chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Batch/Lot number: unknown), on 05May2021 as dose 2, single (Batch/Lot number: unknown) and on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 21 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset Feb2022, outcome "unknown" and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trail.  Causality for BNT162b2: The reporter's assessment of the causal relationship of "covid-19 virus test positive" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for adalimumab (HUMIRA): The reporter(s) causality for the event(s)of covid positive was not provided with adalimumab (HUMIRA) was a reasonable possibility.  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 information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
had vaccine but still got shingles/suspected vaccination failure; shingles; pain horrible for weeks; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. The patient did not have rash, but pain was horrible for weeks. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization, time to onset for event and laboratory test confirming shingles was unknown at the time of reporting. Follow up would not be possible as contact details were not available.
contracted Covid-19; contracted Covid-19; Mild cold- like symptoms; fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 12-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "mild (controlled) asthma." (unspecified if ongoing), notes: Patient has a history of mild (controlled) asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted Covid-19"; NASOPHARYNGITIS (non-serious), outcome "recovered", described as "Mild cold- like symptoms"; FATIGUE (non-serious), outcome "recovered", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: the patient contracted Covid-19 approximately 7 months after second dose of bnt162b2. Mild cold- like symptoms noted along with fatigue. Symptoms lasted approximately 7 days.  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 consumer concerning his 17 yr old son with no known allergies who on 20-MAR-2000 was vaccinated with one dose of measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation). It was reported that since the time of vaccination, the pt was sick with a sore throat and fever. Unspecified medical attention was sought. Additionally, it was noted that on 15-APR-2000 the pt broke out what a Dr termed a viral rash. The pt was on antibiotic and antihistamine therapy; however, it was not clarified if they were concomitant therapies or treatment medications. Additional info has been requested.
One hour, post vax, developed allergic reaction with right arm swollen, red, hot (size of a hand), rash/hives over neck, face, trunk, arms, hands and swelling of lips, scratchy throat, swelling of hands. No SOB or chest tightness. Rash disappeared and swelling gone. No problems, thereafter.
5day p/vax pt devel inconsolable crying, difficulty feeding. md office abd distension & low bowel sounds, tenderness to palpation & blood noted in stool. rt colon seen to be tortuous & redundant.sx resolved by 7/3
Approx 7 days after vaccine given, developed angioedema, deep itching and burning in hands and feet, reddening behind ears and other areas with intense itching. Has been on Zantec and Benadryl for 6 weeks. When stops Rx, symptoms return. Less severe now.
Night of shot- extreme arm pain for 3 nights couldn't raise arm above shoulder. Starting Wed. August 18th, 2021 rash on left forearm and left side rib cage rash began to develop. Thurs. August 19, 2021 right should injection site became irritated and sore again. The rashes and irritation progressed and peaked Sunday August 22, 2021 with blistering painful rashes at sites mentioned. Injection site red and swollen several inches around the injection.
"covid arm" huge red itchy at injection site; "covid arm" huge red itchy at injection site; This is a spontaneous report from a non-contactable consumer. This consumer reported two reports for herself. This is the first of two reports. An adult female patient received the first dose bnt162b2 (Pfizer, Batch/Lot number was unknown) administered in arm on 11Mar2021 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any other medications; and unknown if was diagnosed with COVID-19 prior to vaccination or has been tested for COVID-19 since the vaccination. The patient experienced "covid arm" huge red itchy at injection site in 2021 with outcome of recovered in 2021. The treatment was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Itchy/Scratchy throat at 28-30 minutes after vaccine injection (5:28-5:30 pm). Kept drinking water, throat continued. Itchy tongue. Itchy behind ears and between shoulder blades began at home (5:45-6:00 pm). Roof of mouth itchy and tongue swelling began 1 hour and 15 minutes after injection (6:15 p.m.). Called Primary Care Doctor and they advised to take Benadryl and go to Emergency Room. Took oral Benadryl and called 911 for ambulance assistance. Blood pressure was over 190/110 and itchy/swelling symptoms continued. EMTs administered additional Benadryl by injection into right upper arm and drove me to  Emergency Department. Observed for 4+ hours, symptoms subsided with Benadryl and rest. Discharged home. Recommended Benadryl every 6 hours as needed.  **Symptoms returned 6/1/2021 at 10 pm home (no foods eaten prior, no Benadryl for one day) - swelling lips, itchy inside ears and back of tongue, scratchy throat. Took Benadryl and rested. Woke 6/2/2021, tongue still a bit swollen.
