chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of unspecified event in a male subject of unspecified age who was vaccinated with Twinrix for prophylaxis. The reporting physician is also the subject. On an unspecified date in June 2007, the subject received the first dose of Twinrix (prefilled syringe, unknown). Within one month of vaccination with Twinrix, in June 2007, the subject experienced "an unspecified safety and quality issue with his dose and the lot of Twinrix". The physician reported that the Twinrix vaccine "was donated to a public health clinica by an unknown source." At the time of reporting the outcome of the event(s) was unspecified.
Arm soreness; Fever (101); nausea; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (COMIRNATY), on 05Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness"; PYREXIA (non-serious), outcome "unknown", described as "Fever (101)"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports receiving first dose of SHINGRIX at pharmacy and approximately 10 minutes later she began to have tingling and pain to skin from mid-back wrapping around to front of abdomen in a line. She was seen in PCP office and noted to have raised, red, blistered areas along where she complained of pain. Covering MD and infectious disease MD both examined patient and concur that affected areas are zoster. Pt is being treated with antiviral medication.
Moderna COVID-19 Vaccine  Severe arm soreness at site of injection starting 2 hrs after injection and lasted 2 days. Mild soreness after that  Mild to moderate fatigue and the sensation of my brain feeling fuzzy starting the morning after the injection. The symptoms are ongoing but have improved slightly
Booster; Blood in her stool; Stress; Increase abdominal pain; Interrupted sleep; Bowel movement frequency; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer, Dose number unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "Booster"; HAEMATOCHEZIA (medically significant) with onset 2021, outcome "not recovered", described as "Blood in her stool"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "Stress"; ABDOMINAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Increase abdominal pain"; SLEEP DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Interrupted sleep"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 2021, outcome "not recovered", described as "Bowel movement frequency". Clinical course: Patient reported when she got the Covid booster back in Oct2021, she had an adverse effect while on Xeljanz. after the booster, developed and increase with blood in her stool. md is aware. she also reported having "flare ups," most recently 2-3 days after the holidays. her flare ups, caused by stress, worsened her symptoms. symptoms consisted of increase abdominal pain, blood in her stool, and interrupted sleep because of bowel movement frequency. patient reported it has been improving with spots of blood in her stool and able to sleep 5 hours straight. md is aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event Haematochezia and other reported events and the suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
had a very slight reaction this year; Initial information was received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved an unknown age patient who experienced had a very slight reaction this year (Vaccination site reaction), while being received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Type 2 diabetes mellitus.   On an unknown date, the patient received INFLUENZA VACCINE (unknown manufacturer) (batch number and dosing details were unknown) for prophylactic vaccination.  On an unknown date (unknown latency) after the administration of INFLUENZA VACCINE, the patient experienced had a very slight reaction this year (Vaccination site reaction).  No laboratory test was reported.  It was unknown if the patient received any corrective treatment.  At the time of this report, the event outcome was unknown.  Batch number will not be available for this case.
Pt received vaccines 2/15/07-the morning of 2/16/07, mom noted blood in stool-brought in stool to office-heme positive
pt reported arm soreness, arm swelling, and uterine cramping (not sure if from vaccine or cervix exam)
Post vax, the pt complained of numbness and loss of sensation in left hand for 3 days.
Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experienced lightheadedness, nausea, bilateral hand tingling, hypertension after administration of her first COVID vaccination. No airway involvement. No rash, chest pain or SOB.  Patient states that she thinks she had COVID in March though she tested negative. Patient has never had prior vaccine reaction. She was taken to ED, given PEPCID IV and liter of LR. Her vitals were stable throughout and she felt back to baseline and was released to go home after about 2 hrs.
Wellness checkup on 8/4/2022  Received vaccine injections in both arms.  Both arms were painful by that evening as expected.  Woke up in extreme pain and unable to move my left arm at all. Right arm was very sore but not near as bad as the left.  By the 3rd day my right arm was much better and moving fine but my left arm still had no mobility and I continued to have  excruciating pain in it. I used ice packs anti inflammatory medication to help relieve the pain. Nothing helped.  After 2 weeks of no relief or little sleep returned to doctor on 8/19/2022 referred to physical therapy and orthopaedic surgeon.  After 3 months still have little use of arm and sever pain from nerve damage.
Few after the injections the patient arm sores, stiffness, in the upper left arm that has now lasted a couple months intermittently; and has trouble lifting arm above the head
I took the vaccine on January 29th and I still have extreme dermatographia  that I need to take cetirizine every 2 days to resolve. It's been 6-7 months almost and there is no sign of it disappearing. To explain my symptoms better, I get extremely itchy skin that I cannot help but scratch. I try to scratch it lightly which still gives me a rash (bump like swollen skin where ever I scratch).
