chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 04-November 2013. A 12 week pregnant female patient whose age, medical history was not reported, received a dose of FLUZONE ID (lot number: UT4726AA, expiry date and site of administration was unknown) via intradermal route on 04 November 2013. List of documents held by sender: none.
Suspected vaccination failure/received vaccine, contracted shingles, joined 10% club; shingles//received vaccine, contracted shingles, joined 10% club; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The reporter reported that the he/she apparently joined the 10 percent club as Shingrix as advertised as 90 percent effective. The reporter really would like to talk to an expert on Shingrix to get their perspective from any clinical data that was available. The reporter consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary of vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2022AMR144944, reported by same reporter for himself/herself. The case was kept valid considering that the unspecified number of patients received vaccine and had shingles.; Sender's Comments:  US-GSK-US2022AMR144944:Same reporter
pt recv vax 18JUL97 & pt devel arthralgia  & rash;
total of 30 patients have been vaccinated over the period of 3 weeks from a punctured vial that was stored in the refrigerator for more than 12 hours after the first puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (total of 30 patients have been vaccinated over the period of 3 weeks from a punctured vial that was stored in the refrigerator for more than 12 hours after the first puncture) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (total of 30 patients have been vaccinated over the period of 3 weeks from a punctured vial that was stored in the refrigerator for more than 12 hours after the first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (total of 30 patients have been vaccinated over the period of 3 weeks from a punctured vial that was stored in the refrigerator for more than 12 hours after the first puncture) had resolved. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Rt arm sore and swollen, + 2 edema in office, fever (101.3), Tx with Tylenol, rest and increase fluids.
Received vaccine at 0800-"hot flash," flushing, rash, "little spoits," -EMS called-observed-no treatment-pt remained at work-was symptom free at 1000.
Fever 100.3 - about 4 days; severe shoulder pain (both shoulders); headaches/chills; weakness/leg pain; Began to recover after 2 wk. Saw doctor.
I am 46 year old male. I took Pfizer's Covid 19 vaccine n 13-Oct-2023 at 3:30 PM at a store. I had mild brain stroke on 16-Oct-2023 at 6 AM. I was hospitalized for 4 days. I have medical history of high blood pressure. High blood pressure is hereditary on my fathers side.
leg bruising; muscle pain; This spontaneous case was reported by a physician and describes the occurrence of CONTUSION (leg bruising) and MYALGIA (muscle pain) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (leg bruising) and MYALGIA (muscle pain). At the time of the report, CONTUSION (leg bruising) and MYALGIA (muscle pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Information has been received from a physician concerning a 15-week-old patient who on 06-AUG-2007 was vaccinated PO with the first dose of Rotateq.  There were no problems reported.  No further information was available.  There was no product quality complaint.  Additional information has been requested.
Pain in hips which I have never had before.  No treatment thus far.  Still suffering with it.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA (dose, frequency, route of administration, lot# and expiration date were not reported) all of which underwent a supported temperature excursion on an unknown date. No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Ache; fatigue; chills; This is a spontaneous report from a contactable 56-Year-old non-pregnant female physician reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3249), via an unspecified route of administration on 08Jan2021 at 08:30 as single dose in right arm for covid-19 immunization. The patient medical history was not reported and known allergies included Keflex had allergy. Historical vaccine included bnt162b2 for covid-19 immunization on 17Dec2020 (Lot number: EL0140, administration time: 15:30 PM, vaccine location: right arm and dose number: 1). Concomitant medications were not reported. On 08Feb2021 at 21:45, the patient experienced ache, fatigued and chills. The patient did not take treatment for the events. The outcome of the events was recovered.
29JAN97 t100.8 productive cough, nasal congestion;med given x 21 days 4FEB97;
Pt's left arm became very red, pt was lethargic, poor appetite for three days. Afebrile.
HIVES ALL OVER MY BODY THAT LASTED ABOUT 3 MONTHS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose, 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 experienced hives all over my body that lasted about 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives all over my body that lasted about 3 months. This report was non-serious.
Severe tenderness in the posterior left deltoid for the past 10 days.  Still ongoing.  Also had some neck pain at times over the past 10 days which made it hard for him to turn his head to the side.
