chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 102; Nausea; Threw Up Once; Gurgling in chest; Gurgling with deep breaths and sleep; Very Pale; Dizzy; Couldn't hardly get out of bed; Weak; Coughing up phlegm in the morning; This is a spontaneous report from a contactable consumer (patient's wife). A 70-years-old male patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6208 and Expiration date was not reported), via an unspecified route of administration, administered in left upper arm on 02Apr2021 as dose 2, single (at the age of 70-years-old) for COVID-19 immunization. Medical history included ongoing high blood pressure, thyroid cancer (three types of cancer in the tumor) from Apr2001 to an unknown date, ongoing radiation damage (radiation damage to spine) and pneumonia from an unknown date and unknown if ongoing. Historical vaccine included patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6206 and Expiration date was not reported), via an unspecified route of administration, administered in left upper arm on 10Mar2021 as dose 1, single (at the age of 70-years-old) for COVID-19 immunization. Concomitant medications included gabapentin taken for pain (radiation damage to spine), oxycodone hydrochloride, paracetamol (Oxycodone and Acetaminophen) taken for pain (radiation damage to spine), tizanidine taken for pain, muscle relaxant (radiation damage to spine), oxycodone (Xtampza ER) taken for pain (radiation damage to spine), lisinopril taken for high blood pressure and amlodipine taken for high blood pressure. Patient was always tested negative for covid. Patient was doing so well lately then he had this shot and was back in bad shape. Patient was experienced some hard side effects from the second COVID vaccine. On 03Apr2021 (the next following day), patient had soreness in his arm, very pale, weak and was having terrible dizzy spells and could hardly get up of bed when he was about to go to the rest room. On 04Apr2021, patient experienced one time vomiting/threw up once, because he had nausea and he had fever of 102, his fever subsided but he was freezing last night and now he was totally in his chair. On04Apr2021, patient breathing was still pretty bad, gurgling when he breathes deep or when he was sleeping/gurgling in chest, stayed about the same since it started. On Apr2021, when patient wakes up in the morning, he had phlegm that he needs to cough up. Patient can be heard coughing in the background. Patient symptoms resolved, and the patient says that he feels a lot better. Now, patient's wife was not so sure that it was all from the COVID vaccine, patient had been experiencing health problems. But patient's wife called his doctor and his doctor said that she should call Pfizer because it was a possible side effect from the vaccine, and it was the Pfizer. The outcome of gurgling in chest and gurgling with deep breaths and sleep was not recovered, unknown for coughing up phlegm in the morning, threw up once was recovered on 04Apr2021, and recovered for rest of the events on Apr2021.  No follow-up attempts are needed. No further information is expected
Fever of 100; chills; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042b21a) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Fever of 100), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain). At the time of the report, PYREXIA (Fever of 100), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided          No Concomitant medication were reported. Treatment medication was not provided.
Fever, nausea, fatigue, headache for 12 hours after on-set of symptoms. Dull headache continued for 4 days after shot.
pain; all bones hurt; feel like throw up; aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), BONE PAIN (all bones hurt), NAUSEA (feel like throw up) and MYALGIA (aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker generated rhythm since an unknown date. Concurrent medical conditions included Congestive heart failure.    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 PAIN (pain), BONE PAIN (all bones hurt), NAUSEA (feel like throw up) and MYALGIA (aches). On 11-Mar-2021, PAIN (pain), BONE PAIN (all bones hurt), NAUSEA (feel like throw up) and MYALGIA (aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-230251 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: F/U-1 : AE details of Dose 2
Patient received shot Saturday 11/3 AM. Began vomiting that afternoon. Continued to vomit throughout the weekend. Was seen in our office on Monday 11/5 and was given Rx for ZOFRAN. Today Tuesday 11/6 patient has gone overnight without vomiting, just kept down applesauce, but still nauseous.
Mild rash presented 24 hours after vaccination was administered and was still present after two days. The rash didn't seem to be a bother other than it included a mild temperature, drowsiness, and fussiness. These other symptoms could be related to the other vaccines and may be unrelated to the rash. The only treatment was Childrens Tylenol 1tsp. p.r.n.
Approximately 2 hours after receiving the vaccine I felt a heat flash, people setting in the area asked if I was OK as my face was red. It cleared in approximately a minute. The 2nd heat flash came on about 5 to 10 minutes later and cleared about a minute later. The 3rd heat flash came on about another 5 to 10 minutes, again clearing at about 1 minute. Next I felt like my head was in a fog, found it very hard to focus, and was forgetting what I was doing. I walked over to the office, my supervisor asked if I was ok as she said it looked like my eyes were glazed over, my head was still in a fog. This cleared by 2:30 p.m.
