chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash/Rash is about 6 " below injection site; Large hot itchy welts; Large hot itchy welts; Large hot itchy welts/warmth; injection site has small bruise; arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 55-years-oldnon-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL9263, via an unspecified route of administration from 06Feb2021 12:00 (at the age of 55 years old) as a SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing, supraventricular tachycardia (SVT) from an unknown date and unknown if ongoing.  The patient did not have allergies. Concomitant medication included metoprolol, ibuprofen, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]). The patient did not receive other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 12:00, the patient experienced large hot itchy welts. Turned into one large spot. Approximately 4 inches around. Rash began appearing about 2 hours after injection (06Feb2021 14:00). Rash is about 6 " below injection site. Actual injection site has small bruise from 06Feb2021 12:00, and arm is very sore from 06Feb2021 12:00. Rash and warmth still present after 24 hours. No treatment was received for the events. Outcome of large hot itchy welts, injection site has small bruise, Large hot itchy welts/warmth, arm is very sore, rash/Rash is about 6 " below injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Menstrual Cycle stopped 3 days after 2nd dose and didn't return for 3 months.; Cycle has been extremely heavy upon return and off schedule.; Chronic fatigue and tingles in legs for 3 months after 2nd dose.; Chronic fatigue and tingles in legs for 3 months after 2nd dose.; Cycle has been extremely heavy upon return and off schedule.; Joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 11:00 (Lot number: EW0182) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin for allergy, notes: known allergies: penicillin. Vaccination history included: Bnt162b2 (Dose: 1st, Lot number: EW0126, Dose administration: 11:00 am, Left arm), administration date: 30Apr2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "Joint pain"; MENSTRUATION IRREGULAR (non-serious) with onset 24May2021, outcome "recovering", described as "Menstrual Cycle stopped 3 days after 2nd dose and didn't return for 3 months."; HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 2021, outcome "recovering" and all described as "Cycle has been extremely heavy upon return and off schedule."; PARAESTHESIA (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "recovering" and all described as "Chronic fatigue and tingles in legs for 3 months after 2nd dose.". Therapeutic measures were not taken as a result of arthralgia, menstruation irregular, heavy menstrual bleeding, paraesthesia, fatigue, menstrual disorder.  Additional information: It was unknown if patient was covid prior vaccination and did not test for covid post vaccination. It was unknown if patient received other vaccine in four weeks. Other medications in two weeks was reported as 'no'  No follow-up attempts are possible. No further information is expected.
GIVEN STAFF FLU VACCINE AT 1:30PM ON 10-27-08.  10 MINUTES AFTER RECEIVING FLU VACCINE, SHE APPEARRED FLUSHED ON NECK/CHEST. COMPLAINTS OF "FEELING FUNNY", "HEART RACING", "FEEL LIKE I AM BURNING UP".  BROUGHT HER TO DR.  VITAL SIGNS ELEVATED, BLOOD PRESSURE 162/82, PULSE 140, RESPIRATIONS 28. RECHECKED EVERY TEN MINUTES AS SYMPTOMS WERE LESSENING.  TOOK 30 MINUTES BEFORE BLOOD PRESSURE AND VITAL SIGNS BACK IN NORMAL RANGE.  SYMPTOM OF FEELING HOT CONTINUED.  SHE PHONED HER PRIMARY CARE DR, WHO ADVISED HER TO TAKE BENADRYL.  SYMPTOMS IMPROVED WITHIN 20 MINUTES AFTER TAKING BENADRYL.  TODAY SHE STILL FEELS WARM, BUT MOSTLY BETTER.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ lot # M019707, expiration date 25-OCT-2017, orally (dose was not reported). The doses of vaccine had been stored under the lowest temperature 49.3 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Fatigue began 18 hours after injection.   Acute asthma attack starting 36 hours after injection. Symptoms managed with nebulizer and Xopenex inhalation.   Red swollen rash on inside of both forearms. Symptom started 33 hours after injection and has not resolved.   Autoimmune response.
