chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On September 01, 2021, I got the Pfizer-Biontech COVID vaccination batch FC3182. On September 14, 2021, I had focal impaired awareness seizures all day, and my family and I had no idea what was happening. I would claim there was a strange taste, or I would stop responding altogether. On the morning of September 15, 2021, my mother witnessed another focal impaired awareness seizure, and my boyfriend took me to Hospital to the ER. I was told I was having anxiety attacks and was given Ativan 0.5mg. Since September, I have had a seizure every month. We have tried to keep track of the dates and times, but at the beginning, we weren't too sure what was going on. Because of this, I went to therapists rather than neurologists. I was prescribed Lamotrigine 25mg, which has turned into 100mg twice a day. On September 23, I got my second vaccine, batch 30145AB.      I had a seizure mid-October, but I don't have a date. My first convulsive seizure was the morning of November 14th, around 04:00 AM. My family called 911, and I was taken to the hospital in an ambulance. I seized all day on November 15th, starting at 09:15 AM. I was filmed in a video chewing on nothing and claiming that "it tastes so gross." This lasted about a minute and fifteen seconds. On December 03, I was given an MRI. On December 30, I had seized all day again, including a tonic-clonic seizure that lasted over three minutes which was filmed. I was also caught on a video at 06:37 PM trying to explain how I was feeling. It was a minute and forty-four-second video. I seemed conscious and aware, but I was still affected by a seizure at the time. December 31, I was taken to the  Emergency Department and was there until January 01, 2022. I was then prescribed Keppra 500mg and given a referral to the Neurology clinic for an EEG. On January 31, 2022, I had my first EEG. On February 06, I had my second and third EEG. I had my fourth EEG the next day. And I had my last EEG on the 08. On February 08, I was also prescribed Zonisamide 200 mg to replace my Keppra. I have to take two 100 mg pills every morning.      I had a seizure on March 16 at 11:20 AM. I sat in bed and started chewing and repeating, "no." My subsequent seizure was on March 18 at 03:00 PM. I had eight seizures on April 07, one on the 19, and two on the 20. On May 14, at 08:07 AM, I had a convulsive seizure lasting three minutes. I then had a focal seizure at 01:53 PM. On May 15, I had four episodes. On June 05, I had two seizures; my first one was at 06:22 AM, and my second one was at 07:04 AM. The first one at 06:22 AM consisted of me chewing and moaning as usual, but the one at 07:04 AM, I started to pinch myself along with the chewing and moaning. It lasted four minutes. July 14, I had five convulsive seizures and three focal seizures. One lasted as long as ten minutes and another as long as seven. None of them lasted shorter than three minutes. I was taken to the ER at Hospital, where I was given Ativan to stop my seizures. On August 31, I had seven and was retaken to the hospital, where I was given Ativan. On September 01, I had five. I also saw black dots in my right eye that only moved when I moved.
pain, redness, and swelling at injection site; pain, redness, and swelling at injection site; pain, redness, and swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain, redness, and swelling at injection site), VACCINATION SITE ERYTHEMA (pain, redness, and swelling at injection site) and VACCINATION SITE SWELLING (pain, redness, and swelling at injection site) in a 33-year-old female patient who received mRNA-1273 (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain, redness, and swelling at injection site), VACCINATION SITE ERYTHEMA (pain, redness, and swelling at injection site) and VACCINATION SITE SWELLING (pain, redness, and swelling at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain, redness, and swelling at injection site), VACCINATION SITE ERYTHEMA (pain, redness, and swelling at injection site) and VACCINATION SITE SWELLING (pain, redness, and swelling at injection site) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-042533 (Patient Link).
