chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large red hot painful welt at injection site, appeared Monday morning. I experienced itching in my face, neck and chest. Place cold compress on welt traced welt with pen and took Benadryl 25 mg that evening. Next day welt became thinner but became larger. PCP advised to go to ER. ER prescribed 50mg of prednisone and 40mg famotidine for 5 days. If welt continues to get bigger go back to ER.
severe headache; body aches; This is a spontaneous report from a contactable physician. A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, Lot Number: AT1920), via an unspecified route of administration on 26Aug2020 at single dose for immunisation. There were no medical history or concomitant medications. The patient experienced severe headache, body aches on 26Aug2020. Event details: The physician was calling to report he had a patient who had experienced side effects after the meningococcal group b rlp2086 shot. He had treated him with ibuprofen (ADVIL) and diphenhydramine hydrochloride (BENADRYL). The patient was not responding to treatment with ibuprofen and diphenhydramine hydrochloride and may require narcotics. The patient experienced severe headache and body aches within hours of receiving the meningococcal group b rlp2086 shot. When asked about Concomitant Products or Other Medical Conditions the physician stated the patient was healthy. The outcome of the events was not resolved.   No follow-up attempts are needed. No further information is expected.
Arthritic symptoms started suddenly at night in right thumb with stiffness only at night. The stiffness progressed to being all of the time all day all night over several weeks. During this time the was some pain and mild stiffness in two other fingers in my right hand. After about one month of severe pain and immobility in thumb I was given a cortisone injection in my right thumb.  Within a few weeks of the onset on thumb stiffness I also started having severe pain and stiffness in my neck for which I was also given a cortisone injection in my cervical spine. As the pain in neck was worsening I started to develop severe pain and stiffness in my shoulder to the point that I could do nothing with my right arm without severe pain. A was subsequently given a cortisone injection in my shoulder. I continue to have pain and stiffness in shoulder impacting my daily life. Also pain  and stiffness in my right knee had come overlapping the time of shoulder pain. I have also developed constant pain and stiffness in the joints of my metacarpals and metatarsals. I'm in pain all the time since two weeks after receiving the Moderna Covid-19 vaccination.
an expired PROQUAD was administered to a patient; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 12-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not provided; lot number S003862, expiration date: 08-AUG-2020) as prophylaxis (expired product administered). According to the reporter, there were no previous temperature excursions.
On day of vaccine, patient had headache, tactile fevers, chills, nausea and stomach upset. Fever persisted daily, Tmax of 105 F, responsive to acetaminophen but recurring. 5 days after vaccine, patient developed worsening diarrhea, 8-10 loose stools/day, with blood on wiping but not in toilet bowl. Has decreased oral intake but no change in urine. 7 days after vaccine, he developed numbness in both arms, like they were "going to sleep". Dad also noted progressive weakness in his grip strength. He does have photophobia with his headaches. He was short of breath yesterday and mom gave albuterol treatments with improvement. No eye/ear pain, visual changes, rhinorrhea, nasal congestion, cough, vomiting, muscle pain, joint pain. Patient was admitted to the hospital on day 8 after vaccine (today) and is thought to have viral gastroenteritis overlapping with potential vaccine reaction. Labs reported below. He is being given IV fluids with KCl and ondansetron. He is no longer reporting any paresthesias or weakness.
7/9/2021 - shortness of breath  On 7/10/2021 - loss taste and smell  On 7/11/2021 - shortness of breath , smell and taste came back  On 7/12/2021 - extreme fatigue and chills (no fever) shortness of breath  7/13 - current - shortness of breath
Patient received Pfizer booster on 10/22/2021. Patient contacted us 11/23/21 to report bruising and bump under skin at injection site. Per patient , When did it appear: "It appeared a few days after injection". Is there  pain? " My leg is still sore- I can feel a bump under my skin". The vaccine was administered per patient request in the right thigh, right vastus lateralis. Consent form notes, "per pt request secondary to upper arm issues." The vaccine was administered by a nurse, qualified to administer vaccines to this site. The patient asked a physician family relative about it and he said that they may have hit a capillary. She reports" googling" this and was concerned about blood clots. She spoke with our Clinical Pharmacy team members about her concerns.
