chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RIGHT SIDED HEMIPLEGIA; PONTINE STROKE; This spontaneous report received from a consumer (patient's mother) via a company representative concerned a 22 year old male of an unspecified race and ethnicity. The patient's height and weight were not reported. The patient was previously a healthy college athlete.  It was noted the patient had a Covid-19 infection, and received the vaccine due to a mandate at school 10 days after recovering from Covid-19 infection. The school mandate was to follow the CDC 10-day rule, but the patient's mother reported he received it "two weeks" after he recovered from COVID  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 08-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 21-FEB-2022, 44 days after vaccine administration, the patient experienced a pontine stroke. The pontine stroke resulted in dense right sided hemiplegia. It is reported that despite many diagnostic tests, they were unable to find any cause. Platelet factor 4, fibrin D-dimer, platelets and other laboratory results were pending. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pontine stroke and right sided hemiplegia were not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received via a company representative concerns a 22-year-old male who experienced pontine stroke 44 days after receiving the Janssen COVID-19 vaccine for COVID-19 prophylaxis. Patient was described as previously healthy however, no specific medical history or concomitant medications were provided. Laboratory tests, diagnostics and medical records were not provided. It was noted that approximately two weeks prior to receiving the vaccine, the patient had recovered from a COVID-19 infection. The patient experienced a pontine stroke and "dense right-sided hemiplegia" 44 days after receiving the vaccine. Treatment and patient outcome were not provided. Latency between the vaccine and the event was somewhat prolonged. In addition, the history of a COVID-19 infection prior to vaccination may represent a confounding factor. However, given the current lack of information, the events are considered possibly related for reporting purposes while more information is being requested for further assessment.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 11Apr2022 at 01:45 as dose 4 (booster), single (Lot number: FK9729) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "eye drops allergy" (unspecified if ongoing), notes: known allergies: eye drops allergy; "bandages allergy" (unspecified if ongoing), notes: known allergies: bandages allergy. There were no concomitant medications. No other medication in 2 weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details for event COVID 19 Treatment included Paxlovid, treatment start date: 17May2022 and treatment stop date: 22May2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
I had some pain around the shot area; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 at 14:30 at single dose in left arm for COVID-19 immunisation at the age of 78-year-old. Lot number was EL3302. The medical history and the concomitant medications were not reported. The patient had some pain around the shot area on 19Jan2021 at 17:30 and he took TYLENOL, 2 tablets 500 mg each within 4 hours of receiving the shot. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event.
4th full dose of Moderna on July 1, 2022. Felt fatigue and sore arm for approx. 24 hours afterwards.  On July 11, 2022, came down with scratchy throat and drainage; tested positive for Covid-19 on July 13, 2022. Started a course of Paxlovid, RX from rheumatologist. Was ill at home (chills, fever, cough, drainage, fatigue) for approx. 7 days; did not find relief from fatigue for nearly a month.   On September 27, 2022, came down with scratchy throat, runny nose, and fatigue; tested positive for Covid-19 on September 30. Was ill at home for approx. 5 days, but to a lesser degree than in July. No fever this time. Fatigue lasted for about two weeks. Took Paxlovid again.
Child has history of vomiting, pale appearance and unresponsiveness.  Found to have intussusception and subsequent follow up for + blood culture of Moraxella. He was seen after this in ER and given ceftriaxone IM with repeat blood culture with ID consult.
My arm had a red circular area around the injection site and was painful as if I had been punched, the day of and the day after I got the vaccine on the 16th of January.  This faded and went away.  Saturday January 23, I noticed my arm had a hive like rash around the injection site and it itched.  As the day progressed the itch grew worse so I put aquaphor on it in the event my skin was dry.  Sunday I woke up and my arm had a red circle around the injection site with a raised portion almost as if half a hard boiled egg was under my skin on top of my muscle.  The redness comes and goes. I am guessing from clothing irritation? The swelling is down a bit after I took a Benadryl.
Tingling in arm to finger tips approximately 12 hours prior. Better now after Tylenol and rest. Dose #1
heat rashes all over body, temperature on body rising, skin turning red, white blisters developed under skin. Severe itching all over skin. Bad mentrual cramps when it is not my time to have a period.  Headache, brain fog. Extreme arm pain and heart /chest tightness. Low blood pressure going into dangerous levels. numbness to arms and legs. Body Pain.
