chrisvoncsefalvay/vaers-outcomes huggingface dataset:
platelets had dopped down to nothing/platelets down to a 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 virus", start date: Jan2021, stop date: Jan2021. The patient's concomitant medications were not reported. Past drug history included: Regeneron treatment for COVID-19 virus. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose Number Unknown), administration date: Jul2021, for COVID-19 Immunization, reaction(s): "platelets had dopped down to nothing". The following information was reported: PLATELET COUNT DECREASED (hospitalization), outcome "unknown", described as "platelets had dopped down to nothing/platelets down to a 1". The event "platelets had dopped down to nothing/platelets down to a 1" required physician office visit. The patient underwent the following laboratory tests and procedures: Platelet count: down to a 1. Therapeutic measures were taken as a result of platelet count decreased. Clinical information: Reporter stated that he and his wife both got covid 19 virus in Jan2021 and had the regeneron treatment right after that. They were vaccinated in Jul2021 and in Aug2021 he had a check up, fine looked great, then got booster 12Jan2022, another appt 2nd week of Feb2022 and platelets had dopped down to nothing. He has been in hospital 1-3 times a week since going into almost a year starting in Feb2022 for dealing with this. He was put on 2nd oral medication because 1st did not work, just had a check up yesterday and platelets down to a 1, obviously new oral med hasn't worked. Patient asked if there were any steps or what they have to do about this other than what his oncologist or hematologist has suggested.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005105 same reporter/patient, different vaccine dose and event;
Dev. blotches with fluid-filled vesicles several hours after administration. Parent gave pt. antihistamines. No rash noted the following day, or since.
22JUL91 pt recvd a dose of Engerix-B & devel nausea & vomiting for 3 wks; Within a couple of days of being vaccinated pt's child refused to nurse. Somthing in the milk R/T vaccination ?
This spontaneous report as received from a pharmacy technician refers to a 38 year old male patient. On an unknown date the patient was vaccinated with MMR II (lot # H018945, expiration date 18-OCT-2014) (dose and route were not reported) that was exposed to 11C for 6 hours. Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vomited at 5am on jan 18; Jan18 fever and chills continued, no apetite all day; dizzy; weak; severe body aches; confined to bed all day; severe head ache; very sensitive to light; could not sleep for more than 15-45 minutes at a time; food tasted like chemicals or sickeningly sweet; only rice tasted normal; very sensitive to and repelled by odors. Jan 19: nausea abated, started to eat a few things but eveything still tasted terrible except for rice; got tested: covid negative, flu A &B negative, RSV negative; body aches were much worse; difficult to walk due to shooting pain in feet and back; stayed in bed all day; Jan 20 fever broke, now have right side sore throat; still achy and dizzy; Jan 21 still have headache and mild body aches, not confined to bed but too weak and achy to work
itching near the injection site; it swelled up/ little swollen; little red; lot of soreness on the arm near the injection site/ it was sore to touch/ couldn't sleep on the left side because of the pain; had little swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching near the injection site), VACCINATION SITE SWELLING (it swelled up/ little swollen), VACCINATION SITE ERYTHEMA (little red), VACCINATION SITE PAIN (lot of soreness on the arm near the injection site/ it was sore to touch/ couldn't sleep on the left side because of the pain) and VACCINATION SITE SWELLING (had little swelling) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Occasional summer allergies). Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Seasonal allergy.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced VACCINATION SITE PAIN (lot of soreness on the arm near the injection site/ it was sore to touch/ couldn't sleep on the left side because of the pain) and VACCINATION SITE SWELLING (had little swelling). On 13-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (itching near the injection site), VACCINATION SITE SWELLING (it swelled up/ little swollen) and VACCINATION SITE ERYTHEMA (little red). On 07-Jul-2021, VACCINATION SITE PAIN (lot of soreness on the arm near the injection site/ it was sore to touch/ couldn't sleep on the left side because of the pain) and VACCINATION SITE SWELLING (had little swelling) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching near the injection site), VACCINATION SITE SWELLING (it swelled up/ little swollen) and VACCINATION SITE ERYTHEMA (little red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received for the events experienced.
high pitched cry immed p/pt was consolable by mom & stopped crying;mom went home w/instructions for APAP & cold compress;mom called 19AUG96 c/o pt crying off & on all afternoon;APAP given as directed;knot @ site;
Swelling, redness, tenderness on site of vaccination measuring 1.75 inches in diameter.
Patient was given a dose of Pfizer vaccine on 10/25/2021 however vial of Pfizer vaccine was reconstituted on 10/22/2021 @ 4:45pm. After 6 hours vial should have been discarded and not used. However vaccine was given in error.  No side effects noted from patient at this time
Information has been received from a RN concerning a 24 year old male who was vaccinated with a second dose of hep B vaccine. Two hours after receiving the vaccine the pt reported being lightheaded and nauseated and had to go home from work. The pt responded to rest and Tylenol and returned back to work the next day. No medical attention was sought. Additional info has been requested.
received dose of engerix-b only two weeks after the 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a adult female patient who received HBV (Engerix B) (batch number TB3KN, expiry date 3rd December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was 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: 26-APR-2022 Reporter's Comments: The reporter stated that patient received the second dose of Engerix B only two weeks after 1st dose. The reporter gave consent for a follow-up. Additional Supportive Information: The patient received the second dose of Engerix b only two weeks after 1st dose, which led to Drug dose administration interval too short.
