chrisvoncsefalvay/vaers-outcomes huggingface dataset:
testing positive for COVID-19; testing positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "testing positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negetive; (26May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid .  Additional information: The patient was diagnosed, tested positive for Covid-19 on 26May. He was prescribed Paxlovid for the emergency use authorization. He was 73, his symptoms he was having chills and was having uncomfortable time of it with COVID. He was fully vaccinated and fully boosted but he was immunocompromised. So he has taken the fully course of the Paxlovid and his symptoms began to improve, every day he got better for 5 days that he was taking it. He tested negative yesterday for COVID. He took both vaccines and also both boosters. Most severe side effect that he had from Paxlovid was really very, lot of diarrhea.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Full dose  vaccine was given instead of a booster dose was also given past expiration date / time. No known adverse effects.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient did not receive any other medication in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Negative, notes: after testing negative antigen on the 15th; (17Jun2022) Positive, notes: rebound Covid Stuffy nose, lethargy, brain fog, slight cough returned on 17Jun along with positive tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid for the treatment of covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a 62 year old female patient regarding herself. The patient's current conditions included high blood pressure, cholesterol abnormal, asthma, drug allergies to penicillin, sulfa and codeine or codeine derivatives, and also sensitive to medications in general. On an unknown date in 2006, the patient was vaccinated with ZOSTAVAX. Concomitant medications included unspecified medications for high blood pressure, cholesterol and asthma. On an unknown date in 2006, the patient developed shingles. The shingles lasted 90 days. The patient although  had mostly recovered, she still had symptoms such as seeing bumps under the  skin and her back feeling very hot, especially when the weather gets warm. The patient sought medical attention and spike with doctor. The patient was given treatment for the event with LYRICA and with other unspecified treatment. Product quality complaint (PQC) was not involved. The event was resolving. The reporter did not provide causal relationship between the event and suspect therapy. Additional information has been requested.
Red raised rash around injection sites of right thigh. Advised Benadryl and hydrocortisone cream, cool compresses.
Broke out with shingles; This is a Spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A Contactable Nurse reported for a 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 62 year), as a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR, prolonged-release tablet), via Oral, from 19Mar2021 (Batch/Lot number was not reported; Expiration Date: 28Feb2023) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. It was unknown if the patient was pregnant at the time of vaccination. The patient's medical history included allergies: codeine. Concomitant medications included urea, methotrexate, valaciclovir hydrochloride, hydroxychloroquine sulfate, duloxetine HCL, pregabalin, and methylprednisolone. The patient held her doses of xeljanz prior to receiving her second COVID-19 vaccinations. It was reported that on 29May2021, the patient was broke out with shingles. Outcome of the event was not resolved.  Please provide the Information of lot/batch number of suspect product.
1730 30 year old male patient arrived ambulatory, alert, complaint of itching, pt appears flushed, rash all over arms,back,and stomach.  1733 Pt reports he was vaccinated approx 1345 with Janssen vaccine, while at home at 1650 approx  reported new onset of rash, itchy bumps, generalized body while eating "pozole". Pt reports he had itchy throat, coughing, some mild swelling. Pt called sister and was brought in by private vehicle for observation of rash to facility. Initial VS taken, stable 02 98% on room air, Bp 132/84, P 63, pt alert, no shortness of breath or respiratory distress. 1741 VS 136/84 02 96% P61. Pt assisted to gurney, alert, ambulatory. EMS called for further assessment. Pt denies known allergies, no medical hx, athlete. 1747 Pt alert no  respiratory distress, reports feeling better, flushing diminished. VS 137/83 P 59 02 97% room air, alert, no distress. 1752 EMS arrived, assessed pt recommended pt should take Benadryl q6 hours at home, also call 911 if throat starts to itch, or coughing. VS taken by EMS 129/86 HR 56, pt alert denies sob or itching, no  throat swelling. Pt advised to treat symptoms at home, pt declined to transport per EMS advice, pt agreed. 1802 pt left facility in no distress, ambulatory, accompanied by sister. Instructed to call 911 if symptoms return or worsen.
