chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 13-AUG-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. In 2010, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
a few aches and pains; he had a headache; This is a spontaneous report from a contactable consumer (parent). A 55-year-old male patient (son) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After received the 2nd dose, the patient experienced a few aches and pains and had a headache on an unspecified date. Patient's wife reported that can my husband get the COVID vaccine (probably by Moderna) if he's taking Xeljanz. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
patients were administered improperly stored doses; no adverse effect; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown.  On 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R024022 and expiration date 22-AUG-2019 for prophylaxis (dose, strength, frequency and route of administration were unknown).    The patient experienced no adverse effects. It was reported that the vaccine was stored at a temperature of -9C to 8C (1C) during a time frame of 1 hour, 44 minutes. The vaccine had not experienced previous temperature excursions. Digital data logger was involved.; Sender's Comments:  US-009507513-1904USA010118: US-009507513-1904USA009984:
PATIENT HAD ALL 3 IMMUNIZATIONS ON THE SAME DAY 09/26/2019. HER LEFT ARM HAD BEEN IN PAIN AFTER THE IMMUNIZATIONS. SHE TRIED IBUPROFEN AND COLD/HEAT COMPRESS WITHOUT RELIEF. SHE WENT TO ER ON 10/07/2019 DUE TO THE PAIN.  ALFURIA QUAD AND BOOSTRIX WAS GIVEN ON LEFT ARM. HAVRIX WAS GIVEN ON RIGHT ARM. ER DISCHARGED HER WITH RX ON IBUPROFEN AND TRAMADOL.
this patient was given afluria which is only to be give to 18 and older. No reaction to vaccine.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received dose of shingrix a few months ago. The health care professional reported that, within 1 week after vaccination with dose of Shingrix, the patient developed a case of shingles. The health care professional did not provide the patient details or original vaccination date and stated that, it was a few months ago.
After pt was vaccinated, he was still sitting in a chair when suddenly he arched his back into a plank position, twitched and lost consciousness. After a few seconds he came to with no other effects. Mother recognized this as him fainting.
Achiness; Small fever; A spontaneous report was received from a Consumer concerning a 67-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced achiness and small fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the events achiness and small fever.Treatment details included Advil.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) achiness and small fever were unknown.
Large red swollen area on arm were vaccine was given. Redness and area increased the next 3 days after vaccine given, had some blister patches and then itched for 4 days.
red area at the injection site; felt out of sorts; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt out of sorts), INJECTION SITE ERYTHEMA (red area at the injection site) and INJECTION SITE PAIN (soreness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection site). On 25-Mar-2021, the patient experienced FEELING ABNORMAL (felt out of sorts). On 28-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (red area at the injection site). At the time of the report, FEELING ABNORMAL (felt out of sorts), INJECTION SITE ERYTHEMA (red area at the injection site) and INJECTION SITE PAIN (soreness at the injection site) outcome was unknown.            Action taken with mRNA-1273 was not applicable. No concomitant medication was reported. No treatment information was provided.
Dizziness and syncope; required IV fluids and hospital observation.  Fully recovered.
Shrieking, crying inconsolably, not sleeping lasting 72 hrs, onset w/in 48hrs of inject; Seen on 8FEB90 essentially normal exam; 2nd DTP, no problems w/1st; Only child, no allergies;
Red, swollen, itchy patch, like a big hive, 10 days after vaccination.
(1)  Metallic taste in mouth starting 5 minutes after injection; no treatment; return to normal next day. (2)  Tightness/felt swollen in right hand and fingers with prickly sensations occurring intermittently sometings radiating to forearm starting next day; no treatment; continuing as of 17 Apr 2021.
A non-serious spontaneous report of influenza and vomiting was received from a consumer concerning a seven-year-old male, subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 17-Aug-2009.  On 13-Sep-2009, the patient developed fever of 100.8.  On 14-Sep-2009, temperature was 103.  The patient also experienced some coughing, sneezing, with some congestion.  On 14-Sep-2009, the patient tested positive for Influenza A and seemed tired.  The patient was treated with oseltamivir, which resulted in vomiting.  Outcome and causality were not reported.
