chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my first Pfizer vaccine on 12/22/2020 (Lot: EJ1685) unknowing that I was less than 2 weeks pregnant. I received my second Pfizer vaccine on 3/2/2021 when I was 13 weeks gestation. I developed bright red vaginal bleeding on 3/5/2021 and was later diagnosed with chronic placenta abruption due to an infarction in the placenta.  Due to the chronic bleeding from the placenta abruption, I went into preterm labor at 21 weeks 5 days gestation. I unfortunately hemorrhaged and delivered my stillborn son on 5/1/2021 at 22 weeks 1 day gestation. I have recovered from the hemorrhage without known long term side effects.
Dry skin; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry skin) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DRY SKIN (Dry skin). At the time of the report, DRY SKIN (Dry skin) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  No concomitant medications were reported.  The patient reported that, the hands dried out due to sanitizer and was given cream for treatment  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
Pt recvd series of 3 Engerix-B vax & failed to seroconvert to HBSAB positive; six month dose was given FEB91; 15MAY91 lab tested neg;
Narrative: Unclear reaction. Patient reported chest tightness and dizziness and was taken to emergency department for evaluation. Those records are unavailable. Patient did receive second dose without issue so unlikely to have been an allergic reaction. Possibly panic/anxiety attack.
5mins post vaccination pt had a syncopal event w/ associated flushing/sweating.  LOC x15sec Vitals: 15:45 98/56, 85, 97% O2 Sat -- > 15:55 (standing) 100/64, 88, 100% Pt stable and released from the vaccination site @16:10.
Mother and father report child refused nighttime feedings 9/15, 9/16/15, then was seen for complete refusal of feedings. Baby noted to lose tone according to parents. Presently abnormal feeding and low-tone upper extremities and head. Child seen for feeding therapy. Ongoing P.T/OT and feeding therapy.
Redness, gradually getting bigger over the weekend and now involving half of arm. Dr thinks it is an infection but isn't sure so is treating with antibiotic and steroid.
This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 02-DEC-2013, the two unspecified patients were vaccinated with PROQUAD, 0.5ml subcutaneously, lot # J006569, expiration date 30-NOV-2014. The patients received doses of PROQUAD but were supposed to receive M-M-R II. The doses of PROQUAD that were administered were exposed to temperature outside of the proper storage range. No adverse effects were reported. This is one of several reports received from the same source. Follow up information ha been received from nurse via phone call on 03-DEC-2014 refers to a 5 year old male patient. On 03-DEC-2013 the patient was vaccinated with PROQUAD lot # J006569, .5 ml, subcutaneous instead of M-M-R II. On 03-DEC-2013 the patient was administered vaccine which was exposed to temperature outside of the proper storage range. No adverse effects were reported since administration of vaccine. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
I had nausea, vomiting, and diarrhea. The nausea and diarrhea continued. I also had nasal congestion. My right arm was swollen red. I had a popular rash down my arm and rib cage that was itching. I had a headache, very fatigued, and short of breath. I have just been taking Tylenol, and I have been in bed pretty much all the time. I had a fever. I also had a rash on my face, neck, and chest.
Patient suffered ANCA positive "Pauci immune crescenteric necrotizing glomerulonephritis " and despite prednisone and cyclophosphamide treatment his  kidneys failed and he requires dialysis 3x/week.  He has severe pedal edema.  He had pericarditis, new onset a fib requiring a blood thinner and new blood pressure medication.   He saw nephrology expert  and cardiology team at hospital .  He has progressive severe leg weakness now, MRI brain showed a stroke and his hearing was temporarily diminished due to suspected transient inflammation of a cranial nerve. CRP 158 H, ESR 63 H.  ANA is positive, SSB+.  Now the cyclophosphomide is causing a s/e of hemmoragic cystitis.
persistent headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (persistent headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (persistent headache). At the time of the report, HEADACHE (persistent headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Pt returned the following day with a prescription for steroids to help the should inflammation where immunizations where given. She stated that the shots were given too high up on the arm and that the doctor was afraid of an infection in the bursa sac.
Vaccine leaked out after administration. Unable to estimate proportion of dose received.  Informed patient. Patient agreed to receiving repeat dose in opposite arm. Repeat dose COVID-19 Moderna Lot 038B21A 0.5 mL given intramuscularly on R arm at 4:36 PM.
Employee states she woke up this morning and injection site was swollen (about size of an egg) and super tender.  Also states itching.  Also noted that she started having ear pressure and slight congestion and had covid test on 1/6/21 that was positive.
Arm where area injection was warm; Arm where area injection was hard; Arm where area injection was swell; Arm where area injection was red; feeling pain where injection was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm where area injection was warm), VACCINATION SITE INDURATION (Arm where area injection was hard), VACCINATION SITE PAIN (feeling pain where injection was), VACCINATION SITE SWELLING (Arm where area injection was swell) and VACCINATION SITE ERYTHEMA (Arm where area injection was red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (feeling pain where injection was). On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm where area injection was warm), VACCINATION SITE INDURATION (Arm where area injection was hard), VACCINATION SITE SWELLING (Arm where area injection was swell) and VACCINATION SITE ERYTHEMA (Arm where area injection was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm where area injection was warm), VACCINATION SITE INDURATION (Arm where area injection was hard), VACCINATION SITE PAIN (feeling pain where injection was), VACCINATION SITE SWELLING (Arm where area injection was swell) and VACCINATION SITE ERYTHEMA (Arm where area injection was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. She is a cancer patient on chemo.
