chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Nov2014. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Covid-19 treatment with Paxlovid from 28Jun2022. Patient was taking other medications/ products within 2 weeks of starting Covid-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient stated that one hour after receiving his second dose, everything started to turn yellow, he got dizzy and lightheaded, and his hearing was "off"/impaired. He closed his eyes for about 20-30 seconds, and when he opened his eyes again, he felt better. He has not had any issues since that episode.
Muscle pain; Joint Pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), ARTHRALGIA (Joint Pain) and FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039821A) for COVID-19 vaccination.     Concurrent medical conditions included Nerve pain. Concomitant products included GABAPENTIN for Nerve pain.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (Joint Pain) and FATIGUE (Tiredness). At the time of the report, MYALGIA (Muscle pain), ARTHRALGIA (Joint Pain) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
4/24/21 - severe inner ear pain in middle of the night - Right ear, only while laying on left side of body  4/27/21 - moderate inner ear and jaw pain (19:30) - left ear/side
Immediate burning, tightness, muscle soreness. Continued soreness now through week 2 unable to lift arm in front of/across face without severe pain. Appears to have been injected at incorrect (too high) site, causing either ligament, tendon or joint damage.
Information has been received from a medical assistant concerning a female patient who on 15-DEC-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (LOT#651330/1048P).  The reporter mentioned that it may have been the patient's second dose.  On an unspecified date in December 2005, the patient developed joint soreness that felt like bursitis after vaccination.  The patient sought medical attention and was treated with acteminophen (TYLENOL) and ice.  The joint soreness did not improve and the patient was reported as not recovered.  There was no product quality complaint reported.  Additional information has been requested.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 30th January 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK receipt date: 30-Jan-2023 Reporter's comment: The medical assistant called to inquired that the patient need another one. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered an expired dose of Havirx at their facility, which led to expired vaccine used.
Patient presented to the ED with weakness and generalized pain.  Was subsequently found to have COVID.  Patient discharged on 5/24/22
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 17-SEP-2015 (also reported as today) the patient  was vaccinated with an improperly stored dose of GARDASIL (dose, strength were unknown, lot # L0118546, expiry date: 16JUN-2017; intramuscular). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Temp of 103.0 degrees F. Persistent crying for 2-3 hours.
Sore left arm day #1, discomfort into neck and chest wall on same side, used ice pack to reduce inflammation. That evening took DUEXIS (with food) antiinflammatory before bed. Woke with nausea, diarrhea, clamminess, felt orthostatic and had to lay on bathroom floor for 20 minutes. Day #2, laid on couch all day, decreased appetite, sore stomach, neck and head. Lethargy, mild confusion. History of Reyes syndrome at age 5 when had chicken pox hospitalized at hospital in coma for 5 days.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Dec-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Watery eyes, runny nose, swelling of face adn eyes, slight rash in between eyebrown doen dose and under chin.
This spontaneous report was received from a healthcare worker and refers to 11 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 10-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The pone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Temp to 104.1 (rectal temp) on Tylenol -  fussy.
Presented with gen. weakness, found on floor of retirement center, dx covid 2 weeks PTA; Admitted with rhadomyolysis and Covid 19 infection; CXR clear on admission, SpO2 stable on RA; tx with maxipime, Vit C, Vit D3, Doxycycline; Progressed to PNA; no supplemental O2 required; dc back to SNF
pt presented to clinic stating 2nd day p/vax arm felt hard, red & hot progressed over 3 days;
Hard lump approx 1 1/4" diameter noted under site of injection next day. Over next several days developed 4 1/4" x 3 1/4" Dark red vesicular area R upper arm. Area is very warm, itchy and tender.
This patient received (03/15/01) immunization. On 03/15/01, broke out approximately on 03/24/01 he had a temp of 101.1. On 04/02/01, tactile temp. The patient presented to the clinic on 04/02/01 with a temp of 101.1, cough x 4 days, + rales, and + wheezing. The patient was treated in the ER on 04/02/01, + retractions, 96% O2 sat, Chest x-ray - mild hyperinflation. The mother, 3 siblings, uncle, and housemate (adult), all + for chicken pox.
I started coughing with a sore throat on 9/29/2021; It was worse a few days later. I suddenly couldn't catch my breath while just sitting in a chair. I got tested for COVID-19 that day. I received a positive COVID-19 result on 10/2/2021. I called my doctor and told them I tested positive, and they told me to stay home, and rest, and drink fluids, and go to the hospital if I couldn't breathe. The symptoms worsened with stuffy nose, coughing, and sore throat. On 10/2, - 10/4/2021, I had extreme body aches. It was the worst pain I have ever felt. On 10/5/2021, I was hot and cold at the same time all day long. However, I did not have a fever. On 10/6/2021, I started feeling better. I still had mild symptoms. By the 7th, I was feeling exponentially better with milder symptoms. By 10/8/2021 I just had congestion and occasional coughing which has continued to present day.
