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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 2 (booster), single (Lot number: FF2590) at the age of 43 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (non-serious), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) positive, notes: on day 1 of symptoms/positive test; (Jul2022) Negative, notes: Tested negative on day 4, 6 and 8; (Jul2022) Positive, notes: Light positive test on day 9; (Jul2022) Positive, notes: Started experiencing symptoms again on day 11 immediate dark positive test result on home rapid test on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information:Covid Rebound. Started Paxlovid treatment on day 1 of symptomspositive test. Symptomatic for 2 days (fever, aches, nausea, swollen lymph nodes) then symptom free by day 3. Completed the treatment. Tested negative on day 4, 6 and 8. Light positive test on day 9. Started experiencing symptoms again on day 11 immediate dark positive test result on home rapid test on day 11. New symptoms include swollen lymph nodes, fatigue, head congestion, headache. Anti viral details:product=COVID 19 Treatment,Treatment start date=28Jun2022,Treatment stop date=01Jul2022,Indication=Treatment of COVID-19. Other medication details:other medication in 2weeks product= Iron supplement,Other medication in 2weeks brand=Mini blood builder,Other medication in 2weeks start date=20Jun2022,Other medication in 2weeks stop date=27Jun2022
nasal drainage, dizziness, cough, beginning week after immunization,  rash started 12 days after immunization
Initial report was received from a health care professional on 31 January 2012. A 12-year-old male patient had received an intramuscular injection of MENACTRA, sanofi pasteur Inc., lot number U4271AA (site not reported) on 30 January 2012 and within minutes the patient fainted and loss consciousness for approximately two seconds. The patient's blood pressure and pulse dropped but then recovered. The patient fainted in the shower and hit his face. The patient was going to the office for evaluation. The reporter denied the patient had any illness at the time of vaccination, any pre-existing medical conditions, took any concomitant medications, had any other vaccinations within four weeks of MENACTRA and had any adverse events following prior vaccinations. The patient had no known allergies (NKA). No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
PATIENT DEVELOPED A SORE LEFT ARM IN THE EVENING ON 9/2/20. LATER THAT NIGHT HE STARTED WITH A FEVER, BODY ACHES, CRAMPING AND OVERALL FEELING OF TIREDNESS. ON 9/3/20, FEVER SPIKED TO 102F. ON 9/4 HIS SYMPTOMS STARTED TO SUBSIDE AND FEVER CAME DOWN. ON 9/5 PATIENT FELT COMPLETELY BETTER AND REPORTED NO FEVER OR SYMPTOMS.
This case was reported by a healthcare professional that described the occurrence of injection site burning in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site burning and neck rash. At the time of reporting, the outcome of the events was unspecified. No other information was known by the reporter, and no patient specific identifiers were provided.
[Pfizer COVID vaccine] use for COVID-19 under Emergency Use Authorization (EUA): booster given 5 months after primary series completed instead of intended 6 months.
Information has been received from a physician concerning a 15 year old female patient who on 23-MAR-2009 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot # 661841/0653X). On 05-JUN-2009 the patient was vaccinated intramuscularly the second dose of GARDASIL (lot # 662229/1497X). Concomitant vaccination on the same day included ADACEL and a dose of MENACTRA. Subsequently, after the second dose of GARDASIL, the patient experienced rash and her skin started peeling. It was unknown if the patient experienced any adverse event after the first dose. The patient sought unspecified medical attention. It was unspecified if lab studies were performed. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Nonstop menstrual Bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Sep2021 (Lot number: FC3180) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 02Sep2021, outcome "not recovered", described as "Nonstop menstrual Bleeding". The event "nonstop menstrual bleeding" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient did not receive any other vaccine in four weeks and no other medications in two weeks. Patient did not had covid prior and post vaccination. Patient did not have any known allergies. Patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Pt was given 4th dose of a vaccine and it is only recommended to receive up to 3.  No additional treatments completed  and patient is asymptomatic at this time.
pt experienced whole body aches/muscle aches/ bone pain a few hours after receiving vaccines.  she self treated with around the clock ibuprofen and tylenol and the adverse reaction was resolved in 24 hours.
The patient complained of dizziness, itching, immense sweating within one hour of the vaccine administration. Over the next 12-24 hrs the patient had bloody emesis, diarrhea and noticeable swelling of tongue/lips.
