chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10:30 IN BED FELT CHILLED THOUGHT SHE HAD A SLIGHT FEVER. GOT BLANKETS TO GET WARM AND FELL TO SLEEP. WOKE UP EARLY MORNING UNSURE OF TIME HAD TO GO TO BATHROOM. PT REPORTS EXTREME MUSCLE WEAKNESS IN ALL EXTREMITIES AND COULD NOT MOVE. HAD TO SLIDE OFF BED AND CRAWL TO GET TO BATHROOM. WHEN SHE GOT TO BATHROOM, SHE DOES HAVE LIMITED RANGE OF MOTION IN L SHOULDER BUT WHEN SHE ATTEMPTED TO GRAB BAR IN BATHROOM HER R ARM WAS LIMP AND COULD NOT GRAB BAR TO LIFT SELF UP TO TOILET.  WAS FOUND BY FAMILY IN BATHROOM SOILED. DID NOT APPEAR TO HAVE ANY INJURIES FROM FALL PER PTS DAUGHTER AND PT REPORTED SHE DID NOT HAVE A HARD FALL OR HEAD INJURY.
Achy, slight agitation, stomach ache, diarrhea, fatigue, loss of appetite,  sleeping 16 hrs or more daily. Flu like symptoms .
Patient received shot on Friday and reported that her face started swelling up and became red on Sunday. She went to the emergency room and was admitted. In the hospital she had to be treated for previously undiagnosed a-fib and she stated she had altered mental status while in the hospital with confusion.
Patient developed arm swelling and abdominal pain became diaphoretic within 4 hours of getting the pneumococcal vaccine.
Had two vaccinations still got shingles/suspected vaccination failure; Shingles; Miserable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had two vaccinations still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and feeling miserable (Verbatim: Miserable).  The outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received two doses of Shingles vaccine and still experienced shingles. The patient stated that it was miserable, but it may be would had been even worse without vaccination. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%; Extreme fatigue after 2nd dose , I slept for 20 hours; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%) and FATIGUE (Extreme fatigue after 2nd dose , I slept for 20 hours) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013220A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure high, LEVOTHYROXINE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Extreme fatigue after 2nd dose , I slept for 20 hours). On 11-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%). The patient was treated with METOPROLOL for Adverse event, at a dose of 1 dosage form. At the time of the report, VENTRICULAR EXTRASYSTOLES (Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%) and FATIGUE (Extreme fatigue after 2nd dose , I slept for 20 hours) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Magnetic resonance imaging heart: abnormal (abnormal) Late gadolinium enhancement abnormal. On an unknown date, Electrocardiogram ambulatory: 15 % (abnormal) 15%PVCs and 21% (abnormal) 21%PVCs.         The patient reported that blood pressure has been elevated probably due to stress. On 02-Dec-2020, while blood donation patient did not have antibodies and hence declined every infection. The patient reported that on 11-Mar-2021 blood donation was denied due to PVCs which were asymptomatic to the patient and PVCs every 3rd heartbeat. The patient was informed to obtain timeline symptoms including cardiac laboratory values.
left arm has pain and tenderness/ sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (SEASONAL INFLUENZA VACCINE)).   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient himself. The patient got his first Shingrix dose a day before reporting in the left deltoid and was experiencing a sore arm. He did not see the size of the needle but he believed it was given intramuscularly. He reported that his left arm has pain and tenderness. He looked at the paperwork given to him by the pharmacy who administered the injection but was unable to find a lot number or expiration date for Shingrix. The patient had an appointment to return for Shingrix dose number 2 on October 16, 2020. The patient did receive Fluzone shot also but that was given in his right arm and he stated his right arm did not hurt. The reporter consented to follow up.
Patient was given Pediatric Energix 10mcg/0.5mL instead of the adult dose of 20mcg. Patient was contacted, error was explained, patient will be coming back within 24 hours to receive additional 20mcg and will return in 1 months time to receive second dose.
