chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 86-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dementia with Lewy bodies. On 28th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced localized erythema, pain and skin warm. On an unknown date, the outcome of the localized erythema, pain and skin warm were not recovered/not resolved. It was unknown if the reporter considered the localized erythema, pain and skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. About 2 to 3 inches below the injection site was red covering 3 inches in circumference. It was warm and painful to touch. The patient was currently in a assisted living. The reporter had contacted her doctor for advice and was waiting to hear back. The reporter consented to follow up.
First day:  Exhausted, muscle aches, headache, shivering, fever   Second day:  Nausea
One week after 2nd vaccine, Friday 2/19, woke up with my right eyelid red, swollen, itchy, discharge. Saw eye doctor, OD., whom I work for. She diagnosed "Swollen sub-mandibular & pre-auricular lymphatic nodes."  I am being treated with: 1) Erythromycin Ophth Oint 3.5GM 2) Prednisolone AC 1% Ophth Susp 5ML 3) Pataday  Doctor believes that my viral infection might be a result of the Covid 19 vaccine, and gives assurance that her treatment will resolve issues. She is unsure whether, or not, I am considered contagious during this time? Inquiries at the college were unfruitful.   I hope my reporting this is not a violation in any way. Many thanks.
Patient returned three days after vaccination complaining of fatigue, rash on back. Presentation similar to shingles. Recommended she see doctor. Patient seen by doctor on 09/4/09 and prescribed medication for shingles. Onset appears coinadental.
within 5 minutes of patient receiving 2nd dose she began coughing and subsequently vomited.  she stated she was nauseous and light headed with a developing headache.  we offered to call rescue and patient declined.  she had no other symptoms and a family member picked up patient to take her home.  she was advised to hydrate, take tylenol if  needed, some flat ginger-ale for the nausea and to rest for the rest of the day.  upon follow-up the next morning, patient stated she still was nauseous  and with a headache.
Approximately one and one half hour after my injection, I experienced moderate chest pains that lasted approximately 3 - 5 minutes. I have never had chest pains prior to this event. The chest pains subsided and they have not recurred.
1 week and 10 hours after I received the vaccine, my left arm got red and swollen at, and around the injection site.  I'm not sure if it was from the vaccine, but wanted to report it.  Swelling started to recede after 24 hours, but still a little swollen and red 1.5 days after I first noticed it.
nausea, vomiting, arm swelling, fever, chills, full body aches, diarrhea--from 5:30PM-5AM; loss of appetite, body aches, and arm swelling continue.  I have had similar reactions within the first ~12 hours following the first three doses of the Moderna covid-19 vaccine, but this was the most severe in terms of vomiting and diarrhea.  Primary care provider was unavailable to see me today, but the pharmacist advised that I report this event.
Patient received Fluzone HD which is only indicated for 65 years and older and the patient is only 27 years old
Left thigh approximately 8cm area marked w/ erythema approximately 6cm. Tender to palpation. Ambulating. No fever. Local reaction.
Welts coming and going all over body; next day and day after (today). Also had with 2nd set of immunizations at another provider 7-13-07 unknown to us.
Starting on 5/20/14 (day after shot) upper arm became very sore, red, swollen, warm to touch with swollen gland on same side (neck). On 5/22/14 woke in AM with 102.9 fever and general malaise.
pt recv vax; cried inconsolably for 4 hrs & fever of 104-105; would not walk for 2 days; skin was bright red;
Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster; Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster; Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster"; DISEASE RECURRENCE (medically significant) with onset Apr2023, outcome "unknown", described as "Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster". Additional information: Caller had COVID last Mar and Apr and she already had 2 shots of COVID vaccine and 2 shots of booster, she was told that she cannot take the new booster since she had COVID last Mar and Apr. she wanted to know if this is true. Caller mentioned she has received 2 COVID shots and 2 boosters. She had COVID on Apr and May this year and wanted to know if she can receive the new COVID vaccine formulation as she has had a previous COVID infection.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Tingling and numbness of arm of vaccine- than the other arm, dizziness, weakness, elevated heart rate, mouth trembling legs were shaky , feeling like I?m about to pass out with in 5 min. Of vaccine- later on felt tired and arm pain.  Felt ok / normal then 5 days later ears were popping , head felt fuzzy, heart rate went up, felt weakness, like I?m about to faint, slight vertigo, chills, tired, weak . From that episode I started to get headaches, head was fuzzy , ears ringing slightly, felt vertigo and a lot more weakness. Had to go home from work several times as I felt I was about to pass out along with feeling the vertigo.  Not feeling myself for a few weeks. Then, got my second shot on 4/26/2021. 20 min after the vaccine I had the same reaction and the first vaccine but it lasted 5 min only went home felt extremely exhausted had a head ache. Upset stomach. Super tired for the next day.  I?m still not feeling 100% but I have felt a little better after 2nd vaccine. My life style has changed a bit as I am not able to do that much.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. 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: 205AZ1A, expiry: UNKNOWN) .5 ml, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced confirmed covid-19 infection. On 08-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious. This report was associated with product quality complaint: 90000182110. The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the pqc evaluation/investigation performed. based on the PQC evaluation/investigation performed.
pt recvd hep B vax & devel severe low back pain, severe leg pain, minor bulging of annulus @ L3/L4 & L4/L5, loss of bladder function, neuropathic changes in L5 & S1; GBS, paralyzed fr waist down to feet;  acute sacroiliactic dysfunction;
Patient was given an expired Orange Cap vaccine a day after expiration. expired on 08/31/2022 was administered on 09/01/2022. Patient Mother made aware of the situation. Nurse contacted Pfizer for guidance still waiting a response from Pfizer. Patient waited in Lobby 20 minutes no s/s relating to vaccine occurred.
