chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DID NOT WAKE UP; SUSPECTED COVID-19 INFECTION; STOMACH ACHE; SIDE EFFECTS; This spontaneous report received from a parent concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drinks, and smoker, and other pre-existing medical conditions included: The patient had done drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced did not wake up, suspected covid-19 infection, stomach ache, and side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, stomach ache, did not wake up and side effects was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
tiredness nausea- baking soda in water, with some relief last night.   30cc of mineral water today, with short term relief
Patient reported sore arm/pain at injection site. Although this is a common symptom after receiving vaccine, we are reporting this because the vial used to vaccinate this patient was at room temperature for about 31 hours, which is still within Pfizer's recommended range of 36 hours at room temperature.
I had flu like symptoms from both shots which lasted no more than 24 hours. Nausea, diarrhea, vomiting, fever 100, body aches, headaches. Lot 1st dose 012M20A, IM LA. On 8/3/2021, I had an extremely runny nose, sneezing and watery eyes. I thought I was having allergies. I woke up with gastritis and had vomiting for 3 days. On 8/7/2021, I was not feeling any better, so I went to the ER. I was having vomiting and extreme stomach cramps. My BP 196/92 in the ER. They did a bunch of tests and COVID test and I was positive for COVID. I was there for a few hours to get treated for my stomach cramps. I was given IV meds and once I felt better I was discharged. I am self quarantining for 14 days. I currently have symptoms of migraines, horrible coughing, fever, body aches and hip pain, and extreme fatigue.
21 month old given 1 ml Hep A #2 instead of 0.5ml. Physician and parents informed. Child well in follow up the following days.
medical history of arthritis treated with cortisone; medical history of arthritis treated with cortisone; Rash on her face/rash on the cheek; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included ongoing arthritis in her knee (for 7-8 years) and blood pressure high but so far so good. Concomitant medication included cortisone for arthritis in her knee. The patient previously had cortisone shot for arthritis and experienced rash on her face. On 14Jan2021, patient got the first vaccine dose and had rash on her face/rash on the cheek. Her next one is due 04Feb2021. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
"Pt w/ hx of allergy to ASA (muscle spasms) and tomato (hives). PMH significant for Palpitations, depression.  s/p MVA 10/2019.  Current Medications: No active medications 15mins post vaccination, pt c/o rash/itching in her arm.  Vitals: BP 116/79, HR 74, RR 16, SpO2 100%.  Pt given benadryl 25mg PO @ 16:45 and symptoms resolved.  Reviewed ER precautions including SOB, throat swelling, or any other concerning symptoms.  Pt stable and released from the vaccination site.  Within hours of vaccination, pt developed and numbness/tingling in lower legs, back pain, and intermittent headaches.  Pt presented to the ED c/o these symptoms on 8/25.  Per ED MD, they did not appreciate swelling on exam but does not tenderness over bilateral calves. VSS, neurological exam WNL, intact reflexes.  Pt has 5/5 strength in BLE and BUE with normal gait.  ED MD concluded that this is likely myalgia secondary to an immune reaction from the Moderna Vaccine.  Pt discharged with APAP."
Moderate injection site pain - at least 2 days  Fatigue - at least one day Low-grade fever (100.3) - at least one day Headache - at least one day
He got his vaccine, exactly 2 months later he was lying in bed, opened his eyes and felt like he was in a cement mixer.  The whole room was moving from left to right.  He closed his eyes and the feeling went away, but as soon as he opened his eyes again the room was spinning again.  He had to stay in bed for a while, he was alone and had no family to take care of him.  He then had some healthcare workers come and he was not able to take care of himself and do his chores.  The spinning stopped after about a year, and took him a while to adapt to it.  He had to use a wheelchair to get around, he can walk some but cannot walk for long.  His knee issue he had as a child then started up again due to his loss of not using his leg.  He can get down 6 steps to get to his truck, but has to be very careful.
pt recv vax 12JUL95 & on 27APR96 pt exp full blown chicken pox;no further details were provided;
Beginning at 9:30 am on 10/30, body aches and fatigue and fever of 100. Body aches resolved around 12:00 am 12/31. Fever resolved by 12:00 pm 10/31. Headache started around 5pm 10/31 and continued through 11/1.
