chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (diagnosed with COVID-19) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced COVID-19 (diagnosed with COVID-19). At the time of the report, COVID-19 (diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe with the unknown dose number of mRNA-1273 vaccine. The exact details regarding the vaccine administration were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe with the unknown dose number of mRNA-1273 vaccine. The exact details regarding the vaccine administration were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Dizziness & NauseaVomiting Narrative: Feels better, but has not recovered
Swelling of tongue, lips and face.  Hives.  Benadryl administered on site.  Rapid Response team called.  Patient was transported to ED.  In ED received IV solumedrol, IV fluids and EPI X 1.  Full recovery.  Discharged from ED to home on 4 days of prednisone.
Low birth weight/Birth weight: 2466g; Fetal exposure during pregnancy; This is a serious spontaneous case initially received from other health-professional on 25-Jul-2019, concerning a male neonate patient.   The patient's mother was a 23-year-old, female who had one preterm live birth. The patient's mother had no history of offspring with major congenital malformation and no maternal/paternal history with major congenital malformation. The patient's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The concomitant medication of the mother included Prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy. The mother's last menstrual period (LMP) date was 16-Oct-2018 and type of pregnancy was singleton.   On 09-Jan-2019, at approximately 12 weeks of gestation, the patient was exposed to Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, route of administration: transplacental, batch number: 252675, dose, parent's route of administration, expiry date and anatomical location: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day, the patient's mother underwent panorama prenatal screening test and no major congenital malformation was noted.  On 05-Jul-2019, at gestational age of 37.4 weeks, the mother gave live birth to a male neonate by caesarean section. The characteristics of neonate included birth weight: 2466 grams (reported as low birth weight) and appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 8 and at five minutes was 9. The neonate had no major congenital malformations identified at birth.  The estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) of patient's mother was reported as 23-Jul-2019.  This case is linked to the case 201904228 (the corresponding maternal pregnancy report).; Reporter's Comments: A male neonate delivered at gestational age of 37.4 weeks was considered to have low birth weight baby, after receipt of Flucelvax QIV vaccine administered to mother at approximately 12 weeks of gestation. Considering the timeframe of event with respect to vaccine administration, risk factor (one preterm live birth) and no evidence suggestive of  biological mechanism that could cause the event, the event was assessed as not related to the suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Tachyarrhythmia for 2 days, I had to be admitted from the ER to Inpatient.
Fully vaccinated. Congestion noted 8/10/21, tested positive on 8/13/21
lethargy chills/sweats  pain at injection site for multiple days  nausea  headache
Tinnitus in left ear and sudden mild hearing loss. I've had it for 9 days straight and it hasn't gone away. I saw my ENT specialist and primary care doctor. The only explanation that could of caused this is the shot. I've never had issues with my ear until I got the vaccine.
Hard, swollen, red lump quarter size, and extremely sore. The next day hard, red, swollen lump still there, but redness spread at least double in size and the area is sore and very itchy.
Fatigue day of... and continuing so far Diarrhea for 3 days...continuing so far
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Additional Details: A few minutes after administration, pt was lightheaded and dizzy and reported possibly fainting for a very brief moment. Pt was pale and sweating and reported being short of breath briefly. Pt was hypotensive but blood pressure and heart rate normalized after 10 to 15 minutes after pt lied down and propped up feet in addition to drinking water and juice. Pt reported feeling "normal" after resting for about 30 minutes.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and/or zoster-related conditions by the pharmacist. On an unspecified date, subsequent to patient's inoculation, the patient was treated by healthcare provider for shingles. The outcome of shingles was not provided. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect) 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 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 VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported
small, intracutaneous lump, firm area of induration which is non erythematous & non tender lt leg;
Information has been received from a pharmacist concerning her 14 month old niece with no known allergies, a history of pneumonia and collapse of lung "two months ago" due to "diaphragm positioning" which was surgically corrected, reported as "pushed down" who was vaccinated with first and second doses of MMR, VARIVAX, PEDVAXHIB, and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified) on 12-SEP-2006 and 25-OCT-2006 respectively. Concomitant medication included montelukast sodium for the patient's history of pneumonia and collapsed lung. It was reported that the patient was "a little cranky" but has not developed any other side effects or symptoms. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a doctor of pharmacy refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on an unspecified date when the vaccine first became available. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient stated he had two mild cases of shingles since he received ZOSTAVAX. The patient sought unspecified medical attention and no treatment information was reported. At the time of the report the patient did not have shingles and the outcome of the event was reported as recovered on an unspecified date. The relatedness for has had two mild cases of shingles was not provided for ZOSTAVAX. Additional information has been requested.
