chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EK9231, expiration date unknown), via an unspecified route of administration on the left arm on 28Dec2020 at 11:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension (HTN), obesity, hypothyroid, allergies to penicillin (PCN), and was diagnosed (Dx) with an unknown virus in Feb2020. Concomitant medications included chlorthalidone (CHLORTHALIDONE), levothyroxine sodium (SYNTHROID), olmesartan medoxomil (BENICAR), atenolol, and minoxidil (PANT). The patient previously took levofloxacin (LEVAQUIN), gatifloxacin (TEQUIN), and morphine and experienced allergies from all these medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced left arm pain - mild and mild lightheadedness. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The outcome of both the events was unknown.
Tylenol for injection site  discomfort ,rash below injection site @ 3cm . Chills periodically throughout  the day.
This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns a 60-year-old, adult, male patient. The patient's current condition included blood pressure (reported as medical history) and concomitant medications included Eplerenone, BENICAR, QUESTRAN, CLAVATIN (as reported), CIALIS (reported as sialis). On 03-Sep-2018, the patient under age of 65 years was accidentally administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250788, expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration). At this time of the report, no adverse event was reported. The reporter assessed the case as non-serious.
Menstruation started 3 weeks early, much heavier than normal; Menstruation started 3 weeks early, much heavier than normal; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO162) via an unspecified route of administration, administered in Arm Left on 12Apr2021 15:00 (at the age of 24 years old) as dose 1, single for COVID-19 immunisation. Medical history included food allergy (Known allergies- Food allergies). No known medication allergies, no allergies to anything in COVID vaccine. The patient's concomitant medications were not reported. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced menstruation started 3 weeks early, much heavier than normal on 15Apr2021. No treatment were given for the adverse event. Patient did not tested for COVID post vaccination. Outcome of all the events were not resolved.  No follow-up attempts are needed. No further information is expected.
Patient received two doses of Varicella. On 04/22/2010, Patient broke out with chickenpox #1 12/29/2003 #2 11/16/2007.
This spontaneous report as received from a healthcare worker, who reported that VARIVAX (Merck) was exposed to 40F for an unspecified amount of time longer than 72 hours. Healthcare worker was unsure if any doses were administered. No adverse effects reported. This case is linked to case 1307USA012731 via same reporter link. Additional information has been requested.
Rash started 4 days ago - papules on abd & spread to extremities.  Itchy lesions.  Prior to rash had low grade fever & stomach ache.
Headaches, sore muscle joints, eye blurriness, light headed, neck soreness.
Case number PHEH2016US013040 is an initial spontaneous case received from a consumer via pharmaceutical company (Mfr number:2016144094) on 23 May 2016. This report refers to a 55 year old male patient. Concomitant medication was not reported. The patient was allergic to aspirin (manufacturer unknown), BENADRYL, ibuprophen (manufacturer unknown), morphine sulphate (manufacturer unknown), ZOFRAN, penicillin, egg, dicyclomine, TYLENOL, SINGULAIR. The patient was vaccinated with influenza virus vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On an unspecified date, patient had allergy to flu  vaccine. The outcome, seriousness and causality of event were not reported.
RED ARM AT INJECTION SITE AND UP UNDER ARM, HARD AREA ON ARM AT INJECTION SITE, WARM TO THE TOUCH.  STARTED DAY AFTER SHOT AND CONINUING UP TILL TODAY (8/5/2022) SO FAR.  I SUGGESTED TYLENOL, COLD COMPRESS, AND CALL PRIMARY PHYSICIAN. PATIENT DOESNT HAVE PHYSICIAN, SO I SUGGESTED GO TO URGENT CARE IF SHE THINKS SHE NEEDS TO.
Slept day and night 5 days after vaccination.  Extreme fatigue & weakness still. No appetite for 3 weeks, lost 5 pounds. Eyes very tired - blurry vision.  No arm pain.
Numbness in his leg; This is a spontaneous report from a contactable consumer or other non hcp. An adolescent male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced numbness in his leg on an unspecified date. Device date was reported as 25Jun2021. The patient did not receive any treatment for adverse event. The outcome of event was recovered.  Information on the lot/ batch number has been requested.