Acute onset of intense itching and erythma (area 2cm surrounding injection site) with pain onset 5 minutes after injection.
Pt recvd 3 doses of Engerix-B 26AUG91 it was determined that pt did not seroconvert;
Noticed around 13:30 hours: Swelling and moderate pain around injection site, slight headache; Noticed around 14:30 hours: numbness in forehead, nose & cheeks; drowsiness; Noticed around 16:00 hours: pounding headache requiring ingestion of Tylenol, fatigue; Noticed around 18:30 hours: aches & pain in joints, primarily ankles, knees, fingers, wrists, elbows, and shoulders; Noticed around 03:30 following morning: cramps in right calf muscle lasting for approximately two (2) minutes.  As of 04/16/2021 at around 10:54: slight headache, some fatigue, aches & pain in joints still exist but diminishing with worst pain area in knees, elbows, and wrists.
Achy, low fever, arm soreness, tired for at least 7 days.  Stabbing pain in left eye a few times a day.  Palpitations of the heart at times.  Usually only a few then it would stop.  I would get pain/pressure in my legs and head that would last a few minutes then stop.  Tomorrow will be 28 days and it isn't as bad but just had palpitations yesterday.   I also continue to get a tingly, flushing feeling in my arms and legs almost everyday.  It doesn't hurt just is weird and at times makes you shaky.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 39-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Nov-2020 and the estimated date of delivery was 17-Aug-2021. On 08-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Ultrasound uterus: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of positive pregnancy test was on 15 Dec 2021. Estimated date of conception was on 20 Nov 2021. No relevant concomitant medications were reported. No treatment information was reported.
Severe regional pain syndrome of distal ipsilateral area (left arm) from above elbow to hand. Occurred 15-16 hours following flu vaccine.
Approx 7pm on April 2, night of vaccine I began having chills and body aches. Approximately 4:30 am April 3, I woke with continuing chills body aches and was now experiencing nausea, along with painful  headache and neck ache, dizziness, difficulty standing for very long. Approximately 9am I began running fever. All of these symptoms  lasted  until Tuesday April 6, when my fever broke. (Also on April 5 when I woke my vaccine forearm was red and hot ( looked like a sunburn with a little swelling )Since then my symptoms have  improved including the redness in vaccine arm. As of today I?m still experiencing vaccine arm soreness, fatigue ,headache ( comes and goes) and dizziness when standing (comes and goes, I still have not been able to return to my full daily routine due to symptoms
Patient received Pfizer 6m-4yr COVID vaccine on 7/29/22. Mistake was made and Moderna 6m-5yrs COVID vaccine was given today, 9/14/22, instead of second Pfizer.  Patient showed no adverse effects.
A few  minutes after injection felt a burning sensation in face and ears.   Felt tired that evening with muscle aches and sore arm.  The next morning work up with intense body aches, headache, diarrhea and nausea.  Have had diarrhea, nausea and tired for now for  (4) four days.  Cannot eat without having diarrhea and a general unwell feeling.   I called my doctor who said that it?s unpleasant vaccine systemic side effects and to take Imodium AD and Tylenol. Go into the office if it does not resolve in a week.  This seriously has me reconsidering the second dose.
About 10 hours later Spouce had to help me out of bed very difficult to walk felt like the bottom of my was squeezed, legs felt tingly called hospital and they seem disinterested, next morning  about two or three hours after awakening my face felt very heavy and an overwhelming feeling of fatigue, I had no mucus in lungs or restriction in airway but found it difficult to find the energy to breathe. As the days went on it did become further apart than every two or three hours, but at five days later it is still happening.
