chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness and excruciating pain on entire arm and hand; Numbness and excruciating pain on entire arm and hand; she could not lift it several hours after vaccine/injection until 24 hours later; This is a spontaneous report from a contactable consumer (patient). An adult non-pregnant female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: 6206), via an unspecified route of administration, administered in Right arm on 03Mar2021 at 18:00 (06:00 pm) as single dose for covid-19 immunization. Medical history included Chronic Benign Neutropenia from an unknown date and unknown if ongoing. The patient had no known allergies (known allergies: none). There were no concomitant medications. No other vaccine was received in four weeks. The patient reported that, on 04Mar2021 at 20:00 (08:00 pm), she experienced numbness and excruciating pain on entire arm and hand and she could not lift it several hours after vaccine/injection until 24 hours later. She had pain and soreness for another 1.5. The adverse events did not result in emergency room visit or physician office visit. The patient did not have covid, prior to vaccination and she was not tested for covid, post vaccination. No corrective treatment was received for the events. The outcome of the events was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
No additional AE reported.; Customer reported patient got additional dose (4th dose) of GARDASIL 9 today, 28FEB2023.; This spontaneous report has been received from a nurse practitioner concerning to an 18-year-old patient. The patient's pertinent medical history, concurrent conditions, previously drug reactions or allergies, and concomitant medications were not provided.  On 22-FEB-2022, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; on 18-APR-2022, the second dose and the 3rd dose on 23-AUG-2022 of the aforementioned vaccine (strengths, doses, lot number, expiration dates, routes of administration were not provided).   On 28-FEB-2023, the patient was vaccinated with a dose (4th dose) of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (ml)(strength and route of administration was not provided; lot number W007760  that was verified to be valid, expiration date reported and established as 04-DEC-2024) (extra dose). All the administration were for prophylaxis.   No additional adverse event (AE) reported.
Torticollis/neck pain started 2 hours after immunization given. Left neck pain no associated weakness. Treated with ibuprofen, warm compress. ROM exercises. Slight improvement day 4 of symptoms.
Fever of 101 for 3 days Body aches Significant headache for 4 days Vomiting X3 day after shot Loss of appetite Deep fatigue Loss of taste which continues  And metallic taste with some foods which continues
My arm was more sore and the next days it got worse. After a few weeks, 2-3 weeks - Upper shoulder was red, hot, and sore and gradually got better.
This spontaneous report as received from a Healthcare worker refers to a patient of unknown gender and age, who on an unknown date was vaccinated with GARDASIL (lot number H019495 expiration date 15-AUG-2015). The healthcare worker reported that a prefilled GARDASIL syringe leaked during administration, and that the patient needed to receive the dose of a second syringe. It was also reported that the syringe tip cap was attached properly prior to its use, the leaking occurred from the syringe when the plunger rod was being pushed forward and the needle used was able to be attached securely to the syringe. The reporter stated that the syringe carton tray was intact and undamaged on receipt, with its cellophane cover intact and completely sealed. Additional information is not expected.
Patient states right leg had a burning/tingling sensation for a couple of days, then both legs just felt tired/heavy for a couple of days
first dose 13 months ago and not getting a second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 13 months 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 reporter was the patient. The age at vaccination was nopt applicbale for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not decline or agree to follow up.
Information has been received from a physician concerning an 8 yr old female pt who on 07Dec97 was vaccinated with a dose of varicella virus vaccine live. On an unspecified date in June 2005, the pt developed breakthrough varicella. The breakthrough presented as a full blown case of chickenpox. It was unk as to whether lab studies were performed. The adverse event improved and the pt recovered on an unspecified date. There was no product quality complaint reported. The pt sought unspecified medical attention. The reporter mentioned that the pt's brother (WAES0506USA02032) had a similar experience of breakthrough varicella following vaccination with varicella virus vaccine live. Additional information has been requested.
