chrisvoncsefalvay/vaers-outcomes huggingface dataset:
then she felt shakey; see stars; legs feel heavy; got very dizzy; rapid heart rate; tingling through her legs; had a little bit of chills; This is a spontaneous report from a contactable consumer reported for herself. A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 09:00 (age a vaccination: 46 years) as dose 1, single for covid-19 immunisation. Medical history was re-ported as None. There were no concomitant medications. Patient did not receive prior vaccinations within 4 weeks. The patient experienced got very dizzy, rapid heart rate, tingling through her legs, had a little bit of chills, see stars (feeling abnormal), legs feel heavy on 19Mar2021, then she felt shakey on an unspecified date. The patient underwent lab tests and procedures which included heart rate was increased on 19Mar2021. The reporter got her first dose that morning about 9:00 am in (State Name) she went to (Name), it was a drive through. The reporter was feeling better now but the first 2 minutes after the shot she felt like she was going to black out, she had a rapid heartbeat, really dizzy almost like she was seeing stars. Right after that she called someone over. The caller's legs felt heavy and tingly. The caller was able to drive home, she was feeling a lot better and was still a little dizzy. She was concerned about her second shot; she will not drive herself there. On the chart it had severe reactions- she did not have swelling, or shortness of breath or a rash. She wants to know "if she should get the second dose?" In this chart from the place, it says a severe allergic reaction would happen within an hour of getting the first dose- the reporter only had the dizziness and rapid heartbeat, it could be anxiety. Then at home she was really dizzy, now she was in bed had a little bit of chills, and the dizziness. The caller has 2 out of 5 of the severe risks. She knows someone who had a reaction on the first dose but not with the second dose. She mentioned that she rarely gets sick a lot it could be her strong immune system causing this. The reporter was lying in bed because she feels like her equilibrium was kind of off, not flu like symptoms. The seeing stars quickly went away, then she felt shaky. The reporter has been drinking a lot of water and took a couple of Tylenol and has eaten lunch.  The outcome of got very dizzy, had a little bit of chills, legs feel heavy was not recovered. The outcome of rapid heart rate was recovering. The outcome of tingling through her legs, then she felt shakey, see stars was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient stood up to ask where the bathroom was about 5 minutes after receiving his shot, he felt dizzy and light headed and passed out.  An employee was nearby and was able to gently lower him to the floor.  He was unconscious for only a few seconds, he was light headed and sweating a lot.  He said he felt fine, but after a minute felt lightheaded again and had to sit down.  We got him some water and then the paramedics arrived.  They checked his blood pressure and sugar level and took him to ER
Patient received doubled dose of vaccination in error. No adverse reaction has occurred. Manufacturer and disease control did not recommend any further action unless adverse reaction should occur.
07:00 PM 12/15/20 l arm very sore, awoke at 01:00 am with chills, severe arm pain, headache, stuffy nose, temp 101.9, body aches - arm, head; Tylenol 1000mg - no much relief
This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse reports that 13 patients received FLUARIX recently after the vaccine was stored at -0.4C. No additional information is known at this time.
Pt. received inactivated H1N1 vaccine.  Was held as she'd never had a flu shot before.  Approx. 6 minutes after vaccine developed heaviness of chest & funny feeling in throat.  No hives, wheezing or difficulty breathing.  Ambulance called and transported her to Medical Center.  MD gave Benadryl, Solu-Medrol, Pepcid p.o. and prednisone.  Diagnosis:  Reaction to H1N1 Vaccine.  Patient states had similiar reactions when taking Toradol and a certain brand of oral Acetaminophen. Was treated and released.
Narrative: Veteran contacted telephone triage requesting appt with provider for c/o nausea and body aches since receiving his 2nd covid vaccination 2 days ago.  Veteran states "I had similar reaction after I got the first vaccine but it's worse now. I just ache all over and I'm having nausea on and off. Plus the spot where I got the injection is a little swollen too." He denies feeling feverish, coughing or  difficulty breathing. Please advise, thank you. Class Code: Other specified counseling. Patient/Caller agrees with plan. **Veteran was notified that this visit may include telephone and/or virtual video care appointment. VCC: Veteran does not qualify for VCC due to inability to connect, personal preference, no email address, or no VCC provider available. Caller/Veteran advised to call facilities  VA Clinical Advice Call Center or seek immediate medical attention for new or worsening symptoms.
