chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My Stepson, who is in very good health, received the Flu Mist inhaler on 29 Nov. He became Violently ill with-in 24-30 hours of administration. I would not had given it a second thought except for what  had happen earlier in the week. That narrative follows.                                                 My Daughter received the shot on Tuesday 20 Nov. By Thursday 22 Nov late morning, she was throwing-up. Her symptoms lasted for approximately 5 hours. On 23 Nov, 24 hours after the onset of symptoms in my almost 3 year old daughter, my 45 year old sister, whom lives in my house-hold as well, became violently ill with vomiting, diarrhea chills, etc. On 24 Nov, 20 hours later, I became ill with the same symptoms and 2 hours after me, my wife became ill. My mother came into town that Thursday, 20 Nov, but never became ill. My stepson returned from his fathers on the Sunday, 25 Nov, and did not contract the illness. My 1 year old son was in the same room at the doctor's office when my 3 year old daughter received the Flu Mist inhaler. He threw-up on Thursday and acted ill as well as ran a temperature the same time my daughter did. But, he did not become more seriously ill until the evening of the 24th-25 of Nov. He threw-up several times during the same period that my wife and I became ill. He did not get diarrhea though. I am in the service and in very good health. I receive the flu shot every year and had had one 3-4 weeks prior to these illnesses. My wife is in good health and has not had the flu shot this year.
Ringing in my ear/it seems like the vaccine has elevated that; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in my ear/it seems like the vaccine has elevated that) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037D21A and 044A21A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included METFORMIN for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced TINNITUS (Ringing in my ear/it seems like the vaccine has elevated that). At the time of the report, TINNITUS (Ringing in my ear/it seems like the vaccine has elevated that) outcome was unknown.            Relevant concomitant medications included heart Medications for the heart rate.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received and Non Significant information added patient was not willing to fill out form again and wants to be taken off from FU list
Felt some slight itching and noticed a large red, rash had developed near the injection site 4 days after the second dose of COVID19 vaccine injection. Not sure when it had started exactly, but noticed it in the evening of day 4. It was swollen and not an even, defined shape. The rash got even bigger the next day. Measured around 6 inches length-wise down the arm and around 3.5 - 4 inches across the arm. Felt some itching and general discomfort from the swelling/ size of the rash. Rash was emanating heat on days 4 and 5. Took a total of 2 Benadryl's on day 5. The redness dissipated a bit at day 6.  FYI: First dose of COVID19 vaccine did not result in any significant side effects asides from an extremely sore arm.
pt had t104, convuls (11) following vax;  pt also had LOM;
Lump at injection site x 7 days, red spot at injection site two weeks later Narrative:
First day- no symptoms at all, only sore arm. Second day- Started getting itchy at the end of the day 10pm. Third day- got much worse and then took benadryl.  Today is the fourth day, still rashes all over body, itchy, and continuing taking 2 benadryl tablets every 4-6 hours .
Became ill with cold like symptoms within 2-3 days - body aches, cough, fever, was hospitalized Oct 14th - Oct 18 continued with muscle weakness, pain & CIDP to present day.
24 hours after receiving COVID vaccine I began having symptoms of vertigo and dizziness in my L ear. Vaccination was given in the L deltoid.
Had both shots, got them/suspected vaccination failure; got them a week later; nerve sapping; painful; no sleep; No when i get stressed i feel like that are under a part of my neck; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included neurological disorder nos (went down 3 nerve lines instead of the usual one and all on left side of head, neck, shoulder, back and breast) and blister (had over a hundred blisters and were horrendous for 9 months).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain, pain, insomnia and stress. On an unknown date, the outcome of the vaccination failure, shingles, pain, insomnia and stress were unknown and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain, pain, insomnia and stress to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient's shingles went down 3 nerve lines instead of the usual one and all on left side of head, neck, shoulder, back and breast and over a hundred blisters and were horrendous for nine months. The patient received both shots after. The patient stated no when the patient get stressed the patient felt like that were under a part of neck. It had been crazy. The patient was awful as 2 weeks earlier primary care physician asked the patient about getting it. The patient was going on a trip so the patient said the patient would get it when the patient came back.  The patient got them a week later and never got to go on trip. The patient got some nerve sapping every ten seconds somewhere in body. Painful, no sleep and just wanted to hit someone or something! This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact detail were available.
Right after second dose, very tired; Headache, neck pain /A month later, I still have neck pain and headaches Especially during my period; Headache, neck pain /A month later, I still have neck pain and headaches Especially during my period; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 16:30 (at the age of 44-year-old) (Lot Number: ER8735) as dose 2, single for COVID-19 immunization. The patient medical history was none. The patient was not pregnant at the time of vaccination. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Mar2021 16:30 (at the age of 44-year-old) (Lot Number: EP6955) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 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 reported that right after second dose, patient was very tired, had headache, neck pain. A month later, she still had neck pain and headaches especially during her period. The patient reported that she never had never suffered from headaches prior to taking the vaccine. The patient did not receive treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
VACCINE ADMINISTERED  TO PATIENT PAST ITS TEMPERATURE  EXCURSION; INCORRECT STORAGE OF DRUG; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAY-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 06-MAY-2021, the subject experienced vaccine administered to subject past its temperature excursion. On 06-MAY-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient past its temperature excursion and incorrect storage of drug was not reported. This report was non-serious.
