chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/15/10 arm developed blotches, was hot to the touch and swollen. 1/14/10 arm became sore in the evening.
7/5/2021 he started to notice numbness in his neck and shoulders, which he related to a possible pinched nerve.  On Tuesday, 7/6 he noticed increasing numbness to neck a.m. shoulders with new onset left fingers tingling as well as bilateral feet, at which time he started taking Excedrin. On Wednesday, 7/7 he noticed increasing neck pain and numbness with his "entire spine "painful.  On Thursday, 7/8 he noticed increase BL feet numbness. Today, 7/10 he woke up with numbness to the left side of his face, facial droop, mumbled speech and continued numbness to left fingers and BLE feet, for which he came to the ED for further evaluation management.  Patient is currently hospitalized in ICU at the time of this report.
PAIN IN UPPER BACK AND ACROSS  SHOULDER; FLU LIKE SYMPTOMS; JOINT PAIN; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic hip pain, sepsis-staph infections collected in right hip, seasonal allergies, nerve pain, alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with promethazine for nausea, drug allergy when treated with azithromycin, and doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included gabapentin for chronic hip pain, and nerve pain. On 11-MAY-2021, the subject experienced pain in upper back and across shoulder. On 11-MAY-2021, the subject experienced flu like symptoms. On 11-MAY-2021, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 101.8 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and joint pain on 12-MAY-2021, and had not recovered from pain in upper back and across shoulder. This report was non-serious.
About 5 minutes after leaving the Pharmacy I got into my car. Before I had driven even a block my eyesight because blurry, like I was in a mirror fun house, which made me stop the car. This lasted for maybe less than 10 seconds. Since then I have not experienced this side effect or any other side effect.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of covid symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details for Covid-19 Treatment included; Brand: Paxlovid, treatment start date was 06Nov2022 and treatment stop date was 10Nov2022.  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.; Sender's Comments: Based on limited information in the case a possible causal association between the reported event COVID-19 , Drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Patient's mother stating her son received a tetanus shot lot # U0386AA last summer and developed a severe reaction. He developed a fever of 101F, headache and his arm was red. Her son was not seen by a physician until 4 days post vaccination and by then he was "ok". She stated in her letter that the physician told her to contact us to find out what was in the vaccine so that this does not happen again. She also stated that her son has a past medical history of "reacting" to things and is under the care of an allergist.
became acutely ill w/fever of unk origin; fever was 104; adm to hosp ICU;
Excess bleeding at time of injection that bled through the bandaid along with arm soreness lasting longer than 1 week thus far and very slowly improving.
6 hrs after flu vaccine: 10/7/13 right lower eyelid twitched intermittently until 10/21/13, then on 10/24/13 awoke to discover right face paralysis/numbness and was diagnosed by MD as Bell's Palsy. Rx Acyclovir and Prednisone.
Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted Pfizer and IM/ID physician.  Will re vaccinate in 5 days.  Arm very painful, lump under acromion process. Feels like bursitis.
bad allergic reactions; itchy on my hand, fingers and feet; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, administered in Arm Left on 14Feb2021 09:45 as DOSE 1, SINGLE for COVID-19 immunization. Patient is allergic to Solumedrol, Methylprednisolone and Penicillin. Patient took shots of methyprednisolone and Solumedrol shot, 2 weeks before the Pfizer vaccine shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient had a bad allergic reaction off the methyprednisolone and Solumedrol shot. Possibly patient still had it still in the system. Patient had had itchy on the hand, fingers and feet from the Pfizer vaccine shot on 14Feb2021. Adverse event resulted in emergency room/department or urgent care and received treatment with Benadryl for the adverse event. Event recovered on an unspecified date. Since the vaccination, patient underwent sars-cov-2 test/nasal swab: negative on unspecified date.  Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Dose administered after 30-day Use By Date/01Oct2021 7 doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/01Oct2021 7 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/01Oct2021 7 doses). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/01Oct2021 7 doses) had resolved.        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.
