chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bleeding has now commenced from the ear; Epistaxis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Epistaxis) and EAR HAEMORRHAGE (Bleeding has now commenced from the ear) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Hazelnut) and Food allergy (Celery-severe anaphalaxis).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EPISTAXIS (Epistaxis). On 01-May-2021, the patient experienced EAR HAEMORRHAGE (Bleeding has now commenced from the ear). At the time of the report, EPISTAXIS (Epistaxis) and EAR HAEMORRHAGE (Bleeding has now commenced from the ear) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment medication were not applicable.   This case was linked to MOD-2021-075579 (Patient Link).
left arm was red and hot  - rash continued spreading since day after immunization - right arm unaffected
Sore neck after receiving a Covid vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "Sore neck after receiving a Covid vaccine".  Additional information: patient was under age 18.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient (patient ID # 2082736) of unspecified age and gender. On 08-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2014, 0.5 milliliter (ml) subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10C (acelius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Initially C/O pain at injection site, redness at site, and dizziness. Within 24 hrs patient progressed to arm pain and pain with movement. Determined incorrection injection site, given above deltoid close to shoulder. patient's symptoms relieved with cool compress and Ibuprofen. As of 8/1/16 symptoms relieved.
Severe headache; sore arm.; This is a spontaneous report from a non contactable consumer (patient). A 31-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EW0165) via an unspecified route of administration, administered in Arm Left on 07May2021 at 17:30 (at the age of 31 years old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's past drug history included previously took Norco for allergy from an unknown date and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that after first dose, she had a severe headache the second day (08May2021) and a sore arm. The clinical outcome of the events was recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Patient felt as if he was having an SVT, heart felt racing. Patient was seen by a Physician an ekg was obtained and patient's ekg was normal and patient was released to go home.
Local at injection site:erythematous rash x7+days, 1 week post injection elevated temp > 103, difficult to respond to oral NSAID's, temp has lasted over 5+ days, prickly heat type rash on back and neck (remains evident at time of report), muscle aches, malaise, cough, behavior changes (argumentative and combative even when temp was < 100), URI symptoms runny nose and congestion...URI symptoms are still evident at time of this report. Was seen by pediatrician who diagnosed this as a viral syndrome...
Since injection has had pain in right arm from neck to wrist. Can move arm but very painful. Any pressure on arm is also painful. Can't sleep d/t pain. Also having hives. Giving BENADRYL, TYLENOL, ibuprofen.
Hives and Fungus ( jock itch and ring worm ) never had these issues
Fever, full body rash lasting 2-3 days. Screaming for several hours after vaccines with fussiness lasting for several days. Mom also stated child came down with ear infections after every imm.
Pain started in both arms. She has a burn sensation that never leaves and a dislocated tendon. Her right arm pops all the time and a shot feeling in her left arm. She does not have any muscle in her left arm and she has to sleep sitting due to she cannot bend her arm without being in alot of pain.
Patient reported swelling, redness, warmth in area of injection. She says she had swelling with previous flu shots but not as much. She went to dr and he was not concerned said to just see ice it and take TYLENOL.
15 mo old received 4th DTaP vaccine on 4/13/2004. 6days later had paroxysmal movements, dazed appearances and pds of lethargy intermittently over single day. No other signs of illness. Seen next day in office on 4/20/04 with normal exam. Concern for possible seizures.
4 hours after receiving the flu vaccination complained of bad chills, body aches, head ache, fatigue and upset stomach. (Did not take temperature.) The next day continued to have chills, upset stomach and fatigue but they were not as severe.  Continued to feel tired and have an upset stomach the second day following the injection, but chills were gone.
This spontaneous report was received from registered nurse concerning a 2 month old female patient. The patient did not have medical history and drug reactions or allergies. On 21-APR-2016, the patient was vaccinated with the first dose of ROTATEQ, orally, 1 vial once, (lot number L047185 and expiration date 17-SEP-2017) (dose and strength were not provided). Concomitant therapies were not provided. On the same date, later in the evening, the patient was taken to a pediatric facility because she presented three episodes of blood in the stool which also appeared tarry. According to the reporter, a health care professional at the facility looked at the stool and saw visible blood. Since that same date, the patient's sleep increased and she presented a temperature of 100.0 F. No treatment was given for the event and no laboratory diagnostic studies were performed; however, the reporting nurse scheduled a follow up appointment for the patient. At the time of reporting, the outcome of the events haematochezia, malaena, body temperature abnormal and hypersomnia was unknown. The reporter did not assess the causality between the reported events and vaccination with ROTATEQ. Additional information has been requested.
