chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upset stomach; This is a spontaneous report from a contactable consumer(patient). A 77-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on 25Jan2021 at single dose, left arm for covid-19 immunization. Medical history included hysterectomy from 1993, breast cancer from 28Feb1988 to an unknown date, she had three stents put in on 07Jan2021. Additional Information for Other Conditions reported as they did a mastectomy and had had a prosthesis for 30 years; they took out 18 lymph nodes and still suffers from her right arm being; she had right breast cancer. She shrunk before the vaccine. She had a hysterectomy and breast cancer and could not take any hormones. She guessed that was the reason why she shrunk. She was 5'3" or 5'4" and used to be 5'6". The patient's concomitant medications were not reported. The patient took the shot this morning(25Jan2021). She had an upset stomach on 25Jan2021. She messed her pants. She had three stents put in on the 07Jan2021. This was prior to the vaccine. She ate potato soup a little while before. This was her first dose. Treatment reported as none. The outcome of the event was unknown.
Vertigo very intense for two days.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 28Jan2021 09:30 Am (age at vaccination was 69 years) (Batch/Lot Number: EL9264) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 29Jan2021 the patient experienced vertigo very intense for two days and have some residual. The event led to Doctor or other healthcare professional office/clinic visit. No treatment was received for the event. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Patient experiencing bilateral blurry vision, burning sensation of the eyes, photophobia. Eyes appeared normal on exam, no injection but patient clearly in discomfort and bothered by light.
headache, joint and muscle pain, sore throat, cough, runny nose took OTC Tylenol to help
fever; chills; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer sponsored program COVAX Support. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at single dose on 22Mar2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever and chills on an unknown date of Mar2021 after her first dose of the vaccine on 22Mar2021.  She took Tylenol twice for it. Events outcome was unknown.  Information on the lot/ batch number has been requested.
Within the first day I experienced an extreme migraine, and had experienced hot flashes and bad injection site pain. By the second day the symptoms were less mild, however were still there and even in the early morning were keeping me up. The symptoms would be extreme and then mild out during the day and then become extreme again.
Complete loss of use to both hands, fire and ice sensations in extremities, tremors, temporary paralysis in hands and arms, swollen lymph nodes on neck, itching burning rash on back of neck and head, loss of appetite, chronic headache, chronic hot flashes, swollen joints in hands, feet, ankles, knees, hips, persistent painful arthritis like symptoms in hands to this day, visibly swollen joints in hands and wrist that came out of nowhere and severely limit mobility and use of my hands today, persistent and chronic infections treated with antibiotics of various kinds without much luck and categorized viruses and infections remain,persistent intermittent nausea to this day, Disturbed sleep patterns, irritability, inability to focus, severe short-term memory loss that persists. My life has not been the same. Healthcare professionals tried to be helpful but not sympathetic and never actually believed me; listed almost identical reactions.
BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow; A lump developed and it looked the size of a bicep muscle except it was in the wrong place; I could barely get out of the bed to eat something or go to the bathroom; Chills; body aches that day and next/Very sore arm for 2 weeks.; Felt very tired/Felt exhausted for 3 days; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow), SKIN MASS (A lump developed and it looked the size of a bicep muscle except it was in the wrong place), MOBILITY DECREASED (I could barely get out of the bed to eat something or go to the bathroom), CHILLS (Chills) and MYALGIA (body aches that day and next/Very sore arm for 2 weeks.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (NSAIDS), Food allergy (eggs allergy) and Food allergy (dairy products allergy). Concomitant products included VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for Vitamin B complex supplementation, VIT D [VITAMIN D NOS] for Vitamin D supplementation, PREBIOTICS NOS and CARBINOXAMINE MALEATE (OMEGA 100) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow), SKIN MASS (A lump developed and it looked the size of a bicep muscle except it was in the wrong place), MOBILITY DECREASED (I could barely get out of the bed to eat something or go to the bathroom), CHILLS (Chills), MYALGIA (body aches that day and next/Very sore arm for 2 weeks.), FATIGUE (Felt very tired/Felt exhausted for 3 days) and HEADACHE (Headache). At the time of the report, ERYTHEMA (BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow), SKIN MASS (A lump developed and it looked the size of a bicep muscle except it was in the wrong place), MOBILITY DECREASED (I could barely get out of the bed to eat something or go to the bathroom), CHILLS (Chills), MYALGIA (body aches that day and next/Very sore arm for 2 weeks.), FATIGUE (Felt very tired/Felt exhausted for 3 days) and HEADACHE (Headache) outcome was unknown.            No treatment medications were provided. Indications for the concomitants Omega and Pre-biotics were supplements.   This case was linked to MOD-2021-057826 (Patient Link).
