chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can barely move his arm / can't even exercise or lift things / can't barely lift thing, workout, no range of motion; Lots of pain onsite of the injection; Started feeling muscle pain, pain intensified and continued to get worse; This spontaneous case was received on 15-Sep-2023 from other non-healthcare professional (the patient's spouse) (reference number: SEQW23-02325) and concerned a 39-year-old, male patient.  The patient's concurrent conditions included blood clotting disorder. The patient's concomitant medication included Coumadin (warfarin sodium), used for an unreported indication.  On 09-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as the patient had a little baby daughter and wanted to be the most protected as he could be, and that was the patient's first time with flu vaccine. The batch number reported was 372395.   On the same date, after receiving Flucelvax Quadrivalent, the patient started feeling lots of pain onsite of the injection. Could not barely move the arm. It was becoming worse each day.  On an unspecified date in Sep-2023, the patient started taking ibuprofen, one pill of 800 mg, morning and night. The patient got preoccupied because ibuprofen was not dealing with the problem and the patient could not even exercise or lift things.  On an unspecified date in Sep-2023, at day three, as reported, the patient started feeling muscle pain. The pain intensified and continued to get worse each day until day six. No symptoms were visualized, only felt inside (mostly pain).  At the time of initial reporting, on 15-Sep-2023, the patient was recovering from the events. As reported, ibuprofen helped a little bit, however, the patient was still having the pain. The patient could not barely lift thing, workout, and had no range of motion.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 39-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same date, after receiving Flucelvax Quadrivalent, the patient developed vaccination site pain. Three days later, the patient started feeling muscle pain. Could not barely move the arm and it was worsening every day. Due to plausible time relationship, causal role of the suspect vaccine is assessed as possibly related for all events (vaccination site pain, myalgia and mobility decreased).; Sender's Comments: A 39-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same date, after receiving Flucelvax Quadrivalent, the patient developed vaccination site pain. Three days later, the patient started feeling muscle pain. Could not barely move the arm and it was worsening every day. Due to plausible time relationship, causal role of the suspect vaccine is assessed as possibly related for all events (vaccination site pain, myalgia and mobility decreased).
Chest pains for month. Wake up middle of night difficulty breathing. Lasted almost 2 months
PT recd series of 3 Engerix-B vaxs (20mcg) on 1DEC89, 11JAN90, & 6JUN90; PT was a non-responder; PT is receiving "EBV - IG";
Night of shot - flet like flu (Friday) went to football game. Sat - sick to stomach, swelling of arm, pain in arm at vaccine site. Sunday - Swelling moves up neck and glands, called local physician told to take Benadryl 50 mg - started Benadryl Monday afternoon.
Temperature of the fridge used to store the Flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Extremely dizzy, got extremely hot, saw stars in my vision, couldn't breath was able to get to the ground and get a fan/cold washcloth to my head so I didn't black out. This was 23 hours after I received the first dose of the vaccine. It was over an hour of feeling like I couldn't breath, stars in my vison, extremely hot. I was extremely dizzy from 12pm-6pm that day (everything was spinning)
Case number PHEH2015US003139, is an initial spontaneous report received from a pharmacist on 11 Feb 2015. This report refers to a 20 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: A13066) intramuscularly on 10 Feb 2015. It was reported that during reconstitution the Men CYW-135 liquid component was mixed with an expired Men-A (expiration date: 31 Jan 2015) component. No adverse event was reported following this administration error (expired vaccine used).
