chrisvoncsefalvay/vaers-outcomes huggingface dataset:
almost died from prevnar vaccine; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A male patient (grandson) of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The reporter did not engage a doctor, health care professional or pharmacist to get vaccinated in the past 3 months as the patient almost died from prevnar vaccine. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
I just feel it is like had a weigh on my entire body/ I am feeling like I got run over; Chills; Fever; This is a spontaneous report from a contactable nurse (patient). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 29Jan2021 16:00 at single dose for COVID-19 immunisation. The patient had no medical history and no concomitant medications. On 30Jan2021, when he woke up in the morning, he felt like had a weigh on his entire body and got up and he just instantly started having chills, and fever usual (statement incomplete). He looked at all the symptoms of getting the vaccine and he had like 98 percent of them that was just normal, just like a flu. But he was travelling tomorrow morning at 5am and he don't want to travel right now. He still have a fever on and off. He doesn't know if it was safe enough to go on a plane after getting my first dose and how long the symptoms will last. The patient felt like he got run over. His wife got her second dose a couple of days ago and had really bad reactions like flu and could not move all day and that was a Moderna one. Patient stated that he was 6 ft; however, not appropriately paraphrased and clarified. The patient received unspecified treatment for the events. The patient considered a causality between the event because of the vaccine. Outcome of event fever was not recovered; outcome of the rest of events was unknown.  Information about Lot/Batch number is requested.
Tinnitus (ringing in ears) Slowly got better after 30 days but still persists.
little pain at injection site; redness and itching at the injection site; itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE ERYTHEMA (redness and itching at the injection site) and VACCINATION SITE PAIN (little pain at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and itching at the injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (little pain at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE ERYTHEMA (redness and itching at the injection site) and VACCINATION SITE PAIN (little pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous case reported by a pharmacist, describes the occurrence of inappropriate schedule of product administration (more than 2-month interval between both doses of Moderna COVID-19 vaccine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 051C21A) for COVID-19  immunization. No medical history reported. On May 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jul 19, 2021, patient experienced inappropriate schedule of product administration (more than 2-month interval between both doses of Moderna COVID-19 vaccine). At the time of the report, inappropriate schedule of product administration (more than 2-month interval between both doses of Moderna COVID-19 vaccine): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Shot received 10/1/18 - on 10/2/18 upon awaking - red raised area about 1 to 1 1/2 inches below injection site about 7-8 cm wraps around to bicep area - warm to touch - not itchy - saw a nurse practitioner - no meds prescribed - on 10/3/18 - pt self medicated with BENADRYL - cortisone cream - cool compresses - 10/4 - better this am subsiding some. No other symptom or c/o.
(L) facial paralysis. 3/7/08-records received-1/9/08-C/O left side of face crooked when mouth is open. Seen in office on 1/10/08-Bell's Palsy. 1/17/08-left side mouth still swollen. 1/24/08-Bell's Palsy resolving.
This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and Unknown) for COVID-19 immunisation.     No Medical history was provided by the reporter.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with ACETAMINOPHEN for Headache, Nausea and Dizziness, at a dose of UNK dosage form. At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            The patient took Acetaminophen for as treatment for the events. The patient was feeling little better as of the reporting date. No information of HCP or concomitant medication was provided.
Got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: This case was reported by the consumer via interactive digital media. The reporter's stepmother received second dose of Shingles vaccine and right after vaccination the patient got shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Got his vaccine, had no problems whatsoever.   On Sunday, 4/4/21 he was at a friends house and they were getting ready to go to family's house, his heart started feeling funny, started beating fast, and could feel his heart beating in his neck.  He tested his blood sugar which was okay, and he asked his wife to take him to the fire department.  They said his heart was beating out of his chest.  They took him to Hospital and told him that he had atrial fibrillation.  They kept him in the hospital for 2 days and gave him medications and now he's feeling much better.   They gave him Coumadin for this.
12 - 30 - 13 fever 102, soreness, redness, swelling 12 - 31 - 13 Dr appt. temp, 102.4, red blanching blotchiness around injection site, tender to touch  1 - 1 - 14 cellulitis, 1 - 2 - 14, f/u 1 - 3 - 14 f/u 1 - 4 - 14 1 - 6 - 14.
BODY ACHE; HEADACHE; FEVER 102.7 F; This spontaneous report received from a patient concerned a male 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: Unknown) dose was not reported, administered on 11-APR-2021 15:00 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On 11-APR-2021, the subject experienced body ache. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever 102.7 f. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.7 F, and COVID-19 virus test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, and fever 102.7 f. This report was non-serious.
