chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the ER on 17March2021 for headache with blurry vision. Patient reported symptoms for 1 day prior. Also had persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
sore muscles; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported that. a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as first dose (Batch/lot number: unknown) via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that in Jan2021 patient experienced sore muscles, headache and felt like she's dying. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Missed/Delayed period; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENSTRUATION DELAYED (Missed/Delayed period) in a female patient of an unknown age 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) (Intramuscular) 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 MENSTRUATION DELAYED (Missed/Delayed period). At the time of the report, MENSTRUATION DELAYED (Missed/Delayed period) outcome was unknown.            No relevant concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Information has been received from an infectious disease control nurse concerning a grade school age child who was vaccinated between 1999 and 2000 with a dose of varicella virus vaccine live.  In approximately November 2005 (through December 2005), the patient developed varicella.  It was unknown if medical attention was sought.  No outcome was reported.  No product quality complaints were involved.  This is one of several reports from the same source.  It was reported that there was an outbreak of varicella in a school. Additional information has been requested.
Sore-to-touch; hot, itching; pain under left arm. Red and hard-to-touch. Ice applied multiple times during the day. Tylenol taken PRN.
Numbness at site and down left arm, then in tongue and one side of mouth. Also experienced vertigo. Symptoms subsided within 15 min, almost completely gone 2 hours later.
-Started  of feelings of numbness in knees, shins area. Having pin pricks feelings and sensations throughout body.  No weakness noted. Noted temperature sensitivity on skin. Started having achy pain in feet. NONE of these symptoms have occurred in the past. ALSO had extreme disruption in menstrual cycle . NEVER was irregular or had issues. Got vaccine at end of cycle and then started cycle two weeks later and THEN had irregular cycle and bleeding for 4 months before going bak to normal cycle.
Roughly 1 hour after receiving the shot, I developed tinnitus and partial hearing loss in my left ear
Nausea/nauseous; tired; flu like symptoms; severe headaches/bad headache; Migraine; achy/aches and pains; freezing; hot; This is a spontaneous report from a contactable nurse (patient) reporting for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry Date are not Provided), via an unspecified route of administration on 15Feb2021 at 09:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation assessment was not provided. The Reporter got the COVID shot and had a reaction from it. On 16Feb2021, the patient experienced flu like symptoms, severe headaches/bad headache, migraine, achy/aches and pains, freezing, hot, tired and on 16Feb2021 at 11:00, the patient experienced nausea/nauseous. The clinical course was reported as follows: the reporter stated that she had the first dose of the pfizer covid 19 vaccine twelve days ago on Monday, 15Feb2021 at 9 AM. She reported that 24-25 hours later she had flu like symptoms, severe headaches, migraines and aches and pains. She stated that she has had these symptoms for twelve days and wants to know if that is normal. Twenty-four hours after, she developed flu like symptoms. She still has them. They are the same exact flu like symptoms too. She was achy, freezing, hot, and very nauseous. She had a migraine and bad headache as well. She can't seem to get over it. Then on Tuesday at 11 am, her side effects began with nausea, and increased to aches, pains, etc. The nausea was pretty intense. She still has it. The aches and pain are still there. The nausea was a little milder. She was tired. She is afraid to take the second vaccine. She said she has a question. She had the first COVID vaccine. This Monday will be 2 weeks since her 1st Pfizer vaccine. The reporter wanted to know if there is an issue with her getting the second shot because of her side effects to the first dose. The case was reported as non-serious. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax & in 5min period eyes seemed to dilate;that evening & the next day seemed off balance & wasn't sure of self & not eager to walk;one diarrhea stool evening p/vax;eye dilated, seemed unware of surroundings for moment;
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 05-Jun-2020 and the estimated date of delivery was 12-Mar-2021. On 07-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 07-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        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.   Patient reported that there is no Complications or acute illness during the pregnancy to date . No concomitant medications were provided.  No treatment information provided.