Experiencing symptoms consistent with SIRVA. Muscle aches and sharp pain in left shoulder that radiates to left arm, neck and center back.
Wart like eruption at injection site (L) thigh: DTaP, Varicella site.
Information has been received from an advanced registered nurse practitioner referring to a 54 year old female patient. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dosage and route not reported). The patient had shingles outbreak on calves after ZOSTAVAX subsided in 2 weeks. On an unknown date, the patient was hospitalized due to the event. The outcome of shingles was unknown. The causality of the event with ZOSTAVAX was not reported. Additional information has been requested.
Vaccinee was given a series of 3 Engerix-B vaccinations on 4DEC89 lot no. 585A4, 2JAN90 lot no 586A4, & 31MAY90 lot no 587A4; Serology testing on 22AUG90 showed that vaccinee failed to seroconvert.
I began a very heavy and long menstrual period after receiving my second dose of the COVID-19 vaccination. I began bleeding 4/7/2021 and didn't stop until 3 weeks after my endometrial ablation. The ablation was completed 5/11/2021 and the bleeding didn't stop completely until 6/2/2021. I had multiple CBC tests performed during this period of time and my HGB levels plummeted from 12.6 on 4/13/2021 to 8.4 on 5/14/2021. RBC count went from 4.48 on 4/13/2021 to 3.10 on 5/14/2021. I experienced severe anemia, was incredibly weak, missed multiple days of work, and required surgery to finally stop the bleeding.
Patient is a 22moM with no PMH here with diffuse rash after 2nd covid vaccine. Likely rash 2/2 immune response to vaccine but does not appear IgE mediated; no e/o hives, wheeze, or lip/tongue swelling.  - obs Reexamination/Reevaluation  Rash completely resolved without intervention. Most likely a rash 2/2 vaccine immune response. NOT c/w IgE mediated process. Remains well appearing ~2 hrs out with no wheeze or diff breathing. Safe for home.   Patient was stable for discharge home with outpatient follow-up. Family educated on the patient's condition, anticipatory guidance, and return precautions. All questions answered.
Td administered 25FEB93; no fever; pt reported swelling approx 2" @ inject drowsyness leading to h/a over the weekend; return to MD 2MAR93 w/swelling still present;
Pt had right sided chest pain x3 days starting 4/12/21, had a week of cough, fever, "general not feeling well" prior to ER admission 4/15/21.  Had CT scan in ER on 4/15/21 - per radiology report a clot and pneumonia noted in RUL of lung.  WBC count >22, elevated D Dimer, T Max in ER was 102.2. Was given PO Tylenol, 100mg Lovenox Subq, and IV antibiotics  and flown to hospital.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 24-JUN-2014, a pharmacist administered ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot number not provided). On or about 29-DEC-2016, the patient was treated by a healthcare professional for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Fever, chills, sweats, headache, body aches, brain fog. Beginning a few hours after 2nd vaccine and ending 72 hours later approx.
PT. STATE HEADACHE, DIARRHEA, RASH, AND FEVER FOR 1 DAY. PT. ALSO COMPLAIN OF MUSCLE ACHE
Information has been received from a registered nurse concerning an adult male patient who was vaccinated with a first dose of varicella virus vaccine live. Subsequently, about 15 days post vaccination, the patient developed a mild chickenpox rash on his trunk and neck with about 20 lesions. No other symptoms were noted. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a consumer refers to herself, a 63 year old female patient. The patient's medical history included trigeminal neuralgia. On 25-SEP-2013 the patient was vaccinated with ZOSTAVAX (transdermally in the under arm area", dose and lot number unknown) dose 1. No other suspect therapy was reported. The patient was using unspecified concomitant medication. The patient reported that the route of therapy by which ZOSTAVAX was administered to her was "transdermally in the under arm area". This is an other-than indicated route of administration for ZOSTAVAX. Since receiving ZOSTAVAX (onset date reported as 26-SEP-2013), the patient experienced that her arm is swollen around the injection site and she has developed "itchy spots" on the back of her arm. She stated that this area is red and tender and that new "itchy spots" seem to  appear each day. No treatment was given. The outcome of "itchy spots" on the back of her arm, arm swollen around injection site, area is tender and red was reported as recovering/resolving. The reporters relatedness of "itchy spots" on the back of her arm, arm swollen around injection site, area is tender and red to ZOSTAVAX is unknown. Additional information has been requested.
