chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discomfort in throat, chest, and back; Discomfort in throat, chest, and back; Discomfort in throat, chest, and back; Similar to cold or flu; Similar to cold or flu; Rash; sleeplessness; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FC3182), via an unspecified route of administration, administered in Arm Right on 14Sep2021 at 18:30 (age at vaccination: 51 year) as dose 1, single for covid-19 immunization. Medical history included Asthma, elevated blood pressure, from an unknown date and unknown if ongoing and Known allergies reported as Yes - medications with sulfa. Concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported, salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for an unspecified indication, start and stop date were not reported, fluticasone propionate (FLOVENT) taken for an unspecified indication, start and stop date were not reported. Other medications in two weeks reported as Albuterol, Flovent, amlodipine, vitamins. If other vaccine in four weeks reported as no. Covid prior vaccination reported as no and covid tested post vaccination reported as no. On 14Sep2021 at 19:00 the patient experienced Discomfort in throat, chest, and back similar to cold or flu, rash, sleeplessness. Therapeutic measures were taken as a result of AE. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
p/vax pt exp generalized tonic, clonic movements w/fever >105F, duration 1-2 min; to ER; initially drowsy, tx=tylenol/advil responded well; disch stable & in good spirits;
8NOV91 reported felt chills, sore throat, fever; pt was instructed to see MD if it persisted past 48 hrs; 2NOV91 pt called reporting had gotten the flu from flu shot on 6NOV91; c/o sore throat, chills, fever 102-103 severe lung infection
fever; chills; nausea; body aches; generally felt like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), PAIN (body aches) and INFLUENZA (generally felt like I had the flu) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), PAIN (body aches) and INFLUENZA (generally felt like I had the flu). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 09-Apr-2021, PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), PAIN (body aches) and INFLUENZA (generally felt like I had the flu) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
headache, tingling, hard to swallow, elevated heart rate. Evaluated by EMS-Cleared.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right 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: "adhd" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: greater than 25. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No any other medication in 2 weeks of vaccine. Anti viral details included COVID 19 Treatment, brand was Paxlovid, started on 03Jul2022 to 07Jul2022. It was reported as rebound Covid. Positive on 03Jul2022, Continued testing positive 20Jul2022. Till 22Jul2022 testing positive with symptoms (Fever, heavy sinus congestion).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12/30/2020 around 2:00 nausea, vomitting, diarrhea, and chills started. Insomnia x3 days. Patient states she felt "wired and worked up". Noises made her anxious. Patient states "everything smelled bad". Patient had hallucinations seeing the devil and satanic thoughts 12/31/2020 to 1/4/2021 when patient finally fell asleep. 1/5/21 patient woke up with a headache and took ibuprofen and used a heating pad with relief. Patient took melatonin 1/5/21 before bed to go to sleep. Diarrhea stopped 12/31/20. Nausea stopped 1/5/21.Vomitting stopped  12/31/2020. Chills stopped 1/5/21. Patient has been eating bananas and chicken noodle soup and drinking sweet tea. Patient not as nervous 1/6/21 when she woke up.
Extreme Convulsions (uncontrollable shaking); Fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours; extreme pain in the hips to where he could not move; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 10Jun2021 17:00 (Batch/Lot Number: EW0187) (at age 50 years old) as dose 2, single for COVID-19 immunization. The patient's medical history. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient previously received the first dose BNT162B2 on 19May2021 16:00 (lot number: EW167) (at age 50 years old) in left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On 11Jun2021 21:30, the patient experienced extreme convulsions (uncontrollable shaking), fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours, extreme pain in the hips to where he could not move, and shortness of breath. The events were reported as non-serious. Treatment was not given. The patient was recovering from the events.
I have been affected by multiple ?minor? strokes and I had a big blood clot related stroke in which I lost my speech and ability to swallow. It is still unknown as to why I had so many minor strokes and why I had such a big one which hospitalized me for a few days. Not one doctor will even listen to me if i bring up the vaccine I had many many months ago. And yet no other tests have explained why a healthy 34 father has had multiple strokes
About 2 inch erythema slightly raised to left thigh. Advice to apply warm compress and give Tylenol for pain. Advice mother to return to clinic if signs and symptoms get worse. Mother verbalized understanding.
