chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After she got the first shot, she had numbness in her legs and it is still there now, it has not completely resolved; This is a spontaneous report from a contactable consumer. A contactable consumer reported for a female patient that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was just calling because reporter have a patient here that has come back for her second Pfizer COVID vaccine and she just told reporter today that about three days after she got the first shot, she had numbness in her legs and it was still there now, it has not completely resolved. Reporter didn't know about this previously, but reporter just wanted to call and see if there was any other reports of that and if it was okay to go ahead and give her the second one. Reporter haven't heard of any reports of that, so reporter just wanted to check directly before giving her another shot. Reporter was going to report to VAERS this evening but reporter just wanted to see if they are having any reports of that, as reporter don't know about it and the patient was still waiting for the second dose? Also, it his recommended for her to take the vaccine. The outcome of event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
This information has been received from a nurse prescriber concerning a 10 year old male patient. The patient had no pertinent medical history, drug allergies or concomitant therapies. On 13-APR-2017, the patient was vaccinated with PNEUMOVAX 23 with lot number M013156 and expiration date on 15-OCT-2017 (dose, dose number and anatomical location were not provided), administered intramuscularly for "Cochlear implants, recommended by pediatrician". The reporter stated that within 4 hours, dime-sized lesions started, then kept growing, and within 24 hours he was admitted to an unspecified hospital for cellulitis and treated with two unspecified antibiotics. The patient was discharged after 3 days. At the time of the report, the patient had recovered from the cellulitis and the causal relationship between PNEUMOVAX 23 and the event was unknown. Upon internal review, cellulitis was determined to be medically significant. Additional information has been requested.
while administering vaccine, some of the vaccine liquid leaked out of the syringe and down the patient's arm, no adverse event; while administering vaccine, some of the vaccine liquid leaked out of the syringe and down the patient's arm, no adverse event; while administering vaccine, some of the vaccine liquid leaked out of the syringe and down the patient's arm, no adverse event; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a 31 year old female patient who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, batch number and expiration date were not reported) via an intramuscular route in the deltoid on 05-Oct-2020 for prophylactic vaccination, however while administering, some of the vaccine liquid leaked out of the syringe and down the patient's arm (exposure via skin contact and underdose).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not reported.  The patient did not receive any concomitant medication.  This was an actual medication error case due to vaccine underdose (latency was same day).  Also, this was a case of syringe leak (syringe issue) and vaccine exposure via skin contact.  The reporter wanted to know if another type of flu vaccine could be given and what is appropriate time to re-administer.  At the time of reporting, no adverse event reported to the patient and she did not receive any corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Post vax, the pt developed a swollen area approximately 5 cm x 5 cm. Slightly warm to touch. No redness. Child denies pain when area palpated. No drainage from injection site.
developed 2 more of the same type of sores on inside of my cheek, in mouth; sore under top lip; headache; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 12:00 PM, at left arm, at single dose for covid-19 immunization. Medical history included hepatitis c from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient was not pregnant at the time of vaccination. First day on 24Dec2020 the patient had headache and fatigue, some nausea. Day 3 (26Dec2020) and 4 (27Dec2020) headaches all day, mild. Day 5 (28Dec2020) developed sore under top lip and day 6 (29Dec2020) developed 2 more of the same type of sores on inside of my cheek, in mouth. No treatment was received for all events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  Information about lot/batch number has been requested.
Redness, warmth, induration about 10 cm diameter about injection site & lymphadenopathy in axilla & pain.
