chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer whose son on 17-MAR-2010 was vaccinated with VARIVAX (Merck) (lot number 665586/1227Y) concerning her 11 year old daughter with a history of chickenpox when she was one year old who on 14-APR-2010 developed chickenpox. Her son did indeed receive VARIVAX (Merck) as well as VAQTA (MSD) (lot number 66030/1397Y) and "MCV4 meningitis vaccine " (other manufacturer). Her son did not develop any rash. The patient had chickenpox again and on the morning of 14-APR-2010, she had blisters on her stomach, back, arms and scalp. The patient felt fine otherwise. It was unknown if medical attention was sought. The outcome was not reported. Follow up information has been received which reported that on 30-AUG-2000 the patient was vaccinated with a dose of VARIVAX (Merck) at another office. She had red small pustular lesions on her limbs and trunk, no vesicles were noted. She went to see the physician and the physician's impression was questionable chickenpox, but could not diagnose today. At the time of this report, the patient's outcome was unknown. Follow up information has been received from the physician who reported that the patient did not receive our vaccine and had wild type chickenpox. This is one of several reports from the same source. Additional infection is not expected.
A report was received from a health care professional on 11/18/03 concerning a vaccinee of unspecified demography who experienced thyroid storm, which was considered medically significant (OMIC) in the same month as receiving influenza vaccine (brand unspecified) in November 2003. The vaccinee has a history of hyperthyroidism. On an unspecified date in November 2003, the vaccinee experienced thyroid storm. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Update 1 2/16/04: A follow up report was received from a health care professional indicating that the vaccinee had received a shot of Fluvirin several years previously and subsequently developed thyroid storm (date of onset and vaccination not known). The vaccinee has received several vaccinations since then including Fluvirin in November 2003 without reaction.
Fever started at around 4:30 am the morning after receiving the vaccine. The chills woke me up, so I took Tylenol 1000 mg and my fever broke about an hour later. I had to keep taking Tylenol 1000 mg at 10:30 am and 4:30 pm to control my fever. Each dose worked well for the first 3 hours or so on the fever, but then it would come back. I also had muscle and headaches and fatigue, which made it very difficult to move around. The Tylenol also helped with that somewhat, but I spent most of the day in bed and on the couch (and I am normally very active). By around 5:30-6pm, the symptoms were fading slowly. I felt a lot less achy and my body temperature felt closer to regular by the time I went to bed at 9pm.
Spoke with mother 3/23/18 - was informed of reaction. Please see attached physician note. Patient is a 4 YO male who complains of heat and redness to R thigh. Pt. received vaccines at health department Tuesday. Had preschool shot. We think DPT, IPV and varicella and MMR. Go red mostly the next morning and today. No fever systemically. Acting ok overall. No Hx of RXN in past. Denies - headaches, blurred vision, double vision, earache, decreased hearing, nasal congestion, nose bleeds, runny nose, sore throat. Diagnoses: Cellulitis of right lower limb. Plan: Rx Cephalexin 50 mg/ml, oral suspension 1 tsp. TID. Return to office if any persistent problems.
Headache, Myalgia, Migraine,chills,body aches, soreness to left arm. Narrative:
This is a spontaneous report from a contactable consumer or other non hcp (wife of patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced terrible reaction with the first dose, he was down the first day. The reporter stated that he didn't want to take it, was a skeptic, but reported said to take it. It was stated that the patient would get the second dose. Outcome of the event was unknown. No follow-up attempts were needed; information about lot/batch number could not be obtained.
This report is for my second Moderna covid vaccine injection Fatigue and headache started the same day around 8:30 or 9 pm. The following day at 4am I woke up with a 100.4 F fever and nausea that led to vomiting. I vomited again later that day and my highest fever was 101.4 F. I experienced alternating chills and sweats, headache, nausea and vomiting, fatigue, general body aches, and injection site pain. Symptoms improved with Tylenol taken throughout the day and a morning dose of Zofran (I take Zofran daily as an unrelated treatment), but did not disappear entirely. It is now 4/10/21, two days after the injection, and I do not have a fever (without Tylenol) or nausea, but still have some body aches and injection site pain.
Patient is 11 years old and inadvertently given PfizerBioNTech COVID-19 Vaccine ?12 years formulation (purple or gray cap).
irregular heart beat; 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 HEART RATE IRREGULAR (irregular heart beat) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (irregular heart beat). At the time of the report, HEART RATE IRREGULAR (irregular heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.   Reporter did not allow further contact
About two weeks after the first shot, I got urticaria. I still have it four months later.
No immediate A/E.  At the one hour post-vaccine reported mild nausea, hot flashes on/off for another hour, and bumps on the forehead. Bumps we not visible, mildly palpable, not itchy, and possibly contact dermatitis from face shield - this vaccine is a nurse that returned to duty after the 15 minute observation time.  No treatment, self monitor only .
