chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 6 hours after the vaccine was given, the patient experienced severe shivering/shaking which last approximately 2 hours. After it ended she had a general feeling of soreness for several days.
Altered mental status, confusion and weakness requiring hospital admission, metabolic evaluation, neuroimaging, EEG, neurologic consultation, empiric antibiotic administration.
Exposed to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID-19) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 EXPOSURE TO SARS-COV-2 (Exposed to COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  It was reported that patient's son was exposed and tested positive for COVID-19 and she was exposed to her son.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. On an unknown date these unspecified amount of patient were vaccinated with GARDASIL (lot#, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-073957 (Patient Link).
I developed shingles after the first dose of the Moderna vaccine. I first developed a pain in my waist (left side) and then a rash appeared.   I did not know that shingles was a potential side effect, so I had it (but did not know it) when I went in for my second dose. I was diagnosed with shingles 3 days after my second dose.  I do not have any autoimmune or any other health issues.
Fever; achy chills; shaky and achy all over; shaky and achy all over; Tiredness; pain/ache in the injection site; This is a spontaneous report from a contactable consumer. This 73 year-old female consumer (patent) reported herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150, Expiry Date, NDC number : not reported), via an unspecified route of administration on 12Apr2021 (at the age of 73 years) as dose 2, single for covid-19 immunisation. Medical history included Fibrous tissue in her bone marrow from an unknown date and unknown if ongoing. The caller's red count got low and she had to get blood transfusions about once a month. Concomitant medication(s) included epoetin alfa epbx (RETACRIT [EPOETIN ALFA EPBX]) taken to helps build red blood cells, start and stop date were not reported. She received previously first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 22Mar2021 at 13:00 (at the age of 73 years) as dose 1, single for covid-19 immunisation and by that night her arm was a little sore and it was gone by the next day (sore arm). Investigation assessment was not done. The caller thought it said BPT534, she was unsure. The patient took Pfizer Covid vaccine to try to avoid the Covid. Second dose of the vaccine was administered on 12Apr2021 and side effects were observed starting 22Apr2021. Caller had a sore arm which started on 12Apr2021 (the same day) as when she received the vaccine, but it was not as bad as the first vaccine. Caller also mentioned some pain/ache in the injection site. Referred to HCP for further clinical recommendations. On 22Apr2021 at 15:00 (10 days after the second dose), the caller started having chills and fever. The caller was shaky and achy on 22Apr2021 at 15:00 and that happened over night but then it quit. The caller did not feel well and she feels tired and that began 22Apr2021. The caller has felt really tired since then. The caller had a fever of 103.4 on 23Apr2021 and 24Apr2021. The caller started taking Tylenol to get the fever down but the fever stayed up all night. Unknown lot, NDC, and expiration date for the Tylenol. Caller would like to know if achy chills, fever and tiredness appearing 10 days later after getting the PFIZER-BIONTECH COVID-19 VACCINE was normal and has been reported. The caller takes prescribed medications but declines to provide information on the medications. Reporter asked if there were any reports of this happening days later. Most people said that it usually happens a couple of days after receiving the vaccine. Until 23Apr2021, chills went away. Fever was improved at the time of report. Event tiredness was ongoing but improving. The outcome of event fever recovered on an unspecified date in 2021, shaky and achy all over recovered on 22Apr2021 and chills was recovered on 23Apr2021. The outcome of event tiredness was recovering while the outcome of other events was unknown.  Information on Lot/Batch number was available. No further information is expected.
Left arm outer lateral aspect only from approximately 1" above elbow to upper arm, with redness and small amount of swelling.
Pt recv vax on 2/8/99; on 2/9/99 pt exp screaming w/ fever (103), legs curled up, seemed to be in pain; tx=Motrin
Chills/Fever, Body Ache, Nausea, very sore arm.
On 5/16/01, parents described induration, erythema and pain on right upper thigh, post vax. On exam: right upper thigh 4cm X 5cm area of induration, ITP and indention. Prevnar and MMRII both given in RVL but unclear which vaccine caused reaction. Dx'd with adverse reaction to vaccine or vaccines? Withhold from giving either in future. Parents informed, aware and comprehend.
Off label use; A third (booster) dose of BNT162b2 was administered; Injection site swelling; Injection site redness; Injection site itchiness; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 06Oct2021 at 11:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included heart surgery, knee replacement and cancer. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), dexlansoprazole (DEXILANT), eicosapentaenoic acid ethyl ester (VASCEPA) and ezetimibe/bempedoic acid (NEXLIZET); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the right arm on 11Mar2021 at 17:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the right arm on 01Apr2021 at 18:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient previously received azithromycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Oct2021, the patient experienced injection site swelling, injection site redness and injection site itchiness. The patient reported that four days post shot, the patient still had all of these. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not 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 injection site swelling, injection site redness and injection site itchiness were not resolved at the time of this report.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid from 22Mar2023 to 27Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vomit and diarrhea began at approximately 11pm.; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 09:45(at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient did not receive any other medications within two weeks of vaccination. 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 COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Mar2021 at 09:45(at the age of 59-years-old) as a single dose for COVID-19 immunisation and also allergic to codeine (MANUFACTURER UNKNOWN). On 10Apr2021 at 23:00, the patient experienced vomit and diarrhea. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vomit and diarrhea were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever of 101.0 F on 2/6/14, swelling of (R) arm with 2 in. induration and redness w/ pain from elbow to armpit and swollen lymph nodes in armpit.
