chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received IM vaccination and was told to wait up front in store. Noticed patient seizing in his chair less than 5 minutes after the shot. He was lowered to the floor and placed on his side. Total seizure was about 30 seconds. Pt came around and had no previous history of seizures.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. On 26-MAY-2015 the patient was vaccinated with one dose of RECOMBIVAX HB (dose and route of administration were not reported, lot # K008988 with expiration date 04-FEB-02016), which was improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
arm hurt strongly; Arm was bruised; dry heaving; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt strongly), VACCINATION SITE BRUISING (Arm was bruised) and RETCHING (dry heaving) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt strongly), VACCINATION SITE BRUISING (Arm was bruised) and RETCHING (dry heaving). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm hurt strongly) and VACCINATION SITE BRUISING (Arm was bruised) had resolved and RETCHING (dry heaving) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. The patient did not receive any treatment. Lab details were not provided.   This case was linked to MOD-2021-068406, MOD-2021-068406 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received on 17 MAY 2021, Reporter details added and contact information added.
Next Day woke up and was very weak could barely make it to bathroom or put one foot in front of the other also had trouble breathing . Laid in a reclining position most of day. Thereafter within a few days began having allergic reaction mainly consisting of Hives, Swollen Lip, right eye became very red. This went on often for a month then began to tapper by the end of second month became very infrequent. Note: I had Covid back in August, spent 3 weeks in hospital
3/13 Hives manifested upper legs, upper lip, right wrist, Benadryl 50mg taken. 3/14 Hives manifested stomach, lower lip, 60mg Prednisone prescribed by physician. 3/15 Hives manifested on scalp, neck.  60mg Prednisone AM, Benadryl daytime. 3/16 Severe hives entire back, neck, scalp and forehead, also arms and shoulder, front and back, right eye swollen, 60mg Prednisone, 25 mg Benadryl every 4-6 hours. 3/17  Hives almost gone except stomach and lower arms, continuing Benadryl.
Pt had an axillary temp of 103.9F for 3 days. Pt has been fussy and whiney. Pt had similar experience after 2nd set of vaccinations.  Pt was treated with Tylenol and Motrin.
face swollen; felt congested; Allergic reaction; burning, itching eyes / eyes were really itchy and burning; itching eyes / eyes were really itchy and burning; eyes swollen shut; scratchy throat /throat was scratchy/ burning throat; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd March 2021, 1 days after receiving Shingrix, the patient experienced facial swelling and nasal congestion. In March 2021, the patient experienced allergic reaction, burning in eyes, eye pruritus, eye swelling and throat irritation. The patient was treated with cough cold preparations nos (Cold Medicine). On an unknown date, the outcome of the allergic reaction, facial swelling and nasal congestion were unknown and the outcome of the burning in eyes, eye pruritus, eye swelling and throat irritation were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, burning in eyes, eye pruritus, eye swelling, throat irritation, facial swelling and nasal congestion to be related to Shingrix.  Additional information was provided as follows: On 3rd March 2021, within 12 hours after vaccination the patient experienced burning, itching eyes and scratchy throat and within 16 hours after vaccination the patient experienced eyes swollen. The patient took cold medicine. The reporter consented to follow up.
This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (4 of 10) concerns a 38-year-old male patient, who had a medical history of immunodeficiency. The patient died of respiratory failure (under review), nineteen days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).
Welts all over body; Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts all over body) and RASH (Rash all over body) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced URTICARIA (Welts all over body) and RASH (Rash all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, URTICARIA (Welts all over body) and RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
SINCE TAKING THE SHOT I NO LONGER SEE A REGULAR MENSTRUAL PERIOD AND ALSO I'M HAVE A LUMP ON MY BREAST THAT IS NOW UNDER OBSERVATION. I WON'T KNOW UNTIL MARCH WHAT IS ACUTALLY GOING ON WITH MY BREAST. THIS HAS MENTALLY AFFECTED ME. IM LIVING IN FEAR NOT KNOWING WHAT MY MAMMOGRAM WILL BECOME OF.
explosive diarrhea-  taking loperamide 2mg and eating binding foods  will see if it stops
fever; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation; dupilumab (DUPIXENT, Lot number was not reported) via subcutaneous route of administration from an unspecified date to an unspecified date, at 200 mg for severe persistent asthma. The patient medical history was not reported. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR HFA) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced fever. It was reported that on 31Aug2021, the patient developed a non-serious event missed dose (product dose omission issue) (unknown latency). It was not reported if the patient received a corrective treatment for the event. The patient underwent lab tests and procedures which included fever resulted as unknown, sars-cov-2 test resulted as unknown. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a physician refers to many patients of unknown age and gender. On an unknown date, many patients were vaccinated with M-M-R II (dose, duration, indication, route and lot were not reported). On an unknown date, many patients were not showing as immune to mumps when titers are drawn. This is one of several reports from same source. Additional information has been requested.
