chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On 30-MAY-2017, the patient was vaccinated with an expired dose of injectable VAQTA (Lot number reported as N005885 with expiration date 26-MAY-2017) for prophylaxis (dose, frequency, route of administration and anatomical location were not reported). There were no adverse effects reported. Lot number N005885 is an invalid lot number for Hepatitis A Vaccine, Inactivated. Additional information has been requested.
Felt like 'something running through' her body. no N/V, + abd  discomform. no diarrhea. + headache 6/10 +palpitations no SOB but aware of  breathing. no rash or pruritus, + rhinorrhea.
Initial report received on Nov 11 2005 from a health care professional.  A 40 year old female patient (date for birth not reported) with an unknown medical history received an influenza vaccine on either 11/02/2005 or 11/03/2005. The manufacturer, route, site and lot number of the vaccine was not reported. Per the reporter the patient was diagnosed with encephalomyelitis of undetermined etiology (date of diagnosis not reported). The patient's recovery status is reported as unknown at the time of this report.
Patient passed out. Gained consciousness w/in seconds. Low BP / low sugar. She regained more energy w/ juice. Called EMT (911) - they arrived within 10 min of incident.
pt recvd vax 30JUN93 & devel a red generalized rash, fever & arthralgia; It was felt that the exp was coincidental & not due to the vax; No further details were provided;
This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), LETHARGY (feels a little lethargic), RASH (breakout from top of arm to elbow) and VACCINATION SITE WARMTH (extremely hot, ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 002A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised, Sjogren's disease and Thyroid disorder NOS.On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), LETHARGY (feels a little lethargic), RASH (breakout from top of arm to elbow), VACCINATION SITE WARMTH (extremely hot, ), PAIN IN EXTREMITY (severe arm ache and  painful), VACCINATION SITE ERYTHEMA (extremely red, ), MYALGIA (overall severe body aches), PYREXIA (high fever), CHILLS (chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In November 2021, MYALGIA (overall severe body aches), PYREXIA (high fever) and CHILLS (chills) had resolved. At the time of the report, EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), RASH (breakout from top of arm to elbow), VACCINATION SITE WARMTH (extremely hot, ), PAIN IN EXTREMITY (severe arm ache and  painful), VACCINATION SITE ERYTHEMA (extremely red, ) and NAUSEA (nausea) outcome was unknown and LETHARGY (feels a little lethargic) was resolving.No concomitant drug details were reported.This case was linked to MOD-2021-395848, MOD-2021-395849 (Patient Link).
Approximately 4-5 days after receiving vaccination, patient experienced red, blotchy, irritated skin patches on the extremities only. Patient saw dermatologist for it who performs several tests and drew lab work and was unable to find any specific cause. The only new thing introduced to the patient's system was the Spikevax vaccine.
PT DESCRIBES AFTER INJECTION SHE GOT A RED SPOTTY RASH- FROM IJECTION SITE TO ELBOW. ACHEY FOR A COUPLE DAYS.
Received Pfizer-BioNTech booster vaccine FE3590 on Tuesday, November 23, 2021 approximately 6:05pm at COVID-19 vaccination facility placed Health Department. Shot was administered in left arm.Left arm remained very sore and too painful for full range of motion. -Went to clinic on Wednesday, December 8, 2021 at 8:00am. left shoulder was bright red following shower along with continued pain and concern lacking full range of motion. Given X-Ray of shoulder. Told I had SHIVA; prescribed Meloxicam 15MG 30-day supply, once per day; given home physical therapy exercises for shoulder and follow-up appointment Thursday, December 23, 2021. -Went to  office on Thursday, December 23, 2021 to conduct range of motion exercises on shoulder; MRI prescribed to determine if rotator cuff tear exists on left shoulder; appointments scheduled for physical therapy and MRI review Monday, January 17, 2022. -MRI conducted Friday, January 14, 2022 on left shoulder -Monday, January 17, 2022:  MRI confirmed no shoulder tear.  Prescribed physical therapy Monday, January 17, 2022, Tuesday, January 25, 2022, Monday, January 31, 2022 and home physical therapy exercises to repair/rebuild left shoulder range of motion following vaccination.
