chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 19Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Feb2021, the patient experienced headache. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was resolved on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt report rash 30MAY08, admitted 31MAY08, discharged on 1Jun08.  Rash lower arms & hands no pain some itchy. 7/14/08-records received-6/6/08-rash on bilateral arms, hands times 1 week. Elevated red patches, initially itchy. Occurred after 2nd anthrax vaccine. Impression:dermatitis. PE: multiple red-purple plaques on forearms. Seen at a hospital no records of admittion. 6/3/08-Impression:erythema multiforme.
Information has been received from a registered nurse for the pregnancy registry for Gardasil, concerning a 26 year old female with a drug reaction/allergy to Wellbutrin, factor v laiden mutation/clotting disorder, prothrombin mutation, bipolar disorder, seizure disorder and Mthfr and a history of pulmonary embolism and multiple deep vein thrombosis and herpes virus infection who on 13-SEP-2006 was vaccinated with her first Gardasil 0.5 ml IM (lot # 653735/0688F). Concomitant therapy included Coumadin, Topamax and clonazepam. The nurse stated that the patient was very non-complaint and never returned for the second or third dose of the vaccine. On 16-APR-2007, the patient was found to be pregnant which was confirmed by ultrasound and a pregnancy test. The patient's last menstrual period, gestational age or due date were not reported. On 11-MAY-2007 the patient experienced spontaneous miscarriage which was confirmed by ultrasound. The patient sought unspecified medical attention. The patient was not hospitalized. Upon internal review, spontaneous miscarriage was determined to be an other important medical event. Additional information has been requested.
Severe stomach cramps; Diarrhea; nausea; chills; headache; Intense cramps during bowl movement; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed , COVID-19 Vaccine[unknown manufacturer]), for COVID-19 immunization; Covid-19 vaccine (DOSE: 1st Booster), for COVID-19 immunization.  The following information was reported: DIARRHEA (non-serious) with onset 10Sep2022, outcome "recovering", described as "Diarrhea"; GASTROINTESTINAL PAIN (non-serious) with onset 10Sep2022, outcome "recovering", described as "Intense cramps during bowl movement"; ABDOMINAL PAIN UPPER (non-serious) with onset 10Sep2022, outcome "recovering", described as "Severe stomach cramps"; CHILLS (non-serious) with onset 10Sep2022, outcome "recovering"; HEADACHE (non-serious) with onset 10Sep2022, outcome "recovering"; NAUSEA (non-serious) with onset 10Sep2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper, diarrhea, nausea, chills, headache, gastrointestinal pain.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Some, red, swollen, warm Varicella site on left arm 24 hours after vaccination. Induration measured 2.5 by 3 inches. Increased at 48 hours to 3 by 4 inches. Child remained afebrile and no red streaks at 48 hours. MD stated "vaccine reaction."
I had one enlarged surgical lymph node on left side was seen by a EMT. I went to get a CT scan it appeared to be enlarged.After I went to see my ENT wants to follow up in a month if hasn't gotten any better will schedule appt for ultrasound.(lymph node it appeared a size of a nickel coin in height at first and now has decreased to a size of a raisin)
After 4 hours, pain in arm, swollen arm, hot to touch,  chest muscle pain (not heart related), joint pain moderate in hip, shoulders,  knees, hands.
Patient presented to the ED and was subsequently hospitalized for UTI, and started on a PPI for likely  duodenal ulcer within 6 weeks of receiving COVID vaccination.
The patient presented to the emergency department with 2 weeks of worsening bilateral lower extremity pain, erectile dysfunction and urinary retention.  24 hours prior to presentation he had been experiencing new neck pain/headache.  He had no chronic history of these symptoms apart from arthritic pain in both knees and hips.
Severe chills and weakness.  Ran 6 miles day of getting vaccinated (21st) unable to even reach the end of the street on the 22nd.
had 100 degree temperature; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix. On 27th August 2021, 1 day after receiving Shingrix, the patient experienced fever. On 28th August 2021, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided are as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and had 100 degree F temperature the day after vaccination. On the date of reporting (2nd day after vaccination), the patient was fine. The patient did not want shingles. The patient need the 2nd dose in 2 to 6 week but it was expensive. The follow up would not be possible as no contact details were available.
