chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received shot on Feb. 10. On Feb. 16, I developed rash (about 5 inches long). Red and raised bumps. Also, whole area is raised. Very itchy.I have only had 1 day.Info online said this is normal so I did not go to doctor.
Pain at injection site and shoulder; difficulty with range of motion; burning sensation in the tricep muscle. Initial ice and ibuprofen. Diagnosis of bursitis 5/11/21; cortisone shot 5/13/21; physical therapy 5/17 and 5/18/21.
Patient complained of bruising/purple blotching from the waist down.; Patient complained of bruising/purple blotching from the waist down.; she also complained of itching and the formation of boils from the waist down.; she also complained of itching and the formation of boils from the waist down.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Aug2021 18:45 (Lot number: FC3182) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: other medical history: Arthritis; "Hyperlipidemia" (unspecified if ongoing), notes: other medical history: Hyperlipidemia; "known allergies:Sulfa" (unspecified if ongoing), notes: known allergies:Sulfa. The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies", notes: known allergies:Cipro; Keflex, reaction(s): "known allergies", notes: known allergies: Keflex; Codeine, reaction(s): "known allergies", notes: known allergies: Codeine.  The following information was reported: CONTUSION (non-serious), RASH MACULAR (non-serious) all with onset 28Aug2021, outcome "not recovered" and all described as "Patient complained of bruising/purple blotching from the waist down."; PRURITUS (non-serious), FURUNCLE (non-serious) all with onset 28Aug2021, outcome "not recovered" and all described as "she also complained of itching and the formation of boils from the waist down.". The events "patient complained of bruising/purple blotching from the waist down.", "patient complained of bruising/purple blotching from the waist down.", "she also complained of itching and the formation of boils from the waist down." and "she also complained of itching and the formation of boils from the waist down." were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of contusion, rash macular, pruritus, furuncle.  Additional information: The patient was not hospitalized or hospitalization was not prolonged. It was unknown that patient was diagnosed with COVID-19 prior to vaccination. It was unknown that patient has been tested for COVID-19, since the vaccination. the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
tinnitus; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) from a Pfizer sponsored Program Pfizer.com - General Company Information. A patient of un-specified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tinnitus. Patient further stated that vaccine gave me tinnitus. Was perfectly healthy. The clinical outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a physician refers to a 18 years old female patient. The patient had no pertinent medical history and no history of drug reactions/allergies. The patient was vaccinated intramuscularly with dose 1 GARDASIL (lot number not specified) in approximately October 2008 ("about 4 years ago"). The patient was vaccinated intramuscularly with dose 2 GARDASIL (lot number not specified) on 22-OCT-2012. The patient used no concomitant medications. After the first dose of GARDASIL the patient experienced a gastrointestinal complaint. No treatment was given for the event. The patient had recovered. The physician did not know when after the vaccination the complaint occurred or the exact date the patient recovered. The relatedness for gastrointestinal complaint was not reported for GARDASIL. Additional information has been requested.
26x16cm reddened, edematous area to left arm, warm to touch. Painful upon palpation.
Initial unsolicited report received from a nurse on 17-MAY-2017. This case involves a female patient (age not reported) who was vaccinated with dose of IPV (batch number N1F18, expiry date, dose and dose in series, rout and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient was warm to the touch and experienced Itchiness and getting bigger in size at local reaction. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Having  pain that feels muscular at times and nerve related symptoms. Pain is in right shoulder, arm & radiates down to wrist, NOT numbness & tingling .
rash came out with sort of a bump and that hurt; redness at injection site; injection site swollen; injection site hurt a little; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Modern's COVID-19 vaccine (mRNA-1273) and experienced redness at injection site, injection site swollen and hurt a little and later on developed rash came out with sort of a bump and that hurt.  The patient's medical history included Parkinson's disease. Concomitant medications reported included Sinemet, Carbidopa-Levodopa, Levothyroxine, Antidepressants and Midodrine.   On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) for prophylaxis of COVID-19 infection.    On 21-Jan-2021 the patient developed redness at injection site, injection site swollen and hurt a little. Then it went away and a week later her left arm developed another rash came out with sort of a bump and that hurt, this was 8 days after the vaccine. Now it is not hurting and dissipating.   No laboratory details provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the redness and swelling of the injection site was resolved while the rash developed after 8 days is unknown.
