chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore at injection site; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Feb2021 at 14:45 (Lot Number: EL3247, unknown expiration) as dose 1, single at the age of 47 years old for COVID-19 immunisation.  Medical history included allergies to gluten and dairy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). No other vaccine in four weeks. No history of COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient experienced sore at injection site on 23Feb2021 at 16:30. The patient did not receive treatment for the event. The patient has not yet recovered from the event.   No follow-up attempts are possible; information about batch number was already obtained.
Patient presented to the ED and was subsequently hospitalized on 1/28/22 for COPD exacerbation. She also presented to the ED on 1/23/22 for acute cystitis without hematuria, and on 1/25/22 for chest heaviness. These visits are within 6 weeks of receiving covid vaccination.
Swelling at injection site. Burning, itching, stinging and aching at injection site. Fever, weakness, body aches and headache.
1st dose: soreness on upper left arm for 2.5 days; headache for 2 days 2nd dose: soreness on upper left arm for 2 days; fatigue for 1 day; abnormal thirst for 1 day
Patient stated that her leg swelled up, and she had a rash on her body and face. No treatment was sought, however she did tell her primary care about the event during a routine visit between the time of the shot and telling me. She said the her pcp was not concerned at that time. At this time, patient states that she is doing okay with no symptoms any longer.
The next morning (11/5) after administration client noted large red bumps from shoulder to elbow.  These bumps itched and have become smaller but have not yet dissappeared according to mom today (11/10).  No edema, or other symptoms noted.  Mom states she spoke with family Dr. who stated he sees this type of reaction at times with the 2nd dose and it was ok to go ahead and get third dose.
Pt stated that night she developed whelps / Hives over her body. The injection site had swollen up.
INSOMNIA; CHILLS ON AND OFF; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced insomnia. On 2021, the subject experienced chills on and off. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills on and off and insomnia was not reported. This report was non-serious.
Information has been received from a healthcare worker (certified medical assistant (C.MA)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 13-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
migraine; malaise; arm soreness; This is a spontaneous report from a contactable other hcp (patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route on unspecified date as single dose for COVID-19 immunization. Medical history included Crohn's disease and on chronic steroids from an unknown date and unknown if ongoing. The patient's concomitant medications included chronic steroids for Crohn's disease. The patient experienced migraine, malaise and arm soreness on an unspecified date and asked if these are typical side effects and if she didn't have any side effect after the first dose, would that mean she didn't get the dose? Patient would like to know if she got the full dose and was asking for information about the efficacy of the Covid vaccine while taking a steroid. Patient was on chronic steroids for Crohn's disease and asked if this would minimize the efficacy. She also asked if this means she should get a third vaccine dose and if there was an antibody test she should get to see if the shot was effective or that she got it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Heavy period within 24 hrs - previous uterine ablation and had no period at all until ~24hr after each shot. Continued to have intermittent spotting for 2 months after last shot
This spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc underwent first temperature excursion with Tmax 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes (explicitly coded as incorrect product storage). On an unspecified date, two temperature excursions were identified after an audit. On 29-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse events after administration. This case is linked to (201805262) due to same reporter.
Patient developed upper respiratory symptoms, and also experienced multiple episodes of very low blood sugar, presented to the Emergency dept. She was tested for COVID and tested positive on 9/28/21. Symptoms included cough and shortness of breath with chest xray showing minimal left basilar infiltrate or atelectasis on 9/27.
2-17-08 Pt. presented to ER with intussusception. This was reduced by air contrast enema. He received a Rotateq vaccine on 1-16-08.  3/14/08 FINAL DX: Intussusception, enema reduced. Reviewed hospital medical records which reveal patient experienced bloody stools, irritability & abdominal pain.  Admitted 2/17-2/18/2008 for observation s/p enema administration for IS.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 09-JAN-2015 the patient was vaccinated with an expired dose of GARDASIL (strength, frequency and route not reported), (lot # 0459AE, exp date 13-DEC-2014). There was no product quality complaint (PQC) involved. No adverse events were reported. Additional information has been requested.
pt rpt that 1 wk post vax developed an inject site react with a 2 to 3 inch area of redness & itching. as of 3/22/99 itching abated & redness fading
Big bump, red and hard at injection sight. Hurts to touch. Warm to touch. Appeared following morning. Slight fever and fatigue as well.