Irritability developed about 2 hrs post vaccine given. Infant subsequently developed fever of 102 degrees rectal. This all resolved within 24 hrs. Blood and CSF cultures were negative. The medical record states after the hep B vaccine was given, htey documented respiratory distress, hyperthermia and later hypothermia, jaundice, tachypnea, dehydration, hypernatremia and suspected sepsis. All problems were treated and resolved by discharge.
PT REPORTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF WEAKNESS AND FALL 2/15/21.  PATIENT STATES THAT HE HAS BEEN FEELING WEAK AND TODAY IT SEEMS WORSE.  HE REPORTS ATTEMPTING TO AMBULATE WHEN HIS LEGS GAVE OUT.  HE STATES THAT HE DID NOT TRULY FALL BUT WAS ABLE TO LOWER HIMSELF TO THE GROUND.  HE WAS UNABLE TO GET UP AND THEREFORE CALLED EMS.  EMS WERE ABLE TO HELP PATIENT UP AND AMBULATING.  EMS NOTED URINARY BAG HAD GROSS HEMATURIA.  PT REPORTS BLOODY URINARY OUTPUT THE PREVIOUS NIGHT.  PATIENT COMPLAINS OF PENILE PAIN.  NO RECENT ILLNESS INCLUDING FEVERS, URI SYMPTOMS, VOMITING OR DIARRHEA.    ASSESSMENT UPON ADMIT:  *CONTINUATION SEE BELOW PT REPORTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF WEAKNESS AND FALL 2/15/21.  PATIENT STATES THAT HE HAS BEEN FEELING WEAK AND TODAY IT SEEMS WORSE.  HE REPORTS ATTEMPTING TO AMBULATE WHEN HIS LEGS GAVE OUT.  HE STATES THAT HE DID NOT TRULY FALL BUT WAS ABLE TO LOWER HIMSELF TO THE GROUND.  HE WAS UNABLE TO GET UP AND THEREFORE CALLED EMS.  EMS WERE ABLE TO HELP PATIENT UP AND AMBULATING.  EMS NOTED URINARY BAG HAD GROSS HEMATURIA.  PT REPORTS BLOODY URINARY OUTPUT THE PREVIOUS NIGHT.  PATIENT COMPLAINS OF PENILE PAIN.  NO RECENT ILLNESS INCLUDING FEVERS, URI SYMPTOMS, VOMITING OR DIARRHEA.   ASSESSMENT UPON ADMIT: THROMBOCYTOPENIA (PRESUMED ITP, CAUSE? VACCINE?),  DEXAMETHASONE 20MG PO DAILY. AMINOCAPROIC ACID 5GM IVPB X1 DOSE, 1 UNIT FFP, 2 UNITS PLTS PHERESED
Per Client received second dose of Pfizer vaccine on 2/4/2021 in left arm at the Hospital. Client stated two weeks after receiving the second dose of vaccine to have pain at site in left arm , numbness, tingling into fingers, heaviness while using arm and pain radiating into right arm. Per Client, reported following up with PCP and on today seen by PCP for X-ray of chest, shoulder, lab work up and EKG. Client was taking Tylenol prior to seeing another MD for a cortisone injection in right wrist, d/t pain concerns. Client admits to having underlying medication conditions. Client will plan to continuing to follow up with PCP.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 38 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 at 13:30 as dose 1, single (Lot number: ER8737), on 22Apr2021 at 10:15 as dose 2, single (Lot number: ER8736) and on 03Dec2021 as dose 3 (booster), single (Lot number: FJ1620) for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
pain immediately at the injection site (left upper arm).  Knot formed at injection site within a few minutes.  Developed swelling at injection site which then spread down the left arm to just above the left wrist.  Several hours later felt nauseous and had adverse taste sensation of rotten eggs.  Nausea resolved the next day.  Swelling and pain resolved after 2 days.
Pt indicated that throat was swollen and she had difficulty breathing for the duration of the night. Also complained of nausea & diarrhea, dizziness. Pt did not seek any treatment.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "excessive itching on the injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, faint, around 11pm that night felt very weak Next day soreness in my right arm nothing crazy About 5 days later was very ill, couldn?t get out of bed, and developed strep throat
A report was received from a distributor on 10/12/2001, concerning 2 elderly patients who experienced an overdose, after inadvertently receiving 2 doses of the Fluvirin vaccine 2 days apart, on an unknown date. On an unknown date, 2 elderly patients experienced an overdose after inadvertently receiving 2 doses of the Fluvirin vaccine 2 days apart. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the causality assessment of the reporter.
