chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reaction was related to latex in the product packaging; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who experienced reaction was related to latex in the product packaging, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  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 dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  The patient developed a non-serious reaction was related to latex in the product packaging (unevaluable event) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that latex-related reaction after receiving a Fluzone HD at a hospital 10 years ago.Patient reported the reaction was related to latex in the product packaging.  Other relevant tests were not reported.  Final diagnosis was reaction was related to latex in the product packaging.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.
vaccine was kept in refrigerator on 26 Oct 2021 and administered on 01 Nov 2021; 606 doses were given after expiration date / vaccine was kept in refrigerator on 26 Oct 2021 and expired on 13 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / vaccine was kept in refrigerator on 26 Oct 2021 and expired on 13 Oct 2021) and PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 26 Oct 2021 and administered on 01 Nov 2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / vaccine was kept in refrigerator on 26 Oct 2021 and expired on 13 Oct 2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 26 Oct 2021 and administered on 01 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / vaccine was kept in refrigerator on 26 Oct 2021 and expired on 13 Oct 2021) and PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 26 Oct 2021 and administered on 01 Nov 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  No temperature excursion of the product reported. No adverse event experienced by the patient.
Upon administration of Influenza vaccine in Left upper arm I immediately felt generalized heat all over.  I developed tightness of chest with shortness of breath. Tingling developed down my left arm to fingertips.  I was placed on 3L NC O2 with some improvement.  Benadryl 25mg PO given and symptoms resolved within 30 minutes.
Had a red itchy rash, about the diameter of a tennis ball around the injection site. Site was slightly swollen and slightly painful to the touch. Appeared about a day after administration and lasted for 3 days. Did not seek treatment and resolved by itself.
mediation was noted to be expired after administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 37-year-old female patient who received HAB (Twinrix) (batch number 2ke55, expiry date 22-SEP-2023) for prophylaxis.   On 09-OCT-2023, the patient received Twinrix (left deltoid). On 09-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: mediation was noted to be expired after administration). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 9-OCT-2023 A healthcare professional (HCP) reported that a twinrix injection was administered to a patient and the mediation was noted to be expired after administration, which led to expired vaccine used. The reporter consented to follow up.
Pt had flu shot on 10/16/02 then had nausea/vomiting, diarrhea, feeling weak. Apparently collapsed in apt-found down post three days. Was treated in ICU for pneumonia. Also weak in LE (but reflexes present). Still recovering.  Nurse follow up on 07/21/04 states: "Aspiration, DVT  rt upper ext, Mental status change, Bronchospasm, Rash, flu reaction, dehydration, ecchymosis,
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly store (13.9 degree centigrade for 17 hours) doses of ROTATEQ (lot # L008031, expiration date: 03-AUG-2016 and lot# L023866 with expiration date: 24-MAR-2017, oral, dose was unknown). No adverse effects were reported. No previous temperature was excursion. This is one of several reports received from the same reporter. Additional information has been requested.
pain in the injection site area .Never goes away . Subsides with meds butcomes back after an hour.
Pt received second dose of vaccine and went to the observation area. She was risk stratified into the high risk (30 minute obsevation) category based on a previous anaphylactic response to shelffish requiring epinhephrine. She reported only a minor pruritis after the first dose of the vaccine. While in the observation area she reported auditory exclusion to her male partner, then reportedly went unconcsious immediately.  Employees working in the observation area were notified and summoned medical assistance. A medical provider (PA) arrived and found the pt supine in the passenger seat and unresponsive. Her pulse was weak and thready. One dose of 0.3mg epi autoinjector was administered to her R lateral thigh at 12:03p
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID-19 treatment; (07Jul2022) Negative, notes: Tested negative after 5-day treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included COVID 19 Treatment from 02Jul2022 to 06Jul2022, orally. Clinical course: The patient had rebound covid after completing the paxlovid. Tested negative after 5-day treatment. Symptoms reappeared about 5 days after completing treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
KNOT ON ARM; HEAD COLD SYMPTOMS; CLUSTER LIKE HEADACHE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 175 pounds, and height was 63 inches. The patient's concurrent conditions included neuropathy with surgical intervention, penicillin allergy, abstains from alcohol, and smoker, and other pre-existing medical conditions included no illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, to right arm administered on 02-APR-2021 10:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced muscle aches. On 03-APR-2021, the subject experienced head cold symptoms. On 03-APR-2021, the subject experienced cluster like headache. On 04-APR-2021, the subject experienced knot on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from head cold symptoms, and cluster like headache, and had not recovered from knot on arm, muscle aches, and fatigue. This report was non-serious.
