chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media post and described the occurrence of myelitis in a female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, 12 hrs after receiving Hepatitis B vaccine, the patient experienced myelitis (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis was unknown. It was unknown if the reporter considered the myelitis to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she would have survived hepatitis B if she had gotten it, the hepatitis B vaccine she did not survive intact. The patient stated her life outcome would have come out so much better if she had not taken the Hepatitis B jab. The patient stated better the disease than myelitis, she got 12 hours after a Geo B vaccine.
Vertigo; Dizziness; Nausea; This is a spontaneous report received from a contactable health care professional, the patient. A 57-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN206) via unspecified route of administration in arm left on 20Mar2021 (at the age of 57 years old) as a single dose, for COVID-19 immunisation. Past medical history included low thyroid and high cholesterol from an unspecified date. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and venlafaxine (MANUFACTURER UNKNOWN) from an unspecified date for unknown indication received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unspecified route of administration on left arm on 27Feb2021 at 11:00 (at the age of 57 years old) as a single dose, for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, at 06:00, the patient experienced dizziness/vertigo when moving from lying down to sitting or standing, nausea at the same time. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events vertigo, dizziness and nausea were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected
Injection site was sore for 4-5 days, the usual soreness post-vaccination, resolving; suddenly, 6 days after vaccination, pt experienced a new pain (tenderness) and warmth to the same site; now it hurts constantly and is unrelieved by Tylenol; no visible or appreciable swelling/erythema upon exam;
Hospitalized with viral pneumonia at the end of 3/02. Home in 1 1/2 days. Became unable to urinate, legs weak and would not hold him up. Was re-admitted to the hospital and is now dx'd with Transverse Myelitis and is paraplegic. In Rehab Unit in a wheelchair. Was treated with steroids and anti-viral antibiotics. Hospital records state he also had fever, atelectasis upper L lobe, dehydration
Patient had developed a rash after receiving vaccine. We gave her a 50mg dose of BENADRYL liquid. She stayed in our Immunization both for roughly 45 minutes to an hour to make sure she was feeling ok. She has an extensive allergy profile and was concerned that she might have a reaction prior to receiving the vaccine - although she has had the vaccine previously in her lifetime.
Sore throat, sneezing, cough - Thursday-Monday Body ache/muscle aches - Thursday-Friday Positive Test - Sunday, May 1 Paxlovid - Monday-Friday, May 6 Promethazine-DM - Monday-Wednesday Flonase - Monday-Thursday
Received the vaacine on 2/3/2021 I felt fine that whole day. The following day as I  was  showering I got lightheaded and fell in the bathroom . I went to the ER and  the sent me home because I had no injuries. My blood pressure was high . For a few days  I got lightheaded off and on.  Then on 2/24/2021 I went for the second dose again i felt fine the whole day. On 2/25/2021 as I was showering  I got lightheaded and fainted.  My family called the ambulance and  I was hospitalized from 2/25/2021 to 2/27/2021. I had facial fractures, fractured septum (nose) and  cut upper lip received 10 stitches and teesth and gums were numb and still are a little numb.
Pt reports redness and tightening of his face, resolved by Benadryl. Next morning, pt had an episode of n/v, achiness, fatigued and SOB. Pt admitted to hospital for sepsis and cellulitis from a podiatry procedure. Pt in a state of hypercoagulability r/t to covid vaccine and sepsis. Pt advised not to receive 2nd dose of moderna or j&J.
Initial report was received from a consumer, who is also the patient on 17 January 2011. A 46 year-old female patient who had no illness at the time of vaccination, no known allergies and no reported medical conditions, had received an intramuscular left deltoid injection of Influenza vaccine (reported as FLUZONE, lot number not reported) and three to four hours later, experienced body aches and her "left lower arm went numb". She reported the next day her nose started "running like a faucet", she had gas, her ears were "plugged" and she had mucus and phlegm (spelled flem) when she coughed. Concomitant medications were none. She was not evaluated by a physician. She reported to have had a influenza vaccine "eight years ago" and had no H1N1. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 07 March 2011 reported that the patient received FLUZONE, sanofi pasteur lot number UT3563CA. The patient has not been seen since the administering of the FLUZONE, therefore, it was not known if the patient had recovered. The outcome was reported as unknown. Follow-up information was received from a health care professional on 11 April 2011 reported that the patient has not been seen since the administration of the vaccine and the outcome was unknown. The outcome remained unknown. Documents held by sender: none.
