chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; This is a spontaneous report from a contactable consumer (patient's husband). A 28-year-old female received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3247, expiration date May2021) via intramuscular administered in left arm on 08Feb2021 (at the age of 28 years old) as single dose for COVID-19 immunisation. The patient medical history included Chronic kidney disease  (May2018), helps to lower protein in urine, iron was low, autoimmune disease, to stabilize the kidney. Patient got flu shot last year, months ago. Concomitant medications included Losartan50mg tablet twice a day by mouth used for chronic kidney disease, helps to lower protein in urine, Ferrous sulfate 325mg tablet, one tablet twice a day by mouth and Azathioprine 50mg tablet once a day by mouth. On 11Feb2021, the patient had experienced hives. The adverse event was not resulted in emergency room. Treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. Additional Context included Caller is the husband of the patient. His wife received the first dose of the vaccine on Monday 08Feb2021. She woke up today with itchy bumps around 7am this morning. She went to the dermatologist today at 1330 and the dermatologist confirmed it was hives. States nothing has changed with her aside from getting the vaccine. She has never had hives before. Treatment: She is prescribed a topical cream which has not been picked up yet, she was told take a Zyrtec Outcome: The hives are moving into different areas, some areas of the the itchiness has gone away and she is getting new bumps in different areas. HCP: declined to provide, she is going to see a different primary, she usually just sees her nephrologist Her nephrologist and rheumatologist work together in regards to her medications. She got the flu shot last year, months ago. The outcome of the event was not resolved.
This spontaneous report was received from a pharmacist refers to an 8 month old female patient. On 08-APR-2000, the patient received the first dose of VARIVAX before she was 12 months old. On 19-MAY-2011, the patient was vaccinated with second dose VARIVAX. No adverse effects reported. The outcome of the patient received VARIVAX before she was 12 months old was unknown. Additional information has been requested.
neurological reaction; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 01971214 (Merck).  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious) with onset 2021, outcome "unknown", described as "neurological reaction".  Additional information: Reporter stated that, patient received the Pfizer COVID vaccine, only one dose, back in Jan2021, and had a neurological reaction to it. Patient stated she could not take any more mRna vaccines anymore because of this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 6/5/19 at 12:45pm, two days after receiving immunization, the patient reported to the pharmacist and showed the pharmacist her arm that she had a raised patchy localized rash at injection site. She also stated she feels fine and has no pain at this time but her arm was sore yesterday on 6/4/19, but the slight redness and inflammation occurred this morning on 6/5/19 around 8am. The pharmacist provided a low dose of 25mg diphenhydramine liquid. The pharmacist called the patient's primary doctor at 1:09pm. The nurse, stated that the doctor was very familiar with this common reaction and informed the patient to watch her rash closely and call the doctor if fever develops. She did not have to be seen at this time.
Starting in late August 2021. I have been bleeding every week in different amounts and lengths. In November 2021, I bled for 14 days straight. This Sunday, Jan 23, 2022, I started hemorrhaging. I am now on day 5 and it has slowed. I had to go to Emergency room on Monday. I followed up at Gyn on Wednesday Jan 26, 2022. Medication was prescribed to manage the bleeding.