ON 06/04/04 CLIENT STARTED WITH HEADACHE, MALISE, HEART RACING, DIZZINESS AND BLOOD PRESSURE DROPPED. ON 06/06/04 CLIENT WAS HOSPITALIZED. HE STAYED FIVE DAYS HOSPITALIZED. CLIENT HAD MANY PROCEDURES: BLOOD WORK, EKG, CARDIAC CATHETERISM, CLIENT IS UNDER TREATMENT, TAKING BETA BASE
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 17-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received the 2nd dose of the shingrix vaccine on Saturday 6/15/19 mid-day. By Sunday 6/16/19, he developed a fever of over 100 degrees. He took some acetaminophen and went to see his doctor Monday morning who instructed him to continuing taking acetaminophen as necessary. His fever persisted and by Wednesday evening, his temperature had gone over 102 degrees. On Thursday morning, he went to see the doctor and was asked to go to the Emergency department next door at hospital. He was given many tests and was immediately admitted due to suspicious images in upper lung. He was put in isolation since they did not know the cause of the problem. By Friday, he was admitted to the ICU and by Friday afternoon, he was not able to breathe on his own and a respirator was put in. He was given different antibiotics and various anesthesia and was in an unconscious state for the next 8 plus days. By the time the respirator was removed, he was told he had "acute respiratory distress syndrome". His lungs were not functioning and had dark images throughout. He was discharged on 7/16/19 and has been regaining breathing and physical strength. Pulmonologist says it will probably take 1 year to recover completely.
received his first shot/dose of Pfizer Covid 19 vaccine and had numbness in his left foot (outer side); This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was healthy. No other concomitant issues and known allergies reported. The patient received his first shot/dose of Pfizer Covid 19 vaccine and had numbness in his left foot (outer side). He stated that 24 hours later, the numbness was not as substantial, but the numbness was still present. Event took place after use of product. Outcome of the event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Pale, lethargic, vomited, weakness, not responding well verbally when spoken to.
Patient reported headache, feeling feverish, and chills for 3 days following the vaccine. She also reported that her upper arm swelled and became very painful and that also lasted for 3 days.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored VAQTA lot# L043209; expiration date 17-SEP-2017, dose and route of administration were unspecified. The vaccines had been exposed to 32 degrees Fahrenheit for 11 hours. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chills and fever around 8 hours after vaccine  Throwing up and nauseous shortly after (still currently dealing with this on 2/11) Pain between shoulder blades Heart pounding and shortness of breath
Patient had swelling over the next few days from injection that progressed to swelling 3 inches in all directions around injection site. There was also obvious streaking and warmth at the site. Patient visited physician and was diagnosed with cellulitis and given medications.
trouble walking.; arm at the injection site was sore and swollen; arm at the injection site was sore and swollen; fever of 100.0; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (trouble walking.), VACCINATION SITE SWELLING (arm at the injection site was sore and swollen), VACCINATION SITE PAIN (arm at the injection site was sore and swollen) and PYREXIA (fever of 100.0) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced GAIT DISTURBANCE (trouble walking.), VACCINATION SITE SWELLING (arm at the injection site was sore and swollen), VACCINATION SITE PAIN (arm at the injection site was sore and swollen) and PYREXIA (fever of 100.0). At the time of the report, GAIT DISTURBANCE (trouble walking.), VACCINATION SITE SWELLING (arm at the injection site was sore and swollen), VACCINATION SITE PAIN (arm at the injection site was sore and swollen) and PYREXIA (fever of 100.0) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: high (High) 100.         No concomitant medication details was reported. No treatment medication details was reported.
doses given after temperature excursion; Product storage error; This spontaneous case was reported by a respiratory therapist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The facility had a 20 minute excursion in the freezer that their Moderna  COVID-19 vials were stored in  No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Within 1-2 hours after injection, noted scratchy throat and respiratory difficulty.  Saw MD on 11/17/2009 who felt it was a reaction to the vaccine.  Saw another MD on 11/23/09 due to ongoing burning sensation in stomach.  This MD also prescribed a generic version of Prilosec.