I had incredibly severe menstrual cycle symptoms immediately following my Covid-19 vaccine. I had debilitating pain, increased bleeding, and physically observable cramps. I had increased symptoms of ovulation between periods and was in pain almost constantly. This continued for months. A year later (March 2022), I went to see an Ob-Gyn and was incorrectly diagnosed with endometriosis after reporting my symptoms. I know this diagnosis was erroneous because I since received an ultrasound, lab testing, and a physical examination by another, more qualified Ob-Gyn which ruled out an endometriosis diagnosis. I temporarily was on birth control to treat the alleged endometriosis until I was able to get the diagnosis overturned. Over time, my body is slowly returning to my pre-vaccine menstrual cycle. I no longer experience daily pain, and my symptoms are more manageable. I still consider myself in recovery.  I also still caught Covid-19 in May 2022. I got very sick and had ongoing chest pain, heart palpitations, and shortness of breath for months following my illness. As of now, January 2023, I've received two full doses of the Pfizer vaccine and a required Moderna booster in August 2022 for my school. I don't know if the vaccine contributed to my experience with Covid-19, but no one else in my family is vaccinated and they have either not caught Covid-19 or had minimal symptoms. I recover from colds/routine illnesses slower than I did before, and I still experience shortness of breath during prolonged activity. I'm otherwise perfectly healthy and have no underlying conditions.
Pt received Tdap, PREVNAR and Flu (high potency) f/u 9/4/15. Developed fvr, residual cough.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/2/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This shot was at a drive through site.  This was my 2nd CoVid vaccine.  I likely had a severe case of Covid July 2020 with primarily GI symptoms.  The 1st shot my right arm was sore for 4 days and I felt under the weather.  2nd shot by that evening felt dizzy and went to bed.  Woke up the next morning with extreme nausea and vomiting, not aware of dizziness.  Vomited at least 7 times in the first 5 hours of the day.  unable to keep a sip of water down. Vomiting and nausea persisted into day 2.  Day 3 dizziness began, able to eat lightly.  Couldn't keep my head up.  Had to stay prone or would faint.  Day 4 slightly better but very foggy, lightheaded and dizzy if moved head.  I am on Day 6 now, feel like I have drunk too much alcohol.  Can walk but focus is difficult and have disequalibrium.  Ears feel full and popping, tinnitus is much worse.  Cannot (should not) drive or exercise outside - can do stationary bike which I started Day 4.
Pt fainted about 5 seconds after HAVRIX. Received influenza on same visit prior to HAVRIX (FLUVIRIN) (VASOVAGAL). Pt received water and threw up. Pt. fully recovered after 30 minutes and was released from pharmacy.
This spontaneous report as received from an office manager refers to two patients of unknown demographics. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On 15-AUG-2017 the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N011305, expiry date: 20-JAN-2019) for prophylaxis (incorrect product storage). The doses of PNEUMOVAX 23 were stored at a temperature of 47 degree Fahrenheit (F) to 77 F for time frame of 19 days. No adverse effects reported. No Product Quality complaint (PQC) was involved. This case is cross-referenced with 1708USA007541 (Same Reporter link). Follow up information was received from the office manager on 19-SEP-2017. The improperly stored vaccine was administered to three male patients, this case is one of them who vaccinated with the vaccine on 15-AUG-2017. This case is cross-referenced with 1708USA008930 (Same Reporter link).; Sender's Comments:  US-009507513-1708USA007541: US-009507513-1708USA008930:
2 hours after receiving the vaccine patient became lethargic, and non-responding, she was brought to hospital where she was found to have HSV-1 and VZV encephalitis. Course notable for persistent encephalopathy, acute hypoxic respiratory failure, ICU care, aspiration pneumonia.
first dose of Shingrix on 1/4/2020/ has not yet received the second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 4th January 2020, batch number-L9F99, expiration date-10th May 2020).   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 was reported as follows: The reporter was the wife of the patient. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient had only provided year of birth which is 1950. The reporter did not consented to follow up. The case is linked with US2021117062, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117062:same reporter
Patient with a significant past medical history of COPD who presented to the emergency department with his daughter today with a chief complaint of shortness of breath and dizziness in the setting of a positive home COVID-19 test.  Patient admitted as observation on 7/27 due to acute respiratory failure with hypoxia due to COVID pneumonia. Patient was tested for COVID-19 and was positive on 7/27.
C/O pain left shoulder, et with deep breath -dizziness assisted to lie down-ice bag applied to shoulder-skin w/d, BP 100/60 P-72 regular. Encouraged Mom to give Ibuprofen/TYLENOL when gets home. Reported ate only 2 donuts this AM-enc. to eat also. 2 pm Mother reports is fine.