53 yo female with a history of PE 12 years prior after 22 hour flightreceived her first dose of Pfizer BioNTech  vaccine on March 20.  She tolerated the vaccine without report of systemic adverse events including headache, fevers, chills, myalgia, malaise or nausea.  Eight days later (March 28) she experienced light-headedness and uneasiness reminiscent of her prior PE prompting her to  visit the emergency room. Per patient D-Dimer was extremely elevated and  PE protocol CT chest with IV contrast diagnosed  multiple pulmonary emboli.    This time, no immediate precipitating factors were identified.  She has normal BMI (23), exercises regularly, is a never-smoker.  She was placed on therapeutic lovenox 80mg BID.  She indicated that is undergoing a workup for a hypercoagulable state  and was told she may have antiphospholipid antibody syndrome, although the data and records to support this evaluation are not available for confirmation by undersigned.
The patient had a very sore arm and limited range of motion for several days then presented with erythema at injection site 7 days later. The redness was about the size of a half dollar.
Patient reports injection site reaction of redness and swelling at injection site, starting around 24 hours after administration and improving at 48 hours after administration.
I woke up in the middle of the night with sweats, shivering, nasua, and fever. My fever reached 103 and would not go down even with aspirin. I went to the emergency room and was admitted to the hospital for this TERRIBLE reaction. I had multiple tests and had an iv immediately after my arrival. I was very very sick. It took me weeks for my body to feel better. This sucked everything out of me and was related to the shingrix shot.  It is unknown whether I should take the 2nd shot. I don't want to have this happen again and my doctor said this is the worse reaction that he has ever seen.
Received TD on 12/8/00 and on 12/10/00, went to ER for increased swelling of right upper arm. Dx'd with cellulitis and put on Duricef 500mg po bid.
On 03/18/2021 I got my vaccine. On the 03/19/2021 in the morning  at 05:00AM  I started experiencing chills, pain in the left shoulder nausea, bad headache, I slept a lot. I slept through the night. 03/20/2021 same reactions along with a lot of sleeping. 03/21/2021 chills and headache I slept a lot. 03/22/2021 sleeping, headache, chills were a little. My left arm hurt. 03/23/2021 nausea were back again, my abdomen were making a lot of noise. It was for days I felt this way. It lasted for 10 days. It was very bad. 03/26/2021 I had a rough day I had a major acid reflux. I started feeling better slowly. I had a lot of hard skipping, racing every two weeks. I had trouble sleeping. Month of August I went to my cardiologist. I had heart failure 08/25/2021 I woke up at 1AM with nausea, diarrhea, and a heart rate of 35 my husband called and took me to emergency. On 08/26/2021 they said I  had a heart failure. 08/27/2021 had heart surgery. TEE, heart abrasion were done.
he has not  recieved his 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (he has not  recieved his 2nd dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (he has not  recieved his 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (he has not  recieved his 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the Reporter. The treatment information was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown), 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: cipro, reaction(s): "Known allergies: Cipro". 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: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid form 25Aug2023 to 30Aug2023.  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.
About 24 hours after the vaccine my arm swelled to the size of an average size chocolate chip cookie. It went away after about 60 hours. About 8 days after the vaccine it, reappeared even larger, perhaps 4 inches in diameter. At day 12 it is still swollen to about 4 inches in diameter at the injection site. It is warm and itchy.
Approximately 16 hours after the shot I experienced the inability to stand and walk without assistance. Was unable to vocalize words.  It was like my brain was unwilling to cooperate.  I would try to respond but couldn?t .
Vaccine administered on Tues. Patient called Thurs. indicating she went to an urgent care center and was told she has cellulitis. she was going to PCP on Fri.
Multiple doses administered for single dose series. One dose of Tdap in recommended. No treatment need at time of visit.
