chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 5 mins. after receiving injection (pt was lying) she sat up and felt a sharp pain on left side of Torso (same side of injection), lasting a few seconds.
This case was reported by a pharmacist via call center representative and described the occurrence of passed out in a 60-year-old female patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. On 4th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) 50 µg. On 4th November 2018, less than an hour after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), feeling hot and cramp in hand. On an unknown date, the outcome of the passed out, feeling hot and cramp in hand were recovered/resolved. It was unknown if the reporter considered the passed out, feeling hot and cramp in hand to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could 59 or 60 years. The pharmacist reported that the patient received a dose of SHINGRIX, within 2 minutes the patient passed out, got hot and her hands started locking up. The pharmacist called EMS and the patient was taken out in an ambulance. In November 2018, the symptoms had resolved. The reporter given consent to follow up. The patient required to visit emergency room (ER).
On 4/26/19 Patient states she has severe flu-like symptoms including fever, chills, muscle aching, lethargy. On 4/27/19 Patient continued to be shaking (no chills) and sore arm.
Dizziness, lightheaded, vertigo, imbalance, positive Rhomberg's test, lateralization right with walking. Two brief episodes in evening and during the night. Examined by Dr. the next morning with these findings.
Redness and swelling (left arm) 3x4 cm. Treated with cool compresses and Motrin.
a dose of improperly stored PROQUAD was administered to a patient; This spontaneous report was received from a nurse, regarding a patient of unknown age and gender. Information about the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On 30-DEC-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) at a dose of 0.5 milliliter, for prophylaxis, lot number S013712 has been verified to be valid, expiration date 01-NOV-2020 (strength, route of administration, and anatomical location of vaccination were not provided) (product storage error).   The sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was properly stored.  The temperature of the vaccine administered was reported as -12.2 Celsius degrees (C) and the time frame 25 minutes. Data logger was involved.  There was no previous temperature excursion.
Woke feeling a bit dizzy and just "off." Later in the morning took my blood pressure and it was 212/101.  Tried to relax and went for a short walk. Came down to 168/89.  Late afternoon started feeling poorly again. BP had gone up again to 217/101.  Since I was having no other symptoms (headache, chest pain, etc) and wanted to avoid the ER I took a clonidine, which brought it down. Today it's pretty much back to normal. I do have labile blood pressure, probably due to dysautonomia, but never that high for no known reason.
Admitted in the hospital on 08/09/2021. Date of death 09/02/2021
Lips began itching/swelling after 2 hours.  Itching stopped after 24 hours, swelling in upper lip still evident after 4 days.  No trouble breathing.  Continuing to monitor.
BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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: Unknown) dose, 1 total, start therapy date were not reported 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 blood clots, and was hospitalized (date unspecified). It was unknown if patient was discharged from hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210800582-covid-19 vaccine ad26.cov2-blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
My daughter had the LAIV (nasal spray) and had a severe reaction - hives from her head to her toes.  She needed to be on steroids to bring relief.  Not sure if doctor reported this reaction.
Twelve-year-old patient was inadvertently given a pediatric dose #2 of Pfizer which is indicated for ages 5-11 only.  The first dose of Pfizer (purple cap) was given 11/8/21.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included ADHD (No medications since pregnant) in 1992. Concomitant products included DIPHENHYDRAMINE HCL for Allergy, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy.    On 25-Feb-2021 at 1:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The patient's last menstrual period was on 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2020, Pregnancy test: positive (Positive) Positive. On 30-Nov-2020, Scan: (normal) normal. On 20-Jan-2021, Glucose tolerance test: (normal) normal. On 14-Sep-2021, Blood test: (normal) normal.     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.   Treatment medications were not provided by reporter.  The patient's estimated date of conception was 23-Jul-2020.  The patient was 33 weeks pregnant.
pt admitted as inpatient with congestive heart failure, myocarditis and non sustained ventricular tachycardia
Patient presents w/ PMHx of GERD presented to pain clinic by referral from primary care with new, sudden onset 8/10 sharp pain and tingling in lower extremities bilaterally terminating rostrally at the level of the coccyx. These symptoms began 3 days after receiving the first Moderna COVID-19 vaccine of the two-part series. The pain is refractory to acetaminophen and three sessions of physical therapy. The pain and numbness make it difficult for the patient to fall asleep. The b/l leg pain was so disturbing that the patient presented to the ED where she was noted to be ?slightly ataxic? and was treated by the ER physician for lumbar radiculopathy with one Norco that did not help.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 03-SEP-2015, the patient was vaccinated with an expired dose of (Merck) VARIVAX injection (lot # J009730, expiry date 07-AUG-2015; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Moderna Booster (0.25ml) vaccine was drawn up after max 20 drawn doses allowed. Proper aseptic techniques were used during dose extraction and dose was inspected prior to administration. Patient was given correct dose (0.25ml) and was  monitored for 15 minutes after vaccination. No adverse event/reaction occurred after administration.
