chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Vomiting; Chills; Body aches; Sweating; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration, on 20Mar2021, at 13:30, (at the age of 53 years), on left arm, as a single dose for COVID-19 immunisation. Medical history included EVB and COVID-19.Allergies to medications, food, or other products included penicillin, sulphates, lactose and gluten. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, at 14:30, the patient experienced diarrhea, vomiting, chills, body aches, and sweating. The adverse events were resulted in doctor or other healthcare professional office. Therapeutic measures were taken as a result of adverse event with Zophran, (MANUFACTURER UNKNOWN); fish oil, (MANUFACTURER UNKNOWN); Xanax, (MANUFACTURER UNKNOWN); Tylenol, (MANUFACTURER UNKNOWN). The clinical outcome of diarrhea, vomiting, chills, body aches, and sweating was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Prolonged hospitalization with eventual patient death. Acute respiratory failure with hypoxia secondary to COVID pneumonia. BiPAP, hasd previous hospitalization requiring ICU placemtn on Vapotherm and BiPAP, discharged home then hospitalized again with acute hypoxi respiratory failure, IV antibiotic therapy, IV solumendrol, SVT
allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). Other Case identifier(s): 4518315.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "HER+" (unspecified if ongoing), notes: Past medical history included: HER+. Concomitant medication(s) included: OXALIPLATIN; HERCEPTIN. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blood sugar level fluctuation; Vomiting; aspirations; This spontaneous case was reported by a consumer and describes the occurrence of ASPIRATION (aspirations), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuation) and VOMITING (Vomiting) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03621a and 047b21a) for COVID-19 immunisation.     Concurrent medical conditions included Penicillin allergy, Diabetic, Blood pressure and Acetaminophen.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form once. On 22-Apr-2021, the patient experienced ASPIRATION (aspirations). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuation) and VOMITING (Vomiting). On 20-May-2021, ASPIRATION (aspirations) had resolved. At the time of the report, BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuation) outcome was unknown and VOMITING (Vomiting) had not resolved.            No concomitant medications were reported.   No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment  Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-239195 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021 and it contain event,allergy; Sender's Comments: Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.
In May, 1999 and June 1999, the pt received his first and second doses of Lymerix. Approximately 8 months following dose 2 on 2/1/00, the pt experienced a swollen, purple, warm, and tender knuckle, and morning stiffness in his hand. No treatment was given. Lymerix was discontinued.   The most recent information received on 2/8/00, reports the condition of the pt as improving. his knuckle is less swollen, less tender, less purple, and less warm.
Only slept 2 hours at night; Sore arm at the injection site; Headache; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Only slept 2 hours at night), VACCINATION SITE PAIN (Sore arm at the injection site), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced INSOMNIA (Only slept 2 hours at night), VACCINATION SITE PAIN (Sore arm at the injection site), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, INSOMNIA (Only slept 2 hours at night), VACCINATION SITE PAIN (Sore arm at the injection site), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Syncope X 2, after all 3 shots given. Tx: oxygen, apple juice
PATIENT COMPLAINS OF SEVERE PAIN IN THIGHS AND LOWER CALFS TO THE POINT WHERE HE IS HAVING DIFFICULTY WALKING. STARTED ON 09/17/2012 AND HAS SUBSIDED SOMEWHAT SINCE THIS REPORT BUT STILL CONTINUES TO HAVE PAIN. HAS A HISTORY OF BLOOD CLOTS SO RECOMMENDED SEEING HIS PHYSICIAN FOR EVALUATION AS SOON AS POSSIBLE.
headache; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than an hour after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the pharmacist asked about how fast after giving Shingrix can it cause a headache as the pharmacist had a patient that reports having a headache within 15 minutes, so a pretty sudden onset.
Patient had received Moderna vaccine on 1/7/21.  Patient was scheduled for second dose moderna today, but received pfiezer by accident.
