chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 50 years old male (as reported) patient who was also the nurse via a company representative refers to himself. The patient had various past unspecified vaccine reactions. On 30-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified) (dose, frequency and route unspecified) at left arm for prevention of shingles. On 30-DEC-2013, the patient developed a raised, red, rash going down her left arm with a red spot at the injections site. The patient stated that the red spot was still presented at the insertion site, although the raised red rash had now ceased. Benadryl and Benadryl Spray were given as the treatment. The patient did not seek medical attention. Additional information has been requested.
SUSPECTED COVID 19 INFECTION; TIGHTNESS IN CHEST (FELT LIKE A 10-POUND DUMBBELL WAS ON HIS CHEST); This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced suspected covid 19 infection. On 22-AUG-2021, the patient experienced tightness in chest (felt like a 10-pound dumbbell was on his chest). Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and tightness in chest (felt like a 10-pound dumbbell was on his chest) was not reported. This report was non-serious. This report was associated with product quality complaint: 90000190988.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Patient received vaccination at school through the health department. He cam into the office today to have it assessed. The evening after receiving the vaccine the patient became nauseas and then vomited once. The next day the arm began to get warm to the touch and swell. He had significant swelling, erythema, and pain throughout the weekend and it had improved today compared to the pictures from over the weekend. I did notice that the vaccinator gave the vaccine in the medial aspect of the humeral head. There was an obvious marking from the vaccination insertion site.
Never had headaches. Started having after first shot. After second shot has had a constant headache. Treatments amitriptyline no help. Propranolol no help. ISOM/DIC/AP65/100/325 MG C MAC took edge off, chiros also.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 64 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 5/23/00 and 7/24/00 "according to the client." This represents an inappropriate schedule of drug administration in that the second dose was administered approximately one month later that recommended. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "pain in his hands, pain in his right arm, left shoulder and right and left upper arm, and fatigue." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of an orthopedist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
period delayed for 7-8 days after 1st dose and bad pain, and then 2 period post 2nd dose, I experienced vomiting, diarrhea, worst cramps. I've never vomited with  my previous period, and only light to no cramps before.
received our COVID booster, and had a sore arm and generally felt fatigued the day after.; received our COVID booster, and had a sore arm and generally felt fatigued the day after.; This spontaneous case was reported by a dentist and describes the occurrence of VACCINATION SITE PAIN (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) and FATIGUE (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) and FATIGUE (received our COVID booster, and had a sore arm and generally felt fatigued the day after.). At the time of the report, VACCINATION SITE PAIN (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) and FATIGUE (received our COVID booster, and had a sore arm and generally felt fatigued the day after.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Experienced Chest pains; enlarged heart, a stent put in; Found out has stage 4 colon cancer; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported for a female patient (neighbour). A female patient in her 70's received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on an unspecified date for covid-19 immunization. Medical history included overweight (as reported little fat, happens when you age) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller stated patient received first dose of vaccine a year ago and second dose was received 28 days after the first dose. Patient did not receive any other products (at the time report). Reporter stated that he did not go with the patient to receive the Pfizer Covid Vaccine. On unspecified date, the patient experienced chest pains after received Pfizer Covid Vaccine and went to the doctor with enlarged heart and had a stent put in. On unspecified date, patient found out now she had stage 4 colon cancer and now on chemotherapy. Caller visited the patient every day and could not see any more until and patient was safe to be around. Therapeutic measures were taken as a result of event stage 4 colon cancer with chemotherapy. At the time of this report, the outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (22Sep2021): New information received from a same contactable consumer in response to Non-HCP letter sent via telephonic activity: consumer stated, 'you are working for a company who is giving out a vaccine like Moderna, your vaccine is not a vaccine, is not FDA approved, Consumer states 'is a poison, a depopulation media'  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Headache, 101 fever, congestion, body ache, site of injection pain, fatigue. All beginning at 1:30 AM
On 9-1-2022,  We withdrawn the Pfizer vaccine for age 5 to <12 years, 0.2 ml from the vial.  The vial was NOT diluted with 0.9 % Sodium Chloride for Injection.  The quantity was verified from the vial.  Our Pharmacy Technician withdrew and Injected the medication into the patients Left Arm.  The patient stayed at the pharmacy for 15 minutes. The patient showed no symptoms when she was at the pharmacy.   When we were counting available vials in the box of vaccines, we remembered the vial should have been diluted.  We called the doctors office and the parents regarding the incident. Unable to get hold of doctor.  Called to mother, patient had mild fever of 100'F, body aches, diarrhea. Took some medication for fever.  Patient better today.
pt recv vax 22OCT96 & 16NOV96 serology results included IGM 0.56 & IGG 0.50 indicating the pt exp failure to seroconvert;
Shortly after vax, child had swollen face, wheezing. Mother gave Benadryl at shot site. Treat with Benadryl every 4 hours for three days. Possible allergy to MMR was noted. Benadryl per doctors orders for hives to chest and eyes.