Seen in ER for 101 F fever, Dx'd with Pneumonia. Rash on 7/18/12.
pt devel severe localized rxn @ site of inj;pain, swelling, pruritus & area hot to touch;Ibuprofen given for pain;
Within 30 seconds of administration, patient felt dizzy and lightheaded. He never lost consciousness, but he did stumble and almost faint. Mother caught him - she says he has a history of dizziness after vaccines and is nervous about needles. He was very hot and sweaty, and he did vomit once. He was given water and an ice pack. Epinephrine was on-hand, but not needed. After resting for 15-20 minutes, he felt better and mother took him home.
Red, painful, swollen, hot to touch, itchy injection site lasting for 3 days  Fever 100.5, chills, headache, bodyaches lasting 2 days  Headache lasting 4+ days
Within 15-30 minutes from time of injection, he developed nausea & vomiting. He then developed a sudden onset of cough, wheezing & respiratory distress. Mom took him directly to an urgent care center where O2 sats were 84%, lips were purple & nose was red. No treatment initiated in that office. Rx for steroids given.
Pt was given the MMR vaccine on 4/27/05 because her titres drawn 4/18/05 showed non immune to rubeola. Unbeknownst to pt, she was approx 2-3 weeks pregnant at the time. She came to the employee health office 6/9/05 with the above info.
uncontrollable screaming for 3 days, starting 48 hrs following administartion of vax; pt was seen by MD who dx an upper resp infect & did not prescribe any medication;
Case number PHEH2014US001603 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a 14-year-old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: not reported) intramuscularly on 11 Jan 2014. No adverse event reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Jan 2014: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Immunization given left deltoid on 10/23/15. The patient recently finished a 6 week course of griseofulvin for a kerion that found to have MSSA. Patient also on rituximab for previous history of valve replacement. Cellulitis of Left upper arm (area on vaccine injection site) and scalp on 10/31/15.
This is a spontaneous report from a non clinical study program, received from a non-contactable consumer (patient's mother). A 17-year-old female patient received a single dose of TRUMENBA, via an unspecified route of administration in JUL2015 to an unspecified date. Medical history and concomitant medications were not reported. The patient experienced headache, chills, facing fever and a lot of pain in her legs along with her thighs, all on an unspecified date. The patient was not recovered from pain in her legs along with her thighs. The outcome of the other events was unknown. The reporter stated the patient got this vaccine on an unspecified Saturday morning and, at the time of reporting, it has been 48 hours and there was lot of pain in her legs along with her thighs and she wanted to know low long these side effects would have lasted.  No follow-up attempts possible. No further information expected.
pt recv vax 3JUL95 & on 2MAR97 pt devel a varicella-like rash;It was also reported that pt sibling (WAES 97030587) had a similar rxn to varicella vax;
pain in lower back, going down both legs, numbness in both legs, tingling in both legs 6/14 dr. visit, received medication, prednisone, cyclobenzaprine,  xray of lower back 6/23 tramadol, tylenol,     6/30 oxycodone-acetaminophen,   7/19  MRI  and visit to Dr, 7/23 pre procedure  for ekg and bloodwork
chills; high anxiety; nervous wreck; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had some chills and high anxiety, also mentioned being a nervous wreck on an unspecified date. Outcome of the events was unknown.    Information on the lot/batch number has been requested.
Fever of 100.5 F, myalgia, fatigue, loss of appetite, inability to exercise due to myalgia, nausea, vasovagal faint on day 4.
Throat pain, difficulty swallowing, fatigue Narrative:  69 y/o M received COVID vaccine dose #1 on 1/15/21 (Moderna LOT 026L20A exp 6/28/2021) at 11:35am. Patient visited ED on 1/19/21 w/o c/o of pain in throat, difficulty swallowing for 3 days. Upon evaluation, no stridor swelling, or SOB found and pat was d/c'd on 1/19/21 w/ instruction to return w/ new or worsening symptoms. Patient called ED 1/20/21 at 15:28 reporting chills,fatigue following vaccination and pt was instructed to folllow home care measures. On 1/29/21, patient called again reporting not feeling well the past 2 weeks since taking vaccine with cold sweats, chills, numbness over hands & feet, and BP>200 2 days prior (ran out of BP meds). Patient was instructed to take BP reading but could not obtain value and patient reported constant headache, difficulty concentrating, blurry vision, BG 319mg/dL. Patient was instructed to go to ER immediately but refused and said he'll go in the morning; no ED note avail following this. Patient proceeded to receive COVID vaccine dose#2 (Moderna Lot 031L20A exp 7/22/21) on 2/15/21.