CLIENT CALLED ON 3/19/2009 TO REPORT A VACCINE REACTION.  SHE STATED RIGHT ARM RED AND SWOLLEN FROM HER RIGHT ELBOW TO RIGHT SHOULDER. ALSO PAINFUL.  SHE ALSO REPORTED SHE HAD FEVER ON 3/18/2009 AFTER THE INJECTION.  ADVISED TO GO TO A PHYSICIAN.  CALLED FOR FOLLOW-UP 3/23/2009. STATED SEEN IN ER AND GIVEN IV STERIOD ON 3/19/2009.  ER PHYSICIAN TOLD HER IT WAS AN ALLERGIC REACTION.  SHE ALSO STATED ER PHYSICIAN TOLD HER SHE HAD DIMINISHED RESPIRATION, BUT SHE STATED THAT SHE DID NOT NOTICE BREATHING PROBLEM.  TODAY (3/23/09), CLIENT REPORTS SWELLING AND REDNESS TO RIGHT ARM HAS SUBSIDED.  SHE ALSO REPORTED TO ME THAT SHE WILL BE HAVING HER SPLEEN REMOVED IN A FEW DAYS AND THAT IS THE REASON SHE NEEDED THE VACCINES, MENINGOCOCCAL AND PNEUMOCOCCAL VACCINE.  SHE STATED THAT HER PHYSCIAN TOLD HER SHE WOULD NEED THESE VACCINES EVERY 5 YEARS. I EXPLAINED TO THE CLIENT NEEDED TO DISCUSS THIS REACTION WITH HER PHYSICIAN SINCE THE ER DOCTOR TOLD HER IT WAS AN ALLERGIC REACTION TO THE VACCINES.
her son incorrectly received 1 dose of Trumenba on 13Apr2016. He was not prescribed Trumenba; myocarditis; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 16Nov2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 18-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 13Apr2016 as dose 1, single (Batch/Lot number: unknown) at the age of 18 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 13Apr2016, described as "her son incorrectly received 1 dose of Trumenba on 13Apr2016. He was not prescribed Trumenba"; MYOCARDITIS (medically significant) with onset 2016. It was reported that the reporter's son had myocarditis after receiving the Trumenba vaccine. The reporter asked when might Pfizer begin conducting a study for cardia-related adverse events such as myocarditis for the Trumenba vaccine. Clarified that this event happened in 2016 and was reported to Pfizer by the doctor's office. The reporter also reported this to disease control. Also clarified that the patient incorrectly received one dose of Trumenba on 13Apr2016. The patient was not prescribed Trumenba, it was accidentally administered in place of a different meningitis booster he was supposed to get with an MMR he had received. When the patient had this horrible reaction which was myocarditis, the reporter brought the patient back to the facility and found out that they had given the patient Pfizer Trumenba instead of just a regular meningitis booster shot. The reporter called because she saw on the news that Pfizer and Moderna were going to begin a study of long-term effects of people who developed heart issues after receiving the COVID-19 shot, and specifically said Pfizer. The reporter was thrilled that Pfizer is going to do a study on their COVID-19 vaccine and the young men that have gotten heart problems after the COVID-19 shot because it could possibly give her an idea of what the patient needs to look forward to with this myocarditis even though she knows that Trumenba is a totally different product than the COVID-19 shots. The patient doesn't want vaccinations of any kind because of what happened. The patient was scared. The reporter also clarified that she had no first hand knowledge of any patients that developed heart issues or heart problems after the COVID-19 shot. She was just referring to what was said on the news regarding the study. Outcome of the events was unknown.   The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
approx 10 hours after shot, he felt chills, body aches and then sudden onset of nausea and then woke up next to his desk.  uncertain length of time of LOC.  next day feeling tired and achy but better
Pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (Pericarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered PERICARDITIS (Pericarditis) to be related.    This case was for patient no.2, who experienced pericarditis after second dose of Moderna vaccine.  No concomitant or treatment medications were reported.   This study is based on a evaluation of all adults administered =1 mRNA COVID-19 vaccine, including boosters, Health Administration between 14 December 2020 and 9 October 2022. From 14 December 2020 to 9 October 2022, 2 184 449 first and 2 036 948 second doses of mRNA-1273 (Moderna) were administered. In addition, 1 156 160 mRNA-1273 booster doses were administered. Among vaccine recipients in our aged 1839 (predominately male, as expected), estimated incidence rates of confirmed myocarditis/pericarditis ranged from 0.46 cases per million (for Moderna dose 1, all ages) to 19.76 (Pfizer dose 2, ages 1839). Of the 178 potential safety events identified, only 33 were ultimately confirmed following an mRNA vaccine. Potential cases were ruled out after chart review for various reasons. In summary, the incidence of myocarditis or pericarditis in patients was low across >10 million doses of mRNA COVID-19 vaccines (primary or booster doses) administered.  