chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from a healthcare professional on 18 October 2012. The reporter for this case is the same as for case number 2012-09899. An unknown patient (age, gender and birth date not reported) received an Intradermal injection of FLUZONE intradermal, Sanofi Pasteur Inc., lot number UT4470AA (site and side not reported) on 18 October 2012. On 18 October 2012, within a few minutes after the vaccination, the patient experienced chest tightness and diaphoresis and had to go to the emergency room due to anaphylactic reaction. The patient also experienced numbness and tingling on the roof of the mouth, severe vertigo, flushing and shortness of breath. The patient was observed in the emergency room for one half hour and then the patient was discharged when symptoms subsided. The patient's medical conditions and illness at time of vaccination was reported as unknown. The patient had a penicillin (PCN) allergy and had received Flu vaccines in the past. The patient's outcome was reported as unknown. Follow-up information was received from a healthcare professional on 19 October 2012. Based upon the new information provided, this case has been downgraded to non-serious. The patient was 39-years-old. As information was provided for both cases (cluster), the individual patient's history was not able to be determined. One of the two patients had a penicillin (PCN) allergy and the other patient had no allergies. Neither patient had a food allergy or history of anxiety disorder. Both patients had received intramuscular Influenza vaccines in the past without incident. Both patients had tightness of chest and diaphoresis. One of the two patients experienced flushing and "throat tingling". Both patients were observed in the emergency room (ER); no epinephrine or antihistamine was administered. The patient was discharged from the ER after one half hour observation when symptoms subsided. Based on follow-up information, the events of anaphylactic reaction, shortness of breath, vertigo CNS origin and numbness mouth were removed from MedDRA coding. The patient's outcome was reported as recovered. Documents held by sender: None. Follow-up information was received on 06 November 2012. This case is cluster with 2012-09899 and 2012-10407 same reporter and same lot number. The patient's gender male. The patient had received intramuscular Influenza vaccine in the past without adverse event and had no allergy. The previously reported event diaphoresis was no longer reported in the follow-up. On 18 October 2012, the patient had recovered. The patient did not receive any treatment in the emergency department.
This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she was in bed with flu-like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Description of Event: Patient received Prevnar 20 at office visit and contacted the Dr. the following day stating she was in bed with flu-like symptoms and sore arm. Additional Information: Awareness Date: 12Apr2022. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NUMBNESS IN HAND; LEG PAIN; This spontaneous report received from a consumer concerned a female 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced numbness in hand, and leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in hand and leg pain was not reported. This report was non-serious.
During the patient's 15 minute post COVID vaccine observation, she reported feeling dizzy and unsteady on her feet. Her BP 188/78. HR 98. Pulse Ox 98% on room air. She did state she was anxious about recieving vaccine. While obtaining health history, the patient revealed she was feelin dizzy and unsteady as she was exiting the car this morning. She did not eat breakfast and also recently started allergy shots. She had skipped her allergy shot this week because of this appointment for COVID vaccine. Patient was monitored for an aditional 30 minutes. Vital signs returned to normal but she was still feeling dizzy. Her husband was called to pick her upand she was instructed to follow up with PCP.
Reaction to Pfizer booster after receiving dose 1 & 2 of Moderna vaccine. Rash and swelling at injection site. 50mg Benadryl administered.
Patient had headache at the time of the vaccination. She stated that she had soreness around the injection site. She stated that she had symptoms resembling a migraine with myalgias, nausea and vomiting. She stated that she did have a lot of sun exposure after the vaccination which sometimes leads to less severe, but similar symptoms. The following day at 11:00AM (22 hours after vaccination), she is no longer nauseous, has no appetite, has injection site tenderness, and is still feeling lethargic. She states that she has improved a lot since the reaction. She is only treating symptoms with Aspirin 81 mg every 6 hours.
Patient positive with COVID on 8/9/21 after receiving both doses of Pfizer's COVID vaccine.
