chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 11:30 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation. Medical history included diabetic, arthritis, torn right shoulder, neuropathy plantar fasciitis arthritis back pain, allergies: sulfa, antibiotics, indomethacin, amoxicllin, sulfacetamide. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for an unspecified indication from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for an unspecified indication from an unspecified start date and ongoing; fluoxetine (FLUOXETINE) taken for an unspecified indication from an unspecified start date and ongoing; diclofenac (DICLOFENAC) taken for an unspecified indication from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication from an unspecified start date and ongoing; metformin (METFORMIN) taken for an unspecified indication from an unspecified start date and ongoing; pregabalin (PREGABALIN) taken for an unspecified indication from an unspecified start date and ongoing; simvastatin (SIMVASTATIN) taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication from an unspecified start date and ongoing; amitriptyline (AMITRIPTYLINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced bells palsy on 12Mar2021 with outcome of not recovered, runny nose on 12Mar2021 with outcome of recovering. Clinical course: the consumer said that the Bell's palsy started Friday with a runny nose, her right side nostril. She said Saturday she had it where she can't move the right side of her face properly, and that is when she called to make her doctor's appointment for this morning. The reported events required visit to: Physician office. The patient received prednisone 1 daily for 7 days as treatment for the event Bells Palsy.
SHORTNESS OF BREATH; NOT ABLE TO DO AS MUCH WORK/ CAN'T WORK AS HARD AT WORK, HARD TO GET UP; CANT EVEN WALK ON; THIGHS HURTS ON BOTH SIDES, BUT ESPECIALLY ON THE LEFT/LOT OF PAIN ON MY LEFT; THIGHS SWELL AND TURN RED/LEFT LEG FOULED UP EVERY NIGHT; This spontaneous report received from a patient via a company representative concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known medical history to contribute. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 38 years old. No concomitant medications were reported. On APR-2021, the patient experienced thighs swell and turn red/left leg fouled up every night. On an unspecified date, the patient experienced shortness of breath, not able to do as much work/ can't work as hard at work, hard to get up, cant even walk on, and thighs hurts on both sides, but especially on the left/lot of pain on my left. Treatment medications (dates unspecified) included: ibuprofen, and camphor/melaleuca leucadendra oil/mentha spp. oil/menthol/syzygium aromaticum oil. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thighs swell and turn red/left leg fouled up every night, thighs hurts on both sides, but especially on the left/lot of pain on my left, and cant even walk on, and the outcome of shortness of breath and not able to do as much work/ can't work as hard at work, hard to get up was not reported. This report was non-serious.
flu like symptoms; with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm; arm hurt awful for days; experienced chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug intolerance (Dilaudid) and Herbal allergy (herbal tea (rash)). Concomitant products included ROSUVASTATIN, IRBESARTAN and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm), PAIN IN EXTREMITY (arm hurt awful for days) and CHILLS (experienced chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), RASH (with the 1st dose of the Moderna COVID-19 vaccine, she had a rash in her arm) and CHILLS (experienced chills) outcome was unknown and PAIN IN EXTREMITY (arm hurt awful for days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient never had COVID positive test or diagnosis. Patient reported that none of adverse events experienced after primary series concerned her that much as they were all expected reactions to the shots. No treatment drug was reported.   This case was linked to MOD-2022-657100, MOD-2022-657016 (Patient Link).
Parent called at 14:10, to report child had been crying inconsolably since the time of injection. Injection site on right leg red and swollen. Pt was treated with Tylenol-afebrile. Parent called PP.
ELEVATED BP 170/110 WITH EXTREMELY SEVERE HEADACHES- UNRELIEVED WITH MAX ABOUT OF OTC TYLENOL. ALSO HAD FEVER 102.4, CHILLS, HEART RATE RANGED 120'S-130,  MYALGIAS THAT LIMITED MY ABILITY TO AMBULATE SAFELY ALONE- NEED ASSISTANCE GETTING OUT OF BED AND GETTING DRESSED. HAD TO GO TO ER FOR TX.
Started with muscle soreness at injected arm, progressed to entire body by morning of 30 Jul 2012. Soreness became more severe to the point were walking was not possible without severe pain or grip a pen adequately to write by 31 Jul 2012. Doctor Visit on 01 August, performed tests, determined it was a delayed reaction to the TDAP vaccine.
Case number PHEH2015US018516 is an initial spontaneous report received from a health care professional on 17 Sep 2015. This case refers to a 28 years old female patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 Sep 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error. The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015. Clinical notes updated.
