chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling unwell; aches; Major headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jun2021 16:30 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to nuts" (unspecified if ongoing), notes: known allergies: Nuts; "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: MALAISE (non-serious) with onset Jun2021, outcome "not recovered", described as "Feeling unwell"; PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "aches"; HEADACHE (non-serious) with onset Jun2021, outcome "not recovered", described as "Major headache". Therapeutic measures were not taken as a result of malaise, pain, headache.  Additional information: A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Period delayed 3 days after 2nd dose and 6 days after 3rd dose. Parent requested this be reported.
I was perfectly fine after the vaccine, except for a sore arm. On day 3 I noticed my tongue starting to swell and lips tingling. It got a little worse and I felt it moving towards my throat, and then it stopped. This only lasted maybe a couple of hours, and not more than three hours. I had not eaten anything since the day before, so knew it was not food related. I didn?t associate this reaction to the vaccine until I searched online, and found that tongue swelling and facial paralysis could be common. I was also tired that day. On day 4 I had none of those symptoms but was very tired and did not feel myself; little energy, somewhat lethargic.
This child had erythema in the left arm at the site of injection given on 04/16. In 24 hours it developed erythematous tender area, cellulitis versus local reaction.
Sore arm; Left corner of her mouth started to be numb and started to slightly drill and can't control it; Brain fog; Felt she was about to get a headache; Burning sensation in site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPOAESTHESIA ORAL (Left corner of her mouth started to be numb and started to slightly drill and can't control it), FEELING ABNORMAL (Brain fog), HEADACHE (Felt she was about to get a headache) and VACCINATION SITE PAIN (Burning sensation in site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included Occipital neuralgia (occipital neuralgia in left side.). Concurrent medical conditions included Underweight. Concomitant products included BUTALBITAL for Neuralgia, LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HYPOAESTHESIA ORAL (Left corner of her mouth started to be numb and started to slightly drill and can't control it), FEELING ABNORMAL (Brain fog), HEADACHE (Felt she was about to get a headache) and VACCINATION SITE PAIN (Burning sensation in site of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 01-Apr-2021, HEADACHE (Felt she was about to get a headache) and VACCINATION SITE PAIN (Burning sensation in site of injection) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPOAESTHESIA ORAL (Left corner of her mouth started to be numb and started to slightly drill and can't control it) and FEELING ABNORMAL (Brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications also included Tylenol.  Patient was underweight and got Moderna vaccine on 1st April 2021 and had a medical inquiry. She had a weird side effect. She has medical history of occipital neuralgia in left side, which is the same side she got the vaccine. First symptom she had was a burning sensation in the site of injection with no redness that lasted about two hours. Says that didn't concern her. But two hours after shot the left corner of her mouth started to be numb and started to slightly drill and can't control it. She can't deal with it. She also started to have brain fog and sore arm. Still having these side effects. Brain fog is clearing up. She was about to have a headache so took a Tylenol to prevent it. She has daily medications, but 48hours before her shot she didn't have those medications, so to make sure they didn't interact. Consent for Safety to follow up with her. Preferred method of contact by phone. Consent for Safety to follow up with HCP.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non-Significant follow-up appended
Within several hours I began vomiting and did so 6-8 times for another 24 hours.  Dry heaves after a while.  Also, fever of !01 with chills throughout night, headache and cough.  It was a full 40 hours before I could hold anything down - water or food.  I had the EXACT same symptoms after my First Pfizer Booster on 12/17/2021  as well as a strong, but  lesser reaction on my Second dose of the Pfizer vaccine on 6/20/21.  No reaction at all on my very First vaccine 5/30/21.
Patient is a 74 y.o. female who presented for a COVID-19 vaccine. Patient began experiencing Allergic Reactions to Covid-19 Vaccine: dizziness15 minutes after the administration of Covid Vaccine Manufacturer: Pfizer COVID-19 vaccine. Patient was given the medication specified above 1 minutes after the reaction began. The adverse effects worsened  after receiving rescue medication. Patient was released to  emergency room with significant other.
Pruritic risen red rash, over half of body irregular in shapes, random dispersment. Edema to bilateral hands. Possible Serum Sickness Like reaction.