No adverse effect reported; Expired product administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.      On 10-APR-2019, the patient was vaccinated with an expire vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N009800  and expiration date 24-MAR-2019, for prophylaxis (dosage schedule, route, and anatomical location were not reported).  No adverse effect reported.   The outcome of expired product administered was unknown.
injection site pain, fatigued Narrative:  Received 2 vaccine on 2/17/21, right arm had a lot of pain at injection site and felt very fatigued for rest of day. Woke up 2/18/21 feeling much better slight pain in arm. Advised to take soe otc acetaminophen for discomfort as needed or use an ice pack to arm.
Pt vaccinated via drive through site at 1105. At 1108 the patient was unconscious in her vehicle. Per the patient's spouse, this is a typical response and the pt regains consciousness within 5 minutes. EMS was called and the onsite provider was notified. Upon evaluation, the patient had regained consciousness and was discharged to home.
The patient has had no adverse reaction to the shingles vaccination; However, the patient's daughter, age 43, contracted a severe rash on 10/20/09. The daughter subsequently sought care at an Urgent Care Facility and the rash was diagnosed as shingles on 10/30/09. The patient's daughter had recurring pain. The patient had previously been diagnosed with Type II Diabetes, high cholesterol, high blood pressure and osteopenia prior to receiving the vaccination.
Headache, NauseaVomiting, Dry cough, Stomach pain, chills, palpitation. Narrative:  All was resolved with in 2 hours.
Child was complaining of pain the evening she received the shot and was given tylenol.  Upon waking the next morning, her left arm was swollen from the shoulder to her elbow and she was complaining of pain and itching.
Pt. states that after receiving the 3rd dose of Phizer 01/22/2022, started experiencing symptoms that evening of swelling at and around the injection site and sharp "stabbing" pain in the Left arm through the shoulder area with Minor bruising. No noted Primary visit/communications.
This spontaneous case was initially received on 05-Nov-2015. The case report was received from a Health Professional and concerns a 38 years old female patient. The patient did not normally get her flu shots annually. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 04-Nov-2015 - 04-Nov-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unspecified date after vaccination, the patient complained of an allergic reaction to the vaccine. The reaction was from an egg allergy. The patient was having symptoms of rash. AFLURIA was the only injection that the patient received that day. The outcome was not reported. For relevant tests results see appropriate report section.
Did not feel very well for 2 or 3 days; Arm is hard; Discomfort; Arm is hard, like a bruise; Arm inflammed; A large red circle that does not go away; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MALAISE (Did not feel very well for 2 or 3 days), PERIPHERAL SWELLING (Arm is hard), DISCOMFORT (Discomfort), VACCINATION SITE BRUISING (Arm is hard, like a bruise) and VACCINATION SITE INFLAMMATION (Arm inflammed) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Allergy and Cholesterol. Concomitant products included MINERALS NOS, VITAMINS NOS (CENTRUM PLUS), ASCORBIC ACID (VITAMIN C ACID) and ZINC for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (Did not feel very well for 2 or 3 days), PERIPHERAL SWELLING (Arm is hard), DISCOMFORT (Discomfort), VACCINATION SITE BRUISING (Arm is hard, like a bruise), VACCINATION SITE INFLAMMATION (Arm inflammed) and VACCINATION SITE ERYTHEMA (A large red circle that does not go away). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Did not feel very well for 2 or 3 days) outcome was unknown, PERIPHERAL SWELLING (Arm is hard), VACCINATION SITE BRUISING (Arm is hard, like a bruise), VACCINATION SITE INFLAMMATION (Arm inflammed) and VACCINATION SITE ERYTHEMA (A large red circle that does not go away) had not resolved and DISCOMFORT (Discomfort) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 98.6 (Inconclusive) 98.6 ° F. Not a fever according to the doctor.. On 09-Mar-2021, Body temperature: 97 (Inconclusive) 97 ° F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medications for blood pressure, allergy, cholesterol and prostate. The medications were discontinued for 24 hours after receiving the vaccine. Treatment for the events included acetaminophen.
ModernaCOVID-19 Vaccine EUA       Day after felt very tired and like I had a bad cold.  Today is 10 days later and my arm is still sore and continues to have  large red area similiar to when stung by a bee, is warm, slightly swollen and sore.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# L021214, expiration date: 10-JUN-2017 and lot# M015731, expiration date: 30-MAR-2018), subcutaneously. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from a physician via a company representative concerning a female patient of unknown age and her friend. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with first dose of GARDASIL (0.5 ml) (lot #, expiration date and route were not reported) at different location. On the day the patients got the vaccine, they both felt tired, fatigue and a bit nauseous. At the time of reporting, the outcome of the events was unknown. The causality was not provided. Additional information has been requested.