Initial and follow up information has been received from a physician concerning a 60 year old male journalist who on 14-MAR-2007 was vaccinated IM in the left deltoid, (previously reported as SC) with a single first dose of Zostavax (Oka/Merck) (Lot#656413/1477F).  Concomitant therapy included LIPITOR.  Subsequently the patient developed mild flu like symptoms.  Unspecified medical attention was sought.  Subsequently, after about 1 day the patient recovered.  No other information was provided.  There was no product quality complaint involved.  Additional information is not expected.
difficulting breathing Narrative: Patient contacted telephone triage nurse today requesting appt with provider for c/o, "I got a covid vaccine 3 weeks ago, I'm not sure if I'm having a reaction to the vaccine or what, but I cannot breathe and it's hard to swallow." Patient states right after he received the vaccine he developed difficulty swallowing, "I can't even eat anything, it just won't go down - the only thing I can eat is pudding." States his tongue has been "double the size it should be" since he received the covid vaccine. No worse today than it has been, "just not getting better and I still can't eat." No speech difficulties during conversation (enunciating words properly). Pt is now c/o difficulty breathing, "I just feel short of breath." States he noticed the SOB yesterday, worse today. +CP with both cough and deep inspiration. Some mild wheezing, chills. Cough is nonproductive. No conversational dyspnea or cough during conversation. Recommended local ER now, states he will have family member drive him to ER now.
I cannot eat without throwing it up all back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (I cannot eat without throwing it up all back) 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 04-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 VOMITING (I cannot eat without throwing it up all back). At the time of the report, VOMITING (I cannot eat without throwing it up all back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
After my 1st co-v inj, I began feeling extreme FATIGUE &  BRAIN FOG 1 hour later.    I was on a bicycle for exercise as this was a  10.5-mile ride rt.   Began hitting me on my ride home.  For the remainder of the day and 2 days afterward, I stayed in bed.     My 2nd inj is on the 28th.     I am fine and back on the bike but thought I should report this.
This spontaneous report was received from a licensed practical nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of  GARDASIL 9 (lot# M030380 and expiry date 01-FEB-2019) intramuscularly for prophylaxis. No adverse effects were reported. The vaccine was exposed temperature excursion of 32.7 Fahrenheit for 2 hours and 15 minutes and 33.1 Fahrenheit for 4 hours. No previous temperature excursion were reported. Data digital logger was involved. No product quality complaint (PQC) was filed. Further details were not provided. A call was placed to the licensed practical nurse on 21-DEC-2016 that requested patient identifiers and date of vaccination.  All telephone attempts to obtain follow-up information have been unsuccessful. This case is one of three reports received from the same reporter. Additional information has been requested. Narrative updated. ; Sender's Comments: US-009507513-1611USA002941: US-009507513-1611USA002946:,MERCK 1611USA002299:Mfr number.
Patient received Moderna booster vaccine and began feeling dizzy, weak. Patient remained in seat where she was vaccinated, had a vasovagal reaction, and passed out. Patient was assessed by RN and MD within one minute of reaction. Patient vitals: HR 46, BP 80/50. Patient more alert at this time. Patient became diaphoretic, blood sugar level at 99. Patient given water and apple juice. Vitals 10 minutes after reaction: HR 73, BP 98/62, O2 Sat 99. Patient continued to drink apple juice and ate a banana. Patient left clinic once symptoms subsided. Patient stated she had not eaten that day before getting vaccinated.
He states after taking covax on 2/20 and 5 hours later his eye got better; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable male consumer (patient himself) reported. A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 20Feb2021 as 1st dose, single dose for COVID-19 immunization and viral eye infection. The patient medical history and concomitant medications were not reported. First time patient had Viral infection in eye for over 30 days. After 2 weeks of trying everything patient went to the ER this was the end of January and they sent him to an opthalmologist who confirmed he had a virus in his eye, and it would go away in 14 days. He states it never really did. They never told patient what it was or prescribe medication for it. On 20Feb2021, stated after taking covax, 5 hours later his eye got better. So, he was calling to report a positive note for the covax. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SWOLLEN GLANDS IN NECK, TONGUE SWELLED, RED SWELLED THROAT, TROUBLE BREATHING.
PATIENT REPORTED FEVER (102), FATIGUE , DISCOMFORT AND DIZZINESS. SHE CALLED PARAMEDICS AND EMT'S CHECKED ALL VITALS AND SHE REMAINED WITH FEVER FOR NEXT 2 DAYS, BUT TODAY IS FEELING BETTER.
