chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptomatic rebound infection with positive test; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 at 15:45 as dose 1, single (Batch/Lot number: unknown), in left arm and on 26Feb2021 at 16:15 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing), notes: None except overweight; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: peanuts" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "not recovered", described as "COVID 19 Treatment "; DISEASE RECURRENCE (medically significant) with onset 15Aug2022, outcome "not recovered", described as "Symptomatic rebound infection with positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Positive, notes: Symptomatic rebound infection with positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 04Aug2022 to 09Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
He had aspirated; Slept all day; Too weak to eat and was given a feeding tube; Not been able to talk; Not been able to swallow; Felt tired; Felt lethargic; Felt  weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASPIRATION (He had aspirated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intubation.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced LETHARGY (Felt lethargic), ASTHENIA (Felt  weak) and FATIGUE (Felt tired). On 02-Apr-2021, the patient experienced ASPIRATION (He had aspirated) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk) and DYSPHAGIA (Not been able to swallow). At the time of the report, ASPIRATION (He had aspirated), LETHARGY (Felt lethargic), ASTHENIA (Felt  weak), HYPERSOMNIA (Slept all day), FEEDING DISORDER (Too weak to eat and was given a feeding tube), APHASIA (Not been able to talk), DYSPHAGIA (Not been able to swallow) and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: unknown unknown. On 01-Apr-2021, Chest X-ray: unknown unknown. On 01-Apr-2021, Magnetic resonance imaging: unknown unknown.     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.
Vaccine was given and it was expired on 10/19/18, unaware of this until after vaccination was given.
Moderate erythema, pain and limp. Temp increase 102. 24-48 hours after vaccine left thigh
Information has been received from a physician concerning a female who on an unknown date was vaccinated with the first dose of Gardasil (yeast, unknown lot number) and in July 2007, was vaccinated with the second dose of Gardasil. In September 2007, the patient died. No further details or symptoms were known regarding the patient's death. The physician mentioned that an autopsy would be done however, had not received the results yet. The reporting physician felt that the patient's death was not related to therapy with Gardasil. Additional information has been requested.  10/11/2007 Patient demographics provided by CDC.  10/15/07 Received vax record from pcp.  VAERS database updated w/same.  10/15/07 Received pcp & hospital medical records from CDC which reveal patient experienced vomiting with elevated blood sugars who became unresponsive & pulseless.  CPR started & taken to ER on 9/19/07.  Resuscitation was unsuccessful & patient pronounced 9/19/07. 10/26/07 Reviewed autopsy report which reveals COD as diabetic ketoacidosis & manner of death as natural.  Patient had been found by parent unresponsive at home.  History of severe diabetes mellitus.  Vitreous glucose 667 (H).
Vaccine administered on 12/24/2020. At approximately 1600 on 12/29, I noticed itching near the injection site. Upon returning home from work, I noticed a large red area directly beneath injection site. Area of redness is approximately the size of a baseball, and size increased overnight. Red area is non tender to palpation, but area is more sensitive to touch.
Little worse than the first day; Knot on left arm size of a quarter; Red spot size of half a dollar on left arm; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot/batch no: unspecified) via unspecified route of administration in the left arm as dose 2, single on 14Jul2021 14:45 PM (at the age of 57-years) for COVID-19 immunization at Facility Health Department. The patient medical history and concomitant medications were not reported. No Investigation Assessment was provided. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot/batch no: unspecified) via unspecified route of administration on an unspecified date in Jun2021 for COVID-19 immunization and had no problems. It was reported as first dose taken Three weeks before second dose (14Jul2021). No additional vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks to the administration date of the suspect vaccine and no AE reported prior vaccination. Family Medical History Relevant to AE reported as None. It was reported that 30 minutes after receiving the second shot on 14Jul2021, patient experienced a knot on left arm size of a quarter developed as well as a red spot the size of half a dollar. On 15July201, reported as it was little worse than the first day. The patient asked if these complaints had been previously reported. Relevant tests done were none. Events did not require to visit Emergency Room or Physician Office. The clinical outcome for the events was not recovered except for event little worse than first day was unknown.   Information about lot/batch number is requested.
patient wanted requested to get JJ vaccine. I forgot to calculated her date of birth as the day of vaccination
Headache, Myalgia, Fever, Rash, NauseaVomiting, FATIGUE Narrative:
Localized fever, redness measuring 3" in diameter, area is hardened, tenderness. Instructed to use Benadryl and ibuprofen or Tylenol.
