chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was given tetanus vaccine on December 02/11 AM. Later that day at home my left arm was sore and aching, couldn't move arm. It been over 2 months and still hurts. Cannot function arm properly.
I have had a headache daily since getting the shot and I have a large red mark that is a little warm to the touch around the shot area.
Off-label use administered to a 14yo Moderna is 18yo No adverse effects per patient and grandmother
Tested positive for COVID virus; Tested positive for COVID virus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jun2021 (Lot number: EW0180) at the age of 12 years as dose 2, single and administered in arm left, administration date 22May2021 (Lot number: EW0187) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021 13:41, outcome "unknown" and all described as "Tested positive for COVID virus". The patient underwent the following laboratory tests and procedures: culture throat: (unspecified date) negative; sars-cov-2 test: (22Dec2021) positive.
After 45 minutes of receiving vaccination , the knuckles in my left hand, the arm I received the shot in, began to hurt very badly.  Before I was able to get home,  7 minutes away, both hands hurt so bad I couldn't hole the steering wheel and I was having cramps in my legs.  I could hardly walk up the steps to my house because my ankle joints hurt so badly.  I went to bed  right away and slept .  My hands hurt really badly, but I knew the vaccination caused an inflammatory response so I figured just  rest.  By the end of the day Tuesday, I couldn't type and could not hold the steering wheel to drive home.  I felt out of breath, I hurt all over, my muscles ached and were cramping.  I was nauseated, very emotional.  I had a fever that spiked at over 101 degrees.  I was so chilled that I was shaking violently. I hurt in every joint, my lymph nodes were painfully swollen, my heart was racing, normal pulse for me is 68 to 72, it was 88 to 90.  Halfway up our stairs, I just stopped, couldn't make my legs work.  Day 3 I called my doctor, had a virtual appointment I knew I couldn't drive or ride 45 minutes away.  I missed 3 days of work, stayed home all weekend and was better by Monday.  It was 3 weeks before my hands quit aching.  The pain came and went in my ankles, wrist, knuckles, hips and knees.    Food still nauseates me.
Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6204) via an unspecified route of administration in the left arm on 04Mar2021 at 14:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included LIPITOR from an unknown date for an unknown indication and unknown if ongoing. On 04Mar2021 at 21:30, the patient experienced severe dizziness which lasted 7 hours. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness was recovered on 05Mar2021.   No follow-up attempts are needed. No further information is expected.
No additional  adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 26-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210  and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
The pt states soreness in right upper arm at site for 1 month post vax. Advised a follow up office visit.
COVID-19 Moderna vaccine (Lot #011L20A)  Patient received vaccination, after 10 minutes of waiting patient notified writer that she was very nausea and felt like "bee stings" to her lower back.(0745) VS-164/82, HR 98, RR 18, 98% RA. 25mg PO Benadryl given.  Writer assessed, crusted over scabs located to lower back. Patient states she must scratch in her sleep.   Patient became diaphoretic, blotchy redness to chest and lower back. Dr. came and assessed from ER. No further medications ordered. (0755-) BP 149/94, HR 92, RR 18, 98% RA. Patient resting on and off nausea.   (0815) BP 137/83, HR 88, 98% RA, RR 18. Ate graham crackers, tolerating water. Vital signs improved. Blotchy/redness subsiding.   (0830)- Ambulated hallway with writer. Feeling much better. Patient feels safe to drive home, going to go home and rest for a bit before going to work. Instructed patient if she felt worse to go to the ER, or call 911.
Pt. reported itching in arm shot was administered, starting evening of administration. RXN progressed to redness and swelling that proceeded down to the elbow. Pt. went to her doctor, was prescribed KEFLEX and BENADRYL, diagnosed with allergic reaction.
received an expired dose of fluzone qiv np with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2023SA345594.  This case involves a 21-year-old female patient who received an expired dose of influenza quadrival A-B vaccine [Fluzone QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 27-Oct-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, expiry date: unknown) (lot: UT7680NA) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) and received an expired dose of fluzone qiv np with no reported adverse event (expired product administered) (latency: same day).   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.
Extreme pain in shoulder. Unable to move arm. Saw doctor. Was told by the doctor that the placement of the flu shot had caused my shoulder to freeze. Had x-rays to eliminate any other causes. Prescribed prednisone and therapy.  After a month and a half, it is still very painful. Range of motion is markedly reduced.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 22-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Swollen face; Sneezing; Blocked ears; Sore throat; Swollen lymph nodes underarms; Fever; Chills; Nausea; Left arm pain; Fatigue; Sweating; Dry tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 (Lot number: FE 3592) at the age of 31 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "IBS-D" (unspecified if ongoing), notes: IBS-D; "known allergies" (unspecified if ongoing), notes: known allergies: Yes; "IBS-D" (unspecified if ongoing), notes: IBS-D. The patient's concomitant medications were not reported.  The following information was reported: SWELLING FACE (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Swollen face"; SNEEZING (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Sneezing"; EAR CONGESTION (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Blocked ears"; OROPHARYNGEAL PAIN (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Sore throat"; LYMPHADENOPATHY (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Swollen lymph nodes underarms"; PYREXIA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Chills"; NAUSEA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Nausea"; PAIN IN EXTREMITY (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Left arm pain"; FATIGUE (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Fatigue"; HYPERHIDROSIS (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Sweating"; TONGUE DRY (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Dry tongue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling face, sneezing, ear congestion, oropharyngeal pain, lymphadenopathy, pyrexia, chills, nausea, pain in extremity, fatigue, hyperhidrosis, tongue dry.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient not received other medications in two weeks. Post vaccination, the patient was tested for Covid-19.   No follow-up attempts are possible. No further information is expected.