Pain at injection site. Unable to raise arm or bring arm behind back due to pain at injection site. Pain persists despite several months from injection.
Sore shoulder and upper arm, developed into increased pain, numbness, immobility over next several days, up to and including today 10/20/2014.
In late April 2023 I had a very sore throat, and it lasted several days.  I had a telehealth visit.  I began taking amoxicillin.  I had another visit with an in-person doctor.  I tested negative for COVID-19 and the flu.  After another 5 days I began to feel better but fatigued and a bit congested.
Approximately 1 hour following vaccine a mild headache started and persisted through the evening.  At approximately 11:11 PM I woke with uncontrollable chills and persisting mild headache as well as muscle aches.  Temperature was 98.7.  I took 1000mg Tylenol for muscle aches and chills.  Chills have not yet subsided.
Pt received first dose Pfizer Lot #EW0167 on Aug 5, 2021; received second dose Pfizer Lot #FE3592 on Oct 4, 2021; received third dose Pfizer Lot #FJ6369 on Jan 26, 2022. Provider mistakenly used first dose date to allow for booster (3rd dose). This would be five weeks earlier than recommended by CDC. No adverse effects noted. Patient was told she had received booster early, acknowledged understanding. Patient proceeded to go to work after vaccine administration.
Restless sensation in his body; like having sunburns, face arm leg burning, he calls it paresthesia; Severe pain in the arm; Fatigued; Very tired; Intense nausea; Extremely dry mouth; Thirstiness; Couldn't sit still; Burning feeling skin; Felt like having the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like having the flu), RESTLESSNESS (Restless sensation in his body), GAIT DISTURBANCE (Couldn't sit still), SKIN BURNING SENSATION (Burning feeling skin) and SUNBURN (like having sunburns, face arm leg burning, he calls it paresthesia) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included TESTOSTERONE (ANDRODERM) and SERTRALINE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like having the flu), GAIT DISTURBANCE (Couldn't sit still), SKIN BURNING SENSATION (Burning feeling skin), DRY MOUTH (Extremely dry mouth), THIRST (Thirstiness), FATIGUE (Very tired) and NAUSEA (Intense nausea). On an unknown date, the patient experienced RESTLESSNESS (Restless sensation in his body), SUNBURN (like having sunburns, face arm leg burning, he calls it paresthesia), PAIN IN EXTREMITY (Severe pain in the arm) and FATIGUE (Fatigued). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like having the flu), RESTLESSNESS (Restless sensation in his body), GAIT DISTURBANCE (Couldn't sit still), SKIN BURNING SENSATION (Burning feeling skin), SUNBURN (like having sunburns, face arm leg burning, he calls it paresthesia), DRY MOUTH (Extremely dry mouth), THIRST (Thirstiness), PAIN IN EXTREMITY (Severe pain in the arm), FATIGUE (Fatigued), FATIGUE (Very tired) and NAUSEA (Intense nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT RECEIVED A THIRD DOSE OF SHINGRIX ACCIDENTLY.  PATIENT REPORTED TO THE PHARMACY NEXT DAY STATING HE HAS CHILLS, BODY ACHES/SORENESS, AND COLD SWEATS
Following  dose #1 of COVID-19 vaccine (Pfizer), patient developed tingling in lips. Patient monitored for 30 minutes total. By the next day, patient reported that symptoms had completely resolved. Of note, patient has multiple sclerosis and reported that lip tingling is consistent with MS flare.
Accidentally administered High Dose flu vaccine to a client not yet 65 years old. No specific adverse effects from this flu shot according to client.
On 12/13/21, 44 yo F requested a booster dose of COVID-19 vaccine. Pt's initial vaccination was completed on 04/30/21 with COVID-19 Moderna vaccine. Pt consented to booster dose with COVID-19 Pfizer vaccine. At 1634, 0.3 mL was injected into pt's left deltoid (Lot #FG3527; exp: 2/28/2022; NDC #59267-1000-1). After injection. pt was held for 15 minutes post-injection monitoring. After 10 minutes observation, pt reported throat and chest tightness with feeling of warmth and dizziness. Vitals assessed as stable. A STAT ECG was done with results of Vent. rate 74 BPM, PR interval 158 ms, QRS duration 82 ms, QT/QTc 422/468 ms, P-R-T axes 51 30 44. Pt administered diphenhydramine 50 mg PO. Pt had an episode of syncope. EMS was called and pt was transported to hospital.