Stomach pain began at 3pm the day after my 2nd dose of moderna (5/23). It is a persistent burning pain that has lasted about 19 hours so far and has not subsided.
Awoke in the night with fever.  Fever persisted for about 30 hours.  Temp taken at 102.9.   Felt weak for days afterward.
This spontaneous case, initially received from other non-health professional on 25-Oct-2018, concerns a female patient of an unspecified age. On an unspecified date (reported as in the 90s), the patient was administered Influenza vaccine, (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date, after vaccination, the patient got sick. The patient reported that, the vaccine had 'swine flu' in it. At the time of this report, the outcome of the event was not reported.
Growth on my right ovary, my left ovary and tube removed due to abnormalities, re occurring cysts, monthly, debilitating pain.
Dizziness started within 15 minutes of injection and continues causing nausea ,headaches, confusion, slow processing. All other symptoms experienced after injection have subsided which included flue like symptoms muscle aches, shakes.
Patient received the first Pfizer COVID-19 Vaccine dose on 6/24/21 and the second dose of Pfizer COVID-19 Vaccine on 7/12/21. For unknown reason (not documented in chart) patient also received a third Moderna booster dose on 11/17/21 which is 128 days after the second dose. The recommended waiting period between booster and second dose is 168 days (7 days/week x 4 weeks/month x 6 months). There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Redness, warmness, swelling at the injection site. Symptoms occurred approximately 3 hours post-vaccination and continuing at time of report (28 hours later). Advised patient to ice the area to reduce swelling and warmness.
march 9th received first vaccine, march 20th woke up coughing and couldn't breathe, went home after work and did teledoc who recommended the emergency room. Tested negative for COVID, bipap provided. was in the hospital for 7 days states, "half the heart stopped working" and was diagnosed with heart failure. EF is 30-35%. Is having a nuclear medicine test Friday to evaluate if further intervention is needed. Stress test two years ago was normal
Syncope after vaccinations, unwitnessed. Pt sustained 3x3cm hematoma to (R) frontal. Vital signs stable. Follow up scheduled.
Information has been received through the pregnancy registry from a physician and a 35-year-old Caucasian female consumer with hypothyroidism who on 23-APR-2003 was vaccinated with a first 0.5 ml dose of varicella virus vaccine live. Prior to vaccination, the pt had a physical exam. Prior to vaccination on 14-APR-2003, the pt was negative for varicella antibodies and a home pregnancy test was negative. There was no local reaction at the vaccination site, no varicella symptoms and no herpes zoster symptoms post vaccination. Seven to ten days post vaccination, the pt tested positive for pregnancy (estimated LMP: 31-MAR-2003; EDD: 05-JAN-2004). The pt had no previous pregnancies. Medications used during the pregnancy included pre-natal vitamins and cranberry caps. There were no infections or illnesses during pregnancy. On 14-MAY-2003, 08-OCT-2003 and 14-DEC-2003, ultrasounds to check fetal growth were all normal. An amniocentesis was "ok". Breech was noted as a complication during pregnancy. On 20-DEC-2003 at 39 weeks from the LMP, the pt delivered a normal, healthy female infant (6 lbs, 11oz) by C-section. There were no congenital anomalies, no other complications or abnormalities and no features of congenital varicella zoster syndrome. A product quality complaint was not involved. Upon internal review, breech was considered to be an other important medical event (OMIC). Additional information is not expected.
