chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received concerning an "elderly" female who on approximately 08-OCT-2007 was vaccinated IM with a first dose of zoster vaccine live (Oka/Merck). On approximately 08-OCT-2007, the patient experienced "pain at the injection site, redness and soreness". No further information was provided. The outcome was reported as recovering. There was no product quality complaint. It was noted that the above mentioned patient was a "friend" of a patient within the physician's office. It was also noted that the above mentioned patient was not a patient under this specific facility's care and no lot number was given and demographics were unknown. Additional information has been requested.
Reaction is localized to the injection site.  It is tender and hot to the touch. Redness and swollen area is a large welt: 18 hours after injection it measured = 3 inches by 1.25 inches and was elevated about 1/8th of an inch from surrounding skin.  41 hours after injection it is less raised but the red, swollen welt area has grown to 4 inches by 1.75 inches in area.
pt recvd vax 26FEB92 1030AM @ 7PM cranky, t102 ax & mom gave APAP; 730 projectile vomited @ MN t103 ax; 27FEB92 pt went limp, pale, hyporesponsive; seen by MD recommended use DT next time;
itchy bumps on back of legs while was sleeping the noc got the vax;bumps cont to spread as of today;
Weak; Severe reaction; Fatigue; Severe diarrhea; GI issues; This is a spontaneous report received via Pfizer-sponsored program  from a contactable consumer (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot number: unknown) via unspecified route of administration on 28Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient received first vaccine on 28Mar and had a severe reaction, fatigue and severe diarrhea and GI track problems. They were still occurring. The patient has a vaccine appointment next week. The patient does have a Colonoscopy appointment scheduled before his vaccine appointment. The patient wanted to know if he should reschedule his vaccine appointment or not. The patient does not think his problem is an adverse event. It may be just a coincidence. The patient would like to know if he can stall second shot. The patient was scheduled to get second dose on Sunday, and he was having GI issues that have left him very weak. The patient cannot get into the hospital for the GI test until 28 Apr 2021. The patient was hesitant to receive second shot until these circumstances have improved. The patient wants to know if he can get second shot 2-3 weeks after the 3-week normal time frame from first dose. The patient stated that the GI thing has been going on since last fall and he really did not think it was related to the vaccine. The outcome of the event asthenia was unknown. The outcome of the events severe reaction, fatigue, severe diarrhea and GI issues was not recovered/not resolved.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient expressed light-headedness. Vitals taken and patient observed. Patient had not taken blood pressure medication in the morning, and was on way home to do so. BP was coming back down by 9 am. Patient continued to feel better and at 9:15 went home to take medication.
On 10/14/99, I woke up feeling horrible with heaviness in my chest and pain when breathing. That afternoon I was taken by EMS to the ER and was examined and released with a dx of pneumonia and was given prescriptions for Biaxin and Vicodin. The next day, 10/15/99, I felt worse and again was taken by EMS to the ER and within hours of arrival at the hospital, my heart stopped. I had a pericardial effusion (tamponade). My heart stopped 3 X, once for 20 minutes. My kidneys failed and I went into a coma. My parents came to the hospital and they were told that I was most likely going to die. My family and friends prepared themselves for my death. I spent a total of 3 weeks in the hospital, much of it in ICU, experiencing a myriad of heart problems, kidney dialysis and miscellaneous invasive procedures. After release from the hospital, I did not get better. I was re-admitted to the same hospital on 11/18/99. After 4 days of testing, I was dx'd with Addison's Disease and Hypothyroidism. When I received the medication for these conditions, I felt better and went home. I was off of work from mid 10/99 until 1/00. On 1/21/00, I again felt heaviness in my chest and went to ER. I was immediately admitted and surgery was later performed. I had a pericardial window and 600cc of fluid drained. I missed more work. On 3/13/00, I went to ER and was dx'd with pericarditis, although there was no fluid build up due to the pericardial window. From 3/00 to present, I have had recurrent pericarditis. It occurs regularly and is very painful. I now have 3 autoimmune conditions that I did not have prior to receipt of the anthrax vaccinations. My Rheumatologist is considering putting me on Methotrexate, as well, for Prednisone sparing purposes. I have gained 50 pounds and am quite obese as a result of the continuous steroid use. I am experiencing early onset menopause due to my endocrine problems.  The annual follow up states that, "I will have autoimmune problems for the rest of my life as a result of these vaccinations: Addison's disease, autoimmune hypothyroidism and recurrent pericarditis. I had none of these conditions prior to the anthrax shots. My life expectancy has been shortened."