At about 7PM, I was very tired, and I felt a little feverish, so I went to bed early. I went to bed and woke up in the middle of the night and I was very cold. I couldn't move my arm. I couldn't move anything with my body, and I had a fever. And I was like that the entire day the next day. I was like that for 36 hours and then I woke up after that and was fine. I was unable to get out of bed during that time. It was awful.
On Tuesday, 12/28/21, patient came to Covid-19 Vaccination Site for his Pfizer Covid-19 first dose. Per CDC guidelines, adult Pfizer is eligible for ages 12 and up. Client is 12 years old and eligible for a Pfizer adult dose. At approximately 11:30 AM, client was vaccinated with Pfizer Pediatric first dose (LOT #: FK5618) in his left arm by LVN. After vaccination, LVN realized client was given a Pfizer pediatric dose of 0.2 ml instead of an adult Pfizer dose of 0.3 ml. Lead RN was made aware of situation who elevated to Vaccine Operations Lead. Per Lead, situation to be explained to parents, no further interventions needed. When client comes back in 21 days for their second dose, he will receive adult Pfizer second dose. Lead RN explained situation to client's parents who verbally understood. Client denied any allergies or medications and was to be a 15 minute observation. Client and client's parents was educated by Lead RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client's parents were also encouraged to sign-up on v-safe. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at 12:00 PM.
Given MMR and Varivax on 3/19/03. Child had problem 4/3/03. Mom called answering service at 7pm. Questionable. Ate chalk at 3pm. Sluggish and unresponsive at 7pm. Taken to ER unable to walk. Not recognizing family members. Admitted. Took several days to recover. Recovery totally. LP normal. Urine dry screen negative. large # of metabolic tests normal.
Client started to c/o symptoms approximately 10 minutes after vaccination.  She c/o numbness in her fingers, feet, and lips.  Stated that she had heaviness in her chest and a pain that shot from her chest to her back lasting only a few seconds.  She c/o dizziness.  Client reported her BS was 140 this AM, B/P was 136/82, pulse regular and steady.    EMS called to evaluate the client at 0930.  EMS checked her BS which was 324, and her B/P was increasing.  Client was transported to the hospital for further evaluation.
Pregnancy; Initial Report Received on 20-Jul-2020  A pharmacist reported that a 21 year-old female (race and ethnicity not provided) was pregnant at the time of receiving HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) from a pharmacist.  On 20-Jul-2020, approximately 1 month after having been vaccinated with HEPLISAV-B, the patient contacted the pharmacist asking about information on HEPLISAV-B administration during pregnancy. The patient reportedly received her first dose of HEPLSIAV-B, was pregnant at the time, and was unsure of the exact gestational age.  The pharmacist was not the first-hand receiver of the call, and the injection was given by a different pharmacist. Further information was not available.   At the time of the report, the outcome of the event was not reported.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
5-10 min. after the vaccination patient reported-light headed dizzy, Nausea, had patient seated with legs elevated and ice on back of neck, complaints persisted, Lost color in face and lip's, reported throat closing. placed patient on floor and elevated feet, proceeded with .3ml epi and 50mg benadryl cruet's arrived, o2 given
At the time of injection (11:55 a.m. Tuesday morning Nov. 14th 2006) I was healthy, just finished a 3 mile run, was well hydrated and feeling great.  After the injection I started going down hill in the evening.  Starting with a sore arm at site for injection.  Then aches and pains, followed by very sore throat and still today it is hard to swallow. Could not sleep that night due to the aches, sinus congestion, inability to breath through nose, sore throat and every joint aching as well as muscle aches that included even my gums and scalp.  The next day I had absolutely no energy, could not get up and function.  Stayed in bed all day unable to participate in daily life, and took Sudafed, Advil and throat spray. These symptoms continued through the night of the 14th through all day on the 15th and are some what subsiding but still very much present on the 16th.  The reaction was so severe I swore off ever getting another flu shot.
Hives on face, swelling of the face and throat, difficulty breathing.  Epinephrine injection was administered.  Events continued every 4-6 hours.  Epinephrine injection was required again on 09/26/2014 at 3:15PM.  On 09/27/2014 at 6:15 PM patient required emergency room visit again due to difficulty breathing.
