chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 71-year-old female was given Adacel as a tetanus booster that was out of the age range, with no reported adverse event; Initial information was received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a nurse via consumer via physician (under Medical Information (MI) Inquiry Number: 00807107).  This case involves a 71- years old female patient who was administered with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] as a tetanus booster with no reported adverse event (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   On 02-Apr-2021, the patient received a 0.5 ml booster dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: U6807BB and expiry date: 10-Sep-2022 via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
knee weakness  approximately 3 weeks after 2 dose. patient claim experienced  knee weakness, pain . unable to flex knee. Hard to walk. Xray shows inflammation of femur and tibia .
Received vaccine on 5/20/96, contracted varicella after school exposure 2/6/2000.
Left deltoid (inject site) with erythema papular rash. Tx with cool compresses, TID, Benadryl, Tylenol.
Severe Hives; Severe swelling on eye and lip; Severe swelling on eye and lip; severe swelling arthritic feeling in hands; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:  ENS318) via unspecified route administered in Arm Left on 26Jan2021 09:30 via an unspecified route of administration, as single dose for an unspecified indication. Historical vaccine included first dose of bnt162b2. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D COLECALCIFEROL). No other medication taken four weeks prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test with unknown date. The patient experienced severe hives on, severe swelling on eye, severe swelling on lip, Started roughly 10 hours after the vaccine and are still lasting 4 days later. Also severe swelling arthritic feeling in hands(could not grip anything on day 2) all these on 26Jan2021 19:00. The patient was currently using prednisone, Zyrtec, benedryl, and Pepcid AC and said nothing was helping. The patient said she had no known allergies and have never had hives before. She had to miss two days of work. The outcome of the event was not resolved.  Follow-up (02Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Query:  Dear Manufacturer, Kindly see the attached document received by Pfizer Inc. containing a product in which you have been identified as the manufacturer. Response:  Email received. Case created #. Dear Colleagues,  Would you kindly address the query below and copy it to the mailbox with your reply.
Arrived home from work on 9/14/2021. Sat down. He had been chilled all day. Face was flushed he started to drip with sweat. Stated " I can't breath". VS 114/78,89 T unreadable due to sweat. RR 22, Spo2 91% Room air.  Red, peticial rash noted on chest and abdomen. He quickly became centrally cyanotic. Cap refill to fingers delayed. Lips dusky. Dr called.  Medicated with Benadryl 50mg (chewed), Pepcid 20mg PO, Zyrtec 10mg, Prednisone 20mg PO.  After about 10 minutes his fingers started to pink. Cap refill  slowly improved. The central cyanosis didn't resolve for about an hour. Prednisone taper obtained from pharmacy. An additional Prednisone 40mg PO given for a total of 60mg. After the additional 40mg given the rash resolved.
Narrative: Patient received two doses of covid vaccine. Death occurred weeks after. Reporting per ISN 5 criteria. Patient with progressive dementia. Unclear cause of death, no further reports noted.
12APR99 pt exp crushing sensation in chest;seen in ER & transferred to another hosp poss heart involved;pt in critical care unit until cardiac catheterization done(neg);pain, h/a, nauseated;sleeps 20 hr day;tests on liver & pancreas neg
Legs were numb 12/15/2016 PM, arms were sore 12/14/2016 till present day, couldn't catch my breath without coughing for 10 min 12/15/2016 AM, arms and feet tingled 12/15/2016 to present day, lower back pain 12/15/2016 AM, and couldn't get my bearings for 5 min 12/15/2016 occurs randomly now. No real appetite, things taste funny, 12/14/2016 PM, feeling drained of energy 12/16/2016 PM, went from 5 hours of sleep to 2.5 maybe 3, can't stay asleep, migraine like head aches everyday since 12/15/2016.
Next day: 10/06/14 Body ache, chills, severe headache, insomnia, severe puffy eyes (eyelids completely covered eyes), eye redness, yellow crust discharge - Patient went to acute care. Patient came back to Pharmacy on 10/8/14. Symptoms gone and she reported no more ADR's.