Headache, Myalgia, Fever, Pain at injection site, fatigue, Temp: 100.1,  Narrative:
Pt did not know she was pregnant until a day after the vaccination.  She as 6 weeks pregnant.  On the morning of March 28th, 3 days after the vaccine, pt miscarried.
10/9/13 AM - myalgia. 10/10/13 myalgia, malaise, fatigue. 10/10/13 PM - fever & jaundice. 10/15/13 - to MD; labs drawn.
awakened 25OCT96 w/severe pain lt arm could move hand, could not lift arm;no redness , sl swelling, & warmth;pain cont thru AM 28OCT96, no fever;25OCT96 gen muscle pain in hips, legs & jaw, frequent urination;noc sweats;
I have had a swollen painful lymph node above my left collarbone..causing tingling and sometimes numbess aroind that area..notified where I was given the vaccine amd PCP..I was told to continue monitoring..the pain is still present for all that time
9/8/21 PSC s/p liver transplant on Cellcept and Prograf, who was sent in today per hepatology due to nausea and vomiting.
Three weeks after having gotten the Pfizer Covid-19 booster I started experience severe back pain - which wound-up being three lesions pressing against my spinal cord; biopsy showed DLBCL (Diffuse Large B-Cell Lymphoma).
When the syringe for the second dose of Moderna was inserted into the patient's arm, the patient jerked away and approximately half of the solution was lost when the hub of the needle separated from the barrel of the syringe. The patient was offered the opportunity to receive a second, half qty dose but he declined.
after 9 days from shot # 2 - headache, fatigue and muscle stiffness and aches
Initial report received from non-healthcare professional on 04 March 2014. A female patient (Date of birth and age at time of adverse event not provided), whose medical history and concomitant medications were not reported, had received intramuscular doses of ADACEL (batch number and dose number were not reported), received in deltoid on February 2014. It was reported that on February 2014 after receiving ADACEL vaccine, the patient presented redness and swelling at the injection site. The patient took BENADRYL, as corrective treatment. Laboratory investigations were not reported. On unspecified date, the event had Recovered (Date not provided). Documents held by sender: none.
Patient came to office on shot room only schedule and M.A administered first COVID-19 vaccine #1 on 12/20/2021  Tolerated well. Returned to office on 01/03/2021 and M.A. administered a second dose on 01/03/2022 (14 days after first dose and thus too soon). Followed up with parent and patient.   Patient reported mild headache and fatigue the following day after 2nd injection but denies any lip swelling, tongue swelling, dyspnea, abdominal pain, vomiting, or other anaphylactic symptoms.  Patient stated only some soreness to injection site after date of first injection. She reports otherwise she is feeling fine.
Moderna covid vaccine given on 4/25/23 was a 0.2ml dose with the wrong vial (pink top Bivalent) but should have been 0.25ml with blue top. This change was implemented on 4/20/23 and we were unaware of the vial and dose change. Patient needs one more dose as he is currently now considered undervaccinated.
Report A0355895A describes an injection site reaction in a 13 month old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. There was no illness at the time of immunization. On 1/27/2001, the vaccinee received an injection of Infanrix into the right thigh; it was not known if he had received previous injections of Infanrix. On that date, he also received injections of MMR, ActHIib, Varivax and Prevnar. On 11/28/2001, one day post-immunization, he experienced an injection site, characterized by a 10cm area of redness and swelling, at the site of Infanrix administration. "Severe" induration was present in the center of this area. The reporter stated that "it looks like cellulitis." The events resolved by 12/01/2001. The physician indicated that the injection site induration was severe in intensity, disabling/incapacitating, and related to Infanrix administration.
vial punctured more than 20 times administrated to 2 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial punctured more than 20 times administrated to 2 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial punctured more than 20 times administrated to 2 patients). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial punctured more than 20 times administrated to 2 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details provided.   This case was linked to MOD-2021-362899 (Patient Link).