Pt recvd 1 dose of Engerix-B 31OCT91 & 1NOV91 exp eczema which was not only a skin rash, but red, itchy, inflammed rxn, all over body; tx antihistamines; 1NOV91 events still persisting;
cough; fluid buildup in lungs; elevation in blood pressure; hoarseness; diarrhea; vomiting; This is a spontaneous report from a contactable physician, based on information received by Pfizer(manufacturer control number: EC-2021-087665), for BNT162B2.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization; and lenvatinib mesilate (LENVIMA), via an unspecified route of administration from Jan2021 (Batch/Lot number was not reported) to an unspecified date, at 20 mg, 1x/day; via an unspecified route of administration from 31Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 10 mg for endometrial cancer. Medical history included endometrial carcinoma, pleural effusion, and thoracentesis; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Keytruda infusions (drug therapy). It was reported that on 06Mar2021, the patient experienced vomiting and diarrhea. Oncologist was notified and advised the patient to stop Lenvima temporarily. The patient was also advised not to receive second COVID vaccine at this time. The patient was recently hospitalized for cough (unknown date of hospitalization or length of hospitalization). CXR (Chest X-ray) determined fluid buildup in lungs and thoracentesis completed. The patient had 650 ml of fluid removed. The patient resumed Lenvima and Keytruda infusions on 31Mar2021. The patient continued to experience hoarseness and elevation in blood pressure (unknown date of onset of symptoms). The patient is scheduled to repeat CT scans on 09Apr2021 and meet with oncologist next week to discuss results. Therapeutic measures were taken as a result of cough and fluid buildup in lungs. The action taken in response to the events for lenvatinib mesilate was temporarily withdrawn on an unspecified date. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided, there is no information to suggest a causal relationship between BNT162B2 and the reported events of cough and pleural effusion. This patients underlying malignancy with previous history of pleural effusion is assessed as a contributing factor. Case will be reassessed upon receipt of additional information. 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.
Allergic to 'adult flu shots' and can only take a child flu shot; This is spontaneous case initially reported by consumer via Patient Assistance Program to Communications (reference number: SEQ19-04829) on 16-Oct-2019, concerning an unknown age female patient.  The patient's medical history and concomitant medications were not reported.  On an unknown date the patient was administered INN Flu Vaccine [Influenza vaccine; route of administration: injection; batch number, expiration date, dose and anatomical location not reported] to prevent contracting Influenza.   On an unknown date the patient developed allergy to adult flu shots. It was reported that she can only take child flu shot.  The outcome of the event allergy to adult flu shots was not provided, at the time of this event.  The reporter didn't provide causality and seriousness assessment.  The patient refused to provide any additional information and didn't give permission to be contacted.  Event's causality was assessed as related to the suspect product per company.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
shingles; postherpetic neuralgia; This spontaneous report was received from a consumer concerning herself a female patient with currently 76-years-old. The patient's medical history and concomitant therapies were not reported. Her concurrent conditions included chronic dermatitis.   On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, unk (strength, lot #, expiry date, route of administration, and indication were not provided). After she had her vaccine she experienced shingles and postherpetic neuralgia off and on. On an unspecified date in October 2021, she had another vaccination with zoster vaccine live (ZOSTAVAX) subcutaneous injection, unk (strength, lot #, expiry date, route of administration, and indication were not provided) and a few weeks later she experienced again postherpetic neuralgia on the right side of her stomach that was still present. The outcome of the events was not reported.    The causal relationship between postherpetic neuralgia and shingles with zoster vaccine live (ZOSTAVAX) was not provided.
flu-like symptoms for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms for a couple of days) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms for a couple of days). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms for a couple of days) had resolved.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2022-439005 (Patient Link).
anxiety, mild chest tightness, shortness of breath.  resolved after 2 administrations of 25mg diphenhydramine.  patient remained in clinic for about 45 minutes before being discharged home.