After initial shot started itching on legs.  After 2nd shot broke out in hives on entire body. Soldier was at doctor's office today, had utcaria after 2nd shot (4/23) it is the 3rd week with persistent uticaria and sinus pressure; first nose was stuffy now it is runny. Had review of systems.
temperature excursion for GARDASIL 9 and M-M-R II; No additional AE reported; This spontaneous report was received from a certified medical assistant and refers to 20-year-old female patient. There was no information about the patient's concurrent conditions, concomitant medications or medical history provided.  On 21-JAN-2022, the patient was vaccinated with the first dose (previous dose reported as 0) of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T030746, expiration date 16-MAR-2023, intramuscular, right deltoid  (dose and route of administration were not reported) for prophylaxis, which were involved in a temperature excursion of 0.39 degrees Celsius for 80 hours and 11.2 degrees Celsius for 80 hours (product storage error). This temperature excursion was from 17-JAN-2022 to 31-MAR-2022. The medication error occurred in the process of storage in clinical practice. The operator of vaccine/vaccine-device was healthcare professional who was trained. The vaccine/vaccine-device was used according to the instruction leaflet. The patient wanted to repeat dose on 11-JUL-2022. There was no additional adverse event or product quality complaint reported. No information about previous excursions reported.  This is one of cases from same reporter. ; Sender's Comments:  US-009507513-2207USA000782: US-009507513-2204USA005218: US-009507513-2207USA000784: US-009507513-2207USA000785:
Pt received vax & it was noted that no mannitol or albumin had been adm. Currently pt is not ill
Nervousness, headache, dizzy, pressure in head, cold, weak, could not sleep, in bed 2 1/2 days, rapid heart beat, pain in shoulder and arm. It felt like I was having a heart attack.
Patient called a few hours after the vaccine administration to complain about itching at the injection site. Patient said the site did not look swollen but was slightly warm and said it was slightly red but she said that could be from the scratching the site or the bandaid. The patient removed the bandaid and took some Benadryl. We followed up with the patient within the next hour and the patient said the itching has gone away and was fine. Patient was told that if the itching returns or the situation deteriorates to seek emergency medical treatment.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Syncope lasted for about 5 minutes. Paramedics were called. Paramedics left immediately upon checking the patient, because he was fine. Patient stated that he has fainting episodes with injections due to panic attacks.
Severe fatigue started the following day, followed by severe axillary adenopathy on the left side (the side of the vaccine), then severe muscle spasm and radicular pain on the left arm, shoulder and neck
received an expired product; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa (Infanrix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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.   Linked case(s) involving the same patient:  US2022061834   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comments: The case was reported by patient's mother. The mother informed that her daughter received an expired product. The reporter consented to follow up. Additional Supportive Information: The patient received expired vaccine which led expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061834:Same patient
Started about 5pm yesterday, pain, redness, swelling, warmth, 1 inch from injection site, Red redness 8X15 cm; low grade fever (99.3).  Tx. Extra strength Tylenol , cold packs  Returned to clinic  this am for further evaluation and to report occurence.
Pt was in  office to have ears flushed for wax build up and given hearing screen, after hearing screen, pt given covid vaccine. 1/2 hr after getting vaccine,  pt c/o of not feeling well and started to pass out while while standing at the check out counter, was grabbed by mom, and nurse, put in chair, given some water, then passed out while sitting in the chair, pox 97% ra, heart rate normal, transferred back to exam room, BP 95/63, given blow by O2, after 10 min not feeling well , ambulance was called, took about 20 min to arrive. Pt  started feeling better but not 100% sent ER for further evaluation, HER Attending notified of pt.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2012, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-JAN-2016, the patient was treated by a physician assistant, at a clinic facility, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
WHOLE BODY ACHE AND PAIN; FEVER; This spontaneous report received from a parent concerned a 25 year old male. 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: Unk) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUL-2021, the subject experienced whole body ache and pain. On 01-JUL-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102.8 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and whole body ache and pain. This report was non-serious.
Swollen lymph nodes under both arms. Much larger on the left side, which was the injection site.
01/14/22 presents to ED for "rash under breast and skin folds" "intermittent and persisting cough" "covid 19 infection on 1/9/21". PMHx of "HTN, DM, CKD s/p L nephrectomy 2007, CHF, dementia, splenectomy"
injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; knot at her injection site; This is a spontaneous report from a non-contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL9262, first dose (at the age of 40 years), intramuscular on 28Jan2021 at single dose for covid-19 immunisation.  COVID-19 vaccine was administered at hospital. The patient medical history and concomitant medications were not reported.  It was unknown if the patient was pregnant at the time of vaccination. On 29Jan2021 the patient experienced injection site that was raised, red, itchy and warm.  One week later she still had a knot at her injection site but it was getting smaller daily. It was unknown if treatment was received for the  events. The patient contacted per PCP and it was explained that it was secondary to the vaccine administration. It was recommended to receive the 2nd dose of the vaccine in the opposite arm. The events were non serious with outcome of recovering. No follow-up attempts are possible. No further information is expected.
Client presented back to clinic on 1/26/23 for MMR and varicella vaccines. C/o hives on both hands, arms, and chest.  Stated they started the night she got vaccinated. States that they itch. No other symptoms of allergic reaction present. Guardian gave 1 dose of benadryl on 1/25/23 which helped the itching. Did not vaccinate for MMR and varicella. Advised PCP f/u same day as well as continuing benadryl.