Showed symptoms of Covid; Showed symptoms of Covid; Showed symptoms of Covid and was really sick for 36 hours; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 57-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 17Sep2021 (at the age of 57-year-old) (Batch/Lot Number: 30130BA) as dose 1, single for covid-19 immunisation at a clinic. Medical history included none. The patient's concomitant medications were not reported. Patient previously took tetanus shot on an unspecified date in Aug2021 and states that he experienced events which was described as he had nausea, and a super, super sore arm for from that.The patient received the Moderna shot as the second dose. On 01Oct2021 the patient experienced symptoms of covid. Where the patient states that he got Covid between the 2 shots, stating that he got Covid on 01Oct2021. When attempting to clarify if 01Oct2021 was the date he had a positive test result for Covid, the patient states that he does not have a positive test result. He states that his wife has positive test results for Covid and that he showed symptoms and was really sick for 36 hours. Then, he was fine. It was also reported that family medical history was none.He just got it pumped into him about 15 minutes ago, well, He is really freaked out, they put the wrong crap in him and he wants to get it out. He is just really upset and is freaking out. He has had 2 Covid vaccines but because they are 2 different vaccines, he still can't go anywhere. Outcome of all the events was recovered on an unspecified date in Oct2021.   Follow-up attempts are completed. No further information is expected.
On June 14, 2022, I took 2 amoxicillin pills before my dentist's office visit for cleaning.  In the past I have never had a reaction to this antibiotic.  While driving to the dentist I began to have itching and burning in my hands.  I took a Benadryl.  Then it started in my feet.  I went to the pharmacy to get an EpiPen.  My heart rate was elevated.  They called 911.  EMT's  began administering medications to help and monitoring my heart.  I rode in the ambulance to the ER.  They gave me an IV with epinephrine.  My arms and legs were beginning to swell.  I did not go into cardiac arrest this time.  I stayed for a few hours and was monitored.  In essence, since first booster and second booster I have now become allergic to Keflex and Amoxicillin and it can cause cardiac arrest.
9-25-07 given MMR vaccine after delivery (child birth) 1 1/2 weeks later developed cold symptoms by the end of two weeks had sever arthritic pain in joints, to the point that I could not walk or hold my baby. Lasted approx. 6 days. Now mild to moderate, pain only. Also has shooting pain in (Rt) leg and arm and chest
back pain, couldn't stand up straight, hurt to walk or sit.  was in bed for a 2 days.  I was prescribed PT, a muscle relaxant, and ibprofen 600.  I'm not sure if this is vaccine related.  I've also had swollen lymph nodes, and a hurt knee...I had some back pain before but nothing where I couldn't get out of bed.  I'm getting my lymph nodes and knee checked out next wk
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (administration of an expired vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (administration of an expired vaccine). At the time of the report, administered expired product (administration of an expired vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received an expired dose. This case linked to MOD-2021-369083 (patient link).
Patient went pale, eyes were dilated, and was unresponsive. Emergency protocol was immediately enacted.
COVID-19 Vaccine EUA Nausea and vomiting, dizziness, fever through the night
Information has been received from a licensed practical nurse (L.P.R.) concerning a 9 month old patient who on 17-FEB-2009 was inadvertently given orally a partial dose of ROTATEQ (lot # 663144/1449X).  Nurse realized that the patient was too old and retracted most of the dose.  The patient sought medical attention as physician's office.  No adverse effects were reported.  Additional information has been requested.
Systemic: Dizziness/Lightheadness-Mild, Additional Details: Patient got very dizzy and lightheaded, RN caught the patient before he hit his head on the floor. He did not lose consciousness and recovered himself about 5 minutes after laying on the floor. His blood pressure was 132/74 (stated his blood pressure usually runs on the higher side) and pulse 51. Patient stated he usually faints after vaccine administrations. After monitoring patient for about 20 minutes he was adamant he was okay and wanted to leave.
Patient stated that the swelling at the injection site became progressive worse by the second day post vaccine. She developed a 1.5 inch red wheal that was itching and throbbing. 3/4 of the wheal was very hard. She states that she also developed hoarseness. She states that she started taking Benadryl on the evening of 11/24/13 and has continued to take it each night. The swelling at the site and the hoarseness had decreased but has not completely resolved.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN INC-22-0039643-SR-01 (RA), US-AMGEN-USASP2022023116 (RA). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation; etanercept (ENBREL) (Batch/Lot number: unknown) for product used for unknown indication. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "when she got the COVID-19 vaccine, the Enbrel stopped working". The action taken for etanercept was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
damed sick/happened twice in a row; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who had got damed sick/happened twice in a row (illness), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.    On an unknown date, eight years ago, unspecified time after receiving the vaccine, it was reported that the patient had got damed sick/happened twice in a row (illness).   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.      The reporter assessed the causal relationship with suspect vaccine as related.