Patient stated that his arm is warm, itches, and is hard at the area where the vaccine was given. Started approximately 2-3 days after the vaccine was administered.  Instructed patient to take Benadryl to help with the itching. Also told patient to contact his primary care provider.
Itching hands; Welt on her jaw and bottom of left foot, this was all on the left side; Rash only on her upper chest between neck and breast and on her back; Headache; Chills; Heart was beating faster than normal; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 18Mar2021, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 18Mar2021. The next day (19Mar2021), the patient woke up to itching hands. The patient also noticed a welt on her jaw and bottom of left foot, this was all on the left side (19Mar2021). The patient also had a rash only on her upper chest between neck and breast and on her back (19Mar2021). On 19Mar2021, the patient had headache and chills. All this happened within 30 hours of getting the vaccine. The patient took diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), and it helped. By Monday (22Mar2021), the patient was fine. One week later (Mar2021), the patient woke up from her sleep and her heart was beating faster than normal. The patient went back to sleep and when she woke up, she was okay. The patient was wondering if this has been reported. The patient recovered from "Heart was beating faster than normal" in Mar2021; and from the remaining events on 22Mar2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
POTS; orthostatic intolerance; presyncope; dizziness; headache; fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 14-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, presyncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Body chills; fever; headache; dizziness; exhausted; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 31Mar2021 at 13:45 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 16:00, the patient experienced body chills, fever, headache, dizziness and exhausted. The patient did not receive any treatment for the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event body chills, fever, headache, dizziness and exhausted was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills, swelling, redness and pain at the site, weakness, headache, myalgia, lymphadenopathy.
loss of depth of perception; Double vision; dizziness; dose number=3; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a 78-year-old male consumer (patient).   A 78-years-old male patient received bnt162b2 (PHIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 09:30 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at the age of 78 years old.  Medical history included Hypertension, survivor of pancreatic cancer. The patient did not have any known allergies. The patient received first and second dose of bnt162b2 (PHIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medication within 2 weeks of vaccination. The patient experienced loss of depth of perception, double vision, dizziness, above on 03Nov2021 21:00 with outcome of not recovered. All events resulted in hospitalization with emergency room visit. The patient underwent lab tests and procedures which included nasal swab : negative   on 04Nov2021.  Prior to vaccination, the patient was not diagnosed with COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
heart feeling like a fist when tighten it for a blood draw/heart squeeze; burpy; ocular migraine; seeing the black and white flashy snake thing that makes it hard to focus; seeing the black and white flashy snake thing that makes it hard to focus; almost like a panic attack/Panic; This is a spontaneous report from a contactable consumer (patient) reported that a 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0167), via an unspecified route of administration, administered in arm right on 03Jun2021 18:30 (at the age of 41-years-old) as 1st dose, single for covid-19 immunization. The vaccine was administered at the Pharmacy/drugstore. The patient was not pregnant at the time of vaccination. The patient medical history included situational anxiety and melanoma. Concomitant medications included escitalopram; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); and clonazepam (ZICAM [CLONAZEPAM]); all were taken for an unspecified indication, start and stop date were not reported. It was reported that 2 mornings after (05Jun2021), she woke up at 5:45 am (after a really good sleep) with her heart feeling like a fist when tighten it for a blood draw. She also was burpy. She did meditative breathing and sat up. It helped, but kept coming back that day (almost like a panic attack -- but the patient never experienced that feeling). A few hours later she got an ocular migraine (no pain, just seeing the black and white flashy snake thing that makes it hard to focus). The visual went away within 30 minutes or so with no lights/eyes covered and in reclining position. Panic/heart squeeze continued on and off --- but underlying feeling -- all day. The next day, (today) heart is feeling a tad tight but no where like yesterday. Plan on talking to doctor tomorrow. She spoke to a medical friend and didn't feel it was life threatening, so didn't seek medical care over the weekend. It was unknown if the patient received any treatment for the events. The outcome of the events was recovered with sequel.   Information on lot/batch number was available. Additional information has been requested.
On Friday July 9, I started with severe heaviness/ dizziness in my head because of that event I had to go to the emergency room on 9/14 because the heaviness got stronger. I had an MRI done, and I had to see a neurologist. Apparently, I have strong migrants, something I never suffered from before. I still have appointments and studies with the neurologist.
