chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a register nurse, refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored VAQTA, (strength, dosage, route, and lot# were not reported). None symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
ARM PAIN; HORRIBLE HEADACHE; NAUSEATED; This spontaneous report received from a vaccine facility concerned a male 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced horrible headache, nauseated, and arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible headache, nauseated and arm pain was not reported. This report was non-serious.
Pt has swelling/pain over the injection site next day developed low back pain/dizziness/weakness sent to the ED due to symptoms.
she has allergies and possible allergic to the COVID vaccine and also might have taken Xanax after getting the COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: allergies. Concomitant medication(s) included: XANAX. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "she has allergies and possible allergic to the COVID vaccine and also might have taken Xanax after getting the COVID vaccine".  Additional information: Patient mentioned that she has allergies and possible allergic to the COVID vaccine and also might have taken Xanax after getting the COVID vaccine. Caller wanted to know the correct number for Viatris regarding Xanax. Also mentioned that she haven't gotten her booster dose because they didn't want to give it to her because she is allergies, she knows there is a clinical trials ongoing about allergies and wanted to know what is the outcome.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. called 4/3/14, (1 month post vax) to report an area of rash, redness, itch at site of injection. Unsure when it began. Has not seen a doctor as yet.
headache,nausea.  Headache, bodyache, nausea and chills since this morning. Had J&J shot yesterday. HPI:21-year-old male chief complaint of chills, headache fever and nausea.  He reports symptoms started in the evening after getting his Johnson & Johnson coronavirus vaccine.  He took Tylenol yesterday which helped but he has not taken anything today.  21-year-old male WITH CHIEF COMPLAINT OF FEVERS CHILLS AND HEADACHE.  oN ARRIVAL PATIENT IS AFEBRILE nontoxic and in no acute distress.  Heart regular rate and rhythm.  Patient with no focal neurologic deficits.  Plan to treat supportively vaccine reaction.  Patient in agreement with plan.
chills; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). At the time of the report, CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Patient experienced doubled resting heart rate the next morning (11/16/22). Heart rate was 120 bpm and lasted for 3-4 hours. Denies dizziness, lightheadedness. Had headache, fatigue, and nausea. Took a nap later that day and heart rate was normal. Hasn't happened since.
Information has been received from a nurse through the Pregnancy Registry for GARDASIL concerning a 16 year old female, with a history of obesity (BMI 35), and no previous pregnancies, who on 29-MAR-2007 received her first vaccination with GARDASIL (Lot # 654702/0011U). On 31-MAY-2007, the patient received her second vaccination with GARDASIL (Lot # 654702/0011U). Subsequently, the patient became pregnant (LMP = 28-JUN-2007). On 18-SEP-2007, the patient had an ultrasound for dating purposes which was normal indicated a single IUP at 10 weeks. On 02-OCT-2007 and 01-NOV-2007, the patient had integrated screening for maternal serum alpha-fetoprotein which were negative. On an unspecified date, the patient developed cholestasis of pregnancy and was treated with URSO FORTE, outcome was not reported. It was reported that at 16 weeks (approximately 30-OCT-2007) through approximately 19 weeks (approximately 20-Nov-2007), the patient was treated with REGLAN. Other medications used during pregnancy included prenatal vitamins (not specified) and permethrin cream (not further specified). Additional information has been requested.
No adverse effects were reported; inadvertently administered an expired dose of MMR II; Information has been received from a medical assistant referring to a 13 months old patient of unknown gender. The patient's pertinent medical history, drug reaction/allergies and concomitant medication were not provided.  On 04-FEB-2019, the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R002930, subcutaneous for prophylaxis (strength, dose and frequency were not provided). No adverse effects were reported. The outcome of the events was unknown. The reporter's causality assessment was not reported.  Lot No. R002930 has been verified to be a valid lot number for measles, mumps and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported as 30-JAN-2019, but upon internal validation established as 31-JAN-2019.
A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine; A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine), COVID-19 IMMUNISATION (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine), COVID-19 IMMUNISATION (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine), COVID-19 IMMUNISATION (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine) and COVID-19 IMMUNISATION (A 21 Month old baby received the Pfizer vaccine for the second dose of the Moderna Primary vaccine instead of a Moderna vaccine).    No concomitant medications were reported. Patient received the Pfizer COVID-19 Vaccine for the second dose after receiving Moderna for the first dose. No other adverse events are reported  No treatment medications were reported.   Reporter did not allow further contact
During annual physical-was given PREVNAR 13 injection for first time. Had blood drawn; CBC indicated platelet count 15 (15,000). Dr repeated blood test, 13,000...hospitalized, a few hours later 3,000; given platelet infusion.
