chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 29OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 36 year old female patient received a dose of FLUZONE administered in the left deltoid on 27OCT2003. The following day,the patient woke up with body aches, fatigue, a temperature of 101 degrees Fahrenheit, stomach cramps, nausea and diarrhea. The patient's recovery status is currently unknown. The reporter of this case is the same reporter of case U2001011283.
3 days after pt had extremely high BP about 190/110 and went to ER. He never had this reaction with any previous vaccinations.
Information has been received from an adult female pharmacy student who was vaccinated with a dose varicella virus vaccine live.  In 2004 the patient had a titer which showed no seroconversion.  She has no symptoms.  No product quality complaint was involved.  Additional information has been requested.
Swollen lips, rash, hives, itching. Pt went to Urgent Care. Took 1 dose of Benadryl, hydrocortisone Cr. topically. No relief, so will try Zyrtec, Benadryl spray. Seeing primary care Dr. on Tuesday 9/15/2020.
Local reaction to ADACEL .  Pt has redness, warmth, pain, induration measuring as 3"x5" around injection site.
Client called on 032207 1115 and reported he had rash on both his arms, following his third Hepatitis B shot.  He reported rash was raised, red, and itched.  He first noticed the rash last week and couldn't remember if it was before or after the shot.  He reported that rash was worse on his right arm(arm he recieved the injection in).  He also reported that when he put lotion on the rash it seemed a little better, but rash always came back.  Client denied any use of new skin products, laundry soaps, clothing, or eating of new foods.  Client was referred to his medical provider for evaluation.
A few hours after receiving my first dose vaccine shot, I developed intense ringing in my left ear. Since then it?s been consistent but worse at some times. I went to see my doctor a week before I was due for my second dose shot. I was still having the ringing in my left ear and she gave me a steroid shot to hopefully suppress my bodies reaction to the shot. It did seem like the ringing got better after a week. But then my ear went back to consistently ringing again a few days later. I did not get my second dose of the vaccine at my Doctors suggestion. I have an appointment made with an ENT specialist in July.
Sat out in the sun 04MAR2021.Now has blisters./a couple big blisters on her left knee and a couple small blisters above her left knee; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 91 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 09:30 (Lot number: EL1284) at the age of 91 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "sarcoidosis" (unspecified if ongoing); "stool softener" (unspecified if ongoing); "Bladder" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN (ongoing); SOLIFENACIN taken for bladder disorder (ongoing); HYDROCODONE/PARACETAMOL (ongoing); DOCUSATE SODIUM taken for faeces soft (ongoing).The following information was reported: BLISTER (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Sat out in the sun 04MAR2021. Now has blisters./a couple big blisters on her left knee and a couple small blisters above her left knee".  Additional Information for Concomitant Products hydrocodone-acetaminophen: Makes her sleep a lot, so she only takes a half a tablet when she needs it, which isn't often. No Lot/NDC/Expiry on the pharmacy bottle. Caller is calling about her sister, (name). States that she got the BioNtech Covid 19 vaccine on 02Mar2021 and did well at 91 years old. Her sister went out yesterday and sat out in the sun. States that parts of her left leg were in the sun, and this morning she has blisters on those same parts of her left leg. Have there been any reports of anyone blistering after getting the vaccine? States that she got the vaccine in her left arm. She has no blisters anywhere else. She has a couple big blisters on her left knee and a couple small blisters above her left knee, but she doesn't know if it was the from the sun or if the shot had anything to do with it. States that her sister used to have psychodosis, but is no longer on medication for that. Call handler attempted to clarify, but caller did not know what psychodosis was and she didn't know how to spell it. Psychodosis in this report is spell as pronounced by the caller. States that her sister slept late today and is eating now. She noticed the blisters when she got up today and showered. They have not used any kind of treatment for the blisters. Caller states that her sister got the blisters yesterday, 04Mar2021, but didn't notice them until today, 05Mar2021.   No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION, PRURITUS, INSOMNIA, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced BURNING SENSATION, PRURITUS, and INSOMNIA. On 27-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 27-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved. At the time of the report, BURNING SENSATION, PRURITUS, and INSOMNIA outcome was unknown.            No concomitant medication and treatment reported. Patient stated they were only able to get 3 hours sleep because they believe it might be an interaction from the vaccine and drugs.  This is a case of Inappropriate Schedule of Product Administration concerning a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected events of Burning Sensation, Pruritus, and Insomnia. The event occurred the same month after the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since outcome of events from first dose was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-385687 (Patient Link).
had a sore arm after each of her 2 doses of the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm after each of her 2 doses of the Pfizer-BioNTech Covid-19 Vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514884 same reporter/drug, event / different patient;US-PFIZER INC-2021514882 same reporter/drug,event, different patient;US-PFIZER INC-2021514883 same reporter/drug/event, different patient
40 minutes post vax, the pt called stating left arm numbness, shoulder  and left facial numbness. Pt waited 30 minutes without side effects. The pt was advised to go to the ER, but pt did not go. Symptoms resolved the following evening.
positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date: unknown, at the age of 45-year-old), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 as single for covid-19 immunisation. The vaccination facility was in the stadium. Medical history included support immune system. Concomitant medications included vitamin d NOS, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) for support immune system and ongoing. The patient started taking vitamins since Covid started, for a year ago. No additional vaccines administered on same date of the suspect. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced positive covid-19 test with symptoms on 05Apr2021. The patient asked was it needs to test negative before getting the second dose of Pfizer Covid-19 vaccine on 16Apr2021. The patient was infected with virus after the first dose was given on 26Mar2021. The patient was positive on 05Apr2021, that was when they had the test. Post vaccination, on an unknown date the patient was tired. The patient went to the urgent care where they had the COVID test. The patient was not hospitalised. The patient lab test included COVID-19 test (sars-cov-2 test) was positive on 05Apr2021. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
In addition to the known side effects of extreme fatigue, low grade fever and body aches, I also have right arm pain at the site of injection with right arm swelling, warmth and right axilla swelling and tenderness.  The arm pain was began immediately at the time of injection and did initially lessen some for the first 12 hours until it started worsening mid-morning 22-24 hours after the injection.  Around 26 hours after the injection the arm pain worsened such that it couldn't be ignored and the axilla pain became very prominent almost worse than the arm pain.  Upon inspection I noticed obvious swelling and pain in my right axilla.  The right arm and axilla pain has persisted and worsened over the last 2 days to now include upper biceps, upper triceps, lower deltoid, trapezius, clavicular and right lateral breast pain.  The axilla and arm swelling has persisted and worsened over the last two days to now include swelling in my upper arm, around my clavicle, my upper chest and upper back.  The initial axilla swelling has not decreased any and is more prominent than any of the swelling located elsewhere.  Of note, I cannot easily palpate any axilla, clavicular or cervical lymph nodes.  If there is lymp involvement the nodes are not appearing to be extremely swollen with palpation exam.
This case was reported by a consumer and described the occurrence of influenza in a male subject aged between 30 and 39 years old who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to pet dander, dust mites allergy, gluten intolerance, grass allergy, lactose intolerance, latex allergy, migraine, penicillin allergy, pollen allergy, seasonal allergy, soy intolerance and tree allergy. Historic vaccination included tetanus vaccine (non-gsk); non-GSK manufacturer; unknown given in 2008. On an unspecified date in 2009 the subject received a dose of influenza vaccine unspecified (unknown). In 2009, 2 days after vaccination with influenza vaccine unspecified, the subject experienced influenza. The subject reported at least five years ago (2009) he got a flu vaccine and two days later he had the flu. He stated the flu vaccine gave him the flu (flu vaccine and manufacturer were unknown). At the time of reporting the outcome of the event was unspecified. The subject experienced adverse events with BOOSTRIX vaccine, for that case please see A1062563A and with HepB vaccine, for that case please see A1062563B.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patient were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Oka/Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 25-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX which were improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
As per the doctor the patient's left arm (deltoid) was swollen, warm, with redness, mild tenderness to the touch; But she was using her arm well. Prescribed Motrin, and warm compresses.
the patient experienced left knee joint pain and creeking; I wanted to die rather than endure the pain any longer; 6 hours of all joints pain and body aches; Worried I won't be able o walk or use my hands again; 6 hours of all joints pain and body aches/Left knee joint pain and creeking/Now right knee and all joints hurting all the time.; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: En 6198 en 6207) via an unspecified route of administration, in left arm on 18Mar2021 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. On 27Mar2021 at 03:00, the patient experienced left knee joint pain and creeking. 6 hours of all joints pain and felt like he wanted to die rather than endure the pain any longer. He said that right knee and all joints was hurting all the time. Worried he won't be able to walk or use his hands again. Have read online of others the same. On 12May2021, the patient underwent lab tests and procedures which included negative sars-cov-2 test (nasal swab). The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Patient received steroids as treatment for the reported events. Outcome of all events was not recovered.  Information on the lot/batch was available, Additional information has been requested.
Started have shortness of breath like asthma on day 3 after vaccine#2.  Day 2-3 after vaccine had fever and chills and could not work. Going to urgent care today for difficulty breathing and tightness in upper chest. Never had trouble getting my breath until now
Metallic and Dry taste in mouth High fever 101.7 that wouldn?t go below 100 with both Tylenol or Ibuprofen  Large red circle at injection site that was hot to touch Headache  Dizzy when standing  Very tired
I had a very bad head cold. Tested positive for COVID-19 April 5,2022.