Information has been received from a office manager concerning a 65 year old female patient with allergies to LIPITOR, CRESTOR, "MS04", ciprofloxacin and no pertinent medical history who on 22-MAR-2011 was vaccinated intramuscularly in the left arm with 0.5mL of PNEUMOVAX 23 (Lot# reported as 1158211261 and unspecified expiration date). Concomitant therapy included BENADRYL. On 23-MAR-2011 the patient experienced swelling, pain and itching at the injection site, and the patient went to the hospital emergency room. It was reported that the emergency room records stated the patient's left arm had a red ring around the injection site, and the patient's left arm and biceps were swollen, painful and the patient complained of itching at the injection site. It was reported that an ice pack was applied to the affected area at the emergency room. Also while in the emergency room the patient received dexamethasone (manufactured unspecified) 10mg IV, ranitidine (manufactured unspecified) 50mg IV, ketorolac tromethamine (manufactured unspecified) 30mg IV. The patient was discharged from the emergency room with an improved condition, and the patient was given a prescription for a MEDROL and ZANTAC 150mg. The office manager reported that the patient went to the physician office today on 30-MAR-2011 and her left arm was still swollen and had some redness. The physician recommended that the patient took BENADRYL and performed range of motion exercises. No laboratories were performed. Upon internal review, swelling, pain redness and itching at the injection site treated with dexamethasone IV (manufactured unspecified) were determined to be an other important medical event. Additional information has been requested.
Initial report was received 05 January 2008 from another manufacturer, document number 455211201. The initial reporter to this manufacturer had been a consumer, who is the patient's sister. According to the reporter, her brother received a "DTAP" vaccination (manufacturer unknown, lot number not reported) on an unspecified date and an unspecified amount of time later, "he developed severe seizures and he ended up with severe brain damage". Due to complications, he passed away. No cause of death was reported and no additional information was provided at the time of the report. Documents held by sender: None.
throat is also a little bit sore; extremely exhausted; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm sore), FATIGUE (extremely exhausted) and OROPHARYNGEAL PAIN (throat is also a little bit sore) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced LIMB DISCOMFORT (arm sore). On 22-Feb-2021, the patient experienced FATIGUE (extremely exhausted). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat is also a little bit sore). On 21-Feb-2021, LIMB DISCOMFORT (arm sore) had resolved. At the time of the report, FATIGUE (extremely exhausted) and OROPHARYNGEAL PAIN (throat is also a little bit sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The patient's medical history was unknown Concomitant medications reported included medications for condition probably colitis. No treatment provided
Patient states that he has pain in the arm upon raising and moving the arm since receiving the vaccine for about a month
Flu like symptoms of weakness, aches near shoulders and neck area. Patient claims she could not stay awake and felt like she wouldn't be able to go into work the next day. When waking up at 5 in the morning the day after the vaccine was given she felt completly normal again and was able to attend work.
diarrhea; lethargic; fever of 102; shivering; weak; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th February 2021, the patient received the 2nd dose of Shingrix .5 ml. On 7th February 2021, 1 days after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced diarrhea, lethargy, fever, shivering and weakness. On an unknown date, the outcome of the diarrhea, lethargy, fever, shivering and weakness were not recovered/not resolved.   The reporter considered the diarrhea, lethargy, fever, shivering and weakness to be related to Shingrix.  Additional information was provided as follows: The patient received vaccine in left arm. The patient received 1st dose 2 month before reporting, the patient did not remember if he experienced any side effects after his first dose. The patient woke up a day before reporting, experienced shivering and a fever of 102 Degree F.  The patient was also lethargic and weak and experiencing some diarrhea.  All symptoms improved till the time of reporting except for the diarrhea which had worsened. The reporter did not consent to follow up.