1/25/2023 Hep B (HELPISAV-B) was administered to 17 years old;  Writer consulted pharmacist for advice and 2/6/2023 Patient's mother replied patient did not report no showed any side effect
@ ~4:50 PM after receiving all the vaccinations client was standing at front desk, became very pale, rested head on the counter, weak "feeling like in a dream". Had client sit down in chair, 4:50 Nurse at side Pulse checked 68, gaze fixed, eyes glassy, began having spastic like movement in the upper and lower extremities lasting <30 seconds, eyes open, skin very pale. Placed client into head down position places cool cloth to back of neck. Both nurses at side, client sat up still very pale with glassy eyes no more spastic movement. Placed O2 on at 4L via nasal cannula. Continued O2, client verbally responding however very glassy eyed, flat affect, slow deliberate speech and very pale. VS P 66, SaO2 on 4L 99%, BP 132/72. Decreased O2 to 2L and continued to monitor. Nurse reviewed VIS statements, we discussed adverse reaction form and that we would be placing one, instructed on side effect to monitor for and to take to Emergency department should symptoms persist, reoccur or worsen. @1715 client was much improved able to ambulate on own. Continued to have glassy eyes and flat affect, escorted to car where parent took them home. 4/16/2019 Called parent and she states client has returned to normal and hasn't had anymore symptoms as displayed yesterday.
"Immediate burn sensation at site, rash and red below and to side of injection site started that day, some itchiness to rash, lymph nodes sore.  Symptoms some better after 3 days without treatment."
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot #L014429 and expiration date 15-MAR-2018 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
loss weight; diarrhea; loss of appetite; joint pain; slight fever; chills; feeling sluggy; coughing; could barely walk; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (feeling sluggy), COUGH (coughing), GAIT DISTURBANCE (could barely walk), WEIGHT DECREASED (loss weight) and DIARRHOEA (diarrhea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SLUGGISHNESS (feeling sluggy), COUGH (coughing), GAIT DISTURBANCE (could barely walk), DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), ARTHRALGIA (joint pain), PYREXIA (slight fever) and CHILLS (chills). On an unknown date, the patient experienced WEIGHT DECREASED (loss weight). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (feeling sluggy), COUGH (coughing), GAIT DISTURBANCE (could barely walk), WEIGHT DECREASED (loss weight), DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), ARTHRALGIA (joint pain), PYREXIA (slight fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Information has been received from a health professional concerning an approximately 12 year old female who in 1996 was vaccinated with varicella virus vaccine live (Oka/Merck). In 2004, the patient developed herpes zoster. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information has been requested.
Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). On an unspecified date the patient developed spinal meningitis after vaccination. The medical assistant reported that the patient was not in her practice so no details other than she was hospitalized were known. The reporter stated that she heard of this "second hand" through a person that knew the person that developed the meningitis. She believed this was reported previously. Additional information has been requested.
shots make me sick; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced shots make me sick (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious shots make me sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  It was reported "the shots make me sick, so I won't get them".  There will be no information available on the batch number for this case.
Pt developed temp 103 and had a "seizure".  Mom did not administer fever reducer for the elevated temp.  She called ambulance and was taken to local emergency department.
Patient stated he began "shivering" around 5AM (roughly 12 hours after immunization). He said this lasted roughly 1 hour. He also complained of general malaise/fatigue.
Stuffy ears, tinnitus, hearing loss,  severe vertigo attack on 7/24/21 with vomiting, nystagmus and involuntary  convulsions in both legs, primarily on the left.
No adverse event; VARIVAX administered on 12/15/2016 after MMR Il was administered on 12/5/2016; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 05-DEC-2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 15-DEC-2016, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) with lot # M012992 and expiration date 14-MAR-2018 (strength, dose, route of administration and anatomical location were unknown) along with hepatitis a virus vaccine inactivated (HAVRIX) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis and sterile diluent (inappropriate schedule of product administration). No additional adverse effects reported. There was no product quality complaint associated with the case.
No Adverse Event; HCP calling to report an expired MMRII was administered after it expired. Vaccine expired on 8/4/2023. HCP reports the vaccine has not experienced any temperature excursions.  No additional AE/PQC.; This spontaneous report as received from a medical assistant refers to a 1-year-old male patient.  The patient's medical history and concurrent conditions were not provided. The patient's concomitant therapies included STRILE DILUENT.   On 12-SEP-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) lot #U024229, expiration date: 04-AUG-2023, 0 .5 milliliter (route of administration and anatomical location were not provided) for prophylaxis (expired product administered). It was reported that the vaccine had not experienced any temperature excursions. No additional adverse event reported (no adverse event).
For two days following the vaccine (March 6 & 7) I experienced severe body aches, fever, chills, fatigue. Horrible shortness of breath began on the third day, March 8, and continued to worsen. For the next week my breathing became more and more labored with difficulty in functioning and needing to be in a reclining position in order to breathe. By the 10th day, o n March 15th I was hospitalized and subsequently had tests run on heart and lungs. My blood oxygen would drop to the low 80's if I took just a few steps. Today, on March 19th I am home and slowly improving but still needing to be mostly resting.