chrisvoncsefalvay/vaers-outcomes huggingface dataset:
strokes; She spoke haltingly and had a drooping mouth; She spoke haltingly and had a drooping mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, chest discomfort and shooting pain down her left arm; suffered a minor heart attack), administration date: Feb2021, for COVID-19 immunization, reaction(s): "She suffered a minor heart attack". The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "recovered", described as "strokes"; FACIAL PARALYSIS (hospitalization, medically significant), LANGUAGE DISORDER (hospitalization), outcome "recovered" and all described as "She spoke haltingly and had a drooping mouth".Clinical course: In early Feb2021, patient complained of chest discomfort and shooting pain down her left arm. She suffered a minor heart attack, which was treated at a nearby hospital. She had two strokes five days after her second shot in Mar2021, but she recovered within five days and was back to normal after that. She initially didn't recognize that she was having a stroke, and as a result, her condition worsened. She spoke haltingly and had a drooping mouth. She was admitted to the hospital for the strokes again (at the same hospital), and she made a full recovery in a matter of hours. Private conversations with her doctors revealed that the Pfizer vaccine was the direct cause of her heart attack and two strokes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Small rash that started on my chest, then spread all over my chest, arms, neck, head, back and stomach.
Received vaccine 1/19/21 at 3:30pm.  Next am aches, by afternoon profuse sweating requiring clothing change.  1/21/21 woke up and had 3 watery, explosive diarrhea episodes. He fell and required 911 call.  Admitted to Medical Center with diagnosis of weakness.  Has had difficulty moving, and walking.  on 1/27/21 still in hospital pending transfer to  Rehab Center.
Day 7 after vacination became extremely tired x2 days, day 8 after vaccination, right deltoid became hot, red & swollen. Iced all day. Good the next day
A couple of minutes after shot(s) were administered, client stated she "feels dizzy" and she slumped forward, client was fainted for approx. 10-15 sec. & woke up complaining of a bad headache. She drank some apple juice and went home with her father.
This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received PREVNAR 13; (lot/batch number and expiration date not provided), 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 wanted to know what are the expected side effects of PREVNAR 13 after it was frozen and then stored at a refrigerator. On an unspecified date, the patient experienced local pain, swelling and weakness on an unspecified date. The outcome of the events was unknown. Information regarding lot/batch number has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm 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: "Thyroid (graves)" (unspecified if ongoing), notes: Thyroid (graves); "Severe pre-eclampsia" (unspecified if ongoing), notes: Severe pre-eclampsia; "HBP" (unspecified if ongoing), notes: HBP. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures: Paxlovid from 07Aug2023 to 11Aug2023 were taken as a result of drug ineffective, covid-19.  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-202300291426 same patient/reporter; different drug/AE;
Lightheadedness ,slight fever , severe back pain and bilateral arm pain,  bilateral leg pain severe,  migraine and headache, body aches, exhaustion
Mom reported fever on 11/16/2011 of 102.2 and rash. Pt still with rash despite BENADRYL x 24 hours fever resolved. Pt seen 11/18/2011, Pt reports headache, fever & rash 1 day after vaccine. Rash itchy, generalized fever and HA resolved after 24 hours 11/21/011 Mom reports rash is completely resolved. No fever. No HA's.
Right basal ganglia stroke 11 days following his second COVID vaccine. Left facial drooping, slurred speech, change in demeanor. Started on Aspirin and Eliquis. Have resolved except for change in demeanor.
Fever, Chills, Vomiting, Weakness, Tired, Rapid Heartrate
shortness of breath/difficulty breathing; aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), PAIN (aches) and PYREXIA (fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN (DIOVAN) for Hypertension.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), PAIN (aches) and PYREXIA (fever). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), PAIN (aches) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 91-92 % (Inconclusive) oxygen was about 91-92 % and normal (normal) this lasted several hours and then returned to normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was included diovan and hydrochlorothiazide.   This case was linked to MOD-2021-114403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 as Suspect vaccine, adverse event, medical history, treatment and concomitant medication information was updated. On 15-Jun-2021: Follow up received on 15-Jun-2021 as reporter information was updated.