TESTED POSITIVE FOR COVID ON 3/17/2023 AFTER DEVELOPING SEVERE HEADACHE ON 3/16/2023.  CONTACTED PCP WHO PRESCRIBED PAXLOVID.  RETURNED TO WORK FULLY MASKED ON DAY 6.
Information has been received from a physician concerning a 14 year old female who on 07-MAR-2008 was vaccinated with GARADASIL (lot# not reported). On 09-MAR-2008 the patient fainted. The patient's outcome was not reported. Additional information has been requested.
Nausea chills required visit to take care clinic for ondansetron 4mg script.
12/31/21 pt had a positive COVID test; sx - SOB, fever, weakness, O2 saturation 89-90% on RA; 1/7/22 to ED with increasing SOB; CXR showed atelectasis; CT chest negative for pulmonary embolism, bandlike infiltrate left lower lung lobe, ground-glass densities right upper lung lobe; sent home with inhaler and Tessalon; 1/11/22 increase in weakness and continued cough, fever, headache; back to ED; PCP (name not included in records) had called in prednisone and ABX the week before; COVID pneumonia and respiratory failure; given Dexamethasone and empiric doxycycline; pt's respiratory status continued to worsen; Vapotherm; 1/21/22 emergent code blue called; ACLS/CPR done; asystole; continued with ACLS/CPR without any success; pt passed away in the hospital
Top of my feet, they blown up on both of my feet only from top of the toes to the ankle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Top of my feet, they blown up on both of my feet only from top of the toes to the ankle".  Additional information: The patient reported that the patient got 2 shots, the second one was about 3 weeks ago and the only problem the patient had with it is that top of the feet kind of was blown up a little bit on each side.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was identified  by pharmacy staff that patient had previously received Moderna COVID vaccine on 4/27/21 but did not get 2nd follow up dose.  Came into pharmacy on 8/14/21 and received Janssen vaccine.   Patient did not report any adverse reactions.
Parent (father) reports he noticed a small bump resembling a mosquito bite on child's left thigh and 2 days later he noticed child scratching and saw that it looked like a small blister.  Dad reports child had a flu shot in left arm on Dec. 21st.  Denies child having any rash or swelling and no difficulty breathing.  As of 12/27, has not visited doctor for exam.
Headache, muscle aches, joint pain, nausea, worse today 9/2/2010
Patient did not have her vaccine card. When vaccine was verified on database confirmed she was eligible to receive bivalent.  Then realized that patient had previously received bivalent, and patient found her card after bivalent was administered.
Pt recvd 3  doses of vax in JAN91, FEB91, 8JUL91 & 3AUG91 devel viral synd; 10AUG91 exp visual disturbances, eye pain & dec visual acuity, w/primary loss of red color vision; optic neuritis; pt had dec visual acuity, dec visual fields;
I developed a local reaction the day after receiving the 1st dose of the Pfizer vaccine which includes pain, swelling, redness, and warmth at the injection site.
DULL PAIN/BURN AT REST; SHARP PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced dull pain/burn at rest. On 07-APR-2021, the subject experienced sharp pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain in left arm, and dull pain/burn at rest. This report was non-serious.
Normal vaccine pain within 2 hours. But it never diminished. Deltoid remained sore and then became very painful when trying to raise left arm to the side. Weakness started sometime that week nad both pain and weakness have continued for 7 weeks. 2nd shot was in right arm. No issues.
she recieved flu shot in left deltoid at 3:30 pm. about 1 1/2 hours later, she developed itching upper left arm, shoulder, left lateral neck to her hairline. No rash or swelling. This subsided about two hours later. In the morning, the itch returned and spread to her lateral hips. She applied caladryl with some relief. comlained of having trouble taking a deep breath, but no shortness of breath. Given atarax 25 mg po q6-8 hours prn. Advised not to recieve flu vaccine
No adverse reactions. Child was given influenza vaccine at 4 mo of age- though to be 7 mo when it was given. Infant had no ill effects.