Two weeks following vaccine I developed a superficial blood clot in my right cephalic vein. I am 33yrs old, no comorbidities, no injuries. Not sure if the blood clot is related to the vaccine but I've been told it's worth mentioning.
On 11/20/2022 in the evening around 7-8:00PM. I was feeling tired and I had runny nose. It began to progress. I had a sore throat, fever, headaches, congestions in my nose, and cough. I went to the urgent care on 11/24/2022 I was tested for flu which was negative A & B. They treated me for Sinus infection. They gave me azithromycin 250mg, promethazine DM, and NOREL AD tablets. I called my doctor on 11/28/2022 she prescribed me with antibiotics (doxycycline) and MUCINEX. I tested positive for COVID-19 on 11/28/2022. At night time I get cough, night sweats, lack of energy and Insomnia. I am taking TYLENOL as per needed. As of today 12/07/2022 I am still testing positive. I was positive from 11/28/2022 till now. I though it was just Sinus infection but it's not.
Information has been received from a pediatrician concerning a 14 day old female baby with a history of exposure to GARDASIL while in uterus (approximately on 14-MAR-2007) (refer to WAES # 0705USA00917) and with neonatal jaundice and no known allergies who on 20-NOV-2007 was vaccinated with a first dose of RECOMBIVAX HB (manufacture unknown). On 27-NOV-2007 the baby had a well baby check-up which revealed the neonatal jaundice was improved and the "levels" were starting to decrease. On 03-DEC-2007 the baby had an office check-up and the mother reported the baby had nasal congestion, sneezing, green nasal drainage and no fever. On 04-DEC-2008 the baby was diagnosed with upper respiratory infection and treated with saline suction. On 03-JAN-2008 the baby was seen for well check up  and the mother reported that the baby had bellyache, screaming, "colicky symptoms" and not sleeping well. The baby was diagnosed with colic and treated with ENFAMIL NUTRAMIGEN. On 14-JAN-2008, the baby had a well baby check-up which revealed the colic was improved. The baby also received the following vaccinations that day: RECOMBIVAX HB (manufacturer unknown), ROTATEQ, PEDIARIX and PREVNAR. On 18-Feb-2008 the baby was seen for well check up and the mother reported that the baby had green-yellow nasal drainage, temperature 100.3. The baby was noted to have red cheeks. The baby was diagnosed with upper respiratory infection and eczema and treated with "saline bulb, "propping" and EUCERIN. On 21-FEB-2007 the baby was prescribed nystatin (reason not reported). On 01-APR-2008, the baby was seen for well check up and the mother reported that the baby had sneezing for 1 week and had no fever. The baby was diagnosed with upper respiratory infection and treated with saline. The baby also received the following vaccinations that day: RECOMBIVAX HB (manufacturer unknown), ROTATEQ, PEDIARIX and PREVNAR. On 10-APR-2008, the baby was seen for well check up and the mother reported that the baby had seen spitting up and had constipation. The baby was diagnosed with gastroesophageal reflux disease and treated with "propping" and rice cereal in all bottles. The baby's outcome was unknown for the URIs, eczema and GERD. No further information is available.
Pt. states that after receiving the 1st dose of Influenza High-Dose 10/19/2021, started experiencing symptoms that evening of swelling in the left arm from the injection site to the elbow. No noted Primary visit/communications. Still continuing to experience symptoms.
Patient reports symptoms following COVID-19 vaccine. Patient reports she had brief episode of heart racing, throat tightening, feeling lightheaded.  Symptoms already improved within 1-2 minutes by the time this RN reached patient.  Denies itching, hives, shortness of breath, or any other symptoms.  Has history of anaphylaxis and anxiety attacks, was worried about having anxiety attack with vaccine today.  BP and pulse normal on two repeat checks. Patient alert, oriented, speaking clearly and in no apparent distress.  Symptoms resolved and did not return by end of patient's post-vaccination waiting period.  Patient works on campus in oncology with healthcare providers nearby for help if any further symptoms.
Screaming, 6-8 hour stretches. Didn't eat - 9+ hour stretches, sometimes only 5-7 oz. in 24 hrs. Didn't sleep - less than 4 hrs in 24 hrs. Lasted 12 days w/ 2 mo. vacc and 9 w/ 4 mo. vacc.
Information has been received from a physician concerning a female patient who was vaccinated with a 0.5 ml dose of Varivax on an unspecified date. Subsequently, a few months after vaccination, the patient developed chickenpox. Unspecified medical attention was sought. No outcome status was reported. no product quality complaint was involved. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown demographics. The patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On multiple unspecified dates these patients were vaccinated with improperly stored doses of GARDASIL 9, (lot# M023169 and expiry date 13-JUN-2018) for prophylaxis (strength, dosing details, route and  anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information was received on 20-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. A request was made for patients' identifiers and dates of vaccination. Additional information has been requested.; Sender's Comments: US-009507513-1610USA013965: US-009507513-1610USA013571: MERCK 1610USA013964:Mfr number.