terrible headache; This is a spontaneous report from a contactable consumer (Patient). A female patient with an unknown age received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE, Lot number and expiration date was not provided) via an unspecified route on an unknown date as a single dose for COVID-19 immunization. Medical history included sinus headache and she have problems in the springtime. Concomitant medications were not reported. On an unspecified date, patient experienced terrible headache. Patient states that she is due for the second Pfizer shot tomorrow at 09:45am. She took 2 Advil because she was having a terrible headache. She took it at 6:00 this morning. She enquired if she should get the shot tomorrow or not. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
One day post vax, this child experienced seizure, was convulsive. Taken to hospital on 11/4/99.
Pins and needles pains to left breast area that spreads to left inner axillary and to left shoulder
blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Developed 20 x 25 cm pruritic lesion on right temple 40 hours after receiving smallpox vaccine autoinoculation. Complained of headache also. ESR 5. Will continue to watch. 7/21/03 - lesion has not yet resolved.
Injection site Pain, swelling, erythema and lump - 4 cm to 4 cm size.  Fever, body ache,  back ache
Extreme soreness on the left arm radiate down to patient's elbow. Area is red and hot - 72 hours after vaccinated. Possible cellulitis with treatment of CLEOCIN 300 mg 4 time a day for 10 days with MOTRIN 200 mg every 6 hours.
MD indicates Engerix-B use has been "causing painful injects." Pain @ inject site was experienced by "12 to 15" pts. Pts would not return for 2nd dose of Engerix-B.
Employee began feeling hot about hour after vaccine administration.  Then she began itching and burning on her chest and back. Redness on chest noted. No hive noted.
flu; Initial information received on 15-Dec-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional (under reference number: US-SA-SAC20211222000185).  This case involves Adult and unknown gender patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There was be no information on the batch number for this case.
5-11yr vaccine was diluted prior to admin.  In doing so, patient was given 20mcg booster dose instead of the appropriate 10mcg dose.
Patient contracted COVID-19 approximately 3 weeks after receiving her most recent booster shot; Patient contracted COVID-19 approximately 3 weeks after receiving her most recent booster shot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "recovering" and all described as "Patient contracted COVID-19 approximately 3 weeks after receiving her most recent booster shot". The event "patient contracted covid-19 approximately 3 weeks after receiving her most recent booster shot" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not have COVID prior to vaccination. No known allergies. Patient contracted COVID-19 approximately 3 weeks after receiving her most recent booster shot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Left breast pain and slight shortness of breath began on Sunday am, day after vaccine.; Left breast pain and slight shortness of breath began on Sunday am, day after vaccine.; chills; upset stomach; This is a spontaneous report from a contactable consumer (Patient) who reported for herself.  A 63-years-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 at 04:45 (at the age of 63-years-old), administered in left arm as a dose number unknown, single dose for COVID-19 immunization. Medical history included allergy to Sulfa drugs, birch protein and pollen and epilepsy from an unspecified date. Concomitant medications included Levetiracetam from an unknown start date for unspecified indication. The patient had no other vaccine in 4 weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 14Mar2021 at 10:00, the patient experienced Left breast pain and slight shortness of breath began on Sunday am, day after vaccine. Also chills and upset stomach on 14Mar2021 at 10:00. No treatment was received for adverse events. The clinical outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever of 101, growing rash/swelling on arm with pain and heat for over 1 week
experienced pain at the time of the injection of his 1st dose of the Pfizer COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose-1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "experienced pain at the time of the injection of his 1st dose of the Pfizer COVID vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started having unusual sensation and pain on my head. After 3 days I started getting blisters on my forehead, eye and scalp. I went to see the doctor and determined that this was shingles. My doctor prescribed an antiviral medication. Neurontin and acyclovir were prescribed. In August I started having palpitations and winded breathing along with swelling in my ankle. In October I was diagnosed with hyperthyroidism by an endocrinologist and prescribed methimazole and metoprolol.