Received their first dose of GARDASIL 9 a year ago, and a pharmacist is inquiring about recommendations for series completion; No additional AE or PQC reported; This spontaneous information has been received from a pharmacist via company representative, concerning a 15-years old patient of unknown age. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unknown date in 2019 (also reported as a year ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unknown date, the pharmacist was inquiring about recommendations for series completion (inappropriate schedule of product administration).   No adverse event was reported.
Started with aches and pains, low grade fever, coughing, nausea, vomiting , severe headaches, severe neck pain, brain fog, sweat/chills, Low grade fever lasted 21 days.
pt started w/shrill cry @ 1030PM 19MAY92 t101, very restless, cry cont until next day; pt seen by MD 1PM 20MAY92 t102.7; MD adm pt to hosp temp now up to 104; pt very restless; no local rxn @ site; pt d/c 22MAY92 in AM; also exp diarrhea;
Swollen arm - red - hives - pain. I still have discoloration since 9-4-13 the day I had the vaccine - still itches.
INFLAMMATION, WARMTH AND REDNESS NOTICED 3/25/2020 9:05PM. ENCOURAGED TO PUT ICE PACK ON 3/26/2020 WHEN TOLD TO MSA.
Baby began crying inconsolably and continued for about 5 hours.  Injection site was red, swollen, and warm to touch.  A few days later, I noticed a brown spotted permanent mark on baby's skin at the injection site, which still remains.
Information has been received from a physician via a field representative concerning a 19 year old female patient. There was no concurrent condition, medical history or concomitant therapy reported. On an unknown date, the patient received a dose of GARDASIL 9 injection (lot #, dosage and route not provided). After received the third injection of the series of the vaccine, the patient felt dizzy. She experienced syncope on 09-JUN-2016. The outcome of the events and the causality was not reported. Additional information has been requested
Two hours after vaccine started to feel a flush throughout body and heart rate increased a little. Had flu symptoms the next day only. Then the 2nd day after my heart rate was elevated for about a week then came back to normal.
Live H1N1 nasal vaccine administered to pregnant patient. 10/26/09 OB/GYN medical records received service dates 10/21/09 to 10/26/09. Assessment: Routine OB care. Patient presents for prenatal visits, estimated delivery date 11/22/09.
Vaccine given to a 17 year old male. Paperwork filled out by patient with incorrect date of birth by patient. When given the vaccine card the patient said wrong date of birth which changed his age from 18 to 17. Identification was verified by Credit Card.
This serious initial  spontaneous case, was received from other non-health professional via Merck on 25-Sep-2017, concerning a 23-year-old male patient. On an unspecified date, the patient was administered with influenza vaccine (dose, batch number, manufacturer, trade name, route of administration, anatomical location and expiry date: not reported). On an unspecified date, the patient became sick. The outcome of the event sick was not reported. It was reported that the patient had died due to auto accident on an unspecified date. It was unknown, whether autopsy was done.
Moderna Vaccine was out of the freezer for more than 30 days at the time of vaccination. Receipt was 09/20/2022, administration was 11/14/2022.
PATIENT CALLED PHARMACY AT APPROXIMATELY 6:00 PM TO REPORT DIZZINESS. PATIENT HAD BEEN ASKED TO REMAIN IN PHARMACY WAITING AREA FOR 10 MINUTES AFTER INJECTION, HE WAITED 5 MINUTES THEN CONTINUED SHOPPING. PATIENT STATES HE FELT FINE IN THE STORE BUT EXPERIENCED DIZZINESS UPON EXITING STORE. PATIENT REPORTS RETURNING HOME, RESTING AND FEELING FINE TILL THIS EVENING. HE PUT DINNER IN OVEN AND WHEN HE WENT OUTSIDE HE FELT DIZZINESS AGAIN. NO SHORTNESS OF BREATH, LOSS OF BALANCE, OR FEVER REPORTED WITH DIZZINESS. I ADVISED PATIENT TO REST AND DRINK PLENTY OF WATER. ADVISED TO GO TO URGENT CARE OR MD IF CONDITION PROGRESSES, SUCH AS SPIKE IN FEVER OR WORSENING DIZZINESS OR ACCOMPANIED WITH SHORTNESS OF BREATH.