Pruritis, redness of hands between fingers, elevated heart rate - BENADRYL has not been helping much - redness of head, neck, in joint areas - no known allergies to medications treated with prednisone dose pak & doxepin.
Patient arrived to observation area  around 9am following dose #2, no distress noted. At 9:07am, patient told observation nurse that she was experiencing itchy throat and felt slightly dizzy. Patient's legs were elevated on chair, 10 liters O2 delivered via non-rebreather mask, vitals measured  P88, R 20, BP 134/86, o2 99%.  Patient reports increased itchiness in throat at 9:15am, given 1ml diphenhydramine. Vitals measured again at  9:30am P87, R20, BP 130/80, O2 99%. Patient left at 9:38am, no issues, daughter in law driving her home.
PATIENT PASSED OUT AFTER GETTING THE SECOND VACCINE. PATIENT WAS SUPPORTED BY NURSE AND DAD. WHEN HE CAME TO HE WAS LAID ON A COT AND ICE PACKS WERE APPLIED TO HIS NECK AND JUICE WAS GIVEN AT THAT TIME. AFTER 20 MINUTES OF MONITORING PATIENT STATED HE WAS FEELING MUCH BETTER AND WALKED TO CAR WITH DAD.
Pt. states that after receiving the 3rd Booster of Phizer 11/17/2021, started experiencing symptoms 11/19/2021 of swelling under the left armpit area and pain. No noted Primary visit/communications.
rash; inflammation / on / arm / shaped like a snake / ran 1/4 inch - 1/2 inch wide and 2 -3 inches long; first dose on 12/2/2020 / second dose on 2/15/2021 / received zostavax 4-5 years ago; muscle aches; fatigue / was so tired; slight fever; arm soreness; slept the whole day; Nausea presented after second dose; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received zostavax 4-5 years ago) and Shingrix (received 1st dose on 2nd Dec 2020 and experienced Fever (refer case US2021051419)).   On 15th February 2021, the patient received the 2nd dose of Shingrix. On 15th February 2021, 75 days after receiving Shingrix, the patient experienced muscle pain, fatigue, fever, pain in arm, daytime sleepiness, nausea and extra dose administered. On an unknown date, the patient experienced rash and extensive swelling of vaccinated limb. On an unknown date, the outcome of the muscle pain, fatigue, fever, pain in arm, rash and extensive swelling of vaccinated limb were recovered/resolved and the outcome of the daytime sleepiness, nausea and extra dose administered were unknown.   It was unknown if the reporter considered the muscle pain, fatigue, fever, pain in arm, daytime sleepiness, nausea, rash and extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: The reporter reported that the patient received first dose of Shingrix on 2 nd December 2020 and second on 15 th February 2021 and experienced various common evens like muscle ache, fatigue, slight fever and arm  soreness. Headache was experienced only after first dose and Nausea, Rash was experienced only after second dose. The patient had also taken Zostavax  vaccine 4 to 5 years ago this lead to the event of extra dose administered.  after administration of second dose of Shingrix patient experienced a rash shaped like a snake on her arm below injections site. It ran 1/4 inch - 1/2 inch wide and 2 -3 inches long it was resolved. The reporter consented to follow up.