Headache, achy joints, chills, Fatigue, Weakness Injection site tenderness
Pt received vaccine @8:45 am, at 10:05am pt became nauseous, Increased salivation, vomiting, red rash on chest hands and arms. Pt left work at 10:30 am and went home and took Zofran and Benedryl. Pt began feeling better and symptoms eased up at 2:30 pm.
6/3/04 day after injection decreased appetite. 6/5/04 low grade fever- loose stools. 6/9/04 Temp to 104- loose stools. 6/10/04 temp to 104- fretful. 6/11/04 temp to 104- face rash- seen in office- viral illness/ past MMR reaction 6/12- temp fell, rash. Went to ER. Past febrile seizure. 6/15/04 still rash on trunk- temp 100.
About an hour later, was complaining shoulder and neck pain. Then had body aches. That night had a fever of 101.4 that continued for 5 days. Went to the ER on Jan 7th, they did a physical exam. They said that it was the vaccine taking its course. A few days later, was not getting any better. Went and got a Covd-19 test, negative results. Contacted the pediatrician, that appointment is tomorrow.
This spontaneous report was received from a pharmacist concerning  to an adult female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant therapies were unknown.   On 08-MAY-2017, the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, lot # M019645 with expiration date on 18-JUL-2017 for prophylaxis (the route, strength, frequency, and dose were not provided). Afterwards, on an unspecified date in May 2017, the patient experienced itching, redness, and warmth, as well as a firm lump at the injection site after the vaccination. It was unknown whether the patient sought medical attention and if laboratory diagnostic studies were performed. At the reporting time, the patient's itching had resolved  on an unspecified date in May 2017, after the patient took some diphenhydramine hydrochloride (BENADRYL). It was also stated that the lump was still present, and the site was still a little bit warm, and still had a bit of redness in the area of the injection site. The causal relationship between the events and the ZOSTAVAX was not provided.  Additional information is not expected because the reporter did not consent for further follow up.
Patient is a 100 year old female in otherwise good health who experienced extreme fatigue within 12 hours of receiving second booster. This fatigue was accompanied by incontinence of bowel and bladder.  Patient was less responsive. Patient is three days post second booster with ability to drink and eat small amounts;  somewhat more conversant on day 3.
Initial report was received from a health care professional on 16 November 2009. It involves one patient in a cluster of seven patients who experienced adverse events following vaccination with FLUZONE, lot number U3193AA. The other events are found in case numbers 2009-04035, 2009-05006, 2009-05007, 2009-05008, 2009-050109, 2009-05010. A 36-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number U3193AA) on 30 September 2009. Six hours post-vaccination, she experienced neck pain, back pain, a sore throat, and noted that her throat felt swollen. The events recovered after approximately 18 hours.
Patient experience kidney failure suspected to be caused by the vaccination. Spent several days in local hospital. Potassium levels also reported to be disrupted.
improperly stored vaccine adminsitered; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 16-DEC-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route of administration and anatomical location were unknown) lot # S010727 and expiration date 26-JUL-2020 for prophylaxis (product storage error). It was reported that the vaccine was exposed to a temperature of 48.5 degree Fahrenheit for a time frame of 1 hour. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved.
Nausea and pressure in throat immediately after administration. Face flushed. Smelling salts used and pt. felt better right away. Fluids offered and rest at table with nurse. Pt able to leave at 1:15 PM stating was much better.
Minor side effect- Within 30 minutes of receiving vaccine, I developed an odd taste in my mouth, followed about 15 minutes later by numbness to the center of my tongue.  The numbness lasted about 10 minutes.  When that ended, so did the odd taste sensation.
Immediately after vaccine had a metallic taste in my mouth. Arm was very sore for a while and on March 6th, it started turning red and swollen at injection site. It grew to about 5 inches long and 4 inches wide. Arm was very sore. Did not itch. After 5 days of growing, it went away overnight. I used warm compresses to help.
PATIENT IS IMMUNOCOMPROMISED . SHE  WAS ADMINISTERED    DOSE # 3  OF MODERNA VACCINE 0.25ML INSTEAD OF 0.5ML ON 11-11-21
From telephone contact received at a manufacturer on 4/22/02, it was reported that a female received Imovax vaccine in the gluteal area. Date of vaccination unknown. PT experienced local irritation, redness, warmth and swelling at inject site (gluteal). PT's mother called in report. This case is linked w/U2002-00292.
injection site being a little sore; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6198, Expiration date: 30Jun2021), via an unspecified route on 28Feb2021 (at the age of 73-years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318, Expiration date: May2021), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient experienced injection site being a little sore on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
fatigue; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site). On 10-Mar-2021, FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-JUL-2017 the patient was vaccinated with VARIVAX lot # L023594 for prophylaxis.       On 31-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to VARIVAX.