Large, red, itchy lesion on the arm of the injection (onset 2/07/2021, ongoing) Severe cramp-like muscle aches (onset 2/06/2021, gone by 2/08/2021) Swollen lymph nodes at the top of the shoulder of the injected arm (onset 2/06/2021, gone by 2/08/2021)
ON 4/1/22 PATIENT RECEIVED VACCINE 6 DAYS EARLY
On Thursday 6/9/2022 patient was seen at the office for ADHD and 1st booster COVID-19 vaccine dose. The provider examined and saw the patient and ordered the COVID-19 vaccine for 12 and over (0.3ml) to be administered to the patient. The medical assistant failed to verify the doctor's order or the patient's age and prepare and administered the patient 10mcg/0.2ml dose for 5-11 years of age at 02:17pm. The medical assistant realized the error when she began documenting the vaccine in the medical record. She immediately went ahead and notify the physician, the manager and the director of the west side clinic. The patient did not suffer any adverse effects from administration of the COVID-19 Pfizer vaccine for 5-11 years old.
Breakthrough Covid contraction; sore throat, easily fatigued; irritable lungs and coughing.
patient has multiple allergies.  She was  given vaccine and the next day developed skin rash.
Common cold; Knee to ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Common cold) and ARTHRALGIA (Knee to ankle pain) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Common cold) and ARTHRALGIA (Knee to ankle pain). At the time of the report, NASOPHARYNGITIS (Common cold) and ARTHRALGIA (Knee to ankle pain) had not resolved.            No Concomitant medication was reported  It was unknown if patient was enrolled in COVID-19 Vaccine trial. The reporter causality for events common cold and arthralgia with respect to Humira was not reported. No Treatment medication was reported
wrong age appropriate vaccine given to age of child.  This vaccine is not lisenced for this child's age.
Janssen 5/27/21, Pfizer 1/27/22, 6/11/22. Positive on 8/7/22
This spontaneous report as received from a 53 year old female patient regarding herself. No concurrent conditions or medical history were reported. The patient had a reaction to niacin and also had an interaction between ADVIL and an unspecified antibiotic. In approximately 2012 (reported as three and one half years ago), the patient was vaccinated with ZOSTAVAX (lot, expiry date, dosing details not reported). Concomitant therapies included simvastatin, DIOVAN and PREVACID. Shortly after the vaccination (approximately in 2012), the patient presented with a "bubbly and perforated" skin irritation around the injection site. As the day went on, the injection site area was a little sore. The patient stated that little blisters formed around the injection site. The next day (approximately in 2012), the patient had a blister that "looked like she burned herself". The blister was circular and approximately two inches in diameter. It was "liquidy inside just like a blister". The patient went to the doctor and was told to give it another day. Over the following weekend (approximately in 2012), the injection site was "uncomfortable". No lab diagnostics studies were performed. The patient was afraid she was going to "pop" the blister-like irritation that formed around the injection site. The affected area was approximately four inches in diameter. The patient went to the emergency room because of the pressure she was feeling in this blister-like reaction at the injection site. The area was drained by the emergency room physician. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates in 2016 the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, dose# and route unknown, lot# L044527, expiration date 09-NOV-2017; lot# L042367 (invalid lot#), expiration date 27-OCT-2017). The vaccines were stored under -11.9 degree for 2 hours and 38 minutes on 09-MAR-2016 and -10.8 degree for 2 hours and 47 minutes on 10-MAR-2016. There was no previous temperature excursion. It was called because of a data logger. Cumulative Excursion was -10.8 degree for 5 hours and 25 minutes. No adverse effects were reported. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Have had chills, fever, aches, headache, dizziness since the 12th.  Better but still fatigued and dizzy when I get up
This case was reported by a other health professional via sale rep and described the occurrence of hives in a patient who received FLULAVAL Quadrivalent. On an unknown date, the patient received FLULAVAL Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FLULAVAL Quadrivalent, the patient experienced hives. The patient was treated with steroids NOS. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. No further information was provided. The case was linked with US2017GSK182464, reported by the same reporter.
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 64-year-old male patient who received Shingrix for prophylaxis. The patient's past medical history included shoulder operation. Previously administered products included Shingrix (1st dose received on an unknown date, without adverse events). On 10th September 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 10th September 2018, 4 hrs after receiving Shingrix, the patient experienced shoulder pain, nausea, general body pain, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the shoulder pain was recovering/resolving and the outcome of the nausea, general body pain and pain in arm were not recovered/not resolved and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the shoulder pain, nausea, general body pain, injected limb mobility decreased and pain in arm to be related to Shingrix. Additional details were provided as follows: At 11:00, the patient received Shingrix on the left arm. The patient stated that, at 15:00, his whole arm was throbbing and very painful. The patient had a major surgery on his shoulder about 2 years ago with multiple tendon reattachments and 4 screws and this pain from the vaccine was worse than that. The patient also felt nausea and body ache which have not changed. The 1st day, the patient was unable to move his arm at all. The patient was able to move it a little bit at the time of report. The burning pain he had for the first 24 hours had gone away but it was still very painful. The patient asked for help and requested to call back.