This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer
Patient developed rash and small hives on chest 10 minutes after receiving  Flumist and Moderna Covid Booster Shot.  He had no shortness of breath or swelling.  I gave him 25mg diphenhydramine and observed for 30 minutes.  By this time, itching had resolved and he had no other symptoms.
I had a mild headache for about 6 days. On day 7, I had a temporary vision cut for 43 min and then it returned in full, but I had a severe migraine and nausea. They did CT imaging and labs. Everything was clear. I was medicated with IV pain meds and anti-nausea meds. I continued to have a mild headache for a few days, but it eventually resolved.
Site  arm redness, swelling, at site starting first evening after morning vaccine, progressively worse, making sleep difficult.  Chills 2nd day, fever 100F by evening 2nd day and in morning 3rd day, muscle aches and joint pain, 2nd day evening continued through 4th day, with injection site Arm pain still present on 5th day radiating pain into lower arm and fingers.  Most body aches discontinued.  Difficulty feeling warm on 5th day.  Used Advil to reduce fever and pain.
Dr. diagnosed atrial flutter on March 2, 2022. He performed a cardiac ablation April 7, 2022. Ablation procedure successful.
Initial soreness at injection site gradually subsided over the course of 1 week. On day 11 pain at injection site woke me during the night. There is an approximately 2.5 inch raised area slightly warmer than surrounding area and very tender to touch. Some itching at the site.
This spontaneous report has been received from a licensed practical nurse referring to a 17 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Information has been received from a physician concerning a 13 month old patient who in August 2008, was vaccinated with ZOSTAVAX (Oka/Merck) (lot no. 659763/1875U) SC, instead of VARIVAX (Oka/Merck). The physician noted that although the VARIVAX (Oka/Merck) and ZOSTAVAX (Oka/Merck) vials look alike, the names of the vaccines were clearly written in large letters. This is one of several reports from the same source. Additional information has been requested.
PATIENT RECEIVED SHOT AROUND 8:30 AM ON 12/14/15 AT REQUEST OF HIS DOCTOR.  PATIENT STATED NO SICKNESS NOR PAST ILLNESS ON QUESTIONNAIRE.  HE STATED HE NOTICED RED SPOTS ABOUT 5:00 PM THAT EVENING.  HE WENT ON TO BED AND WHEN HE WOKE UP THE NEXT MORNING HIS UPPER LEFT QUADRANT OF FACE, EYE AND SCALP WAS BLISTERED AND RED. HE WENT TO DR ON 12/15 AROUND LUNCH. DR GAVE RX OF ACYCLOVIR 800MG FIVE TIMES A DAY AND SENT HIM TO EYE DR. THE EYE DR GAVE ERYTHROMYCIN OPTH OINT AND PREDNISOLONE DROPS.
Systemic: Flushed / Sweating-Medium, Additional Details: fainted for 2 secomds and flushed for few seconds and she was fine after that. never had anything like this before and it was her booster dose
This spontaneous report as received from a nurse refers to a 13 year old female patient. No pertinent medical history was reported. No drug reactions or allergies were reported. On 28-AUG-2013 the patient was vaccinated with a second dose of GARDASIL lot # H021346, expiration date 01-OCT-2015, 0.5ml dose, intramuscular. The nurse stated that the patient received GARDASIL series as follows: first dose on 20-JUN-2013, lot# H021346, expiration date 01-OCT-2015, intramuscular, second dose on 28-AUG-2013, lot# H021346, intramuscular, and third dose on 10-APR-2014, lot# H020901, expiration date 05-JUL-2015, dose 0.5ml, intramuscular (also reported as subcutaneous). Concomitant therapy included HAVRIX (dose and indication not reported) administered on 10-APR-2014 in the opposite arm of the GARDASIL. It was reported that on 28-AUG-2013 (immediately after receiving her second dose), the patient experienced nausea and lightheadedness. It was reported that the patient was observed for 15 minutes at the physician's office and sent home due the patient feeling better (it was also reported that finally the patient recovered from nausea and lightheadedness, but exact date was unspecified). The nurse also reports that the patient was nausea right before (on an approximately 10-APR-2014), receiving her third dose of GARDASIL. She states that due to the patient feeling nausea, the patient received her third dose of GARDASIL in the "reclining position". It was reported that the patient's mother "feels" like the third dose of GARDASIL was administered subcutaneous instead of intramuscular but the nurse reported that the first, second and third dose was administered intramuscular. The patient's blood pressure on 28-AUG-2013 (after receiving her second dose) was 106/66 (units not provided). No other laboratory diagnostics were performed. The patient's outcome of event: nausea right before receiving her third dose of GARDASIL was reported as recovered (date unspecified). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
high fever to 105;fussiness these occurred w/in 24hr of vax;
Death Narrative:  Pt was at rehab hospital where he rec his vaccine. No info for Lot or site. Was under Hospice for COPD, CHF, MDD. Passed at rehab center. No other info.