I do not know the specific flu shot. I developed thyroiditis symptoms within 3 days (severe neck pain and diarrhea) lasting for 5 weeks. Mostly resolved.
lumping; Pinkness; Very little appetite; flu-like symptoms; tingling; itching; nausea; tiredness; Very bad chills; Bump; Has gotten very itchy; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and DECREASED APPETITE (Very little appetite) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREGABALIN (LYRICA) for Pain, CARBIDOPA, LEVODOPA (RYTARY), LOVASTATIN and VITAMINS NOS for an unknown indication.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (Very little appetite), VACCINATION SITE SWELLING (Bump), VACCINATION SITE DISCOLOURATION (Pinkness), PRURITUS (itching), VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE PRURITUS (Has gotten very itchy) and VACCINATION SITE MASS (lumping). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (Very little appetite), VACCINATION SITE SWELLING (Bump), VACCINATION SITE DISCOLOURATION (Pinkness), PRURITUS (itching), VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE PRURITUS (Has gotten very itchy) and VACCINATION SITE MASS (lumping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Bloody diarrhea, vomiting, no fever. Required IV fluids in ER for 6 hours and improved  Neg US for intussception
Mom called 7/12/06 with c/o arm pain, redness, swelling. Advised to be seen 7/12/06. Coming home from out of town. Seen in office 7/13/06 for superficial infection post vaccine on Keflex 250mg bid x 5 days.
1 week after Td she had redness and swelling at injection site, worsening for 1 week. She was treated with Fexofenadine and Benadryl with.
Received Varicella injection on 09/15/99. Diagnosed with Varicella 09/02/04.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown demographics. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with the properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. The vaccine underwent the temperature excursions of more than -14 but less than -10 degrees Celsius for 3 hours and 45 minutes and more than -9 but less than 8 degrees Celsius for 3 hours and 30 minutes, which were detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
Turned red few 3 days later lasting a few 3-4 days which turned to a scab and week later have a scar similar to Polio vaccine scar which to the date remains a round scar.
tested positive in the morning on a rapid test; tested positive in the morning on a rapid test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EN6201) and on 18Apr2021 as dose 3 (booster), single at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "SVA tachycardia" (unspecified if ongoing), notes: other medical history: SVA tachycardia. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, 19 days after the suspect product(s) administration, outcome "unknown" and all described as "tested positive in the morning on a rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Negative; (27Apr2022) Positive; (27Apr2022) Negative; (27Apr2022) Positive.  clinical information: patient recieved anti viral COVID 19 Treatment. patient finished Paxlovid on 12Apr2022 and tested negative after having COVID on 14Apr2022 and 15Apr2022. patient felt mostly recovered, except for some headaches and a slight cough. patient happened to test on 27Apr2022 because I was going to be seeing a friend's newborn baby soon. patient tested positive in the morning on a rapid test. Patient took another rapid test immediately and it was negative. Both tests were from separate kits. then took another test in the late afternoon and was positive, on another kit/type of test. Patient started feeling a little chest congestion. On 28Apr2022 I woke up feeling a like I had a little head cold but very mild. Later in the day I felt a bit worse, a bad headache and some slight body aches. Patient now isolating and will continue testing.   No follow-up attempts are possible. No further information is expected.
My daughter was extremely irritable after vaccines, developed a fever of 102.8 F which resolved the next day, appeared to have abdominal pain- lots of grunting, refusal to feed, and resumption of green mucousy stools which had previously subsided with neocate (note the green mucousy stools which were eventually blood streaked began soon after 6 week vaccines). One week later above symptoms continue and unclear if and when will resolve.
Patient became lightheaded and lost consciousness while sitting on the exam table. She had some shaking before she lost consciousness. As the patient came to she has an altered level of consciousness for 3-4 min. She was awake and was orientated, but confused she did not remember what happened.
Since receiving vax on 24OCT89, pt exp fatigue, aches, & pains; Also noted sx w/viral infect on 27JUL89; in OCT89 devel mononucleosis; 26APR90 "chronic fatigue synd", facial puffiness, backache, joint aches, chest tightness;
Information has been received from a 38 year old female with a history of swollen glands every 4-8 years who on 12-DEC-2007 was vaccinated intramuscularly in the buttocks with her first dose of Gardasil (lot # unspecified).  There was no concomitant medication.  On 12-DEC-2007 the patient experienced swollen glands on her face and neck.  The patient reported that she was treated with antibiotics for her symptoms.  Subsequently, the patient recovered from swollen glands on face and neck.  No further information was provided.  Additional information has been requested.
RED, POISON-IVY TYPE RASH ON ARMS, CHEST, LEGS, BACK, STOMACH. RASH HAS BEEN MOVING AROUND THE BODY AND SPREADING. TREATING WITH OTC REMEDIES.