ITCHING THEN RASH ON FEET AND ANKLES, SPREAD TO ARMS AND STOMACH-"BLOTCHES", TREATED WITH BENADRYL LASTED UNTL 6/22/14 - NO FEVER, OR OTHER SYMPTOMS REPORTED BY CLIENT - DID ATTEMPT TO BE SEEN IN WALK IN CLINIC ON 6/21 BUT DID NOT REGISTER DUE TO NUMBER PEOPLE IN WAITING ROOM.
first dose 1/6/22, second dose on 2/17/22; 19 year old received adult dose of 20 mcg; 19 year old received adult dose of 20 mcg; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old patient who received HBV (Engerix B adult) (batch number 2793Z, expiry date 5th December 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 333M4, expiry date 7th April 2024) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th January 2022, the patient received the 1st dose of Engerix B adult 20 ug. On 17th February 2022, the patient received the 2nd dose of Engerix B 10 ug and Engerix B Pre-Filled Syringe Device. On 6th January 2022, unknown after receiving Engerix B adult and not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On 17th February 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the overdose, inappropriate age at vaccine administration and drug dose administration interval too long 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 Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments: The reporter reported that the 19 years old patient received the first Engerix as an adult dose of 20 mcg. The pharmacy technician inquired what was the guidelines to giving 20 mcg and, how to proceed with Engerix series. The reporter did not consent to follow-up Additional Supportive Information: The patient received the first Engerix as an adult dose of 20 mcg which led to overdose and inappropriate age at vaccine administration. The patient received 2nd dose of Engerix B late than recommended time frame, which led to which led to lengthening of interval between vaccine doses.
Sore arm Swollen, red and hot arm about the size of a baseball 9 days after injection  Headaches
Information has been received from a physician concerning a 9-year-old male who on 07-DEC-1999 and 29-MAY-2007 was vaccinated with his first and second dose of varicella virus vaccine live (Oka/Merck) (lot # 657194/0364U 2nd dose). On 21-SEP-2007 (about 4 months after second dose) the patient developed chicken pox. A visual diagnosis was made in the physician's office on 24-SEP-2007. No diagnostic labs were performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
sicker then a dog for over a month; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Shingles vaccine was discontinued. On an unknown date, the outcome of the sickness was recovered/resolved.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's best friend. The age at vaccination was not reported. The patient got the shot and she was sicker than a dog for over a month, thought she had Covid. The patient got tested and it was from the Shingles shot and she was advised by her doctor not to get the 2nd shot. Follow-up would not possible, as no contact details were available.
He got his vaccines, about 6 1/2 hours later he started getting chills, bad, really bad chills.  Then his arm started getting real sore.  He was that way for at least 3-4 hours with the chills.  He did not have enough to get into the shower to get a hot shower.  About 9:00 PM when he went to bed, took his medicine and he had to get up to go to the bathroom, slipped and fell on his side.  He had no strength in his right arm at all, like a miniture stroke.  He could not use his arm to get up, roll over or anything.  His wife could not get him up as he could not use his arm to get up.  She covered him up with a blanket until about 5:00 to 6:00 AM.  He then had enough strength to roll over and get up and get on the bed. The main thing was the no strength in his arm in the right arm.  It scared him bad, as they almost had to call 911 and he has never had any kind of reaction like this before.  He then had weakness for the following 2 days, and just resting and laying low.  On Friday he actually started feeling a little better, but that was his main AE was the lack of strength in the right arm.  He felt it was a stroke-like thing as he had no power to get up.  He did notify his doctor and they Emailed the advice nurse and said that if it persisted to come in.    He is now better and has strength back in his arm.  He has no long-term AE from it.  He will never get another COVID shot, and said that he would rather die first as it scared him so bad.  He is back to where he was before he got the vaccines.