Patient scheduled 1st dose of Moderna vaccine when Entering on system, I realized she had already received one Janssen vaccine back in April of 2021.patient did not disclose this information when asked if this was her first covid vaccine.
Initial report received on 14 December 2007 from a health care professional. A 52-year-old female patient, with no illness at the time of vaccination, had received a right deltoid, intramuscular injection of DECAVAC, lot number U1954BB, on 10 December 2007. One day post-vaccination, the patient developed cellulitis from the shoulder to the elbow of her right arm which was diagnosed by a physician. She was treated with BACTRIM and recovered from the event.
Vaccine squirted out of the side of the syringe, needle not affixed to allow a solid connection.  Gave a second shot which went as expected.
On Jan 12th, my stomach was upset, and the next 5 days I could not eat or drink anything . I had no fever.
Post vax, the patient experienced varicella. The patient was treated with Augmentin.
Client vomited 1 1/2 hr. after receiving immunization then noticed had raised, clear fluid filled 17 mm + 10 mm oval on chin. 10/9/08 a round fluid filled area appeared on (R) side of neck. Every day or every other day they have noticed a new fluid filled circle/oval - (L) side neck, (L) under upper arm, (R) side of chest X 4, abd X 2. Mother has been applying an anti-itch cream & NEOSPORIN CREAM to areas. Client states areas were itchy when they first came up but then itching stopped & discontinued when creams applied. The last oval/circle area that has appeared was on 10/20/08.
Patient received Yellow fever vaccine over deltoid at 45 degree angle.  Potentially and IM administration and not Subcutaneous. reached out to Office and they did not recommend revaccination but recommended a VAERS be submitted.  Pt did not experience and adverse issues related to immunization.
She had arm redness and soreness after receiving the 1st dose; She had arm redness and soreness after receiving the 1st dose; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73 (unit not reported) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included stage 4b cancer; patient had undergone hysterectomy due to endometrial cancer; abdominal tumors then lead to stage 4b cancer. Concomitant medications included pembrolizumab (KEYTRUDA) taken for endometrial stage 4b cancer, start and stop date were not reported; VITAMINS NOS and AHCC mushroom extract; both taken for an unspecified indication, start and stop dates were not reported. The patient experienced she had arm redness and soreness after receiving the 1st dose on an unspecified date. The outcome of events was unknown. The patient asked if she could take Benadryl or Claritin for her symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Fainting / Unresponsive-Medium, Additional Details: lost conciousness during his 15 min wait (while he was sitting). Bumped his head. I immiediately got his legs elevated and put something under his head. He regained conciousness within a minute, but I had him remain on the ground. The pharmacy tech called 911 right away. EMT services arrived within 10 minutes, although patient was persistent about wanting to leave on his own as he stated he regularly passes out with needles and has in the past as well. Emt evaluated him and let him leave.
This spontaneous report as received from a Nurse refers to a 3 patients of unknown demographics. The patients pertinent medical history was not reported. On an unknown date the patients received improperly stored RECOMBIVAX HB. No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 12/1/98; on same day pt exp urticarial lesions at vax site & chest; dx=herpes zoster
breathing problems; hives; knots at the injection site that went away; extremely bad nasal congestion; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events breathing problems, hives, knots at the injection site that went away, extremely bad nasal congestion.  The patient's medical history was not provided. Concomitant medications reported were Excedrin for drug use for unknown indication.  On 26 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025A21A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) breathing problems, hives, knots at the injection site that went away, extremely bad nasal congestion.  Treatment details included She has been taking Benadryl and Mucinex for congestion but hasn't been helping.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), breathing problems, hives, knots at the injection site that went away, extremely bad nasal congestion was unknown.
March Mar. 5 1st Phizer vaccine Mar 26n2nd Phizer vaccine Diarrhea begins and accelerates after 2nd vaccine rampant inflamation throughout the bodyi including bowels and RA and shingle outbreak April continued inflamation and decline Urgent Care visit blood work dehydration potassium deficiency rampant inflamation rapid weight loss May Began taking Pepcid AC and Cytokine Supress some improvement in energy diarrhea persists 20 lb. weight loss (normal weight 120 lbs.) June about the same diarreah persists July decline in health diarreah persists bblood work and stool sample ordered RA symptoms increase with inflamation swelling extreme pain and insomnia A
For about two weeks I had a sudden onset of chest pain. It was not present when I was not moving. Anytime I moved, even getting out of a chair or walking a few feet, I experienced pain. This started to wane the last couple days I experienced it. I went to urgent care and had some tests done, the doctor there said she believed it was Pericarditis and sent me to the emergency room.