Terrible itch all over his body; Terrible red rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Terrible itch all over his body) and RASH ERYTHEMATOUS (Terrible red rash all over his body) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced PRURITUS (Terrible itch all over his body) and RASH ERYTHEMATOUS (Terrible red rash all over his body). The patient was treated with CLOBETASOL for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Terrible itch all over his body) and RASH ERYTHEMATOUS (Terrible red rash all over his body) had not resolved.            No concomitant medications were reported. Patient has been using treatments but it was reported that nothing seemed to help his side effects to completely go away. He was reported to be under doctor's care.
Patient developed significant nausea immediately after receiving vaccine. Cold compress, fluids and food were not effective so ondansetron (4 mg PO) was administered.
Extreme thirst, headache, sinus pressure, achy joints and lower back and chills. Have not taken anything, just staying hydrated.
Approximately 8 days after vaccination, a redness appeared around the vaccination site about 3 inches in diameter.  The area is warm  and tender.  The next day there was little change.
Not feeling well; Dizzy; Body pain all over his body; Cannot stand up; back pain; pain in arms; Issues with articulation; This is a spontaneous report from a two contactable consumers (patient reporting for himself and patient's son). A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE for an COVID-19 immunization, at 73-years-old. The patient medical history and concomitant medications were not reported.  The patient experienced not feeling well, dizzy, pain all over his body, cannot stand up, back pain, pain in arms, issues with articulation on an unspecified date in 2021. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Pt recv vax on 3/26/99; on same day pt exp hives w/ itching on entire body
got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID ", start date: Sep2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "got COVID". Reporter inquired if the updated COVID vaccine be effective against the new BA 2.86 COVID Variant. Patient was fully vaccinated, with latest being multi-variant Pfizer vaccine. Yet in July, got COVID. Patient had much worse symptoms than when had COVID last fall (Sep2022). If it was the new variant, it was brutal especially CNS symptoms of brain fog, tinnitus, visual spatial disorientation, and extreme fatigue.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient's left arm at injection site was red. It was about 3-4 inches in diameter.
Itchiness and hives within 15 min of vaccine. Took (2) 25 mg Benadryl and symptoms were improving after 30 min.  Patient left feeling better.
1st shot delayed rash ten days after near injection site, very itchy, lasted five days; 2nd shot rash within 24 hours, involved half arm from shoulder to elbow, very itchy and red, lasted six days.
Swollen, red, tender rt gluteal site swollen & painful rt groin, left less tender. Yesterday more systemic reaction with chills & painful "lymph nodes" in chest wall, axilla & groin.
Mom reports child is experiencing temp above 102 degrees, vomiting, muscle aches, fatigue, dizziness, sore arm twenty four hours after vaccination--discussed with medical provider--he advised mom to complete a VAERS report.
Localized , reddened, warm to touch area 2.5c, right upper arm.
PATIENT STATED SHE FELT LIKE SHE WAS GOING TO PASSOUT, DIZZY. PT. STATED HISTORY OF FAINTING/SYCOPY. MEDICAL HISTORY INCLUDES ASTHMA, REACTIONS TO VACCINATIONS, AND VOMITS AFTER FLU SHOT. PT.  BP 120/70 HR 79 O2SAT 97 CLAMMY SKIN, BREATH SOUNDS CLEAR BILATERALLYVAT 1555.  OBSERVED TREATMENT: BP 130/76 HR 67 02SAT 95 AT 1613  ELEVATED TO SITTING POSITION AT 1616 WITH NO NEGATIVE EFFECTS.