48yo F present with c/o broken capillaries with red pinpricks on L arm, onset after showering this morning. Associated with mild forearm and dorsal hand swelling. Patient also notes chest tightness and fatigue. + diastolic murmur appreciated at pulmonic and tricupsid ausculation sites L forearm and dorsal hand mildly edematous w/ diffuse red pinprick purpura
Excursion  of -5.6°C for 8 hrs,Vx administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 9th March 2025) for prophylaxis.   On 10th February 2023, the patient received Engerix B. On 10th February 2023, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: The reporter reported that the patient received an Engerix B vaccine which was not stable. The reporter stated that the vaccines had been exposed to a lowest temperature of minus 5.6 degree Celsius for 8 hours. No other information about the patient involved was available at the time of the call. The reporter did consent to follow up via email. Additional supportive information: The Engerix B vaccine temperature was exposed upto minus 5.6 degree Celsius, which led to incorrect storage of drug.
Began with feeling fatigued around 6pm, had chills, palpitations and severe body aches with 101.3 fever. Fever resolved with Tylenol . Woke up then next morning (24 hours later) still with low grade 99 fever with weakness and fatigue. Fever spike again at 1pm 101F. Tylenol resolved fever again. The next day (48 hours after) fever free still with general aches and fatigue.
Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F). Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site. The reaction was reported "from the shoulder to the elbow." The patient sought unspecified medical attention. It was reported that the lot # would not be used and there was concern expressed regarding the lot number. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the authority and was released by the regulatory agency. Additional information has been requested.
Information has been received from a pharmacist concerning a 44 year old female patient with unknown relevant medical history and drug history, who on 01-FEB-2010 was vaccinated in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot number 663889/0632Y). Concomitant therapy included FLONASE, SINGULAIR, ADVAIR, LEXAPRO, RECLIPSEN and unspecified PROAIR. On 04-FEB-2010, three days after receiving PNEUMOVAX 23, the patient called the pharmacy and reported that her arm hurt really bad. On 05-FEB-2010 the patient called the pharmacy again and reported that her arm was so sore that she could hardly move it. As of 06-FEB-2010, the patient called and reported to the pharmacist that her arm was still sore. The pharmacist confirmed that there was no swelling or redness at the injection site. The pharmacist was going to refer the patient to her doctor for assistance. It was unknown if any laboratory tests were performed. Additional information has been requested.
A 37-year-old female presented to vaccination site on 4/9/22 to receive Pfizer 1st booster. Client reported to a nurse that when she received her Pfizer Dose 2, she experienced tongue numbness after a few minutes of vaccination. Client stated she received  Diphenhydramine unknown dose and symptoms subsided. A medical consult was sent to a doctor. Client was approved to receive Pfizer 1st booster. Client was vaccinated at 0922. At approximately 0929, client was in observation area when client reported to the nurse that she was feeling tingling on the upper roof of her mouth and numbness at the tip of her tongue. Client stated she was having the same feeling as the second dose.  She requested to have Diphenhydramine . Client denied closing of the throat or itchiness. No swelling was observed on tongue, lips or mouth. Nurse gave 50mg of Oral  Diphenhydramine at 0931. Client was able to swallow oral medication with no issues. Vitals at 0933 BP 110/85 HR 73 02 100%. At 0944 client reported that the tip of her tongue is not tingling anymore and was feeling better. Vitals at 948 BP 110/80 HR 71 02 96%. Client stated that her mother was driving her home. At 1000, nurse asked client how she was feeling. Client stated her symptoms had subsided and felt better. Vitals at 1000 BP 110/58 HR 76 02 98%. Nurse educated client to seek emergency care for worsening symptoms or any other life-threatening symptoms, as well as follow-up with her primary care provider in the next 24hrs. Client verbalized understanding and left in steady gait at 1004.