Left deltoid -localized redness and warm to the touch 24 hrs after vaccine. No treatment needed.
w/in 1 hrs of vax pt began unconsolable crying that lasted 5 hrs;
Muscle pain and weakness; Unable to bend knees, sit, or walk up stairs; MD diagnosed with Myositis on 5/11/10.
Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea  ) and VOMITING (Vomiting  ) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced NAUSEA (Nausea  ) and VOMITING (Vomiting  ). At the time of the report, NAUSEA (Nausea  ) and VOMITING (Vomiting  ) outcome was unknown.            Treatment information and concomitant information was not provided.
This spontaneous report as received from a pharmacist refers to a 56 year old female patient with headaches who on 19-NOV-2012, was vaccinated with ZOSTAVAX lot # 672676/0069AE (dose and route not provided). Concomitant therapies included trazodone hydrochloride, CELEXA, amlodipine and NAPROSYN. The pharmacist, stated that on 02-APR-2013, the patient reported that she experienced three outbreaks of shingles, after receiving ZOSTAVAX on 19-NOV-2012. The patient reported outbreaks of shingles occurred on 03-DEC-2012 (two weeks after receiving ZOSTAVAX), around January 2013 and on 30-MAR-2013. Pharmacist was not aware of how extensive the rash was with the outbreaks of shingles and reported that the patient had been prescribed FAMVIR for earlier outbreaks. No further information was provided. The outcome of three events of shingles was unknown. The relatedness adverse events was unknown for ZOSTAVAX. Additional information has been requested.
ROTATEQ administered after temperature excursion; no additional AE; This spontaneous report was received from Physician and refers to a 2-month-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (manufacturer unknown), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13).   On 06-JUN-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968386, expiration date: 23-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced ROTATEQ administered after temperature excursion. Alarm believed to be due to sensory issues. Monitoring temperatures with back up logger. Temperature in range. New data logger now in use. Return vaccines/waste in progress. No adverse effects.
Arm ache at injection site; Fever; Difficulty Sleeping; Tired/extreme fatigue; Muscle Aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2020, the patient received the 2nd dose of Shingrix. On 20th May 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, difficulty sleeping, tiredness and muscle pain. On an unknown date, the outcome of the injection site pain, fever, difficulty sleeping, tiredness and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, difficulty sleeping, tiredness and muscle pain to be related to Shingrix.  Additional details were reported as follows: On 20th May 2020, the patient received 2nd dose of Shingrix and experienced fever, muscle aches, arm ache at the injection site, difficulty sleeping, and extreme fatigue. The patient reported that she had worked in the garden and she thought that might be the cause of her muscle aches. The reporter consent to follow up.
A 57 year old female reported that she received Flu-Shield ('00-'01 formula) on 11/29/00. On 11/30/00, she experienced pain and numbness in her right leg and foot. She was seen by her physician "who was more concerned about her elevated blood pressure." On 12/20/00, the pain reportedly intensified and had spread to her left leg. She was admitted to the hospital where a dx of vasculitis was made. She was treated with cyclophosphamide and was released. On 1/25/01, she developed kidney failure, dehydration and clots and was re-admitted to the hospital. She was told that a virus attacked her T-cells. She underwent a cardiac catheterization to look for clots. She was discharged; however, as of 5/14/01, she was still experiencing pain and numbness in both of her legs. Following changes were made: no other vaccines were given within 4 weeks, this event was considered life-threatening. Follow-up info received from the physician on 08/15/2001, indicated that the pt was diagnosed with mononeuritis multiplex, livedo reticularis, and foot drop. Test results revealed an elevated erythrocyte sedimentation rate, elevated C-reactive protein, and a positive p-antineutrophil cytoplasmic antibody.
