chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of felt faint in a 12-year-old male patient who received BOOSTRIX for prophylaxis. On 13th August 2018, the patient received BOOSTRIX .5 ml. On 13th August 2018, immediately after receiving BOOSTRIX, the patient experienced felt faint, sweating, hearing impaired and wrong injection technique. On 13th August 2018, the outcome of the felt faint, sweating and hearing impaired were recovered/resolved. On an unknown date, the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the felt faint, sweating and hearing impaired to be related to BOOSTRIX. Additional details were provided as follows: The pharmacist reported that she gave a BOOSTRIX vaccine to the patient the day before reporting in left deltoid. Half way through the injection, she had to pull out the syringe and inject the rest of the dose with another syringe, which led to wrong injection technique. The pharmacist reported that the needle was out of patient's arm during injection and replaced needle head and finishing injection in the same arm less than 1 inch from previous injection. The patient was experiencing feeling faint, sweating and unable to hear immediately following injection for 15 minutes which recovered after few minutes and went home with parent. She said there was no leaking. She just had to switch syringes because the patient shook a little bit as if the needle was too strong.
Pt called in. Said she has been feeling poorly since she got Pfizer booster on 12/18/21. Feeling achy & jittery. She reported it to her MD who didn't give her much direction. I reported to VAERS for her. She gave me the lot # from the card but I recommended that if sx gets worse to report to ER. --- Vaccine was administered at another facility (patient's local PHARMACY). I do not have contact info for the administering facility. Our pharmacy fills her Otezla so she reported the reaction to us
pt recvd vax 30AUG95 & 1SEP95 pt devel a rash;presented to MD 8SEP95;a strep test was performed & strep was r/o;rash subsequently became bubbly & blistery;again saw the MD 27SEP95;pt seen by dermatologist;
I had been lying down for 1-2 hours. When I got up, I suddenly became lightheaded and nauseous. I had to sit on the floor to steady myself. I became extremely sweaty with chills and my entire left arm (side of injection) became numb and tingly. The episode lasted approximately 20 minutes, and I was symptom-free within an hour. I never fainted or vomited.
Treatment of COVID-19/Tested positive for COVID; Treatment of COVID-19/Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing); "HTN (Hypertension)" (unspecified if ongoing), notes: HTN; "anxiety/depression" (unspecified if ongoing), notes: anxiety/depression; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Zoloft, reaction(s): "known allergies: Zoloft". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jan2023, outcome "unknown" and all described as "Treatment of COVID-19/Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jan2023) Positive; (30Jan2023) Negative; (31Jan2023) Negative; (2023) Positive. The patient started Paxlovid as treatment from 24Jan2023 to 29Jan2023. 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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Vomiting 7-8MAR, dehydration; fever to 102 8MAR (low grade 5-7MAR) lasting 3 days, sl elevation of L.F.T.;
Unresponsive spell lasting approximately 30 minuntes 5 days after receiving DTaP.  Full evaluation at a Hospital with no cause found. 10/15/09 Hospital records received for dates 9/19/09 to 9/22/09. DC DX: Apnea, Acute life threatening event. Presenting symptoms: Brought to ER pt crying and fussy. Parent states pt stopped breathing for a short period of time. Pt was unresponsive to voice and touch. Began breathing independently, but shallow for approx 10 minutes, parent states pt. was limp. When EMS arrived pt was sleeping easy to arouse. Parent denies any c/o prior to event pt. received vaccinations 5 days prior to this episode. Admit to hospital for further testing.  Course of stay pt. improved and dc home. Physical exam: pt crying without cessation, otherwise exam WNL.
Started with serious chills and fever requiring heavy comforter; temp of 100.8 at 8:00 a.m.; headache, chills, fever, muscle aches, significant fatigue.  Basically felt like the flu.  Lasted through the day and into the evening, with fever reduced during the day taking ibuprofen.  Woke up soaked in sweat the next night (early a.m. on the 17th) after the fever broke.  Slept late into the morning on the 17th but, once up, had a regular day with all symptoms gone -- didn't require any ibuprofen on the 17th.
The night she received the vaccine she remembers feeling a little feverish when she went to bed, but that was all she remembers.  She woke up with all her clothes off, on the floor, disoriented, her legs were so weak and arms so weak she could not get herself up.  The next morning the house cleaner knocked on her door and helped along with another person to get her up in her rollator walker.  She slept almost all day long the next day.  The day after that she felt fine.
pt recvd vax 22JUN94 mom noticed large red area @ vax site following AM lt deltoid large warm, hard area of erythema 7cm x 7cm;
a very severe delayed site reaction; it was a reaction where towards the arm was swollen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (a very severe delayed site reaction) and VACCINATION SITE SWELLING (it was a reaction where towards the arm was swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (a very severe delayed site reaction) and VACCINATION SITE SWELLING (it was a reaction where towards the arm was swollen). At the time of the report, VACCINATION SITE REACTION (a very severe delayed site reaction) and VACCINATION SITE SWELLING (it was a reaction where towards the arm was swollen) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This report concerns one of 7 patients, who experienced the same reactions.  No relevant concomitant medications were reported.  No treatment information was provided.
Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulder, arm to palm, thumb and finger tips. Muscular pain from neck (felt like pinched nerve) thru shoulder to wrist (felt like carpel tunnel).  Blooming painful pustule rash from shoulder to wrist on inner arm for one week.  Post-herpetic and muscular pain  continues through rash scabbing and drying, to date March 6, 2021.  This is my second event in 37 years.
Chills, muscle pain, body aches, nausea, loss of appetite, diarrhea, tenesmus.
I went into labor 03-02-2021 at 2:00am. I delivered my baby at 6:47am.  I was 30 weeks pregnant at the time of delivery and my baby is in NICU. At this time baby is doing fine.
itchiness began 8-12hr p/vax;swelling/hives over entire body a few hours later;6/9/99 ER given DPH followed by oral prescription;
On 10/09/2022, I had upper respiratory symptoms, runny nose and gray discharge. On 02/09/2023, I had the same symptoms. On 02/15/2023, I was very raspy so we went to urgent care and had an X-ray done and they sent me to the emergency room. They took a CT scan and said I didn't have pneumonia. On 02/17/2023, I went to my doctor, who prescribed medications. I am much better. I took prednisone, cefepime, benzonatate, albuterol.
Started having breathing problems, bad coughing and fever. On Saturday night I took him to emergency room, because breathing was getting worse. They said it was a reaction to one of his shots. He had 3 shots MMR, chicken pox and Prevnar. I think it was Prevnar because this has happened 2 other times after shots and Prevnar was the shot that he has had before, the other 2 were new shots. He was put on steroids and it is helping. Not sure if he's over this yet.
Pt developed a hard, erythemic induration incorporating entire left thigh from groin to above knee. Pt also developed a pustule at injection site. Pt had no evidence of abscess.
an expired GARDASIL 9 was given to a patient; No additional AE/PQCs reported; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided about the patient's pertinent medical history, concomitant medication, drug allergies/reaction.  On 27-JAN-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml (strength, route of administration, dose number, lot number was not reported with expiration date of 11-SEP-2020) for prophylaxis (expired product administered). No additional adverse event/product quality complaints (PQCs) was reported.
I did not have an adverse reaction to the vaccination but I tested positive for Covid 19 on January 7, 2022. I began having symptoms on January 4: runny nose, cough, fatigue, fever and chills. I took MUCINEX, cough syrup and TYLENOL which helped. I just stayed home and road it out. I did not contact my primary care physician.
sore arm "sore muscle feeling"; a little bit of hardness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm "sore muscle feeling") and VACCINATION SITE INDURATION (a little bit of hardness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm "sore muscle feeling") and VACCINATION SITE INDURATION (a little bit of hardness). At the time of the report, VACCINATION SITE PAIN (sore arm "sore muscle feeling") and VACCINATION SITE INDURATION (a little bit of hardness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment details included ice pack, icy hot, and ibuprofen.
I had a headache starting 15 minutes after the injection then a couple hours later I had what has since been diagnosed by a neurologist as a thunderclap headache around my left temple. My right leg convulsed when this happened. This was debilitating and I lost motor functions in my right arm and leg. I am still recovering and still have migraines everyday. I had a brain MRI which was normal.
About a week and a half after receiving the vaccine, I got my regular period. For the first 72 hours the flow was extremely and abnormally heavy. Due to existing knowledge of my reproductive issues, I know that it was unrelated to pregnancy.
developed diffuse swelling of the face, painful to the touch; developed diffuse swelling of the face, painful to the touch; This is a spontaneous report from a non-contactable other healthcare professional. A patient of unknown age and gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/lot number: not reported, expiry date: not reported) via an unknown route of administration on an unknown date as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included hyaluronic acid, lidocaine (JUVEDERM ULTRA 3) dose 3cc in the nasolabial fold (a month after JUVERDERM ULTRA 3), marionettes and tear trough taken for an unspecified indication. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. On an unknown date, the patient developed diffuse swelling of the face, painful to the touch (next day of vaccination). Telfast and Aerius (Desloratadine) Tabs were given as therapeutic measure for the events. HCP advised, there was a significant improvement a day later. Clinical outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Febrile seizure after immun. Sent to EDfebrile seizure resolved temp was not taken in vd in ED T 103.5.
tested positive for COVID 4/21/21. Completed COVID vaccine series 2/2/21. Symptom onset 4/18/21.  Of note, she also tested positive for COVID 10/20/20.
Symptoms began around 6 pm and became severe around 8 pm when patient entered a cool, air-conditioned space and began to experience chills. Symptoms included fever (101.4 F), spasm-like chills, nausea, muscle soreness throughout arms and legs, severe fatigue, mild headache. Remained in bed the next day with fatigue, mild headache, nausea.