Patient reports 5 minutes after getting covid vaccine she became flushed, heart was pounding and felt dizzy. Patient denies hx of allergic reactions.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554 with an expiration date 25-DEC-2017, lot#M023169 with an expiration date 13-JUN-2018, lot# M011840 with an expiration date 01-FEB-2018 and lot# M011117 with an expiration date 07-DEC-2017. Administered doses of GARDASIL 9 experienced temperature excursion with temperature range from 46.4 degrees Fahrenheit to 58.24 degrees Fahrenheit for 319 minutes. There was no previous temperature excursion. There was digital data logger involved. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
I am currently experiencing Covid-19 or Omicron symptoms.; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I am currently experiencing Covid-19 or Omicron symptoms.) 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. In December 2021, the patient experienced SUSPECTED COVID-19 (I am currently experiencing Covid-19 or Omicron symptoms.). At the time of the report, SUSPECTED COVID-19 (I am currently experiencing Covid-19 or Omicron symptoms.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.  Paitent reported their scheduled planning about Moderna booster on Jan 3rd. but  currently experiencing Covid-19 or Omicron symptoms. Also  a rapid test scheduled for Friday, Dec 31st.  Paitent stated about Query that If the test positive should  go ahead with the booster on Monday, January 3rd? If no, how long should need wait before getting booster? as well as If the test negative should  go ahead with the booster on Monday?.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow-up received contain non-significant information contact info updated.; Sender's Comments: This case concerns a patient of an unknown age and gender with no reported medical history, who experienced the non-serious, unexpected AESI of Suspected COVID-19. The event of occurred after an unknown dose sequence of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
06/22/2021 exercised :30 on stationary bike and not adverse effect. On the morning 06/23/2021 dizziness and started drifting to the left, reflux feeling, waited next day and going 6/24/2021. Hospital did blood sample and CT scan, results of the CT scan said it looks like a possible AVM and shonting and after that he was assigned a neurological interventionist. Wanted an MRI on 06/26/2021 , not AVM or shonting present do a brian anagram, told her that not AVM or shonting present do a brain anagram. 06/29/2021 release and said another MRI after two months on 08/18/2021. Has appoint with Dr. 09/17/2021. Hemorrhagic on right side of  brain intensive care neurological area. Another CAT scan with contrast stayed their for six days. Radiologist
Right arm, crusted spot surrounded by erythema at site of shot and axillary lymphadenopathy.
arm pain, tenderness for minimum of 2 weeks, occasional sore throat, fatigue, unexplained weight loss.  Experienced a mild seizure on 6-6-21.  I have never had a seizure before in my life.
1 of twins was fine following vax; 48 hrs later, devel uncontrolable screaming episode which lasted 2 hrs; pt devel purplish discoloration from mid thigh down (site unspecified); next day was back to nl;
After administering vaccination patient returned to pharmacy w/in 15 min and there were 2 large (size of a pencil eraser) above injection site, called doctor who prescribed VALTREX 1gm TID x 7 days and BENADRYL.
15 mins post shot, lightheaded. Drank water, then 8 oz orange juice from EMT.  Lasted several hours.  Then 30 mins post shot, acute sleepiness. Lasted 48 hours. Because of the above, would not have been able to dtive safely (luckily had spouse with me). No other reaction post shot.
5 minutes post vax, the pt complained of a temp, rapid heart beat, dizziness, not feeling well. 50-60 minutes post vax, still didn't feel well. Fingers felt clenched and tight. Still had feeling of temp.
pt recvd vax;  devel fever & arthralgia, w/ malaise; 2 rpts from same provider;
Immediately p/receiving vax pt became dizzy w/inc resp rate which lasted for 2 days; pt had a low grade fever, achiness, joint pain & extreme fatigue for 2.5 wks; c/o vision changes;
This spontaneous report as received from a physician refers to a 9 month old patient. On an unknown date the patient was vaccinated with a dose of ROTATEQ, (lot# not reported), oral. On an unknown date the patient experienced contracted rotavirus after received the ROTATEQ. The patient sought medical attention with physician and was prescribed dextrose, PEDIALYTES. Not lab diagnostic studies were performed. The patient was recovered and the AE improved due to the virus and symptoms subsiding on its own. This is one of several cases received from the same reporter. Additional information has been requested.
Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284746, 2018SA284747, 2018SA284721, 2018SA284749, 2018SA284750, 2018SA284751, 2018SA284752, 2018SA284753, 2018SA284754 and 2018SA284755. This case involves an unknown gender 37 months old who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: U1997AA, route: intramuscular, site of administration: left vastus lateralis, expiration date and dose was not reported) on 03-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Diagnosed as Ptosis; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at age of 48-years-old on 08May2021 (Lot Number: EW0172) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included haemochromatosis. No Covid prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 48-years-old on 09Apr2021 for COVID-19 immunization. The patient experienced In June started having slightly droopy left eye, which has gotten worse over time. Diagnosed as Ptosis. Left eye only. Hasn't gotten better, has slowly gotten worse over last several months. Adverse event start date: 04Jun2021. No treatment received for the event. The patient underwent lab tests and procedures which included sars-cov-2 PCR: negative on 26Sep2021 Nasal Swab. Outcome of event was not recovered. The event resulted in: [Doctor or other healthcare professional office/clinic visit, Disability or permanent damage]  Follow-up attempts are completed. No further information is expected.