Information has been received from a nurse practitioner referring to a patient of unknown age. Concurrent condition and medical history were not reported. It was reported that the patient was administered the first two doses of ENGERIX-B (dose, route and lot# not reported) on unspecified dates and then was administered the third dose in the series with RECOMBIVAX HB (dose, route and lot# not reported) on an unspecified date (Interchange of vaccine products). No adverse effect reported. Additional information has been requested.
swollen Lymph nodes in left neck/clavicle area; This is a spontaneous report from a contactable pharmacist. A 52-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via intramuscular route of administration in the right arm on 01Feb2021 (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Medical history included breast cancer (CA) female "13 years post breast CA, chemotherapy and mastectomy". The patient's concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 01May2021, the patient developed swollen lymph nodes in left neck/clavicle area. CT scan done (unspecified date in May2021 with unknown results). When visited oncologist for evaluation (unspecified date in May2021), node was negative but the oncologist noted they were seeing this in post -CA patients. He acknowledged it was a bit farther out than usual, the vaccine was a possible reason. The clinical outcome of the swollen lymph nodes in left neck/clavicle area was resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "swollen Lymph nodes in left neck/clavicle area" cannot be completely excluded based on temporal association.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: drank some water-, had 2 glucose tablets and after 30 minutes was fine
This case was reported by a nurse via sales rep and described the occurrence of injection site induration in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site induration. On an unknown date, the outcome of the injection site induration was unchanged. The reporter considered the injection site induration to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. In 2016, 3 weeks before the reporting date, the patient received BEXSERO. The patient experienced a full knot, like a hard ball at the injection site. The field representative was unable to provide any further details and did not have the last name of the initial reporter. The field representative advised to contact another nurse to obtain further details and the contact details were provided from the same. The nurse usually did not come in to the office until 3:00 pm.
Around July of 2021, my shoulder had been hurting prior to that but not a nagging pain, but after I received my shot in the left arm the pain started radiating down through my arm to my thumb. Every night around 2-3 o'clock in the morning, the pains wake me up out my sleep. My whole left arm/shoulder all the way down to my thumb I have pain that is hard to describe. It hurts every night. During the day it doesn't hurt, but every night it hurts around 2-3 o'clock at night. Also, up in my chest by my collar bone is sore to the touch. I contacted my doctor on August of 2021 or, and explained my pain and my doctor told me to contact the other doctor, who is my orthopedic surgeon. I saw my surgeon on Aug 20th, 2021. When I saw my surgeon, he did an X-ray and examined my left arm/shoulder to see what was going on. I cannot find my x-ray results, but it said something about my rotator cuff. I think it was some inflammation in the rotator cuff and doctor gave me some exercises to do to see if it would help with the pain. On September 21, 2021, I went to my PCP and did an EKG, and this EKG differed from my previous EKG test. I am scheduled to take a stress on Oct 5, 2021, for the pain in my chest., with my PCP.
Swelling and redness of L upper arm. (12 cm x 13.5 cm).
We both got the Pfizer vaccines and now we are both taking Paxlovid; We both got the Pfizer vaccines and now we are both taking Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "We both got the Pfizer vaccines and now we are both taking Paxlovid". Therapeutic measures were taken as a result of covid-19.  Clinical course included Reporter states that he is on his 2nd day of taking Paxlovid. Reporter states that his doctor told him to stop taking Lipitor while taking Paxlovid. Reporter states that his doctor told him to continue taking his blood pressure medicine Lisinopril and Hydrochlorathiazide. it was reported that Referred Reporter to follow up with his doctor for clarification and informed Reporter not to stop taking any medications before first consulting with his doctor.Reporter is a male consumer who is calling on behalf of his wife, withheld (female), who was prescribed Paxlovid today and just picked up her prescription from the pharmacy. Reporter states that both he and his wife have both been vaccinated with Pfizer Covid19 vaccines. Reporter states "it is 3pm here now and my wife would like to know if she should take her 1st dose of Paxlovid now or wait until this evening" Reporter also states "I started my Paxlovid yesterday at 9:00 and then took my evening dose at 9pm and then my morning dose this morning at 9:30.  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-202200727764 same reporter/drug/event, diff patients
dizziness, It only occurs when I am sitting down or still; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 18Mar2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included PCOS (Polycystic ovary syndrome), anemia (at the time of this report the condition was reported as on and off, slightly above borderline Anemic). The patient was allergic to minocycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Concomitant medications included birth control, magnesium and zinc vitamin (MANUFACTURER UNKNOWN), vitamin d3(MANUFACTURER UNKNOWN) for unknown indication from unknown date. On 19Mar2021, the patient experienced dizziness only when sitting down or still. It was reported that patient was worried about receiving the second dose. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event dizziness. The clinical outcome of dizziness only when sitting down or still was unknown at the time of this report.   Information about lot/ batch number cannot be obtained. No further information is expected.