1 day after vaccine pt experienced soreness, redness and swelling at site of injection. Redness approx. 7 inches in diameter and induration approx. 3 inches in diameter. No fever.
On 4/12 I started seeing a rash on the right side of my back area which was showing like a cluster and extremely itchy and burning. The next day this was still there and I took photos to send to dr. I received two different opinions from both a dermatologist and an internist that I have shingles. I have always been perfectly healthy and have never had any issues in the past. I also have not received any vaccines aside from this one other than when I was a child, just to note. The doctor immediately prescribed me valacyclovir to take 3x a day and I have two more days to finish. The rash is still there and has spread a little bit more and continues to be incredibly itchy. I am scheduled for my next vaccination a week from today.
She received pneumovax 23 on Friday 10/16 and since has had swelling and redness that has extended down her arm all the way to her elbow. She said that on the first day that she received it, her heart was racing as well. She is currently applying ice and using Tylenol/ibuprofen.  I also advised her to take oral Benadryl in case it was a mild allergic reaction and if it were to worsen, to go to the ER.
Pt reports muscle aches, stiffness in joints, chills, and swelling. Two days of redness of arm.
Patient had COVID-19 after first dose; More than 36 days passed since the first dose and patient has not got the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient had COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose and patient has not got the second dose) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose and patient has not got the second dose). At the time of the report, COVID-19 (Patient had COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (More than 36 days passed since the first dose and patient has not got the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information include No New Information
headache; high temperature; fatigue; tremors; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age (as reported: Age:52; Unit: Unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 07Mar2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Previously the patient took MMR vaccine on an unknown date in Jul2020, for immunization. Approximately on an unknown date in Mar2021, within 10 hours of receiving the vaccine, the patient experienced headache, high temperature, fatigue and tremors. The caller wanted to know if the MMR vaccination she received in July of 2020 may have caused the reaction. The outcome of all the events was unknown. There was no product quality complaint (PQC) found.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Pt reports the morning after receiving the 2nd dose of Moderna covid vaccine feeling "electrical shock in my heart".  Pt reports "feeling miserable"  reports chills
On March 20, I  started with flu symtoms: sneezing, running nose, headache , pain in my body this was the first day.  I stayed on bed,. The second day I had headache,  and my body felt Ok. but no my head so I stay on bed. The third day I felt Ok. but since ever when I get up in the morning I felt dizziness, I would like to know if this is normal and for how long is going to be.  40% of the day I am with headache not so strong.
w/in 24 hrs pt devel temp to 102.5 R & redness over inject site w/ 3x3 cm mass;
Day 1: Monday 15 minutes of routine waiting at the pharmacy for any immediate reaction. Nothing immediately. Went about my day. Sore arm developed later in the afternoon. No biggie.   Day 2: Tuesday. 24 hours later. Reeeeallllly sore arm, feeling okay. An hour after waking up: BAM. Immediately felt lightheaded, dizzy, thought I was going to pass out. Nausea. Pounding headache. No ability to do work the entire day. The couch was my friend. Moving my arm throughout the day alleviated arm soreness. Felt slightly better in the early evening. This was my worst day.  Day 3: Wednesday: 48 hours later. Headache. Energy in the morning. Wave hit me around noon and I was down the rest of the afternoon. Pounding headache. Lightheaded. Nausea. Waves of this mix throughout the day.  Day 4: Thursday: 72 hours later. Thought I had improved but headache quickly set in within an hour or two of waking up. Zoom meeting the first half of the day, tiredness set in halfway through, then waves of feeling lightheaded with headache and occasional nausea throughout the day.   Day 5: Friday: 96 hours later: Headache and waves of struggle all day.   Day 6: Saturday: 120+ hours later (at this time of writing!). Slight lingering headache. Best day so far. Was overcome by stronger headache and tiredness in the afternoon (starting around 3:00pm)
This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 31-JUL-2015, the patient was vaccinated with GARDASIL 9, dose 1 (lot # K026247/ expiration date- 29-JAN-2017), dose 2 (lot # L023230/ expiration date- 28-JUL-2017) on 24-DEC-2015 and dose 3 (lot # L019297/ expiration date- 18-AUG-2017) on 26-FEB-2016 (inappropriate schedule of drug administration). No adverse event was reported. Non concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Traffic personnel brought patient back to observation room after c/o nausea that started at 1030 am.  Patient reported no adverse after her 15 minute observation period   Vital signs at 10140 am    163/86 56 28  99% O2 sat on room air  She reported a history of anxiety.  Given cold compresses and water.  Symptoms resovlved and she left.  Given instructions to call 911 or her PCP as needed.  Ambulated out without difficulty.  She left with her husband at 1055 am.