-Pt started noticing a reaction about a week after, started with a rash, went up to your hair that lead to hair loss, got into both feet (now it  is drying up now), also had red marks around the stomach, under the arms (scaly marks), elbows.. -Pt went to the doctor appt 11/03/2020 -Pt has been telling the nurse about the situation , but the nurse said to give it time to go away (pt stated she contacted nurse 1 month ago) - Md consulted to take bendaryl OTC
pain running down her legs and sometimes her foot is involved; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 04Apr2021 (Lot number: ER8737) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Spinal stenosis" (unspecified if ongoing); "Pain in foot" (unspecified if ongoing), notes: She clarifies she has this issue sometimes. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain running down her legs and sometimes her foot is involved".  No follow-up attempts are possible. No further information is expected.
Information has been received from a 28 year old female with seasonal allergies and no pair  and no past medical history who in November 2001, was vaccinated with the first dose of the Varivax and on 01/16/02  was vaccinated with the second dose of the Varivax. The patient reported that she had her last menstrual cycle. The patient sought unspecified medical attention. Additional information has been requested.
Fatigue; Pain at the left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the left arm injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (No hospitalization due to COVID-19. No treatment received.) in December 2020, Anxiety and Irregular periods. Concomitant products included FLUOXETINE for Anxiety.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the left arm injection site). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the left arm injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-311611 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up received contains no new information. On 13-Sep-2021: Follow-up received contains no new information.
kind of quiet; Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (kind of quiet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION COMPLICATION (kind of quiet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021). On 05-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Her 16 year old son has received 2 doses of the Moderna Covid-19 vaccine by IM injection to the leg on 5MAY2021) had resolved. On 07-May-2021, VACCINATION COMPLICATION (kind of quiet) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  Patient did not take any medications or treatments for his symptoms.  Patient got kind of quiet following the first dose which lasted a couple of days before resolving. Patient has a history of immunocompromise, was non-verbal and has a history of clotting factor disorder.  Patient received second dose on 02 Jun 2021 (lot number 026C21A).   This case was linked to MOD-2022-458050 (Patient Link).
pt exp h/a, nausea, bodyaches & fever to 101.6 day p/vax;
Swelling and erythema for 3 days at site of injection on left upper arm.
This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M012990, expiration date 14-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 0 degrees Celsius to -15 degrees Celsius for an unknown time frame. Data logger was not involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 27-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
She had fever on December 13 along with 2 of her friends who tested positive for influenza.  Patient was not checked for influenza but her friends were positive for influenza A.  Patient was negative for COVID when she had the fever.  Fever lasted for 2 days and she had no associated chest pain or palpitation.  She had no rash on the body. Came to the ER on 12/24 with intermittent chest pain that started 12/23 after she played soccer.  She had no chest pain during soccer.  Her pain was retrosternal without any radiation and she had no palpitation and no sweating.  Because the pain was persistent she was brought to the emergency room.  She had no associated shortness of breath..  Had no cough or wheezing.  She thought sometimes the pain was more when she was breathing in.  She had no lightheadedness dizziness or syncope. Hospitalized for potential myocarditis in the pediatric intensive care unit on December 24th
PT CALLED TODAY, 9/16, REPORTING THAT SHE WOKE UP WITH A SWOLLEN FACE YESTERDAY.  SINCE SHE RECEIVED THE VACCINE ON 9/12, I TOLD HER THAT IT COULD BE A SIDE EFFECT OF THE VACCINE, BUT THAT IT WOULD USUALLY MANIFEST ITSELF SOONER THAN 3 DAYS LATER.  SHE TOLD ME THAT IT WAS GETTING BETTER TODAY. I ASKED ABOUT TROUBLE BREATHING, OR SWOLLEN TONGUE. SHE SAID SHE WASN'T EXPERIENCING ANYTHING BUT SWOLLEN FACE. I TOLD HER IF SHE DID NOT CONTINUE TO SEE IMPROVEMENT OR IF IT GETS WORSE, TO GO INTO THE ED.