Fluad is administrated at age of 39. Informed the patient and patient did not report any side effect nor any change of status after 1 hour 30 minutes of the vaccine administration.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. The patient did not have drug reactions or allergies. On an unspecified date in 2000 the patient was vaccinated with dose VARIVAX (strength, dose number, route, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. On 26-JUN-2016 the patient experienced fatigue, ear pain, scalp and eye pain. The reporter stated that the pain was running along nerve pathways. It was reported that unspecified anti-viral medication was given as treatment. On 28-JUN-2016, the patient went to an unspecified Urgent Care facility, where the following lab studies were performed: Red blood sedimentation rate (normal), full blood count (normal) and bacterial test (negative for streptococcus). No product quality complaint was involved. The outcome of fatigue, neuralgia, ear pain, pain of skin and eye pain was unknown. The reporter did not assess the relatedness between the events and suspect therapy. Additional information has been requested.
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient hospitalized for blood clot (called pharmacy @ 835pm on 4/15/21). Asked by hospital to contact pharmacy. Patient called from personal phone number.
I have tiny red itchy bumps on my back, arms, elbows, thumbs, ankles, neck, chest, stomach, buttocks.  The least affected area is my legs, ears, shoulders. they do show up in these areas but not nearly as bad.
Copied from student's chart note on 1/12/2021 from telehealth visit with Doctor, " 24 year old who had varicella vaccination #2 yesterday, last pm she started with itching and swelling, 5 cm of erythema around shot. See picture in messages. She has mild itching after her first shot which she got with Tdap, it was delayed. No fever today, hurts to touch but mostly intensely itchy".
Mom picked up child, out of crib about 08:00 on 9/6/01. She noticed the back of both legs from the middle of the thighs to the middle of the calves were red, swollen and blotchy. The rash progressed throughout the day to spread to chest, under arms, on thumb, finger and ankle. Afebrile with no wheezing or cough. Child was happy and playful and scratching rash, itchy and hive-like. The rash disappeared on 9/7/01 about mid-morning after 2 doses of Benadryl. Seen in office on 9/7/01 and 9/15/01.
Blisters and pain, went to hospital and doctor sait it was shingles caused from shot. Dr gave Motrin and antiviral acyclovir and will pick up gabapentin today.
12/30/2021: Event occurred after 2nd vaccine.. 71-year-old male with a history of hypertension, PTSD, presenting to the ED today for altered mental status. On ED arrival was noted the patient was significantly hypertensive.  Patient is a poor historian, however I am concerned because of his significant change in mental status over the last 24 hours.  positive for COVID-19. 01/06/2022; remains in hospital. Completed remdesivir therapy
Immediately following vaccination she had a pain in her arm. 2 1/2 weeks later saw MD and was started on Naproxen. Was told by MD that the injection may have burst her Bursa and would need an MRI. Reported her pain to TW 1 month after injection and was instructed to try ibuprofen, ice and rest of the arm x 3-4 days. 1 1/2 months later spoke to participant and she reported that she had broke out in hives and was started on a steroid. At that time the pain in her arm subsided but is now back but the pain is dull. Instructed to notify MD if the pain gets worse. Will continue to follow-up.
Information has been received from a Nurse Practitioner (N.P.) concerning a 23 year old female with penicillin allergy who on 11-JAN-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included lot# 655619/1427F. Concomitant therapy included Ortho-Tri-Cyclen. The patient developed pustular lesions on her face, chest, umbilical area and bilateral upper extremities one and a half days after receiving the first injection. The patient self-treated with Proactiv solution. On 20-MAR-2007, it was noted on examination that the lesions remained "about the same." Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a Nurse Practitioner (N.P.) concerning a 24 year old (previously reported as 23 year old) female patient with penicillin allergy who on 11-JAN-2007 was vaccinated IM into left deltoid with a first dose of GARDASIL lot# 655619/1427F. In follow up it was reported that patient was given second dose on 27-MAR-2007 and on 17-JUL-2007 received the third dose of GARDASIL. Concomitant therapy included ORTHO TRI-CYCLEN LO. The patient developed pustular lesions on her face, chest, umbilical area and bilateral upper extremities one and a half days after receiving the first injection. The patient self-treated with PROACTIV solution. On 20-MAR-2007, it was noted on examination that the lesions on her arms had resolved but the remaining lesions remained "about the same". In follow up it was reported that patient had no shortness of breath, "nonpurited". The pustular type acne started about 3 days after the first immunization. She was seen at the doctor's office on 20-MAR-2007 and was treated for acne and they changed her birth control pill (unspecified). There were no adverse events after the second and third dose. On 27-MAR-2007 patient recovered. Additional information is not expected.