chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ringing in right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EM9810) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "has had ringing in the right ear for years" (ongoing), notes: has had ringing in the right ear for years/ been real quiet and never bothers her except at night. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Lot No: EI3249   , Dosage text: first dose, left arm, injection), administration date: 19Jan2021, when the patient was 68 years old, for Covid-19 Immunization; Flu shot (after a flu shot she got a fever in the middle of the night but by the morning it was gone.), for immunization, reaction(s): "fever". The following information was reported: TINNITUS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "ringing in right ear".  Additional information: Patient was calling about the COVID 19 vaccine. Patient received the first shot on 19Jan2021 and the second dose on 09Feb2021. Patient stated everything has been more or less fine, however something happened last night. She has had ringing in the right ear for years but it has been real quiet and never bothers her, except at night, but she sleeps with a sound machine to mask the sound and she sleeps fine. But all of a sudden last night, she was watching television - it was a regular show and was not loud or anything - and the tinnitus in her right ear got really loud. The tinnitus got better an hour or so later but then the tinnitus woke her up during the night. The noise maker/sound machine was not loud enough to overcome it. She is afraid it might be long term or a side effect of some kind from the vaccine. So, she wanted to report it just for everyone's sake. Patient stated she is not sure if there is any medication for the ringing in ear. Vaccination Facility Type: Hospital. Vaccine Administered at Military Facility: No. Additional Administered Vaccines: None. Other Products: No. Patient History: No. Prior Vaccinations (within 4 weeks): None. Patient stated once many years ago after a flu shot she got a fever in the middle of the night but by the morning it was gone. Caller stated she always gotten flu shot every year more or less of her life and with her being 68 that was the only time she felt anything.  No follow-up attempts are possible. No further information is expected. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to an approximately 48 years old female. Pregnancy was reported as none. Pertinent medical history included asthma, atherosclerosis, psoriasis and rheumatoid arthritis. Drug reactions/allergies were reported as none. On 15-OCT-2014, the patient was vaccinated with PNEUMOVAX23 injection 25/0.5 Y, lot # K010522, expiry date 25-FEB-2016 (dose, frequency and route were not provided). Concomitant therapies included diazepam (manufacturer unknown), HYDROCODONE, LIPITOR and unspecified "thyroid medication". On 15-OCT-2014, the patient developed red, swelling and painful rash at and around the injection site after receiving PNEUMOVAX23. Patient also developed bulbous swelling that was a "big lump" at and around the injection site. Patient was treated with BENADRYL and "icing it". No lab diagnostics studies were performed. Patient did not seek medical attention. There was no intervention to prevent seriousness Criteria. No product quality complaint (PQC) was involved. Also reported as therapy with PNEUMOVAX23 was continued. The outcome of events was not resolved. Causality was not provided. No additional information was reported. Additional information has been requested.
Nausea, chills, fever 101.6, sweats, headache, joint pain,  sore arm with redness and hot
Information has been received from a health professional concerning a 24 year old female who on 15-JUL-2007 was vaccinated IM with a first dose of Gardasil. There was no concomitant medication. On 20-SEP-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil Lot # 658560/1062U). While the patient was in the office she experienced dizziness and flushing shortly after receiving the second vaccination. The patient was told to lay down and within twenty minutes she recovered and was able to leave the office on her own. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Follow-up information was received from the physician's office. The patient stated after that hse watched the needle which caused her to feel dizzy etc. Additional information is not expeceted.
KNEE HURT; BARELY WALK; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride. On 13-APR-2021, the subject experienced knee hurt. On 13-APR-2021, the subject experienced barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from knee hurt, and barely walk. This report was non-serious.
Got COVID again after doing the full course of the treatment; Got COVID again after doing the full course of the treatment; Got COVID again after doing the full course of the treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), on 29Jan2021 as dose 2, single (Lot number: EL8982) and on 24Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 85 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 13Apr2022 as dose 4 (booster), single (Lot number: 046LZ14) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: Jan2000; METFORMIN HCL, start date: Jan2000; NIFEDIPINE, start date: Jan2000; IRBESARTAN, start date: Jan2000; PRESERVISION, start date: Jan2010; HESPERIDIN, start date: Jan2010. Past drug history included: Ibuprofen, reaction(s): "allergies: ibuprofen". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "recovered with sequelae" (31Aug2022), VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "Got COVID again after doing the full course of the treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Got COVID again after doing the full course of the treatment; (27Aug2022) Positive, notes: Got COVID again after doing the full course of the treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Paxlovid start date: 17Aug2022, Treatment stop date: 21Aug2022 Indication:COVID 19 Treatment, Administrator route: Oral  No follow-up attempts are needed. No further information is expected.
onset of ovulation, thickening of endometrial tissue, increase in estradiol in bloodstream, cramping, breast sensitivity- all occurring 18 months after the patient began to enter menopause.