No adverse incident. Only half of prescribed dose was given (0.15mg instead of 0.3mg).  Prediluted vaccine was diluted with normal saline.
1. Dizzy 30 mins later 2. As if I was drugged 1 hour later 3. Not speaking coherent 1:40 hour later 4. Walking supported/leaning by a wall 2:00 hours later 5.  Could not walk alone and had involuntary movements 6. Dislodged jaw 7. Not standing by my self 9. Winking eyes and not able to open them 10. The left side was weaker than my right side
Chills; Shortness of breathe; Cough; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the arm on 07Oct2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On 08Oct2021, the patient experienced chills, shortness of breathe and cough. The events resulted in emergency room/department visit or urgent care. On 10Oct2021, the patient underwent nasal swab test for COVID-19 and the result was negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, shortness of breathe and cough was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that one dose of PROQUAD (dose, route of administration, lot # and expiration date were not provided) that was exposed to -12C for 2 hours, was administered, on 14-JUL-2014, to an unspecified patient. No adverse effect was reported. This is one several cases from the same source. Additional information has been requested.
Extreme  coldness,  uncontrollable shivering ,nausea,  heart beating rapidly, leg and arm movements painful. Lasting until early morning next day . Prayed alot, drink hot.lemon tea. After  chills subsides,  ate yogurt , drink  hot tea.
Fever of over 100 degrees for three days after administration. Blood in stool beginning lasted 7 days after administration of ROTATEQ. Blood in stool lasted for 5 days. Baby was very fussy and sleeping more.
Itching & tingling in face and neck, resolved with OTC Loratadine Flu like symptoms Woke up the next morning feeling totally normal
tested positive for COVID a week after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID a week after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID a week after the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID a week after the vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) positive.     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 medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
pt recv vax 22NOV95 & 19DEC96 pt devel chickenpox which appeared as 20 to 25 reds spots over body;subsequently the number of spots increased to 30 to 40 pt exp itching;
Fever, NauseaVomiting, arm pain, lethargic Narrative:
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old patient who did not get the full dose of first dose of vaccine PENTACEL (batch number, expiry date, dose, route and site of administration were not reported) as they got the liquid but not the powder on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to Vaccine under dose and Inappropriate reconstitution technique. It was not reported if the vaccine was administered or not. 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. Documents held by sender: none.
Varicella onset 09/27/2001. Rx Zovirax, Benadryl PO, topical calamine, fluids and Tylenol.
Fever -6 hours  24 hours other symptoms Headache Muscle aches  Extreme weakness Loss of balance  Nausea
severe vomiting, chills/sweating, dry heaves. Lasted about 15 hours, then it was gone just as fast as it started.
This is a spontaneous, non-serious report from a contactable consumer (patient). A 72-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL9265), at the age of 72, via an unspecified route of administration, on Feb 5, 2021, single dose, for COVID-19 immunisation. There were no concomitant medications or medical history. Caller inquired about the vaccine Pfizer COVID-19 vaccine. He got the shot on Feb 5, 2021. At the point of the injection site, the skin around that area was yellow. He wanted to know if that was normal, since that area was still yellow. After waiting 2 hours, he was hoping to have some answers. He said he has time to answer some questions. He confirmed he received the first dose Feb 5, 2021 and he receives the second dose Feb 26, 2021. He does not know when he noticed it was yellow. He did not pay much attention. He thought it might have been something they put on there. He did not think much about it, but it was still yellow now 2 weeks later. He said whatever was in the needle was what they gave. He will write down the number, but he doubted he would call back. He has been on hold for almost 3 hours now because he started trying to call around noon. He will see his doctor tomorrow. The outcome of the event: unknown. No follow-up attempts possible. No further information expected.
patient become very light headed and dizzy.  She became dizzy 1-2 minutes after the shingrix, but did state she has a history of passing out after vaccine administration.
Pt recv vax on 10/21/98; on same day pt exp headache, burning eyes, nausea, woozy; dx=conjunctivitis of both eyes
24 hours after receiving Quadracel immunization, Patient developed hives to chest, neck, and back and stomach ache. She developed a temperature of 103 degrees F. No breathing trouble or vomiting. Mother gave Epi Pen Jr and Benadryl 1 teaspoon by mouth and took the child to the Hospital ER. In the ER Patient was given Prednisolone 15 mg orally and Acetaminophen 233 mg orally. Hives , stomach ache, and fever diminished and child stated feeling better. 1 teaspoon of Benadryl was given. Patient discharged after 2 reassessments were done by the ER doctor. Discharge medication was Orapred 15mg/5ml oral liquid, 5 ml daily for 5 days.
pt recv vax 16OCT97 & exp pain, puffiness & bright redness @ inj site p/vax;states shot hurt a lot when got it, pain;pain & redness have lessened; 1/2" by 3" red streaks;dx cellulitis;tenderness;
Vaccine td administered 04/01/04 in afternoon. Pt telephoned clinic 04-02-04 afternoon and complained of upset stomach, mild fever and malaise. Upset because of need to leave work due to not feeling well; suspects "bad vaccine."  Plans to go home and rest (TC from cell phone while client driving home from work).