Information has been received from a nurse referring to a 55 year old female patient without pertinent medical history and drug reactions/allergies. On 19-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # K018172, expiration date 02-DEC-2015, 0.65 ml, subcutaneously as vaccination. There was no concomitant therapy. On that same date, the patient developed an injection site reaction including knot under skin at injection site and reddened/itchy area immediately around injection site. No rash noted and no other areas affected. The patient called office to seek advice. No lab diagnostics studies performed. Improvement noted as patient had been using BENADRYL (dose unspecified) as recommended by a physician over the phone. At reporting time, the outcome of the vents was recovering. Additional information has been requested.
Information has been received from a pharmacist referring to a 60 year old female patient. No pertinent medical history or drug allergies were reported. On 05-NOV-2015 the patient was vaccinated with ZOSTAVAX (lot # L021608, expiration date 10-SEP-2016, strength, dose and route unknown). Concomitant therapies included unspecified CELEBREX, MOBIC, cyanocobalamin, ergocalciferol, SYNTHROID, hydrochlorothiazide and clonazepam. Shortly after receiving the vaccine, the patient developed redness and slight warm at the injection site. On 08-NOV-2015, the patient then began to experienced itchiness at the injection site and reached around to scratch it and found that there were bumpy little blisters present. On 09-NOV-2015, the patient called the pharmacy to report the reaction and stated that the blisters had gotten bigger. The reporting pharmacist reported that the patient had 4 blisters that are about the size of an eraser on a pencil and several smaller blisters at the site. The patient reported that the patient's husband drained the blister at the night on 09-NOV-2015 and covered them but by the morning (09-NOV-2015) the blisters had filled back up with fluid. The patient sought medical attention by calling pharmacy. No medication had been administered to treat the reaction and no lab diagnostics studies were performed to the patient. The reporting pharmacist reported that the patient was not experiencing any pain. The outcome of all the events were reported as not recovered. Causality between events and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 22-OCT-2012 10:29, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I got tested because of my job and I tested positive; I got tested because of my job and I tested positive; allergies; stuffy nose; This is a spontaneous report from a contactable consumer (Patient herself). A 43-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. Medical history and Concomitant medication were not reported. The patient experienced allergies, stuffy nose on Apr2021 and on 14Apr2021 patient tested positive. The patient stated she had allergies and had them for three weeks and was around someone that tested positive and so got tested because of her job and tested positive. She had a stuffy nose but that was her only symptom and her 10 days of quarantine would be complete. Scheduled second dose on 23Apr2021. The outcome of the event allergies was recovered. and the outcome of all other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 11/27/2008 for COPD exacerbation. Vaccination took place on 10/04/2007. According to physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request. 3/11/09-records received for DOS 11/27-12/2/08 DC DX: COPD exacerbation. Admitted with increased shortness of breath and cough. Chest tightness. Chills
Fever, Nausea, Chills, diarrhea, fatigue   On March 11,  I  noticed a rash on my stomach. It looked like welts. It wasn't itchy and I didn't feel anything.
Two dime-sized rashes appear on left arm later in the evening shot was given. Several days later radiating red streaks appeared. Spouse called to report reaction on 4-28-2016. Since then the red streaks have disappeared but a rash remains on arms, stomach and ears. They have done no treatments. Referred to medical provider.
- dizziness, nausea, throwing up, and passed out  for approximately 2-3 minutes approximately 17 hours following  vaccine - headache, muscle and joint pain, chills, feeling tired, weak, and unwell from 8 hours following vaccine until 48 hours following vaccine
On 8/4/21: Patient reported and confirmed  never having previously received any COVID-19 vaccine; Pfizer vaccine administered; ImmTrac2 findings show that patient received dose 1 of Moderna vaccine on 02/20/2021.
Took a shower, March 7, started itching in the shower on my chest.  Got out of shower, and looked at my chest and a rash had developed.  I put some Clobetasol on the rash and some anti itch topical, and after about 3 hours, it seems to have subsided.  I did not want to take Benadryl orally as it knocks me out.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 11-year-old male patient who received MENVEO (batch number M15125, expiry date 31st May 2017). On 15th August 2016, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 16th August 2016, 1 days after receiving MENVEO, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved. The reporter considered the injection site swelling and injection site pain to be almost certainly related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. This case was reported by a physician assistant. The patient received a dose of MENVEO in right arm and experienced swelling (8 centimetres) and pain at injection site.