Patient states after 2 months site of injection is still bruised as well as painful to touch.
flare sign encephalitis; This spontaneous case was reported by a physician and describes the occurrence of ENCEPHALITIS (flare sign encephalitis) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ENCEPHALITIS (flare sign encephalitis) (seriousness criterion medically significant). At the time of the report, ENCEPHALITIS (flare sign encephalitis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that a young man after receiving the second dose of Moderna Vaccine experienced flare sign encephalitis.  No concomitant medications were reported. No treatment medications were reported.  Company Comment: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Encephalitis (reported as flare sign encephalitis). The event occurred on an unknown date after receiving the second dose of mRNA-1273. Presenting symptoms, clinical course, diagnostic procedures conducted and treatment details were not provided in the case. The patient also experienced vestibulitis (unspecified anatomic location) after the first dose but the etiology and disease course were not specified. There is insufficient information to assess whether the reported illnesses were related and if caused by the same infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-589814.; Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Encephalitis (reported as flare sign encephalitis). The event occurred on an unknown date after receiving the second dose of mRNA-1273. Presenting symptoms, clinical course, diagnostic procedures conducted and treatment details were not provided in the case. The patient also experienced vestibulitis (unspecified anatomic location) after the first dose but the etiology and disease course were not specified. There is insufficient information to assess whether the reported illnesses were related and if caused by the same infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient had abdominal pain with vomiting last night. Abdominal pain and vomiting now gone but now with weakness and decreased appetite.
Received Pediarix and Prevnar 2/19 in afternoon. Parents gave Tylenol that day. Developed fussiness in late afternoon 2/20. Cried so hard, she vomited. Dozed on and off, but cried a total of 5 hours.
10:55 AM patient reported 10-15 minutes - post vaccination c/o itching tingling over right eye. Itching/welt feeling over lip area and itching/burning sensation in right upper arm area. V/S noted stabled - B/P increased d/t hypotensive -  not taken med in several days. B/P 14/100 25 mg BENADRYL given - po, at 11:10 patient noted s/s had stopped no problems noted via s/s.
pt recv vax & exp poss sz;pt felt warm given APAP;15mins later mom reports was lying on the floor & began to cry vigorously for about 30seconds in a way that she had never heard pt cry before;limp & stopped breathing;lethargic;t38 R;
5SEP91 PT woke up about 930PM screaming for a short time; had low grade fever; was given a tepid bath; became limp; unable to maintain balance; eyes rolled back in head; 6SEP91 ate good lunch; no other episodes of limpness or inc T;
Narrative: Pfizer vaccinated pt admitted overnight for COVID, not boosted, Pt readmitted w/i 24 hrs of discharge for ileus requiring NGT. Resolved with conversative measures.
Headaches, fever, rash, throwing up, heart rate uncontrollable until seen by medical specialists. It?s been 3 months, I haven?t felt better since the day I took the vaccine
Headache one week after first days,  headache again after 2nd vaccine took Advil.
pt recvd flu vax & 3 wks later devel viral encephalitis & was hospitalized;
The patient experienced no symptoms; a patient was administered an expired dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 31-JAN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly, lot# R031045, expiration date: 18-NOV-2019 (exact dose and site of administration were not reported) for prophylaxis. The patient did not experience any symptoms.