chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approx. 24 hrs after I was feeling chilled through out the day. still taking my 800mg ibuprofen q 8hrs. At 9pm 1/28, I was really cold and tired, arm and back of neck very sore and tender.  Took warm shower and to bed. Wokeup at 4am and was drenched and sweaty, changed clothes, drank some water and back to bed. Slept total of 11 hrs.1/29  woke up with a headache and arm and back of neck very sore and tender.  Eyes were watering terribly.  3hrs after taking my 800mg advil I took my temp and it was 99.9'  but I usually run 96.9'  and I did feel warm. Tired that rest of the day. 1/30 I took last 800mg advil and felt ok.
After vaccines had a low grade fever. Thursday night had a fever of 103.5 and cough. Fever down with medication and fever gone 1/6/2023. 1 round of vomiting Thursday night, none since. Was seen 1/6/2023 by the doctor and viral testing done.
Possible vaccine failure. Patient diagnosed with Hepatitis A infection - IgM positive in August 2007. He received 2nd dose of Hep A vaccine 6/22/07 (Lot # 0442U).  9/04/2007 MR received for ER visit 8/07/2007 with c/o 3-4 week hx of L sided chest pain, > with inspiration.  Fever of 104' several days ago.  Seen by PCP 1 day prior to ER visit. DX: with pericarditis.  TC to PCP reporter for clarification on this.  During W/U for pericarditis, pt was found to have Hep A IgM (+).  Pt reported to PCP that several weeks ago while in Mexico pt had symptoms of fever, chills, vomiting and diarrhea. Pt was not seen for this so no medical records.  MD concern for possible vaccine failure.  PCP feels pericarditis is unrelated.
Administered Covid 19 vaccine to patient informed mother to have a seat and wait 15 minutes as a precaution. After a few minutes gets my attention and states her daughter is not feeling good I went outside of the pharmacy and noticed patient looking dazed asked patient how she is feeling she said she felt dizzy I asked if she had any shortness of breath and she said no and lost consciousness for less than a minute asked her again if she was having any trouble breathing she said no then called 911. Before paramedics arrived patient vomited. Paramedics arrived and left with child and mother
Weakness, disorientation, visual hallucinations, tachycardia. Occurred approx. 2 hours after administration of flu vaccine, physician notified. BENADRYL given, hospitalist notified (arrived in 10 mins).
The patient reported that about 12 hours after receiving PREVNAR (PCV13), she developed body aches, chills, fever, and "the shakes". These symptoms persist for 24-30 hours. Patient reported similar symptoms after her last tetanus shot.
Paralyzed from knees down; Diarrhea; Fever of 101.9°F; Vomiting; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralyzed from knees down) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 21-Dec-2020. Concomitant products included GABAPENTIN, DOMPERIDONE, LEVETIRACETAM and OMEPRAZOLE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralyzed from knees down) (seriousness criteria hospitalization and medically significant), DIARRHOEA (Diarrhea), PYREXIA (Fever of 101.9°F), VOMITING (Vomiting) and CHILLS (Chills). The patient was hospitalized from 15-Apr-2021 to 16-Apr-2021 due to PARALYSIS. On 16-Apr-2021, DIARRHOEA (Diarrhea), PYREXIA (Fever of 101.9°F), VOMITING (Vomiting) and CHILLS (Chills) had resolved. On 17-Apr-2021, PARALYSIS (Paralyzed from knees down) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. On 15-Apr-2021, Blood test: normal (normal) Normal. On 15-Apr-2021, Body temperature: 101.9 (High) 101.9 Fahrenheit. On 15-Apr-2021, Influenza virus test: negative (normal) Normal. On 15-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     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 provided was paracetamol  The lab tests were reported as MBR, infection of the spine, tumor of the spine, inflammation of the spine. The results were provided as Normal.  The event paralysis reoccurred on 16 APR 2021 at 08.00 pm and recovered on 17 APR 2-21. Again the event occurred on 17 APR 2021 at 08.00 pm  and got recovered on 18 APR 2021.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Started out felling like a cold. Slight runny nose with some body aches. Took at home COVID-19 which was positive on 12/8. Televisit with doctor, who recommended treating symptomatically. Symptoms were mild for about 5 days and didn't really affect functioning.
patient received expired dose of PENTACEL vaccine, with no reported adverse event; Initial information received on 14-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 07-Jun-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ319AAA and expiry date: 04-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Office manager states that a patient received PENTACEL 3 days after it had been expired, is it still viable. Does the patient need to get another shot. Caller states that a pentacel was given in the left arm intramuscularly on 07-jun-2021 that expired 04-jun-2021. Caller states that she does not feel comfortable giving any other information and declined to provide additional information.   At the time of report, 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 holder's compliance with the requirements set out in the 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.