arm pain; pressure went up; headache; cold; felt sick; sore throat; fever; not feeling well; This is a spontaneous report from a contactable consumer or other non-healthcare professional and from a Pfizer sponsored program. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Mar2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history included pneumonectomy, she had one lung because one lung was removed when she was born, so her heart is over and turned, she also had Type 2 Diabetes but is not on medicine and blood pressure, her blood pressure went up even while taking her blood pressure medication. The patient's concomitant medications were not reported. It was reported that, enquired, the caller had her first dose on last Tuesday (09Mar2021). She had some side effects like pain in the arm, headache, high blood pressure and not feeling well. She heard from other people that the second dose of the vaccine will have worse side effects than the first. Stated that, whether they will be worse she doesn't know if she wants the vaccine. Stated that, she spoke with her doctor and they left it up to her but all of her doctors recommended her to get it. She wanted some advice because she was scared and nervous to take the second dose of her vaccine due on 29Mar2021. She stated her side effects after the first dose were all normal ones. Her symptoms after the first dose included arm pain but it didn't bother her and went away quickly. The next day it was sore but then it was gone. Her blood pressure went up even while taking her blood pressure medication (she has been on hydrochlorothiazide every morning for months). Her blood pressure was 150s/90s. She had a headache for a couple days and stated that, this could have been from the elevated blood pressure. She developed a cold and felt sick. The cold was with her nose and she had a sore throat. She had a fever but was unsure how high because she was taking Tylenol for the headache. She was not sure whether the cold was coincidental or not but it all got better in a couple days. She asked whether people had reported elevated blood pressure. Enquired, the caller asked if after getting the first dose people are nervous about getting the second dose due on 29Mar2021 and just get one dose. Therapeutic measures were taken as a result of pressure went up (blood pressure increased) and headache (headache). On an unspecified date, the patient underwent lab tests and procedures which included her blood pressure went up even while taking her blood pressure medication (blood pressure measurement), resulted as 150s/90s, her blood pressure was 150s/90s. The outcome of the events for pain in arm, cold was recovered while for the other events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Patient is a 38-year-old male who presents for evaluation of left arm injection site reaction. Patient states he had a influenza vaccination injection given in his proximal left upper extremity in early October. States that neither the end of October or early November, he noticed a knot appear on the proximal left upper extremity near injection site. Patient states that the knot grew in size and became red and inflamed. Patient states that the inflammation and redness extended to his upper left chest. Patient states he got an MRI of the chest to evaluate if the infection had reached the bone, but patient states this was negative. Patient states he was started on antibiotics a couple weeks following his first M.D. visit. Patient states the lesion drained were then twice. States the drainage was yellow/dark green. States that the area became swollen again and busted multiple times. States he has been on multiple rounds of antibiotics. Reports fever and chills 2 weeks ago. States his fever was 101-102°F. Reports pain in his left upper extremity is 1/10, which she describes as a sharp pain. Follow-up as needed.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA303390. This case involves a 24 months old male patient who was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (lot UT6259LA and Exp. Date 30 Jun 2019) via intramuscular route in the left thigh on 29-Oct-2018, which was stored at negative 8 Cel. hence had temp excursion. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. There was no reported reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt called on Monday 2/1/21 to say the day after her 2nd Covid 19 vaccine (vaccine 1/29/21)  she had no recall of the events of 1/30/21.  States her mother told her they had been at a hockey game, had a long conversation, and drove to several places that day.  Patient reported she felt "kind of funky" on Sunday 1/31/21 and vomited X1 that eve.   Monday when she called she said she felt fine.  She did not reach out to anyone for medical care and did not feel it was necessary  she "just wanted to report it to someone."  Encouraged to reach out to PCP as necessary.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 02-APR-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient reports going to a hospital ER 2 days after receiving Gardasil vaccine dose #1 due to complaints of body aches, chills, and nausea.  She states she was not diagnosed with any specific conditions and was told to take ibuprofen and go home and rest.  She reports no current complaints and did not inform our office of this event until today.
Loss of hearing in L-ear q:15 min within 5 min post injection. Localized anaphylactoid reaction to upper extremities bilateral. Moderate fever induced within 24 hrs and prolonged at approx. 38.7C for 48 hrs.
12/20/21 he developed myalgias, SOB initially only with activity, and nonproductive cough but was partially vaccinated for COVID x2 (last Moderna 8/27/21) and had a negative COVID test on 12/27/21
4/18/06 about 8:30am phone call from mom, c/o pt having a nose bleed this AM about 7:30am. Pt woke up and used her hands to cover her nose, had a handful of blood with clots. Mom denies any bruising, no H/A's, no occuial disturbance, no fever, does have a stomach ache, decreased appetite. Mom does not recall pt getting hit in the face/nose and has never had a nose bleed. Mom looked on the internet under immunizations nose bleeds and it said 1-24000 who Rec'd MMR developed ITP. Pt Rec'd MMR on Friday 4/14/06. Advised mom to call her MD for further advise or appt as needed. Informed mom I would call back later for any update and info voiced understanding. 4/18/06 9:40am phone call to Pt home and spoke with babysitter, she stated that pts appetite has returned and asking for something to eat. Babysitter stated that pt only had the one nosebleed and it did not last long. Informed babysitter that I would contact Pts parents later today. 4/18/06 4:30pm phone call to mom, mom stated that DR office called CDC and recommended to monitor Pt for now since she only had the one nose bleed, if the bleeding cont, will need to be seen for possible blood work. Also mom states that Pt cont now to c/o stomach ache decreased appetite. Mom will follow up with DR as needed. Informed mom that I will complete a VAERS in regards to pt immunizations and nose bleed voiced understanding.
pt recv vax 24NOV97 1025AM & approx 15min later pt stood up & was comforting another crying student who was to be immunized when pt suddenly started falling & was caught by nurse;
Patient complained she had fever , chills and muscle aches. took two tylenol tablets and the symptoms  lasted for 18 hours. Felt better after 2 hours .
