professional on 04 September 2012. A female patient of unknown age whose medical history and concomitant medications were not reported, had received FLUZONE HIGH DOSE vaccine (Lot number, dose, dose number, route and site of administration not reported) on an unknown date. It was reported that the patient was home sick for 8 days after receiving FLUZONE HIGH DOSE vaccination and had strange combination of symptoms including not being able to eat for 5 days, throwing up and joint pain. Details of corrective treatment and lab investigations were not reported. At the time of this report, the patient's outcome was not reported. Documents held by sender: none.