Patient moved his arm as the injection was given.  Staff giving the vaccine estimated that no more than half the dose was administered.  Mom estimates that little to no vaccine was injected.     Discussed the incident with pediatric infectious disease and consulted the agency website which recommended repeating the dose.  Patient was already at home at that point so he came back and received the full dose the following morning (12/31/21 at 8am).
Dose # 1 8/26/21 Dose #2 9/16/21 Dose #3 1/19/22 - Administered too early.
Pfizer-BioNTech COVID-19 Vaccine EUA 4 hours post injection: fatigue 12 hours post injection: headache, body aches, 100 degree fever, fatigue lasting 24 hours
Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild headache, cotton headed, fatigue, left arm pain, neck/shoulder aches
PATIENT RECEIVED MODERNA FOR HER FIRST DOSE OF COVID VACCINE.  SHE WAS GIVEN PFIZER FOR HER SECOND DOSE OF VACCINEBY A VOLUNTEER NURING STUDENT.   NO REACTION 30 MINUTES AFTER RECEIPT OF VACCINATION.   CALLED PATIENT ON 2/24/2021 AND WAS INFORMED BYTHE PATIENT THAT SHE HAS  NOT HAD ANY PROBLEMS
Patient screened for allergies including Bakers yeast. Denied any known allergies including no allergy to bakers yeast. Shot given. With in 5 minutes of vaccine c/o tingling lips and tongue. No hives, rash or SOB. VSS 126/84 and p88. C/O lightheadedness Dr. notified and patient given benadryl 50mg 30 minutes after onset of symptoms.45 minutes later patient denied tingling or lightheadness. Stated he felt well.
After vaccine was given, patient almost immediately developed an itchy, red rash on the back of both legs. Rash began to fade after about 3 minutes and fully resolved. He was given a dose of Benadryl and monitored; no subsequent reaction noted.
Fluviron vaccine was used for nasal spray flu vaccine instead of FLUMIST: (no needle used) on 10 people.
It was also very red and hot; Swelling around the sight of injection; Strong rash around the sight of the injection; Circle of redness at the injection site of two inches; Felt a little sick; Arm sore; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt a little sick), VACCINATION SITE WARMTH (It was also very red and hot), VACCINATION SITE PAIN (Arm sore), VACCINATION SITE ERYTHEMA (Circle of redness at the injection site of two inches) and VACCINATION SITE SWELLING (Swelling around the sight of injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CALCIUM, MAGNESIUM and FISH OIL for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION COMPLICATION (Felt a little sick), VACCINATION SITE PAIN (Arm sore) and FATIGUE (Fatigue). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Circle of redness at the injection site of two inches). On an unknown date, the patient experienced VACCINATION SITE WARMTH (It was also very red and hot), VACCINATION SITE SWELLING (Swelling around the sight of injection) and VACCINATION SITE RASH (Strong rash around the sight of the injection). On 12-Jan-2021, FATIGUE (Fatigue) had resolved. On 15-Jan-2021, VACCINATION COMPLICATION (Felt a little sick) and VACCINATION SITE PAIN (Arm sore) had resolved. On 22-Jan-2021, VACCINATION SITE ERYTHEMA (Circle of redness at the injection site of two inches) had resolved. At the time of the report, VACCINATION SITE WARMTH (It was also very red and hot), VACCINATION SITE SWELLING (Swelling around the sight of injection) and VACCINATION SITE RASH (Strong rash around the sight of the injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: updated event outcomes, second dose information, concomitant medications, and patient information.