1am this morning chills, later 6am tried to get up severe chills, nausea, very dizzy, and joint pain. Husband laid her down on the floor for about 15-20 minutes, also extremely weak. By 8am symptoms lifted slightly and was able to rest most of the day.
Systemic: bumps all over body-Medium, Additional Details: patient says he got bumps all over body, slight itch
Sore arm at injection site Slight headache Chills Body aches Fatigue All lasted about 12 hours, up until I went to bed. When I woke up the next morning, everything except the sore arm had completely gone away.
The first at 7am on 1/18/2021 and then today 1/19/2021 at 4am. Daughter says that per ppts husband, ppt woke up screaming in rage saying that she is going to die. Patient scratches herself, cried and sounds if she is in agony. The daughter wonders if it is a possible side effect from Covid vaccine ppt received on 1/13/2021. Per daughter, ppts husband would like to speak with Dr to discuss what has been going on and possible treatment needed. Patient states that she does not remember and states that she is going "crazy." Empirical escitalopram is added. Patient states that husband is reported to have positive COVID 19 test. Quarantine instruction is given.
c/o fever, nausea, stomach cramps, diarrhea not 24hr p/vax;
Fever, extreme weakness, extreme body aches, nausea - all began 16 hours post vaccination
Felt headache  about 7 hours after shots.  Today, one day later woke up with severe headache, body aches, chills, fever 100 - 101, tired, tummy a bit upset. Rough day, did not work today and if tomorrow was a work day i would call in sick again? still feel awful and it is a day and a half later. I would say easily twice as bad side effects as COVID, and I had reaction to Covid shots and booster all three times (headache, body aches, tired, chills,? but this is way worse).
could not move; chills; lower back pain; spasm / cramping; can't sit twist or bend without severe pain; severe pain; severe headaches; tiredness; cold sweats; This case was reported by a consumer via patient support programs and described the occurrence of paralysis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 4th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant), chills, back pain, spasms, mobility decreased, pain, headache, tiredness and cold sweat. On an unknown date, the outcome of the paralysis, chills, back pain, spasms, mobility decreased, pain, headache, tiredness and cold sweat were unknown.   The reporter considered the paralysis, chills, back pain, spasms, mobility decreased, pain, headache, tiredness and cold sweat to be related to Shingrix.  Additional details were provided as follows: On 30th September 2020, the patient received 1st dose of Shingrix.  The patient had side effects from Shingrix vaccine. The patient reported sever lower back pain, spasms, cramping, can't sit twist or bend without severe pain, severe headaches, chills, tiredness.  The patient woke up with cold sweats and could not move.
Passed out; I felt faint; I was driving and I got so dizzy; This serious case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 7 hrs after receiving Shingles vaccine, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant), faint (Verbatim: I felt faint) (serious criteria GSK medically significant) and dizziness (Verbatim: I was driving and I got so dizzy). The outcome of the passed out, faint and dizziness were resolved.   It was unknown if the reporter considered the passed out, faint and dizziness to be related to Shingles vaccine.     It was unknown if the company considered the passed out, faint and dizziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that getting vaccinated was very good, but he or she had a horrible reaction. The patient reported that 7 hours after received Shingles vaccine he or she passed out completely, got some rest and on the next day he or she went to the work and he or she was driving and  got so dizzy that he or she felt faint luckily he or she had immediate help, otherwise he or she would had an accident, ask the nurse about the reactions, so we should be careful. Follow-up would not possible as no contact details were available.
MODERNA ARM, RED LIGHTLY RAISED AREA AT INJECTION SITE, WARM TO THE TOUCH. IT STARTED ABOUT 2 DAYS AFTER 1ST DOSE  THEN SOME WHAT THE COLOR  DISSAPPEARED  THEN ON 8TH DAY IT APPEARED RED AND ITCHY
Achy right arm (site of injection) about 12 hours after injection; achy muscles all over body; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809), via an unspecified route of administration on 13Feb2021 10:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant at the time of vaccination. The facility type vaccine was Pharmacy or Drug Store. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None medical history. Concomitant medication included omeprazole, fexofenadine hydrochloride (ALLEGRA). The patient experienced achy right arm (site of injection) about 12 hours after injection on 13Feb2021 21:30; achy muscles all over body about 16 hours after injection on 13Feb2021. Pain was relieved by taking two naproxen tablets. The outcome of events was recovered in Feb2021. The events were reported as non-serious.