Patient presented to office with no temperature and less than 25 erythematous vesico-papular lesions on chest. No other symptoms. Rash started the previous day 3/20/06. Varicella vaccine given at previous pediatrician in 2003.
RN inadvertently reconstituted the ActHIB vial of vaccine with sterile diluent instead of reconstituting with DTaP-IPV Component. RN was new to clinic and had forgotten there were 2 vials for the Pentacel vaccine.  No adverse outcomes. Contacted RN line and spoke with staff and was told to have patient come back for full dose of Pentacel; the ActHIB portion child received was not valid. Patient came back on 1/28/20 for full Pentacel vaccine reconstituted as instructed.
Pt described feeling chills,  headache( reported as a migraine), blurry vision, fatigue x 3d, diarrhea and vomiting
Erythema nodosum in both lower legs. Began on 2/13/21 and resolved without treatment on 2/25/21.
Patient was vaccinated on 4/19/2022 with a beyond used date Pfizer vaccine. Pfizer clinical team was consulted and they could not confirm the viability of the beyond used date product. Patient was informed on 5-6-22 about the error and was advised to get re-vaccinated with Pfizer#4.  Patient was re-vaccinated on 5-10-222 and did not report any adverse events yet.
No additional AE; VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022 and was administered to a patient; This spontaneous report was received from a medical technologist lab manager 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-JUN-2022, varicella virus vaccine live (oka/merck) (VARIVAX), was delivered after receiving by date of 06-JUN-2022. On 15-JUN-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number: W002599, expiration date: 24-JAN-2024; (strength, dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). Temperature and time frame were unknown. There was no reported previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event).
Information has been received from a woman in a doctor's office and an RN concerning a 59 year old Caucasian female RN who on 11/8/01, at 18:00, was vaccinated in the left deltoid with a dose (1st number 635892/1197K) of pneumococcal vaccine 23 polyvalent. There were no illnesses at the time of vaccination. On 11/10/01, sometime in the AM, (also reported as within 12 hours of administration of the vaccine), the pt developed an injection site reaction with an enlarged, raised, reddened area, that was hot to the touch and very painful (12" X 4", deltoid to elbow, also reported as 10" X 4"). The pt was treated with ice and acetaminophen (+) caffeine (Excedrin). The pharmacist who supplied the physician's office with the pneumococcal vaccine 23 polyvalent was worried about using the last vial. Follow-up information received from the female RN indicated that although there was no visible evidence, the area of injection was still painful to the touch. She reported the outcome of the events as recovered. The records of testing prior to release of this lot (635892/1197K) have been checked by GMP Compliance and found to be satisfactory. This lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
outbreak of plaque psoriasis on his legs, elbows, and arms; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (outbreak of plaque psoriasis on his legs, elbows, and arms) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 032B21A) for COVID-19 vaccination.     Concomitant products included CLOBETASOL PROPIONATE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PSORIASIS (outbreak of plaque psoriasis on his legs, elbows, and arms). At the time of the report, PSORIASIS (outbreak of plaque psoriasis on his legs, elbows, and arms) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient had psoriatic arthritis pretty bad as a child but mostly outgrew it, with only occasional small outbreaks. Since the end the June, he developed a worsening outbreak of plaque psoriasis on his legs, elbows, and arms. He was using topical clobetasol propionate 0.05%, but it was not doing too much.  No treatment information was provided.
patient received an expired dose of ADACEL with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via regulatory agency (Reference number- 00871802) and transmitted to Sanofi on 24-Nov-2021.  This case involves an unknown demographic patient who received expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 16-Nov-2021, the patient received a 0.5 mL (once) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5661AA, expiry date: 8-Aug-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired product administered (latency: same day).  At time of reporting, no adverse event reported.  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 the guidelines. 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.
This spontaneous report as received from a registered nurse refers to 2 unspecified children patients of unknown age. On 28-AUG-2014, 2 unspecified patients were administered expired M-M-R II, lot # H015826, expiration date 24-AUG-2014, (dose, frequency and route not reported). No adverse effects reported. Additional information has been requested.
Patient fainted after walking out exam room after immunization, turned blue and pale was unable to get up.