chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe dizzines; Confusion; Tinnitis; Ear pressure, currently intermittent; Vestibular neuritis; Leg weakness; Tingling; This case was reported by a consumer and described the occurrence of vestibular neuritis in a 30-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included egg flu vaccines with an associated reaction of no adverse event (received on an unknown date without an issue) and Fluzone quadrivalent with an associated reaction of no adverse event (received 3 doses on an unknown date with no issue). Concurrent medical conditions included egg allergy (itching and runny nose).   On 5th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. In September 2021, 12 hrs after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced lower extremities weakness of and tingling. On an unknown date, the patient experienced vestibular neuritis (serious criteria GSK medically significant), dizziness, confusion, tinnitus and sensation of pressure in ear. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the vestibular neuritis, dizziness, confusion and tinnitus were recovering/resolving and the outcome of the lower extremities weakness of and tingling were recovered/resolved and the outcome of the sensation of pressure in ear was not recovered/not resolved.   It was unknown if the reporter considered the vestibular neuritis, lower extremities weakness of, tingling, dizziness, confusion, tinnitus and sensation of pressure in ear to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. 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 as follows: The age at vaccination was not reported. 12 hours after receiving Fluarix Quadrivalent, the patient had leg weakness and tingling, which resolved but less than 2 months of vaccination followed with 4 weeks of severe dizziness, confusion, tinnitus, ear pressure.  The events were partially resolved with 2 weeks of steroids.  Less than 2 months of vaccination, the patient also experienced vestibular neuritis. At the time of reporting, the patient was still experiencing intermittent ear pressure. The patient had 2 primary care visits, 3 ENT visits, 1 neurologist visit and 1 emergency room visit.
29May90 pt vax;  devel half-dollar sized redness & swelling at inject site.  W/in 15 min redness gone.
Patient received 2nd dose of Moderna COVID-19 Vaccine 10/12/21. It was noticed the next morning, 10/13/21, that the vial had expired on 10/10/21. Patient has no symptoms of illness or adverse event  at this time.
Chest muscle pain started at 6:15PM in bed while laying down. Deep cough no mucus with the chest wall pain
I developed a rash 10 minutes after 2nd vaccine. I was checked out by EMT. They took my blood pressure, checked my pulse and was monitored for about one hour. The rash disappeared with 45 minutes.
Information has been received from a physician concerning a female was vaccinated IM with a first dose of Gardasil. The physician mentioned that the patient fainted after the injection without any complication. Patient decided not to continue with the series. The patient recovered. Additional information has been requested.
For approximately 2 days - Fever 102.7; chills; sweating; aches all over; headache For approximately 7 days - weakness; tired
BODY ACHE; SEVERE CHILLS; HEADACHE; YELLOW BLOTCH ON INJECTION SITE, DISCOLORATION; This spontaneous report received from a patient concerned an adult male. 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 not reported) dose was not reported, administered on 07-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced yellow blotch on injection site, discoloration. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced severe chills. On 08-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, severe chills, and headache, and had not recovered from yellow blotch on injection site, discoloration. This report was non-serious.
Pt visited our Urgent Care and states that she received the COVID-19 vaccine . The patient states that the vaccine was mistakenly administered via a subcutaneous route, and she could feel the vaccine leak out of her arm after injection. Over the next two days she experienced swelling, redness, and tenderness around the site of injection.
Home AG-Positive (cough, congestion stuffy nose, SOB); Home AG-Positive (cough, congestion stuffy nose, SOB); Dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 26-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 15Oct2021 (Lot number: FF2589) at the age of 26 years as dose 3 (booster), single, via an unspecified route of administration, administration date 23Mar2021 (Lot number: EL3247) at the age of 25 years as dose 2, single and via an unspecified route of administration, administration date 04Mar2021 (Lot number: EL3247) at the age of 25 years as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "Dose 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022 17:00, outcome "recovering" and all described as "Home AG-Positive (cough, congestion stuffy nose, SOB)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Home AG): (04Jan2022) negative; (05Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient received the booster dose in a workplace clinic. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if patient was diagnosed with COVID-19 infection prior to vaccination. In the week of 25Dec2021, the patient had a travel, then on 05Jan2022, the patient tested positive in Ag test with symptoms cough, congestion stuffy nose, and SOB (shortness of breath) that started on 04Jan2022 17:00.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, a causal association between the reported events immunisation, vaccination failure, Covid-19 and the suspect BNT162B2 is possible.