The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023; No adverse event; Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Expired Bivalent Moderna COVID-19 vaccine on 07APR2023 after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-FEB-2023 and vaccine was administered on 7-APR-2023).    No concomitant medications was reported.  The dose of suspect Spikevax Bivalent was reported as additional booster. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 26-FEB-2023. The vial did not undergo any temperature excursions.    No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719045 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719045: Patient 2
DEATH; This spontaneous report received from a consumer concerned a 5 decade old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, UNKNOWN expiry) dose, 1 total, start therapy date were not reported 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 an unspecified date, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). It was unknown whether the Autopsy was performed.; Sender's Comments: V0: 20210733844-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaeous report was received from a healthcare worker and refers to a 5 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 03-SEP-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
On 3/22/21, date of vaccination, my left arm (shot taken) was more than sore.  I could hardly lift it.  I had to hold it as if it were in a sling.  I had chills that evening and couldn't sleep.  The left side of my neck, behind my ear, is sore. On 3/23/21, my left arm was still very sore but better.  I had a temperature of 101.  My neck is still sore.  I was able to sleep a little better that evening.  Today, 3/24/21, my left arm is slightly sore.  I can raise it up  a little without pain.  My neck is still sore.  Symptoms are much better today.
Information has been received from a physician, the author of the literature report, concerning a 105 days infant, gender unknown. The infant was a preterm baby and had low birth weight of 1001-1500 g. This was a prospective observational cohort study in all VLBW infants who were discharged from the NICU from May 1, 2008 to April 22, 2010 when rotavirus vaccination (manufacturer unknown) with RV5 was provided at discharge to all age-eligible infants. The medical records of the infants were reviewed, and pertinent demographic, clinical, and laboratory data were recorded. The number of infants who received the rotavirus vaccine, the number of missed opportunities for vaccination, and the number of infants falling outside the recommended time period for vaccination were recorded and analyzed. There were no complications noted on follow-up. On an unknown date the infant was vaccinated despite being older than the recommended age limit at the time of discharge. Rotavirus vaccination (manufacturer unknown) is recommended for use in preterm infants at the time of discharge from the NICU as long as they are clinically stable and have an age range of 42 to 104 days V.10. Our study highlights the limitations of the currently recommended schedule for rotavirus vaccination, because 22% of all VLBW infants were too old at discharge to receive the vaccine. In addition 52% of all ELBW infants discharged from the NICU were older than 104 days and also were not vaccinated. This is one of four reports received from the same source. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Pt. received rabies post-exposure prophylaxis according to the following schedule:  4/7/07 received HRIG and vaccine #1.  Remainder of vaccines given on:  4/10/07, 4/14/07, 4/21/07, and 5/5/07.  After each dose of vaccine, pt. developed headache, nausea, myalgia, jaw, hip and back pain, fever, extreme fatigue and mild fever.  The fatigue, myalgias, generalized achiness and headache lasted about 5 days.  Approximately 24 hours after each vaccine, diarrhea developed which lasted about 1 day.  Diagnosed by MD as serum sickness related to rabies vaccine.  Treated with tylenol and advil, subsequent doses pre-treated with tylenol and advil with little decrease in symptoms.  Symptoms severe enough to impact ability to work.  The symptoms were more severe after the last three vaccines.  Pt seen in ER after third dose, and in medical clinic after fourth dose for evaluation of symptoms.  One week after last dose, patient reports symptoms resolved.
Missed the second shot 48 days post first vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second shot 48 days post first vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second shot 48 days post first vaccine). On 30-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Missed the second shot 48 days post first vaccine) 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.   No concomitant medications were provided. No treatment information was reported.  The patient was yet to received second dose.