One week after vaccination, patient developed significant pain with limitation in ROM in the right arm.  No swelling or redness.  On exam 11/12/2019, TTP at the site of injection but no weakness or sensory change in the hand or arm; reflexes are normal; no swelling or skin change.
Chills, headache, muscle aches, flushed, hot flashes, insomnia
This spontaneous report was received from a pharmacist regarding a 22-year's old Adult patient of unknown gender. There was no information regarding concurrent condition, pertinent medical history, concomitant medication and drug allergies or reactions. On an unknown date the patient was vaccinated with GARDASIL 9 dose 1 and after 2 weeks patient was vaccinated with Dose 2 of the vaccine for prophylaxis (inappropriate schedule of product administration). No adverse event was reported.
Tested pos for covid 14Nov22. 15Nov tested pos lab. Started Paxlovid 15Nov - 19Nov. Tested neg 20Nov  - 22Nov. 23Nov tested positive again!!! Rebound!. Wish I hadn't taken it !!! Suck time all us; Tested pos for covid 14Nov22. 15Nov tested pos lab. Started Paxlovid 15Nov - 19Nov. Tested neg 20Nov  - 22Nov. 23Nov tested positive again!!! Rebound!. Wish I hadn't taken it !!! Suck time all us; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: El1284), on 11Feb2021 as dose 2, single (Lot number: En6201), on 11Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 22Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 01May2022 as dose 5 (booster), single (Lot number: Fm9992) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 09Sep2022 as dose 6 (booster), single (Lot number: As7144b), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Nov2022, outcome "not recovered" and all described as "Tested pos for covid 14Nov22. 15Nov tested pos lab. Started Paxlovid 15Nov - 19Nov. Tested neg 20Nov - 22Nov. 23Nov tested positive again!!! Rebound!. Wish I hadn't taken it !!! Suck time all us". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Nov2022) Positive; (15Nov2022) Positive; (20Nov2022) Negative; (22Nov2022) Negative; (23Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was not received other medication in 2 weeks. Anti viral details: Patient was treated with Paxlovid. Treatment start date:15Nov2022, Treatment stop date: 19Nov2022. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
DTaP accidentally given instead of Tdap.  No adverse effects noted other than mild soreness at injection site.
Received vaccine on right arm. Tingling and numbness on left side of my body from my lip all the way down to my  foot. Tingling and numbers started two hours after vaccine was administered. Tingling and numbness are still present.
The patient is noting symptoms of worsening headache, neck pain, back pain, subjective fever, and joint pain post 2nd covid19 immunization that is worse than baseline symptoms.
Patient due to receive COVID-19 vaccine booster, but monovalent primary series formulations are no longer acceptable for booster doses. The vaccine inventory was assessed. The product labeled "Moderna COVID-19 vaccine - booster doses only" was removed. There was no age listed on the package. It was clearly labeled as "booster doses only" on the vial and package, therefore this product was administered to the patient. It was later discovered this product (NDC 8077-0275-05) is actually indicated for pediatric patients 6-11. No adverse effects noted. This was an administration error of the incorrect vaccine product.
Information has been received from a physician concerning a 16 year old female who was vaccinated with the first dose of GARDASIL IM, 0.5 ml.  One month after, the patient experienced Bell's Palsy.  On an unknown date, the patient completed the three dose series and the symptom disappeared.  The patient sought medical attention with the physician.  Additional information has been requested.
VACCINE EXPOSURE VIA BREAST FEEDING; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, transmammary, expiry: UNKNOWN) 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 vaccine exposure via breast feeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast feeding was not reported. This report was non-serious.
Information has been received from a physician concerning a 17 year old female with Turner's syndrome and attention deficit/hyperactivity disorder who on 02-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 0250X). On approximately 02-JUL-2008 the patient experienced pain in both legs and difficulty walking. The patient's mother took her daughter to the clinic because the doctor's office was closed. The clinic told the mother that her child experienced a rare reaction to the vaccine. The mother reported that her daughter was 80 % improved. Patient is recovering. Additional information has been requested.
Flu like symptoms (2 days), joint pain & weakness (3 days) followed by diagnosis of Guillain Barre in emergency room & ICU (4 weeks)
Headache, Myalgia, Arthralgia, CoughWheeze, Angina, 1/26 injection site sore , body ache, feeling warm and tired , 1/28 -SHORTNESS OF BREATH, CHEST PAIN Narrative:
Dizziness, NauseaVomiting & HYPERtension Narrative:
Approximately 10 cm local reaction of redness and swelling Left arm. Treatment: warm soaks.
received RX for Arexvy and patient was under age of 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: received RX for Arexvy and patient was under age of 60). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 The pharmacist reported that she received a RX for a patient for Arexvy and the patient was under the age of 60 which led to intercepted drug prescribing error. The reporter consented to follow up via email. It was reported that Healthcare professional was not at work and had no details of physician who wrote Rx.