chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Lot number: 001A21A), in right arm, on 05Apr2021 as dose 2, single (Lot number: 026821A), in left leg and on 23Aug2021 as dose 3 (booster), single (Lot number: 026821a), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (24May2022) COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Pfizer Paxlovid. Conclusion of Previously Completed Investigation: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9893. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. A Regulatory Authority (site withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
11 y/o experienced a short, 5 second seizure like episode five minutes after receiving the following vaccines (Meningococcal (Menactra) lot#, and PPD(Tuberculin test. Pt complained of H/A dizziness and feeling shacky after the seizure no rashes, Dysphea or SOB
Hurt all over. Fever for 2 days, 100.2 degrees and 101.4 degrees F.
Started with a raised bump 8 days after injection. The following day my arm is red, very swollen, itchy, and warm.
Heartburn; Localised erythema; Body Ache; Generalized aching/pain all over; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), ERYTHEMA (Localised erythema), PAIN (Generalized aching/pain all over), PYREXIA (Fever) and MYALGIA (Body Ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Generalized aching/pain all over) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPEPSIA (Heartburn), ERYTHEMA (Localised erythema) and MYALGIA (Body Ache). At the time of the report, DYSPEPSIA (Heartburn) and ERYTHEMA (Localised erythema) had not resolved and PAIN (Generalized aching/pain all over), PYREXIA (Fever) and MYALGIA (Body Ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: Elevated..         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2021-624447 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Significant follow up information received on 22-OCT-2021. Moderna vaccine administration date was updated. On 28-Feb-2022: Significant follow up information received on 28-FEB-2021. Event details, suspect product information, reporter opinion of causality, and narrative description were updated.
The following events were only described to the author of this report 3 weeks after the events happened: A few minutes after the shot, the patient (pt) felt tightness in throat but still was able to breath. The pt then started feeling weird and a little dizzy in her head. This passed after about 15 minutes. The next day  the pt woke up with nerve pain and soreness in the upper, inner part of her arms just above the elbow. The pt also reported nerve pain  in the palm of hand below the thumb. The pt also reports having bad shin pain & muscle soreness. The shin pain lasted 4 days even after she took her regularly scheduled Celebrex along with Tylenol. Arm & hand pain only lasted a day.
Developed 1st time episode of shingles on April 21st, 2021.  Still experiencing very painful post herpetic neuralgia 6 weeks after onset of the shingles.  Was given the medication to stop the progression of the episode of shingles on April 25th 2021. Currently taking gabapentin, nortriptyline, percocet and applying prescription lidocaine.
Red spot at injection site; nodule under the skin at injection site; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021, (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disorder (COPD), diabetes and hepatitis C virus genotype 4 (HCV4a). Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) from an unspecified date for an unspecified indication. Prior to vaccination, the patient was diagnosed not with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 23Feb2021, at 16:00, (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 18Mar2021, at 16:00, the patient experienced red spot at injection site spread to 3 inches by 2 inches (vaccination site erythema) with a 1 inch by 3/4inch nodule under the skin (vaccination site nodule) which developed immediately. It was reported that, the patient still had events under the skin at the time of report (8 days from of event onset). The adverse events were resulted in doctor or other healthcare professional office. The treatment received included heat application to reduce the knot. The clinical outcome of events red spot at injection site and nodule under the skin at injection site not resolved at the time of this report. No follow-up are attempts are needed. No further information is expected.
I had sinus congestion and moved into my throat and lungs and had a lot of coughing and was very fatigued.
Injection site irritated day following injection. On exam (3/17/06). Erythema from elbow to mid-bicep. Treated with cephalexin 500 mg qid 7-10d.
this case was reported by a healthcare professional (nurse practitioner) and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown details). One week after vaccination with ENGERIX B, the subject experienced rash. The healthcare professional requested information on any subjects experiencing a rash a wee after vaccination with ENGERIX B. According to the healthcare professional, the physician had not yet determined whether the rash was related to the vaccine or something else. The healthcare professional was not willing to provide the patient specific information. At the time of reporting the outcome of the event was unspecified.
Type 1 Diabetes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 10:15 (Batch/Lot number: unknown) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. No covid prior vaccination. No covid tested post vaccination. Vaccination history included: Bnt162b2 (Prev dose administration time: 02:00 PM, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 22Nov2021, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: TYPE 1 DIABETES MELLITUS (hospitalization, disability, life threatening) with onset Dec2021, outcome "recovered with sequelae", described as "Type 1 Diabetes". The patient was hospitalized for type 1 diabetes mellitus (hospitalization duration: 3 day(s)). The event "type 1 diabetes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of type 1 diabetes mellitus including Insulin treatment. The lot number for bnt162b2 was not provided and will be requested during follow up.