Information has been received from an immunization coordinator concerning a 72 year old female with depression who in 2001 was vaccinated with the first dose of PNEUMOVAX vaccine (route and site not reported). On 30-APR-2008, the patient was vaccinated with the second dose of PNEUMOVAX (lot # 657143/0380U, route and site not reported). The patient was on "a lot of concomitant medications, some for depression "but medication were unspecified. On 01-MAY-2008 the patient developed injection site reaction. The patient's arm swelled about 1 and 1/2 times its normal size. The patient visited the physician's office and was told to use compresses and to take BENADRYL. On an unknown date, the patient recovered from the vents. The events were considered to be non serious per the reporting immunization coordinator. Additional information has been requested.
Developed red raised rash Friday evening after bathing in bath product (playing with sister in tub) but showered afterward. Rash got worse, has been taking Benadryl x 3 day without relief. Saw Dr. Rx for Prednisone 20mg and Claritin 60mg qd as directed.
Chills; Fever of 100 degrees; Soreness in shoulders; Soreness in neck; Mild stomach ache; Lingering tiredness; This is a spontaneous report from a contactable Consumer, the patient. A 76 years old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration through the right arm for COVID 19 immunisation on 06Mar2021 at 15:30 PM. The patient past drug history includes BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6201) received through the right arm. The patient medical history includes Afib (Atrial fibrillation), diabetes and Age (Acute gastroenteritis). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination. The patient has not been tested for COVID 19 since the vaccination. On 07Mar2021 at 15:30 PM, The patient experienced chills, fever of 100 degrees, lingering tiredness, mild stomach ache, soreness in the neck, soreness in the shoulders. No treatment measures received for the adverse events. The clinical outcome of all events was recovered. No follow up attempts are needed. No further information is expected.
Site: Pain at Injection Site-Severe, Systemic: limited shoulder range of motion-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Fever, body aches, joint pain, fatigue.  The joint pain got significantly worse over the last few months.   I went to my MD for worsening joint pain.
Got the vaccine, and the first 48 hours she had incredible body pain, every inch of her body hurt so bad.  After 2 days that got better, although she still has some random pain.  Really tired, really spaced out.  Had a lot of pain when she breathed deeply for a few days, which has subsided now.  She had headaches, tired, sleeping a lot, nauseous.  She has been off work for about a week.  She is a psychologist and having to cancel appointments.  She still has fatigue and lays down a lot.   She does have some brain fog.   The inside of her ears have been itching a lot as well.  She took some pain medications for the symptoms as well as nausea medicine.    She called her doctor and he didn't give much advise other than rest and take the week off, drink a lot of fluids.   She had extreme chills and put her thermostat on 74 to try to get over the chills, these lasted for several days and had some fever as well.
temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2022, the patient received Menveo, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Boostrix, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Menveo, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Boostrix, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   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 provided as follows: The age at vaccination was not applicable for this report. Nurse manager reporting updated temperature excursion of 49 Fahrenheit for possible 90 days for Menveo, Bexsero, Engerix-B, Boostrix, Kinrix, which led to incorrect storage of drug. Health care professional did not had pertinent adverse event information at this time, but gave permission for safety to follow up for additional information. The reporter consented to follow up.
Racing heartbeat - my RESTING heart rate soared up by 30 points so that during the night, it was about 80 bpm. I also had chills, but I was expecting that. The racing heart thing was scary.
This spontaneous report as received from a certified medical assistant refers to a multiple patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were administered improperly stored PEDVAXHIB lot#M007762, expiry date: 07-DEC-2018 and lot# M020100, expiry date 07-MAR-2019, (dose, strength, site and route of administration were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Severe weakness and fatigue, headaches and "cloudy" .  Severe gastritis.  Unable to perform normal duties as a dentist.
febirle sz lasting 3-5 min;fever over 104;tx @ ER @ hosp;no formal dx made but was told that it appeared to be roseola and to expect  4 days of fever & rash.
