chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling at injection site; Itchy Rash at injection site; Itchy Rash at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included liver transplant (a liver transplant recipient on immune suppression medications.). Concomitant products included cyclosporin (Cyclosporine) and everolimus.   On 13th August 2019, the patient received the 2nd dose of Shingrix. On 15th August 2019, 2 days after receiving Shingrix, the patient experienced injection site swelling, injection site rash and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site rash and injection site itching were unknown.   It was unknown if the reporter considered the injection site swelling, injection site rash and injection site itching to be related to Shingrix.  Additional case details were reported as follows: The patient was a liver transplant recipient on immune suppression medications (cyclosporine and everolimus) received second Shingrix vaccine two days ago from date of reporting and was now experiencing swelling and an itchy rash at the injection site. The reporter gave permission to follow up.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.  The patient did not have any known allergies and any relevant medical history.  On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The reporter's causality for event COVID-19 with ADALIMUMAB (HUMIRA) was not provided and considered possible with mRNA-1273 (Moderna COVID-19 Vaccine). No treatment medications were reported.  Company comment: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, on unknown date after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of report. Kindly note that the two doses of mRNA-1273 vaccine was given on a 28-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, on unknown date after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of report. Kindly note that the two doses of mRNA-1273 vaccine was given on a 28-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chills; Body ache; Nausea; Numbness in left side of face started about 5.5 hours after the shot in left arm.; Also had neck pain with it.; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 21Apr2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin hydrochloride; sitagliptin phosphate monohydrate (JANUMET), pantoprazole (MANUFACTURER UNKNOWN), dapagliflozin propanediol monohydrate (FARXIGA) and lisinopril (MANUFACTURER UNKNOWN), all used for an unknown indication, from an unknown date and unknown if ongoing.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 42-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 21Apr2021 at 14:45, the patient experienced numbness in left side of face starting about 5.5 hours after the shot in left arm; she also had neck pain with vaccine, chills, body ache and nausea. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events numbness in face cleared within 24 hours followed by chills, body ache, nausea and neck pain was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information was received from the physician on 16-OCT-2017. The patient was aged 18 months. On 09-MAY-2017, the patient received the improperly stored dose of PEDVAXHIB (lot # M046140). The patient's identifiers and the patient's guardian's identifiers were provided. Sender's Comments: US-009507513-1709USA007325.
I starting cramping in the ball of my feet immediately after the vaccine. The cramping moved up to my ankles and calves. I'm also having memory issues. Mainly coming up with words is the issue and is frustrating. I was able to take calcium daily until after the vaccine and it made me so sick on my stomach. I started taking the calcium again recently to help with the cramping in my feet and legs. I also had severe headaches for a week after the vaccine too. I did see my doctor but they where unable to help me. I took a generic version of MOTRIN on occasion to help with my headaches.
Information has been received from a female consumer who on 10-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 10-MAR-2008 the patient developed "a hive" that was 3X4, red, itching, tingling and hurting. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. No further information is available.
Seizure lasting about 15 minute seen in Emergency department. Fever T 101.9 rectally TYLENOL given. ATIVAN given I.M.
Woke up 11 hours after dose with upset stomach, body aches. By next morning around 9:00 am had high fever (103 degrees) as well, called in sick to work x2 days.
dizziness; not clear what he was feeling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and CONFUSIONAL STATE (not clear what he was feeling) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (dizziness) and CONFUSIONAL STATE (not clear what he was feeling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIZZINESS (dizziness) and CONFUSIONAL STATE (not clear what he was feeling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.   Reported stated that none of the treatment medications worked.   This case was linked to MOD-2021-133057 (Patient Link).
GOT COVID; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220105113 and 20220105064.
Very little soreness in arm and no redness originally.  1-21-21 started itching.  1-22-21 red puffy area developed. Hurt and itched.  1-23-21. Redness and soreness has spread
Pt was given his 4 month shots without incident. Both extremities had patches of red and according to her mom, it was swollen up later X 1 week. The doctor seen the baby and Rx'd hydroxyzine and Tylenol. No redness at this time. Pt had the same symptoms at his 2 month shots and was seen by a doctor but MD wasn't sure if it was caused by the vaccine or something else.
Wheezing onset 2pm, aching 3pm - next am, fever 101 + approx 5pm, Gone in am.
Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; This is a spontaneous report from a contactable Physician (patient). This 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 15:00 (lot number: EK9231) at single dose in Arm Left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included paracetamol (TYLENOL), ibuprofen (ADVIL) occasionally as needed. The patient previously received first dose of BNT162B2 intramuscularly on 16Dec2020 12:00 at 31-year-old (lot number: EH9899) at single dose in Arm Left for COVID-19 immunisation. The patient experienced Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing on 06Jan2021 03:00 AM. The outcome of Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing was recovering. Tylenol, Advil, Bed Rest was received for the adverse events Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing as treatment. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
As soon as the vaccine was injected into my arm, I screamed out in pain. I had excruciating soreness in my shoulder and my arm felt like it was on fire. This continued for a few days and was considered to be normal. I had mild pain and discomfort for about a week or two and was hoping it would resolve on its own however, I had to go get some labs drawn and I always use my right arm. Historically I very well tolerate blood draws, blood donations, IV?s, plasma donations, etc. This instance was torture from the time she put the needle in my arm until she pulled it out, I?ve never experienced pain during blood draws before and it was unbearable. I had to carry my own arm on the walk back to my vehicle and it hurt the rest of the day. I kept hoping that it would resolve on its own until, about two weeks later, I received another shot in my shoulder and almost fell to the floor immediately in pain. The nurse advised that I follow up with my doctor because that is not normal at all. My PCM tried acupuncture, to no avail. Tylenol, ibuprofen, and physical therapy did not work. I was then sent to have a nerve conduction study performed on the arm because I started experiencing radiating pain and numbness. The doctor could not even complete the test because, upon insertion of the needle into my shoulder, I could not hold back the screaming from the pain.  I am currently still following up with my PCM to try and figure out why this is happening and if my arm will ever be the same.
had the COVID arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had the covid arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) had the COVID arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), had the covid arm was unknown.
pharmacist on duty, administered without "dilute prior to use" for pfizer covid vaccine (age 5-11).