pain at vaccination site; headache; Rash on entire chest area; Vaccination site redness; Rash on face; This is a spontaneous report received from contactable consumer, the patient. A 25-year-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on19Mar2021 at 15:45 (at the age of 25-year-old), as a single dose for COVID-19 immunisation. The patient did not had any medical history. The patient's concomitant medications included buspirone(MANUFACTURER UNKNOWN), ibuprofen(MANUFACTURER UNKNOWN), excedrin(MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162B2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot No:En6200),via an unspecified route of administration in the left arm on 26Feb2021 at 16:00 (at the age of 25-year-old)as a single dose for COVID-19 immunisation. The patient had allergies to thimerosal, T-Dap and tubersol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 16:30, the patient experienced rash on entire chest area within 45 minutes of shot, spread to face within an hour, pain at vaccination site along with redness and headache. Therapeutic measures were taken as the result of events was unknown. The clinical outcome of the event rash on entire chest area, pain at vaccination site along with redness and headache was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
itp; Initial information received on 17-Mar-2023 regarding an unsolicited valid serious case from a physician.  This case involves child and unknown gender patient who experienced ITP after receiving meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 10-Dec-2019, the patient received suspect meningococcal A-C-Y-W135 (D CONJ) vaccine for solution for injection at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  On 29-Dec-2019 the patient developed a serious ITP (immune thrombocytopenia) 19 days latency following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event ITP.  Seriousness criteria: Medically significant. The patient was hospitalized on the same day this event occurred.; Sender's Comments: Sanofi company comment dated 21-Mar-2023: This case involves child and unknown gender patient who experienced ITP after receiving meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra]. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor excluding other predisposing etiologies, temporal association, data on individual patient would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Patient received a Covid vaccine that was expired 23 days prior to injection.  The patient will be contacted for revaccination.
Pt vaccinated with Recombivax developed hives, continued for 4+ months.
Very bitter taste which went away after last dose but strangely reoccurred 10 days later/COVID-19 recurrence; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Very bitter taste which went away after last dose but strangely reoccurred 10 days later/COVID-19 recurrence) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included ROSUVASTATIN for an unknown indication.    On 17-Nov-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced COVID-19 (Very bitter taste which went away after last dose but strangely reoccurred 10 days later/COVID-19 recurrence). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Very bitter taste which went away after last dose but strangely reoccurred 10 days later/COVID-19 recurrence) had resolved with sequelae.            Reportedly, the patient received other medications or products within 2 weeks of starting COVID-19 treatment and the patient previously received a COVID-19 Vaccine.  Device Date was reported as 25-May-2022.  Company Comment: This spontaneous case concerns a patient of unknown gender and age, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred approximately 6 months after a dose of mRNA-1273 vaccine administration, given as the fourth dose. Patient reported very bitter taste which went away after last dose of Paxlovid but noticed reoccurrence 10 days later. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown gender and age, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred approximately 6 months after a dose of mRNA-1273 vaccine administration, given as the fourth dose. Patient reported very bitter taste which went away after last dose of Paxlovid but noticed reoccurrence 10 days later. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Rash, full body "measles-like", erythematous patches of about 3-4 mm, itchy appeared >5 hours after the vaccine.
on 1/7/2022 an  incorrect dilution of Pfizer covid-19 vaccine lot # FJ87757 expiration date: 01/26/22. Vial was diluted with 1.3 ml of sodium chloride and administered to three patients at 0.3ml . All other remaining vaccine was  discarded. Call was placed to Help desk and  Voice message was left on after hours phone number. Pt was contacted and instructed may have increase in side effects. Pt was given after hours number. Pt verbalized understanding  Resolution : CPM and DO were notified as soon as the mistake was noticed. Pt was contacted and instructed may have increase in side effects. Pt was given after hours number. Pt verbalized understanding
adult patient was given a pediatric dose; adult patient was given a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 5th April 2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date:26-Oct-2022 Reporter's comment: The reporter reported that she did not had any patient information at time of call. The reporter consented to follow-up via email. Additional supportive information: The patient was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
No adverse event; VARIVAX was delivered on 07-JUN-2022 after the receive by date of 06-JUN-2022 and was administered to a patient; This spontaneous report was received from a medical technologist lab manager referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  The reporter explained varicella virus vaccine live (oka/merck)(VARIVAX) was delivered on 07-JUN-2022 after the receive by date of 06-JUN-2022 and was administered to a patient on 15-JUN-2022 (incorrect product storage), lot # W002599, expiration date on 24-JAN-2024 for prophylaxis (dose not reported). The temperature was unknown and also the timeframe. There was no previous temperature excursion. The reporter did not have any further clarifying details. No additional adverse event or product quality complaint were reported. No additional information was provided.
1005 - pt clammy, sweating profusely, dizzy, nausea also. Pale after vaccine administered @ 1000 - juice given, H2O given, placed on CO & P-60 slow shallow breathing, EMS called - arrived 1010 ER at 1012 - evaluated. Pt. declined to go to ER. Pt observed until 1030 escorted to car by staff.
1735 Pt reported nausea to obs staff. RN responds as pt loses consciouness x3-5 sec. Regains consciousness, but is weak, pale, diaphoretic. Other 2 RN's respond, help pt to right side on cot. Semi-conscious, reponds to verbal. States she "feels bad." 1737 BP 80/40, P26-55, R14, O2 100%. 911 called. Next door (clinic backup) MFD ALS crew x4 on scene at 1740. Care turned over. BP 68/37, P66, R14, O2 100%, bl gluc 105. 1747 Pt more alert, but still weak and pale. IV access by medic in right arm. IVF wide open. 1750 BP 96/53, P 67, R16, O2 100%. Pt eyes now open, talking, pink lips. Pt. reports her right hand/arm feel numb (vacc inj side). 1755 BP 99/58, P 64, R 16, O2 100%. Transport by amb to ER at 1755.