chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness; Nausea vomiting; Nausea vomiting; Chills; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), VOMITING (Nausea vomiting), NAUSEA (Nausea vomiting), CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in May 2020. Concurrent medical conditions included Hypertension. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), VOMITING (Nausea vomiting), NAUSEA (Nausea vomiting), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm soreness), VOMITING (Nausea vomiting), NAUSEA (Nausea vomiting), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010324: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA010327: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
2 days after the administration of vaccine you experienced sharp pain in the back of the head and neck and into the face and ear on the right side, comes and goes, pain lasts a few minutes. Back of head hurts, feels best sitting in the chair with a heating pad. Went to doctor on Monday who prescribed a muscle relaxer which did not help much.  The sharper bursts of pain have improved.
Extreme pain at injection site during and after Flu shot. 5 days later, the site was spasming, the pain was excruciating and I couldn't lift the arm. Went to the Emergency Room the following morning. Dr. ran Blood Tests, took X-rays and determined I had been mistakenly injected in the Radial nerve.
Fever to 101F-102F X 24 hours, fussy, decreased po intake and restless while nursing. Treatment: supportive with Tylenol.
invalid dose: pediatric use; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose: pediatric use) in a 16-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose: pediatric use). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose: pediatric use) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist called to ask if the patient should receive the second shot and if they can should it still be 0.5ml. No concomitant medications are provided. Treatment to the events not reported.
Strong chills about 14 hours after the shot, then a high fever a few hours after that. The symptoms were very noticeable at the onset, and around noon by the next day it was much more tolerable (though I had taken two ibupofen in the morning as I had a headache as well). The day after and two days after the shot, there was noticeable fatigue, though that could have been due to not getting much sleep the first night because of body temperature changes.
08aug90 pt vax hepta B.  4 dys later pt devel several attacks of upper rt quad abdo pain, w/ v/ and diarrhea. md suspected gallbladder attack.  lab work done.  md felt that gallstones were probably not related to pt sx.
A FEW EPISODES OF RACING HEART, AND OCCASIONAL SENSE OF TIGHTNESS IN CHEST.  CALLED DOCTOR (ON VACATION) AND HEALTH DEPT., THEY RECOMMENDED TYLENOL AND REST.  CONTINUED INTERMITTENTLY ~24 HOURS.
Strep pneumo bacteremia, later otitis media. Treatment 90 mg/Kg/D Amoxicillin for 10 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "AV Heart Block" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive; (Jun2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC)
her mom experiencing ear buzzing; This is a spontaneous report from contactable consumer was reported for the patient (mother) from a Regulatory Authority.  A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 03Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced ear buzzing and had been hearing some kind of noises. Reporter stated that on behalf of her mom to ask for assistance on rescheduling her mom's 2nd dose schedule. Her mom got the 1st shot on 03Mar2021 and her mom is scheduled to return on 21Mar2021 and wants to reschedule the vaccine shot on March 25, 2021 because this is also the day her mom will attend a Physician for general physical exam. The outcome of event was unknown.  Information about batch/lot number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Patient came after one month and told us that after getting  this vaccine he could not able to lift his arm  and after 1 month he is able to move his arm.. getting better
Pt recvd 1 dose of recombivax HB on 4NOV89, & 2 doses of Engerix-B on 7DEC89, & 4MAY90 & was found to be a non-responder;
Fever 106.5 began 4 hours after vaccine 12-11-06. Spoke with 24 hour RN if increased go to ER if not to continue Tylenol. 6am 102 deg resolved within 24 hours, no high pitched cry, no loss of color (white). Pt fussing, cried a little, cheeks red, played some.
Mild headache began after 9 hours. Moderate chills  for about an hour beginning 13 hours after with mildy elevated temp (99.2). Headache became moderate 18 hours after but controlled with tylenol. Moderate tiredness continued through the day until 27 hours after @ about 5 pm.