bad sick; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer or non-healthcare professional.  This case involves male patient  (age not reported) who got bad sick (illness), while he received INFLUENZA VACCINE.  The patient's past vaccination included influenza vaccine with reaction sick (flu shot every winter and got bad sick).  The patient's medical history, past medical treatment and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got bad sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: 9H9694) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TESTOSTERONE CYPIONATE, start date: 01Jan2008. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 97.0, notes: Normal temperature; (06Mar2023) 100.4; SARS-CoV-2 test: (06Mar2023) Positive, notes: Strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After completing Paxlovid on a Thursdayand feeling fairly healthy, he went about his life masked, and was OK until Sunday night. He noticed some nasal congestion but by evening it was complete. His nose was blocked. Today he took antihistamine and flonase, and was able to breathe through his nose, but began to feel ill, and by afternoon had a fever of 100.4 (his normal temperature is 97.0). He felt considerable fatigue as temperature was 97.0). He felt considerable fatigue as well. He took a home COVID test and the result was a strong positive. Other medications in 2 weeks were testosterone cypionate (start date: 01Jan2008), esomeprazole, Tylenol and Zyrtec.
Received 1st vaccine, developed severe headache (possible migraine); Patient never had history of heachache, migraines before vaccine. Headache lasted 3 weeks. Received 2nd vaccine, developed severe headache, lasting for 3 days. Both headache developed within 24-48 hours. Head pain accompanied with posterior neck pain usually over back of head from neck pain
Spontaneous Orgasm while sleeping. Really tender down there; Spontaneous Orgasm while sleeping. Really tender down there. Like there is more inflammation down there; kind of hard to urinate also; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 12:00 (Lot number: 3013084) at the age of 42 years as dose 3 (booster), single and administered in arm left, administration date 22Jan2021 (Lot number: EL3248) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose brand unknown: False, Previous dose Lot number = EJ16905, Previous dose lot unknown: False, Previous dose Administration date= 05Jan2021, Previous dose Dose number= 1, Previous dose vaccine location= Left arm), administration date: 05Jan2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: ORGASM ABNORMAL (non-serious), outcome "unknown", described as "Spontaneous Orgasm while sleeping. Really tender down there"; VULVOVAGINAL SWELLING (non-serious), outcome "not recovered", described as "Spontaneous Orgasm while sleeping. Really tender down there. Like there is more inflammation down there"; DYSURIA (non-serious), outcome "unknown", described as "kind of hard to urinate also". Therapeutic measures were not taken as a result of orgasm abnormal, vulvovaginal swelling, dysuria.  Additional information: The reporter stated that spontaneous orgasm while sleeping really tender down there. Like there is more inflammation down there. It happened after the 2nd shot at night, a couple of hours after the shot. And it happened again after the current booster (3rd shot). It only probably lasts a day. I thought it was just a weird reaction after my 2nd shot. and I was surprised I had the reaction again after my current 3rd shot. I noticed this time it makes it kind of hard to urinate also. Like it is swollen down there. The first reaction eventually went away. The current reaction. I'm still kind of swollen. But I think it will go away like the last time. Facility type vaccine was hospital. Not received the treatment. No Covid prior t the vaccine. Covid test was not performed after vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
CHILLS; This spontaneous report received from a patient 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Difficulty breathing; Difficult time swallow; Difficult time talking; Difficulty eating; Sore; Sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Difficulty breathing), EATING DISORDER SYMPTOM (Difficulty eating), DYSPHAGIA (Difficult time swallow) and APHASIA (Difficult time talking) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder (Kidney disease requiring dialysis) and Dialysis.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). 26-Feb-2021, the patient experienced PAIN (Sore). On 27-Feb-2021, the patient experienced EATING DISORDER SYMPTOM (Difficulty eating). On 28-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), DYSPHAGIA (Difficult time swallow) and APHASIA (Difficult time talking). The patient was treated with CEFUROXIME AXETIL for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Difficulty breathing), EATING DISORDER SYMPTOM (Difficulty eating), DYSPHAGIA (Difficult time swallow), APHASIA (Difficult time talking) and PAIN (Sore) outcome was unknown. Not Provided      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. No concomitant medications were reported.
J&J  vaccine expired on 9/21/2021 at midnight. Patient received J&J vaccine 9 hours after expiration of lot due to a date mix-up. Vaccine was stored properly, but the lot had expired.
Heart racing, heart was skipping beats for up to two weeks 3-4 times a day and about once every other day the 3rd week. Pains in legs.
Headache, Myalgia, FATIGUE, TENDERNESS/REDNESS,SWELLING AT INJECTION SITE APPROXIMATELY 8CM DIAMETER,CHILLS Narrative:
My body ached all over--from my feet to my head. Shoulder where vaccine was hurt the worst couldn't even raise my arm. I was so weak could hardly walk.  I had mild temp and was nauseated.  I laid in bed from 10:30 pm until 8:00 am moaning and groaning because I hurt so bad.  At approx. 2:00 pm 10/3/2014 I was able to sit up and move around more.
After flu shot patient started sweating, feeling hot and faint. She said she blacked out for a minute or so. She came round after a few minutes.
