chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 17th March 2019, the patient received the 1st dose of SHINGRIX. On 17th March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 18th March 2019, the patient experienced fatigue and headache. On an unknown date, the outcome of the pain in arm, fatigue and headache were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for himself. The patient received SHINGRIX into the left arm and experienced a hurt left arm in the afternoon. In the next morning, the patient experienced fatigue or tiredness and slight headache. On the day of reporting, hurt arm was worsened. The patient did not provide the consent to follow up.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". 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: Linked Report(s) : US-PFIZER INC-202300269511 same patient/drug, different dose/AE;
Rash, urticaria pruritus and nausea vomiting. Diphenhydramine 50 mg once, epinephrine 0.3 mg once, prednisone 60 mg once.
Swelling hives itching - sent to ER. 1 HR after receiving vaccine symptoms began - f/u 11-23-15.
Monday 1-25-2021 #2 vacination COVID--Onset 4pm body aching then at 9pm fever 101 and felt tired, achy. Following day tired and less aching.
Patient described 1 week of sore arm which felt weird after the vaccination.  Then, eight days after the shot, her hand was shaking for a few minutes and she could not stop it. Symptoms resolved by themselves.
Fever 101, extreme nausea (no food for 24hours without vomitting), chills, fatigue
Woke up at 1 am with legs cramping then I went to the bathroom and felt like passing out. I stood up and passed out landing on my back. I was sweating profusely and hyper ventilating. I crawled to bed where I continued to have convulsions through out my body for the next hour. The injection sight was swollen and hurt extremely bad. 10 times worse than the flu shot.  These symptoms have gone away and the soreness is slowly getting better.
patient with syncopal episode about 30 minutes after influenza vaccine. Was at home, EMS called. EKG normal, glucose normal, patient returned to baseline quickly (no post-ictal state). No concern for seizure activity. Had fever the following day which resolved within 24 hrs, approximately.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patient were vaccinated with doses of RECOMBIVAX HB (lot # L022261, expiry date: 01-APR-2016) (dose and route unspecified), which had been improperly stored under 10 degree centigrade for 72 hours, and later under 1 degree centigrade for 8 hours. Other suspect and concomitant therapies were not reported. This is one of several reports received from same source. Additional information has been requested.
On 3-27-21 patient returned to clinic for routine appointment for wound care.  At this visit patient reported that she had diffuse pain along the right side of her chest, midaxillary area, as well as a painful rash to her right upper back.
patient recieved flu shot on 10/24, patient states on 10/30 was on the train at 6 a.m started to feel pain, nauseaous, and a bump where he had his injection.  I advised patient to follow up with md and to take advil or tylenol to help with pain. I did follow up with pt on 11/2 stated he was feeling better and pain has subsided.
When he was asked his age he stated he was 11, having forgot he just had a birthday last month and is now 12. He got the dose for children and should have gotten the adult dose.
Severe headache beginning after several hours, lasting about 24 hours; swelling of upper arm with redness and heat lasting six days, soreness, especially to touch,  lasting 5-6 days
Redness, swelling, knot, sore, warm to the touch, inflamed.
T of 104.6 /w local rxn characterized by redness & swelling. Local & general adenopathy. Vomiting. Swelling & redness was from shoulder to elbow,swollen knot the size of a fist for X 3 days.
Information has been received from a physician concerning a child who was vaccinated with Varivax and developed a mild case of breakthrough chicken pox. (WAES # 0604USA00025) Subsequently, the patient's father, a 34 year old male, developed a full blown case of chicken pox and had to be hospitalized for 5 days. No additional information was provided. Additional information ahs been requested.
Myalgia, Fever, NauseaVomiting, left arm pain Narrative:
pt was waiting for Flu vaccine. Rph gave him Covid -19 ( PFIZER ) vaccine instead of flu..Pt. got 1st and 2nd dose of covid-19 vaccine ( MODERNA) 7 months ago.  ( Rphs had 4 people waiting for covid  shots and 1 for flu.so by mistake gave the last customer covid-19 shot)
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. On 23-JUL-2014 the patient was vaccinated with RECOMBIVAX HB (dose and lot # were not reported), intramuscular which underwent an unsupported temperature excursion. No adverse effects reported. Additional information has been requested.
Six days following vaccination upon his birth, pt began having partial/focal petit mal seizures on a daily basis. Seizures range in length from 10-60 seconds each and occur 3-40 times per day. EEG indicates he is also having sub-clinical seizures. Sezures are thus far uncontrolled by Phenobarbital, Tegritol, Trileptol, Zonegran (zonisamide) and Clonipin. The 60 day follow up received on 12/31/03 states pt continues to have uncontrollable seizure, 20-30 each day. His MRIs are clean, "all metabolic" tests continue to come back negative. Doctors cannot determine what is causing the seizures. Medical records state developmental delay, difficulty swallowing.  msv
Injection site turned red and hot, and swelled to size of half a golfball. Gradually went down over a course of 4 months.