IMZ injection error. Indicated for SC, but was administered IM. Patient was fine leaving the pharmacy.
her arm got real swollen and a huge, huge red patch on it; her arm got real swollen and a huge, huge red patch on it; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her arm got real swollen and a huge, huge red patch on it) and ERYTHEMA (her arm got real swollen and a huge, huge red patch on it) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 2) and COVID-19 Vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine.    On an unknown date, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (her arm got real swollen and a huge, huge red patch on it) and ERYTHEMA (her arm got real swollen and a huge, huge red patch on it). At the time of the report, PERIPHERAL SWELLING (her arm got real swollen and a huge, huge red patch on it) and ERYTHEMA (her arm got real swollen and a huge, huge red patch on it) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient had the first two covid shots without any problem. Then on the 3rd booster, her arm got real swollen and a huge, huge red patch on it.   It was unknown that if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication use information was not provided by reporter.   Reporter did not allow further contact
Delayed hypersensitivity reaction with 5cm induration x 4days. Painful
Bilateral tinnitus began approximately 36 hours after receiving booster dose of Moderna vaccine.    Has continued since November 15th , 2021.
Little bit of soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little bit of soreness in her arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No medical history was provided by the reporter.Concomitant products included VITAMINS NOS for an unknown indication.On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Little bit of soreness in her arm). The patient was treated with LYSINE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Little bit of soreness in her arm) outcome was unknown. Treatment drug include OTC Lysine.This case was linked to MOD-2021-392152, MOD-2021-391952 (Patient Link).
pt recvd vax 20JAN94 & 7APR94 pt exp swollen lymph nodes (lymphadenopathy),dizziness,h/a's,nausea,abd pain;seen in ER sx persist;MD states that these adverse events are related to vax;
Muscle pain, goose egg size swelling on injection site, muscle weakness, balance issues, headache.  Weakness in arm that lasted months.
Randomly sharp cramping pain the calf of my leg - last for 5mins. Happened randomly in a span of one weekend would last any where between 2 to 5mins.
Pt reports arm began to hurt more 08/10/13. (R) arm redness started 08/11/13. Came in to office 8/12/13. Area 16.5 x 12 cm reddened, warm. Bruise superiorly.
Client vaccinated with Pfizer vaccine on April 6 and April 27, 2021 at a clinic but does not know where.  Developed symptoms (fever 103.4 and headache) on 8/31.  Tested postive 8/30 after riding in a van back on 8/29.  People in the van were obviously ill and had been ill for several days with coughing, congestion.  Notified client that they tested positive when they returned to NJ so client got tested prior to getting symptoms.  Reported as a case of breakthrough Covid in a fully vaccinated person.
Patient came into pharmacy 10:00am 7-17-14 and presented with a mild red rash at injection site about 1cm by 4cm. She had slight itching and minor swelling. I recommended ice packs for swelling if needed, Tylenol for any mild discomfort and Benadryl if the itching begain or increased in intensity.
Moderate muscle pain and weakness in left shoulder area about 2 hours after injection. No redness or swelling. Excruciating should joint pain with weakness and numbness down the entire arm into the fingers 4 hours after injection. I was not able to move my left arm without assistance. I called my Dr. to notify them of my reaction. My Dr. had already left for the day. I  was told to go to the nearest ER. Went to Medical Center. Was given pain medication, anti nausea medication, and muscle relaxers. Was sent home. Today is 4 days post injection and my left arm is still very sore, weak, and numb. I do have some range of motion but it is painful (pain scale 1-10 = 7) to force my range of motion.
10 days p/vax pt devel severe cough w/fever; difficulty breathing because of cough; tx ATB but pertussis not suspect @ time; sx continued & was sent to ER for throat cult; pos for pertussis organism;
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 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2023) Negative; (14Aug2023) Positive, notes: Experienced symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used from 05Aug2023 to 09Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
spiked fever w/in 4 hr of 14JAN97 vax, appeared to have h/a a lot of pain in leg where shot was given went to PMD;2 days post, went in hosp x 3 days;dx vaccine adverse rxn;
I had two vaccines in the same arm (right) very close together. PNEUMOVAX and Shingles. The next day, there was redness around the injection site and I ran a fever of 103 degrees. PCP sent me to ER. Was treated with IV antibiotics and released. The next day, there was additional redness and streaking up the arm and into the chest. I went back to the ER and was admitted overnight. Treated with strong IV antibiotics.