Right foot numbness grew to right foot,ankle, and leg numbness. Currently have a foot drop making it difficult to walk or even move my right foot. Neurologist says i have ?unexplained? nerve damage in right leg and it is irreversible. Usually caused by an injury he said or in elderly adults. Said it was unusual that my lower right leg just went numb and lost function at 25 years old. This began 3 days after  getting my 2nd dose.
she has cancer; Covid illness; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant) and covid-19. The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the cancer was not recovered/not resolved and the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the cancer and covid-19 to be related to Shingrix.   Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine 2 years ago from reporting date and due to Covid illness she could not receive 2nd dose. The pharmacist would like to know how to proceed with this patient as the patient was probably receiving chemotherapy because she had cancer.  The reporter need time to check patient´s condition and personal details.  The reporter consented to follow-up. For tolerance of second dose refer linked case US2021AMR237320, reported by the same reporter. Note: The event cancer was conservatively captured as it was not clear if the patient got cancer before or after the Shingrix vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR237320:same reporter
4 hrs p/vax had temp of 104 ax; pt was given APAP which promptly vomited; seen by MD rx for APAP suppositories  given;
Ears - warm, Nasal cavity - tingling, Eyes - tingling / fuzziness, Throat - slight swelling sensation, overwhelming feeling of something not right.
Within approximately 48 hours after the patient had her third Hepatitis B, developed excruciating pain in jaw on the left side. Left gum line developed yellow puss. Took Ibuprofen and used oragel swabs for pain.
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. The nurse lives with the family. The patient used no concomitant medication and had no known drug reactions or allergies. On 29-OCT-2013 the pati3ent was vaccinated with GARDASIL lot # 0636AE, expiry date 09-JAN-2015, dose 3, intramuscularly in the right deltoid. No information was provided with regards to the first and second dose of GARDASIL. On 30-OCT-2013 within 24 hours after vaccination the patient experienced fever of 102F. The fever of 102F persisted through the evening but resolved in the morning of 31-OCT-2013. No treatment was provided. The outcome of fever of 102F was reported as recovered/resolved. No action taken with GARDASIL was reported. Additional information has been requested.
Symptoms: hives on left leg very swollen Time; 4 days after 2nd vaccination Treatment; pt has been taking Benadryl and using hydrocortisone cream   Outcome: Hives healing but taking longer, has been there for about 11 days
harsh pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The age at vaccination was not reported. The patient experienced harsh pain and asked what was good for Shingles shot.
no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 16-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Vaccine administration error: Pfizer covid-19 vaccine administered to patient was more than 6 hours old.  It was drawn up the previous day, and should be considered expired.  There is no evidence that the dose was mishandled in any way, but it was not discarded within the appropriate timeframe. Since it was administered approximately 20 hours after the puncture and mixing of the vial, the dose was determined to be expired, and I (as the pharmacist in charge at the time of discovery) determined that the patient should be revaccinated in order to ensure efficacy.  The patient was notified of the error as quickly as possible, and asked to return to the pharmacy to receive a replacement dose.  The repeat dose dose was administered approximately 7 hours after the expired dose.
Performing a flu clinic for nursing facility, and  I did not realize that the age of patient wasn't determined prior to giving her the vaccine. She received the 65 and older Influenza vaccine and he was 64. I had been handed a Fluad 65 and older vaccine and that is what I gave her.  Patient has not had any adverse reactions from this however. She is happy and healthy.
app 15 minutes after vaccination pt complained of itching hands and back with dizziness given benadryl 25mg po at 0850, po fluids, monitored by RN and PA, 2nd dose po benadryl given at 0910.  pt reports improvement in dizziness.  itching improved slightly.
COVID-19 TEST POSITIVE; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Extreme chills that seemed like a seizure - no control over limbs, fever of 102, diarrhea.
Headache started a couple of hours after the vaccine . Tried 600 mg of Motrin that evening. The next morning still had headache tried excedrin. 6 hours later tried zomig. Still have the headache.
I developed a four-inch wide, red,  circular rash on my right thigh near where I had received an Ajovy injection two weeks prior. The Moderna vaccine was in my left arm. The rash faded after about a week and there were no further problems. I would not hesitate to get another booster and will continue the Ajovy monthly injections for migraine.