Silent miscarriage around seventh week of pregnancy not observed until 8-week ultrasound showed no fetal heartbeat. Due date would have been Aug. 1, 2022. No previous miscarriages, 1 healthy full-term pregnancy previously
After 25 minutes of having vaccine had a strong medicine taste in mouth which burned inside of mouth for next 5 days.  Then tongue swelled up, lips numb and could not swallow. I was short of breath sweating and throat and chest tightness.  Sought treatment at Emergency room was given Benadryl IV and oxygen.
This initial spontaneous case, was received on 05-Oct-2017, from a nurse, concerning a 37-year-old adult female patient. The patient's medical history was not reported and the concomitant medications included, ZOLOFT, Ursodiol, temazepam, QVAR, propranolol, PROAIR, omeprazole, cycloserine, levothyroxine, IMITREX, ADDERALL, gabapentin, hydrocodone-acetaminophen for unknown indications. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195221, expiry date: Apr-2018). It was reported that the vaccine was stored at a temperature reduced to 32.54 F for about 25 hours (incorrect product storage) and was administered to the patient. No adverse effects were reported after administration of the vaccine. The reporter assessed the event as non-serious. Significant follow-up received on 24-Oct-2017: It was reported that, the patient did not experience any adverse effects after administration of the vaccine. Narrative was amended accordingly. Significant case correction received 24-Oct-2017: Event "no adverse effect" was assessed and labeling was done. Amended narrative accordingly. Significant case correction received 24-Oct-2017: Added route of administration and anatomical location in the field. No adverse event was deleted from the event tab and classification was added as special case with no AE. Narrative was amended accordingly.
infection in her toe; This case was reported by a consumer via call center representative and described the occurrence of infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine. Previously administered products included infection. Concomitant products included galcanezumab (Emgality) and doxycycline.   On 10th March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th August 2020, 161 days after receiving Shingrix, the patient experienced infection. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the infection was not recovered/not resolved.   It was unknown if the reporter considered the infection to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported an infection in her toe, requiring antibiotic treatment. The patient was concerned about reaction if she gets second Shingrix shot.  The reporter did not consent to follow-up.
Information has been received from a registered nurse concerning a 22 year ld white female student with no other medical history, no known allergies or adverse drug reactions reported. On 26 Sep 2006, at 12:300 PM, the patient was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (yeast) (Lot# 653736/0689F), within 2 hours of the injections the patient developed full body hives, itching and swelling of hands and feet. The patient took Benadryl every 4 hours and the symptoms were gone within 24 hours. At the time of this report, the patient had recovered from the events. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 12/14/2006.  Initial and follow up information has been received from a registered nurse concerning a 23 year old (previously reported as 22 year old) white female student with no other medical history, no known allergies or adverse drug reactions reported.  On 26-SEP-2006, at 3:00 PM, the patient was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Lot # 653736/0689F).  There were no illnesses noted at the time of vaccination.  On 26-SEP-2006, at 4:00 PM, the patient developed a rash over body (previously) reported as full body hives and had itching) and had swelling of hands and feet.  The patient took BENADRYL every 4 hours and the rash was gone within 24 hours.  On 27-SEP-2006, the patient had recovered from the events.  Additional information has been requested.
pain on injection site; swelling on injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 02Mar2021, as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain on injection site and swelling on injection site on an unspecified date on Mar2021. Patient stated that on the fact sheet Pfizer stated that she should report any side effects that she has experienced. Patient added that she called just to report side effects she has experienced- pain and swelling on injection site 3-4 hours after her vaccine which lasted for a day and a half (or 36 hours) on an unspecified date on Mar2021. Patient was scheduled to get her second dose this 30March2021. The outcome of all events was recovered on an unspecified date on Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Flu-like symptoms with vomiting, lethargy, temperature of 103, stuffy head, runny nose, irratibility, crankiness and changed personality. Disorientation and loss of coherent thought/speech for several minutes.