Pt fell at home and presented to hospital with displaced left sacral ala fracture, and left pubic bone. Pt also had bladder injury requiring a foley and cystogram. pt tested positive for covid on a tranfser screen to a facility. Pt discharged to another facility.
On 5/25/01, the pt received his 1st dose of Engerix-B and his 1st dose of Hep-A (Havrix); see 20010157852. Four days later, on 5/29/01, the pt developed "intense" abdominal pain. Five days later, on 6/3/01, the pt developed the characteristic rash of Henoch-Schonlein purpura. The urinalysis was initially normal. On 6/26/91, the pt was seen by the physician and microscopic hematuria was noted. The urinalysis showed moderate red blood cells, no protein, and no glucose. The serum creatine was normal. Henoch-Schonlein purpura is considered to be "Medically Serious". As of 6/27/01, the rest was ongoing. F/U UA results added. No drugs were used to treat the adverse events. The IM doses of Engerix-B and Hep-A were 0.5cc. The reporter stated that the acute abdominal pain was moderate-to-severe and was disabling/incapacitating. The reporter stated that the Henoch-Schonlein purpura skin lesions were moderate in severity and the persistent microscopic hematuria was mild in severity. He considered all the events to be possibly related to the vaccines administered. The most recent information was received on 9/24/01. The reporter indicated that the abdominal pain and skin lesions resolved on 6/15/01. The microscopic hematuria was ongoing. The most recent info was received on 11/27/2001. The vaccinee had completely recovered by 08/28/2001.
Extreme Lethargy.  Could not get out of bed the day following the shot.  For the first shot I had a similar reaction (Extreme Lethargy), but also dry heaves in the morning after the day the first shot was given.
He was in the care of his mother, due to him being Mentally Handicapped. Approximately 10 to 15 minutes after he received the vaccine both of his forearms started to turn red in color. He stated that they were itching. He had no other adverse reactions. Being he was not short of breath and had no facial or tongue swelling, no nausea or vomiting, it was decided that his mother would take him home and contact his primary care provider for direction or she would possibly give him some Benadryl at home and follow up with his PCP as needed. If any other reactions developed she would take him to the Emergency Department if needed. They left the vaccine clinic approximately 40 - 45 minutes after he had received the vaccine.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 800-900 (Inconclusive) 800-900 range.     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.  It was reported that the patient did not report any adverse events or symptoms post 24 hours of vaccination.  On 24 May 2021 the vaccine was placed into the refrigerated storage. The vials had a 30-day expiration date and administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use. An antibody test was done on all of them  and the patients antibody numbers were in the 800-90 0 range.   This case was linked to (Patient Link).
Headache, muscle ache and fever 11 hours post vaccine. Treatment include Ibuprofen with resolution of fever and improvement of headache and muscle aches.  Does not interfere with ADLs.
After 10 minutes - stood up in hallway - collapsed - to floor - got up with help - assisted back to room - gave O2 2 - took vitals every 5 minutes - gave water - after 20 minutes - could walk without help - referred to ER. Was taken by mother.
received 3 total doses of the Pfizer COVID-19 vaccine; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "received 3 total doses of the Pfizer COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200027211 Same drug, different patient/AE;US-PFIZER INC-202200026534 Same drug, different patient/AE
Sore arm, ache and pains all over, sharp pain in in upper abdodmin. Realized it was pancreatitus and   eating and just drank water. Saw the gastroenterologist. Did blood work and x-ray. Officially diagnosed with pancreatitus flare -up.
Lump on the left side of neck, pain on the underarm; Lump on the left side of neck, pain on the underarm; This is a spontaneous report from contactable pharmacist. A 52-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246) via intramuscular in the left arm, on 12Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Patient is not pregnant. It was unknown if patient had COVID prior vaccination. It was unknown if patient received other vaccine in four weeks. Patient previously received first dose of BNT162B2 (Lot number: EL0140) via intramuscular in the left arm on 23Dec2020 at the age of 52 years for COVID-19 immunisation. Patient experienced lump on the left side of neck, pain on the underarm on 12Jan2021. It was unknown if patient received treatment for events. It was unknown if patient tested COVID post vaccination.  Outcome of the events was recovering.
Pneumovax injection given in right and had erythema, pain, and edema from shoulder to the elbow. (OMIC)