Monday 4pm was vaccinated. Left arm. Tuesday morning felt ?icky? but went to work. My left arm was sore at the injection site but no rash.  Wednesday morning I woke up with slight shortness of breathe, and felt some wheezing, horrible headache right behind my eyes, hot flashes, I felt like the inside of my body was on fire. No temperature. My body all around ached. My stomach was extremely upset. I had loose stools multiple times through out the day. When I tried to drink anything my stomach felt like it was also ?on fire? it was just not happy with anything being in there. Thursday same way. Headache, muscle aches, I am so tired. I feel drained of energy. My stomach is extremely upset. I have not ate anything since Tuesday afternoon. I have drank a lot of water. My body still ?aches? I have had loose stools.
First one kicked my rear end; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and it had kicked his/her rear end. For 2nd dose tolerance refer case US2021AMR197871.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197871:same reporter, same patient, different dose, 2nd dose
expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications were reported.  The vial was punctured on 28-Dec-2021, and used for up to 17 hours post puncture. No patients have reported any side effects from this dose.
Severe headaches; Fevers; Chills; Loss of appetite; Diarrhea; Left arm pains and swelling; Left arm pains and swelling; Pounding heart beats; Chest discomforts; Left neck and shoulder stiffness; Joint pains; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male 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 15Apr2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously 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 22Mar2021 at 14:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 20:00, the patient experienced severe headaches, fevers, chills, loss of appetite, diarrhea, left arm pains and swelling, pounding heart beats, chest discomforts, left neck and shoulder stiffness and joint pains. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with OTC ibuprofen (MORTIN), paracetamol (TYLENOL) and unspecified flu/cold medicines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headaches, fevers, chills, loss of appetite, diarrhea, left arm pains and swelling, pounding heart beats, chest discomforts, left neck and shoulder stiffness and joint pains were recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.  No Medical History information was reported.  On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Ever since receiving the vaccine, two months ago now, my left arm has had chronic pain usually radiating out from the injection site but sometimes spreading across my entire shoulder and down to my elbow. I also have quite a bit of pain depending on the motion I try to take and a fairly regular (and worsening) throbbing sensation around where the injection was. - I also regularly feel like I have no strength in my left arm/grip and it?s gotten to the point where it?s now affecting daily life.  Some days, the area around the site swells up and I feel a burning sensation instead of a painful pulsing or throbbing  Painkillers (ibuprofen) don?t seem to help very much though and sometimes I?ll wake up in the middle of the night from rolling onto my left arm and causing the pain to intensify.  I?m not sure if the pain is truly a side effect of the vaccine or if the volunteer performing the vaccine did something wrong when administering it.
arthralgias; Sore arm at injection site; This is a spontaneous report from a contactable other hcp (patient). A 70-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 17Feb2021 10:30 (Batch/Lot Number: EN6201) at the age of 70 years old as dose 2, single for COVID-19 immunisation. Medical history included chronic hypertension (CHTN), hyperlipidemia, bicuspid aortic valve, and known allergies to sulfa (sulfonamide allergy). Other medications in two weeks included atorvastatin calcium (ATORVASTIN); lisinopril; asa; mirtazapine; and amlodipine, all taken for an unspecified indication, start and stop date were not reported. The patient previously took ciprofloxacin and clindamycin and on both, the patient experienced allergies. Historical vaccination included BNT162b2 (Pfizer Biontech COVID-19 vaccine) received by the patient on 27Jan2021 10:30 (lot number=EN9581) administered in right arm, at the age of 70 years old as dose 1, single for COVID-19 immunisation. There are no other vaccines in four weeks. The patient experienced sore arm at injection site and arthralgias on 18Feb2021. No treatment was given for the adverse events. The patient recovered from both events on unspecified date. The patient has no history of COVID-19 and has not been tested for COVID-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Around the holidays, my migraines started coming back. By the end of February early March, the medication I was given to stop them is no longer working. I am also having a hard time with my memory and finding the appropriate words. I go back to my doctors next week to get the results of my test.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The patient's medical history included chickenpox in childhood. On 16-JUN-2013 and on 15-JUL-2013 the daughter of a friend of the patient was vaccinated with first and second doses of VARIVAX (merck) respectively (dose, route and lot number not provided). This weekend, in approximately August 2013 the patient developed bumps. The outcome of the event was unknown. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.