chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Only sore arm for a few days; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported in response to Non-HCP letter sent. A 49-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration, administered in arm left (Left shoulder) on 23Apr2021 10:30 (at the age of 49-year-old) at dose 2, single for covid-19 immunisation. Medical history included Knee surgery from 28Dec2018 to an unknown date (Knee Surgery Meniscus), anxiety from an unknown date and unknown if ongoing. Concomitant medication included buspirone hydrochloride (BUSPAR) taken for anxiety orally from 06Apr2021 to 12Apr2021. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in arm left (Left shoulder) on 25Mar2021 13:25 at dose 1, single for covid-19 immunisation and experience extremely rapid heart rate/heart rate of approx 200bpm/after 25 mins heart rate was still above 150 bpm, Elevated blood pressure/blood pressure was also high, Dry mouth, Lightheaded/dizziness, Shakes/ shaking uncontrollably, Extremely Lethargic, Significant fatigue/tired, Tachycardia. On an unspecified date in Apr2021 the patient experienced only sore arm for a few days. The patient underwent lab tests and procedures which included on an unspecified date EKG, several test were run over with normal result, on 25Mar2021 BPM was approx. 200 bpm, 150bpm. Comments/Narrative: Approx. 5 mins after first shot received, experienced dizziness, dry mouth and tachycardia with a heart rate of approx. 200 bpm. Was shaking uncontrollably. Blood pressure was also high. After 25 mins heart rate was still above 150 bpm, sent to ER for evaluation. Heart rate stabilized and was released from hospital. I was extremely tired/lethargic for 5+ days. Two evening later, woke up in the middle of the night with same symptoms as above. After heart rate didn't stabilize, went to ER for evaluation. EKG came back normal and was sent home. Was later evaluated by cardiologist (approx. two weeks later). Several test were run over the next few weeks and all appeared to be normal. No adverse effects from second vaccine shot. Only sore arm for a few days. Outcome of the event was resolved on an unspecified date in 2021.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Went to facility 1/14 was given NAPROSYN and hydrocodone. No fever. Arm is throbbing, fingers numb. A knot in back of arm. On 1/18 went to Dr urgent care. Got steroid for 5 days and is now on MOBIC.
This spontaneous report received from a registered nurse refers to multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB, dose, route and frequency: unknown) (Lot no: J010613; expiry date: 11-JUN-2016). No other concomitant therapy was reported. No adverse event was reported. The reporter also inquired about the stability of M-M-R II, VARIVAX, and PNEUMOVAX (Merck) single-dose vials, but none of these vaccines have been administered and are not included in this adverse events. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
head ache; chills; fatigue; weakness; I had no appetite but drank water; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201; expiration date: unknown), via an unspecified route of administration, administered in left arm on 01Mar2021 11:15 (at the age of 76-year-old) as a single dose for covid-19 immunisation. The vaccine was administered at Public Health facility. The patient had no known allergies. Medical history included controlled high blood pressure. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 08Feb2021 11:15 (at the age of 76-year-old) at a 1st dose, single dose for covid-19 immunisation. Concomitant medications included lisinopril (LISINOPRIL); naproxen sodium (SYNFLEX DS); ascorbic acid, betacarotene, biotin, boron, calcium carbonate, calcium pantothenate, calcium phosphate, chromium picolinate, cholecalciferol, copper sulfate, cyanocobalamin, folic acid, lycopene, magnesium oxide, manganese sulfate, nickel, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, sodium metavanadate, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (SENTRY SENIOR). On 01Mar2021 at 08:00 PM, the patient experienced headache, chills, fatigue and weakness. These symptoms lasted through the following day and the majority of the second day. The patient had no appetite but drank water. The morning of the third day the patient was back to normal, no more symptoms. No treatment received for adverse event. Patient did not had COVID prior vaccination and did not had COVID tested post vaccination. Patient did not had any other vaccine in four weeks. The outcome of the events were recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Normal C-section delivery on 10/31/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to a 4-years-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 Celsius degrees (°C) to -10°C for 3 hours and from -10°C to 8°C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  On 24-MAR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event). ; Sender's Comments:  US-009507513-2205USA008004: US-009507513- 2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852:
This spontaneous report was received from a medical assistant, and refers to a 5 month old female patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 02-MAR-2018, the patient was vaccinated with a dose of ROTATEQ 1 tube (DF), orally, (lot # N021094 with an expiration date in 12-MAR-2019), for prophylaxis. On 19-MAY-2018, the patient developed an allergic reaction to an unspecified baby formula (food allergy) and the patient broke out in hives after starting the formula (urticarial). As a result, the patient sought medical attention via an office visit, the formula was discontinued and an unspecified oral steroid was prescribed as treatment for the events (details were not provided). At the time of reporting, the outcome of food allergy and urticaria was reported as recovered on an unspecified date in 2018. The reporter considered urticaria and food allergy to be related to ROTATEQ.
pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No chronic or long-standing health conditions.  No known allergies.) and Live birth (full term) on 04-Jan-2000. Concurrent medical conditions included Breast feeding. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 07-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Dec-2020 and the estimated date of delivery was 25-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy) outcome was unknown.        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 treatment were provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
patient received expired vaccine in November and in December; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine in November and in December) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine in November and in December). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine in November and in December) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was reported.  The 9 patients received expired vaccine in November and in December.
No additional adverse events; patient was in office to receive 3rd dose of HPV series after received 2nd dose of GARDASIL 9 more than a year ago; This spontaneous report has been received from a pharmacist, concerning an adult patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date (reported as when the patient was 24-year-old), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, anatomical location, lot number and expiration date not reported) as prophylaxis.   On unknown date (reported as two month), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, anatomical location, lot number and expiration date not reported) as prophylaxis.   Then on 12-FEB-2020 (reported as "today"), more than a year ago after received 2nd dose of vaccine, the patient came to the office to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration).
Case number PHEH2014US026090, is an initial spontaneous report received from a pharmacist on 23 Dec 2014. This report refers to a 64 years old patient of unknown gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1414001) intramuscularly on 23 Dec 2014. It was reported that FLUVIRIN was exposed to temperature excursion at 65 degree F. No adverse events reported after the maladministration.
Pt. states that after receiving the 1st dose of Influenza Dose 10/05/2021, started experiencing symptoms 10/06/2021 of chills, lip swelling, fatigue, weakness, and mouth sores. No noted Primary visit.
Flu like symptoms, tired, malaise and Patient had redness on both arms however right arm was worse. Redness approx. 6-8 inches long and 3-4 inches wide. Slightly swollen and very painful. Started early am 5/11/18. Pt was using Ibuprofen and as of 5/14/18 was feeling better but still red.
5-23-13 Patient has red, itchy, welt size of 50 cents piece told to do BENADRYL, TYLENOL and ice to area. 5-24-13 Patient came into clinic 4.5 x 4 inch red area surrounding inj site c/o itching. Doxy called to pharmacy.
This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX lot# L016959 with expiration date: 12-MAR-2018, lot# L029631 with expiration date: 14-AUG-2017 (therapy type, dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly(lot# and expiration date not provided). The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009051: US-009507513-1707USA009052: US-009507513-1707USA009053: US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057.
Severe shaking chills, headache, fever, muscle aches that lasted several hours. Taking Advil helped reduce symptoms. These symptoms are typical of those who have taken the J&J vaccine and in fact, if you read the actual stories of the side effects of people who took this vaccine, shared on sites, these symptoms are closer to 100% present rather than the far lower and untrue percentage revealed by the CDC. These symptoms need to be better tracked and people should be forewarned how COMMON these side effects are; they are not rare!
fever of 104.0;measles like rash began 2FEB98 lasting 3 days; accompanied by vomiting & h/a;
pain in her right arm; there is pain in her right breast and under arm.; there is pain in her right breast breast and under arm; there is pain in her right breast breast and under arm; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for 60-year-old female patient (reporter wife) that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) On 07Apr2021 administered at right arm as a single dose for COVID-19 immunization. The past medical history and concomitant medication was not reported. On 07Apr2021, patient had experienced pain in her right arm where she received the vaccine. Patient  reported that she could hardly lift up the arm because of the pain, there is pain in her right breast breast and under arm. The patients second dose was due today 29Apr2021 but she did not want to get it because of the pain. Patient  is going to see an MD tomorrow for treatment. The clinical outcome for the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After receiving vaccination, the patient developed blisters on the chest area and bumps on abdomen the evening of the vaccination.  Around a week later, patient developed redness, swelling, and warmth around injection site.