Lump in her left armpit; Left side numbness and tingling; Left side numbness and tingling; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 09Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included sertraline hydrochloride (ZOLOFT), gabapentin, and calcium carbonate/ colecalciferol (VITAMIN D 2000).  The patient previously took ketorolac tromethamine (TORADOL) and experienced allergies; and the first dose of BNT162B2 on 21Dec2020 at 06:00 PM for COVID-19 immunization (intramuscular in left arm). The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a hospital facility. On 11Jan2021, the patient had a lump in her left armpit and it finally has shrunk. The patient also had left side numbness and tingling on 11Jan2021. The adverse events resulted in emergency room or department or urgent care. No treatment was received for the adverse events. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
my arm is still sore at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (my arm is still sore at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (my arm is still sore at injection site). At the time of the report, VACCINATION SITE PAIN (my arm is still sore at injection site) outcome was unknown.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning an eight-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 02-Dec-2010. The patient received the expired FLUMIST on 10-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
RASH AND FATIGUE LASTING 2/5/2021 TO  14 DAYS AFTER VACCINATION
Patient called after receiving vaccine and reported that her arm had developed a lump and some redness under the injection site of vaccine. Was a little painful, no other symptoms. Patient had similar reaction 3 years ago where arm swelled and became red and painful, last 2 years had vaccine with no adverse reaction. Patient was instructed to apply ice, call clinic if symptoms became worse, had difficulty breathing etc.  or go to the nearest emergency room. Patient was also given contact information for clinic staff if she needed to call over the weekend outside clinic hours. Patient was called 3 days later and reported symptoms had all resolved, no other symptoms developed other than the swelling and redness and a little pain.
neck pain; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain) and MYALGIA (muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced NECK PAIN (neck pain) and MYALGIA (muscle aches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (neck pain) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
COVID-19 virus test positive; COVID-19 virus test positive; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a program, other case identifier(s) 21K-163-4214623-00.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; HUMIRA, subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome not recovered. The patient underwent the following laboratory tests and procedures sars-cov-2 antibody test positive (20Dec2021) positive.  Causality for HUMIRA. The reporter causality for the event(s) of TESTED POSITIVE FOR COVID-19 was not provided. Daily dose of Humira Citrate free, COVID-19 virus test positive.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.
Patient fainted miniutes after the injection was given. Pt came to and we monitored pt and rechecked blood pressure and heart rate.  Patient stayed at clinic for 25 min under observation.
Began experiencing pain in my right leg on 1/10/2022. Symptoms increased over the next few days. On 1/21/2022 experienced severe pain and was unable to stand on right leg. Office visit on 1/24/2022 led to diagnosis of DVT in right leg. Began taking Xarelto 1/24/2022. Started wearing compression stocking. Status: Continuing discomfort in leg but became fully ambulatory after 10 days.
Sudden onset of new redness, swelling and itching at injection site 8 days post vaccination.
Patient administered partial dose of Moderna 2.5mL to RVL. Prior to noticing, patient was poked with partial dose. Noticed dose on patient's leg. Patient made aware. Full dose of vaccine given via LVL.
accidentally received the adult dose; 16 year old accidentally received the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 16-year-old female patient who received HBV (Engerix B adult) (batch number 39TZ2, expiry date 7th September 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th January 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 17th January 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comments: This case was reported by practice manager from a medical office. (She was not a nurse or a medical assistant). The provided lot number 39TZ2 corresponds to Engerix B. Other supportive information: 16 years old female patient accidentally received adult dose of Hepatitis B instead of the pediatric dose, which led to accidental overdose and adult product administered to child.
Patient developed left armpit lymphadenopathy for one week along with body pain and aches.
The patient received the vaccine on the afternoon of Thursday, 1/28/21. He was observed for at least 30 minutes following administration of the vaccine with no reactions noted. He was found dead in his car on Sunday, 1/31/21. It is unknown if the vaccine contributed to his death.
On 6/4/2008 the patient presented with about three small, red bumps on her chest and three on the back of her neck. She described them as slightly painful and itchy. Within a week of onset the bumps had scabs form and went away soon after.
Sore arm and swelling in right side of neck with pain that through ear.  Patient took tylenol for pain 1 time. Swelling lasted for 1 week in neck, ear and head.  Back of neck patient complained of knot that formed.  Patient put ice packs on side of neck and back of neck to keep swelling down.  Symptoms decreased within a week.
progressive bilateral visual loss 3-4 wks following vax; exam consistent w/bilateral anterior ischemic optic neuropathy;
Right arm was sore for 2-3 days after shot. A week later, site started itching, turned red and a lump or bump developed unde4 skin. And is sore again.
Patient was given Pfizer Bivalent in error. Patient should have received primary #1 dose.  No treatment necessary.
Severe nerve/muscle pain starting 3/10/2021. Appearance of shingles blisters on 3/14/2021. Pain worsening.