Patient passed out after Gardasil vaccine.  A few weeks after first injection, she started showing signs of being unusually afraid of things (being alone, strangers, etc).  She also complained of being tired, shortness of breath and stomache issues.  She completed the series of shots in December of 2008 and continued to have 'strange' symptoms more often.  She was tested for mono and thyroid issues.  Her doctor said she was borderline anemic and suggested vitamins.  She continued to deteriorate and we finally realized she was having severe panic attacks.  Eventually, she was diagnosed with Panic Disorder with Agoraphobia and Depression.  She was terrified to leave our house and we had to pull her out of school and enroll her in a psychiatric partial hospitalization program for 6 weeks.  She continues to be treated by a physician to this day.
extreme left arm pain; can't lift arm over her head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme left arm pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (can't lift arm over her head) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU (Patient took flu and Shingles vaccine 2months ago).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (extreme left arm pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (can't lift arm over her head). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (extreme left arm pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (can't lift arm over her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Janssen Biotech vaccine was in right deltoid not left deltoid. Very rarely get headaches but got the most severe headache I've ever had for approximately 48 hours starting about 18 hours after injection. Sore arm at injection site and extreme tiredness started about 12 hours after and continued to progress worsening along with headache onset. I'm very rarely nauseous and became nauseous during the severe headache.  Headache severity gradually decreased after 48 hours but was present for another 36 hours. Have now been having  mildheadaches sporadically and this did not occur prior to the vaccine.
I was administered the Hep A vaccine around 1:30 pm Friday 05/27/2005.  While at work at about 4 pm  I began to feel tired and my allergies became worse than ever!  Every time I sneezed or coughed I felt light headed and eventually I told my employer that I was too "messy" to be working with the public.  I went home and coughed all night producing chunks of green phlegm.  Saturday morning the fever started around 6 am where I alternated sweats and chills throughout the day.  Again I called in sick.  I took Advil for the aches in my back, head, neck, abdomen and ribs.  I ate some cereal and a donut over the course of the day, drank a liter of water and a cup of diluted grape cranberry juice and a few sips of black tea.  The sweats and chills continued through the night into this morning.  I have felt weak, short of breath and continue to have a headache and neck ache, the back ache has been reduced with moving around.  Rib and abdominal pain are almost gone.  The coughing had decreased, but is still painful and far less productive.  It's the headache that continues and the shortness of breath.
COVID vaccine vial inadvertently mixed with only 0.8ml diluent instead of 1.8ml. full 0.3ml given as injection. This was discovered after patient had left the clinic. Error discovered after 3 doses given that there was not enough in vial to provide 3 more doses.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer, cataract extraction, chemotherapy and axillary lymphadenectomy (of right arm). Previously administered products included ZOSTAVAX (received on an unknown date). Concurrent medical conditions included neuropathy peripheral (severe neuropathy of hands and feet). In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient was a breast cancer survivor. She could only receive vaccines on the left side, on her arm since she has had lymph node removed from the right arm. She was on chemotherapy regimen while she underwent treatment for breast cancer. She inquired about optic ischemic neuropathy and its instance with SHINGRIX vaccine, since she had severe neuropathy in her hands and feet. The patient received SHINGRIX on the left arm. The patient stated she experienced redness, and raised skin at the injection site which lasted for about total of one week. The patient had denied permission to contact their physician. The patient was provided information in regards to optic ischemic neuropathy from the prescribing information. No further details were provided.
Severe headache for over a week,  upset stomach, runny nose, nauseated, no appetite, poor taste and it lasted 2 weeks then went away and repeated in 3-4 weeks with same symptoms  and then it did the same thing again.  It has happened 3-4x since the vaccination.  On 9/29/21 I tested positive for COViD.
Pt presented herself Nov 5th with Lt upper arm swelling & rash most of upper arm - had multiple immunizationts on the 3rd with another provider.
Received the vaccine on Oct 15 at 2:00 pm. About 3:00 am, work up feeling achy, feverish and chilly. Took temperature at 10:00 am, it was 100 degrees. Felt very sick all day with aches, chills and nausea. Temperature climbed to 101 degrees in afternoon. I vomited 3 times when I tried to make dinner   I could not stay awake, I kept falling asleep. I didn?t eat snuthing all day, no appetite. I started feeling better on October 17th. I was not able to eat much until October 19, because I was nauseated, gassy, and had no appetite.
8 hours after shot, I got very fatigued, weak, and achy with some mild nausea. This continued until about midnight that night.   I woke up feeling a little better, but then it hit again about mid-morning the day following the shot.
Brain tingle, brain fog, extremely fatigued, less active, always dissy, headaces,nauseous, feeling of passing out, chest pain, face pain, sensitivity to light.
The pt experienced an itchy rash on skin all over. No respiratory symptoms. Resolved with Benadryl.