diziness; aches and pains; vomitting; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (diziness), MYALGIA (aches and pains), VOMITING (vomitting), CHILLS (chills) and PYREXIA (fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced DIZZINESS (diziness), MYALGIA (aches and pains), VOMITING (vomitting), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PHENIRAMINE at an unspecified dose and frequency. On 01-Feb-2021, DIZZINESS (diziness), MYALGIA (aches and pains), VOMITING (vomitting), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, COVID-19: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
dizzy; Feeling sick; vertigo; Difficulty in standing; vestibular neuritis; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), MALAISE (Feeling sick), VERTIGO ( vertigo), DYSSTASIA (Difficulty in standing ) and VESTIBULAR NEURONITIS (vestibular neuritis) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B2NA and 001B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE for Sleep disorder, VITAMIN C [ASCORBIC ACID], LYSINE, MULTIVITAMINS [VITAMINS NOS], LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS PROBIOTIC), ASPIRIN [ACETYLSALICYLIC ACID], BIOTIN, FAMOTIDINE, MELOXICAM, TELMISARTAN (MICARDIS), ESCITALOPRAM, ROSUVASTATIN, METHOCARBAMOL (ROBAXIN), METFORMIN and OXYCODONE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (dizzy), MALAISE (Feeling sick), VERTIGO ( vertigo), DYSSTASIA (Difficulty in standing ), VESTIBULAR NEURONITIS (vestibular neuritis) and NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy) and NAUSEA (Nausea) had not resolved and MALAISE (Feeling sick), VERTIGO ( vertigo), DYSSTASIA (Difficulty in standing ) and VESTIBULAR NEURONITIS (vestibular neuritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: abnormal (abnormal) Vestibular neuritis.         Patient was prescribed to took meclizine , but declined to take. Patient was taking stool softener 100 milligram as concomitant medication.
pt recv vax 21MAY98 & 22MAY98 devel temp of 101.5 on 23MAY98 T99.7;24MAY temp 104.0, + sz activity, inc resp distress transferred from inpt floor to stepdown unit;
9-24-17 Malaise, h'ache inj site red, tender. 9-25-17 Temp 104.5+ vomiting, confusion, severe h'ache. ER-IV fluids, packed in ice. Admitted. 9-26-17 Discharged.
p/vax pt exp shock-like reaction was unresponsive & limp for 1-2 minutes per mom; reaction occurred approx 20 min p/recvd vax;
within 24 hrs of the 2nd dose, I developed  what they thought were a shingles like rash to my face. Swelling in my lower legs up to groins so extreme that my lower extemiyi malar rash to my face,  uticaria all over my body , hidradenitis suppuritiva (face, legs, Raynauds, Systemeic Lupus Eurythramatosis symptoms, brain fog, insomnia, anxiety - primary care treated with steroid and topical creams.
NAUSEA; DIZZINESS; WEAKNESS; ARM PAIN; THROAT PAIN; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20/JUN/2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 09-APR-2021, the subject experienced throat pain. On 09-APR-2021, the subject experienced arm pain. On 09-APR-2021, the subject experienced headache. On 19-APR-2021, the subject experienced dizziness. On 19-APR-2021, the subject experienced weakness. On 19-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat pain, arm pain, and headache on APR-2021, and had not recovered from nausea, weakness, and dizziness. This report was non-serious.
pt recv vax 20MAR84 & in 1994 pt exp SOB, hives;pt had mono-meningitis & hepatitis that was never dx but liver enzymes were high;the mono & liver enzymes were not felt to be r/t vax;pt hosp about 4 days;
day 1 and 2 injection site pain, day one swollen  glands  Narrative:
started  having symptoms on 30DEC2021/tested positive on 01 Jan 2022; lightheaded/dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 (Lot number: FL0007) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 30Dec2021, outcome "not recovered", described as "started having symptoms on 30DEC2021/tested positive on 01 Jan 2022"; DIZZINESS (non-serious) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "lightheaded/dizzy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19, dizziness.  Additional information: The patient started symptoms on 30Dec2021 and tested positive on 01Jan2022. The patient was scheduled for his second dose on 21Jan2022. Reporter was asking if patient needs to test negative before getting the second dose.  Follow-up attempts are completed. No further information is expected.