Fever 102; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 102) and HEADACHE (Headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included DIAZEPAM (VALIUM) for an unknown indication.   On 21-Mar-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 22-Mar-2021, the patient experienced PYREXIA (Fever 102) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 102) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 102 (High) Fever 102.         Concomitant products included blood pressure medications.
Pain in fingers after both shots./  experienced same pain as before in the same two fingers and about 4-5 minutes later in left hand too, but only in my first finger on this side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0175) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: shellfish; "Known allergies: mold" (unspecified if ongoing), notes: Known allergies: mold; "Known allergies: weeds" (unspecified if ongoing), notes: Known allergies:weeds; "Known allergies: grasses" (unspecified if ongoing), notes: Known allergies: grasses; "Known allergies: trees" (unspecified if ongoing), notes: Known allergies: trees; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: dust; "Known allergies: mangos" (unspecified if ongoing), notes: Known allergies: mangos; "Known allergies: possibly peanuts" (unspecified if ongoing), notes: Known allergies: possibly peanuts; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: ENALAPRIL; AMLODIPINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Ceftin, reaction(s): "Drug allergy", notes: Known allergies: Ceftin. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer ,, lot number=EW0158 , lot unknown=False, administration date=09Apr2021, administration time=02:00 PM, dose number=1, vaccine location=Right arm), when the patient was 55 years old, for COVID-19 IMMUNIZATION, reaction(s): "Pain in fingers after both shots. First shot received in R arm and about two minutes later I began experiencing stinging pain in the first and second fingertips in my R hand.". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in fingers after both shots./ experienced same pain as before in the same two fingers and about 4-5 minutes later in left hand too, but only in my first finger on this side". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Instant anaphylaxis after receiving shot during the 15-minute waiting period, 4 hour later had COVID symptoms which lasted for 7 days, experienced vertigo, anaphylaxis didn't subside, medication for vertigo was prescribed. Having pain when I vomited and pooped and the same time.
Patient presented for 1st dose of Pfizer vaccine today and had concerns of lightheadedness, anxiety, and feeling general malaise. History of fibromyalgia and allergy to sulfa. Patient was assessed by onsite EMTs and was released. States that she has anxiety and with rest and reassurance returned to baseline.
swelling and warmness at the injection site, and swelling again at day 8; swelling and warmness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (swelling and warmness at the injection site ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE WARMTH (swelling and warmness at the injection site ). On 10-Jan-2021, VACCINATION SITE WARMTH (swelling and warmness at the injection site ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 09JAN2021 consumer took first dose of Moderna COVID 19 vaccine last Saturday and she got swelling and warmness at injection site. But it went away on second day but on 16JAN2021 after 8 days her arm is swollen again.    Treatment information not provided.
Patient complained of right arm numbness, right sided facial numbness and drooling about 6 hours after the vaccine was given.  Was taken to the ER where they diagnosed him with a possible seizure.  He had not had a seizure since age 4 and is not on anticonvulsants.  He had had a set of vitals taken at the clinic before the vaccines which were all normal.  His symptoms had resolved at the time of the ER discharge.  The mother listed on page 1 has more details about the ER visit as that was not in our healthcare system.
Would feel something if I move it a certain way or made a certain movement; mentally foggy/started to feel off; uncomfortable flu-like symptoms; Headaches; Chills; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (I would feel something if I move it a certain way or made a certain movement), HEADACHE (Headaches), CHILLS (Chills), PYREXIA (Fever) and FEELING ABNORMAL (mentally foggy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second 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 DISCOMFORT (I would feel something if I move it a certain way or made a certain movement), HEADACHE (Headaches), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (mentally foggy), FEELING ABNORMAL (started to feel off) and INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms). At the time of the report, VACCINATION SITE DISCOMFORT (I would feel something if I move it a certain way or made a certain movement), HEADACHE (Headaches), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (mentally foggy), FEELING ABNORMAL (started to feel off) and INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Patient also include blasted event.   This case was linked to MOD-2021-329230 (Patient Link).
COVID arm; COVID arm itchier; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) and INJECTION SITE PRURITUS (COVID arm itchier) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID arm) and INJECTION SITE PRURITUS (COVID arm itchier). At the time of the report, VACCINATION SITE REACTION (COVID arm) had not resolved and INJECTION SITE PRURITUS (COVID arm itchier) outcome was unknown.