chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.
Narrative:  COVID infection following COVID VACCINE SERIES 05/10 Janssen, dose #1 12/28 COVID swab, result: detected 12/28 pt cc: chills myalgias exposure: unknown
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Red Food dye). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Aug-2020 and the estimated date of delivery was 18-May-2021. On 18-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. Current pregnancy outcome was unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included: pro-biotic and anti-nausea product once daily and pre-natal vitamin twice daily. Pregnancy test was positive on 05-Sep-2020. On 12-Feb-2021, an ultrasound was performed.
1 x 1.5 cm urticaria within 2 cm of injection site with 2-5 minutes of injection.  Skin was normal prior to injection.
11.5"cm x 7"cm area of erythema and increased warmth to right thigh.
I've had Tinnitus for 11 years, however I experience a drastic spike in my Tinnitus after getting the first dose of the Moderna vaccine. It has since, lasted.
Heavy breathing, thighs, legs and face was shaky on left side of body.  Irregular heartbeat for a little while, unable to sleep, itching arm at injection sight.
I fell like sinuse and sneeze from that date to now....TYLENOL sinusitis.
greatly fatigued, sore entire leftside of body; greatly fatigued, sore entire leftside of body; 4 inch round circle of inflammation around injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 10:00 as dose 4 (booster), single (Lot number: GJ3274) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Elevated BP" (unspecified if ongoing); "Some dehydration issues" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex, hay fever, tramadol - that's IT. Concomitant medication(s) included: FLU VACCINE VII, in Oct2022 as dose number unknown, single; LEVOTHYROXINE; AMLODIPINE BESYLATE. Vaccination history included: Covid-19 vaccine (Primary immunization series completed unknown manufacturer), for COVID-19 immunization; Bnt162b2 (Dose Number: 3, Batch/Lot No: FJ4989, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: Jun2022, for COVID-19 immunization.  The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 16Nov2022, outcome "recovered" (18Nov2022), described as "4 inch round circle of inflammation around injection"; FATIGUE (non-serious), PAIN (non-serious) all with onset 16Nov2022, outcome "recovered" (18Nov2022) and all described as "greatly fatigued, sore entire leftside of body". Therapeutic measures were not taken as a result of fatigue, pain, vaccination site inflammation.  Additional information: It was reported, the patient took other medications in two weeks include Levothyroxine/Amlodipine Besylate/several supplmts. The patient did well on initial Covid shot and follow up booster. Did fine on 3rd booster in June of 2022. This last one in Nov of 2022 - greatly fatigued, sore entire left side of body - 4 inch round circle of inflammation around injection. Duration of "reaction" a full 48 hours on 16Nov2022 12:00 AM. The patient was recovered. No treatment was given. Covid was not tested prior to or post vaccination.
Patient experienced very high fever (104-105F) after Moderna booster dose. Kept fever down with Tylenol, fever broke after 24hrs
This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (Merck) (Lot# L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received on 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with the improperly stored doses of VARIVAX (Merck) (Lot# L008271) was 8, not 9 as previously reported. Follow-up information has been received on 27-OCT-2015 from the certified medical assistant. The reporter provided that the patient of unknown age and gender was vaccinated with the improperly stored dose of VARIVAX (Merck) on 28-SEP-2015. It was reported that the vaccine was 2304 hours out of range. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and event details and analysis were updated.
The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023; No Adverse Event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 18-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023).    Concomitant medication was not provided.  Reporter reported that the vial was one vial and size were 10 dose vial. The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023. The vial did not undergo any temperature excursion.  Treatment information was not provided.