Well- demarcated erythema, swelling increased warmth, mild tenderness, itching at site within 24 hrs. of inoculation KEFLEX 250 mg QID x 7 days. BENADRYL 12.5 mg Q6 hr PRN. Temp 99.3 which was the same prior to vaccination injection.
On the morning of March 10th, upon sitting up in bed I felt dizzy like I wanted to faint. I lied back down. After 30 minutes, I attempted to sit up on the side of bed and still felt like I wanted to faint.  Waited for 5 minutes, got up but was still dizzy.  While standing beside counter, I passed out.
Swelling in arm, hard raised bump for a week, severe itching. One week after shot, severe itching, red rash circle approx 2 inches in diameter
15 hours post vax ; chills for a couple hours -- then sweats -- dizziness (needed cane to walk) -- diarrhea -- tiredness (slept for about 5 hours). Arm sore.  Symptoms eased up about 12 hours after onset; meal eaten.  Back to normal 72 hours after that.   Only treatments -- sleep and acetaminophen every 6-8 hours
soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within 10 minutes of vax, the pt complained of difficulty breathing, throat closing up. BP 132/72, P 80, Resp - 20. EMS transported to local ER after injection of Benadryl. Received oxygen in ambulance, discharged to home.
No problem at time of injection 10/13/11. 12 hours later c/o stiff neck on the same side of injection. Headache today 10/14/11 continues with sxs.
Cardiac operation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4290526-00.  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Aug2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single, intramuscular, administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: CARDIAC OPERATION (medically significant), outcome "recovering", described as "Cardiac operation". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab)The reporter's causality for the event(s) of heart surgery with Humira(Adalimumab) was no reasonable possibility. (Company name) opinion is that there is no reasonable possibility that the event of heart surgery is related to Humira(Adalimumab).Drug:   PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN), Causality: Cardiac operation (Cardiac operation), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, De challenge: N/A  The reporter's assessment of the causal relationship of the (CARDIAC OPERATION) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
vomiting after second medera shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting after second medera shot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting after second medera shot). At the time of the report, VOMITING (vomiting after second medera shot) outcome was unknown.            No concomitant medications provided.  No treatment medications provided.
HIGH PRESSURE 175/100, TACHYCARDIA, EXCESSIVE COLD, HEAD MOVEMENTS, DIDN'T FEEL MY ARMS, DISCOMFORT IN BOTH LEGS. I VISIT THE EMERGENCY ROOM AND I DID AN ELECTRO AND TROPONINS. THE DOCTOR SAID IT WAS ANXIETY.
Given dose 1 of vax 24JUL90; Next morning had sx of cervical myelitis, "inflammation sp cord effected all 4 extremities." sx eventually abated; @ time myelitis occurred, anemia, along w/kidney infection, was discovered; Also neuritis;
Two doses of vaccine at interval of 4 days; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two doses of vaccine at interval of 4 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two doses of vaccine at interval of 4 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two doses of vaccine at interval of 4 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As reported patients has been accidently given 2 doses at interval of 4 days. No concomitant medications were reported. Treatment information was not reported.
My Father received his second COVID19 shot on May 19th, 2021. He felt fine the day of his vaccine and the day after. He experienced minor side effects. On May 22nd, 2021 my Father suddenly died while driving to work.
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB (lot # M001813, expiry date: 14-OCT-2018) via intramuscular route (incorrect product storage). No adverse reactions were reported. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Administration of an expired dose of Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 74-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On 17th September 2021, the patient received Menveo. On 17th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The age at vaccination was not reported but it could be 73 or 74 years. Health care professional reported the administration of an expired dose of Menveo to the patient, which led to expired vaccine used. The reporter also reported product complaint. The reporter agreed to be contacted for follow-up through email address. GSK Note: as there was no real event, product complaint was not coded.
Tingling of lips and tongue, scratchy throat - gave EPIPEN x 1 dose called 911 - pt brought to hospital.
Per nurse at where patient is employed, he tested positive for COVID-19 on 4/26/21 through a self COVID test then PCR COVID test through employer. Patient is quarantining at home with no reported symptoms.
WORST FEVER EVER; This spontaneous report received from a consumer via a company representative 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced worst fever ever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worst fever ever was not reported. This report was non-serious.