Over an hour post vaccination with the COVID-19 vaccine, she reported a tightness in her lungs and a rapid heartbeat.  She sat down in an office with a table top fan blowing on her and was evaluated and monitored.  When I arrived, she was not having difficulty breathing or communicating with me, but still felt some chest tightness.  Her Pulse Ox was 94 and while monitoring began to improve. Her symptoms continued to improve without any medical intervention.  Approximately 30 minutes after the initial signs, she was feeling well and was able to stand up and walk without any issue.
Received vaccine at 6:15pm on Friday night.  Approximately 30 minutes later, my face became very itchy and my face was covered in a red puffy rash.  At 8:00pm, I took 25 mg Benadryl. On Saturday, I still had the rash, so I took 3 doses of Benadryl over the course of the day to relieve the rash and itching.  The rash resolved Sunday.  On Saturday afternoon, I began to develop mild respiratory symptoms as well.  My chest became very tight. I took 30mg of prednisone at 4:00pm. This provided relief. The tight chest fully resolved Monday morning.
BELLS PALSY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 was not reported, one total, administered on 15-APR-2021 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 15-APR-2021, the patient experienced numbness on left side of face, bells palsy diagnosed, was in emergency room it was direct effect from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210441515- Covid-19 vaccine ad26.cov2-Bell's palsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient given Pfizer booster dose in error at age 17, should have waited until age 18.
Shock, Body aches and pains, Fever, Shortness of breath, Chills, Loss of appetite,
I felt like I was hit by a bus /Her whole body was in shock; was cold; My body was in shock and had loss of appetite; sweating; unable to sleep; throwing up; chills; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt like I was hit by a bus /Her whole body was in shock), FEELING COLD (was cold), DECREASED APPETITE (My body was in shock and had loss of appetite), HYPERHIDROSIS (sweating) and INSOMNIA (unable to sleep) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071721a, 004M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (I felt like I was hit by a bus /Her whole body was in shock), FEELING COLD (was cold), DECREASED APPETITE (My body was in shock and had loss of appetite), HYPERHIDROSIS (sweating), INSOMNIA (unable to sleep), VOMITING (throwing up), CHILLS (chills) and MYALGIA (muscle ache). At the time of the report, FEELING ABNORMAL (I felt like I was hit by a bus /Her whole body was in shock), FEELING COLD (was cold), DECREASED APPETITE (My body was in shock and had loss of appetite), HYPERHIDROSIS (sweating), INSOMNIA (unable to sleep), VOMITING (throwing up), CHILLS (chills) and MYALGIA (muscle ache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade, adolescent male.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider  clip; 21 children received only half a dose.  No adverse effects were reported;  the event is considered resolved.
Patient given 0.5mL instead of 0.25mL. Patient has not shown any side effects. We called her to  explain the situation and she seemed satisfied.
sore throat; COVID-19 positive after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and SARS-COV-2 TEST POSITIVE (COVID-19 positive after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and SARS-COV-2 TEST POSITIVE (COVID-19 positive after 1st dose). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and SARS-COV-2 TEST POSITIVE (COVID-19 positive after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
thrombocytopenia-petechiae 20OCT94 platelet count 17,000.
extreme pain on left side of face, throat, and neck. swelling in throat that caused fair amount of difficulty in breathing, talking and swallowing received epipen at urgent care on 04/09/2021 as the doctor felt I was having an allergic reaction to the covid vaccine and was told to go to the emergency room. was given IV of benedryl and pepcid. had a CT with contrast do to feeling of having something lodged in my throat. sent home with perscriptions for steroids and pepcid. still having  symptoms though they are less severe
Rash all over upper body, shakiness started 3-4 minutes after vaccines were given.
PALPITATIONS, SWEATING AND MILD LIGHTHEADEDNESS  POST VACCINE ADMIN REPORTED BY PATIENT, BROUGHT TO OBS VIA WC. PLACED IN TRENDELENBERG ON STRETCHER IN OBS, PATIENT STATES S/S RESOLVED SOON AFTER. VSS. ESCORTED TO EXIT WITH NO ISSUES AT 1415.1408 BP 128/80 HR 72 RR 16 SATS 96% RA.
Approximately 6 1/2 hours after receiving MMR vaccine started to notice throat tightness, no SOB.
2nd Shot Feb 12. No side effects till 6th day -Feb 18 lower back pain. Feb19 extreme cramping in upper right thigh and right calf by shinbone. Feb20 same cramping as above described plus pain  had moved to outer right hip muscles. Pain improving Very slowly till feb 26 one week later. still have pain in hip muscles on right back outer area.