Information has been received from a physician concerning a 6 month old male who on 28-JUN-2007 was vaccinated with Rotateq PO. The physician reported that on 28-JUN-2007 the patient received Rotateq PO and later that evening experienced a brief bout of severe vomiting, which was followed by bloody mucous diarrhea. The physician reported that the patient was brought to the emergency room and was given IV fluids. The patient was admitted to the hospital for evaluation. The patient was found to be clinically fine and was discharged from the hospital. After a few days of symptoms, on 02-JUL-2007 the patient had a repeat experience with the same symptoms. The physician reported that the patient was being evaluated for intussusception. The patient had a stool culture and barium enema on an unspecified date. The physician reported that the patient had not yet recovered. The lot number was not available because the reporting physician did not administer the vaccination. Additional information has been requested.   08/13/2007 MR requested for ER visit 6/29/2007 for c/o 15 episodes of vomiting over a 2 hour period 1 day s/p Rotavirus vax.    PE revealed listlessness, sunken eyes, otherwise WNL. No further vomiting after admission but did have 2 episodes of bloody, mucusy stool.  Final Dx:  Gastroenteritis.  Hematochezia.  Recent Rotavirus vaccine.  Probable Campylobacter.
Dose two of the Pfizer vaccine  lot: ELU140 administered to right arm at 0800 01/04/2021. Symptoms began at 2000 01/04/2021 which are; Fever 101.8, resting heart rate sustaining 140 bpm, right wrist pain and swelling to that joint, right supraclavicular node enlargement, tremors, burning sensation on skin to the entire body, severe headache, weakness, frequent urination, fatigue, eye pain, chills, sweating.
About 25 hours after  getting my shot I had a metallic taste lasting for 23 hours
1)Heart Palpitations-went to ER 3 times to check; had a ZIO patch test--waiting for results;   2)increased asthma--taking all 3 asthma medications that I have not taken in many years;   3)severe tension headaches that required an injection of Torodol;
rt arm red & swollen & tender from shoulder to elbow 2 days p/vax-afeb; tx Dicdoxacillin & warm packs p/5 days improved w/dec in swelling; no more tenderness;
Client received Flu vaccine at School flu clinic between 2 and 4 pm on 10/15/2019.  The flu clinic was operated by County Health Department registered nurses.  Clients mom came by the office on 10/21/2019 requesting a handout with the vaccine ingredients due to the fact that her son had a reaction to the vaccine and she was taking him to see his pediatrician on 10/21/2019.  Mom reported that hives at the injection site started within 24 hours of receiving vaccine.  She gave him Benadryl but the hives continued to spread.  On 10/20/2019 he started having swelling of the lips and she took him to urgent care.  He was prescribed Prednisone, Zantac and Zyrtec. Clients mom took him to his pediatricians office, on 10/21/2019 and was seen by FNP. Health Dept received information from Peds on 10/21/2019 that the client was seen; allergy testing was done, lungs were clear, cheeks were flushed, no rash on body or lips seen; stated client felt better.
Achy legs/Sore arm; Weak and very tired; Weak and very tired; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 14:45 at single dose for COVID-19 immunisation.  Medical history included multiple sclerosis and Raynaud's phenomenon. Concomitant medication included natalizumab (TYSABRI) from 30Dec2020. The patient previously took and experienced allergies with celecoxib (CELEXIA), amoxicillin, desipramine and pantoprazole. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 13:30 at single dose for COVID-19 immunisation. On 12Jan2021, the patient had achy legs. The patient was also weak and very tired that afternoon, with slight headache. She was much better on 13Jan2021. Her sore arm developed the day after vaccination after both injections lasted a day or two. No treatment was received for the adverse events. Clinical outcome of the events was recovered on Jan2021.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Significant Follow up received on 08-OCT-2021- ADR form received, batch number updated
Chills (5-6 hours) Fatigue (24 hours) sore arm (2 days)
Information has been received from a registered nurse concerning a female who on 19-DEC-2009 was vaccinated with "one dose" of ZOSTAVAX (Oka/Merck) (lot # not reported). It was reported that the patient visited the clinic yesterday, 22-DEC-2008, because her arm got swollen and she was experiencing pain and itching on her neck. The patient experienced upper arm swollen, pain in neck and itching in neck. Patient's outcome was unknown. Additional information has been requested.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of refrigeration was mentioned as 7-MAY-2021. No concomitant medications was reported. No treatment drug details was reported.
