chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna COVID 19 vaccine 25.5 hours after the vial was punctured) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2022 at 1:00 PM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Mar-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna COVID 19 vaccine 25.5 hours after the vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna COVID 19 vaccine 25.5 hours after the vial was punctured) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was initially stored in the refrigerator on 21-Feb-2022. The vial was first punctured on 03-Mar-2022 at 9:30 AM. Post puncture, the vial was stored in room temperature. The vial did not underwent any temperature excursions. Total amount of time the vial was exposed to room temperature was 25.4 hours. No treatment medications were reported.
Vaccinee experienced "palpitations" without chest pain, starting 20 days post smallpox vaccination.  EKK normal at that time.  COntinues to experience these palpitations although states they are decreasing in frequency. No cardiac history.Parents are both in their 90's and well. Mildly elevated cholesterol being treated with Lipitor. Is scheduled for an echocardiogram and an exercise stress test over the next weeks
Headache started within half hour of vaccine. The headache lasted until about 4:30 p.m. The next morning, when I got up I was very dizzy and very nauseous. I called my doctor and asked if I could take Pepto Bismol. She said yes. Nausea subsided. I also took Tylenol. After that for about 3 weeks I felt absolutely drained. I felt as if I was recovering from the flu. Her doctor told her that her body thought she was coming down with Covid and it will subside.
Chills onset 5 hours after injection.  Fever gradually increased.  Took Tylenol to reduce fever.  Nausea began 12 hours after injection.  Fever broke approximately 15 hours after.   Vomiting.  Diarrhea began 24 hours after.   Tightness in chest.  Light-headedness.  At 36 hours, awoke with vertigo (room spinning) and nausea.  Would lessen to dizziness upon laying still in dark room.  Chest still feels strange.
COVID break through Case  I received my 1st booster shot on 11/12/2021 and my COVID symptoms started on 12/23/2021  i had extreme  fatigue, i was sleeping so much,  i had no fever,  very severe vertigo  and  I had to go see an ENT. I lost balance. I was like sea sick. I felt like was drunk and i couldn't walk on an straight line. i was exhausted .  it was different than what i normally do. I didn't go to a doctor. I stayed in bed and took it like a flu or cold. my husband was positive with a PCR test and was positive. So i was positive too.  the vertigo lasted for 3 weeks.
After first dose I experienced light headed ness  After second dose I experienced muffled hearing in both ears five days later
Recd vaccine at around 6PM Friday March 12, started having symptoms at around 4AM Sat the 15th:  horrible headache, fever, nausea, body aches.  Lasted all day Saturday, started feeling better Sunday morning.  As of Monday morning (the 15th), feeling a bit of lethargy but otherwise much better and back to "normal".  this is the first time in my experience of taking vaccines of having this kind of reaction.
Patient didn't mention about this ADR till today and said he thought it was Flu shot that caused Numbness on his face possible Bell's Palsy, however, he said he has seen md in hospital, Urgent Care, and Neurologist, none of them said bc of vaccines that caused this kind of reaction.  Neurologist couldn't find any evidence of the correlation between his issue to any vaccines.  Patient was not sure if it 's was the Flu shot he got 9 days prior or Moderna vaccine he got 5 months prior. Patient has gotten Flu shot every year for years without issue in the past.  He had no issue with tdap or shingrix either.
This case was reported by a nurse and described the occurrence of mononucleosis in a 18-year-old female patient who received BEXSERO. In August 2017, the patient received the 1st dose of BEXSERO. In September 2017, less than a year after receiving BEXSERO, the patient experienced mononucleosis. On an unknown date, the outcome of the mononucleosis was unknown. It was unknown if the reporter considered the mononucleosis to be related to BEXSERO. Additional details were provided as follow: The next month after vaccination with BEXSERO, the patient came down with mononucleosis. The reporter was asking, if it would be safe for the patient to have her 2nd BEXSERO shot in November, if she felt better.