Elevated heart rate, this came and went for the remainder of the day, and for the 72 hours after the shot. I also had serious mental fog, nearly fugue level as I lost time (on the drive home I ended up 2 hours off track in an unfamiliar location, with no recollection as to how I got there). I was foggy for about a week. I had a fever the night after the vaccine (102). This has all mostly resolved now at the 2 week mark, and I've only had a little body ache that seems to be holding on (nothing unmanageable). I am prone to anxiety and I'm sure that made the dissociation worse, but it is new to me at that level. I was concerned about the irregular heartbeat but am told this is not dangerous. I did not take any medication or anything to offset the symptoms as I want to make sure the vaccine works best.
A little of pressure chest, a little of pain and burning in the heart area. Noticeable inflammation in the area.
INJECT ON 2-28-90. ONSET OF BURNING SENSATION ON 3-2-90. RASH AROUND SOI ONSET 3-5-90 WHICH CLEARED BY 3-8-90.
Starting at about 6 pm that evening, had a fever of 100 and uncontrollable chills and shivering. Shivering became extreme (teeth actually chattering) by about 7pm, and whole body aches becoming profound. At about 7pm or so, I took 2 tylenol and got into a very hot bath. It took about 15 minutes for the chills/goosebumps and shivering to stop. But then I worried about pushing my temp up higher and protecting my brain, so I got out, took my temp, and it had shot up to nearly 102. So, I dried off and began shivering again, got into bed under 2 quilts and a wet cloth on my forehead and neck to cool my head. Finally the chills calmed down about a half hour later and I slept fitfully til I got out of bed about 6:30. But my heart was pounding hard all night, and in the morning  I still had a degree temp over my morning normal and the aching felt worse.  I finally relented again at about noon and took 2 more tylenol. Within about 1-2 hours, I finally started to begin feeling better. That evening  I went to bed early after taking one of my cetirizine allergy pills and slept like the dead. Yesterday I felt pretty good except my arm was still a bit spore, same thing today except arm seems better.
This spontaneous report as received from a clinic manager refers to an unspecified patients of unknown age and gender. On an unknown date, the patients were orally vaccinated with improperly stored doses of ROTATEQ  (dose and lot numbers were not reported). The reporter was not aware of an adverse experience. There was no previous temperature excursion. The call was made because of data logger. Administered vaccine experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments:  US-009507513-1705USA012737: US-009507513-1705USA012738: US-009507513-1705USA005716:
Patient was unknowingly give Dose #2 of expired vaccine.  Patient was notified by his provider once this was realized
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, chills, fatigue Narrative:  Fever 101.3, myalgia, arthralgia, headache, N/V/D, chills, fatigue
Experienced temporary blind spots in vision, numbness in fingers and lips followed by difficulty speaking. Had CT and bloodwork done, no significant findings and the symptoms resolved without treatment to this point.
Body aches, nasal congestion, headache,  shortness of breath,  muscle soreness at injection site
Information has been received from a mother concerning her daughter who on 14-AUG-2007 was vaccinated with a first 2 ml oral dose of Rotateq. It was reported that the patient spit out the vaccine at the physician's office. The patient's mother then asked the office for a replacement dose to give to the patient again when she got home. The patient's mother gave the patient another dose, and it was spit out again. It was reported that the patient had no ill effects from the event. No product quality complaint was involved. Additional information is not expected.