Initial unsolicited case received from a non-healthcare professional (healthcare worker) on 11-Sep-2015. This case involves a male patient (age not reported) who was vaccinated with a second dose of MENACTRA (batch number, expiry date, route and site of administration were not reported) on 31-Aug-2015. Medical history and concomitant medications were not reported. On unspecified date, after vaccination patient developed breaking out in rash from top to bottom that appeared as raised hive-like welts that were very much swollen. Patient was taken to emergency room. Patient had previously received MENACTRA when he was "11 years old" on unspecified date. Lab tests and corrective treatments were not reported. Outcome of the events was not reported. Documents held by sender: none.
GOT SICK; MESSED UP; This spontaneous report received from a patient via a company representative 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 not reported, batch number: Unk) 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 got sick, and messed up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from got sick, and messed up. This report was non-serious.
Rash all over body. Shot was given Saturday morning and rash occurred Saturday evening. She took BENADRYL.
Patient was given a Kinrix and was age 3 at time of vaccination. Vaccine not licensed for this age. No adverse effects reported.
This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a female patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cold symptoms. On an unknown date, the outcome of the cold symptoms was unknown. It was unknown if the reporter considered the cold symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient was due to her 2nd dose of SHINGRIX by 25th January 2019. The reporter wanted to know, if the patient could opt out of 2nd dose. The call center representative advised to the reporter to follow up with their physician and informed that the patient did not have to receive 2nd dose if the patient chooses not to, however there was no guarantee of any effectiveness with only receiving one dose. The reporter would follow up with a physician. No other information could be obtained as the reporter disconnected the call. The reporter did not consent to follow-up.
1)  12 hours after getting vaccine, patient experienced severe pain in right lower flank over ovary.  Pain was sharp, stabbing, lasted about 12 hours.  Since then has been having intense cramping, menstrual type pain which did not have prior to that.   2)  Reports chest pain she states that it started right after her first Covid vaccine, Pfizer.  Pain worse with lying down, better sitting up.
This case was reported by a consumer and described the occurrence of influenza-like symptoms in an unspecified number of male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were unknown. It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not applicable. The reporter stated that the people were getting flu like symptoms from the flu shot all at the same time, after they got their shots. Sometimes these symptoms were much worse. The reporter's father all group home boys got sick with flu like symptoms. The reporter stated that that Flu shots were not properly tested and well known not to be effective and these flu like symptoms were contagious. This case is 1 of the 3 linked cases reported by the same reporter.
11/6/02 pneumonia vaccine given. R arm 14xmc 17cm red, raised area. 11/6/02 flu vaccine given L arm 5cmx 4cm red, raised area. Was splotchy red day of imm. Today all areas remained-but not getting any larger.
Reaction within hours of given immunization to right upper thigh - redness and warmth at site of injections.
On the morning of March 15, I developed  a red rash on throat, lower facial cheeks, and chin.  Lips tingled a little bit.  Rash did not itch.   Took 2 Benadryl three times that day, contacted doctor via email.   The rash was better the next day (March 16) but took 2 Benadryl again three times that day.   Sent photo to doctor who had an allergist in the clinic look.  He said it was a reaction to the vaccine.    March 17 rash was completely gone and have had no other reactions since.
itchy rash developed 3-4 days later on same arm as injection, also developed on opposite arm and trunk
Dizziness; Weakness; Chest pain; Nausea; Felt like throwing up; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 15-years-old female patient (daughter) received bnt162b2 (BNT162B2), Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Sep2021 (at the age of 15-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot Number: FC3181 and Exp. Date: Oct2021) intramuscular on 27Aug2021 (at the age of 15-years-old) for COVID-19 immunisation. It was reported that on an unspecified date, the patient experienced dizziness, weakness, chest pain, nausea, felt like throwing up and sore throat. Additional information provided as, patient (daughter) got her second shot yesterday and she was almost 16 (Further clarification unknown). She was feeling some of the side effects that is supposed to be reported. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Fevers, Chills, Sweating, Nausea, Upper GI discomfort and pain, Headaches, Malaise, Loss of Appetite, Dehydration for a FULL 8 days and then weakness and muscle pain have continued over the past two days.
