chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received her 1st dose of the Pfizer-BioNTech vaccine on March 08, 2021. About a week later she started complaining of feeling fatigued, confused, and disoriented some days. These symptoms progressively got worse over the next 3 months. She received her 2nd dose of the Pfizer-BioNTech vaccine on April 05, 2021. A week later she mentioned waking up more disoriented in the mornings and would look at her hands and think to herself, "Who's hands are these?" She said she felt like she wasn't in her right mind. Soon after this she felt she couldn't go to the grocery store alone or drive because she might get lost. She never had symptoms of Dementia prior to March 2021. On May 10, 2021 I noticed she was moving slower and using walls to guide her through her home as she walked. She mentioned she felt more fatigued at this time. On the weekend of May 21, 2021 we took a trip for her birthday and she was mentioning how it was a struggle for her to pack for the trip because she couldn't think clearly and had made a mess in her room trying to find her clothes. She was a very tidy & organized person, so this was very unusual. A week after the trip she mentioned losing some strength in her left leg and needing to lean on walls as she walked through her home. On June 4, 2021 the weakness got worse and she mentioned she felt more "off" and wanted to shower before heading to the hospital to be evaluated - when she got out of the shower she completely lost strength in her left leg and fell to the ground, but was conscious. She was taken to Hospital where a CT scan was done that showed brain swelling and a mass. She was then transported to Medical Center where an MRI was done, confirming the swelling and 4cm mass - doctors there believed it could be a Glioblastoma and mentioned it is very aggressive.  When asked if the vaccine may have caused this, we were quickly dismissed and told there could be no connection at all. After further research we found that GBM (Glioblastoma) could grow as quickly as .5mm per day and when calculating the time between her 1st dose and her hospitalization (approx. 90 days) it equated to 4.5cm, her mass was 4cm. Even if there was a mass there before her vaccine, there is reason to believe it may have been aggravated by the vaccine.   Surgery was suggested, but after 4 days she expressed that she wanted to opt out of the surgery and pursue a second opinion or natural treatments. She was discharged on  June 9, 2021 and taken home with medication. She was more alert and lively at home - able to converse and move around with assistance, but did not have strength in her left leg and was losing more strength in her left arm. On June 13, 2021 she suffered a heart attack and was rushed to the emergency room by ambulance. CPR was performed in the ambulance and she was taken to Hospital where they stabilized her but she never regained consciousness. She was taken home for Hospice on June  16, 2021 and passed away on June 19, 2021.
Pt suffered right Posterior cerebral artery occlusion; This is a spontaneous report from a contactable physician (reporting for a patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 30Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 56 years old. Medical history included hyperlipidaemia and hypertension from an unknown date and ongoing, both well controlled. Concomitant medications included atorvastatin and hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of bnt162b2 for covid-19 immunisation on 09Mar2021 1200 (intramuscular left arm) and terfenadine and experienced allergies. The patient suffered right posterior cerebral artery occlusion (hospitalization, life threatening) on 01Apr2021 treated with mechanical thrombectomy with stent placement. Event required emergency room visit.  The patient was hospitalized for suffered right posterior cerebral artery occlusion for 4 days on Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Apr2021. Outcome of the event was recovered on Apr2021 with sequelae (Recovered with lasting effects).  Information about Lot/batch number is requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Posterior cerebral artery occlusion cannot be excluded.  However, the medical history of hyperlipidaemia and hypertension may provide plausible alternative explanations for the events.   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.
A few hours after treatment this child was crying a lot, and uncomfortable. Woke up a few times more that night. She felt warm to the touch. He was uncomfortable. About 2-3 days after that he was not looking at his parent when she called his name and this strange behavior continued. The patient lost all eye contact, and did not say anymore words.
pt recv vax approx MAR94 & since the vax exp elevated SGOT & GGPT; No further details were provided;
This spontaneous report as received from a pharmacist, as part of a marketing research program refers to a female patient in early 60's. The patient did not have any relevant conditions and did not take any concomitant medications. On an unknown date (also reported as "sometime in 2012-2013") the patient was vaccinated with a dose ZOSTAVAX (dose volume, route of administration, lot number were not reported). On an unknown date the patient developed a rash that looked to originate from the injection site and went around three-fourth of her arm. The patient called the pharmacist next day to ask what to do and said it was a little itchy. There was no lab studies performed. The rash resolved in 3-4 days (date unspecified). The outcome of the event was reported as recovered/resolved. The reporter considered the causality between the event and ZOSTAVAX as related. Additional information has been requested.