CLIENT STATES HAVING SEVERE FATIGUE ON DAY 3 FOLLOWING VACCINE ADMINISTRATION, WITH DIFFUSE RASH RADIATING FROM LEFT SIDE OF BACK TO FRONT SIDE OF LEFT ABDOMEN. SHE WAS SEEN LATER THAT WEEK AT URGENT CARE BY NP AND WAS TOLD THE VACCINES SHE RECEIVED OVERWHELMED HER IMMUNE SYSTEM CAUSING HER SHINGLES. SHE WAS TREATED WITH VALTREX 1GM 3XDAY FOR 1 WEEK. CLIENT CALLED HEALTH ON DAY 20 FOLLOWING VACCINE ADMINISTRATION TO REPORT SYMPTOMS OF ADVERSE REACTION AND STATES HER SYMPTOMS HAVE NOW RESOLVED.
She had a reaction to the first one.     She had her 2nd vaccine, had no reactions other than a sore arm.  After about 10 days she started having swelling inside of her lip on the inside, puffy where her mouth goes out.  In the middle of her top lip is a little redder, more irritated in the center of the lip.  The lips at times on the outside are so dry and for a while they all cracked.   She continues to have swelling of her lips inside today 4/28/21.  She has not taken anything for her reaction.  She called her doctor who said that he did not want to see her, and told her to see an ENT.
Eye itching, burning, swelling. Tight chest. Patient contacted medical advice and took diphenhydramine. Symptoms gradually subsided.
a 79 year old got rosacea after receiving moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ROSACEA (a 79 year old got rosacea after receiving moderna vaccine) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ROSACEA (a 79 year old got rosacea after receiving moderna vaccine). At the time of the report, ROSACEA (a 79 year old got rosacea after receiving moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
9-year-old patient came to vaccine center to receive her Pfizer pediatric (Orange cap, 5-11 years) booster dose. The nurse administered an adult Pfizer bivalent booster dose in error. Staff physician, Dr, was advised and Dr. did not believe there would be a problem. He advised the patient's family to consult with their primary provider. Patient and family were contacted via telephone message.
Wet cough, diarrhea, 88% on RA, encephalopathic, DNR patient- expired, etc.
Patient has pain, tenderness, and swelling around injection site since the day injection was administered for the past two months. Still hurts to lie on and has been massaging the area and taking ADVIL, TYLENOL but without relief.
This case was reported by a nurse via call center representative and described the occurrence of loss of consciousness in a 62-year-old male patient who received RABAVERT (batch number 643011E, expiry date unknown). This case was associated with a product complaint. On an unknown date, the patient received RABAVERT. On 17th May 2018, less than a year after receiving RABAVERT, the patient experienced loss of consciousness (serious criteria GSK medically significant) and memory loss. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the loss of consciousness, memory loss and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the loss of consciousness and memory loss to be related to RABAVERT. Additional details were provided as follows: The nurse reported that the patient presented to office on the reporting date with memory loss and losing consciousness that started a day before. The nurse reported the patient stated that someone from GlaxoSmithKline called him and stated lot number was defective. The nurse reported they would assess and treat as appropriate. This case was linked with US2017GSK149004 and US2018026733, cases reported for same patient with pre-exposure schedule and booster dose of RABAVERT respectively.
This spontaneous report was received from a registered nurse concerning an unknown number of patient of unknown age and gender that were vaccinated with dose of LIQUID PEDVAXHIB (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) eight (8) reports from the same reporter. Additional information has been requested.
No additional AE reported; potential temperautre excursion/but could not confirm if a temperautre excursion had occurred prior to the administration; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not provided.  The nurse reported that her data logger did not record temperatures for about a week. Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was "assumed to be in normal storage range", but could not confirm if a temperature excursion had occurred prior to the administration.   On 05-OCT-2022, the patient was vaccinated with a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5ml, lot #U029144, expiration date: 31-MAR-2024, (strength, site and route of vaccination were not provided) for prophylaxis. No additional adverse event (AE) was reported (no adverse event). The temperature excursion for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was unknown. It was unknown if the previous temperature excursion occurred.
Pt reported her age as 65 on her  Consent for Immunization.  As insurance was down, shot dose was provided to her based on her age.   Fluzone HD was given instead of Flublok