About 2 weeks after injection I had joint pain, stiffness, weakness, physical fatigue, abdominal pain, depression, nausea, muscle and nerve pain, raised liver enzymes, limited range of motion in knees, elbows, fingers and wrists. I had to cut my work schedule down to cope.  Treatment included medication: gabapentin, opiods, antidepressants, Nsaids, possibly infusion of benlysta, plaquenil. Lots of diagnostics testing that have taken time out of being able to work.  No diagnoses have been formally made, but they speculate on PCOS as well as fibromyalgia, RA, lupus, Autoimmune hepatitis, myocitis/dermatomyosis, liver disease, etc.
Itching and swelling of right hand. Erythema. Began about 30 minutes after injection and lasted through the night, decreasing in intensity but still itching through the next night.
vaccine expiration date is 11/30/2021, however, the use by date was 8/31/2021 @ 8pm - the injection was administered at 9/1/2021 @ 1106am.  from that vial. Supervisor, medical director, director of pharmacy, and patient were all notified of the event. the patient denied any adverse reactions at this time. According to the ACIP, the patient will return to the health center within the next two days for a repeat injection.
Moderna COVID?19 Vaccine EUA. Tinnitus. Not sure exactly when it began. It was not present before the vaccination (December) and have noticed it has been constant for at least the last month.
I do not know for sure if it was shingrix or zostavax, but it was the shingles vaccine, second dose. Any my eyes especially my left eye has what looks like lightening fashes on the side of my eye and it is not sore, but there are these lightening flashes it has been going on all night and this morning also. My right eye so far doesnt seem to have it, but both look red. I did contact my dr and the nurse told me it was an ocular migraine. I have not ever had migraines, and I do not have any kind of head ache. Just my eye is weird with these flashes of lightening in it.  I received my second dose vaccine around 10 am on 1/7/2021, then about 2-3 pm, i started to get these lightening flashes in my eyes.  Thankyou
I started having a sharp, shooting pain in my left armpit about 3 hours after receiving the vaccination. The pain would happen every few minutes, then increased to constant pain by about 9:30pm. I took tylenol and started using an icepack at about midnight to be able to sleep. The pain decreased enough to sleep from about 3am to 10am. The pain has continued to be constant since Friday evening with tylenol and ice helping enough to let me sleep.
Vaccination site warmth; injection site became hard; very itchy; "at the injection site just a little redness, a little swelling and the muscle sore"; very swollen; Muscle soreness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA ("at the injection site just a little redness, a little swelling and the muscle sore") and VACCINATION SITE SWELLING (very swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026I20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA ("at the injection site just a little redness, a little swelling and the muscle sore"), VACCINATION SITE SWELLING (very swollen) and MYALGIA (Muscle soreness). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (injection site became hard) and VACCINATION SITE PRURITUS (very itchy). The patient was treated with CORTISONE (topical) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA ("at the injection site just a little redness, a little swelling and the muscle sore"), VACCINATION SITE SWELLING (very swollen) and MYALGIA (Muscle soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included for high blood pressure medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fatigue set in, after 6 hours, chronic pain in the right arm/shot location that drastically affected sleeping ability, At 18 hours or so, achy, pains, headache, fatigue, loss of appetite - very flu-like symptoms, until about 3pm (24 hours after) At 32 hours or so, extreme fatigue set in Right arm pain (though less) still evident, some 48 hours after
Patient experienced hives all over her body. Described them as red, raised, and itchy. She said she started to get hives the day after she rec'd her flu shot. She started to take Zyrtec in the morning and Benadryl in the evening. She says she still gets itchy. Patient also stated she rec'd her 3rd Pfizer shot on 8/30/21 and is uncertain whether they are related.
