chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinated second was 11/12/19, iritis flared up again on 12/12/19; This non-serious case was reported by a physician via call center representative and described the occurrence of iritis in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of iritis (received 1st dose on 25th June 2019, for tolerance of 1st dose , refer case  US2023AMR097538).   On 12-NOV-2019, the patient received the 2nd dose of Shingrix. On 12-DEC-2019, 30 days after receiving Shingrix, the patient experienced iritis (Verbatim: vaccinated second was 11/12/19, iritis flared up again on 12/12/19). Rechallenge with Shingrix was positive. The outcome of the iritis was not reported.   It was unknown if the reporter considered the iritis to be related to Shingrix.  It was unknown if the company considered the iritis to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR097538   Additional Information: GSK Receipt Date: 14-JUL-2023 The patient was vaccinated with Shingrix and iritis flared up again. The doctor would like to be contacted by email by medical information to discuss his condition. The reporter agreed to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2023AMR097538:Same patient, first dose
Sore arm; noticed odd sensation in her throat/Itchy sensation on throat/burning sensation on throat; Pin point dime sized headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), THROAT IRRITATION (noticed odd sensation in her throat/Itchy sensation on throat/burning sensation on throat) and HEADACHE (Pin point dime sized headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), THROAT IRRITATION (noticed odd sensation in her throat/Itchy sensation on throat/burning sensation on throat) and HEADACHE (Pin point dime sized headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and THROAT IRRITATION (noticed odd sensation in her throat/Itchy sensation on throat/burning sensation on throat) and HEADACHE (Pin point dime sized headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She does not remember the exact date of receiving the first dose. Concomitant product information was not provided. Treatment information was not provided.
Patient received the vaccine on 1/30/09.  The next day, 1/31/09, he vomited twice.  He also didn't eat very much that day, prompting me to think he didn't feel well.  He slept much more than usual on 1/31/09.  On 2/01/09, he had diarrhea and vomited a little and still wasn't eating as much as usual.
The first I used vaccine, I have a pain. A 3-4 days pain. I try to measure temperature, it was slight 96.1, there was no temperature. After the 4th day, I wake up very tired, very cold with chills in my back. I took baby asprin. That was almost 2 weeks. Then yesterday, I start to feel like I couldn't take a deep breath. I try to take deep breath and couldn't. I have blurry vision on saturday and day before. I then almost fainted, I laid down. I did a covid test, it was negative. I laid down, i take lots of water. Then that afternoon, I took baby asprin. Then on Monday, it happen again. I went to the doctor yesterday. He did the ekg, the bloodwork, the chest xray. Before that, I have never been sick or on any medication. My symptoms was, short of breath, chills, and tiredness, and blurry vision.
12/31/2020 H/a, diarrhea, SEVERE  joint pain all through body, severe exhaustion., nausea, chills, fever 99.9. It felt almost identical to my first couple says of covid.
COVID-19  06/04/2022  1 of 3  Comirnaty-PFR t-s 30mcg  COVID-19  07/14/2022  2 of 3  Comirnaty-PFR 30mcg     Admitted to hospital, COVID positive 8/5/22
dementia; cold; Initial information received on 06-Dec-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional via digital media under reference number US-SA-SAC20211210001289.  This case involves adult female patient who experienced dementia and cold (nasopharyngitis), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious dementia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date the patient developed a non-serious cold (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case involves adult female patient who experienced dementia and nasopharyngitis after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is not known for all the events. However, patient's medical condition at time of vaccination, Lab data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the individual vaccines cannot be assessed.
Bilateral lower extremity aches and pain. Rx Motrin 800mg #30 one tid prn pain. Rx Vicodin 5/325 #30 one qid prn pain.
7/15-7/19: 88-year-old female (PMH significant for CAD, s/p CABG, A Fib, HTN and hyperlipidemia) presented on 7/15/2022 from home for outpatient care. Within the procedure, difficulty obtaining vascular access in the left groin due to adiposity despite attempts with 6F and 5F sheaths. A large superficial tear exposed adipose tissue during manual pressure and vascular surgery was called. Hemostasis achieved. The skin was sutured in the lab. Patient transferred to CCU for further monitoring. Since that time, patient cleared by vascular surgery. She has been having wound care within the CCU. Patient reevaluated today and stable for discharge at this time.