8-10 hrs post injection (this was the second dose) nausea, fever, chills, diarrhea, headache, weakness, dizziness, could not get out of bed or stand.
Patient at the clinic for their first COVID-19 Pfizer vaccine today.    Patient, sister and their mother were scheduling their second dose appointment when the writer heard a "thump" on the ground. The writer turned around to see the patient laying on the ground underneath a chair on her stomach with her eyes closed and not responding to voice command at approximately 1520.    The writer and another nurse immediately rolled the patient to her side, a nurse moved the patient's hair from her face and the patient began to open her eyes. Patient began to become alert after less than 30 seconds of the episode.    Patient remained laying down for approximately 2 minutes and stated she was embarrassed. Patient began responding to verbal commands and questions. Patient then began to go from a sitting and then to a standing position. Patient and her family escorted to the recovery room and assessed, refusing wheelchair transport.   Patient's mother stated no history of this adverse event previously.    Vitals taken x2 (See flow sheet). Nurses performed a head-to-toe focused assessment. Patient A & O to person, place, and time. Pupils equal and reactive to light. Patient asked "what day is it" and responded " The 18th." Patient asked "where do you go to school" and responded appropriately with school location. Patient asked "what is your mom's name" and responded. Patient asked "what is your name" and patient responded with her name. Patient asked "how old are you" and responded "12."  Nurse assessed the back and both sides of the patient's head and witnessed no bumps, bleeding, or swelling. Nurse noted redness and slight swelling on the right eyebrow approximately an inch in length. No laceration or bleeding noted. The patient's mother touched the site and the patient stated that it hurt. Nurse advised the patient to place an ice pack on the site and the patient declined. Patient denies any neck pain, headache, nausea, dizziness, lightheadedness, or trouble breathing. Patient skin warm and pink.   Nurse offered ice, animal crackers, and juice and patient declined.   Nurse offered EMS evaluation to patient mother and the patient's mother declined.   Patient's mother and the patient educated on the s/s of a head injury and allergic reaction and instructed to call 911 or go to the nearest ER. Patient and mother also instructed to follow up with a PCP and inform them of today's episode at their next visit.   The patient and the patient's mother also instructed to ask to be given the vaccine in the recovery room for the second dose at the next appointment.   Patient and family remained at the clinic for 30+ minutes. Patient stated that she felt ok and the patient's mother stated she felt ok to take the patient home.    Patient left in the company of her mother and sister in stable condition without transport assistance out of the clinic.   Patient's mother informed that a VAERS report will be filed and that they may contact her for further follow-up.
08/05/2017 seen in ED for cat bite obtained on 8/4/17. Bite to right middle finger and scratch to right palm and left fingers. Vaccine given 8/5/17 as well as ABX and tetanus (Tdap). Clindamycin PO QID x 1 week and rabies vaccine day 3, 7, 14 needed. 08/08/2017 - rabies shot (day 3). 08/12/2017 - rabies vaccine (day 7; rash under breast noted. DIFLUCAN PO x 1. 08/14/2017 - rash all over body x 2 days and diarrhea x 1 week.given DIFLUCAN for candidiasis; started having diffuse rash on Saturday, itching and intermittent diarrhea. 08/15/2017 rash is spreading since in ER on Saturday for injection. Pt reports needing more clobetasol. Pt seen in ER Saturday and yesterday for rash after receiving rabies vaccine. Final vaccination to be given on 8/19/17. Derm consulted.
In first vaccine I had a week long back pain. Shoulder , back neck area. Didnt move my head because of pain a week.Second vaccine fever at night a lot of nightmares.
Case number PHEH2013US013416 is an initial spontaneous report received from a nurse on 19 Jun 2013, and with a follow up report received from nurse on 09 Jul 2013. This case refers to a 16-year-old male patient. His medical history was not reported. Concomitant vaccine included GARDASIL (batch number: H021194) at a dose of 0.5 ml into left deltoid on 13 Jun 2013. He was vaccinated with a booster dose of MENVEO (batch number: A1225), at a dose of 0.1 ml (under dose) intramuscularly into left deltoid on 13 Jun 2013. No adverse event was reported at the time of this report. The PTC complaint was registered with reference number 70763. No other information was available. Follow up report received from nurse on 09 Jul 2013. Updated patient demographics, concomitant vaccine, site of vaccination.