Mom called at 2:50 pm on 2-25-14 stating baby has been crying non stop. Unable to soothe him. Tried rocking, giving bottle, walking. Mom gave TYLENOL at 11:30 AM. Took to ER.
88-year-old male with lymphoma that received a transfusion of 2 units of packed red blood cells prior to admission.  The patient has a history of pleural effusions and he states after the blood transfusion, he became increasingly more short of breath and could not catch his air.  He was dyspneic at rest and exertion.  There is no cough.  No fevers.  He also has a history of cardiomyopathy and chest x-ray is suggestive of increasing sizes of his pleural effusions. Tested positive for COVID on 4/20/2021. Moved to hospice and expired on 4/22/2021.
Patient always said that was his first dose the that nurse administer the vaccine he gave her the Covid 19 Immunization card and his first dose was moderna.
Patient came in 2 days post injection. She had large red area at site of injection. She stated it was not painful but was itchy. Also felt hot to touch.
Case number PHEH2014US003957 is an initial spontaneous report received from a nurse on 24 FEB 2014. This report refers to an 8-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on 21 FEB 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult provide administered to child".
expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), 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 included: "Atrophy of 1 kidney" (unspecified if ongoing), notes: Slight atrophy of 1 kidney; "UTI" (unspecified if ongoing), notes: male UTI. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a male child who was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. It was reported that the pt developed breakthrough chickenpox and had less than 50 lesions. The child also had a mild fever. Subsequently the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Mother called office and reported pt received ROTATEQ in January, Feb 18 pt presented in ED for blood in stool, transferred to hospital and had surgery same day for intussusception. Mom is wanting VAERS info to report adverse event.
Case was hospitalized for Covid 8 months after completing primary Covid vaccine series.  * Acute hypoxemic respiratory failure due to COVID-19  Assessment & Plan Presented hypoxic to 81% 10/7 in the setting of recent COVID diagnosis 10/5 (found on routine testing at SNF). Background h/o of COPD. Initially requiring bipap but improved oxygenation with normal O2 saturation on room air to 1 to 2 L supplement, he was somnolent, lethargic and poorly engaged earlier in hospital course with gradual improvement to show good humor, smiling, and discussion regarding the care plan. He has been afebrile since October 22. He completed a 10-day course of dexamethasone and remdesivir. His hospital stay was prolonged due to poor oral intake, confusion.
no adverse effect reported; one dose of improperly stored VARIVAX was administered to one patient; Information has been received from a medical assistant referring to a patient with unknown age and gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 24-APR-2019, the patient received one dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number: R029518; expiration date: 14-OCT-2020; strength and dose were not reported), subcutaneously for prophylaxis. No adverse effect reported. The temperature of storage was -9 degrees centigrade to 8 degrees centigrade (2.5C), the time frame was 5 hours and 23 minutes. The previous temperature excursion was 9 degrees centigrade to 25 degrees centigrade (9C) for 17 hours. Data logger was involved.
COVD vaccine breakthrough case. Pfizer 5/1/21 EW0158, 6/4/21 EW0172 and boosted 3/12/22 FK9729
On 12/21/1999 the patient developed a multidermal herpes zoster on his thigh. The symptoms consisted of approximately 100 papulovesicular lesions and lasted for 4 weeks. The patient was treated with Acyclovir and recovered. Additional information has been requested.
pain in arm; Vaccine Administered at Inappropriate Site; Circumstance or information capable of leading to medication error; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, vaccine administered at inappropriate site and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the pain in arm, vaccine administered at inappropriate site and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix about 5 months ago, exact date unknown and experienced pain in her arm during injection. To lessen the pain she was considering having the 2nd dose injected into her hip or thigh, vaccine administered at inappropriate site and circumstance or information capable of leading to medication error.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-OCT-2014 the patient was vaccinated with GARDASIL INJ (route, dosage and dose number unknown; lot # J015378 EXP 09-APR-2016). The nurse reported that a patient was administered an improperly stored dose of GARDASIL. No adverse events were reported. Additional information has been requested.