19 y/o male presented to ER 4 days after receiving 2nd dose of vaccine for chest pain. Pt had elevated troponin, d-dimer and mildly elevated ESR. CT, CXR, Echo normal. EKG revealed NSR with right axis deviation, incomplete RBBB and ST segment abnormalities. Pt was admitted where troponin was trended and still elevated. Pt was diagnosed with myocarditis and prescribed colchicine.
I had a strong off-cycle menstrual period 2 weeks after my first dose. /I had a full menstrual cycle 14 days; This is a spontaneous report received from a contactable consumer (Patient). A 47-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 at 09:00 (at the age of 47-year-old) as dose 1, single for COVID-19 immunization at Doctor's office/urgent care. The patient had various other medical history, none related to hormones or menstrual cycle and had no known allergies. Patient concomitant medications were not reported. Prior to vaccination, the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On an unspecified date in 2021, patient had a strong off-cycle menstrual period 2 weeks after her first dose. Even though she was 47 years old, she has a period every 26 days for years. This month, she had a full menstrual cycle 14 days after her last period which also happens to have been 14 days after first dose. No treatment was received to treat adverse event. Since the vaccination, the patient has not been tested for COVID-19. The event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
hives ( told to take 2 benadry tablets every 4 hours by pharmacist), warm sensation all over body, bad taste in mouth (instant),  chest (tightness)
Double vision developed two weeks after vaccination.  Consulted Dr. on 11/13/2009, who then referred me to another Dr. Examined on 1/14/2010 and diagnosed by Dr. with myasthenia gravis/ocular.  Rx: Prednisone, mestinon, and cellcept.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: pt complains of numbness/ tingling in arm of injection
As of today, 4/3/21, 72 hours post vaccine, still experiencing sore arm, headache that won't go away despite taking ibuprofen, hard to breathe - weight on chest.
After my first vaccine (EK5730--on 12/26/20), I had absolutely NO reactions. The second one was quite a different matter.   14 hours after the shot, I developed shaking chills. The next day I had myalgias and arthralgias pretty much all over. It was that "run over by a truck" feeling of the flu. Headache, fatigue followed. Appetite was down. No fever.   Slept for many hours.   Now in my third day after the vaccine and not feeling better.   Still, I remain grateful that I was immunized and am taking the optimistic spin that this kind of intense reaction shows my immune system is responding strongly and nicely to the vaccine.  It is miserable though, particularly since the first one was so benign.   I am a family doctor (MD) and am torn between discussing this in my weekly health column which may dissuade patients, some already on the fence, from getting vaccinated. I saw the FDA info confirming higher incidence of side effects with second shot, which was definitely the case with me.
2 hours after receiving vaccine, severe headache-lasting all day (24 hrs). Relieved with EXCEDRIN within 2 hrs then returned in hour or so. Completely gone in 24 hrs.
pt developed limp on 8/6 suspected transient synovitis lasted about 1 day  pt had second covid vaccine on 8/11/2022 and developed limp again 8/26, lasted several days
Subsequent to receiving one dose of varicella virus vaccine live the pt broke out in chickenpox.
Pt developed approximately 20 skin lesions on chest, abdomen and back.  The lesions were limited to the upper extremities. Pt was afebrile.
sweating; not feeling well/Feeling pretty poorly; Dizzy; Nauseous; This is a spontaneous report from a contactable consumer via medical information team. This is three of three reports. A male patient (physician) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: Unknown) via an unspecified route of administration on an unspecified date at 07:00 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: Unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On unspecified date, on the of vaccination the patient was scheduled to perform surgery at 08:00. About 08:00-09:00 on the day of vaccination the patient started feeling pretty poorly, not feeling well, sweating, dizzy and nauseous to the point that patient had to postpone the surgery he was supposed to perform. The consumer reported that was a pretty extreme reaction to the vaccine. The clinical outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
A nurse reported PROQUAD was improperly stored and administered; This spontaneous report was received from a nurse referring to patient of an unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.  On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) (dosage regimen and route of administration were not provided), lot # T034823, expiration date 11-APR-2022, administered as prophylaxis.   On that day, the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature of -5.3 degree Celsius (C) for 1 hours and 42 minutes, with no previous temperature excursion. The call because a digital data logger.
