chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL DISCOMFORT (stomach uncomfortable after dinner), TENDERNESS (arm of injection tender) and FEELING ABNORMAL (not feeling 100% good) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. Concurrent medical conditions included Headache, Blood disorder NOS, Bone disorder NOS and Heart disease, unspecified. Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]), PANTOPRAZOLE and PARACETAMOL (TYLENOL) for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL DISCOMFORT (stomach uncomfortable after dinner) and TENDERNESS (arm of injection tender). On an unknown date, the patient experienced FEELING ABNORMAL (not feeling 100% good). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL DISCOMFORT (stomach uncomfortable after dinner), TENDERNESS (arm of injection tender) and FEELING ABNORMAL (not feeling 100% good) outcome was unknown. Treatment: last night took Tylenol concomitants - medicine after breast cancer survivor, heart medicine, headache medicine, blood medicine, bone medicine. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
I gave a healthy 42 year old female a Janssen covid shot on 7-7-21.  she was taken to the ER on 7-29-21 after experiencing dizziness, severe headaches and numbness and decreased motor movement on her left side.  she was complaining to her mother on the phone that she didn't feel right and she passed out.  She woke up to emergency assessing her in her home.  she declined transport to the ER and had a family member take her.  She was assessed her and determined she may have had a TIA.  She was prescribed  Hydroxyzine HCl,  Fioricet,  lipitor and aspirin.   A  consult with a cardiologist and neurologist in a few weeks.   On 8-4-21  she reports a sluggish feeling and swelling in her left leg and feels her leg might have decreased circulation and a cold feeling as well.
Received MMR 2/4/03. Noticed he did not feel well on 2/16/03, noticed rash 2/17. Currently with rash, joint aches.
The pt experienced a redness at injection site , nausea, vomiting. Probably systemic reaction to pneumonia vaccine. The pt developed vasovagal syncope after the nausea and vomiting.
Swelling and redness at injection site, first noticed on 02/13/2021, eight days after injection, resolved after ~48 hours. No other symptoms.
This case was reported by a nurse via call center representative and described the occurrence of fever in a adult male patient who received FLUARIX QUADRIVALENT (batch number AF29T, expiry date 25th June 2017). Concomitant products included PNEUMOVAX. On 24th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 25th September 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever and general body pain. On an unknown date, the patient experienced pharmaceutical product complaint. In September 2016, the outcome of the fever and general body pain were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the fever and general body pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The patient reported that she experienced fever and body aches after receiving FLUARIX QUADRIVALENT in his right deltoid. On the same day, the patient received PNEUMOVAX vaccine concomitantly. The nurse reported that vaccine was given to 3 health care providers. She insisted AF29T particular batch of vaccine was defective as this batch was producing adverse symptoms, which were not experienced in previous year's vaccines. She was unable to credit per content. This was one of the 3 cases reported by the same reporter.
The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.; No Adverse Event; Patient received vaccine after 30-day Use by Date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date) and PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.).    Concomitant drugs were not reported.  Number of doses/vials: around 50 doses from 5 vials.  Date of Vaccination was from 07-Aug-2022 to 11-Aug-2022  The vials were initially refrigerated on 08-Jul-2022.  The vial did not undergo any temperature excursions.  Treatment details were not given.
Hives started local approximately 1 1/2 hours after vaccine given.  Spread down arm, legs, bottom, & feet.  Gave Benadryl the evening of 07/23/19.  Itching.  Dr. advised to continue Benadryl and watch.  At this time not resolved.  Parent to call if persists or worsens.
No adverse effects reported; HCP called to report a TE with PROQUAD. Improperly stored. TE case reference 02490108. No adverse effects reported; This spontaneous report has been received from a medical assistant and refers to a 5-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, at a dose of 0.5 milliliter (ml) that had suffered a temperature excursion prior to being administered (product storage error) (lot number w029555 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 14-MAR-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). No adverse events were reported for this patient.
nausea, feels like could pass out, anxiety with vaccination 84/50, 98/64,104/68 100% RA 74 HR, 18 RR
Little welts breaking out on the back of her neck; She has one right in the center of her throat and a few in the middle of her chest; Itching on her scalp; She has broken out in a rash on the entire left side,; It is burning; Hurts; This spontaneous case was reported by a consumer and describes the occurrence of RASH (She has broken out in a rash on the entire left side,), SKIN BURNING SENSATION (It is burning), PAIN (Hurts), PRURITUS (Itching on her scalp) and URTICARIA (Little welts breaking out on the back of her neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced RASH (She has broken out in a rash on the entire left side,), SKIN BURNING SENSATION (It is burning) and PAIN (Hurts). On 26-Apr-2021, the patient experienced PRURITUS (Itching on her scalp) and URTICARIA (She has one right in the center of her throat and a few in the middle of her chest). On 28-Apr-2021, the patient experienced URTICARIA (Little welts breaking out on the back of her neck). At the time of the report, RASH (She has broken out in a rash on the entire left side,), SKIN BURNING SENSATION (It is burning), PAIN (Hurts), PRURITUS (Itching on her scalp), URTICARIA (Little welts breaking out on the back of her neck) and URTICARIA (She has one right in the center of her throat and a few in the middle of her chest) outcome was unknown.
