chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child given appropriate flu dose but current flu vial (by Novartis) licensed only for 4 yrs of age & above. Previous multidose vial licensed for age 3 yrs & above.
severe pain in right arm, threw up, headache dizzy shakes, sweats, rash and swelling on both legs difficult to concentrate balance is off
3 day migraine, aches, hives all over body that keep coming back even on prednisone. Swollen hands and lips.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: 5 min post vaccine pt stated she felt hot all over.  Gave her a cold bottle of water.  10 min post vaccine pt stated she felt like her heart was beating rapidly.  Gave her Benadryl and told her she would have to wait 30 minutes.  20 min post vaccine pt said she felt her chest was getting tight.  I called EMS and was about to administer Epiephrine but they arrived before I gave it.  They examined her and ask if she wanted to go to the hospital to be seen by doctor.  Pt ok today 9/26/21
Child had tonic-clonic seizure a few hours after vaccination. Doctor was notified night of seizure and child was taken to doctor the following day. Seizure not relatd to fever. No diagnosed seizure disorder and no prior seizures or seizures since.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # K007980, expiry date: 03-JUN-2016 and lot# L003777, expiry date of 04-FEB-2017). No adverse effects were reported. Additional information has been requested.
About 1 month afters second dose, each time I ran the comb through my hair I would have hundreds of hair in the comb. The root/folicle  of the hair had a bulge that appeared to be cut off. All hair had the same physical profile, like it was cut off inside the folicle.
Received the Moderna Vaccine (Lot# 025L20A) on 1/11/21. 1/13/2021 had swelling and pain to my left upper arm near and around site of injection. The swelled area was the the whole with of my arm. The injection site was also warm to the touch with some itching associated. On 1/14-16/2021 I had extreme exhaustion including irritability. On 1/17/2021 woke up feeling good, the arm pain went away and had no other symptoms. On 1/18/2021 at night I noticed a bump feeling like a cyst at the cite of injection and the itch reappeared. 1/19/2021 around 11am I visited a health clinic to show them my arm after asking fellow colleagues if any of them had the same reaction. At the health clinic we looked at the injection site and there was a red rash covering part of my upper arm and the nurse looked closer and said she saw puss granulars.'
flu; administered 2 vaccines to a pregnant patient, Flublok and Adacel with no reported adverse event; Initial information was received on 17-Feb-2021 regarding an unsolicited valid non-serious case from a pharmacist (Inquiry Number: 00479816).  This case involves a 28-year-old female patient who experienced flu and administered 2 vaccines to a pregnant patient, flublok and adacel, while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Batch number: UJ448AB, Expiry date: 22-Mar-2021). The event occurred at unknown gestation period.  Data regarding this pregnancy were received prospectively for example before pregnancy outcome was known.   The date of last menstrual period was not reported.  The estimated due date is 05-Apr-2021.  Gestation period at onset was unknown.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL).  It was a case of vaccine exposure during pregnancy as patient was pregnant when she received vaccine.  Relevant prenatal testing after exposure was not reported.  At the time of reporting, the patient experienced flu and the event outcome is unknown.
3SEP94 10PM PC from om to MD pt recvd vax 2SEP94 & now has welts, sl pruritic; mom has Atarax home instructed to give 1/2 tsp q 6 hrs;
sore arm; Initial information received on 12-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (Patient) via social media.  This case involves a patient of unknown demography who developed sore arm (Pain in extremity), while she received vaccine INFLUENZA VACCINE.  On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.   On an unknown date (unknown latency), the patient got INFLUENZA VACCINE and patient developed sore arm (Pain in extremity),  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Deep, aching pain in upper right arm (area where vaccine was administered), some days worse than others. Still present after 3 months.
Pt presented to the ER on 6/21/07 with c/o weakness, HA, rights sided pain and elevated temperature. Temp at time of visit 103. Admitted to the hospital for IV fluids and evaluation. Admitting diagnoses included febrile illness, probable viral, possible heat syndrome and possible small pox reaction. D/c'd on 6/26/07 from hospital with diagnoses of pneumonia.  07/17/2007 MR received for 3 night admit for initial c/o generalized weakness, malaise and sore throat. One episode of vomiting and R sided abd pain, fever, chills, SOB as well.  Pt developed hemoptysis during hospitalization.  DX: Right middle lobe pneumonia
I have a cold sore; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer First Connect.  A female consumer of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at single dose for COVID-19 immunisation. Medical history included cold sores (treated with VALTREX). Past drug history included VALTREX for cold sores. The consumer inquired regarding medication to take over because she took the vaccine. So, the consumer was calling because she had the Covid vaccine on Wednesday (as reported) and developed cold sores and she said she normally took VALTREX and she wanted to know if it was still safe to take VALTREX after receiving the vaccine (she wanted to make sure it was not going to compromise the efficacy of the vaccine). The outcome of the event was unknown. Information on the lot/batch number has been requested.