Increased optic nerve pressure, papilladema, intracranial hypertension  First prescribed acetazolamide 250mg 4x/daily for 10 days - could not tolerate medication side effects Dosage dropped to 250mg 2X/daily - side effects lessened but had constant shortness of breath Neurologist switched medication to topiramate 25mg 2X/day - tried for 7 days and could not function effectively with brain fog Now taking Trokendi XR 50mg 1x/daily
Arm was red; Arm was swollen; This case was reported by a consumer and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown.   The reporter considered the erythema of extremities and swelling arm to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked if there any discounts/coupons that could be applied to the Shingrix vial shot for Shingles. The patient reported that she and her husband they had different insurance options. The patient received 1 of 2 shots, and she paid 45 (co-pay) and her husband paid the total cost of 170. They were still facing these costs to receive a 2nd shot in 2 to 4 months. The patient reported that her arm was red and swollen. The patient reported that it was strange that insurance did not help out with vaccinations, just the flu shot!  The patient did not want to come down with Shingles and was thankful you have a vaccination as a remedy.
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ALPRAZOLAM from 01-Jan-2015 to an unknown date for Anxiety, AMLODIPINE from 01-Jan-2020 to an unknown date, HYDROCHLOROTHIAZIDE from 01-Jan-2017 to an unknown date and LOSARTAN POTASSIUM from 01-Jan-2015 to an unknown date for Blood pressure, ROSUVASTATIN from 01-Jan-2013 to an unknown date for Cholesterol, LEVOTHYROXINE from 01-Jan-2013 to an unknown date for an unknown indication.   On 02-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021 at 5:00 PM, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). On 12-Mar-2021, VACCINATION SITE PAIN (sore left injection site arm) had resolved.            Patient treatment include Ice packs on shoulder.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up information on 22-SEP-2021 included reporter mail id, vaccine facility information, patient demographics and concomitant medications were added. Event stop date and outcome updated.
Menveo 2 vials presentation instead of MMR vaccine; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Menveo 2 vials presentation instead of MMR vaccine) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt date: 14-SEP-2023 Medical Assistant reported that a 4 year old patient received by mistake Menveo 2 vials presentation instead of MMR vaccine which led to wrong vaccine administered and Inappropriate age at vaccine administered.  The reporter consented to follow up by e mail.
about 20 hours after receiving vaccine I started getting a bad headache and then became diaphoretic, shortly after I started feeling dizzy and had to leave work. Around 6:30pm I had the chills and my body was aching, had a 103.0 temperature. Bundled up with blankets and sweatshirts and fell asleep woke up a couple hours later dripping sweat and had nausea. Not feeling well through the night and had a temp of 102.5 the next morning - stayed home from work and started feeling better by late afternoon. Injection site was swollen, mild redness, feels like a knot is there and is it tender to the touch - still has some mild swelling and tender to touch even today (9 days later).
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. On 15th May 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient experienced pain at the injection site, but it went away fairly quickly.  The patient did not experience any other side effects. The patient had same initials as reporter. There is a discrepancy with respect to the outcome of the events injection site pain. In core the outcome is reported as recovered/resolved, however in provided source document it is recovered/resolved with sequel. The outcome of these events retains as per the structural field.
PATIENT PRESENTED ON 1/21/2005 WITH TWO DAY HISTORY OF RASH - ERYTHEMATOUS PATCHES THAT DEVELOPED INTO PUSTULES - BEGAN ON TORSO WITH NEW LESIONS ON ARMS DIAGNOSIS OF POSSIBLE LOW GRADE POST VACCINATION CHICKEN POX.
Received 1st dose of Pfizer at Pharmacy approx 4 hrs later developed rash on back of legs.  Rash then spread to back of knee to calf muscle.  States rash was raised and itchy, describes it has "hives."  Pt tried to treat with calamine lotion to help with itch and then used benadryl  topical cream and that turned areas purple.  Pt stopped using Benadryl and called PCP.  Went to PCP and was given steriods, and 2 other medications to help.  Also experienced "feeling like you were hit by a train", vertigo, and shortness of breath.