Patient developed redness around injection site from the top of the shoulder extending down to the elbow. Area was sore and tender to the touch. Patient complained of pain on 2/7/07.  Area was still sore on 2/8/07 and was noted to have the above mentioned erythema
Patient with past medical history of diabetes, ESRD, obesity.   Per chart review, she tested positive for COVID-19 on 11/1. Patient was brought to the ED on 11/8 after exhibiting an altered mental status at her nursing home. En route to the ED, her temperature was 102 F, O2 sats 75-80%. Patient had another COVID PCR test done in the ED which was positive. She was admitted 11/8, eventually diagnosed with secondary bacterial infection and COVID pneumonitis. She did need to be intubated for acute respiratory failure. During admission she was found to have suffered bilateral embolic strokes. This was thought to be secondary to hypercoagulable state from COVID as well as pre-existing atrial fibrillation. Ultimately, patient was discussed with the family and the decision was made to proceed with compassionate extubation. This occurred on 12/7 and the patient passed away shortly after.
BAD ARTHRITIS FLARE UPS; POSSIBLE GOUT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bad arthritis flare ups, and possible gout. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad arthritis flare ups, and the outcome of possible gout was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Overall body aches and pains.  Slight fever, exhaustion.  Called MD: take 3 advil at HS; Called ER: bring pt to ER if symptoms became worse.
Swollen joints are most likely agout flare-up from the vaccine'singredients.; swollen joints; hot flashes due to fever; body aches and soreness; various degrees of fever; headache; chills; achy joints, mostly concentrated on the left side of the body - fingers, elbow, knee, ankle and foot.; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) via an unspecified route of administration in the left arm on 06Apr2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol high, gout, body mass index high (high bmi). The patient previously received niacin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. The patient received other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 16:00 after the second dose of COVID-19 vaccine, the patient experienced various degrees of fever, body aches and soreness, headache, chills and hot flashes due to fever, swollen and achy joints, mostly concentrated on the left side of the body - fingers, elbow, knee, ankle and foot. Swollen joints were most likely a gout flare-up from the vaccine's ingredients. It was unknown whether therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events various degrees of fever, body aches and soreness, headache, chills and hot flashes due to fever, swollen and achy joints, swollen joints and gout flare-up were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
I95.89 CHRONIC HYPOTENSION 4/6/2023 COMPLETE PLACENTA PREVIA WO HEMORRHAGE, THIRD TRIMESTER
A report was received from a health care professional on 10/10/02, concerning approximately 15 employees, 80 % of who developed injection site reactions after receiving Fluvirin on 10/08/02, approximately. The vaccinees developed erythema ranging from 2 to 6 inches which was hot and swollen at the site of the injection. Vaccinees were administered 0.5ml Fluvirin into the deltoid region of the arm using a tuberculin syringe. It was stated by the reporter that the vaccinees had received a different brand flu vaccine in the past. It was also reported that the reaction had not resolved in all of the vaccinees. There was insufficient information to determine the reporter's causality assessment.
arm just hurt; She was tired; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 01882227.  A female patient received BNT162B2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. 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 "arm just hurt"; FATIGUE (non-serious), outcome "unknown", described as "She was tired". Additional information: The patient received her first dose of the Pfizer Covid-19 vaccine on 02Mar2021 and her arm "just hurt a little and she was tired, she took a nap at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.
began feeling body aches, flushed immediately after vaccine,  about 2 hours later began feeling lethargic and slow progression of difficulty swallowing. At about 2:00 pm left work and called supervisor was asked to return and be assessed. On return BP was 90/80, pulse 100, 02 sat 99% on RA. Laid down in recumbent position and was going to give benadryl, and OTC H2 blocker but symptoms began to worsen, about 15 min later BP was 80/90, pulse 90, 02 sat 96% on RA and was transported to Hospital Emergency room by private vehicle.