not able to feel hot or cold sensation to the back of the LU thigh/he noticed the coldness of the toilet seat on the back of his R thigh, but could not feel anything to the back of his L thigh; numbness and some discomfort to the L foot, great toe; toes on L foot felt "fat"; numbness and some discomfort to the L foot, great toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 08:00 (Lot number: EN6201) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SENSORY DISTURBANCE (non-serious) with onset 24Feb2021 08:00, outcome "not recovered", described as "not able to feel hot or cold sensation to the back of the LU thigh/he noticed the coldness of the toilet seat on the back of his R thigh, but could not feel anything to the back of his L thigh"; HYPOAESTHESIA (non-serious), LIMB DISCOMFORT (non-serious) all with onset 24Feb2021 08:00, outcome "not recovered" and all described as "numbness and some discomfort to the L foot, great toe"; OEDEMA PERIPHERAL (non-serious) with onset 24Feb2021 08:00, outcome "not recovered", described as "toes on L foot felt "fat"". The events "not able to feel hot or cold sensation to the back of the lu thigh/he noticed the coldness of the toilet seat on the back of his r thigh, but could not feel anything to the back of his l thigh", "numbness and some discomfort to the l foot, great toe", "toes on l foot felt "fat"" and "numbness and some discomfort to the l foot, great toe" were evaluated at the physician office visit. Therapeutic measures were taken as a result of sensory disturbance, hypoaesthesia, oedema peripheral, limb discomfort.  Additional information: The patient reported that 24 hours after 1st Pfizer injection, patient was not able to feel hot or cold sensation to the back of the LU thigh and toes on L foot felt "fat," with numbness and some discomfort to the L foot, great toe. He stated when he woke the next morning (24Mar2021), he noticed the coldness of the toilet seat on the back of his R thigh, but could not feel anything to the back of his L thigh. He received treatment of medication for the neuropathy like symptoms. The patient received second dose of bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EP7534) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine, He received other medications within 2 weeks of the vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Narrative: 65yo male with a history of SCC of the anus, left tonsil SCC, and lung SCC s/p chemoradiation c/b recurrent pneumothorax, COPD, CAD, HFrEF (LVEF 45%), T2DM,HTN, HLD, and chronic anemia. Died on 06/12/21 at a long term care facility. Patient was administered covid vaccinations on 01/29/21 and 03/01/21. Appears patient died due to complications of cancer and is not related to the covid vaccinations.
Client was walking out to waiting room after vaccines were given. HE had to sit down, hot flash, pale, sis not pass out. Went into the bathroom with mom and nurse and vomited, sat on floor. Taken to exam room with lights off. Felt better sat up sipped water. After resting, stood up and after a few minutes walked out with mom to go home.
I started getting muscle cramps and flu-like symptoms on Mar. 7th. I felt better Mar. 9th and 10th. On March 11th, I started projectile vomiting and getting migraine headaches. (Day 6). On Mar. 13th, I developed a fever of 101. 2 days later, I continued with headaches daily and started developing respiratory symptoms. I felt better on March 15th except for daily migraines. I've had episodes when I have high fevers, leg cramps, or shortness of breath on and off since this point. I haven't felt right, the migraines have been on and off. I've had random high fevers and respiratory symptoms.
Information has been received from a physician concerning a 3 month old male who on 24-MAY-2007 was vaccinated with the second dose Rotavirus (Lot# 656104/1167F). There was no concomitant medication. There was no medical history. On 26-May-2007 the patient experienced diarrhea that lasted 8-10 days. The patient sought unspecified medical attention. Additional information has been requested.
I got my 2nd shot yesterday and feel terrible today; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I got my 2nd shot yesterday and feel terrible today) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced FEELING ABNORMAL (I got my 2nd shot yesterday and feel terrible today). At the time of the report, FEELING ABNORMAL (I got my 2nd shot yesterday and feel terrible today) outcome was unknown.            No concomitant medication information was provided.  Patient had no fever though No treatment medication were provided.
I have no family history of kidney stones and had never had them in my life. Have to see Urologist, Nephrologist and visited ER multiple times for pain and eventually had surgery for removal. I still am experiencing kidney stones to this day.
Prolonged drowsiness p/receiving immun; also cold sx on day of immun;
Initial report was received from a patient on 02 December 2011. A male patient (age not reported) had received an injection of FLUZONE Intradermal (lot number, route and site of administration were not reported) on 30 November 2011. On the same day during the evening after the injection, the patient developed a sore throat, felt achy, sinus infection, bronchitis, green mucous and a red bump the size of a "bug  bite" at the injection site. The patient received corrective treatment with antibiotic. No further information was available at the time of the report. The patient outcome was not reported. Follow-up information was received on 06 February 2012 from a health care professional. The patient had received FLUZONE Intradermal; lot number UT4163AA in the left deltoid. No further information was available at the time of the report. Documents held by sender: none.
pt's history & autopsy findings consistent w/SIDS; had recvd routine vax OPV/DTP/HIB earlier on same day;
Approximately 9 hours post vax, the pt experienced a fever of 101, diarrhea, body aches, swelling of digits 3 and 4 on right hand. Pt also complained of nausea for more than 24 hours accompanied by a headache.