Left gym felt ok. (worked for 20 mins). Picked up husband and started feeling sluggish with a small headache (around 4pm). Around 11, started feeling bad, went to use restroom, blacked out. Called husband to come help her in restroom. Started vomiting with diarrhea, urination on floor due to incapability to get up. Started feeling better around 6 am next morning. Tried to sleep but couldn't sleep. Still has sore arm and body sore from fall.
Shoulder hurt initially. About a day later couldn't lift shoulder or arm. Cannot sleep on left side. Still pain and stiffness in shoulder.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "factor V Leiden heterozygous" (unspecified if ongoing), notes: factor V Leiden heterozygous. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE(medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound of COVID symptoms with home antigen test becoming positive again; Negative, notes: after being negative; Positive, notes: rebound of COVID symptoms with home antigen test becoming positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid treatment started on 02May2022 and stopped on 06May2022, Lot number=FY8914. Adverse event: After completing course of Paxlovid, rebound of COVID symptoms with home antigen test becoming positive again after being negative two days in a row. Patient was recovering. No treatment for adverse event.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 7th grade).   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient reported that, he or she had shingles 7th grade and had received the shingles shot.  The patient still got the shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
PATIENT COMPLAINED OF RASH OVER HIS BODY. ALSO REPORTED AN EAR INFECTION  AND WAS NOT SURE IF RELATED TO VACCINE. PATIENT HAS HAD BODY RASH BEFORE. ADVISED PATIENT  TO SEE DOCTOR. PATIENT AAT PRESENT TREATING EAR  INFECTION WITH AMOXICILLIN. PATIENT STATES NO ALLERGIES
minutes in observation I asked if she was feeling okay. She explained she "felt a little dizzy and nauseous" .She was guided to a cot to lie down. Water, crackers and ice pack were provided. Vital signs were taken an were as follows: BP 122/80  T 97.2 F P 86 R 16 02 98-99% RA. 50 minutes have passed and is feeling better. Patient slowly sat at the edge of the cot, dangled feet and stood up and is ambulating well. Vitals were taken a 2nd time after ambulating to the restroom and were as follows: BP 130/90 T: 97.3F P.87 02: 99% RA. Symptoms have resolved. Leena reports that she will start her period tomorrow and does usually have cramping the day before onset. She explains a history of pain and a heavy flow etc with each menstural cycle. She does mention a concern of endometriosis and will follow up with a GYN. She mentioned concern about GI issues and does see a specialist. Denies possibility of pregnancy.
This spontaneous report as received from a pharmacist refers to a 60 year old patient. On 16-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M032141 for prophylaxis. Concomitant therapies included sterile diluent. On 16-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information is not expected. Sender's Comments: US-009507513-1708USA012397: US-009507513-1707USA007162: US-009507513-1708USA012396: US-009507513-1708USA012399: US-009507513-1708USA012394: US-009507513-1708USA012395.
she is unable to raise the right hand due to the pain; it is hard to get up due to the pain; she has been experiencing  pain in her back near kidneys and lungs, from shoulder all the way down her back; her right hand her was hot; pain from the injection site of the right arm; Initial information regarding this unsolicited valid non-serious case received from a consumer (patient) and transmitted to Sanofi on 11-Dec-2020.  This case involved a 67 year old female patient who was unable to raise the right hand due to the pain; it was hard to get up due to the pain (movement disorder), she had been experiencing pain in her back near kidneys and lungs, from shoulder all the way down her back and pain from the injection site of the right arm (back pain and vaccination site pain) and her right hand her was hot (skin warm), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Relevant medical history included cardiac failure congestive.  Past medical treatment, vaccination details, concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing diabetes, high Cholesterol, high blood pressure. It was reported that her blood pressure stayed high now. The patient was a pacemaker user.   On 02-Dec-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route in the right arm for prophylactic vaccination. No other vaccines were administered.  On 03-DEC-2020, the patient developed non-serious pain from the injection site (vaccination site pain) of the right arm, to the right shoulder, and to the lungs and kidneys (back pain). She was unable to raise the right hand due to the pain; she felt terrible due to the pain; that it was hard to get up due to the pain (movement disorder) her right hand her was hot (skin warm). The caller reported that the reactions begun 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. She did go to the emergency room; that in the emergency room they ran many tests described as having x-rays, being taken through a tunnel shaped machine, and having the blood drawn but none of the test showed anything.  It was also reported that the providers thought it might be an allergic reaction and she was given something for the pain that helped some but she still continued to have pain. The patient had gotten the flu vaccine for years and this had not happen. The pharmacy reported to her that she did not get the high dose. She was scared and upset with the pain and the only thing different this year is that she was on more medications.  Final diagnosis was vaccination site pain, back pain, movement disorder and skin warm.   An unknown corrective treatment was received.  At the time of reporting, the patient had not recovered from the reported events.  There would be no information available on batch number for this case.