FEVER, RIGORS, FATIGUE, NAUSEA,PAIN AT SITE,MYALGIA WORSE 3 DAYS THEN TRANSIENT TO PRESENT
TIV given 10-6-11 in Rt. deltoid IM around 0900AM. By afternoon, employee c/o tenderness. Next day 10/7 1350, site was examined. IM appeared to be given toward posterior side of deltoid area, warm & swollen. Appears to be improper site.
Hypoxia like symptoms (internal chills under skin, and brain fog) within 5 minutes of getting the vacccine. Pressure around heart, fluttering/ irregular heart beat feeling. Headaches, muscle aches that lead to muscle fatigue/failure. Hot/ cold spells, dizziness. O2 levels (measured with pulse ox) dropped to 86 and remained between 86 and 89 for approximately 10 minutes. Vomiting with bright red blood. Tightness in chest with couching spells and labored breathing.  Visited ER on 15 Sep with nothing noted and follow up with cardio.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 40 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Lot number: EW0164), in left arm and on 14May2021 as dose 2, single (Lot number: EW0183), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nerve damage" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 11Oct2023 to 15Oct2023.
14OCT97 pt devel sx of n/v & freq BM's;elevated temp of 102.3;uncontrollable shivering;NPO 14OCT97 p/7PM;clear liquids for 15OCT97 & full liquids 16OCT97;compazine supp PRN for n/v;
Initial report was received from a health care professional on 20 January 2012. A 46-year-old female patient had received an injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C3971 (sanofi pasteur Inc. lot number U4103AA) on 03 November 2011 and following vaccination developed pain in the left arm and shoulder which still persisted at the time of the report. Illness at the time of vaccination was reported as none. The patient had allergies to sulfa and mannitol. The patient had a medical history of high cholesterol. It was unknown if the patient took any concomitant medications. No other vaccinations were given within four weeks of ADACEL. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
31yr old patient with allergy to bees (anaphylaxis) and other comorbidities presented on 10/24/23 for COVID-19 VACCINE  30MCG/0.3ML(>=12YRS)PFIZER-BIONTECH (23-24 FORMULA) .  EPIC Immunizations notes patient received COVID-19 Pfizer monovalent vaccine (11/2/21, 4/19/21, 3/16/21), COVID-19 Pfizer Bivalent vaccine (10/3/22).  COVID-19 Vaccine (>=12yrs) Pfizer biontech (23-24 formula) administered IM in patient's left deltoid (LOT # HG2649) by RN ~ 1100 on 10/24.  Patient observed for 15minutes with no issues.  On 10/25 patient called clinic noting limited range of motion ( ~10%) in left arm and pain (8/10) with movement, no pain at rest following COVID vaccine administration.  Patient took ibuprofen to treat pain. Patient denied swelling or warmth at site.  Patient instructed to follow up with PCP or urgent care if symptoms did not improve.  No indication in chart that patient required office visit follow up.
Information has been received from a physician and a staff member from the pediatrician's office concerning a 7 year old white female who on 06Mar97 was vaccinated SC with a second dose of varicella virus vaccine live (617265/0566D). In May 1997, the pt experienced chickenpox. On 01Aug05 the pt was seen and diagnosed with herpes zoster. No product quality complaint was involved. Additional information has been requested.
Had a herpes infection that was healing up, day after the first dose, he had a flare up; had a herpes infection that was healing up, day after the first dose, he had a flare up; At the site of injection I had joint pain; slight fever night after vaccine; This is a spontaneous report from a non-contactable consumer (patient). This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history included herpes infection, presented as sores, patient had a chronic history with reoccurrences was healing before the vaccine. Concomitant medication was not reported. Patient took first dose of Pfizer covid vaccine, had a herpes infection that was healing up, day after the first dose, he had a flare up, was on herpes medication. Patient asked if valacyclovir was contraindicated with vaccine. Patient stated the sores, he had a chronic history with reoccurrences, was healing before the vaccine. Then it really was a strong reaction. At the site of injection patient had joint pain, slight fever night after vaccine, then there were new sores that came up, that had never happened before. The outcome of events was unknown.  Patient asked if there was any information on this response in people with herpes after the vaccine. Patient asked the vaccine prompted the immune system to rev up, if there were any reports or information on this reaction in others. Patient also asked people who had suppressed immune system, if the first shot was making more vulnerable. Patient did not have a suppressed immune system. Patient wanted to get his second dose, asked if there was any contraindication for taking antiviral medications.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 minutes after vaccination, patient developed nausea and vomiting. He was given promethazine and APAP and sx resolved.