Bexsero, Havrix low temperature excursion: 31.5F Time: 2hrs 45 min; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Havrix and Bexsero. On an unknown date, an unknown time after receiving Havrix and Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero, Havrix low temperature excursion: 31.5F Time: 2hrs 45 min). 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: 17-JUL-2023 The reporter was a licensed practical nurse. The Bexsero, Havrix low temperature excursion: 31.5F Time: 2hrs 45 min.  The reporter did not know which vaccine was administered, if in fact it was.  No patient's information was reported.  No vaccine data (lot number, expiration date) were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that Bexsero and/or Havrix might be administered after a temperature excursion where the vaccines were determined to be unstable, which led to incorrect storage of vaccine.
Major soreness in right arm at injection site, then all around my arm, neck and upper back; Major soreness in right arm at injection site, then all around my arm, neck and upper back; insomnia; some nausea; Major soreness in right arm at injection site, then all around my arm, neck and upper back; chills; Simlar symptoms as with 1st dose but a little worse,pain in the left arm is not getting better and is only getting worse,The pain is worse with movement; pain in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), BACK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), INSOMNIA (insomnia), NAUSEA (some nausea) and PAIN IN EXTREMITY (Major soreness in right arm at injection site, then all around my arm, neck and upper back) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20a) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLIXIMAB (REMICADE) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in his left arm). On an unknown date, the patient experienced NECK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), BACK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), INSOMNIA (insomnia), NAUSEA (some nausea), PAIN IN EXTREMITY (Major soreness in right arm at injection site, then all around my arm, neck and upper back), CHILLS (chills) and PAIN (Simlar symptoms as with 1st dose but a little worse,pain in the left arm is not getting better and is only getting worse,The pain is worse with movement). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Advil at an unspecified dose and frequency. At the time of the report, NECK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), BACK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), INSOMNIA (insomnia), NAUSEA (some nausea), PAIN IN EXTREMITY (Major soreness in right arm at injection site, then all around my arm, neck and upper back), CHILLS (chills) and PAIN IN EXTREMITY (pain in his left arm) outcome was unknown and PAIN (Simlar symptoms as with 1st dose but a little worse,pain in the left arm is not getting better and is only getting worse,The pain is worse with movement) had resolved.
four to six drops of the vaccine came out with the needle; A spontaneous report was received from a  Consumer concerning his father a male patient of unspecified age  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced four to six drops of the vaccine came out with the needle/under dose.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that the patient received four to six drops less of the vaccine that came out with the needle.   Treatment details not provided..   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event four to six drops of the vaccine came out with the needle was considered resolved.; Reporter's Comments: This report refers to a case of possible underdose for mRNA-1273 with no associated AEs.
Developed rash with redness/blisters. Painful on my right lower quadrant. MD diagnosed as shingles.
My hAnds, both of them are painful. Mostly my thumbs and fatty part of the thumbs on both hands.. I have hard time now with opening water bottles, zip my pants up, just conditions pain. Never had it before.
On 1/24/21, 5 days after vaccine started getting sore throat and runny nose, 3 days after symptoms started loss of smell and taste.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date in March 2017, the patients were administered improperly stored doses of ROTATEQ lot # M040270, expiration date 29-APR-2018 for prophylaxis. The doses were stored at temperatures in the range of 32 degrees Fahrenheit to 35  degrees Fahrenheit for a time frame of 4 hours; 36 degrees Fahrenheit to 46 degrees Fahrenheit for a time frame of 12 hours. There were no previous temperature excursions. The call was not because of a data logger. No adverse effects were reported. No further information was provided. This is one of the several reports from the same reporter. Follow up information was received from nurse on 25-AUG-2017. The nurse stated that it was determined that they did not have a temperature excursion and the state was looking at wrong records. Sender's Comments: US-009507513-1707USA002699.