Pt woke up the next morning after vaccination with a swollen right upper arm. No pain, but warm to touch.
tinnitus; fatigue; frontal lobe pressure/bilateral pulsating headache; mild tingling in fingertips; paresthesias; dysesthesias; chest pain; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female (non-pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: 8731), via an unspecified route of administration, administered in Left arm on 16Apr2021 14:30 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation (in pharmacy). The patient's medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported and multi-vitamin, taken for an unspecified indication, start and stop date were not reported. The patient had no covid prior vaccination. The patient did not receive any other vaccine in four weeks. On 16Apr2021 15:00, few minutes after shot the patient experienced mild tingling in fingertips that I chalked up to regular vax stuff (tech also gave a bit high). On 17Apr2021 (Next Day), the patient experienced frontal lobe pressure, bilateral pulsating headache, tinnitus and fatigue. On an unspecified date in Apr2021, the patient had progressed over the course of several days to full-body being symptomatic paresthesias/dysesthesias, headaches, chest pain, etc. 3 weeks on symptoms were worse, not better, and still evolving. The events resulted in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was tested for Covid post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: negative on 20Apr2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a 1 year old patient of unknown gender. On 30-DEC-2014 the patient was vaccinated with the first dose of PROQUAD (Merck), which was improperly stored, lot# K007801 with expiration date of 29-NOV-2015, 0.5 ml once, subcutaneous. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial unsolicited case received from a non-healthcare professional on 24-Sep-2015. This case involves a 40-year-old male patient who was vaccinated with a dose of ADACEL (batch number- U5241AA, expiry date: 13-Jan-2018, route and site of administration were not reported) on 10-Sep-2015. Concomitant medications were not reported. Patient had migraine at the time of vaccination and also he had no known allergies. On 11-Sep-2015, one day after vaccination patient developed arm pain and injection site pain and swelling, dry cough and chest pain. On 12-Sep-2015, patient went to ER doctor visit. Lab tests were not reported. On 12-Sep-2015, patient received steroid shot, MEDROL dose pack and cough medicine as corrective treatments. It was reported that patient felt great after steroid shot and outcome of events at the time of report was reported as unknown. Upon medical review, case was considered as serious due to important medical event: chest pain. Documents held by Sender: none.
This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th June 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site warmth. On an unknown date, the patient experienced injection site nodule and injection site pain. On an unknown date, the outcome of the injection site warmth, injection site nodule and injection site pain were recovered/resolved.  It was unknown if the reporter considered the injection site warmth, injection site nodule and injection site pain to be related to SHINGRIX. Additional details were reported as follows: Two hours after receiving the SHINGRIX vaccine, the reporter began to experience a little warmth at the injection site.   A painful nodule then developed at the injection site. He was not able to lay on the arm. This lasted for two weeks. The reporter consented to follow up. The reporter gave permission for his physician to be contacted. Unable to obtain additional information. For tolerance after 2nd dose refer case US2018GSK225475.
Pt received PREVNAR-13 vaccine on 2-9-15, then developed gradually worsening rash on upper left arm around injection site. The rash was characterized by itchiness, swelling, redness, pain, and dryness. By 2-17-15 the rash covered most of her upper arm. Pt scheduled appt with PCP.
1st shot: Dizzy within 10 mins, and fatigue set in within 2 hours.  Body aches, chills, and sore arm occurred at 7pm.  Headache lasted for one week along with fatigue and anxiety.  Nausea and stomach issues occurred 2 days within the shot. Body aches lasted for four days.   2nd shot: Extreme fatigue set in within  two hours. Followed by dizziness and a headache.  Hunger and body aches.  Anxiety with depression.  All lasted for 7 days, slowly going away day by day.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 46 year old male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no illness at the time of vaccination and no history of similar event, no history of adverse event after any previous vaccination, no pre-existing acute illness 30 days prior to vaccination, no History of hospitalization in last 30 days. Patient had no history of allergy to vaccine, drug, or food and no family history of any disease (relevant to vaccination) or allergy. On 23-MAR-2021, The patient was previously treated with covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1805018 and expiry date: unknown) dose was not reported, 1 total, administered on 23-MAR-2021 on right side for prophylactic vaccination. No adverse events reported following vaccination. It was unspecified whether patient had any adverse reaction following primary vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, (Dose number in series 2) 1 total, administered On 16-DEC-2021 on right side for prophylactic vaccination.  No concomitant medications were reported.  On 16-DEC-2021, the patient administered expired vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220261011, 20220261039, 20220261092, 20220260967, 20220261043, 20220261022, 20220261000, 20220261030, 20220260995 and 20220261042, 20220261024, 20220261048, 20220261014.
Lymph  nodes under my arm swelled up two days after second injection. Day three my underarm and breast became very painful, felt like a burning sensation, even as swelling went down. This lasted over three weeks. I went to my OBGYN after two weeks who gave me a breast exam and stated it was reactive tissue from the vaccine.