Shortly after vaccine felt dizzy; nurse gave me water and a granola bar to eat.  Employee took a bite or two and then felt dizzy.  Employee sat down and blood pressure taken 170/ 80 and then 10 minutes later B/P 200/90.  Nurse manager came and recommended employee go to ER for assessment.  Blood sugar was checked and employee states "they were not low"
scitomata: light yellow spot generally round w/edge approx 6cm diameter, noted in lt eye against white/light colored background that inc then dec intensity over 2wk;it began 48hr p/vax;
Day after shot had a terrible headache, back and body?s aching, back of neck hurt, lips were very hot and had a fever of 101.8. I took 3 Motrin, bundled up with flannel pj?s and 3 blankets. Around 8:30 Pm I went into a total sweat and broke the fever. I woke up at 4 am and took 2 Motrin.  I felt somewhat better the next day, just very tired. I also had a a large red rash and swollen arm around the shot sight the. I took my temperature around 4 pm I had  100.7 fever . The next day I felt better. On the 5th day the rash was gon
After administering vaccine, vaccinator noted "2 drops" running down patient's arm.  Vaccinator and pharmacist inspected syringe, and fluid was noted where needle threads into syringe.  Verified needle was threaded into luer lock, although there was still room to be tightened.  It is thought that these drops came from the intersection of needle and syringe.  Unclear how much of this vaccine dose was included in those two drops.  Is a revaccination warranted?
This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 29th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th November 2021, 1 days after receiving Shingrix, the patient experienced fever, headache, muscle pain and feeling unwell. On an unknown date, the outcome of the fever, headache, muscle pain and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the fever, headache, muscle pain and feeling unwell to be related to Shingrix. Additional details were provided as follows: The case was reported by patient herself. The patient received her first dose of Shingrix in left deltoid one day before reporting and on the day of reporting experienced fever, headache, muscle pain and felt like she just wanted to lay down. No lot or expiration date for vaccine was known. The reporter did not consent to follow-up. The reporter declined to provide health care professional contact information.
After 7 days; sweeling, red, itchy, the red area expanded.  Treatment; augmentin 800mg bid, benadryl 50mg hs, hydrocortisone cream bid. Waiting for results.
Went to ER, the night of vaccination with swollen neck, fever, sore throat more on right side and had a severe headache. MD called CDC 8/11/00.
Information has been received from a medical assistant(also reported as office manager) referring to a 9 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 09-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # reported as  L025738, expiration date: 14-AUG-2017; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 2. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
Redness / erythema in 24 hours, itching within 12 hours, swelling at injection site and (R) axillary node, non resolving.
Initial unsolicited report received from Other Health Care Professional on 06-Aug-2018. This case involves a 5 years old female patient who was vaccinated with 0.5 ml fourth dose of PENTACEL (batch number: C 5371AA and expiration date: 04-Jun-2018) (site of administration was not reported) via intramuscular route on 06 Aug 2018 (Powder: C5371AA expiry date: 04-Jun-2018 NDC 4928151005 and Liquid: C4976AA, expiry date: 04-Jun-2018 NDC 4928156005). The patient's medical history were not reported. No other concomitant given. It was an actual medication error due to expired dose of PENTACEL. No reaction 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.
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date as single dose for immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced redness on an unspecified date. A separate concern regarding the color of PREVNAR 13 after shaking vigorously was also reported, date unspecified.  The outcome of redness and separate concern regarding the color of PREVNAR 13 after shaking vigorously was unknown.
Received vaccines in addition to bicillin and with subsequent syncopal event. When awoke from syncope had throat swelling, tightness, and SOB. Given epi and benadryl.
EXTREME FATIGUE   ENDED AFTER ABOUT 4 DAYS HEADACHE     ENDED AFTER ABOUT 3 DAYS  FATIGUE       STILL CONTINUING
Pt was given 2nd Shingrix vaccine on 3/19/2018. On 4/2/2018 he presented to my office with x1 day history of painful itchy rash on left forearm, this was consistent with herpes zoster.
Localized swelling and redness on L thigh at injection site, minimal bruising first noticed 4 hours after injection.
(Applies to both doses) - 10 minutes after shot, I experienced a hollow sensation in/around my uterus. It felt like my period had suddenly started. It disappeared after 5 minutes. The exact reaction happened after each Pfizer shot. After Dose 1, my period was 3 weeks late but otherwise normal. After Dose 2, I had a timely but very abnormal period. Abnormal bleeding and debilitating pain. This information is submitted before an impending doctor visit over symptoms from the latter period and sensation post-vaccines.
Excessive fussiness, vomiting, came to urgent care asystolic, time of death called after resuscitative efforts failed, small bowel necrosis determined at autopsy.
Pt. was being driven home in passenger seat & told father he was "feeling funny" & then lost consciousness for about 20 seconds. Father flagged down police driving by & EMT were called. EKG performed w/ normal results. Pt. scheduled appt w/ PCP but nothing was found.
I had my vaccination on 09/09/2022. In 11/2022 I had a lymphatic masseuse that noticed I had enlarged nodes. Dr. noticed in neck the nodes were still swollen on 01/27/2023. I had Ultra Sound and CT Scan and mammogram 02/032023 which confirmed swelling of nodes. I was referred to an ENT. A biopsy was done 02/13/2023 and no cancer was found. I have a follow up appointment with ENT in 07/2023.