Following her COVID vaccination patient developed GI symptoms and was diagnosed with CMV colitis.  Patient failed outpatient therapy and was admitted to hospital on 5/21/2021.  Upon admission, she was found to have a vulvar lesion that was biopsied and proven to be CMV positive.  Despite maximal medical therapy, patient developed CMV viremia.  She was admitted to ICU on 7/23/2021 for sepsis, requiring pressors.  She subsequently had episodes of altered mental status and possible seizure, and had a negative head CT and equivocal EEG results.  Patient then developed respiratory failure.  Family at this time deemed patient DNR/DNI and then patient expired on 7/26/2021.
Pt was administered second dose in the vaccine series 16 days after the 1st dose. The recommended second dose from the manufacturer is 28 days after the 1st dose.
4/13/21 evening; c/o eyes feeling weak since receiving vaccine and vision blurry she did call PCP to make an appt prior to calling Covid line to report reaction; awaiting callback from PCP Caller does have hx of TIA, but states she did not experience visual disturbances with TIA; denies dizziness, lightheadedness, muscle weakness. Will await call back from PCP to make appt to have vision eval. 4/21-will be making in an appointment to see pcp & optomologist. states she is doing "fine"
my legs are like bubbling like in a hot tub; nerves have never stopped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "my legs are like bubbling like in a hot tub", "'nerves have never stopped". The following information was reported: NEURALGIA (non-serious) with onset Mar2021, outcome "not recovered", described as "nerves have never stopped"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "my legs are like bubbling like in a hot tub". The events "my legs are like bubbling like in a hot tub" and "nerves have never stopped" required physician office visit.  Additional information: Patient took the two covid vaccine almost 3 years ago, in Mar two days after the vaccine and patient didn't know it was yours it was Pfizer and the day after she took it, she went to the doctor because her legs maybe patient should have called you about that a long time ago but her legs are like bubbling like in a hot tub and like little pop all over the place i called it like 'popcorn' . The nerves have never stopped since that time they're like the feeling that it is, Because of that concern patient concerned about taking the Paxlovid patient called the neurologist that patient go to and she didn't tell problem, but patient told them that her legs stopped doing that nerve issues since Mar2021, so it's not a hurting nerve issue. Caller stated "I did not take the booster because my doctor because the doctor questioned taking that because my nerves. and i didn't took a shingle issue and it's not shingle either.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1145 Patient received vaccine 1150 Patient reported feeling flushed and lightheaded. Denied shortness of breath, difficulty breathing and hives. Patient instructed to lie down. Vital signs taken and within normal limits. Patient drank 4 oz of orange juice. After, patient reported feeling better. Observed patient for 15 minutes following episode. Patient denied any symptoms prior to leaving
CHILD GIVEN WRONG PFIZER FORMULATION FOR AGE. AT 13YO SHOULD'VE RECEIVED THE ADULT FORMULATION FOR 12+.
pt stated that after her vax that on her left arm she developed swelling, red rash, pain around the injection site extending from her shoulder to her elbow.  Pt contacted her PCP regarding her symptoms and advice regarding her second dose.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 21-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
3 hrs after immunization, fevers to 101, floppy throughout, eyes glassy, decrease formula intake. This resolved and now with episodes of shaking and staring off into space.