Company Comment: This literature-non-study case concerns a patient of unknown age and gender, with no medical history reported, who experienced the expected and serious (due to medically significant) event of Pericarditis, which occurred on an unknown date after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.      This case was linked to US-MODERNATX, INC.-MOD-2023-734758 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2023: Live follow-up received by safety on 27-JUL-2023 has email with full text article, contains significant information: Reporter information, literature information and an updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734758:Same literature (Master case)
arm tingling/pins and needles; arm burning; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (arm tingling/pins and needles) and BURNING SENSATION (arm burning) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (arm tingling/pins and needles) and BURNING SENSATION (arm burning). At the time of the report, PARAESTHESIA (arm tingling/pins and needles) and BURNING SENSATION (arm burning) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
received a pediatric dose of Havrix vaccine.; received a pediatric dose of Havrix vaccine.; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HAV (Havrix pediatric) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the patient experienced adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: A medical assistant reported that, a 23 years old patient received a pediatric dose of Havrix vaccine, led to underdose and adult use of a child product. The reporter consented to follow-up.
My left are is still swollen  and is a little tender to touch.  There is a big lump on my upper arm.
within 10 minutes very dizzy.  Husband had to help to car.  Within 10 minutes whole body was tingling and MASSIVE headache.  I have never had one but it appeared to be migrane.  Eyes felt the size of tennis balls and couldn't open eyes.  Could not stand any noise or any light.  Could not pick head up off pillow.  Constant swallowing like going to throw up.  Day #2 same thing.  Day #3 same thing but eyes felt like golf balls.  Eyes blood shot.  Day #4 (today) still some head ache and swollen eyes.  No energy.  Am scheduled for March 8 to have second shot.     WILL NOT.  Getting on plane on March 10 and will not take chance of this happening again.  Husband read that second shot has worse effects.  I sincerely feel like a "lab rat" since no one knows what happens to people after vaccines.  Would be really great if someone will contact me to explain reaction to shot.
When I got home couple hours later I felt my heart beating fast and started getting stomach pains. Went to the ER where I found out I was pregnant less than 6 weeks.
I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my heart rate doubled. It took around an hour for my heart rate to slow down again.  By bedtime all I had was a sore arm. That was gone within 24 hours.
rash-pinpoint, started 12/15/99. By 12/16/99, child was covered with rash.
Left arm with area of redness and swelling 20cm below the injection site.  Area of redness 10cm above and 10cm on the left and right of the injection site.  Area is painful when touched.
This spontaneous report as received from a Healthcare Worker refers to a female patient of unknown age. The patient received her first dose of GARDASIL (lot # was not reported) on 12-AUG-2012 and the second dose of GARDASIL (lot # was not reported) on 14-DEC-2012. Healthcare worker stated that patient was in the office to receive her third dose of GARDASIL (lot # was not reported) on 27-FEB-2013. No adverse symptoms reported. This is one of the two reports from the same source. Additional information has been requested.
This spontaneous report as received from a physician refers to a  patient of unknown age and gender. On 17PR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physical therapist concerning a friend's daughter, a 19 year old female who was vaccinated with 3 doses of GARDASIL. It was reported that the patient had alopecia. The patient lost her eyebrows, eyelashes and was completely bald. At the time of the report the patient had not recovered. It was unknown if the patient sought medical attention. No further information is available.
BURNED ON THE WAY GOING INTO THE ARM; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced burned on the way going into the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of burned on the way going into the arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210642390.