Throat fullness with no rash or shortness of breath noted. Pt got IM Benadryl and felt much better in the car and was observed and DC home. BP 160/84 P 95   Sat 98%. BP went down to 146/89
Information has been received on 14-JUL-2017 from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. The pharmacist reported that improperly stored vaccines of RECOMBIVAX HB (Lot number N002202, expiration date 14-NOV-2019) were administered to multiple unspecified patients on multiple unspecified dates. (The doses, routes of administration and sites of administration were not reported.) The excursion information was reported as: The temperature was reported as 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F). Time frame was reported as 23 hours and 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. No additional information was provided. Product quality complaint was not involved. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 67-year-old male patient. On 19-SEP-2012 the patient was vaccinated with dose 1, 0.65 milliliters (ml) ZOSTAVAX (lot # 0564AE, expiration date 21-MAR-2013) subcutaneously. No concomitant medications were reported. The reporting pharmacist stated that the patient's wife called on 20-SEP-2012 and reported that the patient was complaining of "being weak, not feeling well and was pale". Treatment information was unspecified by the reporter. Outcome of the reported events was unknown. No further information was provided. Additional information has been requested.
Rash on neck and chest.  Cleared with prednisone and steroid cream.  A couple of weeks later, high liver enzymes that kept rising to the level of almost 1000 over a 4 week period.  Symptoms were nausea, weight loss, and feeling unwell.  Doctors ran lots of tests (including a liver biopsy) with all results being normal.  Finally normal levels after almost 4 weeks.  Now having symptoms again and waiting for liver enzyme test results and new doctor visit.
Extreme pain at injection site with swelling and redness. Redness and itchy area covers upper arm and is present after 4 days. Flu like symptoms requiring bedrest on day 2. Nausea and diarrhea on day 3.   Around the clock APAP, ibuprofen and antacids taken x 3 days.
Pt has small bump on leg that is red and warm to touch. Told mother to ice the area and massage periodically.
Congestive Heart Failure, I was healthy prior and heart issues. medical records to prove of heart.  I had surgery 3/3/2021, ekg good. Less than 7 days after vaccination, couldn't breath, eat, difficult walking any distance, couldn't lay down to sleep, couldn't really sleep sitting up, shortness of breath.  Cardiologist gave a diagnosis of CHF stage C, I was hospitalized for 3 1/2 days.  They wanted to keep me longer, I asked to be released.  Cardiologist thought I had a viral infection to the heart, still working on improving the heart.  Adhering to CHF rules for medicine and diet.
Prior to 3 vaccines, patient had recovered from low AM blood sugar.  After juice and food consumed blood sugar was 225 (patient tested herself) as reported by patient and she requested 3 vaccines.  She rested 30-40 minutes after immunizations given, then complained of fatigue and "feeling funny".  Paramedics took her blood pressure and vital signs where were within normal limits and escorted her to public transportation.  She ended up being taken by ambulance to local ER where she left without being seen after waiting 3 hours.  No diagnosis oz f.u.  Noted in ER record.