a dose ofGARDASIL9 that experienced a temperatme excursion.; Patient did not experience any symptoms; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), by intramuscular route, lot number S008154, and expiration date 20-NOV-2021 for prophylaxis (strength, dose and frequency were not provided) that experienced a temperature excursion (product storage error). The patient did not experience any symptoms.   The temperature was for 2 celsius degrees (°C) (-5.7 degrees (C)) for a timeframe of 16 minutes and a previous temperature excursion of above 9 celsius degrees (°C) (10.7C) for a timeframe of 45 minutes. The call was due to data logger.
area on arm swollen, red & hot to touch, very painful, T99;DPH, warm compresses, APAP for fever;
Very tired; fever; dizziness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever) and FATIGUE (Very tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DIZZINESS (dizziness) and PAIN IN EXTREMITY (Sore arm). On 23-Apr-2021, the patient experienced PYREXIA (fever). On 24-Apr-2021, the patient experienced FATIGUE (Very tired). At the time of the report, DIZZINESS (dizziness), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant details were provided  No treatment details were provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up appended
Adacel give LD on 9-10-07. Pt. stated on 9-15-07. area became tender, red and itchy, warm to touch but no fever. Pt. came to office 9-17-07 with redness, swelling and tenderness LD area T-96.8 Treatment-Ice and Tylenol Prn
On September 24, 2022, I developed a huge cold sore / shingle on my face below my lip.  - this was day after the vaccine, I know this was from vaccine.  I started to feel kind of sick then the sore broke out on my face.  Very itchy and multiple blisters.   On October 9, 2022, I became severely ill with nausea/vomiting/diarrhea and had to go to the ER for treatment. As I told the representative, I do not know if this was directly related to the vaccine.  The diagnosis from tests given at ER was abdominal pain and colitis.   The representative wanted me to report my illness to have it on record.
very sick; body aches; headache; chills; low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (very sick), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced ILLNESS (very sick), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (low grade fever). At the time of the report, ILLNESS (very sick), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports already seeing doctor for the symptoms.  No concomitant medications reported. No treatment reported.   Reporter did not allow further contact
Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "MS". There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Sep2022, outcome "unknown", COVID-19 (medically significant) with onset 13Sep2022, outcome "not recovered" and all described as "Positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was unblinded, the patient received Prevnar, Control For Pneumococcal Conjugate Vaccine, 13-Valent. Information regarding Blinded Vaccine For Pneumococcal Conjugate Vaccine, 13-Valent was received from an investigator regarding a 10-month-old male participant in a study who experienced distended abdomen and possible wilms tumor. The participant received the third dose on 05-Apr-2007. On an unspecified date, the physician noted a distended abdomen. An ultrasound of the abdomen on 31-JUL-2007 showed a mass rising from the right kidney. The patient was diagnosed with a possible wilms tumor (nephroblastoma). As of 01-Aug-2007, the patient has not recovered. No additional information was available at the time of this report. Abdomen scan (results: noted a mass rising from the right kidney, possible Wilm's tumor) was done on 31-Jul-2007. The investigator (s) considered nephroblastoma and abdominal distension possibly related to the study product. The medical monitor (s) considered nephroblastoma and abdominal distension not related to the study product.
Irritation; Anxiety; Unable to concentrate; Blurry vision; Loss of appetite; Fatigue; Pounding headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: AE178057) via an unspecified route of administration in the left arm on 01May2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06May2021 at 20:00, the patient experienced irritation, anxiety, unable to concentrate, blurry vision, fatigue, event loss of appetite and pounding headache. The clinical outcomes of irritation, anxiety, unable to concentrate, blurry vision, fatigue, event loss of appetite and pounding headache were recovering.   No follow-up attempts are needed. No further information is expected.
Body  myalgias, headache,  skin pain, nausea, diarrhea,  sore throat,   cervical  &  axilary  lymphadenopathy
Symptoms: 1. Rash. 2. swelling at injection site. Treatment Drugs Used: 1-CEPHALEXIN Dose: 500 Units: MG Freq: QID Route: PO.
Patient received vaccine 10/5/07.  She came to clinic 10/9/07 and states she has a reaction from the vaccine of itching, bumps and rash generalized over the body.  Patient was encouraged to seek treatment from her primary care physician or urgent care for any unresolved symptoms.
Shortness of breath and chest tightness 1 hour after vaccine.  Saw her cardiologist right away who gave her Benadryl and Pepcid.  Did and ekg and echo in office--both were normal.  Symptoms resolved that day.  Of note, this employee tested positive for Covid 19 on 1/9 and had been asymptomatic for several days prior to getting vaccine.
Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; bitter taste; This is a spontaneous report from a contactable consumer(patient).   The 51-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Apr2021 14:30 (Batch/Lot number was not reported) as second dose, single for covid-19 immunization.  Medical history included hashimoto. Concomitant medication included collagen, peptide powder, multi vitamins. She previously received sulfur based antibiotics. Historical vaccine included first dose of BNT162B2 on 03Apr2021 09:30 AM for COVID-19 immunization and experienced bitter taste in back of throat for half day on date of administration.  After second dose, the patient experienced same bitter taste for 24 hours from time of administration. Pulse continued body aches especially in legs making her almost immobile, all on 26Apr2021 06:00 with outcome of recovering. Treatment included alternated taking ibuprofen(ADVIL) and paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID 19, Since the vaccination, the patient had not been tested for COVID 19.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466738 Same patient/drug, similar AEs, different dose
on 10-14-15 he was given flu la1v4 nasal noy sure if i marked it right above.  On 12/21/2015 he went to the dr he had been sick for a week or so fever, 3 weeks before sore throat possibly strep . The dr dx with bronchitis.
Caller wanted to know when can they have the second dose, their doctor told them to wait for 90 days.; Caller wanted to know when can they have the second dose, their doctor told them to wait for 90 days.; on 20Mar he contacted covid; on 20Mar he contacted covid; This is a spontaneous report received from a contactable consumer (wife of patient). This consumer reported same events for two patients. This is the second of two reports. A 55-year-old male patient (husband) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on 24Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had his first dose of the COVID vaccine on 24Feb2021 and on 20Mar2021 contracted COVID, quarantine completed and was back to work. The reporter wanted to know when can they have the second dose, their doctor told them to wait for 90 days. The clinical outcome of COVID was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381231 Same reporter/drug/AE, different patient
I was out with Covid. I got it 2.5 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I was out with Covid. I got it 2.5 weeks ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (I was out with Covid. I got it 2.5 weeks ago). At the time of the report, COVID-19 (I was out with Covid. I got it 2.5 weeks ago) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Patient had 2 shots of Moderna, either the end of 2020 or beginning of 2021. Patient was out with Covid. Patient got it 2.5 weeks ago. He was back to work, 10 days later. He was being told he had to get a booster shot.  Company Comment: This spontaneous case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Left arm cellulitis. 19/11.5 cm pain, red, and swollen.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. Since 02-APR=2015, the unspecified patients were vaccinated  with ZOSTAVAX (lot # K024031 and expiry date: 20-FEB-2016) which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
As per stated as side effects, I had general flu like symptoms early morning on 6/5/18 which worsened into 6/6/18 when a rash appeared at the site of injection but also 2"(now1") from that site. I took ADVIL for aches and BENADRYL for what looked like hives forming. Arm is rock hard and painful to lightest touch but this is part of normal side effects. Muscle aches have for most part subsided as of today 6/7/18.
Patient reported that she feeling very heavy like a weight is on her body... she has difficulty breathing and also has pain in her right side
hives all over the body/Redness of hives; itchy sensations on hives/large red, itchy circle around the injection site; Redness of hives/itchy sensations on hives/large red, itchy circle around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives all over the body/Redness of hives), VACCINATION SITE PRURITUS (itchy sensations on hives/large red, itchy circle around the injection site) and VACCINATION SITE ERYTHEMA (Redness of hives/itchy sensations on hives/large red, itchy circle around the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever. Concurrent medical conditions included Allergy to antibiotic (tetracycline _skin rashes) and Sulfonamide allergy (sulfa drugs _skin rashes). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Reflux esophagitis, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (hives all over the body/Redness of hives), VACCINATION SITE PRURITUS (itchy sensations on hives/large red, itchy circle around the injection site) and VACCINATION SITE ERYTHEMA (Redness of hives/itchy sensations on hives/large red, itchy circle around the injection site). On 10-Apr-2021, URTICARIA (hives all over the body/Redness of hives) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy sensations on hives/large red, itchy circle around the injection site) and VACCINATION SITE ERYTHEMA (Redness of hives/itchy sensations on hives/large red, itchy circle around the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient continued to had redness, itching and splotches off and on her arms. Treatment medicines included anti histamine.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Patient demographics, medical history, allergic reaction, concomitant medication, treatment medication added. event hives stop date and event outcome updated, reporter causality updated.
Immediate redness and swelling of all 4 sites - especially (R) lower anterior thigh site injection. Pt. has history of rashes due to allergies. BENADRYL 6.25mg given orally.