Dizzy; This is a spontaneous report from a contactable consumer (patient herself). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: and expiry date were not reported), via an unspecified route of administration in the right arm on 27Jan2021 10:30 at a single dose "to not get the disease." Medical history included ongoing mood disorder and ongoing hypertension. Concomitant medication included alprazolam (XANAX) from Apr2020 for hypertension, valproate semisodium (DIVALPROEX) from Dec2020 as mood stabilizer, risperidone from Dec2020 as mood stabilizer and for hypertension, and amlodipine besilate from May2020 for blood pressure. The patient previously took alprazolam (XANAX) for hypertension and had been trying to wean herself because she was getting addicted to it. Alprazolam (XANAX) also made her dizzy and depressed. She also previously took escitalopram (LEXAPRO), fluoxetine (PROZAC), and Zoloft  as antidepressants and stated that "they drove her crazier." The patient had no additional vaccines administered on same date of the Pfizer Suspect. The patient received that vaccine at housing complex where she resides and was looking at the list that she was given that had reactions. She was feeling dizzy on 27Jan2021 and wanted to know if she should be concerned. The patient reported that she will be speaking with her psychiatrist at 1:30pm during an online appointment asked if she should mention this to her. The event did not require visit to the emergency room or physician office. No relevant tests were conducted. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
was more like a brain fog; Dizziness; A spontaneous report (United States) was received from a consumer concerning, a female patient of an unknown age who received Moderna (mRNA-1273) vaccine and experienced lots of dizziness/dizziness and more like brain fog / feeling abnormal.  The patient's medical history provided included the patient received both the first and second of their planned doses of mRNA-1273. Concomitant product use was unknown by the reporter.  The patient received both the first and second of their planned doses of mRNA-1273 (Lot number: unknown for both) via unknown route for prophylaxis of COVID-19 infection. The patient experienced events from both the doses.  Post receiving the first dose of (mRNA-1273) vaccine the patient experienced lots of dizziness, which more felt like brain fog. The patient was able to do stuff but still felt dizzy.  The patient experienced more fatigued after the second dose of mRNA. It has been 3 weeks still patient felt dizzy in doing stuffs. Treatment information was unknown.  Action taken with mRNA-1273 in response to the event(s) was Not applicable.  The outcome of the events, experienced lots of dizziness more like brain fog, can do stuff but it still felt dizzy were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
With the first dose, I had Pain at injection site, swelling, redness, fatigue..overall not good feeling.  With second dose, I had pain and swelling at injection site, fever about 6 hours post injection, along with chills and Nausea, diarrhea, along with severe skin rash 4 days post injection.  The skin rash started on both forearms and then went to middle chest area and up left side of my neck, severe itching, red, raised skin, hot too touch.  The forearm rash went away on its own and then week later the chest rash was very significant.
fever of 104.5; Based on information received on 20-Nov-2020, the report previously considered as non-valid became valid: [suspect product corrected from SANOFI PRODUCT NOS to INFLUENZA VACCINE].  Initial information was received on 11-Nov-2020 regarding an unsolicited non-valid serious social media  case from a consumer/non-healthcare professional.  This case involves a patient (with demographics unknown) who had fever of 104.5 (pyrexia), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed fever of 104.5 (pyrexia) (unit not reported)(unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for 10 days.   No other relevant test was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  The information on lot number was requested for this case.  Follow up information was received on 20-Nov-2020 regarding an unsolicited valid serious social media.  Case upgraded to valid from non-valid. Suspect product corrected from SANOFI PRODUCT NOS to INFLUENZA VACCINE.; Sender's Comments: Follow up information reported on 20-Nov-2020: This case concerns a patient (with unknown demographics) who had pyrexia after vaccination with INFLUENZA VACCINE. The time to onset was unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
warm arm at the site, then 4 hours later chills, and having vomiting over night
Information has been received from a physician concerning a 5 year old female who on 09 Nov 2006 was vaccinated with a 0.5 mL dose of Proquad. Subsequently, the patient developed a red swollen arm after vaccination. Unspecified medical attention was sought. There were no labs or diagnostic tests performed. Subsequently, on an unspecified date the patient recovered. No further informatoin was provided. There was no product quality complaint involved. Additional information has been requested.
elbow joint swelling and pain in same arm as injection beginning about 5 days post inoculation and lasting well through day 14 following vaccination.
First dose / on 06Apr2019 / had not been able to come back / until recently; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th April 2019, batch number-BF4J5 and expiration date-5th July 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that Patient had not been able to come back for several reasons until recently and now was wondering how to go about this. The reporter consented to follow up. The Healthcare professional agreed to follow up via email address.
On 8/22/01, right arm was red and swollen (upper part of arm) and was complaining of itching this AM. On 8/23/01, arm was red, swollen and hot. Mother of child considering taking child to MD.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 3-year old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-DEC-2022, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2302USA000400: US-009507513-2301USA010889: US-009507513-2302USA000401: US-009507513-2302USA000947:
This spontaneous report was received from the mother of a 27 week old male patient, concerning her son. No information was provided regarding the patient's medical history, concurrent condition or concomitant medications. On an unknown date, the patient was vaccinated with ROTATEQ dose 1, per oral route, for prophylaxis (lot number and expiration date were not reported) at 27 weeks old. No adverse effects were reported.