Pain, swelling in arm, shoulder Nauseous, fever  Still no mobility in shoulder 10/4
Ataxia, fine tremor both arms and body, isolated falls, inability to walk or stand without support, severe fatigue, loss of bowel and bladder control,  motor skill to brain disassociation, severe weakness, inability to walk or stand without assistance.  Slurring if speak, dribbling, unable to feed self.
area of redness at injection site 2x3 cm worsening redness going up to shoulder appears to be cellulitis
Fever began on 8/16/04. Had vomiting a few days after that. Hospitalized on 8/19/04. Has multiple system organ failure. Currently is in ICU with failing lungs, liver and kidneys.
Tachycardia after the first dose and the dr gave her a monitor for heart rate, 20 mins after the second dosse her heart rate was 140.
From initial information received on 08MAY2003 from a nurse regarding adverse events of seven children after being vaccinated with TD on 05MAY2003. No information was provided regarding the identities of the pts or their adverse events. Telephone contact was made with the reporter on 16MAY2003 and follow up is expected. From additional information received on 29DEC2003 through a telephone call to a registered nurse regarding a VAERS report involving seven children, it was reported that in the opinion of this public health nurse, she felt that two of the seven cases required reporting. The nurse stated that reports were submitted to VAERS, but b/c she did not keep copies, she was unable to provide pt identifying information at this time. She described the first case as an immediate reaction post vaccination. The nurse stated that the child had lasted a few minutes and disappeared. The child saw a PMD that afternoon, but had no symptoms at that time. Reportedly,t he child recovered. The child did have a similar reaction to a DPT vaccine. The reporter HCP promised to follow up and fax completed VAERS forms to Aventis by 07JAN2004. No other information was provided at this time. The reporter of this case is the same reporter of case 200400003.
BLOOD CLOT; This spontaneous report received from a consumer concerned multiple patients. 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, Expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210815176.; Sender's Comments: V0: 20210819161-COVID-19 VACCINE AD26.COV2.S-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
He mentioned in passing that he had a sore arm from the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Physician) for a Pfizer sponsored program (164402). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28May2021, outcome "unknown", described as "He mentioned in passing that he had a sore arm from the vaccine".  Additional information: The primary care internist was asked which Covid 19 vaccine he prefers in an individual market research interview. He stated that the Pfizer vaccine was his favorite and that it was the vaccine he had gotten himself. He mentioned in passing that he had a sore arm from the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 3 weeks after receiving vaccine client noticed vesicular rash on her chest and back. On December 20th, came into the clinic for second Varicella, but it was not given due to rash. Client stated rash was still developing. Denied fever, but felt tired. Was seen by physician at Urgent Care Clinic and was diagnosed with probable vaccine reaction.
After immunization patient reported feeling dizzy and increased heart rate. We gave patient cold water, ice packs on face, neck, and wrist. Patient waited an additional 15 minutes at the pharmacy until she felt better to leave.
Max/Low Temperature reached: 8.56 C, Duration out of labelled range: 45 minutes, with no reported adverse event; patient was administered with vaccines that was exposed to excursion, with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who was administered IPV (vero) [IPOL] after it was exposed to a temperature excursion of 8.56 degree Celsius for 45 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mL dose of suspect IPV (vero) (lot: U1A601M, expiry date: 27-Feb-2023; formulation not reported) via subcutaneous route in the left thigh for immunization.  On an unknown date, the patient was administered IPV (vero) [IPOL] after it was exposed to a temperature excursion of 8.56 degree Celsius for 45 minutes with no reported adverse event (product storage error) and (circumstance or information capable of leading to medication error).  Action taken was not applicable.  Outcome: Unknown    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.
Sore Arm, chills, full body aches. Brief nausea only lasted maybe 2 hours. Body aches persisted for about 2 days before subsiding. Fatigue on day of onset but improved gradually.
No adverse event; A alternate dosing interval for GARDASIL 9; Error ocurred during dispensing; This spontaneous report as received from a registered nurse and refers to a 18-year-old male patient. The patient's medical history, concomitant medications, previous drug reactions and allergies were not reported. The patient had no concurrent illnesses.  On 05-OCT-2020 the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis.  On 30-NOV-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the left deltoid, lot# 1687290, expiration date 06-SEP-2022 (dose was not reported) for prophylaxis.  The registered nurse reported that the patient inadvertently received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) early due to dispensing error. The patient did experience any adverse events. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Received the new SHINGRIX vaccination and had very bad side effect for 15 hours including shivering, sweats, nausea, wretching vomiting, and light headedness.