bleeding on the left side of his brain that later spilled to the right side of his brain; Felt hot like he had a fever; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (bleeding on the left side of his brain that later spilled to the right side of his brain) and PYREXIA (Felt hot like he had a fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (bleeding on the left side of his brain that later spilled to the right side of his brain) (seriousness criteria death and medically significant) and PYREXIA (Felt hot like he had a fever) (seriousness criterion death). The patient died on 24-Apr-2021. The reported cause of death was bleeding in brain. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Computerised tomogram: bleeding on the left side of his brain that later spilled to the right side of his brain.         Very limited information regarding these events have been provided at this time. Patient's age can be a confounding factor to the events. No further information is expected.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Upon internal review on 16-SEP-2022 non-significant correction was performed to update the case received from field. On 27-May-2021: Suspect product lot number updated.; Sender's Comments: Very limited information regarding these events have been provided at this time. Patient's age can be a confounding factor to the events. No further information is expected.; Reported Cause(s) of Death: Bleeding in brain
Skin rash papular pustular upper back and buttocks, right ear drainage and right face swelling noticed by mother, 4 days after MMR. Right ear drainage and right face swelling resolved. Skin rash persisted.
The injection caused pain in the shoulder area. Affecting the whole shoulder joint. Was not able to extend, swing, or move my should for at least a few months with out plans.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: Fc3184) and on 31Mar2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 72 years 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 included: "Usually stable moderate severe asthma on maintenance meds" (unspecified if ongoing), notes: Usually stable moderate severe, asthma on maintenance meds. Concomitant medication(s) included: PREDNISONE, start date: 09Jul2022, stop date: 20Jul2022; MONTELUKAST; LISINOPRIL; OMEPRAZOLE; ASA; SYMBICORT; INCRUSE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (Jul2022) Positive, notes: Now on day 14 since Covid I am still testing positive on home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Covid-19 treatment was with paxlovid on 09Jul2022 and stopped on 13Jul2022. Reported that the started 5 days of Paxlovid. On day 1 patient's expected URI viral induced asthmatic bronchitis was the mildest ever compared to other URI induced asthmatic bronchitis he had. Prednisone was also started from 09Jul2022 to 20Jul2022 as usual early in URI because of patient's experience with asthmatic bronchitis exacerbations. Within 2 days of finishing 5th day of Paxlovid, patient's asthmatic bronchitis worsened requiring rescue inhaler/ nebulizer. Now on day 14 since Covid patient still testing positive on home test and the bronchitis is pretty typical of any other post URI asthmatic bronchitis. As per patient Paxlovid effectively minimized the effect of the virus on his asthma for 6 to 7 days but without it now, his bronchitis was worse, though it was a typical post URI. The patient has no known allergies.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Patient called yesterday afternoon. She stated the following: She had soreness the day of the vaccine. In the evening, she felt a sensation in her arm, leg, and ankle. Twelve hours after receiving the vaccine, her whole body felt like it ripped apart. She said it was a 10/10 on a pain scale. That pain lasted through the night. At 2pm or 3pm the next day, her pain backed away to a 5 or 6, which is not uncommon for her.
In addition to expected flu-like side effects, four days after this 2nd dose brought on spells of vertigo, ear pressure, ear pain, pain behind the left eye, slight blurred vision, and intense brain fog. Patient waited for symptoms to resolve for two weeks after onset before seeing a doctor on May 10th and being diagnosed with Eustachian Tube Dysfunction. Symptoms improved with a 7 day course of Prednisone, but upon finishing the medication the symptoms and inflammation returned. Patient is still dealing with these effects.
Red rash  within a few days.  Is about 2 inches in diameter and is warm to the touch but no pain.
I experienced a bubble on the side of my knee, it doesn't hurt when you touch it, but it is warm, and they put me on a strong dose of Ibuprofen, and I also experienced a lymph node under my armpit.
Case number PHEH2016US030851, is an initial spontaneous report received from a physician via Pfizer Inc on 22 Nov 2016. This report refers to an adult female patient. Past medical history was not reported. Current condition included as allergy to LOVENOX, all calcium channel blocker, Vitamin C, Ferrous sulfate, Multiple Vitamin, Vitamin D3, ZYRTEC, NEURONTIN, REVATIO, Metoprolol ER, Tizanidine, Promethazine, Duloxetine, Dicyclomine, Pantoprazole, Amoxicillin, XARELTO, Bumetanide, Metolazone, Biotin, Pravastatin, NORCO, Calcitriol, HYSLINGA ER, Cyanocobalamin, Folic Acid, Calcium Citrate, VSL 3 Probiotic, VESICARE, SYMBICORT, SYNTHROID and Ondansetron. Concomitant medications was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unspecified date, the patient had allergy to FLUVIRIN. The outcome, seriousness and causality of the event were not reported.