I received the vaccine on a Friday morning.  Extreme fatigue set in approx. 6-7 hours after receiving vaccine.  I could hardly keep my head up.  When I went to stand up, my legs almost buckled underneath me.  Muscle weakness in legs.  The next day I had diarrhea and a headache.  The fatigue lasted approx. 1 week following receiving the vaccine, lessening day by day.  I took Advil and felt much better.  I slept for most of that weekend.
OFF LABEL USE; JANSSEN COVID VACCINE DOSE GIVEN AFTER 6 HOUR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 23-JUL-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced janssen covid vaccine dose given after 6 hour. On an unspecified date, the subject experienced off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the janssen covid vaccine dose given after 6 hour and off label use was not reported. This report was non-serious.
Patient was administered the Pfizer COVID vaccine instead of the Pfizer Bivalent COVID vaccine.
his closest friend who got the Moderna mRNA second dose/had a booster; Off Label Use; his friend had a booster; friend had a booster it worsened his tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing), notes: he knows someone who had tinnitus already. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Moderna vaccine (Dose: 2, got the Moderna mRNA second dose and lost hearing a couple of days after that in his left ear), for Covid-19 Immunization, reaction(s): "lost hearing a couple of days after that in his left ear". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "his closest friend who got the Moderna mRNA second dose/had a booster"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off Label Use"; IMMUNISATION (non-serious), outcome "unknown", described as "his friend had a booster"; TINNITUS (non-serious), outcome "unknown", described as "friend had a booster it worsened his tinnitus".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient complained of swelling, redness, itching to left rear upper arm in area where vaccine was given.  States it started around dose #3 after the vaccine was given, size around 3-4#.  Darkish discoloration - remains to rear of left arm per patient.
Developed Bells Palsy R side of face within 3 weeks of the booster which was my 3rd pfizer Covid shot
MUSCLE PAIN, JOINT PAIN LEFT UPPER THIGH/LIP. NO FEVER, BUT "FLU-LIKE ACHINESS". MILD STIFFNESS.
Premature rupture of membranes at 32 weeks gestation.  Patient being monitored as inpatient, no delivery of baby at time of report.  Patient is not in labor.
Feeling very lethargic ("can barely walk"); Feeling very lethargic ("can barely walk"); Severe tiredness; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In the morning of an unspecified day in Jan2021, the patient was feeling very lethargic. The reporter (patient's wife) stated that they both received the vaccine at 2AM on Saturday and was asking if the event was common. It was also reported that the patient had severe tiredness all of a sudden after receiving the vaccine. The reporter stated that it had been about 55 hours since the shot and she wanted to know if this was a time frame to expect this; stated that it came on so sudden. Outcome of the events was unknown. Case was reported as non-serious.  Information on the lot/batch number has been requested.
This non-serious spontaneous case, initially received from Merck (Ref ID: 00750520) via other health professional (nurse) on 14-Mar-2018, concerning a patient of an unspecified age and gender. On an unspecified date, the patient was administered with AFLURIA (TIV) (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after the vaccination, the patient experienced allergic reaction. At the time of this report, the outcome of the event was not reported.