Patient was non-communicative but sitting still in the chair.  Appeared to be in a mild type of seizer temporarily.  After a few minutes was able to communicate and was feeling better.
pt recv vax in 1995 & w/in 7 days pt exp feeling very weak & tired almost unable to walk or stand up;all test were nl x/an elevated sed rate which was triple that of an adult;w/in 2wk pt recovered from feeling weak;
Rash - round, red rash (bumps) on leg and arms (same area on each legs - started small and getting bigger)  -  it's itchy and scaly. I've been spraying with Benadryl and try to keep the area dry and clean. It's been going on for about three weeks. Now I have one under my right breast as well and it has a dark scaly top. One minute - they look scaly and one minute they are red and inflamed and one minute they are dark and one minute they are light - on and off.
Caregiver said patient had swelling around eyes starting on 12/22/21. Caregiver said that the patient has MS, and she thought it was likely due to that versus the vaccine.
Fatigue, headache,muscle pain,joint aches,chills starting in afternoon, nausea immediately after shot, dizziness and lightheaded feeling immediately after shot.  Early afternoon till bedtime there was a heaviness on the chest that was better able to breath if lying down rather than sitting up.  Hot flashes every 50 minutes to 30 minutes all day and night for first day.   Day 2 headaches, extremely tired, tender arm, light dizziness.  By day 3 -back to almost normal- just residual tiredness
1st Shingrix shot about 3 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter asked, if they need to restart the series or just 2nd dose needed. This case has been linked to US2022AMR044662, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR044662:Same reporter.
Breakthrough case admission 3/3/21 Moderna Lot# 010A21a 3/31/21 Moderna Lot# 025B21A
About 5 days after receiving my first shot I was in the ER and diagnosed with chronic insomnia.  I have trouble sleeping ever since.
1st dose: 7-feb-2023, 2nd dose: 18-feb-2023; More energy, feels happy, no longer needs to take Adderall; This non-serious case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic drug effect in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of therapeutic response unexpected (1st dose received on 07th February 2023, refer case US2023059011) and Adderall.   On 18-FEB-2023, the patient received the 2nd dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic drug effect (Verbatim: More energy, feels happy, no longer needs to take Adderall). On 18-FEB-2023, the patient experienced drug dose administration interval too short (Verbatim: 1st dose: 7-feb-2023, 2nd dose: 18-feb-2023). Rechallenge with Shingrix was positive. The outcome of the unexpected therapeutic drug effect and drug dose administration interval too short were unknown.   Linked case(s) involving the same patient:  US2023059011   Additional Information: GSK receipt date: 21-APR-2023 The patient self-reported this case. The reporter stated that she had the complete Shingrix vaccination series.  With both injections the patient reported she felt happy and had more energy.  She felt happier than she had been in 20 years.  She no longer needs to take her Adderall.  The reporter said the feeling goes away after 31 or 32 days. The reporter consented to follow up. The patient received second dose of Shingrix vaccine, earlier then recommended interval, which led to shortening of vaccinations schedule.; Sender's Comments:  US-GSK-US2023059011:Same report/Other dose
Pt was vaxed w/MMR 10SEP87 & approx 8FEB91 pt had vomited; 4 day later devel intermittent fever; 15FEB91 exp dizziness & had a rash; seen by MD dx a viral flu;
then they say positive; then they say positive; I have a little mild cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "I have a little mild cold"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "then they say positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, nasopharyngitis. Clinical course: Patient had all the booster shot, so patient went to the doctor yesterday because patient's daughter and her friend I've been babysitting had the COVID, so the doctor checked patient and patient had been checked, it said negative they said patient had negative but then they said positive when they called patient back home after they said negative, so patient got the medication but patient was not sure should patient take it if patient had a cold, patient had a little mild cold and was wondering should really take this Paxlovid, patient get it from the pharmacy yesterday. Patient guessed, if patient get the side effect, patient just quit taking it. The patient was just kind of skeptic by taking it. When probed if any side effect after taking the booster shot: Consumer stated, "No. Patient just wanted to know should patient take this medicine (Paxlovid) but patient get this. Right now patient was okay and they said patient test positive, so before they say negative, patient just wanted to make it sure was kind of skeptical on taking it right now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
in between doses he tested positive for Covid-19; In between doses he tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). A 81-year-old-male patient received BNT162B2 (Pfizer-Biontech covid-19 vaccine, formulation: solution for injection, Batch/Lot number not provided) first dose via an unspecified route of administration on 26Jan2021 and the second dose on 17Feb2021 as single dose for COVID-19 immunization. On an unknown date, the patient underwent lab tests and procedures which included sars-cov-2 test: positive, he's almost done with quarantine, he also received an infusion for antibodies. The patient medical history and concomitant medications were not reported. The study excluded participants who had previous clinical or microbiological diagnosis of COVID-19 LAB-1457-5.0. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.