developed temp and congested cough 12/2/22- tested positive for covid on abbott ID now molecular test
This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report from a physician concerns a 27 year old female: US 9402. The subject's medical history was unknown, and the subject's weight was 51.5 kilograms. Other medical history included the subject was not pregnant, a non smoker, drinks 3oz beer/week, has no known medical problems, and has experienced no drug reactions in the past. Concomitant medications were not reported. The subject received TYPHOID VACCINE ORAL TY21A (capsule, hard, oral, batch 130611b, expiry DEC-1994) administered on 28-DEC-1993 and on 30-DEC-1993 for foreign travel. On 28-DEC-1993, the subject took first dose of TYPHOID VACCINE ORAL TY21A and 10-12 hours later experienced weakness and myalgia. 20 to 24 hours later the subject developed a temperature of 102.8 degrees, a severe left temporal headache and chills. On 30-DEC-1993, symptoms had subsided and the subject was advised to take the second dose of TYPHOID VACCINE ORAL TY21A. 3 hours after taking the second dose the patient experienced the same symptoms (weakness, myalgia, temperature of 102.8 degrees, a severe left temporal headache and chills). She was evaluated approximately 16 hours after her second dose. Her temperature was 99.8 and neuro examination was negative. The subject's outcome was unknown for weakness, myalgia, a temperature of 102.8 degrees, temporal headache and chills, although the physician reported that the events were 'mostly gone' by 48 hours after the second dose of TYPHOID VACCINE ORAL TY21A. Action taken with TYPHOID VACCINE ORAL TY21A was unknown. This report was serious (permanent disability).
When woke up in AM of 10-29-13, right arm was very sore and painful, right arm was difficult to raise, appeared to have stroke-like symptoms - symptoms got worse and hospitalization was needed - was first time receiving Flu vaccine. Diagnosis - Transverse Myelitis.
a lot of pain; Abdominal pain/The pain that radiated down her right leg; a lot of cramp in her stomach, like the bladder area, more like period cramps; a lot of cramp in her stomach, like the bladder area, more like period cramps; tingling; she missed her regular menstruation period.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 24 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot number EJ1686, at the age of 23 years) via an unspecified route of administration on 06Jan2021 and second dose (lot number unknown, at the age of 24 years) on 27Jan2021 both at single dose for COVID-19 immunisation. The patient previously received a depo-provera shot in 2020 and her experience was similar to that no period and cramping. The patient's concomitant medications were reported as none. The patient missed her regular menstruation period. She said she was 16 days late but she was not sexually active, she never had this problem ever in her life. She was supposed to have her menses on 18Jan2021 that was when every month on the 18th, but never did get a period in Jan. she also mentioned she got some negative results for pregnancy tests. She did talk to her primary care doctor and 'OB' (not clarified) doctor on Thursday and they did do the blood work to see her hormone level and then they did do the urine exam. So, it was okay. She talked to infection disease doctor that worked at the hospital. She was scheduled for an ultrasound 11Feb2021. Since she got the vaccine, she was having a lot of pain, abdominal pain. She had a lot of cramp in her stomach, like the bladder area, more like period cramps; It came in and goes and then she thought it was normal and it had been progressive every day. Tingling and pain. She had been taking ibuprofen for her pain but she had stopped taking it now, didn't want to dull the pain, because she wanted to know when it resolves. She was just putting like ice on and then kind of lay down with it when it started. The pain that radiated down her right leg. The outcome of events a lot of pain and lot of cramp in her stomach, and especially down to the, like the bladder area was not recovered; events missed her periods, abdominal pain and tingling was unknown.
DIZZY, PASSED OUT IN HIS SEAT, MOVED TO COT, REMAINED UNRESPONSIVE FOR 30-45 SECS, INCONTINENT OF URINE. EMS CAME, BP 137/72, HR 56, PROVIDED GATORADE AND SNACKS, SYMPTOMS RESOLVED, REFUSED TRANSPORT.