Lymph node around armpit really sore/hurts and swollen on the night of the 4th day out from the first shot continuing into today
Retested myself again (3times) and Once again Positive; Retested myself again (3times) and Once again Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm 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 was not reported. Concomitant medication(s) included: SERTRALINE; ADDERALL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Retested myself again (3times) and Once again Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Negative; (30Apr2022) Positive, notes: retested myself again (three times; (30Apr2022) Positive, notes: retested myself again (three times; (30Apr2022) Positive, notes: retested myself again (three times. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient previously received a COVID-19 Vaccine. The patient taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient tested negative for Covid the following Tuesday (26Apr2022) and woke up this morning with a sore throat and headache. Patient retested again (three times) and was once again positive. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 20Apr2022, Treatment stop date: 24Apr2022, Indication: Treatment of COVID-19. Adverse event start date: 30Apr2022, Ae resulted in: None of the above, If patient recovered: Recovering, If treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nose bleed 11-10-23 in the evening, not long, nose bleed 11-11-23 in the morning that lasted for about 30 minutes
pneumonia; This spontaneous report was received from a consumer reporting on her spouse, who was of unknown age.   His medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown day in October 2023 (reported as 3 weeks ago), the patient received an unknown pneumonia vaccine (potentially Pneumococcal Vaccine, Polyvalent (23-valent) or pneumococcal 15v conj vaccine (CRM197)) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date in 2023, the patient experienced pneumonia. The consumer reported she believed she contracted pneumonia from her spouse (captured in MARRS# 2311USA001033). The outcome of the event was not provided.  The causality between pneumonia and suspect vaccine was not provided.  Upon internal review, the event of pneumonia was considered to be medically significant.
Pt recvd vax & the next day, p/2nd dose, had redness & heat @ site;
Received the vaccine the the morning of Oct. 21 and woke up with fever, sore throat, body aches, etc. at 3:00am on Oct 22. In bed with flu like symptoms until Oct. 31. As of today (Nov. 2) feel better but very fatigued with lingering cough and headache. I had the flu vaccine approx. 1 month ago.
Pt was vaccinated with first and second dose of varicella virus vaccine live in May 1999 and July 1999. In January 2000 the pt had blood work which revealed a negative titer.
had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020).   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, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Healthcare professional stated it was not a safety concern.
PATIENT RECEIVED A HD FLUZONE SHOT WHEN WANTED A COVID BIVALENT BOOSTER BY PFIZER. PATIENT HAD ALREADY RECEIVED THE HD FLUZONE SHOT ON 10/20/22.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt was a little shaking before the vaccination. Confirmed with pt that he had no problem with 1st vaccination of covid. Right after the vacciation of 2nd shot, pt told me he was feeling dizzy, sweating, and warm. He told me actually he is afraid of needles so he is not feeling nervse. Stay in the vaccination room wit hpt for about 5 to 10 min. pt felt better after 5 to 10 min. Have pt stay for additional 15min after, he stated he was totally fine now and thanks for my help.
FEBRILE SEIZURE LASTING 1 MINUTE. FEVER 102.2, TONIC CLONIC SEIZURE BY DESCRIPTION. RHINORRHEA EARLIER THIS DAY. BILATERAL PNEUMONIA SEEN ON CHEST XRAY. PATIENT PLACED ON AUGMENTIN.
Headache, tightened muscles and aches in the neck and shoulder muscles, fever, chills. The symptoms began approximately 22 hours after receiving the vaccine and  lasted for approximately 14 hours.
After receiving my first vaccine on 4/2 my menstrual cycle was 14 days long. Typically my period only lasts 4-5 days long. I received my second vaccine on 4/23. I did not menstruate in May at all. Multiple negative pregnant tests after now being 7 weeks since my last period
Left deltoid noticed yesterday 5/21/07 swollen apply ice, rest, elevate
Heart attack at home, called 911, taken to hospital, couldn't revive.  County coroner called because sudden death.  Family thinks death is a result of flu shot received about 2 weeks ago.