Vaccine given on 12/29/20 by Pharmacy. On 1/1/21, resident became lethargic and sluggish and developed a rash on forearms. He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of codition reported, doctor and Hospice ordered comfort meds (Morphine, Ativan, Levsin). Resident expired on 1/4/2021
About 4 months after 2nd Janssen Covid dose I developed Tinnitus, which has been seriously troubling me since. It is unrelenting. I live where I received my 1st dose of AstraZeneca. After 8-week I went back to the same clinic to get the 2nd dose, but they had no vaccines of any type. I traveled and tried to get another Covid vaccine dose but no one would give me a vaccine of any type because I had received the AstraZeneca. So, I went to a Dept of Health clinic and explained my situation. After some checking I was okayed to receive the Janssen dose, which no one in wanted. 6 months after returning I went for another dose of the Janssen treatment.
reactivation of Epstein-Barr virus, extreme fatigue. First reactivation. Initial EBV 30 years ago.
12HRS after covid vaccine flu like symptoms, nausea, headache, chills, low grade fever, body aches.lasting less than 24hours.
Information has been received from a 68 year old male patient referring to himself. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date (reported as "recently"), the patient stated he was given an unspecified influenza virus vaccine inactivated. The patient also had received a zoster vaccine live (reported as "a shingles vaccine") during the summer of 2015. On 10-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, once, intramuscular, lot # not reported, expiry date: 09-FEB-2017). Concomitant therapies included loxapine, ACCUPRIL, atorvastatin and a thyroid medication. On 10-FEB-2016, the patient had been experiencing injection site pain, fatigue, stiffness at the injection site and he felt feverish. There was no treatment given for the events. No diagnostics studies were performed. The patient didn't provide his doctor's name because he had not seen his current doctor yet. The patient had spoken with his pharmacist for medical attention. The outcome of the events was reported as recovering. Additional information has been requested.
On Jan. 26, 2021, I had an accident at home an suffered  broken ankle, tibia and fibula broken from tarsus.  I was rushed to hospital and had ORIF surgery.  I later found out the surgeons failed to order blood thinners and about a month later, I was rushed to the hospital with 5 blood clots, one in each lobe or each lung and one forming in the calf muscle on the left leg.  I have been taking Eliquis since late February and will be on it through May.  I have had an echocardiogram which was normal but the doppler I had on my legs may have indicated the problem is still on-going.  I don't know yet.  I did contract medical facility to ask if I should get checked out due to recent clotting incidents and was told I did not.  I decided I should report it anyway and my clotting situation probably has nothing to do with vaccine but I just want to make sure.
Patient was checking out and fell backwards, hitting her head on the door; loss of consciousness 30 seconds. 4-5 cm laceration right head and c/o bilateral hand and lip paresthesias. Patient transported to ER via ambulance.
Also had a PPD test placed on LFA at same time as vaccines. Patient presented to my clinic (different from vaccinator's clinic) on Monday 7/17/17 at 3:45pm for the reading. Mother asked me to look at his arm. I noticed the deltoid and surrounding area was red, hot to the touch and felt HARD to the touch. Patient stated 'ouch' when I touched it and tried to pull away but not roughly. I told mother to put ice on it for 30m on and then off for 30m and repeat. Also told parent if it gets worse to see his PMD for an evaluation. Vaccinator was RN at clinic as listed.
(7/13/07) developed right foot pain, refused to bear weight seen 7/15 and 7/19 and had referral to another dx: reactive synovitis  - resolved over ~ 3 weeks. 7/15 ESR = 9; re xray
Chills; Fever; Nauseous; Felt like i got in the head with a shovel; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nauseous) and HEAD DISCOMFORT (Felt like i got in the head with a shovel) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER and PFIZER. Past adverse reactions to the above products included No adverse event with PFIZER and PFIZER.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 3. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nauseous) and HEAD DISCOMFORT (Felt like i got in the head with a shovel). At the time of the report, CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nauseous) and HEAD DISCOMFORT (Felt like i got in the head with a shovel) outcome was unknown. Not Provided          This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment and concomitant medication provided.  It was reported that patient got first and second Pfizer shots without any side effects.
After each vaccine, I had flu like symptoms for 3 days.  I would feel better for a couple days then one week after injection I developed Joint pain, muscle pain, and incredible stiffness.  The joint pain and stiffness mostly hips, legs, knees feet at this point mostly left sided
After administering the vaccines, the patient presented abdominal pain, nausea, dizziness and vomit. He was pale, sweaty and cool to touch. B/P 80/50 P-62.
The next day after the vaccine, I felt terrible - flu-like symptoms. I was achy and very fatigued. Those lasted about two to three days. Strep Throat - In June, 2021 - very sore throat and sticky throat and difficulty swallowing. It hurt even when I wasn't swallowing. I was very cold - couldn't get warm. On the following Monday, I got an appt with Kaiser and they said it Strep throat. (No culture.) It was a phone doctor's visit. I had white patches on the back of my throat. Prescribed amoxicillin. That helped. I took it for one week.
deep muscle pain in left arm, numbness, tingling, radiating pain down arm to fingers.
