chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is the 2nd report I am filing.  I was put on the following medication to stop the reaction  methylprednisolone, fexofenadine and triamcinolone.  on 9/1/2021.  Today 9/302021 my symptoms have returned.  I have welts and itching on my neck, face, hairline, eyelashes, chest and in my ears.
This spontaneous report was received from a pharmacist, via interpreter, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or drug allergies were not reported. On an unknown date in 2017 (reported as "on an unspecified date after 19-MAR-2017"), the patient was vaccinated with an expired dose of M-M-R II injection (dose, and anatomical location were not reported) lot number L009544; expiration date 19-MAR-2017 for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were unknown). No adverse effects were reported. Additional information has been requested.
tested positive COVID; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613), dose 1 administered via intramuscular route of administration on arm left on 20Mar2021 at 12:00 as single dose for covid-19 immunization. Medical history reported that patient is overweight but has not diagnosed with diabetes, has a lot of symptoms though, seasonal allergies and was really young around 14-15 and had two surgeries for it. One surgery at age 16 and another later to deal with it. All prior to getting the vaccine and family medical history: Diabetes. Concomitant medications were not reported. On 30Mar2021, the patient tested covid positive and scheduled to get second dose in 13 days and is not sure what to do. He would like to get some guidance about when to get second dose. Outcome of event was unknown.
Swelling; Arm at injection site is still painful,Sore, Painful to lay down on the side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Arm at injection site is still painful,Sore, Painful to lay down on the side) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Arm at injection site is still painful,Sore, Painful to lay down on the side). At the time of the report, VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Arm at injection site is still painful,Sore, Painful to lay down on the side) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not reported Treatment medications were not reoprted
Day 1: sore arm, tingly skin, body aches, headache (combination of migraine and hangover), fatigue Day 2: No other symptoms, except COVID Arm - almost entire upper arm is red/rashy, swollen, and hot to touch
Paxlovid: COVID 19 Treatment; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE; LISINOPRIL; BENADRYL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of covid-19. Patient took a 5 day dose of paxlovid-his symptoms disappeared and after 5 days patient tested negative on rapid tests. Patient tested negative two other times and then 3 days later patient developed covid symptoms again-patient tested lsiirice on an antigen test on May 11th and again today on 12May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions or concomitant medication were not informed. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, sterile diluent (MERCK), VARIVAX, GARDASIL 9, RECOMBIVAX HB and ROTATEQ all for prophylaxis (dosage information, lot numbers, expiration dates and route of administration were not informed). No adverse effects reported. Temperature and Time frame: 15°F to 46°F for 5 hours and 30 minutes. Previous temperature excursion: 15°F to 46°F for 2 hours and 59 minutes, 6°F to 14°F for 18 hours and 56 minutes. Call was because of a "data logger". For GARDASIL 9, RECOMBIVAX HB and ROTATEQ: Temperature: 32°F up to 35°F multiple excursions. Time frame: 19 days and 12 hours. No previous temperature excursion. Call was call because of a "data logger."
Syncopal episode few minutes after administration, sustained head injury and sent to ER for evaluation & management.
Pt recvd 2 doses of Engerix-B on 10DEC91, & 13JAN92 & no events initially devel; following 2nd dose 19JAN92 @9PM started to have difficult resp x 45 min & devel hives, edema of face & hands;
Fat lips, sore lips, constant peeling of lips, tingly lips, very sensitive and sore, cycling of issue - lips get really fat, peel, peel and peel some more, go down and the cycle starts all over again
This report describes a male subject of unspecified age who tested positive for Hep B surface antigen after being vaccinated with Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history included "renal dysfunction resulting in hemodialysis." Concurrent medications were unknown. On an unspecified date, the subject received his first 40 mcg injection of Engerix-B. Subsequently, the subject tested positive for Hep B surface antigen. "The PT's liver function tests were all within normal limits, as they have consistently been in the past."
Case previously recorded as MA2009-4323. Initial case report received from a health case professional via agency, on 11 NOV 2009. A female patient was vaccinated with 0.5 mL once of FLUVIRIN (batch no. 102125P1) i.m on 11 NOV 2009. No adverse events were reported. Agency reference no: NA09-007978.
Headache, myalgia, arthalgia, anosmia, nausa, vomiting and diarrhea.
Very sore arm the next day. Foggy for a couple of days. Got Covid 6 days after the injection. Never had Covid before this. My arm is also magnetic at the injection site to this day. A small magnet will grab at my injection site as well as a small circular metal battery, the type that goes in a key fob, for example.