Initial onset was an extremely sore throat, low grade fever, muscle/body aches. The next few days the sore throat was accompanied by a dry cough. Then chest congestion with inability to sleep due to excessive coughing. Dr prescribed increase fluids, Tylenol and benzonatate 200mg 3xday.
One week after the shot I  have a large red spot in the area about 3 inches long and 1 1/2 inches wide.   No soreness but maybe little itching
sinus congestion and stuff; sinus infection occurred 4 days ago from today; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 24-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Batch No. not available/lot Number: unknown, Expiration Date: unknown), via an unspecified route, administered in left arm on 25Feb2021 at 15:00 (at the age of 24 years old), as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior vaccinations within 4 weeks were none. Additional vaccines administered on same Date of the Pfizer suspect was none. The reporter stated that, he was calling about the Pfizer COVID Vaccine and had some general questions and stated that he had the 1st dose of the Pfizer COVID Vaccine and then as of 4 days ago he got a sinus infection and got a covid test to make sure he was not positive, and the test came back negative. Stated that he was now wondering if it was ok to get the 2nd dose of the vaccine as he was currently taking Azithromycin and has no fever or anything. The reporter stated that, he got the 1st dose of the Pfizer COVID Vaccine 3 weeks ago from today and it was administered on 25Feb2021, and the sinus infection occurred 4 days ago from today and began on 14Mar2021 and stated that the sinus infection was ongoing and was about the same as when it began. The reporter stated that for treatment he was taking Azithromycin 250mg one tablet per day by mouth and is taking Mucinex but does not know the dosage of the Mucinex and stated that he had no lot numbers, expiry dates or NDC numbers for the Azithromycin or the Mucinex with him at this time to provide. The reporter stated that, he had some sinus congestion and stuff, and it was not related to the vaccine itself but more related to his seasonal allergies that he always gets and always gets a sinus infection around this time of year. The reporter stated that, he did go to see a HCP virtually to get the medication for the sinus infection but did not go to a physical HCP office. He had a COVID test yesterday 17Mar2021 and stated that it was negative for COVID. Therapeutic measures were taken as a result of the event. The outcome of the event was not resolved at the time of this report. No follow up attempts are possible. Information about lot/batch number cannot been obtained.
This spontaneous report as received from a consumer's wife refers to a 57 year old male patient with medical history of high blood pressure, migraines and with none drug reactions or allergies. On 22-MAY-2014 the patient was vaccinated with ZOSTAVAX (in the right arm, dose, units, route of administration, lot number, expiration date were not reported). Concomitant therapies included dopamine hydrochloride, FLOMAX, aspirin and unspecified medication for blood pressure. On 01-JUN-2014 the patient subsequently developed a red, blotchy, itchy rash over the entire trunk of his body. The reporter stated that the rash disappeared sometime within that week and then reappeared again on 16-JUN-2014. None lab diagnostic studies were performed. The patient sought medical attention. The patient received treatment with prednisone (reported as presidone)and BENADYRL. The outcome of reported adverse effects was reported as recovered on an unspecified date in June 2014. The relatedness between reported events and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information has been requested.
shortness of breath. high pulse rate. (130-132) hives with itchiness. red spots in my neck and stomach and arms. red swollen arm 4 inches in diameter. dizziness. headache. nausea with vomiting. tightness in my chest.
arm soreness/ache after receiving the injection; arm soreness/ache after receiving the injection; arm soreness/ache after receiving the injection; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 04Mar2021 as a 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated she and her husband (77-years-old male). They both received the first dose of the Pfizer Covid vaccine on 04Mar2021. They both reported arm soreness/ache after receiving the injection. She was calling to find out whether it was ok for her husband to take his regular daily medications (lisinopril, flonase, pravastatin, and pepcid AC) around the time of receiving the vaccine or should he wait. She stated that, he took advil 4 hours after the vaccine for reported aches and also took Benadryl, she wanted to know whether that was ok or did that affect the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021261995 Same reporter/drug/AE, different patient