Vaccine was administered on 7/24/19 at 11:39 a.m.  Around 1:30 p.m. patient was out shopping with her mother when she suddenly did not feel well. She started with a fever, headache, shaking and fingertips were cyanotic.
I had it today (side effects)/ Had it few hours ago (side effects); This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (I had it today (side effects)/ Had it few hours ago (side effects)) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (I had it today (side effects)/ Had it few hours ago (side effects)). At the time of the report, ADVERSE EVENT (I had it today (side effects)/ Had it few hours ago (side effects)) outcome was unknown.            Treatment information was not provided by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a 43 year old female who on 17-December was vaccinated IM with the second dose of PNEUMOVAX 23 (lot#661528/0867X). Subsequently the patient developed injection site reaction after vaccination with PNEUMOVAX 23 vaccine. The patient developed cellulitis and was treated with unspecified antibiotics. The patient's injection site reaction and cellulitis persisted. It was reported that the patient sought medical attention; seen in office. This is one of several reports received from the same source.
On 8/19/99, the pt felt dizzy and lightheaded. On 8/29/99, the pt developed a small less than 1 x 1 cm firm, slightly tender adenopathy. There were two nodules in the occipital scalp. One on the right preauricular and one on the right and left post auricular area. Additionally, there was one on the right lower posterior cervical lymph node. The pt was treated with Keflex. On 9/21/99, it was reported that some of the lymph nodes have disappeared and some remain.
Systemic: Tinnitus-Medium, Additional Details: Patient is hearing static and ringing in her ears ever since the shot.
2 month old patient receiving a dose of HAVRIX; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received HAV (Havrix) (batch number 2JD3Y, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 17th November 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Havrix vaccine, which led to inappropriate age at vaccine administration. No further information was reported. The reporter consented to follow up.
Patient stated she was not feeling well, volunteers/staff moved her into the shade, moments later she fainted. On assessment HR rate was 45, BP not obtained. Patient was pale, eyes wide open staring off into space, arms ridged contracted outward, not able to answer questions. Patients body was supported, cold compress applied to back of next. HR monitored.  Continuously asking patient questions until able to respond. Thirty seconds to a minute patient started to ask what happened, her color began to come back. She was able to drink water and orange juice. Patient stated she felt tired and her legs felt heavy.  Patient was monitored for thirty more minutes with no other effect. Parent was told to notify physician.
Seen in clinic on 12/8 and received hep A (right deltoid) and HPV/MenQuadFi (left deltoid), first dose for each. Developed a rash on her dorsal right wrist (about 5 cm area of pink raised spots, non-pruritic, not bothersome), throat swelling, and lightheadedness about 45 minutes after receiving the vaccines. No difficulty breathing. Went to urgent care and, per note, had a reassuring exam. Received Benadryl and was prescribed epi pen. Rash and throat gradually improved after getting Benadryl and had resolved within a few hours. Lightheadedness lasted most of the night but had mostly improved by the morning, fully resolved after about 24 hours. No prior history of allergies or vaccine reactions. Was otherwise feeling like herself prior to vaccines and once recovered. No recent fever, cough, or runny nose.
A report has been received from a Health Professional concerning a male patient, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent, (intranasal) started on an unknown date. The patient stated two doses 4 days apart (off-label use). FLUMIST quadrivalent was continued. The outcome of the event of off label use and 2 doses 4 days apart was unknown. The report was considered to be non-serious.
patient had covid arm (swollen, hot to touch, painful and 6x6 red area). Patient first dose was given 5/22/21 and second dose 6/5/21. She had made an appt that she didn't keep at another store, so when she got that call, she came in for her second dose. Our system didn't catch that patient had gotten her first dose 18 days earlier (should have 28 days between doses). Patient went to the ER and they gave her triamcinolone but were not worried based on her side effects.
his only complaint has been pain in the injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "his only complaint has been pain in the injection site.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101302225 same reporter/product, different patient / event.
received the first dose of the vaccine on April 8. He presented to the emergency room on April 27 with generalized weakness and inability to ambulate. He had an episode of blurred vision, pain and weakness in his left leg. A stroke was ruled out. His family refused the second dose of the Covid vaccine.
Patient states a delayed reaction after a few days.  Patient experiencing (still) stomach pain described as fire coming out of her stomach, diarrhea, vomiting, fever, epiglotis is swollen at night causing a cough, pain running along the inside of her right arm and loss of appetite.