Patient got scared and did not get his second dose; tried to urinate and could not; passed a clot with some drops of blood; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (tried to urinate and could not) and HAEMORRHAGE URINARY TRACT (passed a clot with some drops of blood) in a 73-year-old male patient who received mRNA-1273  (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tumor (Malignancy in the tubular tumor in Penis) and Bladder operation (in past 3 months). Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, LISINOPRIL, AMLODIPINE and ESCITALOPRAM for an unknown indication, PRAVASTATIN SODIUM (PRAVASTATIN NA).    On 16-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced URINARY RETENTION (tried to urinate and could not) (seriousness criterion medically significant) and HAEMORRHAGE URINARY TRACT (passed a clot with some drops of blood) (seriousness criterion medically significant). On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got scared and did not get his second dose). At the time of the report, URINARY RETENTION (tried to urinate and could not), HAEMORRHAGE URINARY TRACT (passed a clot with some drops of blood) and PRODUCT DOSE OMISSION ISSUE (Patient got scared and did not get his second dose) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Treatment medication was not reported.  Based on the current available information and the temporal association between the product use and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start of the events a causal relationship cannot be excluded.
2 days p/vax devel a gen rough red rash w/extreme itching;resolved p/4th day;
Pt reports he was diagnosed with Guillain-Barre Syndrome on follow up phone call yesterday (9/23/13). Started having neck pain / back pain / chest pain / numbness on 9/13/13. Was returned to ER - pt went but didn't stay because of cost on 9/17/13. Went back to urgent care on 9/18/13. Came back to work on 9/20/13. Went back to ER - was hospitalized thereafter for worsening symptoms.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient with drug reactions/allergies to quinolones and no pertinent medical history. On 23-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as: J006153, expiration date: August 2014, dose was not reported), subcutaneously. On 23-OCT-2013, 1 day after onset of therapy the patient experienced redness and warmth that spread to a large area around the injection site following the administration of ZOSTAVAX. This area got smaller after approximately 20 minutes after vaccination and the patient went home. The patient called back on 25-OCT-2013 and reported that she had a raised bump that was approximately 1.5 inches in diameter around the injection site. On 25-SEP-2013 the patient received unspecified flu vaccine (manufacturer unknown) (also reported that there were no concomitant medications). It was reported that no labs were done. There was no treatment given for the events. The outcome of the events was reported as not recovered/not resolved. The patient sought medical attention via contacting pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
My stomach and back start to become extremely sensitive to touch and what I thought at the time was hives developed on part of my back. Over the next few days this became worse and much more painful.  I went to urgent care on 10/11 and was diagnosed with Shingles.  I have never had shingles before and was feeling fine before taking the shot.  I am now on medication for treatment.
After second COVID vaccine did felt fatigued and weak; when weather changed start plaque psoriasis small spots; After second COVID vaccine did felt fatigued and weak; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (After second COVID vaccine did felt fatigued and weak), PSORIASIS (when weather changed start plaque psoriasis small spots) and FATIGUE (After second COVID vaccine did felt fatigued and weak) in an adult male 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.    Concurrent medical conditions included Plaque psoriasis.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ASTHENIA (After second COVID vaccine did felt fatigued and weak), PSORIASIS (when weather changed start plaque psoriasis small spots) and FATIGUE (After second COVID vaccine did felt fatigued and weak). At the time of the report, ASTHENIA (After second COVID vaccine did felt fatigued and weak) and FATIGUE (After second COVID vaccine did felt fatigued and weak) outcome was unknown and PSORIASIS (when weather changed start plaque psoriasis small spots) had resolved.            No concomitant medications were reported. No treatment medications were provided.  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.
Herpes-Zoster reactivation resulting in shingles.  Typical shingles symptoms occurring  on right side of body include rashes and blisters.  Standard treatment of Valacyclovir 1000mg 3x per day prescribed.
Left arm tingling; Left hand fingers tingling; left side of face swollen; left sides of glands swollen; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (Left arm tingling), PARAESTHESIA (Left hand fingers tingling), SWELLING FACE (left side of face swollen), LYMPHADENOPATHY (left sides of glands swollen) and FATIGUE (feeling tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PARAESTHESIA (Left arm tingling), PARAESTHESIA (Left hand fingers tingling), SWELLING FACE (left side of face swollen), LYMPHADENOPATHY (left sides of glands swollen) and FATIGUE (feeling tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) ongoing since an unknown date at a dose of UNK dosage form; AMINO ACIDS NOS ongoing since an unknown date at a dose of UNK dosage form and TURMERIC [CURCUMA LONGA RHIZOME] ongoing since an unknown date at a dose of UNK dosage form. On 01-Mar-2021, LYMPHADENOPATHY (left sides of glands swollen) had resolved. At the time of the report, INJECTION SITE PARAESTHESIA (Left arm tingling), PARAESTHESIA (Left hand fingers tingling), SWELLING FACE (left side of face swollen) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's treatment medications included unspecified vitamins.
This pt who a number of years ago reportedly received one dose of vax and subsequently developed a severe swelling at the injection site and down her arm.