1st vaccine 2/13/2021; 20 mins post vaccination developed flushing and since developed HA, and CP onset 2/19/21. seen in ED 2/19/21 and admitted to hospital for additional workup; Dx on admission: Chest pain, unspecified type ;Acute nonintractable headache, unspecified headache type; Hepatic steatosis.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
arm soreness; Pain; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Shingrix. On an unknown date, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and pain. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix and Shingrix.   Additional details were provided as follows: The age at vaccination not reported. The age group has been selected as per vaccine specification. Reporter claims that he knows of 5 different people that did not get the second Shingrix shot because of arm soreness and pain. The soreness in arm and pain AEs came after the first dose of shingrix. This is 1 of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054377:same reporter US-GLAXOSMITHKLINE-US2021AMR055619:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055620:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055621:Original Case : US2021054379
Guardian brought 12 year old to 5 to 11 vaccine event for COVID 19 vaccine. Staff did not catch that the child was 12 and not 11.
Headache, Arthralgia, Injection site soreness Narrative: Day 1=Injection site soreness Day 2- Headache.
Arm numbness at and around the site of the injection; Tingling of arm; This is a spontaneous case, initially received from other health professional via agency (reference number: SEQ19-07201) on 03-Dec-2019, concerning a 46-year-old, male patient.   The patient's medical history was not reported.   The concomitant medications of the patient included hydrochlorothiazide, rosuvastatin, amlodipine and unspecified multivitamins for an unknown indication.   On 15-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: P100110961 and expiration date: 23-May-2020] for prevention of seasonal influenza.   On the same day, the patient experienced numbness at and around the site of injection and tingling of arm. No treatment measures were taken.  At the time of initial reporting, the patient was not recovered from numbness at and around the injection site, while the outcome of arm tingling was not reported.  The events were considered serious per reporter. The reporter did not provide causality assessment to Afluria Quadrivalent.  Company Comment: The patient experienced hypoaesthesia and paraesthesia on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Multiple concomitant medications may have contributed to development of the events. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced hypoaesthesia and paraesthesia on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Multiple concomitant medications may have contributed to development of the events. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Tachycardia and irregular heartbeat throughout the day, especially in the morning and evening.   I have a history of occasional transient arrhythmia, but symptoms became almost constant and quite strong about 2 wks after my second vaccine dose.
Fainting, patient fainted after administration and was being monitored for 30 minutes sitting down in our pharmacy.
Excessive swelling in L side cervical and supraclavicular lymph nodes; Excessive swelling in L side cervical and supraclavicular lymph nodes; Excessive swelling in L side cervical and supraclavicular lymph nodes with pain.; This is a spontaneous report from a contactable nurse, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 26Apr2021 at 10:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified OTC prenatals (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient previously received morphine (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN) and codeine (MANUFACTURER UNKNOWN) on unknown dates for unknown indications and experienced drugs allergy. The patient did not receive other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 20:30, the patient experienced excessive swelling in left side cervical and supraclavicular lymph nodes with pain. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events excessive swelling in left side cervical and supraclavicular lymph nodes with pain was unknown at the time of this time.  No follow-up attempts are needed. No further information is expected.
Administration error: Pfizer vaccine given as dose 1 on 12/17/2020, Moderna vaccine given as dose 2 on 1/7/2021.
Face went numb, followed by arms, then a couple days later the legs. With tingling and sharp pains that run down arms and legs. Weakness and fatigue. Chest tightness and shortness of breath.
We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Number of doses/vials: 3. The vial was initially stored in the refrigerator on 13-Apr-2022. The vial did not undergo any temperature excursions. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up received contains no new information.
itching, pain and injection site plus red bumps/scabs on arms, neck, shoulder, and trunk
Vaccine approved for 18 years old. At the time of report, no adverse reaction yet, within 2 hrs of injection.
