chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was administered a dose of improperly stored MMRII; The patient was administered a dose of improperly stored MMRII; no adverse event; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.     On an unknown date, the patient was vaccinated with an improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) via subcutaneous route, lot # S005249, expiration date on 20-FEB-2021 (formulation, strength, dose, frequency, route of administration, anatomical location, indication, lot #, and expiration date were not reported) that reconstitutued with Merck sterile diluent that did not undergo an excursion. No adverse effect reported.      The administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (46.9 degrees Fahrenheit) for 37 minutes. There was no previous temperature excursion reported. Data logger was involved.
This case was reported by a nurse and described the occurrence of pseudotumor cerebri in a 12 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date in August 2003, the pt received the first dose of Engerix B. At an unspecified time following the first dose of Engerix B, in 2003, the pt was seen by an opthalmologist and was diagnosed with pseudotumor cerebri. The outcome of the event is unknown. This case was considered medically serious (OMIC) by manfuacturer.
Patient was administered one dose of Fluad 65+ and Spikevax (moderna) by our pharmacy intern. The pharmacist was under the impression that the Spikevax that was administered to the paitent lost its integrity because it had been out of the fridge for more than 1 hour (but less than 24 hours). The needle tip was also already attached to the Spikevax syringe from Friday, which led the pharmacist to believe it also lost its integrity. Therefore the pharmacist administered a second dose of the Spikevax to the patient.
I was having difficulty with arrhythmia and my heart racing. I made 2 separate trips to the emergency room. The first time was December 05, 2022. When I went into my annual checkup the provider sent me because my heart rate and blood pressure were elevated. The placed me on a heart monitor and completed and there were no findings. The 2nd time I went, and they placed a heart monitor on me that I had to wear for 4 days. The spells were not at all consistent. I do not know the results of this testing yet. I was not prescribed with any medication. They reduced one of my medications. I am finally getting better. I have not had any racing events within the last five days. I think that I am 90% recovered.
One hour after vaccine patient said she became hot and was sweating. The site got red, swollen and started itching. She had a fever, headache and couldn't eat. She felt like she was going to vomit, patient took ADVIL to treat. Site red and swollen down to elbow.
Extreme pain at injection site.  Pain radiates down the arm, into the hand. Using the arm magnifies the pain.  Pain still exists after 1.5 months.  Have used ice, moist heat.  Have taken extra-strength Advil.
05/06/2022 I had stomach distress, vomiting for 12 hours. My blood pressure was high off and on.  I went to the ER the next day and had my gall bladder removed. Stayed overnight in the hospital. I was diagnosed 30 years ago with gall stones, but they did they did not want to take it out then. It hasn't bothered me until 05/06/2022.  I feel good now, just a little sore at the incision site.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On 17th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on left arm. The patient could not recall the time of day she received the 1st shot. The patient experienced a sore arm with the after the vaccine shot. The soreness lasted for 4 days. The patient's physician was her husband. This case has been linked to the case US2018GSK185723 (2nd dose case for the same patient), reported by same reporter.
Patient was administered a second moderna primary series after receiving both a pfizer primary series and moderna primary series. Provider mistakenly read the guidelines that a second dose of the same manufacturer was needed.
Patient reported rash to left hand side of body (upper chest, back, and side of torso) beginning approximately 6 hours after vaccine and ending roughly a day after receiving vaccine. Patient has not had a reaction to vaccine in the past.
Rash developed at injection site approximately 3 inches in diameter and warm to the touch. Slightly swollen and firm to the touch.  No pain. No discomfort.
Large red, hot, swollen, hot area on arm; on day 2 -5 moving down towards elbow on upper arm, same size and pain level, but not increasing in size
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (route, dose, anatomical location, lot # and expiration date were not reported). There was not concomitant therapy reported. No adverse effects reported. The reporter did not have the lot numbers of GARDASIL at the time of this report. This is one of several cases from the same reporter. Additional information has been requested.
Administered Bexsero after exposed to 29.8 F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Receipt Date: 13-SEP-2022 Reporter's Comment: The CMA (Certified Medical Assistant) reported that the patient received Bexsero vaccine which was exposed to 29.8 F. The reporter consented to follow-up via mail. Additional supportive information: The Bexsero vaccine was exposed to temperature 29.8 F, which led to incorrect storage of drug. This was one of the 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022132075:Same reporter. US-GSK-US2022132077:Same reporter. US-GSK-US2022132078:Same reporter. US-GSK-US2022132079:Same reporter.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 12-DEC-2016, the patient was inadvertently administered a dose of PREVNAR 13 (dose and route were unknown), instead of the indicated PNEUMOVAX 23 (wrong drug administered). No adverse effect was reported. Additional information is not expected as there is no consent for follow up.