Case number PHEH2014US020511, is an initial spontaneous report from a nurse received on 13 Oct 2014. This report refers to a 25-year-old female pregnant patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUCELVAX (batch number: 015011A) intramuscularly on 09 Oct 2014. It was reported that the patient was pregnant and no adverse event was reported.
Patient received an expired dose of Havrix; 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 44-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On 24-MAR-2023, the patient received Havrix. On 24-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Patient received an expired dose of Havrix). 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 Recipt Date: 27-MAR-2023 HCP (healthcare professional) reported that a patient received an expired dose of Havrix. The reporter consented to follow-up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used. This case has been linked to the case US2023AMR045953 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR045953:Same reporter/different patient
Fever, sore throat, congestion, headache, nausea, chills, fatigue.
My armpits swelled up, left arm worse than right. The urgent care nurse described it as a "softball sized lump". I had sharp acute pain in my arm when moving it. The urgent care doctor presumed that the lymph node was so big that it was pushing on a nerve and causing the pain. They gave me a steroid shot and that helped. My armpits eventually were swollen to the same size and have not gone down in size. I have been to the doctor twice for it and she said that she does not believe the lymph node is still enlarged. She thinks that it is now fatty tissue where it swelled. The lumps are about baseball sized in each armpit. They have not changed since about 2 weeks after the shot.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 27 month old patient who received FLUZONE QUADRIVALENT (batch number UJ025AC, expiry date, 30 June 2018) left deltoid on 30 june2019. It was a case of actual medication error due Extra dose administered Aand Drug administration error as 27 month-old child, received FLUZONE QUADRIVALENT (0.5ml) in her left deltoid. The child pulled away during injection. The MA continued injecting and states that all but a few drops went in, but child's mother is MD and states that only about 0.25ml. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Shingles.  On the evening of the vaccine, he had a low grade fever and chills (from approximately 7 pm to 1 am).  Two days later, he developed shingles.  They started as a red rash spot in the middle of his back, approximately the size of 2 quarters, 2 days after the vaccine.  On the 3rd day, the red rash was apparent along the right side of his midsection.  Blisters started to appear on day 4.   He phoned his doctor and provided photos for a virtual patient visit, and the doctor diagnosed shingles.  The area affected is both itchy and painful.  The doctor prescribed Valocyclovir.   After taking the medication for 3 days, the blisters started to dry out and scab.   The itching and pain are still present but reduced from their peak.
ACUTE RESPIRATORY FAILURE 4/8/2023 DYSPNEA ACUTE RESPIRATORY FAILURE 4/8/2023 CHF EXACERBATION, UNSPECIFIED ACUTE RESPIRATORY FAILURE 4/8/2023 LATE EFFECT OF STROKE ACUTE RESPIRATORY FAILURE 4/8/2023 MIDDLE CEREBRAL ARTERY SYNDROME ACUTE RESPIRATORY FAILURE 4/8/2023 ELEVATED LIVER FUNCTION TEST
Information has been received from a physician concerning multiple young children patients who on an unspecified date, were vaccinated orally with a 2ml dose of ROTATEQ (doses and lot # were unspecified). Physician reported that in December 2010 there was a hospital outbreak of Rotavirus that was seen where in over 12 cases and over half had been fully immunized with "3 doses series" of ROTATEQ. Patients were hospitalized for an unknown amount of days. It was reported that on an unspecified date a "serotype analysis" was made (results not reported). At the time of the report patients' outcomes were not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
I had extreme muscle pain in my thigh muscles throughout the night and the next day.; Initially slight case of raised bumps on opposite arm; I feel exhausted no matter how much coffee I have had today, and it has been plenty; I woke up, ate breakfast and fell back asleep until 1:30 pm. Felt OK for two days. Can't seem to stay awake today. Woke up late, fell back asleep until 1:30 pm; This is a spontaneous report was received from a contactable consumer (patient). A 67-year-old non-pregnant female patient received 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, administered in left arm on 04Mar2021 as 1st dose, single dose (at the age of 67) for covid-19 immunisation. The patient's medical history included allergy to Quinolones. Patient had not received any other vaccine prior four weeks of vaccination. Patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included mirtazapine (MIRTAZAPINE), oxcarbazepine (TRILEPTAL), lamotrigine (LAMOTRIGINE), diazepam (DIAZEPAM) and zol (as reported) taken for an unspecified indication. On 04Mar2021 at 22:45, the patient had experienced initially slight case of raised bumps on opposite arm and had extreme muscle pain in my thigh muscles throughout the night and the next day, woke up, ate breakfast and fell back asleep until 1:30 pm. The patient felt okay for two days and could not seem to stay awake today. Woke up late, fell back asleep until 1:30 pm. The patient felt exhausted no matter how much coffee she had today, and it has been plenty. Since vaccination patient not tested for covid-19. Patient has not received any treatment for the events. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
After receiving the vaccines at 2:30pm 9/24/2022, the patient stood up from the chair, in which then he experienced syncope and fainted and fell to the ground. Patient regained consciousness within seconds, and sat on a chair and was observed by the pharmacist for half hour after the incident. Patient did not experience any further lightheaded or any pain anywhere from the fall. Patient did not hit his head. After half hour patient was driven home by his mother. Pharmacist followed up with the patient at 4pm. Mother stated patient was doing fine and has not experienced any other issues.