Fatigue; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm  on 26Feb2021 at 12:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gastroesophageal reflux disease (GERD) and postural orthostatic tachycardia syndrome (POTS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexlansoprazole (DEXILANT), budesonide; formoterol fumarate (SYMBICORT) and salbutamol (ALBUTEROL); all for unknown indications from an unknown date and unknown if ongoing. The patient previously took sulfamethoxazole; trimethoprim (SEPTRA) for an unspecified indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 at 15:00, the patient experienced fatigue, chills and headache. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, chills and headache was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
I experienced the next day, had chills and slight fever, lasting 6 hours. Then on April 8 2021, I developed shingles and I went to urgent care on 04-12-2021, started with rash on my face. No medical tests were done.   Today I am still dealing with shingles.
Swelling of jaw line and neck black and blue along jaw line, rash, swelling of lips and tongue.
This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult female patient who received SHINGRIX. The patient's past medical history included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX one month ago after recurring Shingles. The patient was told that she will never get them again. The patient experienced Shingles and currently laying in bed and pissed off with the worst case of Shingles ever had. The patient asked whether she should receive the booster dose of SHINGRIX.
Aches in all joints; diarrhea; nausea; shortness of breath. Absolutely no energy.
Pt admitted to hospital 11/8 for thrombocytopenia with plt count of 12k.  Pt notes receiving COVID-19 booster and flu shot 2 weeks prior to admission (flu shot documented as given 10/27 and COVID-19 booster 10/31).  Underwent extensive workup, which noted elevated ANA levels.  Pt noted previously high ANA levels 8/2022 during autoimmune workup.  Pt presumed to have vaccine induced ITP and was treated with dexamethasone.  Plt count recovered and pt was discharged from hospital in stable condition on 11/11.
Day of injection for 2 days, arm sore, however starting 8 days after injection arm is now red and sore at injection site.  This is new.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which was included with treatment Paxlovid from 08Dec2022 to 13Dec2022. Clinical Course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No other medication taken in 2weeks. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female who's daughter was vaccinated with a dose of Varivax on 19-APR-1996. It was reported that the patient's daughter developed chickenpox on 02-APR-2006 (WAES# 0604USA00617) which she then transmitted to her. Additional information has been requested.
Shortly after receiving the booster shot patient felt dizzy and hot followed by syncope and  seizure. patient then experienced a second episode of syncope and seizure minutes post the initial episode. patient had no prior history of seizures. patient was transferred to the emergency department for evaluation.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 11:25 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Jan-2022 at 11:25 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Jan-2022 at 11:25 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Vial was refrigerated on 17-Jan-2022 at 36 F and no temperature excursion happened.   Reporter did not allow further contact
Patient was administered Pneumovax and immediately after receiving vaccine he became diaphoretic and tachycardic. Patient was transported via ambulance to the ER for evaluation. Symptoms: 1. Tachycardia (2) diaphoresis.
Immediately and for the rest of the day and into the next day- sore left arm. The night of the injection and into the following morning (now) fatigue, congestion, tightness in chest (hard to breathe) and headache.
presents to ED; pt in respiratory failure secondary to community-acquired pneumonia; COVID test came back positive; COPD exacerbation; sepsis; prolonged QT interval; hypokalemia; O2 supplementation; initiated Remdesivir, Decadron, Baricitinib; pt's condition worsened; code blue was called; ACLS protocol, pt intubated; pt passed away in the ED.
I got the second dose of the vaccine on May 11th 2020. I am currently on my second week for completing the vaccine. When it all started I was just laying down on my couch watching Netflix with my laptop on my lap (this was Thursday night, May 20th). My leg fell asleep but I didn?t think anything of it because once I started walking around it went back fine. However, On May 21st, Friday morning I was having serious pain in my left thigh. I believed it was a muscle strain. I did a cold compress, warm bath and took Tylenol from Friday to Saturday. I thought it got better but however by May 23rd, Sunday night I was incapable of walking on my own and needed assistance just to go to the bathroom. On May 24th I went to Urgent Care and they stated that I may have a blood clot so I went to the ER. While at the ER they stated I had a massive blood clot that would need a procedure done to remove it and was later admitted into the hospital and scheduled for the procedure. The blood clot travels from my groin to my ankle on my left thigh. They stated the reason for my blood clot would of been because of my birth control. And it?s possible reaction to me also taking the Pfizer vaccine. I have been on birth control for over 5 years and have not had any problems until now. I also do not have any history or family history of blood clots. I did not hit my thigh or have done any exercises for this to occur.
Pt seen in our office on 12/28/2001. Stated she received flu vaccine 10 prior. Diagnosed with herpes zoster. Treated with Acyclovir, prednisone and Vicodin.