Covid19 breakthrough. 1st vaccine received on 2/21/2021. 75 y/o with PMHx of Cardiomyopathy, breast CA, HTN, HLD, chronic pancreatitis, Kidney stones presents to ER after near syncope episode/hypotension at PCP office. Upon arrival, pt hypotensive, c/o cough, congestion and tested positive for Covid.  Rm air sat 97% and CXR with no acute disease.  Started on IV fluids/ IV abx and steroids.
On 6th day, injection site became swollen, hard, warm, enlarged, painful, and itchy. The previous days beforehand, the site was starting to return to normal appearance.
Pain at injection site immediately, but manageable (5:00pm). Onset of lethargy, then joint pain, muscular pain (especially neck), headache (7:00am following day), as well as swelling/pain of injection site. Fever, chills, and rash on left arm (2" diameter) observed at (9:00pm). Fever subsided with 2 doses of ADVIL (overnight), but pain and swelling at injection site remain, as well as heat to touch at injection site, rash on left arm remains, lump under rashy area. All other symptoms remain, but less pronounced compared to previous day.
Right arm has swelling, erythema, tenderness and pain since administration of vaccine on 10/16/06, area began to increasing site on day of administration yesterday (10/17/06)  bullae which continued to increase in number and weep today. Put on Keflex 10 day.
CARDIOVASCULAR HEALTH HAS DETERIORATED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced cardiovascular health has deteriorated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiovascular health has deteriorated was not reported. This report was non-serious.
Muscle weakness; Fever; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle weakness and fever. On an unknown date, the outcome of the muscle weakness and fever were unknown.   It was unknown if the reporter considered the muscle weakness and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had extreme muscle weakness and fever.The reporter asked had anyone died from this vaccine.  The patient concerned about getting 2nd dose. The reporter asked also was there any contraindication to giving it to a person with type 2 herpes. The reporter asked who should not get the vaccine. The reporter asked had been diagnosed with herpes 2, or your reaction to the 1stinjection was severe muscle pain and fever.Enough to be bed ridden, what was the mortality rate from this vaccine. The reporter asked I should be getting my second dose soon, but not sure after the problems I had with it.
can't even sleep at night; still swollen; couldn't lift her arm/ All week she still couldn't and she still can't lift it fully; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't lift her arm/ All week she still couldn't and she still can't lift it fully), INSOMNIA (can't even sleep at night) and PERIPHERAL SWELLING (still swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Mar-2021, the patient experienced LIMB DISCOMFORT (couldn't lift her arm/ All week she still couldn't and she still can't lift it fully). On an unknown date, the patient experienced INSOMNIA (can't even sleep at night) and PERIPHERAL SWELLING (still swollen). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (couldn't lift her arm/ All week she still couldn't and she still can't lift it fully) and INSOMNIA (can't even sleep at night) outcome was unknown and PERIPHERAL SWELLING (still swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines are not provided by the reporter  Patient stated the shot was given very high up on the shoulder and thinks it could have interfered with the arm bone.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter declines to complete ADR  form
INJECTION SITE PAIN WITH SORE ARM BODY ACHES MUSCLE PAIN AND ACHES IN LEGS AND CALFS  TIRENESS, WEAKNESS HEADACHES DIZZINESS CHILLS
Day of vaccine: extreme stomach pain, fever, chills, body shaking, diarrhea, hot flashes, chest pain, heart rate of 130. Days later, still feel nauseated and tired and have increased heart rate and upset stomach
Rash- Information has been received from a healthcare professional concerning a 20 year old female who was vaccinated with one dose of varicella virus vaccine live Unknow site.  Three hours after receiving the vaccine, the patient experienced a papular rash on her trunk, arms, and neck which has persisted for four weeks.  the patient sought unknown medical attention.
severe headache (uncommon) the morning after.  Went away after 600 mg. of Motrin + 1,000 mg. of Tylenol
bump at the injection site; bump at the injection site/just a bump and it hurts; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249), via an unspecified route in the arm of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had his first COVID Vaccine and right now, he had a bump at the injection site. He was wondering if this is a normal reaction. He said it hurts to the touch or if he moves his arm. It was just a bump and it hurts. It hurts a little bit if he raise his arm up and down but right now it's not as bad as it was as patient had taken some Aspirin. When patient was asked about the lot number, patient stated "She gave me like 2 of them. She ran out of one bottle, so she had to get another bottle, she threw up the thing rest away. You know what I mean?". Outcome of the events was unknown.
The patient received a second dose of COVID Vaccine 9 days earlier than what is recommended by the manufacturer guidleines
Immediately following injection I, patient became warm and flushed. The next day an injection site reaction occurred. My arm was swollen, red, and warm for 3-5 days.
The next day after receiving the flu vaccine, she noticed a bright red rash to her upper chest, numbness and tingling to her face, itchy eyes. No fever, no hives, no swelling, no shortness of breath/ difficulty breathing, no increased HR. She took BENADRYL and rash and itching subsided. Ibuprofen 40 mg x one day given by NP. She reported similar reactions in previous years. She was referred to PMD for follow-up.