I went to a wellness visit with severe anemia ferritin. We did a CT scan I have a hernia that has moved up to my esophagus. I took four weeks of iron infusions. I just ended that last Monday I am still waiting for blood results to see if further treatment is needed. I had leg cramps and depression, and my mind was very foggy. It was all caused because of lack of blood I have a colonoscopy schedule as well GI appointment.
Mother reports about 5 PM noticed swelling left arm from shoulder about midway to elbow. Arm very sore. By 10/27 PM, swelling gone and not sore. Took Motrin. On 10/27 at 8:30 PM, complained of lips numb and noticed lip very swollen and face puffy. Seen in ER. Given Benadryl and not any better 10/28.
Mixed series - COVID 19 vaccine 1st dose Pfizer and 2nd dose Janssen No treatment required, vaccine series considered complete
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ019) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.   Reporter did not allow further contact
After receiving flu vaccine, 10 min later, c/o splotchy, reddened area with soreness at site. Also c/o tingling around mouth 10 min later hives developing lower R arm. Diphenhydramine 25mg/.5cc IM given.
PATIENT REPORTS EXPERIENCING PAIN AND NOT BEING ABLE TO LIFT LEFT ARM VERY HIGH AFTER RECEIVING SHINGRIX VACCINE. SHE HAS UNDERGONE PHYSCIAL THERAPY FOR THIS ISSUE.
Felt fine the first 6 hours, then around the 6.5 hour mark started feeling mild chills and muscle aches. Progressively got worse through the night into really bad chills, aches, feverish, sweaty, and woke up at 7am the following day with pounding headache, mild chills, and moderate achy muscles.
pt recvd vax; 5 1/2 hrs of shrill screaming; no relief from APAP;
1st dose Jan2021, never came for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2021, batch number 9h234, expiry date 27th August 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by the registered pharmacist. The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
p/each of first 3 immun, pt devel a papular rash @ the site;they were progressively worse w/subsequent vax;p/3rd vax the rxn was more generalized w/severe pruritus & dermatitis;abd area became infected d/t scratching;
Where immuz was given left arm went numb, felt sick to stomach and felt like throwing up. Diarrhea, fever, forgetfulness, felt disoriented and dizzy for days.
Severe flu-like symptoms consisting of myalgias, nausea, vomiting, fatigue, generalized weakness.
Nausea, vomiting, swollen hot red injection site, cellulitis, axilla tender to palpitation.
11/01/2021 vaccination. Discomfort in chest for 2 days; funny feeling and some discomfort. Cataract surgery coming up and screened before surgery. Annual visits with Dr. He ordered an EKG; abnormality. R Bundle Branch Block; 'Electrical'. Send for Echocardiogram; Neg.
My period is horrible I'm on day 6 with excessive bleeding hasn't stopped yet this vaccine is clearly affecting female hormones and needs to be addressed adequately
Patient was giving injection of Varicella to patient and the vaccine squirted in her face and eye. This caused pain and redness in eye, diagnosed with corneal foreign body and given Gentamicin ophthalmic eye drops.
severe Diarrhoea; leg felt like pins and needles; cough; patient keeps running out of breath; headache; fever; could not sleep 3 nights; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe Diarrhoea), PAIN IN EXTREMITY (leg felt like pins and needles), COUGH (cough), DYSPNOEA (patient keeps running out of breath) and MYALGIA (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced MYALGIA (sore arm). On 07-Mar-2021, the patient experienced DIARRHOEA (severe Diarrhoea), PAIN IN EXTREMITY (leg felt like pins and needles), COUGH (cough), DYSPNOEA (patient keeps running out of breath), HEADACHE (headache), PYREXIA (fever) and SLEEP DISORDER (could not sleep 3 nights). On 09-Mar-2021, SLEEP DISORDER (could not sleep 3 nights) had resolved. At the time of the report, DIARRHOEA (severe Diarrhoea) had not resolved and PAIN IN EXTREMITY (leg felt like pins and needles), COUGH (cough), DYSPNOEA (patient keeps running out of breath), MYALGIA (sore arm), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patients treatment information included Tylenol & Pregablin.
Approximately 10 minutes after receiving vaccine patient began filling nauseous. Later that evening patient went to hospital because she thought she was having a heart attack. Entire left side of body was in pain and she was having a hard time breathing.
little hard bump at site of injection, no treatment recommended but counseled the patient to watch for any color change or warmth and give us a call.
Moderate fatigue, mild chest discomfort, mild stomach pain, mild vertigo, left arm pain and weakness, mild muscle weakness, chills, occasional sweats, dry mouth, loss of appetite, sudden/short located head pain, nausea, malaise/lethargy
CHILLS; FELT WEAK; FEVERISH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced chills, feeling weak, and feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, feeling weak, and feverish. This report was non-serious.