16yoF patient came to our Moderna Mass Vax clinic on 4/26/21, inadvertently  received COVID-19 vaccine Moderna lot 007C21A ext 10/12/21. EUA for moderna is for age over 18. Patient reported later that patient had fever, HA, loss of taste, weight loss, increase in liver enzymes. Patient went to ED on 5/14/21 and came back again on 5/21/21, getting admitted to Ped unit x2days.   She was diagnosed with infectious mononucleosis hepatitis, unlikely related to vaccine admin as per Dr., Ped ID specialist**.  Patient became afebrile, LFT improved (ALT 577> 126, AST 349>74), condition stable and discharged on 5/23/21.  Dr. follows up with the patient at his OP clinic.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (route and lot # not reported0. The medical Assisi stated that M-M- R II was not improperly stored and (OkaMerck) PROQUAD was not administered to patients. At the time of the report, the patient outcome was unknown. Additional information is not expected.
4 1/2 days after second shot, develop swelling in right arm pit and breast. That was a week ago. Subsequent a rash has developed and I continue to have temperature (as high as 100.9), chills and significant night sweats. Swelling continues. I get some relief from Tylenol and Ibuprofen
pt recv vax 22AUG97 & pt exp nausea, h/a, coughing & incredible sleep disturbance which persisted since the first evening was vaccinated;pt had no fever or lesions;
2 weeks after receiving MMR and varicella vaccine pt had bone and joint pain and lower extremity and hand edema - edema lasted for 1 week and pain for 1 1/2 weeks.
I have been sick for 18 days now.  I called the pharmacy and got no support there.  Red, hot, swollen arm, fever, chills, tossing & turning in bed, mild nausea, headache, hart to sleep, exhausted, ringing in ears, then more severe nausea, fatigue, malaise, no energy...  I'm sick of being sick!  I thought maybe Shingrix contained thermiasol, but was told no.  But I MUST have been allergic to something in the shot!  I have no idea what I'm sensitive to~ I'm usually healthy and active, and this sucks!
Child given 0.2ml of undiluted 5-11 yr old Pfizer vaccine.
myositis  3+ weeks of muscle cramping with exercise. Labs reveal elevated CK of 811, and LD of 409 plus AST of 53. Normal Sed Rate and CRP and elevated WBC of 13.3 with a left shift.  referral to rheumatology
Pain in arm of injection site including numbness and pins and needle tingling in the lower arm and hand, loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects. Dizziness and weakness, severe joint pain. Throbbing Headache.
5 minutes after vaccine was administered, pt slumped over and slid out of chair, pt did hit his head, regained consciousness. BP was checked within 5 minutes 101/56, 5 minutes later 118/76, pt did throw up and was visibly sweating. pt was given a wet rag. EMTs arrived and took over. Pt
Rapid heart rate which lasted pretty much all day, stronger than normal heartbeat, chills with temp of 96.2.
The day of the injection there was swelling at injection site with a large bump and pain.  As the day went on I was unable to lift my right arm due to extreme pain.  The swelling lasted for 1 week and the pain never ended.  My doctor was seen for the issue the day of  the injection and then again several times after. I had PT in August of 2021 when nothing else helped. PT helped slightly but still have continuous aching pain in my right upper arm. It has been over a year since the initial injection.
swelling and pain at injection site, headache, chills, tiredness, severe body aches all over body (same as each previous covid vaccination--see below. Each time the side effects are worse.  moderna 032120A on 1/27/2021 moderna 010A21A on 2/24/2021 Pfizer fH8028 on 11/30/2021
Information has been received from a consumer concerning her son a 3 yr old male (currently 6 years old) with borderline low immunity and a history of multiple ear infections who in approx 2000 was vaccinated around his first birthday without incident with a dose of varicella virus vaccine live. In 2002 the pt developed a case of shingles while hospitalized for an unrelated ear infection. It was noted that the pt's shingles did not prolong his hospital visit. The rash was on his arm and was not properly diagnosed until he was discharged from the hospital and see by his own doctor at a follow up visit. It was unclear if he had any other varicella infection prior to the shingles. It was unk if testing was done on the shingles three years ago when it happened. The pt's outcome was recovered. There was no product quality complaint involved. Additional information has been requested.
Reporting for a friend she is in the hospital, all events may not be filled in, but I thought it was important to report sooner than later due to the news on other vaccines. Patient had her second shot around 3/7/2021 u sure as she is in a rehab facility time of day was 1630. On the 17 th of March she started having back pain then wasn?t able to get herself to the hospital called 911 and was transported to the hospital and that night had emergency surgery for a blood clot in her neck. She was in rehab and got rushed back to the hospital and had a pacemaker placed.  She is still in a rehab facility.
Around 4:00pm the day of the vaccine the left shoulder where the injection was made swelling and pain began. The pain got to the point where I could not raise my left hand. In the evening I developed a mild fever and severe headache along with possibly an elevated heart rate. By the morning the symptom so far has been pain in the left shoulder.
At the time of my vaccines, the lymphnodes on my right side swelled up.  Went straight to the doctor, kept an eye on it everything cleared up.  Shortly after, I started jerking in my sleep, didn't think anything about it, thought it was caffeine related.  Then I started noticing tremors in my hands, again, thought it was stress related, did not seek medical attention.  Then on December 12, 2021, I woke up and part of my thigh was "asleep"...for the most part it feels numb, but "friction" (drying with a towel, scratching, tight clothes) make it feel like someone is cutting into my leg with razor blades.  My doctor has sent me for an MRI of my brain (everything was normal) and we are awaiting an appointment with a neurologist.