This spontaneous report as received from an other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL 9 (lot # N014470, expiration date 27-JUN-2019) for prophylaxis. This vaccine was exposed to 21 degrees Celsius (°C) for 1.5 hours. No adverse effects were reported in the patient. There was no previous temperature excursion. The call was made because there was a "data logger".
Dizzy / Dizziness; Nauseous; Vomit; Fell in bathroom a few times; Feeling hot; Muscle aches; Sore arm/feet hurt; Severe flu like symptoms; Headache; Chills; Feeling off center; vertido; hyperventilating; not able to catch her breath; feel thristy; breathing more deeply and through her mouth; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer. Previously administered products included Shingrix (received 1st dose 2 months ago,refer case US2019AMR168728).   In September 2019, the patient received the 2nd dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, headache, chills, muscle pain and feeling hot. On 13th September 2019, the patient experienced dizziness, nausea, vomiting and fall. In September 2019, the patient experienced feeling abnormal, vertigo, hyperventilation, shortness of breath, thirst and mouth breathing. The patient was treated with ranitidine, antiinflammatory/antirheumatic products (Anti-Inflammatory), non-drug therapy (Heating Pad (Nos)) and non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, chills, nausea, vomiting, muscle pain, fall, feeling hot, feeling abnormal, vertigo, hyperventilation and shortness of breath were recovered/resolved and the outcome of the influenza-like symptoms, thirst and mouth breathing were unknown and the outcome of the headache and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, headache, chills, dizziness, nausea, vomiting, muscle pain, fall, feeling hot, feeling abnormal, vertigo, hyperventilation, shortness of breath, thirst and mouth breathing to be related to Shingrix.  Additional details were provided as follows: The patient had injections in her right arm.  The patient received Shingrix and had sore arm and experienced severe flu like symptoms. All the symptoms she experienced are listed in this report under adverse events.  The patient felt so dizzy that she fell in her bathroom a few times. The dizziness caused her to be nauseous and vomit. She has been taking Ranitidine and anti-inflammatories and they have helped with the nausea and muscle aches. All symptoms have resolved except for headache, dizziness and nausea which are still present on and off. She described it as still feeling off center. She used a heating pad and ice packs for the muscle aches. She said her feet also hurt but they always hurt. The reporter stated that the dizziness has gotten better and was more like vertigo at the time of reporting. She states she has been drinking alot and feels thirsty since receiving Shingrix. It could be that she was breathing more deeply and through her mouth, hyperventilating, not able to catch her breath when she was vomiting. The reporter consented to follow up.
This spontaneous report was received from a pharmacist regarding a male patient of unknown age. On an unknown date, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously (lot number was not reported). No concomitant medications were reported. On an unknown date, the patient received ZOSTAVAX and got a rash at injection site that was itchy and a red patch, no treatment was given. The patient sought medical attention. On an unknown date, the patient recovered from the events. This case is linked to 1209USA011205(same reporter link). Additional information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of hallucination in a 83-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th May 2018, immediately after receiving SHINGRIX, the patient experienced hallucination and memory disturbance. On 5th May 2018, the outcome of the hallucination and memory disturbance were recovered/resolved. The reporter considered the hallucination and memory disturbance to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported on behalf of the patient. At 16:10, the patient received SHINGRIX on the left arm. Immediately after receiving SHINGRIX, the patient experienced hallucinations. The patient stated, during this hallucination she imagined that she drove her car through her neighborhood and could visualize the street signs. She could not remember where she parked her car and that there was a time period of 20 minutes where she had no recollection of what happened. The patient believed that this event was caused by the vaccine. However, the pharmacist did not believe this event was caused by the vaccine.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # N008828, expiration date 16-MAR-2019 (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018. (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.); Sender's Comments: US-009507513-1712USA008050:
Information has been received from a consumer, for GARDASIL, a Pregnancy Registry Product, concerning her 17 year old daughter with allergic reaction to antibiotics, acne and no pertinent medical history who in 2008 was vaccinated with a dose of GARDASIL. Concomitant therapy included acne medication and NAUSEA. The consumer mentioned her daughter's pap smear was abnormal and believed it was due to GARDASIL. She also mentioned the doctor did not want to conduct the biopsy during her daughters pregnancy. A blood work was performed and the outcome was unknown. It was reported that the patient sought unspecified medical attention. The patient was 9 weeks pregnant at the time of the adverse event occurred. The patient's last menstrual period (LMP) was approximately 12-JUN-2009. Expected date of delivery (EDD) was approximately 19-MAR-2010. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Has 4" diameter reddened area at injection site.  Area is warm to touch and swelling present.
No reaction until 10pm.  Injection site became sore and tender,  Had chills during the night.  Following morning was running 102 degree temperature,  heart rate was 107 and blood pressure was 90/60.  Took two 650 mg  tylenol and  temperature was back to normal  within 5 or 6 hours.  Heartrate never got below 102 until late afternoon and blood pressure was still low at bedtime.  Uneventful night and all was normal the following morning.  No reaction since.