Redness; Pain; Chills; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness), PAIN (Pain) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Specific product reported as: No, product was inferred.  .  Previously administered products included for Product used for unknown indication: Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included Chills with Pfizer vaccine; Headache with Pfizer vaccine; Lipoma with Pfizer vaccine; Mobility decreased with Pfizer vaccine; Skin red with Pfizer vaccine; and Vomiting with Pfizer vaccine.    On an unknown date, 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 an unknown date, the patient experienced ERYTHEMA (Redness), PAIN (Pain) and CHILLS (Chills). At the time of the report, ERYTHEMA (Redness), PAIN (Pain) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported.   Pfizer's vaccine sent patient into such a tailspin, thought would die. A huge lipoma on right arm, severe chills, clustered deep red spots on hand (all on the right and started within hours of injection), neck would not move after dozed off, headache but the worst was incredibly vicious vomiting, every 3-5 minutes for close to 9 hrs. All but the neck and hand occurred with both vaccinations. Doctor used Moderna for boosters and though had some redness, pain and chills, so far have not had to deal with the beastly parts either time.   No treatment information was provided.
A few hrs. post vaccine parents noticed quick head movement that was not normal for patient, parents thought at first it may have been water in ear  as patient was in the bath. But both parents had noticed similar abnormal head movement tilt to one side, 3 to 4 quick head tilts. No muscle stiffness or decreased muscle tone. No eyes staring or rolling back, no LOC. SHE was holding a chewing on toy during movement. She is cruising, standing. patient seemed a little more tired this morning. No head movements when sleeping.
On 11/30/99, the pt developed breakthrough varicella from which he subsequently recovered. No further information is available.
On Friday (05.19.2021), fourteen days after receiving the first dose of the Moderna COVID-19 vaccine (on 03.05.2021) at pharmacy, I began experiencing body aches (mostly leg cramps) followed by nausea, headache, and fatigue. They continued through  the next 36 hours. Today (Sunday, 03.21.2021) the headache subsided, but the nausea and fatigue remain, albeit less so than yesterday. I had similar symptoms in the first 24 hours of receiving the first dose but understand that to be a very common experience.
normal the first 5to6 days until the10th it started itching. and it was pale pink color. on Thursday morning is was burning red and itching so bad. and its hard and swollen. I had a rash on my chest  also. took Benadryl
Mild fatigue; Joint stiffness; Chills; This is a spontaneous report received via COVAES. A non-contactable nurse (patient) reported a non-pregnant 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EK5730 and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 23Dec2020 17:00 (at the age of 38 years old) as dose 1, single for COVID-19 immunisation. The vaccine was administered in a hospital. The patient's medical history included Lyme disease and insulin-dependent diabetes. The patient had known allergies to watermelon, mayonnaise, and penicillin. Concomitant medications included insulin lispro (HUMALOG) via pump for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 24Dec2020, one-day post-vaccination, the patient had mild fatigue, joint stiffness, and chills for 24 hours. The patient did not receive treatment and recovered from the reported events on 25Dec2020.  No follow-up attempts are possible. No further information is expected.
Medium menses started on day five after vaccine and have not subsided.  This is very unusual for me due to the fact I have an IUD, and for the last 10 years I have had  short and light menses.
01/26/21-11:00pm : Sore arm at injection site 01/27/21-5:30am : Full body muscle aches most prominent in the legs, joint pain, mild nausea, chills Symptoms occurred for one full day (01/27/21) following the injection and disappeared the next morning (01/28/21) No pain medication or other treatment was taken during this time.
Discharge Diagnosis:  ARF, COVID 19, UTI, Elevated d.dimer, Dm2, Hematuria, Bladder retention.    Hospital Course:  The patient was admitted with the above. He was severely retaining urine so had a foley placed. He had some hamaturia after this. Urology saw him and felt that the foley catheter should stay in until he could be evaluated by his urologist outpatient. He had COVID 19 but was asympomatic. Given his comorbidities he was given 3 days of remdesevir. His urine grew pansensitive pseudomonas. He was treated for a total of 7 days of levaquin and asked to follow up as an outpatient
Fully vaccinated employee tested positive for COVID-19 11/23/21 . EE vaccinated 12/23/20 and 1/12/21 Pfizer
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt reported feeling tingling in her fingers approximately 10 min post-immunization.  The shakiness, light headedness, and tingling subsided after approximately 30 minutes.
began to have increased shortness of breath, lightheaded, sought care from Emergency Department. Told his lungs looked like junk and was prescribed albuterol.