Injection did not sting but noticed that the needle felt like if it was 3 or 4 times larger than usual. Shoulder felt stiff. After vax doctor took blood for testing. By noon, shoulder started hurting. By bedtime, could hardly touch it or turn over. Pain was intense. Felt like kidneys were working extra to clean body so was going to the bathroom repeatedly until 2 am. Then shoulder quit hurting. Next day while eating breakfast passed out on the floor from a minute to the next with no warning. Got up to go rest on couch and passed out again on the way there. When got up rested on couch and did not get dizzy spells again since.
Patient complains of pain in the left arm for more than 30 days. She said she can move her arm up and down but have pain in the shoulder if she put her hand in her hip or waist. Patient took ADVIL twice a day, but is not helping with the pain. Rph advised patient to see a medical doctor and get checked for the cause of the pain.
Mom states child ran fever of 105 was taken to MD p/getting rash which appeared 5APR91 MD dx viral infect per report of pts mom rash kept getting worse & still has it 10APR91;
Patient came in to have a flu vaccine. Technician accidently gave 1 dose of Covid-19 Pfizer. Spoke to the patient to inform her of the error followed by apologizing . Patient was very understanding .Told her to monitor if any adverse effects and if  occurs to contact her MD or go to an ER. Contacted the patient twice that afternoon and evening to check in with her, patient stated she is feeling fine with no adverse effects. Told patient we will continue to call her over the next few days to see how she is doing.  We have contacted her doctor to inform them about the vaccine incident.
Student received vaccine, passed out, hit head on floor, positive loss of consciousness, positive seizure like activity, EMS called, student transported to hospital, regained consciousness prior to transport. 11/25/09 , 12/11/09 and 12/17/09:  ED and hospital Records received for date of service 11/19/09.  Dx:  Seizure, concussion with LOC.  Presented after syncope with LOC, hit head with fall, experienced urinary incontinence.  Nursing staff saw seizure activity.  No postictal state, few bouts of emesis. N & V and headache.
This spontaneous report was received from a certified medical assistant regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient was not reported. On 29-MAR-2016, the patient was vaccinated with unspecified doses of improperly stored GARDASIL lot # K011562, expiry date 08-APR-2017 (dose, units, frequency, route and anatomical location were not specified). Concomitant medication were not reported. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the product was exposed was 33 degree Fahrenheit for 72 hours. Temperature and time frame at which the product was exposed previously: 34 degree Fahrenheit for 72 hours and 47 degree Fahrenheit for 12 hours. This is one of several reports received from same reporter. Additional information has been requested.
uggg. Got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date:25-May-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient took the shingles vaccine and got sick. Additional Supportive Information:  The follow up would not possible as no contact details were available.
Dizzyness..nausea...diaherria...cold sweats...lite headed...chills...passed out briefly
Patient presented to pharmacy 10/2/16 - arm was swollen, red, itchy, painful, weak, and patient felt weak, poorly, and nauseated.
Light headedness, dizziness, and weakness that occurred the morning after receiving the vaccine and lasted for 2 days.  Patient fainted the morning after the second dose was administered.