according to mom noticed pt shivering while was eating lunch;1:30 mom gave APAP 1:45 pt became pale & limp & dec responsiveness;parents took pt to ER about 3PM; unresponsive, warmth x 2 T102.2R
pt recvd vax 30JUN95 & 16JUL95 pt devel 20 lesions all over trunk & arms;No further details were provided;
NO adverse events. Vaccine 2nd dose given 21 days apart from 1st dose as patient will be discharged from the rehab and will not be able to get vaccine next week as he is resident in different state and was hospitalized in another state and due to difficulties getting an appointment for vaccine. Patient with multiple medical problems and complex hospitalization and getting 2nd dose of covid vaccine 21 days apart from 1st dose is more beneficial rather then not getting 2nd dose. Patient was explained that getting 2nd dose 21 days apart from 1st dose is deviation from the protocol-patient verbalized full understanding and agreed to get 2nd dose as he feels strongly he will not be able to get the dose in the community next week.
This spontaneous case was reported by a pharmacist and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (Received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (Received dose from vial that had black particulates in previous syringe) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (Received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (Received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, LIQUID PRODUCT PHYSICAL ISSUE (Received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (Received dose from vial that had black particulates in previous syringe) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided.No treatment medication was provided. Pharmacist called because when she withdraw the first dose of a Moderna vial. she thought she got a piece of rubber stopper in the syringe. Then, she looked better and there were like black specks floating in it. Pharmacist also referred to them as black things. Even though this particular syringe was not used on any patients, pharmacist withdraw from this same vial and administered to 14-15 patients.
Breakthrough case admission after 2 vaccines Moderna 3/15/21 lot# 045A21A;  Moderna 4/2/21 lot# 037A21B
EDC 2/13/22 no fetal movements perceived beginning the day after receiving vaccine  patient was 22w5d on day of vaccine no FHR was detected on 10/22/2021
Mother called today states pain in arm. c/o pain in arm where needle given. As per mother, movement of arm less no Hx of loss of sensation upon questioning mother stated that he had some numbness in area where needle was given.
A report has been received from a Health Professional concerning a 53 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The health professional reported, that they inadvertently gave FLUMIST to a 49 years old patient which started on 02-Nov-2013. The outcome of the event of administration to individual over the age of 49 is unknown. The report was considered to be non-serious by the reporter.
Complains of soreness at site of DTAP. 7cm area of induration and redness; no fluctuance; limp secondary to sore muscle about 1 day after DTAP shot. Treated with warm compress. Local reaction only.
second dose in 6 weeks; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in 6 weeks) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in 6 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in 6 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported   Reporter did not allow further contact
mom stated child exp dizziness & lightheadedness p/vax;rash on arms, legs & face following rash hands & feet peeled;child's doctor notified;
Hospitalized during vaccination process; Missed dose; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Hospitalized during vaccination process) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalized during vaccination process) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, HOSPITALISATION (Hospitalized during vaccination process) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) 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.   Concomitant medication was not provided. No Treatment information was provided.  Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Swelling in face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling in face) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030A21A) for COVID-19 vaccination.  No medical history was provided by the reporter. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.  On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced SWELLING FACE (Swelling in face). At the time of the report, SWELLING FACE (Swelling in face) outcome was unknown. Not Provided          Relevant concomitant medication was also included blood pressure pill. Treatment medication was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, swelling face, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 02 JUN 2021 and updated adverse reaction verbatim and AR onset date.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, swelling face, a causal relationship cannot be excluded.
102 degree fever after both shots; chills, body aches... all lasting a day and a half.
The patient got a PNEUMOVAX shot in her right upper arm and developed a 4-5 cm raised erythematous patch which decreased over 24 hours. She has since been discharged.
1:05 pm pt got light headed and sweaty after leaving the office after getting a MCV4 vaccine and a Tdap vaccine.
t105 max temp (48 hrs p/DTP), unconsolable crying, loose stools, dec appetite; dx r/o bacteremia vs UTI; rxd w/Rocephin;
Fully vaccinated and booster 12/13/21.   COVID infection breakthrough and inpatient hospital stay for non COVID reason.
Explosive diarrhea; This is a spontaneous report from a non-contactable other healthcare professional. A 31-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration on an unknown date (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced explosive diarrhea. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event explosive diarrhea was unknown at the time of report.  No follow-up attempts are possible. No further information is expected
Prior to the pt's administration of the 1st Covid vaccine shot  (Moderna- Not administered by nurse) she had intermittent tremors. Following administration, they became more frequent (being addressed by PCP).  Due to this the patient did not want to get Moderna as the second shot to complete the series but requested that she received Pfizer. nurse discussed this with nurse practitioner who said that she could get the Pfizer as the second but a VAERS would need to be completed after. Pt waited 30 minutes after administration of Pfizer vaccination without any adverse reactions.