Large hot welt on arm; 3 day migraine; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 23Jun2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took codeine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 01Jul2021 at 14:30 the patient experienced large hot welt on arm, 3-day migraine. Patient also stated that migraine continued. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with medications in the ER. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large hot welt on arm, 3-day migraine was not recovered at the time of this report.
decreased therapeutic effect; irritates her stomach; missed dose; Hernia; throwing up; sick to her stomach; abdominal pain; Shingles; Information has been downloaded from regulatory authority (US-GLAXOSMITHKLINE-US2014GSK020480) on 06-JUL-2020.  This spontaneous report was received from a consumer referring to a female patient of unknown age. The patient's current conditions included high blood pressure high (hypertension), diabetes and gallstones removal (cholelithotomy). Information regarding the patient's medical history, concomitant therapies, drug allergies or reactions, and historical drugs were not provided.  On an unknown date in 2012, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (reported as shingles vaccine) (indication, dose, and lot number were reported as unknown; concentration, dose number, frequency of vaccination scheme, anatomical location of vaccination, and expiry date were not reported). Other suspect therapies included eltrombopag olamine (PROMACTA) tablet, which was started on an unknown date in 2012 at a dose of 50 milligram (mg) every other day (qod) via oral and also at a dose of 2 dosage forms a day from an unknown date (conflicting information as also reported as twice a day (bid) for this dose) for platelet count decreased (strength, and expiry date were not reported; lot number reported as unknown).      On 01-SEP-2014, the patient experienced shingles (herpes zoster).  On 01-OCT-2014, the patient experienced hernia.  On an unknown day in October 2014, the patient developed abdominal pain, felt sick to her stomach (nausea) and was throwing up (vomiting). The patient recovered from the nausea and vomiting on 01-NOV-2014.  On 08-SEP-2015 the patient missed a dose (product dose omission).    On an unknown date, the patient experienced a decreased therapeutic effect and she had an irritable stomach (epigastric discomfort).  These events caused the patient to be hospitalized on an unknown date.    The action taken with eltrombopag olamine (PROMACTA) was reported as unknown.  The outcome of herpes zoster, abdominal pain and hernia was reported as resolving. The outcome of therapeutic response decreased, product dose omission and epigastric discomfort was reported as unknown.     The causal relationship between Zoster Vaccine Live (ZOSTAVAX) and the occurrence of all the events was not reported.  The causal relationship between eltrombopag olamine (PROMACTA) and the occurrence of herpes zoster, and hernia was considered not related; and for vomiting, nausea, abdominal pain, decreased therapeutic effect, and epigastric discomfort, the relatedness was reported as unknown.
Information has been received from a nurse referring to the patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant therapies were not reported. The doses of M-M-R II were improperly stored at 1.5 Celsius degree for 29 minutes on 15-AUG-2016. Prior excursions included 10.2 Celsius degree for 6 hours 35 minutes on 21-JUN-2016 and 1.4 Celsius degree for 53 minutes on 09-AUG-2016. On unknown dates in 2016 (reported as "after 15-AUG-2016"), the patients were vaccinated with improperly stored M-M-R II( dose, lot #, expiration date and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. was nervous about getting a shot and right after vaccine was administered she fainted. 911 was called and per parent's request patient was transported to hospital despite normal vitals.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 23-SEP-2014 the patient was inadvertently vaccinated with expired PNEUMOVAX 23, injection, 0.5 ml, intramuscular (IM), lot # J009827 that had expired on 10-AUG-2014. Concomitant therapy was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a consumer concerning her 26-year-old son with no pertinent medical history or allergies who on 04-NOV-2007 was vaccinated subcutaneous with 0.5 mL dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 18-NOV-2007, the patient "broke out with three chickenpox lesions and now has five". The patient did not seek medical attention and did not have any diagnostic labs performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
loud noise in ear, that comes and goes; This is a spontaneous report from a non-contactable consumer (patient). This female patient of an unspecified age (age: 55, unit: unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 20Jan2021 17:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced loud noise in ear, that comes and goes on 21Jan2021 10:00 with outcome of unknown. The reporter wanted to know if this has been reported before and wanting guidance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Incredibly sore arm; Redness / of the arm; Swelling of the arm; Flu like symptoms; Headache; Achy; Hot/fever; Fatigue; This case was reported by a consumer via market research programs and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for shingles.   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, between 4 and 6 months after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, swelling arm, influenza-like symptoms, headache, pain, fever and fatigue. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm, influenza-like symptoms, headache, pain, fever and fatigue were recovered/resolved.   The reporter considered the pain in arm, erythema of extremities, swelling arm, influenza-like symptoms, headache, pain, fever and fatigue to be related to Shingrix.  Additional details provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced sore arm,redness and swelling of the arm,flu like symptoms,headache,achy, hot/fever,and fatigue which lasted for a week. The patient did not seek medical care. This case has been linked with US2021AMR106935, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106935:Same reporter
VACCINE LEFT OUT OVER NIGHT ABOUT 12 HOURS BEFORE ADMINISTRATION; MEDICATION ERROR; This spontaneous report received from a pharmacist 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, and batch number were not reported) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 03-MAY-2021, the subject experienced left out over night about 12 hours. On 03-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and left out over night about 12 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210512313.