Asthma symptoms (after 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma symptoms (after 2nd dose)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced ASTHMA (Asthma symptoms (after 2nd dose)). At the time of the report, ASTHMA (Asthma symptoms (after 2nd dose)) outcome was unknown.            Patient occasionally used rescue PII(36) but was using 2-3 times daily at the time of reporting.  Concomitant medication information was not provided.  Treatment information was not provided.
A lump has developed at the injection site. It is firm to the touch.  It's red and occasionally itchy.
This spontaneous report was received from a physician regarding 3 patients of unknown age and gender with no pertinent medical history reported. It was reported that on an unknown date the patients were possibly vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose, route and frequency not reported), that was stored in the fridge door for a long time (unspecified what is a long time). No adverse effects reported. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a 58 year old female patient. There were no concomitant medications, pertinent medical history, drug reactions or allergies. On 08-MAR-2016, the patient was vaccinated with ZOSTAVAX subcutaneously, lot # reported as L037791, exp. 30-DEC-2016 (dose was not reported). On 08-MAR-2016, the patient experienced redness and swelling at the injection site that was "about the size of a half dollar." The pharmacist stated the patient also reported that the redness "streaked down toward the elbow." No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and the vaccine was not provided. Additional information has been requested.
Initial report received on 26 February 2010 from a health care professional. A five-year-old female patient had received a fourth dose subcutaneous left arm injection of IPOL, lot number B0052 (lot number invalid) and a third dose intramuscular left deltoid injection of HEPATITIS B (manufacturer Merck, lot number 1678X) on 01 February 2010 as part of a well child visit, and during vaccination the patient screamed. Within a few minutes after receiving the vaccines, she became stiff and her eyes rolled back. No treatment was prescribed and all symptoms were fully resolved within 30 minutes. The physician diagnosis was syncope versus seizure. The patient had not received any other vaccines during the four previous weeks. Her past medical history included reactive airway disease and she had been taking albuterol prn. Outcome was recovered. No additional information was provided at the time of the report.
Subject reports that she experienced increasing joint pain during the evening on date of vaccination. Next day severe joint pain with body aches and headache. She was seen at the health clinic on 07-MAR-07, prescribed Tylenol Ext. Strength and rest. She noted redness and swelling at injection site beginning 08-MAR-07.
12/9/22 I noticed a spot on my scalp that was dry and itchy. My annual dermatology appointment was on 12/15/22. My doctor took a biopsy and told me I had a Peri Oral Dermatitis and a type of Psoriasis. I was put on VTAMA cream. I started using that on my scalp and metronidazole. At the beginning of January, my entire neck, face and head were engulfed in a bright red, itching, burning, and screaming Psoriatic rash. After that, I got a red rash and was given clobetasol shampoo and triamcinolone ointment and cream. It proceeded to get worse over the next few weeks, six weeks or so. Around the third week in February, I started SOTYKTU medication. I have improved about 90%.
2 days p/vax pt awoke during the noc w/runny nose, warm & clammy sweat & high pitched crying; no fever; starting 27MAY90 thru 30MAY90 pt had constant eye blinking 30MAY90 taken to MD sx w/strep throat & lt ear infect; given Ceclor 8JUN90
Shaking like a leaf; Appetite lost; Inflammation on neck and hands; sick after both doses/sicker after the second dose; Headache; Fatigue; pyrexia; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking like a leaf), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation on neck and hands), ILLNESS (sick after both doses/sicker after the second dose) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) for Atopic dermatitis and METOPROLOL for an unknown indication.    The patient's past medical history included COVID-19 (For about 7 days) in 2020. Concurrent medical conditions included Atopic dermatitis and Weight increased.   On 23-Apr-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 mg once a week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and METOPROLOL (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking like a leaf), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation on neck and hands), ILLNESS (sick after both doses/sicker after the second dose), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (pyrexia) and CHILLS (Chills). At the time of the report, TREMOR (Shaking like a leaf), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation on neck and hands), ILLNESS (sick after both doses/sicker after the second dose), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (pyrexia) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Body temperature: 102 (High) 102 Cel. In 2020, Weight: weight gain (abnormal) Weight gain that worsened.         No treatment medications were provided.   This case was linked to MOD-2021-215394, MOD-2021-215394 (Patient Link).