Information has been received from a pharmacist concerning a 12 year old female, with a history of asthma and no known allergies, who on 08/28/2001 was vaccinated with the first dose of hep b vaccine recombinant. There was no concomitant medication. Immediately after vaccination, on 08/28/2001, the pt passed out and experienced a severe headache, that lasted a few minutes, at the same time. The pt sought unspecified medical attention. Additional info has been requested.
gross hematuria, painless, urinary frequency, urgency, started 6 am upon awakening 4.75 days following vaccine administration
Facial droop and slurred speech began 10/24/2023. Hospital admission 10/27-10/28/2023, MRI "IMPRESSION: 1. Small acute infarct in the posterior right basal ganglia. No associated hemorrhage. 2. Multiple chronic lacunar infarcts and moderate to advanced leukoaraiosis, most commonly seen in the setting of chronic ischemic disease.   3. Mild atrophy. 4. Complete opacification of the right maxillary sinus, possibly representing chronic sinusitis". Discharge Assessment & Plan (Problem List) Principal Problem: Infarction of right basal ganglia  Active Problems: Age-related physical debility HTN (hypertension) Resolved Problems: Stroke-like symptom Subjective Assessment: Patient evaluated on the day of discharge, she is awake, alert and oriented does not appear to have any neurological deficits at this time with improving facial droop. Full review of systems was performed and found to be negative. Discharge to home, diet and activity as tolerated.  Referral to PCP to establish care. MD
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 13-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sore arm; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "tiredness".  Additional information: The reporter really just wanted to know how long these symptoms were going to last. Stated if they were going to last until the 21 days until the second dose, he might not get the second dose because he did not like the way he was feeling. Also wanted to know how effective the vaccine was if he only gets the one dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The baby found unresponsive in the morning on 6/30/12. Resuscitation attempts done by Paramedics and in the ER failed.
Information has been received from a healthcare worker concerning a 23 year old female patient who was vaccinated with a 2nd dose of GARDASIL and experienced lightheadedness. Then on 18-Aug-2009 around 12:30, the patient after received the 3rd dose of GARDASIL (LOT 663451/0216Y), she mentioned that she felt a little funny and then she asked if she could get a glass of water and then she started dripping down and she end up passed out. The medical assistant used ammonia smell and when the patient woke up from passing out she came back, but she looked really haggard and then the nurse and the medical assistant took her blood pressure and it was normal. The patient recovered that day but when she went home, she called the clinic back and told them that she was not feeling right and that she felt anxious. A Blood test was performed but results were not provided. At the time of report, the patient was not recovered. Additional information has been requested.
rash c/w measles, coryza, cough, runny nose, mild conjunctivitis;
Hives all over body; rash; itching; This is a spontaneous report received from a from a contactable consumer (wife) reported for a 65-year-old male patient (husband). A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), via an unspecified route on 09Mar2021 at 12:00, as a single dose for covid-19 immunization. Medical history included diabetes. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies were reported. On 10Mar2021 at 00:00, patient had hives all over body, rash and itching the day after his second dose of the Pfizer Covid vaccine. He still has it and it has been a month since he had vaccine. Doctors seem to be clueless on what to do. Pfizer is not able to make any treatment recommendations for individual patients. During the clinical trials, systemic symptoms (symptoms throughout your body) were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. However, everyone's body is different, and some symptoms may last longer in certain individuals. Please continue to discuss this with his HCP so they can evaluate his symptoms to determine the best treatment recommendations. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures taken as a result of the events included steroid shot. The clinical outcome of the events was reported as it has been a month with no relief from itching.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within (3) hrs on 10/6 noted swelling/pain at inj site on 10/7 at 330/AM woke with SOB, swelling of hands & burning. Also noted rash on face 10/7 with piercing pain in (L) ear x (1) hr (10/7). H/A x (1) day. Questionable bronchospasms.
Diarrhea, fatigue, severe headache lasting several days, severe muscle cramps lasting several days
Patient given a temperature compromised vaccine that was left out overnight. Patient notified and called back in to receive proper vaccination.
3.5 x 2.5 cm wheal, tender, warm. No decreased ROM, (+) CMS. No exudate or hemorrhage.
Sore arm for 36hrs, followed by pain in right armpit 2-4 days post injection.  7 days after injection, developed an itchy rash at the injection site that continues to grow in size and is now 4" x 3" in diameter.
The RN administered 1mL of the Moderna vaccine as opposed to 0.5mL. Office, contacted the patient to notify and follow up on how the patient was feeling. The patient self-reported no symptoms other than arm soreness. Did not experience any side effects or symptoms on Wednesday (7/28).