SWELLING, REDNESS at SITE.  DIAGNOSED WITH CELLULITIS AT URGENT CARE CLINIC.  RECEIVED ORAL ANTIBIOTICS.
developed a red, raised, itchy area 3 inches by 5 inches at injection site 8 days after receiving the vaccine. Area less red and itchy at this time.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On an unknown date in 2012, the patient was treated by a physician for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Post flu shot found unresponsive and rigid. Not breathing - two rescue breaths, CPR started; second breath given - after second breath client took self induced breath - became alert. 911 called - transported to medical center.
administered a booster dose of Menactra that was expired by 5 days with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional via A (Reference number- 00617105) and transmitted to Sanofi on 26-Apr-2021. This case involves a 20-year old male patient who administered a booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was expired by 5 days (expired product administered) on 26-May-2021 (lot number: U6594AA and expiration date: 21-May-2021] at an booster dose of 0.5 ml once (total) via intramuscular route in the left deltoid for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination was not reported.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd 4 doses of Engerix-B & was determined to be a non-responder;
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 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8733), on 16Apr2021 as dose 2, single (Lot number: EW0151) and on 26Aug2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: PENTASA, start date: 01Feb2006; 6-MP, start date: 01Oct2007; Aurobindo (birth control pill) on 01Sep2013; Vitafusion multivitamin on 01Jun2017. Past drug history included: Sulfa drugs, reaction(s): "Known allergies: Sulfa drugs". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (27Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient received other medication in 2weeks. Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 18Jul2022, Treatment stop date: 22Jul2022.
Client previously vaccinated with Moderna for first 2 vaccinations. Client given 3rd dose vaccine of Pfizer
chest congestion had worsened  than the last time; felt like she had the virus all over again; shortness of breath; lightheaded; felt very weak; Diarrhea; Vomiting; Nausea; fever of 101.8 F; Headache; body hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath) and DIZZINESS (lightheaded) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Syndrome lupus.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath), DIZZINESS (lightheaded), ASTHENIA (felt very weak), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), PYREXIA (fever of 101.8 F), HEADACHE (Headache) and MYALGIA (body hurt so bad). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath), DIZZINESS (lightheaded), ASTHENIA (felt very weak), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), PYREXIA (fever of 101.8 F), HEADACHE (Headache) and MYALGIA (body hurt so bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) 101.8 F..         No concomitant medication was provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-073200, MOD-2021-066597 (Patient Link).
sharp pains in the lower left lung.   went to ER -- x rays didn't show anything / white blood count was high.    next day rash on stomach.  advised could be shingles  --currently on Valacy clovir
Patient reports that arm was very black and blue after vaccination.  In addition, 4 days after the vaccine on 7/23/2019 patient developed a rash and pain on her back and side, and sought medication care from her PCP who diagnosed her with shingles.
Shingles; This is a spontaneous report from a non-contactable nurse (patient). A 35-year-old female not pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on an unspecified date (Lot number was not reported) as single dose (at age of 35-year-old) for covid-19 immunisation. Medical history included Hereditary haemorrhagic telangiectasia (HHT) and allergies to sulfa. Concomitant medications were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on unknown date for Covid-19 immunisation. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On an unspecified date patient experienced shingles. Event resulted in Emergency room/department or urgent care, patient was treated with Antiviral,steroid, pain medication. Outcome of the event was unknown.  Follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
with only mild GI symptoms as a reaction; This is a spontaneous report from a contactable consumer or other non-HCP. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced with only mild GI symptoms as a reaction. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) same reporter/drug/event, different patient.
caught COVID-19 after first vaccine; caught COVID-19 after first vaccine; This is a spontaneous report from a contactable physician. A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Aug2021 16:00 (Batch/Lot number was not reported) (at the age of 21-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Attention deficit hyperactivity disorder (ADHD) from an unknown date and ongoing, vitamin d deficiency from an unknown date and ongoing. Concomitant medications included methylphenidate hydrochloride (CONCERTA) taken for ADHD from an unspecified start date and ongoing; colecalciferol (VIT D3) taken for vitamin d deficiency from an unspecified start date and ongoing. The patient caught covid-19 after first vaccine on an unspecified date and then when he had the second vaccine he had fever, chills and fatigue. The patient had covid infection between dose1 and dose2. Vaccines were not given at this clinic. Not treated for covid here. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Aches and Pains, Tiredness Low energy starting within hours after vaccination. Lasted about 1 week. On May 2, 2021 (19 days after vaccination) intense weakness and shortness of breath. Treated at the Emergency Room  of Hospital. Chest x-ray used to diagnose pneumonia. Treated with Amoxicillin. Discomfort lasted over one week.