N&V  and pain in right arm from shoulder to hand. Pt was taken to ER via Ambulance. Pt was sent home. Pt still reports pain in her Right arm.  Care management spoke with pt. daughter 10/26/2023 and advised follow-up with Dr next week and to call if symptoms worsen.
Pt recvd 1 dose of Engerix-B 4JUN92 had an exp of becoming lightheaded resolved in 2 hrs; had a temp that noc;
pt told dad felt like was going to throw-up;lt hand got cold;passed out; c/o h/a, pt had cup of H20 & candy to chew on;released to parents;vitals signs 225PM 114/60, p 64;240PM 110/60, p64;3PM 118/70 P80;
Information has been received from a registered nurse concerning a 16-year-old female with no pertinent medical history and with an allergy to EXTENDRYL and RAD who on 21-APR-2006 was vaccinated with a 0.5mL dose of Varivax (Lot # 652722/1127R). There was no concomitant medication. ON 04-MAY-2006 the patient experienced a rash at the injection site and two lesions on her abdomen and one on back. No treatment was required. There were no lab diagnostic studies performed. The outcome was reported as recovering. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the nurse indicated that the patient had a rash at the injection site, 2 lesions on the abdomen and one on the back, a fever of 101.5, a headache and dizziness. It was reported that the patient recovered. Additional information is not expected.
hives all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over her body.) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives all over her body.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISOL [HYDROCORTISONE] at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over her body.) outcome was unknown.            Concomitant medication was nasal spray
Pt  describes  pain  in shoulder/neck that   started day after  injection .  She went to ER on 9/18/21 . Pain worsened on day 4 . Pain in injection site  on deltoid resolved  within 4 days & started evening of injection day.
Rash and lump covering most of my upper arm. Extreme fatigue, sore throat, headache - although they may be chronic fatigue symptoms, not from the vaccine. I don't know.
C/O redness, heat at raised area about the size of a half dollar. Advised Tylenol, warm compress et to call office of condition worsened.
Child had MMR in left leg on 3/28/06. Parent returned to clinic with patient on 3/30/06 complaining of swelling to child's left leg and child scratching area. Doctor referred patient and parent to emergency room to rule out possible infection to leg. Discharge summary states cellulitis. msv
Muscle and joint pain, chills, nausea, fever (99.2). Took two Tylenol Extra Strength Rest Symptoms resolved after 36 hours
Diarrhea began 3 weeks prior to vaccination. Evaluated by physician at University of Central Missouri Health Center in Warrensburg MO 64093. Was prescribed Cipro. Diarrhea worsened and then started to resolve after he finished course of Cipro. Diarrhea resolved one day prior to vaccination. Diarrhea returned (and color different) and developed abdominal pain evening after he was vaccinated. Returned to clinic and was prescribed a different antibiotic. He says that the abdominal pain has resolved but that the diarrhea continues.
Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter's address updated.
Received Dtap/Prevnar 9/15. 9/15 with high temp, vomiting, febrile seizure seen at ER (Hx of febrile seizure). Pedi. neuro. consult arranged.
The patient reports that a few days after her 1st Shingrix shot, she developed her usual outbreak of localized vesicular shingles in a dermatomal pattern (same distribution that she has had several times in the past) on her left shoulder; the same side as the Shringrix vaccine was administered.  She took Valtrex bid for a week after first noticing the rash and it ultimately resolved with no sequelae or symptoms of post herpetic neuralgia.  She was administered her 2nd Shingrix dose in the series 13 weeks after the first dose, but in her contralateral deltoid (right side)
I had no reaction to vaccine. I started feeling sick with a dry cough for a week prior to testing positive for COVID-19. Throughout the week, I tested multiple times for COVID-19 and each one was negative. I had a PCR test too and it was negative. On 07/10/2022, I tested positive with a home test for COVID-19. I went to an urgent care center and was given the prescription for PAXLOVID. It made the taste of my coffee icky. It knocked out the congestion in my chest fast and I did not rebound.