Highest temp measured 106.0, one convuls following immun; sz for 25-30 minutes; duration of illness 1 day;
This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-JAN-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot # L013188, expiration date: 02-NOV-2016 (exact dose was not reported). There were no concomitant medications provided. Administered doses of vaccines experienced the temperature excursion of 31.3 degrees Fahrenheit for 22 hours, 30 minutes. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Patient experienced injection site soreness and swelling as well as dizziness and nausea after receiving the first dose of the COVID-19 vaccine.
minor fever, soreness, feelings of having a fast-beating, fluttering, or pounding heart
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product BAMLANIVIMAB for an unknown indication.    No medical history was provided by the reporter.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started BAMLANIVIMAB (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has been administered with a monoclonal antibody. No relevant concomitant medications reported.
pt recvd vax;noticed mouth burning & sore throat;approx 4pm,lips & tongue swollen;co-workers noticed voice change & slurred speech;advised to take DPH;saw PMD approx 4:30,given meds;p/ 4hrs pt states swelling cont & moved to hands; now nl;
8 days after injection. Had redness/tenderness and warmth in the area of injection site. Pt saw her MD and was given antibiotics.
a fever of 100 degrees; chills; headache; tired; my body felt sore; My arm was sore the evening of the day I received the shot/I woke up the next day with my arm more sore; This is a spontaneous report from a contactable consumer or other non HCP (Patient) and a Pharmacist. A 66-year-old female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 66-year-old) for covid-19 immunisation. Medical history included COVID-19 (Prior to vaccination the patient diagnosed with COVID-19) from an unknown date and unknown if ongoing, The patient had no known allergies. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) and estradiol (ESTRING) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that "My arm was sore the evening of the day I received the shot, I woke up the next day at 07:00 AM with my arm more sore. I had a fever of 100 degrees along with chills and a headache. I was tired and my body felt sore" . Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events reported as recovered on an unknown date of May2021.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt is 48 yo male, s/p full Pfizer COVID vaccination: dose 1 on 1/12 and dose 2 on 2/2. Patient reports new onset cough, SOB, headache, sore throat, congestion/runny nose on 8/6. Reports close contact with confirmed case of COVID. PCR test results positive on 8/6. On 8/11, presented to receive casirivimab/imdevimab infusion, however transferred to ED due to hypotension (systolic low 80s). Receiving saline infusion and discharged same day. Casirivimab/imdevimab received on 8/13.
Red spot(2X4) that looks like a rash; It is warm; Sometimes it itches; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Red spot(2X4) that looks like a rash), VACCINATION SITE WARMTH (It is warm) and VACCINATION SITE PRURITUS (Sometimes it itches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     no medical history provided by reporter.  Concomitant products included NYSTATIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 11-Mar-2021, the patient experienced RASH MACULAR (Red spot(2X4) that looks like a rash), VACCINATION SITE WARMTH (It is warm) and VACCINATION SITE PRURITUS (Sometimes it itches). At the time of the report, RASH MACULAR (Red spot(2X4) that looks like a rash), VACCINATION SITE WARMTH (It is warm) and VACCINATION SITE PRURITUS (Sometimes it itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included use of ice pack as advised by her physician.
Fever, red streaks running down arm around vaccine site, body aches, arm swelling and extreme joint stiffness.
Developed thickened tongue and choking feeling about 1 hour after receiving vaccine. Developed "itchy" feeling - Took BENADRYL. Swollen lips by morning took CLARITIN.
About 4-5 hours after receiving the 2nd injection I began to feel tired and weak.  I took my blood pressure which is normally a little high at say 135/80.  At this particular time it was the lowest I have ever had and was 115/54.  I remained feeling tired and weak until about noon the following day.  Now I feel fine and my blood pressure has been back to between 120-140/70-80.  Am feeling good at this time.
Itchy bumps face, arms, neck and trunk x 48 hrs makes itch. Dx Varicella.
Patient received a booster dose but did NOT meet the qualifications as only being 17 years of age and not having any risk factors.
Skipped period (still having irregular cycles, which has never happened)  Heart burn Loss of sex drive  Depression
Patient is fully vaccinated and boosted.  COVID + 2/28/2022.  74-year-old male history of pacemaker, bladder cancer, atrial fibrillation on Eliquis at home, small lymphocytic lymphoma following with oncology,  CHF 4/20/21 cardiac cath showing EF of 30%, presents to ED complaining fatigue and shortness of breath for the past 3 weeks.  CXR:  Patchy pleural and/or parenchymal opacity at the left lung base could be acute and/or chronic.Suspected CHF exacerbation component, most recent EF of 30-35%O2 supplementation as needed,remdesivir, bronchodilators and steroids. Prophylaxis with heparin. Elevated troponin. Discharged home.
Pt states 06/17/2021 received 1st dose of Phizer vaccine, soreness of the right arm. (Continuing 2 weeks out)> Was informed 06/24/2021 by Pharmacy that the diluting solution was the wrong agent. Mistake was on their behalf. (Offering to re-issue the original dose due to error)
Patient was administered a vaccine which was ket in the freezer longer than the 2 week recommended time.
Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left arm was injection site. Malaise. Have appt today 1/14/2021 at 230 at doctor's office.
The pt experienced an elevated low grade temp on 5/10/01. The pt experienced a fine red rash that appeared on 5/10/01 on the forehead and broke out on neck, abdomen and arms. On 5/11/01 the child felt warm. No phone for follow-up.
sore at vaccination point; tightness and heaviness in chest about two hours following injection, lasted about two minutes.
Pfizer 11/3/21, 11/24/21. Positive on 9/7/22