Information has been received from a physician concerning a 6 year old white female with food allergy to corn products, amoxicillin and zithromax allergy who on 10-DEC-2001 was vaccinated with first dose of varicella virus vaccine live (Oka/Merck) (Lot #640119/0965L). Concomitant vaccines included measles-mumps-rubella vaccine (MMR) (Lot #639138/0738L). On 02-MAY-2007, the child developed 3 lesions (site unspecified). On 03-MAY-2007, the child developed 15-20 lesions. There was no itching or any other problems. The child's mother had called and stated child was exposed at school. In May 2007, the patient recovered from lesions. There was no diagnostic labs done. There was no illness at time of vaccination. Additional information has been requested.
No additional AE reported; the vaccine was administered after expiration; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 07-APR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot #1707499, expiration date 30-MAR-2022 (strength, and route of administration were not provided), for prophylaxis (expired product administered). No additional adverse event (AE) reported.
Fever on the day of injections 102.9 (4hours later) Rashes on forehead, arms, cheeks, trunk.  Headache, fussiness, emotional, and left/right arm pain. All started about 4/6 hours after injections and are still ongoing
Ache/pain and itch at injection site - 1am welts - later on Sat. sx started going away - but some SOB/wheezing. On Sunday - all sx resolved.
PT NOTICED LOCALIZED EDEMA AND ERYTHEMIA ONE DAY AFTER INOCULATION (PT VISIT WAS 2 DAYS AFTER INOCULATION). NO PAIN OR TENDERNESS TO AREA. PT WAS AFEBRILE. INPECTION REVEALED LOCAL AREA TO BE 14.5 CM. NO ASSOCIATED SXS. PT WAS TREATED WITH CEPHALEXIN 500MG, TID, F10D. WILL RETURN TO CLINIC IS SXS ARE DO NOT RESOLVE.
I had been receiving immonutherapy shots for over a year (paused and started over due to pandemic). I had an allergy shot scheduled the week after I received my first COVID vaccine. I had an anaphylactic reaction to the allergy shot. I did not recognize the symptoms during my waiting period and made it home. Once home I started to recognize signs of anaphylaxis (severe rash/nausea/burning throat). I called the allergy clinic and they told me to call an ambulance. I received epinephrine, benadryl and a steroid and was monitored for several hours and returned home. I returned to the ER the following day because my heart rate remained elevated and would not return to normal. I was screened for any heart issues, cleared and returned home. They dropped the dose and gave me another allergy shot on 28 January and I had another anaphylactic reaction  treated with benadryl and two epi-pens. This may or may not be related to the COVID vaccine. I got the second shot on 4 February and had a less severe allergic reaction on 5 February treated with a steroid and benadryl. I continued to have a rash on and off for a month after the allergic reactions.
1) 5-6 episodes of seizure like activity, lasting 34-40 sec (motor) total including staring (1-16 mins), started w/in 12 hrs of vaccine administration, no seizures after 72 hrs, encephalopathy. 2) Inconsolable crying for 5 hrs.
This patient received there 2nd dose 3 weeks after their 1st dose which was too soon. This patient should have received their 2nd dose 4 weeks after their 1st dose. No other adverse events have been reported.
Telephone report received from a consumer on 02/27/01, regarding an adverse event possibly associated with Influenza vaccination. A retired veterinarian called to report that a male friend of his developed an autoimmune disease, glomerulonephritis, approximately 1 1/2 months after receiving an influenza vaccination. The patient required hospitalization and intravenous steroids. Recovery was complete; without known relapse. Medical history is significant for hypertension and hypercholesterolemia. This patient has had two subsequent influenza vaccinations without incident. No other info is available.
This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 58-year-old male patient who received FLULAVAL Quadrivalent (batch number 93T79, expiry date June 2016). On 13th October 2015, the patient received FLULAVAL Quadrivalent (intramuscular). In February 2016, 122 days after receiving FLULAVAL Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria other: serious as per reporter), fever, nausea, vomiting and muscle pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza, fever, nausea, vomiting and muscle pain were recovering/resolving. It was unknown if the reporter considered the vaccination failure, influenza, fever, nausea, vomiting and muscle pain to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: Approximately 4 months after vaccination, the patient subsequently contracted influenza, verified by nasal swab which read positive for several strains, including H1N1 2009. The patient was presented to an urgent care clinic with symptoms of fever, nausea, vomiting, and muscle aches.