Information has been received from a physician assistant concerning a 16 year old female with penicillin allergy and sulfonamide allergy who on 05-JUN-2008 was vaccinated with a first dose of GARDASIL (lot number 659657/1487U). On 05-AUG-2008 the patient was vaccinated with a second dose of GARDASIL (lot number 659657/1487U) (injection site and route not reported). There was no concomitant medication. The patient developed a rash around her stomach lasting one week after the first vaccination. The rash came and went since the first vaccination. The patient also developed extreme fatigue, joint pain and was pale. The patient was tested positive for a variety of medical conditions. The patient had been tested for rheumatoid arthritis and mononucleosis but the results had not been received. The patient was prescribed prenatal vitamins, but she was not pregnant. The patient was seen in the physician's office. Laboratory test included pregnancy test, mononucleosis, AlC, blood cell count, MMA, thyroid and swallow study H. pylori Complete medical panel (results unspecified). The patient's mother refused the third dose due to the adverse events. At time of this report, the patient's events persisted. Follow-up information was received from the physician assistant concerning the 16 year old female. The Physician's assistant reported that it was determined on 27-MAR-2009 that the patient's mononucleosis and not the fact that she received two of three doses of GARDASIL resulted in the reported adverse events. Additional information is not expected.
"shingles vaccine" given to patient at the Pharmacy on 12/9/2020 patient developed a 11cm x 15cm erythematous plaque distal to the administration site. I am not the vaccine administrator so i do not know the vaccine information beyond this.
First, pain in arm  before bed. Took Tylenol so I could sleep. Next day toward late afternoon, had soreness somewhat at upper center between shoulders.  Tired and listless.
After the second dose of the moderna vaccine, I had deep upper chest pain and costochondtitis for which Motrin 600mg/day is necessary to keep the pain tolerable. This is aside from a few days of general malaise and fever which is resolving after 4 days.
Moderna COVID?19 vaccine EUA. On day 8 bright red area, hot to the touch, covering deltoid with hives, itching and swelling. Continues even 3 days later. Using 1% hydrocortisone cream to handle itching.
slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "slight headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient took TYLENOL as treatment for slight headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had sore arm; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had sore arm) and VACCINATION SITE RASH (Rash at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Had sore arm) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, PAIN IN EXTREMITY (Had sore arm) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.   It was reported that post first shot had sore arm and week later rash at injection site.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624806 (Patient Link).
Nausea 15 min after GARDASIL Dizziness 30 min after vaccine still c/o dizziness, now on 4/2 , got vaccine on 3/31/09
Developed watery diarrhea; malaise; weight loss; collagenous colitis on colonoscopy biopsies; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was none. No covid prior vaccination. No known allergies. Concomitant medication included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN), simvastatin (ZOCOR). Historical vaccine included BNT162B2 details: (Product= COVID 19) for covid-19 immunisation, Lot number= EL1284, Administration date= 31Dec2020, administration time= 11:00 AM, vaccine location: Left arm, dose number= 1, Developed watery diarrhea about 5 days after the dose. No other vaccine in four weeks. Adverse event: watery diarrhea improved somewhat but worsened again after the second dose of vaccine, along with some malaise and weight loss, since 05Jan2021. Extensive investigations eventually revealed collagenous colitis on colonoscopy biopsies in Jan2021. May well be coincidence, but interested to know if others have been reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Anti-diarrheals, budesonide. The event outcome of collagenous colitis was recovering, watery diarrhea was  not recovered, outcome of other event was unknown. Covid test post vaccination covid test date=19Jan2021, which was negative.; Sender's Comments: Based on the available information, the company considers that a causal relationship between collagenous colitis on colonoscopy biopsies and bnt162b2 cannot be excluded due to plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021229604 same  patient/reporter, different AE/first dose
Covid 19 Bivalent booster given as a 1st dose. No adverse reaction to report.
Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced INSOMNIA (Insomnia). The patient was treated with MELATONIN ongoing since an unknown date at an unspecified dose and frequency and DOXYLAMINE SUCCINATE (UNISOM 2) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INSOMNIA (Insomnia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.