Pt. states that after receiving the 2nd dose of Moderna 06/10/2021, started experiencing symptoms 07/26/2021 of Nausea, body aches, light headed, shortness of breath. Still continuing, Primary visit planned.
ACHES; CHILLS; TIREDNESS; DULL HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. 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: 1821286 expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced aches. On 19-JUN-2021, the subject experienced chills. On 19-JUN-2021, the subject experienced tiredness. On 19-JUN-2021, the subject experienced dull headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, dull headache, chills and aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210643041.
On 11/2/03, pt received one dose MMR and one dose IPV, approx 24 hrs later he felt "chilled and noticed small bumps on back of both arms bilat that progressed to back of legs, trunk, bilat. thighs. Denies other c/o-no URI sx. or fever. C/O tickling in throat given 50mg Benadryl repeat at ns prn. Report to Dr if sx increase.
Initially developed earache, fever sore throat so went to Urgicenter on 3/19. Diagnosed with ear infection and given prescriptions for Cefdinir and Dexmethasone. On 3/27 had not improved & had a rash on left side of face, in/out ear and scalp. Earache had intensified to a stabbing pain. Returned to same Urgent care and was diagnosed with shingles in my left ear. Left side of face had started to droop, particularly left side of mouth and jaw was sagging and swelling. Had lost hearing in left ear. This was if most concern since I already have hearing loss and wear hearing aids. Follow up visit with Audiologist revealed no additional hearing loss from previous tests. After changing medications
This initial spontaneous report was received from a physician referring to a 7 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 08-SEP-2015 at 12:24 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
4 month old male was administered ADACEL instead of PENTACEL, no AE; 4 month old male was administered ADACEL, no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four month old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 14-Sep-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6737AA and expiry date: 09-Jul-2022) via an intramuscular route in the left leg for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (same day latency).  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 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 felt faint, paled with in 5 minutes post vaccination, began to sweat.  Patient had admitted to fainting with first dose.  Patient also claimed history of light headedness with flu vaccine in the past.   After sitting for 25-30 minutes patient recovered enough to leave under own power accompanied by his wife.  Followed up with patient at home 3 hours later, patient claimed to feel fine just had a sore arm
This spontaneous reprot has been received from a pharmacist referring to a 50 year old female patient, reporting on herself. The patient was allergic to morphine and had no pertinent medical history. On 28-JUL-2015 the patient was vaccinated with ZOSTAVAX lot # K018172 exp. date 02-DEC-2015, unknown dose, subcutaneous, on unspecified anatomical location. No concomitant medication was reported. The patient stated she began to experience discomfort at the injection site on 30-JUL-2015, which became worse in the evening of the same day. The pharmacist reported that the patient experienced an area at the site of injection of approximately 6 inches in diameter, red, warm and "tender to touch". The patient did not receive treatment and no lab diagnostic studies were performed. At the time of the report the outcome of redness, discomfort, warmth and tenderness in the injection site was reported as not recovered. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients might have received doses of GARDASIL (dose, route and lot # not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
localized swelling w/pain, fever, n/v onset next day p/vax;pt improving by 9/21/99;
circumstance or information capable of leading to medication error; extra dose; first dose before getting a transplant on 2018/ second dose on 26May2020; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included transplant.   On an unknown date, the patient received the 1st dose of Shingrix. On 26th May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. On 26th May 2020, not applicable after receiving Shingrix and Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles, circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the shingles, drug dose administration interval too long, circumstance or information capable of leading to medication error and extra dose administered were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the drug dose administration interval too long to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix before getting a transplant on 2018 and two years after that he developed Shingles that lasted for 22 days and after that the patient received the second dose of Shingrix, which led to lengthening of vaccination schedule. The patient might administer another dose. The reporter consented to follow up.  The reporter said she believed that patient received the first dose on another pharmacy but agreed to follow up. She reported to second line agent that she may administer an extra dose of Shingrix, which led to circumstance or information capable of leading to medication error and extra dose administered.
Patient felt lethargic post vaccine. Looked pale. Awake, alert and oriented. No respiratory distress. Allowed to rest with feet up. vital signs normal. BP 100/75-110/86, O2 sat 97%, HR 76 BPM.  Water given. Went home with no incident after 20 minutes. Her partner drove her home and texted friend that she is ?ne when she arrived home.
seizure like activity of upper extremities. slumped over in chair vomited pale in color