At 12:00 pm on 03Jun2022 the joint pain was more intense; mild headache; about 11:00 pm on 02Jun2022 I noticed fatigue and joint pain in the back, hips and shoulder; about 11:00 pm on 02Jun2022 I noticed fatigue and joint pain in the back, hips and shoulder; sore arm at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 13:45 as dose 4 (booster), single (Lot number: 33036BD) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "MDS" (unspecified if ongoing); "bone marrow transplant" (unspecified if ongoing); "GVHD" (unspecified if ongoing); "graves disease" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot No: EL3248), administration date: 03Mar2021, when the patient was 55-year-old, for COVID-19 immunization.BNT162b2 (DOSE 2, SINGLE; Lot nub: EP7534), administration date: 15Apr2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3, SINGLE; Lot nub: EW0176), administration date: 22Oct2021, when the patient was 55-year-old, for COVID-19 immunization The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Jun2022 at 16:00, outcome "recovering", described as "sore arm at the injection site"; FATIGUE (non-serious), ARTHRALGIA (non-serious) all with onset 02Jun2022 at 23:00, outcome "recovering" and all described as "about 11:00 pm on 02Jun2022 I noticed fatigue and joint pain in the back, hips and shoulder"; CONDITION AGGRAVATED (non-serious) with onset 03Jun2022 at 12:00, outcome "recovering", described as "At 12:00 pm on 03Jun2022 the joint pain was more intense"; HEADACHE (non-serious) with onset 03Jun2022 at 12:00, outcome "recovering", described as "mild headache". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, arthralgia, condition aggravated, headache.  Additional information: Patient noticed events joint pain was more intense and a mild headache.  Follow-up (06Jun2022): This is spontaneous follow-up report received in response to the mail trail sent regarding the confirmation query and the response included:
Developed hives within hours of receiving FLUMIST. Mother gave BENADRYL, child did fine.
Missed 2nd shot and asking for 2nd shot passed 42 days of 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd shot and asking for 2nd shot passed 42 days of 1st shot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd shot and asking for 2nd shot passed 42 days of 1st shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd shot and asking for 2nd shot passed 42 days of 1st shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD21-083293 (E2B Linked Report).; Sender's Comments:  MOD21-083293:
Initial unsolicited report received from a Consumer via non-healthcare professional on 10 November 2015. This case involves a female (age not reported) patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu SHOT) (batch number, dose, dose in series, expiration date, route and site of administration were not reported) on an unspecified date. The patient had a medical history of diabetes and neuropathy. It was reported that lantus did not really work for patient and sometimes made patients sugars drop really low. Patient did not drive anymore because of diabetes. Patient could hardly walk because of the neuropathy. Concomitant medications included Lantus, Humalog and metformin. On an unspecified date, following the vaccination, the patient experienced entire arm turned black and blue. Lab data and corrective treatments were not reported. Outcome of event was not reported. List of documents held by sender: none.
Patient diagnosed with COVID-19 on 13May2022.; Patient diagnosed with COVID-19 on 13May2022.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adolescent female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 02May2021 as dose 1, single (Batch/Lot number: unknown), on 23May2021 as dose 2, single (Batch/Lot number: unknown) and in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "unknown" and all described as "Patient diagnosed with COVID-19 on 13May2022.". The event "patient diagnosed with covid-19 on 13may2022." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: (test name). Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
On February 1st (8 days after the first dose), I woke up and noticed my arm had a red rash at the injection site. It was a red prickly rash, kind of swollen and felt a little bruised and sensitive, it wasn't itchy like hives but mildly irritated. It was about 10" in diameter.
Pt received both vaccines in left upper arm on 9/4/19 and also had blood drawn.  Immediately after receiving vaccines and having blood drawn, pt became dizzy and needed to lay down.  (He has history of syncope in the past after mom had blood drawn in the ED).  He felt better in about 15 minutes and was able to leave the clinic and go home.  Vaccines received about 8 pm. The next morning mom called and stated pt's arm and shoulder were very painful, he was only able to sleep for 2 hours due to the pain, mild swelling, and that he had tingling down the back of his arm.  Pt was seen in clinic later in the morning (9/5/19) and exam revealed minimal swelling of left upper arm, no erythema at injection site.  Pt holding left arm flexed and in toward body, mom assisted him in removing his sweatshirt for examination of his left shoulder and arm.  Vitals were normal.    Recommended ibuprofen, warm compresses, soaking in bathtub.  Pt voiced that he wanted to go back to school for the day.  Discussed that severe shoulder pain is a rare side effect of the vaccine.  Provided written information of side effects from CDC regarding both meningitis vaccines.  Provided reassurance that in a few days his symptoms would likely significantly improve.  Mom or pt to call if symptoms worsening or persisting.
Body tingling; arthralgia, fatigue, night sweats  Narrative:  Some body tingling for a couple of hours beginning approx 1 hour after administration. Following day: moderate deltoid pain/soreness, mild arthralgia and myalgia, fatigue, night sweats. By day 2 after injection all sx resolved
Extreme muscle weakness, could not get out of bed unassisted, slight nausea.  After 48 hours symptoms went away rapidly. Never had a reaction to a vaccine previously. Have had flu, shingles, pneumonia previously..
I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)