After the vaccination, my arm was sore for a day. On 11/27/2022, I began not feeling well with a runny nose, sore throat chest congestion and a fever. On 11/29/2022, I tested positive for COVID-19 with a home test. I contacted my doctor and I had to insist for the prescription Paxlovid. The doctor did not recommend the medication because of the side effects and the potential to rebound. I did not have any side effects and I did not rebound.
Monovalent Pfizer was selected and administered to patient instead of bivalent. RPH in the process of contacting patient to notify error.   Per cdc guideline, we are not going to repeat the dose, and one dose of bivalent might be given 2  months as appropriate in clinical judgement of provider.
Dizziness, headache, chills, fast heartbeat, palpitations, fatigue, body ache.
Pt recvd 2 doses of Engerix-B & 2-4 day p/2nd dose had stiff neck, shoulder pain, joint swelling & pain;
Repeated vomiting, severe nausea, dizziness, moderate to severe muscle pain throughout body, pain at site of injection, severe headache
today he presents with complaints of dyspnea at rest, associated with a cough, abdominal and scrotal edema and bilateral leg edema.  He also reports getting his 2nd COVID vaccine yesterday which causes him to have a 102 temperature and worsening cough.  He reports a 30lb weight gain since January.  He was on tikosyn for AF rate control which was recently stopped, but he was unsure why.  He was regularly using CPAP machine, but stopped using about last year due to concerns with coronavirus.  He was previously active going to the gym which she is also stopped during the pandemic due to inaccessibility
her tongue felt a little weird; she got nervous; her arm was really sore; something about her tongue was like feeling lazy or heavy or something like that; she had like a taste of metal, like a lingering taste of metal; she was starting to feel a little weird, overall she was getting weird; This is a spontaneous report from a non-contactable consumer.  An approximately 47 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Dec2020, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020 the patient experienced her tongue felt a little weird, she got nervous, her arm was really sore, something about her tongue was like feeling lazy or heavy or something like that, she had like a taste of metal, like a lingering taste of metal and she was starting to feel a little weird, she just said overall she was getting weird. Last night, on 21Dec2020, the reporter was speaking to her sister who took the COVID vaccine and she said her tongue felt a little weird and she was starting to feel a little weird and she got nervous and she got up and started walking around just to like clear herself and just to make sure there was nothing going on. She said it took about half an hour, it happened about half an hour but sure went ahead. No treatment was given. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a register nurse and refers to a 18-year-old female patient. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient was vaccinated with three doses of RECOMBIVAX HB (5 mcg/0.5ml, route of administration, lot number, and expiry dates were not reported). On 05-JUL-2016, following that administrations, an unknown type of blood test was performed to test for hepatitis B immunity. The primary reporter stated that, the results concluded that, the patient was seronegative for hepatitis B immunity. No additional adverse event was reported. The patients outcome was not reported. Relatedness between the adverse event and the vaccinations were not reported. Additional information has been requested.
Rec'd shot at 9:20 am.  Onset at 9:29 am of "tingling and numbness" radiating from just distal of injection site down posterolateral arm to all fingers.  No proximal radiation, no pain.  No SOB, face/mouth swelling, rash, dizziness, lightheadedness.  Neurovascular check left arm = pulses 2+, sensation intact, strength 5/5 all muscle groups.  Ice applied to injection site at 9:33 am.  No change in symptoms.  Discussed sxs as side effect of injection with patient.  Discharged home at 9:43 am with instructions for icing, use of OTC acetaminophen PRN, FU with PCP if symptoms worsen or persist longer than 24 hours.
Vaso-Vagal syncope with small seizure. Immediately upon receiving the vaccine, the patient?s head fell back, all the color drained from his face, his eyes rolled back. He had been sitting up in a chair at the time of the shot. His dad caught him as he slumped over. He jerked three times (his whole body) as if having a very brief seizure, then went limp. Dad laid him down on the floor. The nurse went to get the doctor (myself). I found the patient lying on the floor, eyes half open, and slightly disoriented. Dad said he did not fall and hit his head. I found his pulse to be 40 BPM. He was pale, not sweaty. Within about 15 seconds he become more oriented and stated he knew he was at Dr. office. HR continued to be low at 40 BPM. BP was 110/70. After several more minutes his HR improved to 60. The child rested on the floor for another 20 minutes. HR came up to 80 BPM. More alert. He was still complaining of feeling faint and ?weird? and wanted to keep lying down. Neuro exam was grossing WNL except that his left arm was slightly weaker than his right arm on exam. Injection site appeared normal. This report is being filed about 3 hours later.