about an hour shot her left side of her face became numb, left side of her throat, arm and tongue was numb she went to urgent care
Severe full body pain and cannot find relief for it. Joints hurt, eyes and feet constantly swollen. large black circles under the eyes. Can barely turn head and now sleeping in a reclinder due to difficulty climbing stairs. I have had a constant headache and not able to find anything to relieve it. Extreme exhaustion with the potential of sleeping as much as 18-20 hours a day and still exhausted, that is without my nightly sleeping pill. I will be making my doctors appt. soon, I just made this connection friday when there was a woman admitted with the same symptoms after receiving the vaccine. I keep thinking everyday that it will start getting better to only wake up and find the symptoms the same or worse.
1st dose 3 years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago 0.5 ml intramuscularly).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 29-NOV-2022 Reporter's comment: The case was reported by the husband for her wife. The reporter stated that the patient got the first shingles vaccination several years ago around 3 years ago (exact date unknown) but failed to get her follow up shot. The patient asked was it okay to get 2nd dose or should she start the series over. Reporter was unable to provide any additional details. Reporter did not consent to follow up. Consent to contact HCP not given. Additional supportive information: Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case US2022178653 was identified as duplicate of US2022178654. The case US2022178654 would be voided, and all the future correspondence would be added in this case US2022178653 which stands as a case of record for this patient.
Case number PHEH2014US024300 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 46 year old female patient.  Past medical history and concomitant medication  were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 21JAN2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 71 years, in left 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Nov2022) Negative; (06Nov2022) Positive; (08Nov2022) Positive; (10Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Oct2022 to 03Nov2022. It was unknown if patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.
This spontaneous report was received from a nurse concerning a female patient of unknown age and race. Concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. It was reported that on 02-OCT-2018, the patient received improperly stored doses of  PEDVAXHIB, lot number: R005114 (expiration date: 26-NOV-2020) and ROTATEQ, lot number: R002516 (expiration date: 13-SEP-2019) (strength, doses and frequencies not reported) for prophylaxis. The vaccines were stored in between 32 degrees Fahrenheit (°F) and 35 °F for a timeframe of 4 hours and 11 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA
Arm is hard, red and hot at the injection site, about the size of a softball; Arm is hardt at the injection site, about the size of a softball; Arm is hard, red and hot at the injection site, about the size of a softball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is hard, red and hot at the injection site, about the size of a softball), VACCINATION SITE INDURATION (Arm is hardt at the injection site, about the size of a softball) and VACCINATION SITE ERYTHEMA (Arm is hard, red and hot at the injection site, about the size of a softball) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Arm is hard, red and hot at the injection site, about the size of a softball), VACCINATION SITE INDURATION (Arm is hardt at the injection site, about the size of a softball) and VACCINATION SITE ERYTHEMA (Arm is hard, red and hot at the injection site, about the size of a softball). At the time of the report, VACCINATION SITE WARMTH (Arm is hard, red and hot at the injection site, about the size of a softball), VACCINATION SITE INDURATION (Arm is hardt at the injection site, about the size of a softball) and VACCINATION SITE ERYTHEMA (Arm is hard, red and hot at the injection site, about the size of a softball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Coughing, Shortness of breath, copious white mucous, fatigue, in bed for a week, but no sore throat, and uncertain if he had a fever.
Started approximately 36 hours after vaccinated. Arm red, swollen and painful. Patient taking OTC analgesics and applying ice pack. Nausea and vomiting first day after vaccination. Skin around injection site peeled off.
Swelling and bump (size of a silver dollar) and red with heat. On left arm also fever. According to the sheet. This is consider a mild problems (common).
Information has been received from a medical office coordinator concerning a 71 year old male patient, who on unspecified date was vaccinated with dose of PNEUMOVAX. It was reported that the patient experienced cellulitis after receiving PNEUMOVAX. This is one of two reports from the same source. Additional information has been requested.
Moderate psychological symptoms.  Headache, anxiety, brain fog, mild depression.  Fatigue, difficulty concentrating, memory issues. No prior history of any of those.
Had body aches and fatigue for 4 days. Sore throat developed after second day.
48 hours S/P immunization to left deltoid, painless erythema without fever. Immediately noted at daycare. Ice applied with improvement. Examined non indurated area of erythema left deltoid, non tender no warmth. Pt discharged in good condition.