Patient experienced abscess all over the arm and shoulder where the injection was given but not the other arm. Patient reported the adverse event after 2 months (all the signs were gone) when she came for the second shot. Patient was advised to postpone the 2nd shot until further notice to check with her PCP and manufacture.
Started having a high fever, sore throat and a cough. Took a home test COVID-19 test, positive. Was prescribed PAXLOVID. Helped within a few days.
States she woke up next day achy, with fever and swollen red arm at site where injection was given. Red sore area with streaks noted today.
slight headache, extreme fatigue, body aches all over, fuzzy brain, couldnt function, no appitite, dry mouth,  arm hurt where shot wa s done, took tylenol, for two days
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The physician assistant mentioned that a patient received the first dose of GARDASIL (dose, route and site of administration were not reported) on approximately 2010 (reported as 4 years ago), the second dose of GARDASIL (dose, route and site of administration were not reported) on approximately 2011 (reported as 3 years ago) and the third dose of GARDASIL (dose, route and site of administration were not reported) on 04-MAR-2014. The physician assistant having the specific dates for the 1st and 2nd dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
pt became limp & unresponsive w/in half hr p/vax;pt has stable vital signs w/nl BP;no tx;pt was observed & fully recovered w/in 1/2 hr;
No additional AE; An improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 06-JUL-2022, the patient was vaccinated with an improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot number 1879870 with expiration date 16-OCT-2023, administered orally for prophylaxis (strength and vaccination scheme were not provided) (product storage error).   The administered vaccine experienced a temperature excursion at 34.5 fahrenheit (F) for 1 hour 7 minutes 0 seconds. Also, was reported a previous temperature excursion of 66.7 fahrenheit (F) for 13 hours 52 minutes 0 seconds. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005936: US-009507513-2210USA005917: US-009507513-2210USA005916: US-009507513-2210USA005624: US-009507513-2210USA005916: US-009507513-2210USA005979: US-009507513-2210USA005942: US-009507513-2210USA005994: US-009507513-2210USA005996: US-009507513-2210USA006007:
Within 24 hours of vaccine, patient had fatigue, swollen cervical lymph nodes, malaise.  These symptoms improved but did not resolve by dose #2 and were much worse following dose #2 and are still persisting with minimal improvement in the last 4 weeks.
Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.
Left thoracic chest "twinges" repeatedly, approximately every  5 minutes for 1-1/2 days, starting on awakening 3/7/2021, ended around noon on 3/8/2021.  No radiation, no associated symptoms.    Occasional soreness, left scapular area also occurred periodically during this same time period.
A nurse reported the occurrence of an injection site reaction in a 5 year old female who received Infanrix for prophylaxis. The subject's medical history included history a possible allergy to an unspecified vaccine. Initially, the reporting nurse stated that this subject "always" reacted to vaccinations. However, on follow-up, the nurse stated the subject had experienced no adverse events following previous immunizations. No concurrent conditions or concurrent medications were reported. In March 2002, the subject received her fifth injection of Infanrix 9531A2); the nurse was unsure into which arm the Infanrix had been injected. On that date, the subject also received inactivated poliomyelitis virus vaccine (IPOL) injected into the left arm.Twenty-four hours post-immunization, she developed swelling at the Infanrix injection site, measuring four inches by four inches. Two weeks post-immunization, she experienced itching and bruising at the injection site. Additionally, the subject experienced injection site pain, erythema, and induration. The subject was seen by a physician; no treatment was given. The events resolved. The nurse considered the injection site reaction to be related to Infanrix administration.
This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, headache and rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, headache and rash were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 71 or 72 years. The patient experienced headache, swelling at injection site size of a grapefruit and rash over torso and arms. The reporter agreed to receive follow up from GlaxoSmithKline.