Partial dose of vaccine (less than 1/2 dose) was given in error and repeat dose has been rescheduled per Guidelines.  No adverse events reported per patient. Patient notified and will return for revaccination today.
This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash (received 1st dose 3 months ago and experienced similar reaction as that with 2nd dose refer case US2018GSK176765). On 18th September 2018, the patient received the 2nd dose of SHINGRIX. On 18th September 2018, less than a day after receiving SHINGRIX, the patient experienced discomfort and pain. On 19th September 2018, the patient experienced generalized muscle aches, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness and influenza. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza and pain were unknown. It was unknown if the reporter considered the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The patient got a dose of SHINGRIX vaccination a day prior to reporting date in afternoon. There was not much pain or discomfort at all until the reporting date. This morning the patient woke up with moderate or greater muscle pain in my whole body-especially my lower back, pain at the injection site, headache, flushing, itchiness in various areas-mostly the face, head and back, some dizziness and some tiredness. The patient stated that If the patient did not know any different the patient would thought to came down with the flu, except for the itchiness part. The patient stated that, that the side effects were downplayed quite a bit in your disclosures (1 in 10 experienced side effects). The patient had a very similar reaction adding a rash as well with the first injection 3 months ago. This case has been linked to the US2018GSK176765, reported by the same reporter.
Her whole arm hurt right at the injection place; Chills; Muscles and joints aches; Pains; This is a spontaneous report from a contactable pharmacist.  A 17-year-old female patient started to receive meningococcal group b rlp2086 (TRUMENBA, Lot Number: AL8468 and expiration date: Feb2021), via an unspecified route of administration in May2019 (a month ago), at a single dose for immunization. There were no relevant medical history nor concomitant medications. After the administration, the patient's whole arm hurt right at the injection place and then the next day she had chills, muscles and joints aches and pains which was considered as the side effect but she said she threw up after that for 2 days in May2019, patient was not sure  if it was due to the vaccine or if it was just stress. In addition, it was also reported that the caller came back and rejected it as a booster, said that it was a booster vaccine and they rejected this. The patient's mom came in with a paper work from the college for which the patient needed a booster to go the college. The patient's mother  was advised to put ice on the injection site if it's still hurt or she needed to take a acetaminophen (TYLENOL). Outcome of the events was unknown.
10/21/09, 13:00, INFLUENZA H1N1 injection. 10/21/09, 17:30, left eye itchy-18:30-full blown hives on left eye, 18:45-antihistamine x 2 PO-headache. 10/22/09, 06:00, antihistamine x 2 PO-still swollen (eye), hives break out on hands/arms.
SEVERAL BOUTS OF NUMBNESS (RADIATED ON ONE SIDE OF BODY, WENT FROM SHOULDER DOWN THROUGH LEG, EACH EPISODE LASTED ABOUT 10 MINUTES); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced several bouts of numbness radiated on one side of body, went from shoulder down through leg, each episode lasted about 10 minutes. Treatment medications included acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from several bouts of numbness radiated on one side of body, went from shoulder down through leg, each episode lasted about 10 minutes. This report was non-serious. This case, from the same reporter is linked to 20211232860.
Pharmacist called patient back into consultation room by last name.  Patient acknowledged the name and proceeded back to the room.  Pharmacist then announced that she would be vaccinating him with moderna booster and asked patient if he was immunocompromised.  He then answered no.  Pharmacist then proceeded to inform patient that this would be a half dose due to not being immunocompromised.  Patient didn't respond.  After the vaccine, pharmacist thanked patient and wished him happy holidays.  After patient left room, wife took covid card from patient and was about to put it in her purse when she noticed the name on the card was wrong.  Long story short, patient was at pharmacy for Hep A/B shot and received Moderna booster by accidnet.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days.  This report is for patient 13 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 13 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid 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 Jan2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Serious criteria reported as no any results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. COVID 19 Treatment received from 03Jan2023 to 08Jan2023, lot number was not sure. Other medication details: other medication in 2weeks product=Zoloft, Sulfazalasine, Atorvastatin, Prednisone. Adverse event: I tested negative on day 7 of the original covid infection after taking Paxlovid. 2 days later I felt weak and woke up with a cold, had some chills and took 2 tests and tested positive again. Patient was recovering. No treatment for adverse event. No known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Flu shot administered to Lt. arm. Patient C/O hot feeling, and dizziness. Stated that she might pass out. Red blotchy area noted to both arms, no C/O itching. 25mg BENADRYL provided PO. Taken to ER.