14 year old female patient is in the observation area. Report to the paramedic having chest pain. Vital signs are taken BP 80/40, P83 in 89, SP02 98%. We consult with Doctor R. and she indicates to elevate patients legs and give her "GATORADE" and to evaluate vitals in 30 mins. 30 minutes later we take her vitals BP90/60 pulse 75, SP02 99% DEXTROSE. Patient reports not having pain. We consult with Doctor R. and tells patient to go home. She leaves the center accompanied by her mother.
pt recv vax 12MAY97 & 14MAY97 pt devel mult raised, red bumps @ inj site;
This medically confirmed report (initial receipt 21-Oct-2013) concerns a 31-year-old female patient with a medical history of endometriosis. The patient did not have any allergies or drug reactions. Concomitant medications included an unspecified birth control. On the 18-Oct-2013, the patient received AFLURIA (batch number R53207) via the subcutaneous route. On the 19-Oct-2013, the patient's arm was red and swollen around the injection site. On the 20-Oct-2013, the injection site reaction was a six inch by five inch red welt and her arm was 1.5 times its normal size. Lab diagnostics studies were not performed. Treatment included diphenhydramine. The site greatly improved. The patient was advised not to receive another flu vaccine. Outcome was reported as recovering.
Headache, fixed with ibuprofen   Janssen COVID-19 Vaccine EUA
This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at age 32 years, via an unspecified route of administration on the left arm, first dose on 29Jan2021 09:30, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. On 30Jan2021 , the patient experienced migraine. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other medications within 2 weeks of vaccination. Treatment was not received for the adverse event. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Received shot at 2:00 pm felt fine. 8:00 pm felt jaw pain. Hurt to chew. 1:00 pm woke up with vomiting diarrhea , rapid heart rate, throat felt swollen 09/13/21 2:00 pm rapid heart rate, dizziness, headache, throat felt swollen, felt like i was having a hard time taking breaths, back of neck extremely swollen 5:00 still not feeling good called an ambulance given oxygen on the way to hospital.Blood pressure high At ER I was given a steroid and hydroxyzine felt better 09/14/21 3:00 pm felt sick again took hydroxy. felt a little better 9:00 pm took one more hydroxy before bed. ER Dr suggested to help sleep 11:00 pm woke up mouth extremely dry and felt fatigued and felt like my body was extremely .heavy 9/15/21 finally got into family Dr told I had a panic attack and was given zoloft. Said I had a bad reaction to hydroxy and said I had to wait to wear off so I can feel better. I continued to feel very weak and extremely fatigued. Still very dizzy. I never took zoloft and I am finally feeling a little better. Very hard to do certain tasks because I feel so weak.
Narrative:  Patient is a 78 year old MALE Covid vaccinated with PMH of HFrEF LVEF ~ 20-25% (2 D ECHO 07/07/2021) with s/p AICD placement Feb 2021, PAD, HTN, COPD and HOT prn, DM type II non-insulin-requiring, h/o gastric ulcer,CAD with recent NonStemi 07/2021 (Type II MI),Cardiac Amyloidosis (ATTR)on Tafamidis , tobacco dependency,h/o prostate carcinoma came to the emergency room for complaint of 2 to 3 weeks of cough and COVID - 19 detected with O2 sat at RA ~89% and CTA Chest : Neg PE but + RLL infiltrate. Acute on chronic hypoxic respiratory failure:2/2 COVID Pneumonia and COPD exacerbation Acute COVID infection /Pneumonia : Vaccinated - s/p IV remdesivir (10/23 -10/27),Decadron po 10/23 - 10/26. Decadron changed to IV methylprednisolone for COPD exacerbation -s/p IV ceftriaxone and azithromycin completed 3 days therapy -LFTs: Improved after IV remdesivir COPD on home oxygen in acute exacerbation Chronic Nonobstructive CAD # Cardiac Amyloidosis on Tafamidis # Cardiomyopathy HFrEF LVEF ~ 20-25% (2 D ECHO 07/07/2021) compensated, with s/p AICD/pacemaker placement Feb 2021 Chronic tobacco use with dependency Type 2 diabetes mellitus non-insulin-requiring, hemoglobin A1c 6.8% (07/07/2021), complicated with neuropathy wit noted hyperglycemia 2/2 Steroids Chronic hyperlipidemia Chronic vitamin D deficiency Mild to moderate protein/calorie malnutrition, BMI of less than 18% - Obtain dietary consult for dietary supplements CONDITION AT DISCHARGE: Patient is seen and evaluated in the day of discharge, he is very comfortable laying flat speaking in full sentences. He denies any new complaints. He is feeling better and is ready to go home. He has been afebrile.
Non-pruritic purple macules on bilateral inner thighs several hours after 3rd injection. No side effects with previous injections. No new irritants used. Symptoms persisting over 24 hours. No treatment used.
Extreme tiredness, headache, chills, low-grade fever, upset stomach, aching, sleeplessness , fainting
soreness at injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 14:00 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovering", described as "soreness at injection site.". Therapeutic measures were not taken as a result of vaccination site pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness in upper left arm, slight muscular pain, moderate itchiness.   Pain and redness basically gone but itchiness continues constantly