Severe pain L arm, L breast, L neck with hypersensitivity to skin touch withiing 6 hrs of vaccine. Low grade temp 99.2 within 24 hrs.
Pt presented to the emergency room 4/19/21 in the evening c/o the sudden onset of severe dizziness, light-headedness, nausea and diaphoresis. She received her second covid 19 vaccination at 10am earlier that day. pt was brought in via ambulance. she had a past history of vertigo but felt this incident was very different than her past episodes. she denied any problems with the first vaccine dose. she was admitted with a near syncopal episode and observed overnight in the hospital on telemetry. she was discharged home the following day feeling better with improvement in the dizziness. orthostatic blood pressures were negative.
Arm developed Cellulitis; Needed help out of bed; Muscle pain; Vaccine was given Subcutaneously; This serious case was reported by a nurse via sales rep and described the occurrence of cellulitis of arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2022, the patient received the 1st dose of Shingrix (subcutaneous). In MAY-2022, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Vaccine was given Subcutaneously). On an unknown date, the patient experienced cellulitis of arm (Verbatim: Arm developed Cellulitis) (serious criteria GSK medically significant), bedridden (Verbatim: Needed help out of bed) and muscle pain (Verbatim: Muscle pain). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)) and steroids nos (Steroids). The outcome of the cellulitis of arm was recovered/resolved and the outcome of the bedridden and muscle pain were not reported and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the cellulitis of arm, bedridden and muscle pain to be related to Shingrix.  It was unknown if the company considered the cellulitis of arm, bedridden and muscle pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 14-MAR-2023 The reporter was the patient herself. Arm developed Cellulitis from below the elbow on up, treated with antibiotics and steroids and resolved. Also complained of significant muscle pain a couple days later and needed help out of bed.  The reporter did go on to receive second dose later as an intramuscular (IM) injection and had no troubles with that.  The patient had received the Shingrix vaccine by subcutaneous route instead of Intramuscular route, which had led to Intramuscular formulation administered by other route. The reporter had consented to follow-up. Several days after receiving Shingrix, the patient experienced muscle pain.
On Friday morning I woke up and my upper left arm was very sore and itchy. The pain was mild all day, as if I had been punched hard in the arm. The next morning when I woke up (Saturday) my arm was very itchy with a large red rash around the injection site. The rash and mild itchiness lasted all day. This morning (Sunday) my arm is slightly red though the rash appears to be gone.
Vertigo two days after vaccine. Got worse on day three. It was debilitating for three days. The dizziness and vertigo has gone away slightly. I went to physical therapy on day seven. I am now on day  eleven and I can use a cane to walk. Still feel dizzy when I turn my head to quickly. I feel like I'm in a constant states of nonequilibrium.
states had swelling pain redness & tenderness on rt deltoid @ site of DT given on 31AUG92 pt in for flu shot today 26OCT92;
2 weeks prior to taking COVID booster that he tested positive for COVID; 2 weeks prior to taking COVID booster that he tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 10Aug2021 as dose 1, single (Lot number: FA6780) and on 31Aug2021 as dose 2, single (Lot number: FC3183) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: Other medicines unknown blood pressure medication: Has been taking a few years, low dose; "Psoriasis" (unspecified if ongoing), notes: Other medicines unknown medication for Psoriasis: taking a few years,only takes a half a dose. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "2 weeks prior to taking COVID booster that he tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: It was like 2 weeks prior to taking Covid booster that he tested positive for Covid.  Clinical course: Prior Vaccinations (within 4 weeks): No but, had Covid right before that. He told them he just had Covid and asked if he should be taking the booster. Went to the ER and they told him he should have waited 3 months. It was like 2 weeks prior to taking Covid booster that he tested positive for Covid. Was released to come back to work. Clarified that he went to the ER and they explained that he should not have taken the booster and should have waited 3 months.