Low grade temp 99, 2 and red, pin-point, unraised rash abdomen.
Came in to have PPD read and then told nurse about arm swelling. Described in chart 12 cm x 12 cm red, raised, warm, with 3 1/2 x 2 cm blister incenter cultured (virus not isolated-final 5/7/07 Pt was given scrip-Keflux 500 mg-1 cap BID x 10 days
Developed a UTI after 1st Moderna Vaccination; Pain in injected arm; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Developed a UTI after 1st Moderna Vaccination) and INJECTION SITE PAIN (Pain in injected arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history information was provided.  Concurrent medical conditions included Blood pressure high and Hyperlipidemia. Concomitant products included VITAMINS NOS and PARACETAMOL (TYLENOL) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INJECTION SITE PAIN (Pain in injected arm). On 07-May-2021, the patient experienced URINARY TRACT INFECTION (Developed a UTI after 1st Moderna Vaccination). At the time of the report, URINARY TRACT INFECTION (Developed a UTI after 1st Moderna Vaccination) and INJECTION SITE PAIN (Pain in injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also  included  High Blood Pressure medications and Antihyperlipidemic medications. No treatment information provided. Patient is going to see MD today for evaluation
Received the Flu vaccine on 9/30/13. Pt has had same doctor since 2013. In May 2018, after vaccination was itching in hair/face. Went to doctor and doctor diagnosed a shingles rash; prescribed antiviral medication for 7 days. The medication did help with the itchiness. Still has feeling of crawling/ itching on head/ears. Went back to doctor and doctor said that symptoms would last about 1-2 years. The itchiness is worst at night time. Symptoms remain the same--have not changed. Pt took Flu vaccine today.
Sore arm at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DR2GR, expiry date 29th November 2024) for prophylaxis.   The patient's past medical history included febrile seizure. Concurrent medical conditions included pertussis (patient had pertussis allergy from infancy) and allergy to vaccine (pertussis allergy from infancy).   On 16th November 2022, the patient received the 1st dose of Boostrix. In November 2022, less than a week after receiving Boostrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Boostrix.     Additional Information: GSK Receipt Date: 21-NOV-2022 Reporter's Comment: The reporter reported that the patient had a pertussis allergy and received Boostrix vaccine. The reporter stated that the patient told by her mother it was an allergy from infancy were she had a febrile seizure. The reporter reported that after received Boostrix vaccine the patient experienced no reaction except sore arm at the injection site. The reporter did consent to follow up via mail. Additional supportive infirmation: From the narrative it was not clear if patient had pertussis vaccine allergy or had pertussis condition. Conservatively both considered as medical history and query raised.
For my second dose, I experienced fever, nausea, explosive diarrhea and headaches that lasted two to three hours.     I had no adverse reaction to my first dose Pfizer vaccine. (lot#: EL0140)
YMy main problem seems to be with the  Moderna Covid booster jag which has now disappeared from this form.
Fever with rash starting on 1/17/2002. Fever lasted 48 hours after 24 hours of fever, erythema, papule type rash developed. Seen in office 1/21/02 and continued rash but no fever.
Chills; Aches; Tiredness; This is a spontaneous report received from a contactable consumer (Patient) via Medical Information Team. A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration on 15Apr2021 10:30 as single dose for COVID-19 immunisation. The patient medical history included triple bypass surgery three years ago. Family history included multiple sclerosis (his wife had history of multiple sclerosis). Patient concomitant medications were not reported. On 18Apr2021, three days after the vaccine on a Sunday morning it hit him around 3 AM where the patient had chills, aches, tiredness and he was in bed for three days. Later he felt 40% better, but it hit him again and he was in bed for another 4 days. He was due for the second dose on 06May2021. The outcome for the events chills, aches and tiredness was recovering as he felt much better.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Narrative:  Patient received one dose Janssen Covid 19 Vaccine Apr 2021. The patient tested positive for COVID 19 on 20 Jan 2021. The patient presented to the ED with chest and rhabdomyolysis. The patient was admitted, treated, and monitored. The patient was discharged from the hospital on 22 Jan 2022.