Patient 4:  given dose >12hrs post vial puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient 4:  given dose >12hrs post vial puncture.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, DILTIAZEM HYDROCHLORIDE (DILTIAZEM XR), ATORVASTATIN, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), GABAPENTIN, CYCLOBENZAPRINE, VITAMIN D3, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FAMOTIDINE, ALBUTEROL [SALBUTAMOL], CHLORTHALIDONE, KCL, ONDANSETRON (ZOFRAN [ONDANSETRON]) and LISINOPRIL for an unknown indication.    On 30-Nov-2021 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient 4:  given dose >12hrs post vial puncture.). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient 4:  given dose >12hrs post vial puncture.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided.  It was reported that vial was opened on 19-Nov-2021 at 11:29 AM and storage condition from 19-Nov-2021 to 30-Nov-2021 was unknown.   This case was linked to MOD-2021-407133, MOD-2021-407134, MOD-2021-407056, MOD-2021-406232 (Patient Link).
Red, itchy, hives, soreness, hardness at injection site. Lasted 2-3 days
rash on face, neck & chest w/low grade fever 3-6 days p/flu inject; sores in mouth resembling thrush w/peeling skin in mouth; swollen lymph nodes; gained 7 lbs about 8-10 days p/shot;
Patient had fever on 7/1/22. Rash, swelling and itching since 7/1/22 for 3 days
Pt devel bronchitis several days following immun w/pneumococcal vax; treated w/Cortisone; required hospitalization for 2 wks;
trouble breathing 915PM shot recv @ 5PM face became blue & then ashen, unresponsive, lethargic;rushed to hosp-given 02 on way;
Had varicella vaccine in (R) deltoid on 01-24-2012 and within 6 hrs. Had large red area at site - called & evaluated in clinic. On 01-27-2012 with 10 cm red area with mild edema & tenderness at site.
pain in her arm; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "she is allergic to Aspirin". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "not recovered", described as "pain in her arm". The event "pain in her arm" required physician office visit.  Additional information: The patient received the vaccine 2 months ago. Since she got the vaccine, she had pain in her arm and it doesn't go away. She wanted to know recommendations for arm pain that has not gone away since she got the Pfizer Biontech COVID-19 bivalent vaccine two months ago. She went to an orthopedist, and he prescribed naproxen but the patient referred she was afraid to take it since she was allergic to Aspirin.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Member reported with concern due to break out from sweating, he has two satellites one is located just below the original site, the other one is on right elbow (Brachial area). All sites are being covered and member received additional care instructions to prevent any further sites. Member instructed to follow up if any additional sites appear or if symptoms become worse.
RECURRENT COLD SORES (AROUND, TOP AND BOTTOM OF LIPS AND SIDE OF TONGUE); SPLITTING OF THE LIPS; BITING OF THE TONGUE; BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 165 pounds, and height was 64 inches. The patient's concurrent conditions included: neuropathic pain, social alcohol drinker, and non smoker, and other pre-existing medical conditions included: No known allergies. 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 30-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for neuropathic pain, cyanocobalamin for neuropathic pain, ergocalciferol for neuropathic pain, and pregabalin for neuropathic pain. On 31-AUG-2021, the patient experienced recurrent cold sores (around, top and bottom of lips and side of tongue). On 31-AUG-2021, the patient experienced splitting of the lips. On 31-AUG-2021, the patient experienced biting of the tongue. On 31-AUG-2021, the patient experienced body aches. On 31-AUG-2021, the patient experienced chills. On 31-AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 07-SEP-2021, and had not recovered from recurrent cold sores (around, top and bottom of lips and side of tongue), splitting of the lips, and biting of the tongue. This report was non-serious.
Date of symptom onset: 05/08/21   New cough, New sore throat
A report has been received from a Pharmacist concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, Once/Single administration. FLUMIST Quadrivalent (Intranasal) started on 11-Feb-2016. The reporter stated patient inadvertent expired product administration which started on 11-Feb-2016. FLUMIST Quadrivalent (Intranasal) was discontinued on 11-Feb-2016. The outcome of inadvertent expired product administration is unknown. The report was considered to be non-serious.