Info has been received from a registered nurse concerning a 30 y.o. female w/no known allergies who on 11/5/01, was vax'd w/her first dose of Hep B vax recombinant. Concomitant therapy included multivitamins (unspec'd). On 11/5/01, post vax, the PT reported feeling tired, feverish, and somnolent. These Sx's continued for approx 3 wks. On 8/5/02, the PT was vax'd w/her 2nd dose of Hep B vax recombinant. On 8/5/02, post vax, the registered nurse reported that the PT experienced the same "constellation" of Sx's. As of 8/14/02, the registered nurse reported that the PT had not been treated w/any interventions. Add'l info has been requested.
Flushed face, itch, eyes and face slight pinpoint rash, red hands, swelling eyelids, lips and tongue. Sent to Emergency Room
Hot around injection area, Redness on upper arm. Nausea, headache Joint pain
RASH ON BUTTOCKS, STARTING ON ONE SIDE THEN SPREADING TO OTHER SIDE.
Pt recvd Hep B vax  31JAN92 & on 1FEB92 devel rash on face; no tx given fully recovered;
Patient felt flu like symptoms evening after the vaccine, was extremely fatigued the next day, at 3pm the next afternoon had sudden onset nausea, fainted and hit her head leading to a concussion, when she resumed consciousness she called 911 and was medivacked to the hospital with signs of stroke (no stroke was confirmed)
pt called in to c/o flu lik sx extreme diarrhea, stomach cramping, h/a;
Patient reports arm was sore and achy evening of flu shot. Continued to be more sore over next few days. 2 days after vaccine - arm was red and hot. Patient also says it feels hard & itchy. Patient considering seeing MD for possible cellulitis.
Patient is evaluated today because of complaint of 5 days of fever, headache, sore throat. Patient states: " 8 days ago, I got the vaccine. I had not been feeling good since then. I have sore throat, bad headaches. I have been dizzy and weak, and had stay in bed. I have been spitting up blood. I have red itchy spots all over. I also have raised itchy red bumps over the abdomen, that come and go ".  Start PredniSONE Tablet, 10 MG, 4 tablets daily x 4 days, then taper by 1 tablet every 4 days, Orally, Once a day, 16 day(s), 40 Tablet Symptoms probably related to Covid 19 vaccine; should probably not get the second dose.
Patient made appointment to receive the COVID moderna booster vaccination. Patient consented to vaccine and notified staff that she has had previous reactions to vaccinations, doctor recommended she still should receive this shot. Patient was informed to remain in pharmacy for 30 minutes for observation. About 10 minutes into the observation period patient disclosed to staff she was experiencing lip/tongue swelling. Pharmacy staff asked patient if she wanted benadryl but patient said she was not comfortable swallowing pills and wanted to have EMS assistance. EMS came on scene and ended up giving the patient the Benadryl tablets. The patient and EMS remained in pharmacy until patient's son was able to  get to her.
Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient had severe fear of needles. He was shaking before during and after vaccine. While in the waiting area, with the older brother and mom, he told her he felt like was going to faint. I told mom he was shaking from  anxiety but she wanted 911 called for both her son. Paramedics came and determined he was okay and his fear contributed to the shaking and weakness. He said he felt fine before leaving store. He returned home with mom and brothers.
Breakthrough COVID-19 case with symptom onset 8/27/2021: Shortness of breath/difficulty breathing, chest pain, and brain fog. Patient states that he felt he couldn't breathe, so he called an ambulance to take him to the hospital. Patient was taken to Hospital and was admitted on August 27th. PUI was there until he was discharged on August 30th. Patient states he has no idea how he was exposed to COVID. Patient states he stays at home since he is retired. Patient states he has no pre-existing conditions.
Extreme hair loss. Spiked a very bad response with my alopecia areata. Typically I have small bald patches on my scalp, apron 5-6 weeks after receiving my final Pfizer shot I noticed very large clumps of hair falling out. Now I have 75% bald.