Information provided by patient as follows: I received my covid vaccine on 1/28/2021 in my RUE. On Sunday 2/7/2021 I started to develop a "rash" starting on my RUE and R thigh. By the next day 2/8/2021 B thighs were covered in a rash, B elbows, B knees and lower abd.  Some areas itchy and some warm. I had no new exposures to environmental, chemical or food. I called Employee health on 2/9/2021 and they advised me to see my PCP. I made an appt and saw her on 2/10/2021. Scripts given. To follow closely.  Documentation from clinic visit on 2/10/21 as follows: 42 y.o. female ,with a PMHx sig for problem list as described above, who comes in today for rash. She notes she had her first Moderna COVID-19 vaccine on 1/28/2021. She had headache, fatigue and chills 24-36 hours after this vaccine. She then felt normal until a rash began to appear on 2/7/2021. She first noticed this on her right arm, then spread to left arm, abdomen and legs. She did receive the injection in the right arm. She has had some itching, but this is manageable. She notes the rash on her legs feels warm by the end of the day and after taking a shower. She denies any new or changed medications, foods, products at home or work. She denies fevers, chills, nausea, vomiting, pain. She denies shortness of breath, tongue swelling/itching, lip swelling/itching, cough. She has used hydrocortisone or Benadryl cream, otherwise has not tried any interventions.    cetirizine (ZYRTEC) 10 mg tablet; Take 1 tablet (10 mg total) by mouth 1 (one) time a day. cimetidine (TAGAMET HB) 200 mg tablet; Take 1 tablet (200 mg total) by mouth 2 (two) times a day. Will start patient on cetirizine and cimetidine to help with urticaria. Encouraged to use ice on any itchy spots, follow with hydrocortisone or Benadryl cream. Encouraged to avoid triggers for worsening hives. No indication to not move forward with planned second Moderna dose, as this was delayed reaction, but will pre-treat with H1 and H2 blockers prior to second dose. Discussed with allergy who agrees with plan. If issues with second dose despite pre-treatment with H1 and H2, could consider short course of low dose prednisone.
Mom reported a red, itchy rash on the patient's neck about 2-3 hours after receiving immunizations.  No other symptoms.
Loss of taste; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 27Mar2021 at 15:00 (Batch/Lot Number: Er8732) as dose 1, single (at the age of 33-years-old) for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced loss of taste on 28Mar2021 with outcome of unknown.   No follow-up attempts are needed. No further information is expected.
15 min after injection, pt c/o tightness in his throat; vital signs - P 72 regular - B/P 100/?, skin warm to touch. No difficulty in breathing. Color good. Given Benadryl 50mg PO 9:25 - 15 min later - P 74 - B/P 120/90 - color good - 10 AM - no problems. Checked via phone with friend "no problems" 6 hrs later.
had the shots, most painful shot I can ever remember having; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site pain (received 1st dose on an unknown date and experienced injection site pain, , for tolerance refer case US2021AMR180445).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient got the 2nd shingle shot and for some reason, it was the most painful shot he/she could ever remember. The patient was glad that he/she did it though.
Headache, Arthralgia, Fever, Diarrhea, NauseaVomiting, swollen glands Narrative:
7 vesicles-pustulous lesions on the legs & arm 6 days after imm.  No fever, mild malaise.
Ameliorated varicella rash (Sib with same despite 2 VARIVAX immunizations).
Got sick as heck like I was hit by a truck. Sweating like crazy, colder than I?ve ever been wearing tons of clothes and blankets, etc. it was awful. One of the sickest I?ve ever been. That got mostly better by the next day but before I got vaccinated I was working out like a madman and doing a strict fitness regimen. It totally killed my moment and I was unable to work out all of a sudden for weeks. It was so weird
Within 6-8 hours, Injection site and upper arm, shoulder, left upper back, neck felt sore and achy.  Headache developed.  Upper arm tender. Generalized malaise.  Lasted about two days.  COmplete resolution after 48 hours.
Redenss and induration at injection site 30 x 30. No other symptoms other than sensitivity.
VACCINE ADMINISTERED TO A PATIENT 25 MINUTES AFTER THE 6 HOUR EXPIRATION TIME FRAME; EXPIRED VACCINE ADMINISTERED TO 1  PATIENT; This spontaneous report received from a pharmacist concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 05-AUG-2021) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-JUL-2021, the subject experienced vaccine administered to a subject 25 minutes after the 6 hour expiration time frame. On 26-JUL-2021, the subject experienced expired vaccine administered to 1 subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered to 1 patient and vaccine administered to a patient 25 minutes after the 6 hour expiration time frame was not reported. This report was non-serious.