Heavy bleeding and passed a large clot during period; Heavy bleeding and passed a large clot during period; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER; Formulation: Solution for injection; lot number: ER8733), dose 2 via an unspecified route of administration, administered in left arm on 10May2021 at 09:45 (at the age of 33-years-old) as dose 2, single for covid-19 immunisation. The patient was not diagnosed with COVID-19 prior vaccination. Medical history included PCOS (polycystic ovary syndrome) from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. Concomitant medication included vitamin d nos, probiotics, fexofenadine hydrochloride (ALLEGRA), Multi vitamin, and flonase from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER, Lot number: ER8737), in the left arm on 20Apr2021 at 14:30 (at the age of 33-years-old), as dose 1 single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heavy bleeding and passed a large clot during period on 12May2021 17:00. The patient did not receive any treatment for the adverse events. The outcome of the events was recovered on an unknown date in May2021.  Information on Lot/Batch number was available. Additional information has been requested
This spontaneous report as received from a nurse refers to a patient of unknown age. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in February 2019, the patient was subcutaneously vaccinated with a dose of M-M-R II lot # R013129, expiration date 03-FEB-2019, albumin status of rHA (recombinant human albumin) (exact dose was not reported) for prophylaxis. The dose of M-M-R II was after its labeled expiration date. No adverse effects were reported.
bad rash on lower legs that is very itchy; small red spots on bilateral legs spreading to upper legs; bad rash on lower legs that is very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bad rash on lower legs that is very itchy), RASH MACULAR (small red spots on bilateral legs spreading to upper legs) and RASH (bad rash on lower legs that is very itchy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PRURITUS (bad rash on lower legs that is very itchy), RASH MACULAR (small red spots on bilateral legs spreading to upper legs) and RASH (bad rash on lower legs that is very itchy). On 20-Feb-2021, PRURITUS (bad rash on lower legs that is very itchy), RASH MACULAR (small red spots on bilateral legs spreading to upper legs) and RASH (bad rash on lower legs that is very itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Patient used topical cream to help relieve symptoms.
Patient called pharmacy today (10/16/10) and complained of bump at injection site. She said the bump has progressively gotten more painful and larger, she received the vaccine a month earlier (9/15/10). She as advised to go to doctor.
the patient experienced the event of not feeling well (malaise).; This is a spontaneous report received from a non-contactable consumer. A 50-year-old female consumer (patient) reported for a herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Other co-suspect included treprostinil diethanolamine (TREPROSTINIL DIETHANOLAMINE), oral from 30Nov2018 (ongoing), (Extended release tablet) taken for pulmonary arterial hypertension and treprostinil diolamin (ORENITRAM), oral from an unspecified date (Batch/Lot Number: 2101650; Expiration Date: 31Jan2022) ongoing, at 5 mg (every 8 hours (q8h)) (Extended release tablet,) for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication included tadalafil. It was reported that, the patient was not feeling well after getting her COVID vaccine on an unspecified date. The patient did not elaborate it any further. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 7 year old white male, with no pertinent medical history and no known allergies, who on 06/09/1998 was vaccinated with a dose of varicella virus vaccine live.  The patient was exposed to his father, who had shingles, and on approximately 10/22/2004 the patient experienced chickenpox breakthrough with a mild rash of less than 20 lesions.  There was no specimen testing and no treatment and the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information is not expected.
Localized hive like reaction near site of injection doctor examined and told mom to monitor and given BENADRYL if worsened and call our office. 1:30 pm 7/23/13 - Follow up call to mom - she notes symptoms are resolved.
Wheezing, cough, chest pain, pharyngolaryngeal pain, ocular hyperemia, dry eyes, nausea. Hyperhidrosis. This case was received on 11 March 2009 via a QSCAN search on the VAERS database, under reference number 296998. A 36 year old female patient whose medical history included allergies to sulfa, minocycline, and tetracycline antibiotics and IV Ferrlecit, received a second intramuscular injection of FLUZONE (lot # U2466AA) on 31 October 2007. Approximately four hours post vaccination, the patient experienced a gradual onset of a mild dull and achy chest pain, wheezing, sore throat, non-productive cough, and very dry and reddened eyes. At approximately 7 pm that evening, she felt mild nausea and sweaty palms. The patient researched her symptoms and believed that she experienced ORS (Oculo-Respiratory Syndrome). The symptoms resolved by the next day. The patient recovered.
- SEVERE MIGRAIN HEADACHE - Debilitating - SEVERE FATIGUE - HIGH TEMPERATURE 102.4 - Severe swelling and pain at injection site