Patient reported increased frequency in migraine headaches post vaccination. She normally has 2-4 migraines per week, but has noticed an increase in frequency post vaccination despite an increase in prophylactic migraine meds. Also, patient has asthma and noted increased shortness of breath upon exertion and reports having to use her rescue inhaler more often than normal (up from once a month to twice in 2 weeks).
Chest pains, sharp and random.  High resting heart rate.  Seeing OB today.
Fatigue; Weak; Achiness; First shot got caller down for a week.; Flu-like symptoms; This is a spontaneous report from a contactable consumer, the patient. This case is for first dose. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200, Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Feb2021 evening, the patient experienced flu-like symptoms. Stated reaction was three to four days. First shot got caller down for a week. Took her down for about a week. It was about five days. She had fatigue and was weak. She clarified as aching all over, joints and muscles too like the flu. Was not running a fever after first dose. On 20Mar2021, she had achiness. Outcome of the event depressed mood, flu-like symptoms was resolved on 03Mar2021; achiness was resolved on 22Mar2021; for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Low fever (<1 degree over normal), fatigue, joint aches, chills. Fever and sweating started 12 hours after dose. Alternating chills and hot spells throughout day. 2 Tylenol Arthritis capsules taken 8 hours after start of fever, giving minor relief to aches. Symptoms ended after 24 hours.
Initial unsolicited report received from a pharmacist  on 15 December 2016. This case involves a 74-year-old female patient who was vaccinated with a dose of FLUZONE HD (Batch number, expiration date, dose, dose in series and site of administration were not reported) via intramuscular route on 27 October 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as allergies were none unknown. Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 30 October 2016, three days following the vaccination, the patient had below the waist weakness, numbness and tingling. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
Vaccine Leak: I felt liquid run down my arm. I?m unsure how much leaked out because I wasn?t looking due to my fear of needles but I did feel the liquid run down my arm. I asked the pharmacist if it was blood she told me no that it was the vaccine liquid. I am worried because I do work with people although I?m not in healthcare and I?ve been waiting for the 3rd shot vigilantly. But now I don?t feel as safe and would like to ask for an extra booster or even 1/2 the dose if possible?
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. 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) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reportedly the patient did not had any known allergies. No Other medication in 2weeks. On 17Jul2022 the patient started receiving Paxlovid for the treatment for COVID-19 (therapy stop date 21Jul2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I got the second vaccination on 06/09/21 at 9:30 AM nothing wrong, the day after arm moderate pain. Then on 6/14/21, I went to PCP for a year's check-up, during  the Vital chek up my pulse went up over 150, but my Blood Pressure not too bad. The Dr took EKG show arritmia. He did't prescribe medication. I came home and call my Cardiologist, went the day after, and new medication was prescribed Metoprolol er succinate 100MG and Lisinopril -HCTZ 20/25 mG taking and Lisinopirl 20 mg at night
Facial flushing followed by rash with oozing sore on forehead.  Over time rash has abated and then returned and now has spread to extremities with papillar eruptions, including oozing sore on hand which developed staph infection.  Rash continues to this date.
From ED MD notes:  Chest pain x 2 days; substernal; hurts worse with mvmts and cough; pt covid + 4 days ago; +HA/ST/NP COUGH; negative fevers/n/v/d; fully vaccinated  From ED DC summary: You were seen in the emergency department for evaluation of chest pain. While you were here we did a physical exam, bloodwork, chest xray. All of your tests were normal and did not show a cause of your symptoms. We do not think you are having a heart attack or a pneumonia. However, there is still a risk that you may have a blood clot in your lungs. If your symptoms are not improving, you should come back to the emergency department for further evaluation.
Low grade fever, nausea, felt short of breath, area very swollen, warm, red. All started 12-24 hrs after imm.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 27-JUL-2011, the patient was administered with a dose of VARIVAX (Lot # 0750Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.