06/14/19: Pt received vaccine at approx. 11:00 am.  Approx 20-30 mins later, he noticed a petechiae-type rash of the forehead, eyelids and facial areas. He felt mildly dizzy. He then returned to Employee Health Service. Vital signs were all stable.  A petechiae rash was noted of the forehead, eyelids, facial areas, the posterior pharynx as well as bilateral upper/lower extremities. Benadryl 50 mg PO was given at 11:50 am. His condition was closely monitored over the next hour or so. He was discharged in stable condition at 13:10 from Employee Health Service accompanied by his daughter. He was sent home with Benadryl 25 mg #20 to take as directed (one q 1-2 every 4-6 hours PRN) as well as prescribed Prednisone 40 mg PO daily x 5 days. He was sent home from work. The rash  resolved within 24  hours and he resumed work the next day without difficulty.
12/29/2020 Day one; sore arm, headache, aches/pains. Worsening symptoms over serval days; developed severe abdominal cramping and diarrhea on 1/2/2021 and 1/3/2021 with more intense, myalgia/arthralgia. Saw MD. (1/8/2020) still had all symptoms.  Prescirbed codeine cough medicine and prednisone. All Labs drawn 1/6/2021.. Reported elevated inflammatory markers.  CT scan (1/9/2021) showed acute Ulcerative collitis.. Hx. of diverticulitis.  Given antibiotics and prednisone. Still having symptoms, seeing GI specialist.  Unable to work.  "I thought I had COVID and was tested; it was negative." (1//4/2021) Still having abdominal pain, cramping, diarrhea and fatigue when checked on for an update on 1/15/2021.
This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age, with no known drug reactions/allergies and no other pertinent medical history. On 11-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, and route not reported) (lot # H019040). There was no concomitant medication. On an unknown date the patient experienced pain, redness, swelling, warmth and itching at the injection site following the administration of ZOSTAVAX. The pharmacy doctor reported that the size of the affected area around the injection site was approximately 1.5 inches by 3 inches. The reported also mentioned that the patient stated she had difficulty moving her arm. The patient sought unspecified medical attention. No treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Urinating every 10 minutes; Fever of 102 deg F; Headache; Arm ache; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urinating every 10 minutes), PYREXIA (Fever of 102 deg F), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm ache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced POLLAKIURIA (Urinating every 10 minutes), PYREXIA (Fever of 102 deg F), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, POLLAKIURIA (Urinating every 10 minutes), PYREXIA (Fever of 102 deg F), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 deg f 102 deg F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
pt experienced a "~dime size lump that was short and puffy" in the armpit of the same arm as the shot 3-4 days after the first dose and lasting 3-4 days
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient is known to have syncopal events after receiving needles and she did not notify the team. She was sitting in observation when she had a syncopal event and experienced a loss of consciousness for a second. By the time the medic got over to her she was AAOx3 and denied any help from the medic. No further intervention.
Pt was given 0.3ml of Pfizer adult dose, rather then childs dose.  Pt immediately vomited
This spontaneous report as received from a 68 years old female consumer refers to herself with cancer and sulfamethoxazole, BACTRIM allergy. The patient was vaccinated with a dose of PNEUMOVAX23 (lot number, route and site not reported) on 07-AUG-2012. No other co-suspects were reported. Concomitant medications included CRESTOR, TOPROL XL tablets, CELEBREX and VALTREX. On 07-AUG-2012 immediately after the injection, the patient had a bad skin reaction. She had a raised area the size of a nickel and grew to be the size of an orange; the area was red and hot. Her arm muscle was sore and painful to move. By the second day after the shot on 08-AUG-2012, her arm was red from shoulder to elbow. The patient saw the doctor for medical attention. No treatment or laboratory diagnostics studies were performed. The outcome was reported as recovering/resolving. Additional information has been requested.
feb 14, sore arm, feeling tired feb 15, body aches, tired, sore muscles on back feb 16, body aches, tired, sore muscles "all over"
Several hours after flu shot, she developed hives, have been spreading & now looks like urticarial vasculitis, on ZYRTEC & BENADRYL.
Four days after the shot, I woke up with a burning sensation under my eye with some redness. The next day I woke up and it was very red. The third day I work up with some minor swelling and tiny blisters. The following day my under eye was swollen, very red, and irritated. The blisters were crusty but not scabbed. I went to Urgent care and the provider there thought it was Shingles but wasn?t sure. Directed me to the ER because they have an Ophthalmologist on staff. The ER doctor confirmed it was shingles and it had not spread to my eye. The doctor also thought I had a skin infection also and that was causing the swelling. I was sent home with  antiviral medication and also and antibiotic.