Initial information was received on 12 November 2010 from a healthcare professional. The reporter provided individual patient identifiers for each of the five previously reported unidentified patients in a cluster of five. The initial case (2010-05065) now contains information for the first of five patients. A 54 year old female received on 15 September 2010 an injection of FLUZONE (lot number U3568AA). No pre-existing medical conditions, no allergies and no concomitant medications were reported. Post vaccination on an unspecified date, the patient experienced a headache, feeling foggy and weakness in legs. No further information was provided. The patient recovered the next day on an unspecified date. Follow-up information was received 19 January 2011 from a health care professional. The patient had no illness at the time of vaccination and she had not received any vaccines within four weeks of vaccination. The reporter had no additional information to provide at the time of the report. Follow-up information was received 18 February 2011 from a health care professional. FLUZONE had been a right deltoid intramuscular injection and symptoms began on 15 September 2010, the same day as vaccination. According to the reporter, no treatment was required. The reporter for this case (2010-06445) is the same reporter for cases 2010-05065, 2010-06447 and 2010-06448. Documents held by sender. None
Patient started vomiting.  She vomited until 11:00 off and on.
very sick with fever; chills; was very tired; very sick; could not get her 2nd dose on time due to Shingrix vaccine being on back order; the COVID-19 pandemic the reason she could not get her 2nd dose on time; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 3N7F2, expiry date 25th March 2020) for prophylaxis.   On 17th September 2018, the patient received the 1st dose of Shingrix. On 4th August 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, chills, tiredness, sickness, product supply issue and social problem. On an unknown date, the outcome of the fever, chills, tiredness and sickness were recovered/resolved and the outcome of the product supply issue and social problem were unknown.   It was unknown if the reporter considered the fever, chills, tiredness and sickness to be related to Shingrix.  Additional details were provided as follows: The patient got her 1st Shingrix dose in her left arm.  The patient reported she got very sick with fever, chills and was very tired. The symptoms last one day or so. The patient got her 2nd vaccine dose in her left arm. The patient reported she had no reaction at all.  The patient stated that she could not get her 2nd dose on time due to Shingrix vaccine being on back order, which led to product supply issue.  The patient stated that after this it was the COVID-19 pandemic the reason she could not get the dose, which led to social problem. The reporter did not consent to follow up.
Pt received vaccine 8/23/02, persisted 8/27/02 with c/o redness, swelling and hives about site. No SOB. Swelling began 1-2 days post injection.
This spontaneous report as received from a Registered Nurse regarding a 6 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 20-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Patient reported SOB, diaphoretic and heart racing. Reports the same affect from 1st vaccine. MD evaluated and Zyrtec given. HR 105-120. 4 minutes later patient reports feeling better. Also states baseline anxiety.
redness of left arm, will trial topical Benadryl/hydrocortisone.
fever 101. for 48 hours not relieved by asprin.  Pain at RT Deltoid site lasting for 48 hours.  Palpatations, difficulty breathing on onset lasting for 3-4 hours. Condition resolve after 50 hours.
Developed reddened skin over deltoid about 2 inches down arm from vaccination site, starting the day after vaccination and remaining for about 3 days. Patch was painful and warm to the touch, and itchy as it resolved. Patch approximately oval w/ uneven boundarym and about 2 inches wide, 3 inches long.
Patient received vaccine on 6/24; on the evening of 6/25, she felt achy, had chills, and general malaise. The following morning (6/26), she got very dizzy, and her vision "went black" and she fell. She was also diaphoretic.  Mom does not think she lost consciousness because she remembers everything, but she almost had a syncopal  episode. She recovered, and mom got her up and walked her to a different room, and she fell again. Mom called the office when she was recovering on the couch. she ate some food, and drank something, and she was then fine.  No further symptoms.
It was reported that a female pt received vax on 09/16/99. Reportedly sometime post vax, the pt experienced a red bump at the injection site. From correspondence received on 03/20/00, it was reported that the pt recovered from this event.
headache, joint ache, low fever, chills, 17 hours later took one advil. on the third day from the vaccination I am fine.