10 days after receiving vaccination hives appeared,  itchy rash, burning sensation on skin, a swelling throat, nausea,
within 12 hours, felt like ear was plugged, after 24 hours lost all hearing in left ear with severe tinnitus, multi tone ringing in ears, 2 days later experienced pain in neck lower head area, also leg pain increased
pt recv vax 8JUN95 & 15OCT97 pt devel chickenpox that consisted of approx 12 lesions described as 12 spots that were very itchy;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Additional Details: Pt received the flu shot and Pfizer 3rd dose on 10/14/2021. after vaccine administration during the 15min wait time, pt became dizzy and light headed. Vital signs taken Bp 100/60 HR 70, SP02 99% on room air, FSBS 87,  patient placed in siting position and verbalized that he started feeling better, and he stated that he usually vasovagals after blood draws and he suffers from hypertension. Patient also verbalized his father died from covid 1 week prior.  EMS arrived and transported patient.
Pt admitted that  a purple like area found at injection site on 08/18/2002. He lanced it and put topical antibiotic on it. The night of 8/22/02, he went  to a medical facility's urgent care. The site looked good but they gave him a course of antibiotics.
Headache, Myalgia, SkinRash & Rash Narrative: Employee reports arm soreness, redness at injection site and 2-4 inch raised "hive." Employee further reports headache, body ache, sweat and fatigue. She has taken Tylenol with relief, reports that condition is improving.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck), subcutaneously, dose 0.5 ml, (lot # K022447, expiration date: 13-MAY_2016, 4 doses: lot# K025766, expiration date: 08-JUN-2016, 3 doses), (injection site was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Follow up information has been received on 18-JUN-2015. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
patient states she felt dizzy on day of shot, then now with portal vein clot in June 2022
she started to have itching in her hands and ears. Her Ears are red; she started to have itching in her ears; Her Ears are red; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm), PRURITUS (she started to have itching in her hands and ears. Her Ears are red), PRURITUS (she started to have itching in her ears) and ERYTHEMA (Her Ears are red) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). On 06-Mar-2021, the patient experienced PRURITUS (she started to have itching in her hands and ears. Her Ears are red), PRURITUS (she started to have itching in her ears) and ERYTHEMA (Her Ears are red). At the time of the report, PAIN IN EXTREMITY (a sore arm), PRURITUS (she started to have itching in her hands and ears. Her Ears are red), PRURITUS (she started to have itching in her ears) and ERYTHEMA (Her Ears are red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
VERY SICK FOR 12 HOURS STRAIGHT; FEVER WAS AT 102 FOR A FEW HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 patient experienced very sick for 12 hours straight, and fever was at 102 for a few hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick for 12 hours straight, and fever was at 102 for a few hours. This report was non-serious. This case, from the same reporter is linked to 20211031768.
could hardly turn her head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (could hardly turn her head) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04HA21A) for COVID-19 vaccination.   The patient's past medical history included No adverse event (No reported medical history).  On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (could hardly turn her head) (seriousness criterion hospitalization). The patient was hospitalized from 22-Mar-2021 to 23-Mar-2021 due to MUSCULOSKELETAL STIFFNESS. At the time of the report, MUSCULOSKELETAL STIFFNESS (could hardly turn her head) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications were not provided. Treatment information was not reported. The patient was hospitalized for 2 days where the doctors ran many tests which included electrocardiogram, blood tests conducted among other things. The Healthcare professional assessed the causality between the event was considered as possibly related to the mRNA-1273.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Received pneumonia shot at 3:30 pm on September 1, 2009 on right arm. About 6 pm arm started to get red and swell and hurt. Patient cannot lift arm. Put ice on area and took BENADRYL. Arm is worse today September 2, 2009.
Pt recv vax on 1/26/99; on same day pt exp swollen/ red right leg
body aches, fatigue, chills, headache. All gone by 3/16/2021
18AUG91 c/o edema & pain rt knee eventually shifted to lt knee; devel a cold; 20AUG91 c/o pain, edema joints of fingers to the hands; 28AUG91 some swelling in fingers otherwise no problems;
Received vaccine on 5/9/11. Overnight pt cried all night & was extremely fussy. Emesis 1x. IAM of 5/10/11. Refused to bear wt/walk. Mom appreciated red swollen Rt thigh which was painful to touch. Seen at clinic at 4pm with 3 in x 2 in area of painful induration & temp=100.8.
SYMPTOMS:  FELT HOT THEN DIZZY AND DIZZINESS BECAME WORSE.  NAUSEA, SKIN TINGLING ON FACE.  IN AMBULANCE, REDNESS AND RASH ON NECK AND SHOULDERS.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 27-OCT-2014, the patient was vaccinated with (Merck) VARIVAX, 0.5 ml, subcutaneously, (anatomical location, lot# and exp. date were not reported), which underwent a supported temperature excursion. No adverse experience was reported. The outcome of the event was not reported. Additional information has been requested.