Pt vaccinated with DTP/OPV SIDS presumed as of this date pending coronor's report.
01/30/2023 I started to feel nauseous, and I had shortness of breath and had a hard time walking off the ship. 02/01/2023, when we got home, I was feeling alright again, I tested on 02/01/2023 with a COVID-19 Home Test, the result was positive.  5 or 6 day later I started having breathing problem. I tested myself with a COVID-19 and I tested positive. I ended up walking into an emergency on 02/21/2023. At the emergency room, they told me I had COVID-19 infection and they gave me an infusion and then they discharged me. In the emergency room they also told me I had a mild heart failure. A few days later, I had breathing problems again I went to see my internist. and he checked me into emergency.  In the emergency on, I went into a hospital on 03/17/2023. I was having tightness of my chest and trouble breathing and the doctor put me on a heart monitor and blood pressure and something to measure my oxygen level. At the hospital they put me in the bed, and I got treatments for my lungs, like nebulizers and inhalers. I was in the hospital for about 3 days. I was treated at the hospital for heart failure, and I have been on medication ever since.  I still have shortness of breath and have been on rehabilitation. And I have trouble sleeping and have to adjust my CPAP machine. and I do not have much of an appetite. I was having trouble breathing prior to COVID-19 infection after COVID-19infection it was exasperated.
began w/pain @ site, rapidly progressing to erythema, & swelling; cellulitis from elbow to shoulder present w/in 36 hrs; treated w/Rocephin & dicloxacillin- resolved w/in 5 days
Got diarrhoea 2 days following second Moderna vaccine injection; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Got diarrhoea 2 days following second Moderna vaccine injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (Got diarrhoea 2 days following second Moderna vaccine injection). On 20-Feb-2021, DIARRHOEA (Got diarrhoea 2 days following second Moderna vaccine injection) had resolved.            Concomitant medication was not reported. Treatment medication was not reported.    Reporter did not allow further contact
Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 3 months old patient of unknown gender who received immunization with IPV component only of intended vaccine PENTACEL (Liquid portion batch number: C5447AA, HIB Component batch number: C5576AD) (expiry date: 18-Oct-2019) (dose, dose in series, route and site of administration were not reported) on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccines were given concomitantly. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was experienced. Reported as no ill effects 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.
4 month old male status post pediarix, prevnar, and hib on 06/26/2003.  Cried non stop x 24 hours with very little periods of consolement.  (+) fever.  No other symptoms.
Lose of hearing in right ear.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 10:45 as dose 4 (booster), single (Lot number: GH9697) at the age of 61 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive any other vaccine in four weeks. The patient did not have Covid prior to vaccination. The patient was not Covid tested post vaccination. The patient had no known allergies. Vaccination history included: Covid-19 vaccine (Dose: 3 (1st booster), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The patient experienced lose of hearing in right ear in Oct2022. No treatment was received for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Redness and inflammation for 2? at injection site -> resolved in 7 days with Benadryl and Hydrocortisone cream. Chills for 1 hour - > no treatment necessary.
got the first dose of the Moderna vaccine on 14Jun2021 and has not gotten the second dose yet.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 14Jun2021 and has not gotten the second dose yet.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 14Jun2021 and has not gotten the second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 14Jun2021 and has not gotten the second dose yet.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   As per source document HCP was calling to know about the second dose after getting the first dose on 14 june 2021. Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
Seems shingled and RA feed each other; Get shingles even after taking the shot/Suspected Vaccination Failure; Shingles once or twice a year; This serious case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rheumatoid arthritis (Verbatim: Seems shingled and RA feed each other) (serious criteria GSK medically significant), vaccination failure (Verbatim: Get shingles even after taking the shot/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles once or twice a year). The outcome of the rheumatoid arthritis and shingles were not reported and the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the rheumatoid arthritis, vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the rheumatoid arthritis, vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient interactive digital media. The patient stated got shingles once or twice a year, even after taking the Shingles shot and seem that shingle and Rheumatoid arthritis (RA) feed off each other. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.