Approximately 30 -45 minutes after receiving the vaccine patient had difficulty communicating; patient was in like a trance his arms were limp; patient was in like a trance his arms were limp; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 16:00 (Lot number: FC 3183) at the age of 14 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 01, Lot number: EW0177, Vaccine location: Left arm, Administration time: 04:30 PM), administration date: 06Aug2021, when the patient was 14 years old, for Covid-19 immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset 27Aug2021 16:45, outcome "recovered" (Aug2021), described as "Approximately 30 -45 minutes after receiving the vaccine patient had difficulty communicating"; TRANCE (non-serious), GAIT DISTURBANCE (non-serious) all with onset 27Aug2021 16:45, outcome "recovered" (Aug2021) and all described as "patient was in like a trance his arms were limp". The events "approximately 30 -45 minutes after receiving the vaccine patient had difficulty communicating", "patient was in like a trance his arms were limp" and "patient was in like a trance his arms were limp" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of speech disorder, trance, gait disturbance.  Additional information: Approximately 30 -45 minutes after receiving the vaccine patient had difficulty communicating, patient was in like a trance his arms were limp, reporter's older son took patient for the vaccine flagged down an EMT who couldn't get a response from him and patient was taken to the hospital. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Patient was not covid tested post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
Patient presented to the ED with weakness and shortness of breath. He reports needing assistance with activities of daily living due to weakness. Patient reports the shortness of breath has been ongoing for approximately 2 weeks. Patient was found to have hemoglobin of 4.4 with a suspected GI bleed. The patient will be admitted to the hospital. Patient is to receive 3 units PRBCs.
Histamine-like reaction. Hives - several days 1 week apart for 1 day.
Information has been received from a registered nurse concerning a male weight lifter in his thirties with no known allergies who in May 2006, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  On an unspecified date, the patient developed brachial plexus neuritis and had severe pain for two months post vaccination. The patient's experience was considered to be disabling by the reporter.  Additional information has been requested.
After first booster {shot 3} declined into heart failure with ejection fraction of 21-23%.  Hospitalized by 11/25.  Recently got booster #3. Pericarditis returned within a month. Pericardium thickened.
A few hours after the shot, arm got fairly red and started swelling. It was very sore. For several days, half of my upper arm and slightly below my elbow was red and my arm was swollen. It lasted about 9 days. There were no symptoms of extreme nature that required medical attention. I had a slight reaction over 6 years ago when I had this vaccine. This was much worse. Am concerned if any components of this vaccine are in any other vaccines.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 6-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Sensation in the right lower leg b/w knee and ankle, a throbbing sharp pain/ sensation, constant she is unable to walk and bear weight on leg w/o the sensation
Lightheaded, dizzy, 11:45A -> 12:30P - pt stayed stationary, symptoms resolved. Elevated BP (180/87) 11:45A (157/92) 12:30P - pt states this is normal, treated but uncontrolled.
Hospitalization: 1/7/2023 - 1/16/2023 (9 days) Presentation to the ED: SOB. COVID + date: 1/7/23. Treatment: remdesevir and levaquin.  Discharge to: home.   Moderna 033B21A 5/17/2021 Moderna 051C21A 6/15/2021 Moderna 078J21A 12/16/2021
Shot given at 9 am. Chills, body aches, headache, and 100.6 fever started at 9 pm. Temp went up to 101.6 at 10 pm. Chills stopped about midnight, headache persisted, temp dropped to 100.6. Did not sleep well. The next morning about 6 am, temp dropped to 99.9, headache persisted. Temp normal 24 hours after shot, headache went away, body aches subsided. Never took any pain medication, though I knew I could. I do take excedrin migraine about 5x per week normally. Was happy about side effects as it confirmed my immune system strong. Symptoms tolerable and subsided after about 24 hours. Spent most of day after shot in bed. Arm did not get that sore (Shingles shot 2 much worse). All side effects gone after 48 hours. Glad I resisted temptation to take pain meds though I know it would have been ok to take after shot. No side effects after Moderna shot 1, except for a sore arm.
SOB, body aches, fever, chills for a period of at least 48 hrs, SOB continues, she was sent to ER and ran lab work, MRI and administered breathing tx. D-Dimer was 1300. She was released and sent home
Approx 12 hours later, airway tightening, chills. Prior) started coughing, flushed, hives. Hx asthma) used albuterol inhaler 2 puffs. 45 mins later able to take 2 BENADRYL-felt better.