Narrative: PATIENT PRESENTED TO NON-FACILITY HOSPITAL: Chief complaint: fall, Covid-19, thrombocytopenia
Very sore arm - 4:30 pm - took Advil Woke up 1:00 am (9-24-2020)with chills, fever , nausea, aches - flu like symptoms - took more Advil
atrial fibrillation/it is not improving at all, it's bad, it's worse; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single (at the age of 45 years old) for COVID-19 immunization. Medical history included diabetic from an unknown date, ongoing atrial fibrillation (years and years he had it, been probably 6 to 7 years). Concomitant medications included apixaban (ELIQUIS) and metformin, both were taken for an unspecified indication, start and stop date were not reported. Patient's weight was 140.61 kg and height was 165 cm. No family history with the same adverse event. The patient experienced atrial fibrillation on an unspecified date. It was reported that the patient has been hospitalized many times and the reporter heard that it could had been the vaccine that causing it and he keep having atrial fibrillation. Patient has been hospitalized even over night from it. No prior vacciantion (within four weeks). The patient was still experiencing the adverse event, reporter stated that he has goes in and out atrial fibrillation like every single day and sometimes it doesn't get back to normal so patient has to be taken to the hospital and put him on 'IV'. It was not improving at all, stated that it's bad, it's worse, it's has been overnight sleepily. The patient was hospitalized for atrial fibrillation from 16Oct2021 to 17Oct2021 then on 30Oct2021. The patient underwent lab tests and procedures which included blood work: unknown results on Oct2021 (all kind of blood work, He just went again last week). Therapeutic measures were taken as a result of atrial fibrillation. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Redness and swollen starting from the left arm injection site to left elbow. Patient also report tired.
arm a little sore; A spontaneous report was received from a consumer concerning a  female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm a little sore.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) arm a little sore.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm a little sore was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
He has an existing painful shoulder; This is a spontaneous report received from a sponsored program from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on 18May2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The medical history reported is painful shoulder. Concomitant medications were not reported. The patient experienced he has an existing painful shoulder on an unspecified date. It was reported that, got the first dose of the Pfizer vaccine on 27Apr2021 and the second dose was given today 18May2021 (correct dosing schedule). Patient was asking if he can take Tylenol now or should he wait before taking it to avoid contamination of the vaccine. Patient said he has an existing painful shoulder that's why he wants to take Tylenol. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
For the last 6 years I have been on the same birth control and have my period every 3 months. My last normal menstrual cycle was in July 2021 (right before 2nd dose). When I came off my birth control pack to have my cycle in October, nothing happened. I did not menstruate and still as of today February 2022, have not had a normal cycle. I've stopped taking birth control to see if that will help come back to normal. Only new thing I've put in my body is two Pfizer vaccines.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient were vaccinated with a dose of MMR II (lot number not specified). Route was unknown. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were MMR II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA005704, 1210USA009230 and 1210USA009231). Additional information has been requested.
Adverse effects chronology: Mar 25 sore arm only Mar 26 cough, diarrhea, dizziness, fatigue, loss of appetite Mar 27-30 all symptoms intensified daily, intermittent chills started on 29th Mar 31 all symptoms intensified, started using Albuterol inhaler Apr 1 all symptoms intensified, room spinning dizziness resulted in fall, temperature 99.9F Apr 2 Hospital emergency room, covid tests negative, diagnosis: diverticulitis and pneumonia. 3 intravenous antibiotics started metronidazole, clindamycin, rocephin Apr 3 admitted to hospital floor, continued antibiotics Apr 4 electrolyte infusion series started Apr 5 cough lessening, continued antibiotics and electrolyte infusions Apr 6 covid test negative Apr 7 transferred to rehab facility, continued antibiotics, electrolyte drinks Apr 8-14 antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs), negative covid test Apr 15 released to home Apr 16 diarrhea stopped, slight dizziness remains, appetite improving
Information has been received from a medical assistant referring to a 6 months old male patient. No relevant medical history or concurrent conditions were reported. On 19-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Employee states since receiving flu shot has been experiencing severe pain, unable to lift arm above head- denies it became red, swollen or knotted at area of injection.