Rash x 4-5 days, diarrhea x 2-3 days x 3bm qd
He is complaining of rhinorrhea, nasal congestion and a dry cough.  He denies any fevers or chills.  Patient said that he felt off yesterday.  Since getting up today patient has felt more short of breath on exertion.  He feels like he is breathing heavy.  He is denying any chest pain or pressure.  Patient did feel some pain behind his left knee over the last week, but has none at this time.  He is also felt some mild right ankle discomfort, but that has resolved as well.  He denies any recent COVID-19 exposures.    Treated with heparin and catheter directed alteplase
pt was in observation room, felt hot, passed out around 13:12, took patient to the recliner  lifted legs, ice pack, head back. Patient alert and oriented times 3, bp 126/71, 93 pulse, 97% o2 on room air.
Fatigue, body aches, chills began 1/19/21 @ about noon, following 2nd dose
Syncope; This is a spontaneous report from a contactable health care professional via Pfizer Sales Representative. This health care professional reported similar events for 3 patients. This is 1s of 3 reports.   A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope on an unspecified date. Event took place after use of product. The outcome was unknown.  The information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019341788 same drug/event/reporter, different patient;US-PFIZER INC-2019341787 same drug/event/reporter, different patient
This spontaneous report as received from a physician via company representative refers to a 4 month old male patient. On an unknown date patient was vaccinated with first dose of ROTATEQ (strength, dose unit, lot number and expiry date unknown). On 10-FEB-2014 the patient was vaccinated with second dose of ROTATEQ suspension, 2 ml with lot # J008385 and expiry date unknown, orally. Other suspect therapies included PENTACEL with lot# C4658AA (expiry date unknown) and PCV13, lot # H41948 (expiry date unknown). Concomitant therapies included amoxicillin (manufacture unknown). On 10-FEB-2014, after 45 minutes of vaccination with ROTATEQ, patient developed rash on both sides of his mouth, two spots on his trunk and a rash at the site that the PENTACEL was administered. On the same day patient sought medical attention and was administered with dexamethasone (manufacture unknown) for events and the rash started to clear. At home patient's mother gave BENADRYL to the patient after the dexamethasone (manufacture unknown). The outcome of rash on both sides of his mouth, a rash on injection site of PENTACEL and two spots on his trunk was reported as recovering/resolving. No further information was provided. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-Feb-2021.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Coronavirus test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Began getting a headache the next day which became progressively worse until she vomited and did not go away until after she went to bed and slept through the nigh. No history of headaches or migraines.
This spontaneous report as received from an unspecified healthcare worker refers to a 24 year old female patient. No concurrent conditions or medical history were provided. On 02-OCT-2014 (reported as: yesterday), the patient was vaccinated with the first dose of GARDASIL injection, administered intramuscularly at a dose of 0.5 ml (lot # J007850 with expiry date: 07-APR-2016), that had been improperly stored at -13C. No concomitant medications were reported. The dose administered on 02-OCT-2014 was intended to be the patient's first dose of GARDASIL, but the dose would not be counted as valid. The plan of care for this patient was to administer a dose of GARDASIL to her on the day that she was scheduled to receive her second dose of vaccine. The dose administered on that day, on 02-DEC-2014 (reported as "two months from yesterday"), would be counted as the first dose in her GARDASIL series. The patient had not reported or demonstrated any adverse effects. Additional information has been requested.
Temperature excursion involving Proquad; This spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.       On 28-JUL-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) began experiencing intermittent temperature excursion.  On 17-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) 0.5 ml, Lot # T009929, expiration date 16-SEP-2021, and Lot # S031882, expiration date 07-APR-2021 for prophylaxis (Frequency and patient route of administration were not reported). The storage temperature reported was between -14°C to -10°C, being the maximum temperature at -9..5 °C for a period of 38 hours and 30 minutes.     There was digital data logger involved and  no previous temperature excursion was reported.; Sender's Comments:  US-009507513-2008USA014709:
5 minutes after receiving DTaP, HIB and Influenza, patient had a febrile seizure.