Went to bed the night of the injection. The following morning I had a fever of 104.
while removing the needle from patient's arm, some of the medication ran down his arm, no AE; while removing the needle from patient's arm, some of the medication ran down his arm, no AE; Syringe leaked when administered, no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a male patient of an unknown age who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ251AD, expiry date: 01-May-2020) via unknown route in the arm NOS.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to vaccine underdose.  It was also a case of Exposure via skin contact and syringe issue.   Reporter stated that when she was removing the needle from his arm, some of the medication ran down his arm.  Syringe leaked when administered.  At the time of reporting, no adverse event was 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.
Rec'd 5 ml tetanus toxoid injection 11/25/09 - noted 11/27/09 (lt) deltoid with 5 x 4 cm round, red, warm to touch area - ROM WNL - Radial pulse present - c/o (lt) arm "sore" @ injection site.
Respiratory Therapy Appointment - Spirometry, DLCO and Lung Volumes completed. This visit was within 6 weeks of receiving the COVID vaccine.
Pt recv vax on 9/1/98; on 9/10/98 pt exp lymphadenitis &rash.
had double vision; > 35 days past first dose; headrush; Could not lay still; Felt as if she was going to faint; felt like bugs were crawling on her head and body; she could strongly taste the vaccine in her mouth; had a panic attack; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt as if she was going to faint), FORMICATION (felt like bugs were crawling on her head and body), TASTE DISORDER (she could strongly taste the vaccine in her mouth), PANIC ATTACK (had a panic attack) and DIPLOPIA (had double vision) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Vibramycin and Flu shot. Past adverse reactions to the above products included Crawling sensation with Flu shot and Vibramycin. Concomitant products included LOSARTAN POTASSIUM for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Felt as if she was going to faint), TASTE DISORDER (she could strongly taste the vaccine in her mouth), PANIC ATTACK (had a panic attack), FEELING ABNORMAL (Could not lay still) and HEADACHE (headrush). 04-Mar-2021, the patient experienced FORMICATION (felt like bugs were crawling on her head and body). On an unknown date, the patient experienced DIPLOPIA (had double vision) and PRODUCT DOSE OMISSION ISSUE (> 35 days past first dose). At the time of the report, DIZZINESS (Felt as if she was going to faint), FORMICATION (felt like bugs were crawling on her head and body), TASTE DISORDER (she could strongly taste the vaccine in her mouth), PANIC ATTACK (had a panic attack), DIPLOPIA (had double vision), FEELING ABNORMAL (Could not lay still), PRODUCT DOSE OMISSION ISSUE (> 35 days past first dose) and HEADACHE (headrush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concurrent conditions were reported. No concomitant medications were reported. Patient reported that she felt very tingly like she had bugs crawling in her head and her body, after 10-15 minutes of vaccination. The patient waited for 45 minutes after the vaccination before she was able to drive home. Later, on the same day, the patient felt a headrush that lasted all night and she could not stay still that night. A week and a half later, she had a double vision. Caller inquired if she can still receive the second dose.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 28-AUG-2015, the patient was vaccinated with LIQUID PEDVAXHIB (lot # K016964 and expiration date 16-JUL-2017) (dose and route were not reported) which were improperly exposed to the following conditions. 25-AUG-2015: 30.2 for 4 hours 30 minutes. 26-AUG-2015: 31.6F for 5 hours. 27-AUG-2015: 33.4F for 2 hours 45 minutes. 28-AUG-2015: 33.8F for 1 hour. It was also reported that LIQUID PEDVAXHIB was improperly exposed on the following dates to following conditions that had been administered to unspecified patients. 29-AUG-2015: 32.9F for 1 hour 30 minutes. 30-AUG-2015: 33.0F for 2 hours 15 minutes. 31-AUG-2015: 33.6F for 4 hours. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.