Hashimoto's autoimmune disease; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimoto's autoimmune disease) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Thyroid disorder NOS.    In November 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE THYROIDITIS (Hashimoto's autoimmune disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE THYROIDITIS (Hashimoto's autoimmune disease) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient stated that she had Hashimoto's Autoimmune Disease and she's taking Thyroid Synergy, a non-FDA approved supplement for her thyroid problem. She's also taking gluten free diet. The problem had been there all along even before she took the 1st Moderna dose, but the diagnosis of Hashimoto's autoimmune disease was only made this year.  Company Comment This spontaneous case concerns an female patient of unknown age with medical history of Thyroid disorder who experienced the seriousness criteria medically significant unexpected AESI of autoimmune thyroiditis unknown days after MODERNA COVID-19 VACCINE, BIVALENT ORIGINAL AND OMICRON BA.4/BA.5 vaccine. The problem had been there even before she took the 1st Moderna dose, but the diagnosis of Hashimoto's autoimmune disease was only made this year. The medical history is a confounder for the event. The benefit-risk relationship of MODERNA COVID-19 VACCINE, BIVALENT ORIGINAL AND OMICRON BA.4/BA.5 vaccine is not affected by this report.
02/15/2022 Mother presented to office and spoke with Dr. regarding patient's death and her concern regarding death being related to prior vaccination.    According to hospital May 2018 medical records,  the patient was pronounced brain dead by both Dr.'s at Hospital with accordance to the Statutes. Cause of death was no brain function as a result of Hypoxic Brain injury suffered during the out of the hospital cardiorespiratory arrest.
It looks like my arm was burnt because it is all black; Itching all over the arm; Rash started to get bigger and covered whole arm; Little red spot at injection site; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (It looks like my arm was burnt because it is all black), PRURITUS (Itching all over the arm), RASH (Rash started to get bigger and covered whole arm), INJECTION SITE ERYTHEMA (Little red spot at injection site) and INJECTION SITE RASH (rash at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20H) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Little red spot at injection site) and INJECTION SITE RASH (rash at injection site). On 22-Feb-2021, the patient experienced PRURITUS (Itching all over the arm) and RASH (Rash started to get bigger and covered whole arm). On an unknown date, the patient experienced SKIN DISCOLOURATION (It looks like my arm was burnt because it is all black). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, SKIN DISCOLOURATION (It looks like my arm was burnt because it is all black), PRURITUS (Itching all over the arm), RASH (Rash started to get bigger and covered whole arm), INJECTION SITE ERYTHEMA (Little red spot at injection site) and INJECTION SITE RASH (rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that after receiving vaccine, on 15-Feb-2021 the patient had rash, little red spot on arm at injection site. It started to get bigger on 22-Feb-2021 and it covered whole arm. She also said that it was itching all over the arm. She said that she was given steroids and diphenhydramine (Benadryl) by her HCP. She said it was better now but it was looking like her arm was burnt because it was all black. She mentioned that her doctor asked her to not to get second shot. According to the patient, she was not taking concomitant medication.
High fever, body aches, muscle aches, fatigue - -  rest,  tylenol
Patient tested with rapid test on 12/19/2021 because mother is symptomatic and positive for COVID-19. Patient has no symptoms but tested positive.
Nurse accidentally administered another dose; Wrong vaccine administered; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.  Additional details were provided as follows: The patient recieved Boostrix and patient returned 4 weeks later to get Meningitis ACYW vaccine.  The nurse accidentally administered another dose of Boostrix, which led to extra dose administered and wrong vaccine administered. The patient and his mother were notified immediately after Boostrix dose of the mistake and monitored for adverse events. The incident was reported into the medical group community care physicians legal department as the mother was very upset and said they ruined her son.
A few days after getting the vaccine, we had bad wind storm come in and I was without power for about a week. I was unable to shower and could not see my arm good. Around the 22nd I went over to my granddaughter's home to shower and noticed that my bicep was black, over the next week it spread to the left breast, collarbone to the elbow.  The where the shot there is about a mark on the muscle where I got the shot. On 28th of January, I went to see my doctor, my shoulder was swollen and I could not raise my arm to about my shoulder level. When I try to move I could feel a pain up there. Doctor put ice on it and told me to take Aleve. Since the swelling has went down I am no longer putting ice on it, I am not using heat. I tried to put my arm in  a sling but it is painful. The other pain I feel no pain in my arm is I sit on the couch and put my arm straight out and do not move. The black area on the bicep is almost gone, the darkened area up by my collarbone went away, most of the darkened area is on my left breast. If I rotate my arm counter clockwise or clockwise there is pain there and it feels like it is stretching the muscle. I have also seen Doctor on the 2nd or 4th of this month. I am thinking of going to see him again this week. My doctor thinks that the person who gave me the vaccine, hit a blood vessel and that is what caused the blackness on my arm. The pain is mainly in the collarbone area and in the bicep.   Before this started, about the first of January I came home and  went to put my keys up and went to reach up  and had some pain in my arm, but the pain and mobility issues both went away before receiving the vaccine.