This spontaneous report as received from a consumer concerning her daughter, a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On 19-MAR-2014 the patient was vaccinated with first dose of GARDASIL (lot number, dose and route unspecified). On 19-MAY-2014 the patient was vaccinated with second dose of GARDASIL (lot number, dose and route unspecified). Concomitant medications were not reported. On an unknown date in June 2014 the patient came down with sinus infection. The patient was treated with 3 day course of prednisone. The outcome of sinus infection is unknown. The causality of the event with GARDASIL was not reported. Additional information has been requested.
pt recv vax 1DEC96 & same day devel over 100 chickenpox lesions over the body, swollen arm & dime sized necrotic spot @ inj site;9DEC96, all of the pt sx had resolved;
having Skin Cancer removed; About a week ago, started experiencing a lot of pain from a vasculitis flare up.; a lot of pain from a vasculitis flare up/a lot of pain in various parts of the body; This is a spontaneous report from the Pfizer Sponsor Program. A contactable consumer (patient's daughter) reported that a 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. Medical history included arthritis (had pain sin those areas during cold weather), 2 autoimmune diseases, surgery and shoulder joint pain. The patient's concomitant medications were not reported. Clinical course: patient started experiencing a lot of pain from a vasculitis flare up. It was as if it just happened and was having a lot of pain in various parts of the body in Apr2021. Patient was actually in the care of her vasculitis doctor because she was having skin cancer removed by him. Patient had glasses. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Flu like symptoms started the next morning after the second shot, approximately 14 hours.  Fever, chills, body aches, nausea, headache and tiredness all presented very prominently about 24 hours after the shot.  I had to miss the next day at work (second day) due to fever.
March 4, 2021 - 1:30 PM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. The right arm swelled up at the point of the injection for a few hours. Was hot to the touch.   March 11, 2021 - 9:40 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.  March 17, 2021 - 3:17 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.
4/22/21- Fever, Chills, night sweats, body aches 4/23/21- Fever, Chills, Body aches 4/24/21- Body aches, numbness and weakness on right side of body 4/29/21- Went to healthcare facility complaining of numbness and weakness on the right side of the body. Was seen by a doctor and did a neuro assessment. She then decided that she was having a ?stroke? or a ?brain bleed?. While at ER the PA did another neuro assessment and said could be having a stroke and was admitted into the hospital on 4/29/21
Allergy and redness on the arm where the Covid-19 vaccine is injected; Allergy and redness on the arm where the Covid-19 vaccine is injected; This is a spontaneous report from a contactable consumer (patient) from a program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 20Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 04May2021, patient was experiencing allergy and redness on the arm where the Covid-19 vaccine was injected. She got these symptoms 2 weeks after getting the first dose on 20Apr2021. She wants to know if these symptoms are normal. She also added that her second dose schedule would be on 11May2021. Caller hung up intentionally and so no transfer of call was made. The outcome of events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Lot number: GC9431) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Jul2022, outcome "unknown" and all described as "got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: her husbands was positive for covid also. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Reporter states that she got covid from her husband. Reporter states that she herself did not have any vaccine, but her husband had the vaccines. Reporter again repeats that she herself did not have any vaccines. Reporter states that she wanted something added to this. Her husband went to a family gathering before 04Jul2022, and then he came home coughing and sneezing, coughing and sneezing just everywhere, and after 2 days or 3 she found out that she has fever. She did a test at urgent care with her husband, the doctor said to do a PCR test, and when they did PCR in which she would told the result would come the following day and be ready by 05Jul2022 so she did the test. She also did a rapid test which tells the result after 15 minutes. After 15 minute the rapid antigen test was positive for and then her husbands was positive for covid also. Reporter states that she did have a fever prior to Paxlovid. Reporter clarified that before the covid test, her husband, 1 weeks before 04Jul2022 Monday, her husband was coughing and stuff. Reporter states that she had a fever on 03Jul2022 but because of the holiday her husband told her not to bother with testing since everything will be closed, that's why she checked on 05Jul2022. Reporter was probed if she had her husbands covid vaccine Lot number or Dates they were administerd, call responded stating that she does not have any of her husbands information, and she knows is that his first 2 shot were Pfizer, and he had 2 booster so all together that's 4 vaccines. He is very careful he is 68. Reporter states that whatever he took for his symptoms the doctor gave him an antibiotic and cough syrup and he was okay, he's coughing a little bit.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
DTAP-HIB combo given before 15 months of age. No side effects reported.