3/4 Erythema and induration left upper arm at vaccine site. 3/6 Follow-up linear reddish hve 1104 cm without tenderness.
Difficult to distinguish at present if 10cm X 10cm erythematous non-tender induration is early cellulitis vs immune response vs sensitivity.
Head felt fuzzy, chest pain, fever, then it turned into appearing as if he had a stroke. He was not oriented to person, place or time. He did not know who he was or where he was.
After administration of H1N1 vaccine. Patient complained of itching at site of injection - called her physicians after - they said for her to take BENADRYL, put cold compresses on. Patient took advice and left.
Patient has not received their second Moderna Covid-19 vaccine yet and it has been greater than; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received their second Moderna Covid-19 vaccine yet and it has been greater than) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received their second Moderna Covid-19 vaccine yet and it has been greater than). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received their second Moderna Covid-19 vaccine yet and it has been greater than) outcome was unknown. Not Provided      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 concomitant medication provided.  No treatment medication provided.  patient went to receive  2 dose of vaccine after 90 days.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 10 JUN  2021 contain No New  Information.
Pt vaccinated with DT experienced local urticaria neck, generalized malaise, headache.
Starting after the vaccine, the patient started experiencing intermittent joint pain and pain and/or numbness in his left arm. He has yet to seek out treatment. Symptoms still persist.
Swelling knot in the injection arm, close to injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 14th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2019, 1 days after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist reported that, next day after vaccination, the patient went to pharmacy to report experiencing swelling knot in the injection site arm, closer to injection site but in bicep area.
Rash around base of neck and upper chest area began day after 1st shot but attributed it to warmth at night.  Same happened after second dose and continues.  To  visit dermatologist on Wednesday Feb 10, 2021.
Vaccine was retrieved from pharmacy on the morning of 12/9/2021.  It was mistakenly grabbed from the area of the refrigerator that had been partitioned off for recently expired vaccine that is separate from the active vaccine refrigerator area.  Vaccine was brought to clinic in a temperature-controlled cooler that stored the vaccine at refrigerated temperatures (36F to 46F).  Vaccine was reconstituted and drawn up to administer.  Pharmacist gave vaccine and documented for CDC and state data.  It was discovered that vaccine was expired at this time.  Any additional vaccine from expired vials planned to give was postponed and remaining vaccine wasted.  No adverse effects noted post administration. Called pharmacy who ensured expired vaccine was removed completely to prevent any further errors.  Notified facility administration and patient of error.  Followed up again in less than 3 hours with patient who had no adverse effects noted and felt fine.  Patient questioned if additional vaccine would be needed.  Followed CDC guidance to contact manufacturer regarding error and gain additional information (Form #).  Will follow-up with facility and patient tomorrow to make sure there have been no adverse effects/events post administration.
Arm got stiff; Little headache; Little nausea; She ate a lot; This is a spontaneous report received from a contactable consumer. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, and Lot Number: EL3646), via an intramuscularly in left arm on 07Jan2021 (at the age of 66-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that on an unspecified date in Jan2021 her arm got stiff, she had a little nausea and a little headache. She didn't get sick to her stomach, but she ate a lot. The patient had things going on long before the 2 weeks but did not provide any other details. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Dull achy pain in upper left arm, 3 months and pain has now traveled fine elbow to wrist.
This spontaneous report was received from a pharmacist refers to 69 year old female patient. On 140-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified dates, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
About 5 minutes following immunization, parent came to alert pharmacist that patient was experiencing nausea and light-headedness. Pharmacist observed that patient had a drowsy appearance and her eyes would periodically roll to the back of her head. Patient was also warm to the touch. She was given a cold pack which we placed on her wrists and she said that seemed to help. Patient remained under observation for about 20 minutes before she felt comfortable to leave the store.
headache, chills, fever, palpitations found to have NSVT, A Fib with RVR and hypomagnesemia
Given DTaP on RVL-reaction area bigger than 50 cent-red-swollen given PROQUAD on left thigh Sub Q area larger than 50 cent, red, swollen.
Swelling / at the injection site/reaction progressed to her entire upper arm/reaction progressed to / her elbow/t was in her entire upper arm to her elbow; Itching at the injection site; Redness / at the injection site / site was red and round / 7 cm; it was raised; reaction progressed to her entire upper arm and to her elbow; reaction progressed to her entire upper arm and to her elbow; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number B93K4, expiry date 7th May 2022) for prophylaxis.   On 13th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site itching, injection site erythema, injection site induration, pruritus and erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site itching, injection site erythema, injection site induration, pruritus and erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching, injection site erythema, injection site induration, pruritus and erythema to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and experienced redness, swelling and itching at the injection site. The patient stated that initially, the site was red and round, measuring approximately 7 centimeter. The patient also stated the reaction progressed to her entire upper arm and to her elbow. The reaction lasted approximately five days and currently resolved. The reporter consented to follow up. The patient stated that her physician filed an adverse event report as well and had no further information.
Severe diarrhea (20-30x a day), severe dehydration, acute kidney damage, pancolitis