Pt recvd vax & devel pos test for hep following vax w/Hep B vax; No further details were provided;
ARM & SHOULDER PAIN, INABILITY TO USE MY ARM, MOBILITY RESTRICTED, PAIN INCREASED DAILY, SHARP BURNING STABBING PAIN IN MY SHOULDER, TRAVELING UP TO MY NECK DOWN TO MY HAND IN THE LEFT ARM WHERE THE INJECTION WAS GIVEN. I HAD CALLED MY DOCTOR AND REPORTED MY SYMPTOMS AND REQUESTED TO BE REFERRED TO PT FOR RELIEF OF THE PAIN.  SHE SUGGESTED I COME INTO THE OFFICE FOR HER TO EVALUATE.  I WAS UNABLE TO MAKE THE APPT. DUE TO A DEADLINE AT WORK, AND CONTINUED KEEPING IN TOUCH WITH HER DAILY TO REPORT MY SYMPTOMS.  I HAD FAMILY EMERGENCY AND HAD TO LEAVE TOWN ON JUNE 29TH AND WILL BE RETURNING JULY 13.  AT THAT TIME I WILL BE ABLE TO CONTINUE WITH TREATMENT & FURTHER TESTING.
This spontaneous report was received from a pharmacist and refers to an approximately 55 year old female patient. It was reported that the patient had no drug reactions/allergies. No information regarding the patient's medical history and concomitant therapies was reported. On unspecified dates in 1989, the patient received a complete series of unspecified Hepatitis B vaccine (manufacturer unknown) (exact doses, route of administration and schedule of vaccination were not provided). On an unspecified date in 2014, the patient was diagnosed with breast cancer and began chemotherapy and radiation treatment. It was reported, that on unspecified dates, the patient began treatment with tamoxifen for breast cancer and promethazine for unknown reason. On an unknown date, unspecified bloodwork revealed low Hepatitis B antibody titers. The outcome of breast cancer and low Hepatitis B antibody titers was unknown. The relatedness between the events and unspecified Hepatitis B vaccine (manufacturer unknown) was not reported. Upon internal review, breast cancer was determined to be medically significant. Additional information has been requested.
Warm skin & swelling on the injection site + redness on the injection site.  Left deltoid (Tdap).  Size of swelling 30 mm.
Approximately 2 hours after TdaP vaccine, patient developed rash and itching to mid chest and face as well as feeling of puffiness to left cheek.  Patient stated she was fine except for the itching.  No difficulty breathing.  Mild redness noted to chest and neck.  She took 25 mg benadryl before returning to clinic. Patient followed up w/our clinic the next morning via telephone and stated the itching and redness resolved by 9pm and only experiences soreness to the touch at injection site.
No adverse event/reaction occurred. The patient was given a bivalent Covid vaccine today, and had already rec'd one on 09/30/22 at his place of employment.
Auditory hallucinations (hearing voices); This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 26-years-old via an unspecified route of administration, administered in Arm Right on 09Apr2021 (Batch/Lot Number: EW0158) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included amfetamine aspartate monohydrate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (MYDAYIS); quetiapine fumarate (SEROQUEL); levetiracetam (KEPPRA); amlodipine maleate, valsartan (AMLODIPINE-VALSARTAN) all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in arm left on 19Mar2021 (Batch/Lot No: EP7534) for covid-19 immunisation at the age of 26-years-old. The patient experienced auditory hallucinations (hearing voices) on 09Jun2021 and was hospitalized due to the event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Jun2021 Post vaccination. The patient received dose 3 via an unspecified route of administration, administered in Arm Left on 27Sep2021 (Batch/Lot Number: FF2588) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient did not recover from the event.   Follow-up attempts are completed. No further information is expected.
Vaccine was given "Beyond Use Date" of 6/19/23. Not expired. Healthcare provider informed. Moderna contacted and assessed vaccine to be viable. No known health complication for patient.