SUFFERED A STROKE ON 5-16-21 REQUIRED EMERGENCY CARE AND 18 DAYS HOSPITALIZATION
no side effects other than a sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: no side effects other than a sore arm.).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 21-SEP-2023 This case was reported by patient's wife via interactive digital media. The reporter reported that the patient got the RSV vaccine as soon as it was available, no side effects other than a sore arm. Follow up was not possible as no contact details were available. This case was linked with case US2023AMR132088, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR132088:same reporter, different patient
A nurse reported that a 44 day old female received injections of a 1st dose of Prevnar, a dose of DTAP, IPV and COMVAX on 2/12/01. On 2/13/01, 24 hours, post vax, the pt developed an erythematous rash on her face extending down onto her neck. She also developed a fever of 102F. Follow up information received from the original reporter on 04/02/2001 who indicated the patient's symptoms reportedly resolved. The rash actually occurred 3 days following vaccination on 02/15/2001 and was "probably" unrelated to vaccination.
Systemic: Fainting / Unresponsive-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted briefly and was weak and had tingling in both arms and hands-tried hydration and fan cooled air circulation-revived within 10-15 min-kept for observation for 30 -45 minutes and had mother pick her up so she didnt drive
This spontaneous report received from a medical assistant refers to unspecified number of patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of with PNEUMOVAX23 from lot # M032635 with expiry: 05-MAY-2018 and lot# M041394 with expiry: 23-MAY-2018  (dose, route and anatomical location not reported), for prophylaxis. No adverse effects reported. The vaccine lots were exposed to a temperature excursion of 32 degree Fahrenheit and 36 degree Fahrenheit for 135 hours. The vaccine did not have previous temperature excursion. It temperature excursion was determined by data logger. No product quality complaint (PQC) involved. This is one of the three reports  received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009721:
pt recv vax & devel a nodule w/a blackhead pimple @ the inj site;pt had been squeezing it & draining a lot of stuff;nodule was still palpable 5 wk p/vax;
Minor patient brought in by mother for second dose of Pfizer Covid Vaccine.  Mother said she couldn't find his card.  Only ONE dose was recorded previously in our EHR, on 8/18/21. Vaccine was administered. Mother found patient's card after dose administered, showing a previous "first" dose on 7/21/21.  Both doses, July & Aug were given at Rec Center.  Patient monitored for 15-20 min. with no immediate adverse reactions.
*On 10/27/2021, 10/29/2021, 11/1/2021 and 11/03/2021 there was a combined total of 30 vials of lot 014F21A that were punctured more than 20 times. *There was a total of 145 additional doses drawn up from the vials above and beyond the recommended 20 doses per vial. *There was a total of 753 doses administered on those four dates. *There is no way possible for us to identify the 145 patients who received doses 21 or greater out of the 753 total doses administered on those dates. *We have received no reports of adverse events from patients related to these vaccine clinic dates.
REDNESS AT INJECTION SITE (WHICH IS COMMON) BUT BECAME MORE RED AND ITCHY AFTER 9 DAYS. STILL VERY SWOLLEN, RED AT SITE, AND PT REPORTS VERY ITCHY
Within 1-2 hours following receipt of vaccine, developed pruritis and urticaria-possible type 1, IgE-medicated hypersensitivity reaction. See clinical summary-skin testing will be completed in 03/04. Follow-up: Patient was skin tested for the flu vaccine. He had a positive intradermal skin test to 1:10 dilution of influenza vaccine.
Information has been received from a physician concerning a 10-year-old male with seasonal allergies who on 08-Aug-2005 was vaccinated with a dose of varicella vaccine live.  Concomitant therapy included budesonide (Rhincort).  The physician reported that on 23-Aug-2005, the patient developed chickenpox.  Unspecified medical attention was sought and the patient subsequently recovered from the chickenpox.  Additional information has been requested.
Information has been received from a registered nurse, via a nursery school administrator, concerning a child (age and gender not reported) who was vaccinated on an unspecified date with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # not reported).  Nine days after vaccination (initially reported as approximately ten days post vaccination) the child developed a rash.  It was reported that "the child was diagnosed as having mild measles."  The nurse reported that she was informed that the parent took the child to the "primary MD" who diagnosed "mild measles".  No further information is available.
Information was received from a physician concerning a 20 year old female patient, who was vaccinated with her first dose of GARDASIL in 2009. In JUL-2012, the patient was vaccinated with her second dose of GARDASIL, 0.5 ml intramuscularly. No further information was provided. No additional adverse event. Additional information has been requested.