Chills, body aches, headache, 14 hrs vomiting, muscle and joint pain.  Vomiting stopped after about 14 hours.  Muscle aches, joint pain, headache continue.  Temperature 99,8 with use of Tylenol
After the vaccination was given, I asked the patient if he felt okay. He stated he felt fine. He left the pharmacy and just as he took a few steps out of the door, he started to lose balance. The patient was with his mom and his younger brother. He was conscious just felt weak. We took him back to the vaccination room and I asked him what he felt. He stated he had a head rush, tingly arms, and nausea. He was given water and Gatorade. Waiting in the waiting room for an hour (or more) as I periodically checked on him. Mother thinks its likely due to anxiety with getting vaccines. Called the patient tonight around 6:30 pm 11/12/20 to check, and he is feeling ok
Warm; Itching; Feels Infected; Looks Allergic; Sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore), FEELING HOT (Warm), PRURITUS (Itching), INFECTION (Feels Infected) and HYPERSENSITIVITY (Looks Allergic) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included TOPIRAMATE and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Sore). On 16-Mar-2021, the patient experienced FEELING HOT (Warm), PRURITUS (Itching), INFECTION (Feels Infected) and HYPERSENSITIVITY (Looks Allergic). At the time of the report, PAIN (Sore), FEELING HOT (Warm), PRURITUS (Itching), INFECTION (Feels Infected) and HYPERSENSITIVITY (Looks Allergic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Symptoms: fever 101, body aches, chills, extreme fatigue, nausea.  Treatment: bed rest, intermittent Ibuprofen 600mg &  Tylenol 700mg.  Symptoms began around 10pm, 12 hours post injection & lasted until 10pm the next day, 24 hours.
FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Body Aches; loss of energy; slept all day; head pressure; sinus; nose congestion; sneezing; coughing; fever; burning in the chest by the 20 that was worse by the 21 /22nd; Headache; cold; I used my Nebulizer to help with breathing; Wheezing; pain in right back area of the lung.; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for the patient in response to consumer letter sent via follow up letter. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jan2021 as single for COVID-19 immunisation. The patient experienced headache on 17Aug2021, head pressure, sinus, nose congestion, sneezing, coughing, fever, burning in the chest by the 20 that was worse by the 21/22nd on 20Aug2021, loss of energy, slept all day on 21Aug2021, body aches on 23Aug2021, cold, i used my nebulizer to help with breathing, wheezing, pain in right back area of the lung on Aug2021. Reported as, patient was exposed to COVID19 On 31Aug. He had lunch with 4 others that were also fully vaccinated. Patient and his wife were vaccinated with Pfizer in Jan/Feb2021. Symptoms began for him on Monday the 16. Patient began symptoms on Friday the 20. His symptoms included head pressure, sinus, nose congestion, sneezing, coughing, day 7 ended with a fever, day 8 loss of all energy & slept all day with a fever that night. Day 9 & 10 the cough & cold symptoms continue with some energy loss. His symptoms began with a headache on the 17 that persisted for 4 days, then burning in the chest by the 20 that was worse by the 21/22nd. The 23 began with body aches, head pressure, cough, wheezing, chest burning worse with pain in right back area of the lung. patient used nebulizer to help with breathing. Major energy loss. He began taking Prednisone on the evening of the 23 and symptoms have abated greatly by the 25. He still have a cough and cold Symptoms but energy has returned well and the wheezing has abated quite a bit. He continued the Prednisone treatment until the 28. Received Azithromycin 250mg and Benzonatate 100mg on 18Aug to help with symptoms. Patient received the same on Aug2021 along with Prednisone 20mg to take if symptoms worsened. Outcome of the event headache was resolved on 21Aug2021, loss of energy was resolved with sequelae in Aug2021, resolving for wheezing, not resolved for coughing, cold, burning in the chest by the 20 that was worse by the 21/22nd, pain in right back area of the lung, and unknown for other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After Dose 2 month later got really bad headaches, pressure in my neck. I noticed at work being a (Privacy) checking my vitals. I continued to have pressure in my neck, nose running, sore throat. My lymph nodes on my left side of my neck (interior) was swollen. I went to my PCP checked my ears didn't see anything referred me to ENT specialist. I followed up with ENT prescribed Flonase which didn't do anything my pain in my neck continued. He tested me for allergies, Ultrasound on June 29,2021. I still had pain I had CT scan on September 2, 2021. In November 2021 had a lymph node biopsy  (no cancer, no infection). I became pregnant in October 2021 first appointment in December 2021 was told I had a Sub chorionic hematoma pregnancy. A ultrasound was given to confirm was told might miscarriage. I went along with my pregnancy placed on bedrest on January 20, 2022 I miscarriage had a DNC. I don't' know if this is related, wanted to report. My expected due date was July 28, 2022.