This spontaneous report has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose was not reported) lot# M040267 with expiration date 14-MAY-2018, lot# M041184 with expiration date 31-MAY-2018, orally for prophylaxis. The vaccines were exposed to temperature excursion of 9 degrees Celsius to 25 degrees Celsius for 2 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of several report received from  the same source.; Sender's Comments: US-009507513-1708USA000378: US-009507513-1707USA012435:
pt recv vax 20JAN97 & it was reported 30 to 60 seconds later that the pt went into cardiopulmonary arrest & underwent successful resuscitation;pt exp vagal-vagal response
Swollen, extremely tender lymph node in R axillary region, with general aches to body. Node appears nickel to quarter size in diameter, raised area. Will see PCP tomorrow if ice and HYDROCORTISONE cream continues to not work.
This spontaneous case, initially received from other health professional (pharmacist) on 05-Oct-2018, concerns a 55-year-old, adult male patient. The patient's medical history was not reported. The concomitant medications included CYMBALTA, celecoxib and glimepiride. It was reported that the patient might take losartan (reported as: losartan was not guaranteed). On 28-Sep-2018, in afternoon, the patient (less than 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250792 and expiry date: 30-Apr-2019] (explicitly coded as drug administration error). It was reported that the patient experienced several adverse effects after the administration of suspect vaccine. On 30-Sep-2018, at night, the patient woke up dizzy, with extreme nausea and dry hives, but did not vomit. The events happened again on 02-Oct-2018 during the day. It was reported that the events stopped and then came back. On 03-Oct-2018 the patient felt ok but on 04-Oct-2018, the events happened again during the day and overnight. The patient did not know if the effects were correlated with the vaccine administration, because they had started only 2 days after receiving the flu shot. The patient had an appointment with the physician at 4 PM (reported as: today). At the time of report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Non-significant follow-up received from a pharmacist on 25-Oct-2018: No new information obtained. It was reported that the primary reporter (pharmacist) no longer works in the pharmacy. Hence, they do not have further information on the patient and adverse event to provide.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 38th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
pt recvd vax & 10 min later inject site was red hot, swollen area, hive like area 15min;
Muscle pain, shivering, headache, nausea, upset stomach, frequent urination, moderate pain on injection sight. Experienced similar side effects from  Shingrix dose 1 but the dose 2 symptoms seemed more severe.
Severe inflammation in all joints severe pain, incontinence,  extreme fatigue, hearing lose, bells palsy, headaches confusion severe neck pain
Sharp pain in left hand/Feet swollen and in pain; Slurred speech eyes dilated; Body heavy and in pain; Body heavy and in pain; Throat feels like it's closing up; I can feel my heart beating and like their are ants in my veins.; Felt like arms swollen/Feet swollen and in pain; My vision is now blurred and reduced significantly; My vision is now blurred and reduced significantly; Severe panic attacks; Slurred speech eyes dilated; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; 43-year and non pregnant at the time of vaccination), first dose via an unspecified route of administration, in arm left on 20Mar2021 11:00 (Batch/Lot Number: EN6204; Expiration Date: Jun2021) at unknown dose single for covid-19 immunisation. Medical history included Hashimoto's Thyroiditis; Metronidazole Allergy. Concomitant medication included levothyroxine at 25 ug. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination was Levothyroxine 25 ug. On 20Mar2021 11:30, patient had "I have chronic disease, Hashimoto's thyroiditis. Severe reaction, sharp pain in left hand, 20 mins later slurred speech eyes dilated, body heavy and in pain, throat feels like it's closing up. I can feel my heart beating and like theirare ants in my veins. Felt like arms swollen. Feet swollen and in pain. Took antihistamine Benadryl. Doctors at Urgent care said I'm not having anaphylaxis but having severe panic attacks. Given steroid injection. Swelling reduced, pain reduced. I was able to see again although my vision is now blurred and reduced significantly ". Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, covid test post vaccination: covid test type post vaccination=Other, covid test date=08Jun2021, covid test result=Negative. The outcome of the events was resolved with sequel.