inflammed bilateral lymph nodes in both breasts; arm pain/arm was generally sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm pain/arm was generally sore) and LYMPHADENITIS (inflammed bilateral lymph nodes in both breasts) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Blood pressure high.   On 26-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced PAIN IN EXTREMITY (arm pain/arm was generally sore). On 29-Oct-2022, the patient experienced LYMPHADENITIS (inflammed bilateral lymph nodes in both breasts). At the time of the report, PAIN IN EXTREMITY (arm pain/arm was generally sore) and LYMPHADENITIS (inflammed bilateral lymph nodes in both breasts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2022, Mammogram: The mammogram showed suspected cortical thickening involving bilateral axillary lymph nodes and possible intramammamry lymph nodes at bilateral upper outer quadrants warranting additional evaluation. On 29-Oct-2022, Ultrasound breast: several lymph nodes with 3 to 4 mm of thickness. The result showed conistencies with inflammed bilateral lymph nodes in both breasts 4 weeks after receiving the Moderna Covid-19 bivalent vaccine.         Patient was using high blood pressure medication as a concomitant medication. On 28-Jan-2021, the patient received first dose of Moderna COVID-19 Vaccine with lot number 007M20A on unknown arm. On 27-Feb-2021, received second dose of Moderna COVID-19 Vaccine with lot number 014M20A on unknown arm. On 15-Nov-2021, received third dose of Moderna COVID-19 Vaccine with lot number 026021A on left arm. On 18-Apr-2022, received fourth dose of Moderna COVID-19 Vaccine with lot number 066K21A on left arm. No treatment information was provided by the reporter.   This case was linked to MOD-2022-667014 (Patient Link).
Heart Attack; This is a spontaneous report from a contactable consumer reported for himself. This 59-year-old male patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at age of 58 years old as single dose for COVID-19 immunization. Medical history included having risk factors for heart disease, Covid prior vaccination, known allergies: penicillin. Concomitant medications included other medications in two weeks. The patient had no other vaccine in four weeks. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in the left arm on 22Jan2021 at age of 58 years old for COVID-19 immunization. The patient suffered from a heart attack on 26Feb2021 at 02:30 AM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. AE treatment was received including cardiac catherization. The patient had Covid test post vaccination with negative result via nasal swab. Outcome of the event was recovered with sequel.   Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 64-year-old male patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 4 years after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), sickness and cough. On an unknown date, the outcome of the vaccination failure, whooping cough, sickness and cough were unknown. The reporter considered the vaccination failure, whooping cough, sickness and cough to be possibly related to dTpa vaccine. Additional details were reported as follows: This case was reported by the patient's wife. A few years before reporting date, the reporter's husband got whooping cough, but had his DTP shot 4 years before vaccination. However, he was deathly sick. The reporter stated that this was so dangerous  to infants but, adults got it because of transmission from other adults and unvaccinated children. The patient was deathly sick, coughing his brains out for a solid month. The blood test was sent to the country health department which confirmed it was in high count and the patient was told not leave the house. The reporter stated it was a dangerous virus and dangerous to everyone. The reporter denied consent to be contacted. The details regarding dose number, batch number and expiry date of the vaccine were unknown. This case was considered as suspected vaccination failure since details of completion of the primary vaccination schedule and confirmatory laboratory test was not provided.