C/O chest pressure, throat irritation, feeling like she "couldn't breathe". Pt expressed no difficulty speaking. No flushed skin, no perspiration, no swelling of lips or tongue.  Vital Signs:  1045: 100% RA, PR 138 1052: 99% RA, PR 101 1057: 100% RA, PR 99 1131: 98% RA, PR 87, BP 135/64  Client stated she was feeling better and remained in observation area. Client was advised to have friend or family pick her up, but declined, and exited the facility to her own vehicle.
I also  have a dull headache on and off during the day; wake  dizzy in the morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 23Apr2021, outcome "unknown", described as "wake  dizzy in the morning"; HEADACHE (non-serious), outcome "unknown", described as "I also  have a dull headache on and off during the day".  Additional Information: The patient stated that she wake  dizzy in the morning when she first get up and get out of bed. She have had to sit or hold onto something for a bit and it goes away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
THIS FORM IS SUBMITTED AS PER FAMILY REQUEST: DO not have the details of the vaccine Patient presented with abdominal pain 1 day after receiving her 2nd booster dose admitted for acute pancreatitis with necrosis with respiratory failure and renal failure
1 week after receiving the vaccine I developed a lesion on my lower lip that resembled a fever blister. I have been treating it with ABREVA for a week with no improvement.
Havrix administered to an 11 months old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   On 23rd August 2022, the patient received Havrix. On 23rd August 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comment: The reporter reported that, Havrix was administered to an 11 month old patient, he would turned one on 9th September 2022. Did not ask about follow-up. Additional Supportive Information: The reporter reported that, Havrix was administered to an 11 month old patient, which led to inappropriate age at vaccine administration.
weakness; sore arm; This is a spontaneous report received from Pfizer-sponsored program. A contactable consumer (patient) reported that: a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, after first dose the patient experienced weakness, and sore arm. The outcome of the events asthenia, pain in extremity was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Wrong dose given, 0.25 ml was administered instead of recommended dose of 0.5ml.
Fever, chills, fatigue, muscle cramps, joint pain, headache, metal taste. Condition continues after 9 days.
Abdominal pain that began at center of abdomen upon waking up at 8 am on 2/7/2021 and progressively got worse throughout the day . Developed nausea and multiple episodes of vomiting around 3 pm. Abdominal pain then moved to RLQ, was persistent, dull and achy, worsened with movement. Pain was still present throughout the night and the next day, went to the ER for evaluation. There was concern for appendicitis. Imaging and labs could not confirm diagnosis but examination was concerning. Laparoscopic surgery was performed and confirmed appendicitis.
Right thigh with 10 cm erythematous swollen skin, subcutaneously 2 nodules about 2.5 cm each, palpable at injection site and adjacent to it.
Patient had 4 inch round area on L thigh that was very red, hard, swollen & hot to the touch.  Prescribed BENADRYL prn & KEFLEX 250/5ml.
Patient loss consciousness and fell onto floor. During fall, patient hit his head on the ground and had a seizure. EMS was called and patient received medical attention.
12JUN96 pt exp dizziness, weakness, numbness in lips, fever & chills;pt was better following a nap & tx w/APAP;13JUN96 pt devel a warm, red, swollen, tender area 3inches by 2 1/2 inches in diameter @ inj site;arm felt tingly;
Diarrhea about 20 minutes after injection- has not stopped since today is Monday 8:15 pm.