STATUS EPILEPTICUS 1/3/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/3/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA STATUS EPILEPTICUS 1/3/2022 HIGH DENSITY LIPOPROTEIN DEFICIENCY ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/3/2022 HIGH DENSITY LIPOPROTEIN DEFICIENCY
Painful Rash on left forehead. Painful Swollen left neck side. Left 2nd toe has red circle on it and hurts. Body aches and Chills sometimes.
2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided. It was reported that 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated.  The total number of vials were 2. The vial was not initially stored in the refrigerator The vial did not undergo any temperature excursions   This case was linked to MOD-2022-582637, MOD-2022-582638, MOD-2022-582650 (Patient Link).
Severe lower back pain. No position relieves it. Worse at night and in the morning. Taking anti-inflammatory drugs to relieve pain but it is not very effective.
Pt recvd MMR vax 30OCT90; pts last menstrual period 26OCT90 & approx 2 wks following vax pt noted to be pregnant; during pregnancy pt devel diabetes mellitus; placenta previa was also noted;  24JUN91 pt had  C-section & delivered male;
Mom reports pt was fussy then to bed at 1:00am temperature 100.5 rectally. Gave cool bath then slept at 10:00am rectal temp was 102.1. No nausea/vomiting or site irritation noted. Was rechecked at 4p, in office 8/19/03 temp 99.5.
Developed a high fever on 5/10/03 and rash appeared on the 5/11/03. Vesticles dried up by the 16th.
Pt. was really fussy. She slept 8 hours continual overnight & increased napping during the day. Decreased nursing. Stools very watery with a lot of mucus & frank blood. Symptoms continued for about 4-5 days total. On 11/4/13 mom states that stool has improved, still some mucus but no frank blood seen. Appetite is improving.
Patient is under 18 and was given the first Moderna dose by mistake on 1/19/21. Mom was insistent that he receive the 2nd dose since he received the first already. I was told by legal department to go ahead and give the 2nd dose today. He did not have any reactions to the first dose and so far none from the second dose as well.
Within hours post vax, the pt experienced malaise and was very tired. The next day she experience severe muscle weakness, joint achiness, GI upset and nausea. No vomiting or diarrhea was noted. The pt also experienced chills and fever up to 104 which was treated with acetaminophen. The fever resolved after 2 days and the rest of the symptoms resolved within 2 weeks. The reporting health care professional noted that the CDC stated this was not related at all to the vaccine. No further information is available.
Patient called in 10/8/08 stating that 30 minutes after receiving the shot, she started to feel back pain. About another 30 minutes later she felt shortness of breath and the back pain was then extreme. Patient stated she went to ER a few hours later. Patient was concerned, she stated her back was fine prior to shot. Patient was advised that this is not a normal reaction that is usually expected from any vaccine and she should follow up with her primary care provider. Patient was also told that a VAERS will be filed. Patient verbalized understanding.
The pt received total of five vaccines on 04/01/2002. He developed inability to walk for 24 hrs and fever up to 102 deg. F.
Left Temporal  tenderness swelling, with Jaw claudication suspected Giant Cell Arteritis. No vision changes. Treated immediately with Prednisone 60mg qd. with resolution of symptoms over three days.  Bilateral Temporal artery biopsies done 16 Feb showed no arteritis. Prednisone cut to 10mg qd. No residual symptoms.  Covid antibody titer on Feb 12 showed Zero antibodies.
Pt called about 5 hours after receiving the vaccine and was complaining of extreme pain in the right arm-- the pain was from her deltoid down to her elbow. She was also nauseous. No erythema or swelling. No numbness or tingling.
Last known alive on the date of vaccination (September 4). Found dead and decomposing in his residence on September 7.
Hypertension, headache, muscle ache left side, shoulder and top of neck, Fatigue,  lethargy.