left arm is sore; slight bruise at the injection site; injection site bleed, It looked like a hematoma; ballooned up a bit, made a raised knot, was a small ball; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm is sore), VACCINATION SITE BRUISING (slight bruise at the injection site), VACCINATION SITE HAEMORRHAGE (injection site bleed, It looked like a hematoma) and VACCINATION SITE SWELLING (ballooned up a bit, made a raised knot, was a small ball) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 041L20A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (injection site bleed, It looked like a hematoma) and VACCINATION SITE SWELLING (ballooned up a bit, made a raised knot, was a small ball). On 02-Nov-2021, the patient experienced PAIN IN EXTREMITY (left arm is sore) and VACCINATION SITE BRUISING (slight bruise at the injection site). On 01-Nov-2021, VACCINATION SITE HAEMORRHAGE (injection site bleed, It looked like a hematoma) and VACCINATION SITE SWELLING (ballooned up a bit, made a raised knot, was a small ball) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm is sore) and VACCINATION SITE BRUISING (slight bruise at the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
This case was reported by a nurse and described the occurrence of swelling injection site in an 18 month old female subject who was vaccinated with Infanrix for prophylaxis. On 8/4/05, the subject received the 4th dose of Infanrix in the left thigh (lot AC14B002AA). On 8/9/05, 5 days after vaccination with Infanrix, the subject experienced injection site swelling. The subject was treated with ibuprofen and warm compress. The events resolved on an unspecified date on or after August 2005 and on or before 8/15/05. The nurse considered the events to possibly be related to vaccination with Infanrix.
diarrhea; bad bowel; This is a spontaneous report from a contactable consumer or other non-health care professional reported for a patient (son) and report received from a Pfizer sponsored program. A 40-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 12Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea and had a bad bowel for 3 days on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Death. Doubt any relationship other than temporal. Cause of death given as cardio-pulmonary arrest.
weakness, nausea, vomiting, shortness of breath, diarrhea, muscle aches  concern about antibody-dependent enhancement
Pt brought to the ER with SVT.  He was given 2 doses of adenosine by EMT's.  Pt was found to have hypomagnesemia and hypophosphatemia in the ER.  He was admitted for observation and evaluated by Cardiology. He remained stable with NSR during admission.  Pt has a follow up appt with Cardiology EP clinic on 2/18/21.
This spontaneous report as received from a health professional (manufacturer control number 58348) refers to an elderly female patient of unknown age (over 65 years old). The patient did not have any known allergies. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route not reported, lot # K005797, expiration date 21-MAR-2015, or lot# reported as K07773, expiration date 01-MAY-2015). Concomitant medications were not provided. On 18-AUG-2014 the patient experienced redness, fever in the area upper arm and itching in the area from the last two vials of pneumonia vaccine. After a couple of days it went away on its own and the patient was okay. The healthcare worker stated the office already disposed one of the lost numbers that was used that was causing the issue lot # K005797. This is one of four reports received from the same reporter. Additional information has been requested.
patient received the Fluzone quadrivalent (prefilled) instead of the Fluzone HDQ with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received the influenza quadrival A-B vaccine [fluzone quadrivalent] instead of the  influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT8129JA, Expiry date: 30-Jun-2024 with unknown strength) via unknown route in unknown administration site as immunization instead of influenza quadrival A-B high dose HV vaccine with no reported adverse event (wrong product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
High fever, hypotension, tachycardia, lethargy, major swelling and redness at injection site.
new lot / was administered / asking to know if they could continue using that lot of vaccines; 3 out of 18 patients fainted; This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   In August 2021, the patient received Menveo. In August 2021, less than a week after receiving Menveo, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fainting and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the fainting to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called to report, a new lot of Menveo was administered to 18 patients since 2nd August 2021. The patient fainted after receiving the Menveo vaccine.  The health care professional called on behalf of a nurse manager who was asking to know if they could continue using that lot of vaccines.  The health care professional who made the call did not have any patient's demographics information nor vaccine information. Follow-up was not asked because the health care professional who reported the event did not have any information. On 5th August 2021, call back to nurse manager, but she was not available.  As per the judgment there has to be a PQC associated, for that the health care professional was transferred to the GRC, but not sure if they collected it, because the agent said it was not, and afterwards she took the call. The data in health care professional detail was from the nurse manager who has all the information on the event. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167017:Same reporter US-GLAXOSMITHKLINE-US2021AMR167724:Same reporter
First shot before getting ill felt high and very happy. Then any movement nausea with vomiting for 5 days with migraine - recovered Second shot pinched nerve in shorter and my whole right side was weak for a month to the point disable on a cane - recovered Third shot a cough emerge on deep breaths or any inhale. I still have the cough not recovered