Headache  fever 100.5 chills.  Nausea Stuffy nose aches Today tired and weak. Nearly better
The pt reports that "three days after I received the I began to experience difficulty moving my left arm. I noticed the pain to be different from injection point tenderness or general muscular ache but thought it was probably just a variation of the norm. The pain increased to the point where I was barely able to abduct the arm or bear any weight and my ability to work was severely impaired. I saw my primary care physician 11/20/2001 who prescribed a nine day course pf Prednisone. That treatment gave me almost complete relief from the pain and loss of mobility. Four to five days after completing the course of Prednisone the symptoms and pain returned. The pain increased, it involved my entire shoulder and hsoulder blade area, I was not able to sleep through the night and no matter what I did I couldn't find relief. I called my primary care physician who referred me for orthopedic consultation. On 12/10/2001 the orthopod decided to retreat me with a longer course of Prenisone. Again I experienced almost full relief while on the medication, but the symptoms returned within a week of ending the medication. I did not like the side effects I had experienced on the longer course of Prednisone and since the improvement wasn't sustained, I tried to find other sources of relief from the pain. I worked with a massage therapist for over a month who subsequently advised me to return to a physician because the area was not responding to the treatment. On 02/22/2001, I returned to the orthopod who diagnosed the condition as a "chemical induced neuritis" and prescribed physical therapy and medication for the pain. The electric current therapy has greatly reduced the pain but I still experience swelling in my left axilla and some loss of motion. I continue to do home exercises and have regular massage therapy. I am not pain free.
Morbilliform rash on trunk and face. It started 1 week after MMR and Varivax vaccines.
Information has been received via a company representative from a male patient of twenty-five or twenty-six years old referring to himself. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with an unspecified human papilloma virus (HPV) vaccine (manufacturer unknown) (lot #, expiration date, dose and route were unknown). The patient stated that the shot really hurt. It was unknown if the patient sought medical attention, if treatment was given for the event or if lab diagnostics studies were performed. At the reporting time, the patient "looked fine". The causality of the event was not reported. Additional information is not expected as no contact information was provided.
child devel gastroenteritis 4 days p/vax; probably unrelated-devel worsening emesis & diarrhea over 2 days;despite intervention, pt subsequently went into shock & was taken to ER blue & pulseless;
was administered an extra dose of BOOSTRIX / and/ extra dose of MENVEO /received both vaccines one year earlier; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA518A, expiry date 30th April 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 9335X, expiry date 29th January 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Menveo (already received a doses, 1 year earlier of reporting date) and Boostrix (already received a doses, 1 year earlier of reporting date).   On 7th July 2021, the patient received Menveo (intramuscular) .5 ml, Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On 7th July 2021, unknown after receiving Menveo, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was recovered/resolved.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On 7th July 2021 the patient was administered with an extra dose of Boostrix 0.5ML and an extra dose of Menveo 0.5ML.  The patient had received both vaccines one year earlier. The HCP ( healthcare professional ) contacted the patient (parent of patient) and the patient had no symptoms. The reporter consented to follow up. This case has been linked with US2021152833,US2021152840 and US2021152845 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152833:same reporter US-GLAXOSMITHKLINE-US2021152840:same reporter US-GLAXOSMITHKLINE-US2021152845:same reporter
9/29/21 Pfizer vaccine #1 injection 10/6/21 Onset symptoms day 11 after injection T99 Body ache 10/11/21 Began Ivermectin + doxycycline 10/13/21 + COVID TEST 10/15/21 monoclonal antibodies 10/20/21 postmenopausal vaginal bleeding
Significant pain at injection site began immediately following injection. She felt feverish and sick with swollen glands through the weekend following injection. Her arm was red, swollen and warm from about one inch below shoulder to about 1 inch above elbow. There was a significant amount of pus, enough to soak through a heavy sweatshirt. Pain continued to worsen to the point that she needed morphine (prescribed for an unrelated condition). She visited her primary physician and was prescribed an antibiotic (cephalexin) 0n 11/22/13. It took over two months for infection to heal. On 1/9/14, she removed a scab about the size of a half dollar.
04/19/2021 - 2 weeks post vaccine severe left sided headache and left sided visual disturbances - no previous history of migraines/ocular migraines
Injection site became inflamed 7 days after vaccination. Red, hot and itchy. Also sore. Would flare up most in the middle of the night, but also irritated during the day. Lasted about 48 hours.
Approximately 9 minutes post second vaccination EE developed chest tightness. Waited 30 minutes and was then ok.  BP 130/85 HR 66. EE was provided a Benadryl to take if needed and escorted to elevator.
This spontaneous report as received from a health care worker refers to a female patient of unknown age. No information about medical history, concurrent conditions was reported for the patient. On an unknown date in June 2015 the patient was vaccinated with RECOMBIVAX HB 2.5mcg/0.5ml) (route unspecified) for vaccination. On an unknown date in June 2015 the patient experienced an allergic reaction to RECOMBIVAX HB and developed a rash at the injection site. The outcome of hypersensitivity and injection site rash was reported as recovered/resolved approximately on an unknown date in 2015. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
presented with fever, cough, SOB &  hypoxia; + Covid 8 days PTA; admitted Covid PNA; tx singulair, maxipime, steroid, remdesivir, zinc, Patient's symptoms improved significantly and was not needing oxygen
Onset of swelling, induration within 2 hrs of DTAP #1 (L) thigh. Max girth thigh (L): (R): Infant presented this afternoon about 4-5 hrs after immunization, pt had about 5 x 7.0 cm2 area induration, warmth with irritability on palpation, irritability improved after formula feeding. Chest CTA, good aspiration.