Flushed skin (red, hot face/ears/neck( Tingling lips and tongue Throat felt coated with mucous
2nd Moderna Vaccine past 42 days; 2nd Moderna Vaccine past 42 days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna Vaccine past 42 days) and PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccine past 42 days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Inappropriate schedule of vaccine administered on 05-Apr-2021, Drug allergy (Thiopental sodium) and Inappropriate schedule of vaccine administered on 05-Apr-2021.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccine past 42 days). On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna Vaccine past 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccine past 42 days) 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 considered INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna Vaccine past 42 days) and PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccine past 42 days) to be possibly related.    The concomitant medications was not reported.
She got her vaccine, she was going to expect some pain.  She started getting a chronic pain from her left shoulder, up to her neck like a tired feeling which was around 8:30.  It started as a dull pain, then started increasing.  When she went to bed she felt like a heaviness in her left side from the armpit to the breast area, difficulty breathing.  She did not know if it was her heart or her lungs.  It felt funny, every 5 minutes she would get a shooting pain, like a sharp shocking pain.  She got a little bit of reflux and took a TUMS so that she could rest, but could not due to the pain that kept coming on.  When she got up in the morning she took Ibuprofen to help.  It started happening again and felt dull pain a  again and would come back, pain, then back to excruciating pain that she could not stand up after she came back from work.  She did not want to go to the hospital as she does not want a big bil.  She did not go to work today due to the fatigue.  She bought a Salonpas patch, which did help with some of her pain.  She has been getting reflux everytime when she eats, but does not have a problem with reflux.    She saw her doctor on the 15th for routine check up, has taken flu shot for years, and this is the first time that she had been giving a flu shot and felt so bad.  She is still getting the dull pain up her shoulder, in the back of her neck that feels like fatigue.  Really bad pain on the side of her breast like a pulled muscles inside, which is very very painful.  The breathing is hard for her to breath and catch her breath.  She has not had any history of breathing problems either.  She had just had her physical on the 15th and everything was fine until she took the flu shot on Wednesday.    She called her doctors office and they could not see her, and not go to the UC for increased bills.
Incorrect vaccine for age--Janssen vaccine given to a 16 yo.  No AE.
Rash on Stomach, Lasted One Night - was gone in the morning.  No treatment.
Entire upper arm and shoulder area swelled to more than twice the normal size.  The injection site turned black.  the doctor prescribed Zyrtec and said not to report issues.  After five days the swelling went down.  The child's behavior changed with/after the vaccination.  No follow up was done.  No labs.  Doctor believed it was related to family situation, blew off concerns.  My child's personality changed after this event.
This spontaneous report was received from a medical assistant and refers to a patient of unknown demographics. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 18--SEP-2017, the patient was vaccinated with a dose of VARIVAX injection, lot # M041081 with expiration date on 06-OCT-2017 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 53 hours. No previous excursions were reported. Digital Data Logger was involved in recording the temperature excursion. The vaccine was reconstituted with correctly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1709USA010333:
Left pharmacy and almost immediately felt hot, had stomach ache and headache; was able to drive home but slept for rest of the afternoon; tongue also swelled on one side, but not throat, took 1-2 BENADRYL and swelling eventually subsided; symptoms resolved in 24 hours.