heavy menstrual bleeding, break through bleeding throughout cycle, ongoing as of 9/18/22
2-3 days post injection a "nodule" was noted. She presents today, 1/28/2013, with complaint of warmth, redness, and pain to the area of injection that has worsened. Treated with BACTRIM DS #28 1 PO BID x 14 days.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu Vaccine. Past adverse reactions to the above products included No adverse event with Flu Vaccine.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-369007, MOD-2021-369010 (Patient Link).
A few week after shot, I started feeling foggy and light headed.  Also very tired and unable to concentrate.  I did not feel any of this after my first shot. My vaccine was Moderna.    today, Sept 14, I am still feeling like that.  My head is full, I am always tired and do not last long while doing anything.  I was very active in walking, dancing, golfing etc., and now can not last long enough to do anything.  everything has changed in my life.  I just want to get back to myself.....  I have seen my doctor who has sent me to all the specialist, but they can not find out what is going on in my head....I just keep hoping it will wear off and I will get back to my old self....
My son received his first Pfizer booster for COVID-19 on 5/20/2022. One of classmates tested positive for COVID-19, so I had him undergo a PCR test on 5/24/2022, even though he showed no symptoms at that point. On the morning of 5/25/2022, however, he woke up with an elevated temperature of 99.7 and body aches. I administered a home test for COVID-19, which immediately came back positive. About half an hour later, the results of the PCR test also came in, and they were also positive. We kept him home from school. His symptoms were better by later that afternoon, though, and the symptoms never returned. He tested negative on a home test on 5/30/2022, and he returned to school on 5/31/2022.
Within 15 minutes of receiving flu and Pneumo shots at flu clinic pts did not feel well, was seated I went to him, he stated he felt some numbness on left side of face, no pallor, no difficulty breathing. I gave him smelling salts and took his BP 195/101 pulse 68, Pt admitted he did not take BP med that am. He sat for 1/2 hour longer and wife administered BP med. Pt was oriented, not confused. Advised him to call MD ASAP and they left. DC DX: probable transient ischemic attack with left facial and hand numbness resolved. poorly controlled hypertension dilated ascending aorta with mild aortic insufficiency and aortic valvular sclerosis and left ventricular hypertrophy with normal left ventricular ejection fraction. Repeat echo via transesophageal echocardiogram showed no cardiac source of emboli. Mild aortic regurgitation with mild aortic vale thickening. Trace tricuspid and mitral regurgitation. Normal LV/RV size and function. Pulmonary artery of normal size. Ascending aorta/root is normal in size. Dyslipidemia Anxiety History of Lyme Disease not presently active Palpitations. BP on admission 190/93. Neurologic exam 5/5 bilateral upper and lower extremities. Cranial nerves 2 through 12 grossly intact other than decreased sensation on left side initially. Per 60 day follow up: I have received no further information regarding this patient.
Severe rash affecting both injected arm AND traveling to face - side of cheeks. Rash has raised skin, itches, and can be painful when dry.
Big red circle about 3 inches by 5 inches at injection site.; Arm soreness; Headaches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headaches), MYALGIA (body aches) and VACCINATION SITE ERYTHEMA (Big red circle about 3 inches by 5 inches at injection site.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included VITAMIN D [VITAMIN D NOS], PROBIOTICS NOS and COLECALCIFEROL, FISH OIL (OMEGASAN 3) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headaches) and MYALGIA (body aches). On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red circle about 3 inches by 5 inches at injection site.). On 15-Feb-2021, PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headaches) and MYALGIA (body aches) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Big red circle about 3 inches by 5 inches at injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-057826 (E2B Linked Report).