Last night had heart burn worse then had in years. hot flashes with no temp. muscles soreness and soreness in joints. symptoms are still happening currently
Local reaction, red and warm left anterial thigh 8cm x 10cm in size.
Fever 102 degrees (R) the night after immunizations per mom. Woke up next morning with welts on face: improved at that spot but reappeared at other spot on face arms. Went ER: Rx BENADRYL/prednisone - much improvement as per mom. Here for f/u added ZANTAC and monitor.
Patient was administered Moderna vaccine on left deltoid intramuscularly 7/12/22. Patient received incorrect dosage of 0.5 ml instead of the 0.25 ml recommended at age range. Monitored at time of vaccination for 15 minutes and patient was tolerating well. Provider informed and communicated with patient father through phone of vaccine error 7/13/22.  Doctor informed father of adverse effects and recommendations, father informed doctor patient was currently stable and had gone to play. . No known adverse effects at this time. Will continue to monitor.
It started in the afternoon with a shiver that was so cold in my bones. The whole night I was having trouble breathing with nasal congestion. I had body aches. I took ADVIL, TYLENOL and THERAFLU to help with symptoms. I tested positive for COVID-19 the next morning of March 25th. It got worse and my sense of taste was not working, everything tasted too strong. I was coughing phlegm and I was weak and unable to breathe freely. This continued the rest of the weekend. I contacted my doctor on the 27th and received PAXLOVID. As of today, April 5th, I am unable to taste anything, and I still have a bit of a sore throat. I am hoarse and fatigued.
Narrative: Patient received two covid vaccine doses. Patient was admitted to hospital shock trauma 3 weeks after second dose and passed. There is no documentation of exact cause of death. Reporting per facility instruction. PMH includes severe AS s/p TAVR at Hospital 5/28/2019, CAD s/p multiple prior PCI (3 PCI's to LAD most recent in 2008), CHF with mid-range EF of unclear etiology (EF 40-45% based on TTE 8/2019), symptomatic bradycardia s/p PPM (2011), HTN, HLD, Afib (CHADSVASC 6, on apixaban), prior CVA (2009), BPH, GERD, and RA
Right arm (erythematous & edematous at vaccine site) upper arm.  Apply ice, BENADRYL.
Spreading reddened area, on leg af injection site. Pt referred to family medicine to MD and antibiotics were prescribed.
Had swelling and redness occ I was given the Shingrix vaccine in the above date. Within an hour it was red, swollen, hot. Over the weekend I had fever and flu like symptoms. It continued to swell and get red to the under side of my left arm. I stayed in contact with my PCP. It started fading by weeks end. Still sore and slightly swollen as if today 1/13/20.
fever, exhaustion, headache, achy entire body, listless, confusion, weak, overall difficult to function Tested positive in July 2020 with same symptoms.
8/25/16 In (R) deltoid IM Tdap - developed fever 101.7 8/27/`6 - noticed (R) swelling, pain and erythema 8/29/16.
p/vax pt devel vomiting w/ no diarrhea & was then hosp later in the day cont vomiting & was found to be obstructed;was transferred to another hosp & had surgery for intussusception;
migraine headache; leg pain; increase in blood pressure /  has ranged from the upper 140s to 160; systolic blood pressure increased /; This case was reported by a consumer via call center representative and described the occurrence of migraine headache in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date 14th November 2021) for prophylaxis.   On 13th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th October 2020, 1 days after receiving Shingrix, the patient experienced migraine headache, leg pain, increased blood pressure and blood pressure systolic increased. On an unknown date, the outcome of the migraine headache, leg pain and increased blood pressure were not recovered/not resolved and the outcome of the blood pressure systolic increased was unknown.   It was unknown if the reporter considered the migraine headache, leg pain, increased blood pressure and blood pressure systolic increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had migraine headache, leg pain and increase in blood pressure and these are all still ongoing currently.  The patient reported the leg pain had subsided some but was still ongoing.  The patient reported his systolic blood pressure increased and had ranged from the upper 140s to 160. The reporter consented to follow up and gave consent to follow up with HCP.
Pt recvd 3 doses Engerix-B approx JAN91, FEB91 & AUG91; no rxn noted p/2 doses; p/3rd 4OCT91 pt exp acute arthritis/vasculitis as dx by MD; pt exp acute swelling w/not much pain of joints; MD visits required; pt tx med  poss lyme dis;