Kidney stone; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney stones (She's gotten a kidney stone after taking a medication a long time ago. After she stopped taking the medication, the kidney stone went away.).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Kidney stone) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was reported as acidity medication. Treatment information was not provided.  Patient reported that she had gotten a kidney stone after taking a medication a long time ago. After she stopped taking the medication, the kidney stone went away. They said it was because of the acidity of the medication. They did not confirm that the kidney stones was from the Moderna COVID19 Vaccine.  This spontaneous case concerns a 54-year-old female patient with a relevant medical history of Nephrolithiasis, who experienced the unexpected serious (medically significant) event of Nephrolithiasis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the second dose of mRNA- 1273 vaccine. Nephrolithiasis was also reported at an unknown date after the first dose. However, very limited information was provided regarding clinical course and treatment of both events. The rechallenge is not applicable due to limited information. Previous episode of nephrolithiasis remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.      This case was linked to MOD-2021-395991 (Patient Link).; Sender's Comments: This spontaneous case concerns a 54-year-old female patient with a relevant medical history of Nephrolithiasis, who experienced the unexpected serious (medically significant) event of Nephrolithiasis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the second dose of mRNA- 1273 vaccine. Nephrolithiasis was also reported at an unknown date after the first dose. However, very limited information was provided regarding clinical course and treatment of both events. The rechallenge is not applicable due to limited information. Previous episode of nephrolithiasis remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
muscle pain; twitching in all extremities; ice pick like sensation in all muscle groups, pin pricking like sensation all over the body; This is a spontaneous report from a non-contactable consumer. A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included hypothyroid. Concomitant medications included unspecified Thyroid medication. The patient experienced muscle pain, twitching in all extremities and ice pick like sensation in all muscle groups, pin pricking like sensation all over the body on Mar2021. The events resulted in emergency room visit and physician office visit and were assessed as disability by the reporter. The patient did not received any treatment for the events. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness onset approximately 30 minutes after shot, resolved after laying down for a while.  Development of fever, body aches, and chills by about 10 pm. Fever went from 99.5 at 10 pm to 103 at 5 am (was wrapped in blankets to try to control chills). Attempted to bring fever down with cold washcloth and drinking ice water, which dropped it to 101 within an hour, but then it went back up to 102.7 at about 6:30 am. Chills have somewhat improved, muscles still quite tender. I did not sleep all night secondary to these symptoms.
tested positive for COVID after receiving Pfizer COVID 19 vaccinations; tested positive for COVID after receiving Pfizer COVID 19 vaccinations; Long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male 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; bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2023, outcome "unknown", described as "Long Covid"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "tested positive for COVID after receiving Pfizer COVID 19 vaccinations". The clinical course was reported as follows: The patient informed that he was fully vaccinated and had boosters, then he got COVID about two to three weeks ago. Since then, he has had Long COVID; consisting of a low grade fever, heavy chest (not painful, just heavy breathing). He had a chest X ray and that looked fine. His D-dimer was a little elevated. CT angiogram was scheduled for 11Oct2023. He was put on a blood thinner. The patient underwent the aforementioned laboratory tests and procedures.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314650 same patient, different vaccine dose/AE;
Patient came for in for first covid shot at the pharmacy excited, after giving her the Moderna shot we billed it and insurance came back saying that she already had her limit. We checked and it stayed she had received  it March and April of 2021. The patient was approached and asked if she had received her shots and she said she had not and do not remember and would have to contact the other facility and her son. She was given all of the information for the other facility and told that a third shot is not recommended and we do not know what her side effects will be.
vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    Case contains the information regarding patient 90 of 100 reported.  Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the HCP.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Severe Thyroiditis. Did not seek care immediately as it seemed like a bad muscle pull in the neck. Took quite a while to get tests and to get a specialist appointment. Much improved but still undergoing tests to check for permanent damage.
After my second shot of Covid19 vaccine, I had fever, body aches,vomiting, loss of taste and weakness.It lasted for 3 days and I slowly regained my normal health. I still had loss of taste and I thought I will regain my taste in a couple of days. Unfortunately , it did not completely come back.I can only taste if food id extra extra salty or extra extra sweet. I it same with spicy foods.So , on the 11th or 12Th of March , I called Hopkin's covid19 hotline. I spoke to a nurse and she advised me to contact VAERS and report my condition.
headaches, weakness, and "some coughing."; headaches, weakness, and "some coughing."; headaches, weakness, and "some coughing."; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient (wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunization. The patient was working in hospital, they provided the vaccine and the nurse gave her the vaccine. Next shot will be 3 weeks after that on 07Jan2021. The reporter thought that the patient was the height of the patient was 5 (feet) 6 (inches) and the weight was 68 kg. The patient had no other medical condition or concomitant medication. On the 2nd day on 18Dec2020, the patient experienced headaches, weakness, and "some coughing." The patient was taking acetaminophen (Tylenol) 500 mg every 6/8 hours as treatment. The reporter wanted to know if there was anything his wife can do to get rid of these side effects, how long it would last, and what kind of precautions she has to do. The patient was still have them. Just not getting worst or not getting better somehow. She had test for COVID 19 around 09Dec2020 and she was negative. The outcome of the events was not recovered.