Began spotting in mid-November, and it waned. At the end of December, menstruation began and didn't end until mid-February, after medical intervention. Was unable to leave house because of heavy, unmanageable flow.
watery diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (watery diarrhea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (watery diarrhea). At the time of the report, DIARRHOEA (watery diarrhea) outcome was unknown.            No concomitant and treatment information was provided. Treatment information not provided. The action taken with mRNA-1273 with respect to the event was not applicable.
Woke up with injection site feeling sensitive. Over the course of the day, slight swelling occurred in upper left arm. The area is hot and hard. No rash at this time. The affected area is about the size of a small yogurt lid.  Does not itch unless I touch it. I have iced it several times and it is still hot.
Pt is 6 year old male who received the Moderna 6m-5year dose of vaccine. Pt had no adverse reaction. Monitored pt for 15 minutes after injection. Informed pt mother of adverse event.
ABDOMINAL PAIN DESCRIBES AS A GRABBING ACUTE PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced abdominal pain describes as a grabbing acute pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain describes as a grabbing acute pain. This report was non-serious.
t105 reported by mom on 21JUL92 @ clinic; mom called MD did not see pt;
Client experienced facial tingling - 5 minuest after immunization - predominently on the right side. Given 50mg Benedrly P.O. 10 minutes after immunization. Vital signs stable. Hx: allergy to iodine - anaphylaxis. Tingling decreased by 30 minutes following the event. Client's vital signs remained stable. Client instructed to follow-up in the ER if client experienced difficulty breathing or tingling returned.
Thrombocytopenia. Abrupt onset; resolved spontaneously. Nurse Follow up on 05/18/04 states: Bruises. Labs now normal: not sure if illness in future will make ITP flare up again. This patient has been discharged from our practice  so we will no longer be seeing him. You will need to contact family for any further follow up.
Patient reported flu like symptoms and felt like she was going to faint the next day after she received vaccine. This lasted 3-4 days. Tuesday following the vaccine administration she reported a red itchy arm that went from the site down to her elbow
sore arm the day after; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm the day after on an unspecified date. The clinical outcome of sore arm the day after was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Extreme muscle weakness, not able to walk without a walker, slurred speech, blurry vision, loss of smell & taste, muscle spasm in hands, extreme fatigue & chills.
Area started itching, stinging approximately 2 hours after injection. Area also felt warm to touch, When pt. went home, area became hard and swollen. Area difficult to move sore to touch. Febrile 101.6 during night of injection. Pt states she felt weak and lifted.
6/23/2019 swelling, redness and blister near left eye with small blisters on forehead traveling toward hairline, thought to be spider bite, painful to touch 6/24/2019 swelling subsided, blister crusting over, pain mediated 6/27/2019 large outbreak on chest, bilateral,  pain like insect bite, growing during the day, blisters forming nd breaking, facial scabs completely formed and hardened 6/28/2019 chest outbreak worsening by the hour, blisters forming and breaking, small new breakout on throat, 2 on face, 2 farther up on chest, bilateral 6/29/2019 chest oubreak continuing to worsen, very large and fragile blisters, but pain subsided, other sites unchanged 6/30/2019 chest outbreak large blisters, now some bleeding, pain nearly gone, other sites unchanged
When I woke up on 1/26/21 my arm was very sore and the injection site was red, painful to touch, hot to the touch, and there was a firm lump about an inch and a half in diameter beneath the site. I also did not feel well- with a headache, fatigue, and was very overheated/sweaty. When I woke up on 1/27/21 I felt much better, but the symptoms around the injection site remained the same. Today, 1/28/21, the redness has increased in size, the lump has increased in size, however it is not as firm to the touch. I was prescribed antibiotics by my PCP.