Heartburn and gastritis; Heartburn and gastritis; each covid vaccine+boosters caused a flare-up of my fibromyalgia; each covid vaccine+boosters caused a flare-up of my fibromyalgia; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (14Jun2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 10Aug2021 at 16:00 as dose 1, single (Lot number: FA6780) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia", start date: 1993 (ongoing), notes: Pertinent Details: take medications for sleep and pain; "Osteoporosis", start date: 2000 (ongoing); "Chronic fatigue syndrome", start date: 1993 (ongoing), notes: Pertinent Details: take medications for sleep and pain; "Tachycardia", start date: 1995 (ongoing); "Anxiety", start date: 1995 (ongoing); "sleep" (ongoing). Concomitant medication(s) included: AMITRIPTYLINE oral taken for fibromyalgia, start date: 1995 (ongoing); CLONAZEPAM oral taken for anxiety, sleep disorder, start date: 1995 (ongoing); METOPROLOL oral taken for tachycardia, start date: 1995 (ongoing); NABUMETONE; CELEBREX oral taken for fibromyalgia, start date: 2021 (ongoing). The following information was reported: DYSPEPSIA (non-serious), GASTRITIS (non-serious) all with onset 10Aug2021 at 16:20, outcome "not recovered" and all described as "Heartburn and gastritis"; FIBROMYALGIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Aug2021, outcome "recovering" and all described as "each covid vaccine+boosters caused a flare-up of my fibromyalgia". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fibromyalgia, condition aggravated. Therapeutic measures were taken as a result of dyspepsia, gastritis.  Additional information: Patient had some minor side effects after the first dose. Heartburn and gastritis started 20 mins after 1st booster of Covid vaccines. Treatment given were Pantoprazole and Famotidine. Each Covid vaccines and booster caused a flare-up of her fibromyalgia that started to resolve itself within one week after vaccine shot. She nowhad to take medication for heart burn and gastritis every day. Medication controled it but without medication, heart burn and gastritis came back. She was at higher risk for this due to long term use of anti-inflammatory drugs.  Follow-up (14Jun2022): This is a spontaneous follow-up report received from a contactable Consumer. Updated information included: RMH, lab data and dosage regimen updated. Concomitant medications product indication and dosage regimen updated (amitriptyline, clonazepam and metoprolol). Concomitant drug added (Celebrex). New event added (dyspepsia and gastritis).
Mom reports (L) arm from shoulder to elbow swollen red hot to touch on 12-11-15 took child to dr and was given antibiotic and antihistamine.
Soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Coumadin.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported the patient experienced soreness after 1st dose of Shingrix.  The reporter consented to follow up. For tolerance in 2nd dose of Shingrix refer case US2020AMR193446.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR193446:Same patient, 2nd dose
I have been feeling extremely dizzy for the last two days. The dizziness has lasted all day for both days. This was not present prior to receiving my vaccination dose.
Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, headache, tremors in neck overall difficulty with balance. Have had similar symptoms with antibiotic use.
High fever 3 days, rash entire body. Vax on 5/26, reaction started on 5/28/06 evening with light fever. Onset was on 5/29 PM.
I  awoke about 7:00 am this morning, I felt achy in my legs, arms, hips and my head,  My stomached is fine.  My temperature ai 11:52   97.6. F.
Sharp pain in left eye with readness, lasted a couple of days.  Rash, still present after two days, worse second day.  Headache, mostly associated with left eye pain, Fatigue - felt like I was weighted down.  Developing a cough.
Revaccinee. Pt experienced chest pressure, bilateral arm numbness and diaphoresis; called 911. Selfmediated w/ Aspirin and was given NTG by EMS. Pt hospitalized x 1 day and discharged to home w/ folic acid and Norvasc. No contraindications to vaccine. No significant PMH. Cathel 6 pm helped only by integration (helps plts; g? as bolus). Dx: coronary artery disease. Cath= 20% plague in two vessels. Low grade coronary artery disease, mild aortic regurgitation, LVH with normal LV systolic function, and hypertension. Her echo clearly shows evidence of mild aortic regurgitation with LVH.
Headache, Malaisa, Fever, Sinus congestion for several weeks ongoing, dizziness, cough, vision distorted, rash to trunk and lower ext.
Red area surrounding injection site. has been increasing in size each day, taking up most of the upper area of her left shoulder. Is itchy and warm to the touch. Slightly swollen at direct inject site.