Patient woke up next day with swollen knee.  The patient took an antiinflammatory and felt better after 3 days.
Rash at injection site. Itching comes and goes.  Consulted pharmacist no treatment recommended. Using topical Benadryl cream for itchiness.  Arm pain but may he related to exercise.
Sore throat; congestion; headache; she will vomit; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program: Pfizer First Connect. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730, exp date: 31Mar2021), via an unspecified route of administration on 19Dec2020 for COVID-19 immunization. Medical history included being COVID positive on 16Nov2020. The patient had no other relevant history. There were no concomitant medications (no other products). She was working at a doctor's office. The patient mentioned she was due to receive the 2nd dose of the vaccine on 09Jan2021 at 9 am but currently has a sore throat, congestion and a headache (onset date: 05Jan2021). Her symptoms worsened. It started as just a headache. With the congestion now when she blows her nose, sometimes she will vomit (onset date: Jan2021). She was asking if it was okay for her to take the vaccine tomorrow and for any recommendations. She was tested for COVID the day of reporting (08Jan2021) but had no results with her; she hasn't received the COVID test result back (unknown). No investigation assessment performed. The outcome of she will vomit was unknown while the other events had not recovered.
Pt recv vax on 3/17/99; approx  1 hr post vax pt exp red lump on arm, flushed face
Not sure if this is related to shot. I have never had flu before. This October was the second year I received flu shot.  I received the covid vaccine and continued my normal routine of distancing, mask, hand washing. 2 weeks after I began to feel extremely tired, headache, chills, muscle aches, cough and after 6 days went to walkin in and tested negative for covid and positive for flu type A. Dr said it was extremely rare as they had not seen any case of flu this season.
No adverse effect; improperly stored vaccine administration; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient with unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On 11-SEP-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency and route were not reported) (lot # S002874, Expiration Date: 29-JAN-2021) for prophylaxis. There was no adverse effect. The stored temperature was 6 Fahrenheit (F) to 14 F (10.2 F, multiple) for 50 minutes and the data logger was involved. There was no previous temperature excursion. It was used to reconstitute sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The storage of sterile diluent was properly.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005220:
Vaccine administered at 4:40 PM. At 4:50 PM patient reported sudden onset cough, dizziness, and throat closing. Onsite nurses attended to patient immediately. Vital signs stable. 911 called. EMS transport at 5:00 PM to hospital.
Severe sore throat for 7 days, then chest congestion and hoarse voice for 3 days. Followed by back and neck muscle spasms causing pain at any slight movement. Telemedicine visit to doctor suggested the sore throat was something viral (not Covid), and that it should go away. Two PCR tests were negative for Covid. Muscle pain has not been addressed yet, as I cannot make an appointment until I have been symptom-free for 72 hours.
Patient has received ZOSTAVAX and Flu in the past. On 7/18 Per reporter, patient had vomited, had fever, headaches and myalgia. On 7/19 since patient was not responding to calls or emails, they checked-in on him and was taken to ER by ambulance and was admitted. 7/21 Per reporter, patient was being treated for listeria, had collapsed lung and could not breathe on his own, and was being treated for pneumonia. 7/29 patient alert and trying to communicate, test results found West Nile virus, and had a tracheotomy that week. Patient transferred to another hospital on 8/19 and have noticed marginal improvement to his condition. As of 9/9 patient was still in hospital. See attached letter for additional details.
Information has been received from a registered nurse concerning her daughter with eczema and allergies who in June 2008 was vaccinated with the first dose of GARDASIL. On 09-MAR-2009 the patient was vaccinated with her third dose of GARDASIL subcutaneously in the left upper arm. Concomitant therapy included CLARITIN. On 09-MAR-2009 the patient experienced soreness, warmth and redness at the injection site after the vaccination. The reporter added that an unspecified amount of vaccine "run down my daughter's arm" during administration. The patient self treated the injection site reaction with cool compresses and at the time of reporting, 10-MAR-2009, was recovering. Additional information is not expected.