11:08 10 minutes after receiving inj. client presented to me with a slight rash on both arms from elbow to finger tips both arms. No itch, no other symptoms. B/P & temp unable to attain. Administered 3 melt away BENADRYL tabs (total 37.5mg). client wt 100 lbs. 11:15AM mother notified, slight rash on back of hands only. 11:24AM returned to class. No itch, no other symptoms, slight rash on back of (R) hand.
Altered Mental Status, Polycythemia, Occlusion of bilateral carotid arteries, seizures, death
Child was crying a lot and mother noticed that he broke out with hives about 28 hours after receiving the vaccinations.  The hives lasted about 12 hours.  Mother called urgent care for advice and was told to give child Benadryl.  Mother did not have any on hand so child was treated with a cool washcloth.  After the hives ended, the child began exhibiting cold-like symptoms which included a stuffy nose, cough, and loss of appetite.  He was then treated with Benadryl on the evenings of 11/05/2010 and 11/06/2010.  The child's appetite is now starting to improve and the cold symptoms are improving.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter and her husband were both on the phone. They mentioned that, they had several friends who got the SHINGRIX vaccine and that the side effects of fever and flu-like symptoms were worse after the second dose vs. the first. They tried to get specifics. The only specific they could got was one male friend was in bed for several days with flu like symptoms after dose 2. This case was linked with case US2019GSK005444, reported by the same reporter.
This spontaneous report was received from a male patient of unknown age via a company representative concerning on himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number N022303, expiration date 03-MAR-2019 (strength, dose and route of administration were not reported) to prevent pneumonia. On the same date, later that evening, the injection site was warm to the touch and the area was blotchy and red. At the time of the report, the patient had not recovered from the events. The causality assessment between the events and therapy with PNEUMOVAX 23 was not reported. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1711USA004606:
After less than 24 hours, pt reported to mother, itching of arm, and right arm became erythematous and papular rash with vesicles.
09/19/22 presents to ED for "respiratory distress". PMHx of "hypertension, emphysema and CHF"
Period came 1 week early.; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 31Mar2021 at 11:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and precancerous breast lump removal. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration on 10Mar2021 at 08:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 the patient experienced period came 1 week early.  The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of irregular menstruation was unknown.   No follow-up attempts are needed. No further information is expected.
rash 3 1/2 inches long by 3 1/2 inches  wide by injection site on left arm tenderness, itching, swelling, red
entire body began trembling,lasting only a few min;temp was approx 100-101;pt alert,no LOC;did contact MD office-advised close observation
Red, oval shaped rash approx. 3" near injection site; fatigue. Very painful, feels hard under skin pt. seeking medical attn. today.
Herpes Zoster Information has been received from a registered nurse (RN) concerning a 10 year old female who in 1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The RN reported that in early October 2005, the patient developed lesions which followed a dermatome on the head, ear and neck. Unspecified medical attention was sought. A diagnosis of herpes zoster was made and the patient was treated with acyclovir. At the time of this report, the patient's herpes zoster persisted. Additional information has been requested.
2-3days after the first dose a rash appeared on his leg/ rash on my forearm too and it looks like Poison ivy; This is a spontaneous report received from a contactable consumer (patient himself) via a 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EK9231), via an unspecified route of administration on 13Jan2021 at 01.30 (at the age of 59-years-old and weight: 230 or 235 lbs) as 1st, dose single for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. It was reported that, the patient had his first shot 2 days ago the first Pfizer shot and within two days he developed a rash on his leg that was about may be six inches long and two or three inches wide. Patient had a rash on her forearm too and it looks like Poison ivy, but he lives in the north and it was Feb now so he don't think it was Poison ivy but the rash has been gone way since he got the rash couple days after the shot. The patient just put Calamine and he had no medical treatment. The outcome of the event was recovered in 2021.   Follow-up attempts are completed. No further information is expected.