Originally patient received 0.1ml dose of Moderna vaccine. Patient called and returned to the vaccination site where  they were administered 0.5 ml of Moderna vaccine (as instructed) in patient's left arm. This was his second dose.
felt faint; Has been breaking out in sweats; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Has been breaking out in sweats) and DIZZINESS (felt faint) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced HYPERHIDROSIS (Has been breaking out in sweats). On 25-Jul-2021, the patient experienced DIZZINESS (felt faint). At the time of the report, HYPERHIDROSIS (Has been breaking out in sweats) and DIZZINESS (felt faint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received: contains no new information about husbands case.
Immediately started feeling hot, sweating, abnormal metal taste in mouth, increased heart rate to 100, skin turned red all over. Subsided after 15 minutes. After 15 minutes had rash all over body, throat tightening, hot feeling. Subsided after 60-90 minutes
Information has been received from a physician and medical assistant concerning a female patient with seizures who on 03-JUN-2010 was vaccinated with a dose of GARDASIL in her arm which was not fully injected. The patient most likely got a drop, if that, of GARDASIL when all the sudden the patient had a seizure and the medical assistant pulled out the shot immediately. The patient had a seizure a couple of months ago while at a dentist office. The patient called a neurologist and her primary care physician to be seen. The patient felt exhausted after her seizure. The patient was in the process of trying to become pregnant. The office kept the vial of GARDASIL to show that most of the dose was still in the vial. At the time of the report, the patient's status was unknown. Upon internal review, "seizure" was determined to be an other important medical event. Additional information has been requested.
He developed a change in mental status described as "feeling out of body."  Was acting strange for several hours after vaccine and found in neighbors yard randomly yelling with shirt off despite being winter.  Seen in ER and given IVF bols.  Mom thinks he was very anxious about the vaccine and may have had a psychosomatic reaction
2 days post vax-upper arm began to swell, hot, itchy, red & hurting-spread below elbow;3wk post vax area still swollen & discolored
This is a spontaneous report obtained from a contactable consumer (patient) via Pfizer sales representative. A 65-years old female patient received, on an unspecified date, pneumococcal 13-val conj vac (Dipht CRM197 Protein) at single dose, in the arm, for immunization. On the same day, the patient received also a flu vaccine. Relevant medical history was unknown. She mentioned the arm she received the pneumonia shot in swelled. She believed she received an antibiotic in the ER for swelling. Clinical outcome of the adverse event was unknown at time of this report. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Minor cough and minor shortness of breath. No change in symptoms after using previously prescribed albuterol rescue inhaler.
Sore arm; Fatigue; FLARE UP/ITCHY AND FLAKY SCALP; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and PSORIASIS (FLARE UP/ITCHY AND FLAKY SCALP) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and Psoriatic arthritis.    There was no reported medical history.  Concurrent medical conditions included Psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS.) and Psoriatic arthritis.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Oral) at an unspecified dose. On 13-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and PSORIASIS (FLARE UP/ITCHY AND FLAKY SCALP). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) outcome was unknown and PSORIASIS (FLARE UP/ITCHY AND FLAKY SCALP) had not resolved.            Concomitant medication information was not provided by the reporter.  The patient had a flare up, itchy and flaky scalp a week before next injection of SKYRIZI (RISANKIZUMAB).   It was unknown if the patient was enrolled in COVID-19 vaccine trail.  Reporter causality for the event condition aggravated was reported as probable and for other events it was not reported with respect to SKYRIZI (RISANKIZUMAB).  Treatment information was not provided by the reporter.
redness to site of inj area size of fist;t100-101 2 days;inc soreness x 2 days;
After about 20-30 minutes after receiving a shot in my left arm I began to feel a very minor allergic reaction. The left side of my face, neck, and mouth became slightly numb, similar to how it feels after the anesthesia in your mouth begins to subside after an appointment to the doctor's office. This lasted for about 60 minutes. No other symptoms were present outside of my left arm being somewhat sore.