States about 3 hours after receiving Moderna vaccine experienced headache, nausea, chills. The symptoms
Patient reports that starting around 12 days after his COVID-19 booster in April, he had progressive onset of pain in the left upper arm (deltoid) around where he received the vaccine. He noticed increasing pain with elevation of his left arm. Over the following 4 weeks his symptoms gradually improved, but were not completely resolved. Around 4 weeks after onset of his pain, he had a sudden increase in pain along with numbness in the 2nd and 3rd fingers on the left. At this time he was seen by his PCM and was prescribed a 1 week course of 80 mg followed by a 10 day taper. Following the first dose of prednisone, his sensory symptoms and pain were completely resolved. However, as he began the steroid taper, he had rebound of his numbness and pain. He states that over the past 6 months, his numbness and pain have gradually improved, although still present. He has pain with movement of his left arm but is without pain at rest.
shingles; Information has been received from an attorney regarding a case in litigation, concerning a female patient of unspecified age. Information about her past drug and medical history, concurrent medical conditions, illnesses at vaccination, and concomitant medications was not provided.  In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider in a hospital, for the long-term prevention of shingles and/or zoster-related conditions (concentration; administered dose, dose number, frequency in vaccination scheme; route and anatomical location of vaccination; lot number and expiration date were not reported).  On an unspecified subsequent date, the patient was treated by a physician for shingles. Her outcome from shingles was not reported; however, it was stated that as a direct and proximate result of her use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future; therefore, the reporter's causality assessment between shingles occurrence and zoster vaccine live (ZOSTAVAX) administration was considered related.
Suffered TIA at 6 am on 10/5/2023 at home, 18 hours after Covid vaccination. COVID VACCINATION TAKEN WITHIN ONE MINUTE OF HIGH-DOSE FLUI VACCINATIKON. BOTH TAKEN AT PHARMACY, INSIDE GROCERY STORE
Tachycardia, dizzy, increase in blood pressure. Started  day 2 Post vaccine and continues intermittently.
He and his wife both tested positive; He and his wife both tested positive; This is a spontaneous report from a Pfizer-sponsored program Support from a contactable consumer(patient himself). A 66-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on Feb2021 (at the age of 66 years old )as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization . Medical history included pulmonary embolism , chronic obstructive pulmonary disease, pneumonia, influenza. The patient's concomitant medications were not reported. Call transferred from (Name) with DSU NTID: (ID) REPORTUM: # who originally received the call as a transfer from (name) with Covax US support CEP 159558. She reports a consumer, 66 years of age, having had his 2nd dose of the Pfizer COVID 19 Vaccine in February, his wife received hers a few days after his. He and his wife both tested positive. He tested positive for COVID-19 on 23Aug2021. The caller states he did talk with his HCP and they advised him to wait until November to get the booster shot and scheduled him for his flu shot on 19Oct2021. The caller also notes having spoke with his pharmacist today that advised him to wait "3 months after the last COVID bout." He states he also asked the pharmacist has anyone had the vaccine, caught COVID and then caught COVID again, but she was unable to answer this question and he did not pursue answers from Pfizer MI regarding it either. The caller states he is "glad I got the vaccine because I would have been pushing up daisies." He states "August COVID was horrendous, the worst I've ever had. I've had pneumonia and the flu and that was really bad. I'm back to mask and hand sanitizer protocol, delivering my groceries. Back to all my safety measures before the vaccine, locked in my house. The patient underwent lab tests and procedures which included sars-cov-2 test on 23Aug2021 positive. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up .; Sender's Comments: Linked Report(s) : -PFIZER INC-202101333814 same reporter/drug/event, different patients
Chills, fever, fatigue, injection site pain, body aches, tiredness, nausea, feeling unwell.  Injection site pain started approximately 12 hours after shot and was significant through 36 hours, then slowly went away and was gone by 72 hours after shot. Nausea started approximately 12 hours after shot and was gone by 18 hours after shot.  Chills, fever and body aches started approximately 13 hours after shot. Body aches ended by 24 hours after shot. Chills and fever (102 degrees F) continued significantly for 36 hours post shot and then periodically at night until 60 hours. Significant fatigue and tiredness 12  hours post shot until 48 hours after shot.  Took Tylenol (2 pills) at 18 hours post shot, reduced fever for 1 hours. Alternated Advil and Tylenol starting 24 hours post shot for next 48 hours.