Tonic Clonic Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.1 (BNT162B2, BNT162B2 OMI BA.1), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE: 3, BOOSTER SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 1 , MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization, medically significant) with onset 09Oct2022 at 20:15, outcome "unknown", described as "Tonic Clonic Seizure". The patient was hospitalized for generalised tonic-clonic seizure (hospitalization duration: 1 day(s)). The event "tonic clonic seizure" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Negative.  Clinical course: The patient received more than 3 dose. The most recent dose is of Pfizer dose 4 (Lot unknown reason: Not available/provided to reporter at the time of report completion) is bivalent on 29Sep2022. There was no other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination on 09Oct2022 was negative.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.1 has been requested and will be submitted if and when received.
Patient was given a high dose FluZone (influenza) vaccine at age 64 years when high dose is indicated for patient's 65 years and older
This spontaneous report was received from a physician refers to a 9 year old female patient. The patient has seasonal allergies. The patient has no pertinent medical history. On 03-AUG-2013, the patient was vaccinated with second dose of 0.5 ml VARIVAX (Merck), (lot number, expiry date was not reported and the route was subcutaneous). Concomitant medications were none. Approximately on 07-AUG-2013, the patient developed varicella type rash on the abdomen five days after receiving second dose of VARIVAX. Treatment rendered for the event was calamine lotion. There was no laboratory studies performed. The outcome of the event was unknown. The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
on May 4th 2022 accidentally administered an expired dose to a patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva520A, expiry date 30th April 2022) for prophylaxis.   On 4th May 2022, the patient received Menveo. On 4th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: Registered nurse accidentally administered an expired dose of Menveo to the patient. The reporter consented to follow up. Additional Supportive Information: The patients received vaccine post its expiry date, which led to expired vaccine used.
Developed fever of 100.6, chills and was tachypneic.  Presented to Hospital Emergency department on 1/8/21 at 6 am.  Discharged at  10am.
Stomach cramping; Stomach and intestines burning sensation.; Stomach and intestines burning sensation.; Feet hot and burning sensation.; Feet hot and burning sensation.; Back pain; Forgetting; Headache; Extreme fatigue; Stiff joints; This is a spontaneous report from a non-contactable consumer, the patient. A 41-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 in the left arm on 19Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), known allergy to penicillin and carrots. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included methylphenidate (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 20Apr2021 at 06:00, the patient experienced stomach cramping, stomach and intestines burning sensation, feet hot and burning sensation, back pain, forgetting, headache, extreme fatigue and stiff joints. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach cramping, stomach and intestines burning sensation, feet hot and burning sensation, back pain, forgetting, headache, extreme fatigue and stiff joints was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed an itchy mouth and throat, I was having difficulty swallowing.  I was never asked about my allergies.   I was administered the vaccine at 1501, and was released at 1509.  When they released me, I was feeling nervous but overall fine.  As I was driving home around 1515 I began having difficulty swallowing and the itchy feeling in my throat
A report has been received from a Physician concerning a child of unknown gender, who had been receiving Intraocular FLUMIST. FLUMIST started on an unknown date. The patient received FLUMIST inadvertently in the eye. The outcome of the event of inadvertent inoculation in eye is unknown. The report was considered to be non-serious by the reporter.
The vaccine refrigerator went out and the  MMR vaccines were compromised and were invalid at time of administration. No adverse effects were reported. We plan to revaccinate patient.
Severe vertigo, Nausea, racing heart, bruising, for 3 days