Information has been received from a physician concerning a 15 year old female who on 18-FEB-2008 was vaccinated with the first dose Gardasil.  Subsequently, the patient developed "flu like" symptoms such as a fever and chills after receiving the first dose of Gardasil.  No diagnostic laboratory studies were performed.  At the time of this report, the patient's mother did not want the patient to receive the second and third dose.  The outcome of this event was unknown.  No product quality complaint involved.  Additional information has been requested.
Disabling pain and swelling x 7 days after vaccine. Patient could not exercise with shoulder and needed wife to massage at night to try to relieve pain.
Information has been received from a doctor of chiropractic medicine concerning his 9 year old son with a "minor issue with attention deficit" who "several years ago" was vaccinated with a dose of MMR II. On approximately 11/6/02, the pt developed high levels of lead and arsenic which was found in a hair analysis. The doctor of chiropractic medicine indicated that he was not stating that MMR II was the cause, but was told that childhood vaccines could produce "this type of results." The pt sought unspecified medical attention. Additional info has been requested.
Red, swollen, itchy bicep w/ bruising. Tender & warm to touch 20mm x 30 mm.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from Health Authorities, This case is linked to case 2018SA286240, 2018SA286241, 2018SA286243, 2018SA286244, 2018SA286233, 2018SA286242 (same reporter). This case involves Adult female patient who experienced local redness and swelling that warm to the touch, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On 09-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI982AA. On an unknown date, the patient developed a non-serious local redness and swelling that warm to the touch 48 hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was also reported 7 of the 10 individuals who received the vaccine had significant local reactions of redness, swelling, warm to touch. 47% reported pain at injection site, however, redness is not reported, and we all had the redness below the injection site not directly at the injection site. Day 2 after injection seemed to be the most significant timeframe for peak reaction. (Other relevant tests included no lab data.) Final diagnosis was local redness and swelling that warm to the touch. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for local redness and swelling that warm to the touch. Reported as 3 days post vaccine all are showing signs of improvement. Follow up information was received from a Pharmacist on 12-Oct-2018. No new information was received.
The fourth night after my first Pfizer vaccination I awoke at 2:30 am with severe chest pain. It felt like my heart was being squeezed.  I was worried I was having a heart attack.  I sat up in bed and felt some reduction of pain. I decided to sit in a chair and see if I continued to get relief. After around 2 hours the pain reduced to the point I could fall asleep.  The same thing happened for the next three nights. I concluded it was a side effect of the vaccination. I had an appointment scheduled with my cardiologist, the day before the second dose so I decided to ask him about this.  Dr  perform an EKG that he said was "Perfect".  He said my pain was probably from acid reflux.  I received the second dose the next day and the same chronology of symptoms occurred but the pain was a little less that with the first dose.  I was now certain this was caused by the vaccination. My vaccinations were administered on a base. The lot numbers are hard to read on the vaccination card.  The second dose lot number looks like ER9727.
5 MINUTES POST ADMINISTRATION PATIENT FELT FAINT AND SAID SHE WAS SEEING COLORS - INSTRUCTED HER MOM THAT WE WOULD BE MOVING HER TO THE FLOOR SO SHE WOULD NOT FALL OUT OF HER CHAIR AND HIT HER HEAD. I CHECKED HER BLOOD PRESSURE BEFORE DOING SO AND IT WAS 78/60. SINCEI T WAS LESS THAN 80/60 AND SHE WAS VISIBLY NERVOUS AND NOT WELL, I HAD HER LIE ON HER BACK ON THE FLOOR, AND RAISED HER LEGS IN THE AIR TO INCREASE HER BLOOD PRESSURE. I HELD HER LEGS UP ON MY SHOULDERS FOR 10 MINUTES AND THEN REASSESSED HER BLOOD PRESSURE, IT WAS THEN 118/80. SHE REPORTED FEELING FINE AND WITH HELP SAT UP ON THE FLOOR. AFTER TEN MORE MINUTES, SHE THEN MOVED TO THE CHAIR AND I INSTRUCTED HER TO WAIT FOR 30 ADDITIONAL MINUTES TO ENSURE IT WOULD NOT DROP AGAIN. SHE LEFT AMA WITH HER MOM AND PROCEEDED TO SHOP IN THE STORE.