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). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 12:30 as dose 1, single (Lot number: EN6206), on 26Mar2021 at 12:00 as dose 2, single (Lot number: ER8730), on 27Oct2021 at 15:45 as dose 3 (booster), single (Lot number: FH8020) and on 23Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 59 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (ongoing); "hypothyroidism" (unspecified if ongoing); "atopic dermatitis" (unspecified if ongoing); "known allergies: Sulfonamides" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; AMLODIPINE; HYDROCHLOROTHIAZIDE; LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; LOSARTAN; OMEPRAZOLE; POTASSIUM CHLORIDE; MONTELUKAST; DUPIXENT, reported as other medication in 2weeks. Past drug history included: Cephalosporins, reaction(s): "known allergies: cephalosporins"; Neomycin, reaction(s): "known allergies: neomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid, treatment started on 08May2022 and treatment stopped on 12May2022. Clinical course was reported as, Rebound covid on 19May2022 after taking the full 5 day course of Paxlovid, patient was asymptomatic and tested negative. A short time later she began developing symptoms again, worse than when she was first diagnosed and tested positive again 10 days after finishing Paxlovid. Symptoms stopped on 31May2022. Patient not received any treatment for symptoms and was recovered from symptoms.
transient reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (transient reactions) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced VACCINATION COMPLICATION (transient reactions). At the time of the report, VACCINATION COMPLICATION (transient reactions) outcome was unknown.            No concomitant medication reported.   Reporter stated she received the Moderna primary two dose series approximately one month part. Patient received the third dose about 4 to 6 months after the 2nd dose and was given 0.5 ml because of her immune problems. On 01-Apr-2022 she received the 4th Moderna dose (a booster) 6 months and 3 weeks after receiving the 3rd dose. She reported she received 0.25 ml for the booster dose. Patient has never gotten COVID-19 infection.  No treatment medication reported.   This case was linked to MOD-2022-531820, MOD-2022-531830 (Patient Link).
On day 5 after receiving the first dose of the Moderna vaccine, I woke up in the morning to feeling pain on my left armpit where the lymph nodes are located. The pain feels tender and constant. It helps to take tylenol to decrease the pain.   My left armpit feels tender and sore. It looks a bit swollen. I know I slept on my left arm, so it may be sore from that, but it does not feel like arm strain. It is just on my armpit area I feel the pain and discomfort. I do not feel pain on my injection site.  It is now day two that I am experiencing this pain. I do not feel pain on my right arm or armpit.
Information has been received from a physician concerning a 66 year old male patient with no known drug allergies who on 14-JUL-2008 was vaccinated IM in the deltoid with a second dose of 0.5 mL PNEUMOVAX (lot # 661039/0248X) and developed localized and systemic reactions. Concomitant therapy included atenolol, fexofenadine hydrochloride, piroxicam, triamterene/hydrochlorothiazide, aspirin and FLONASE. The local reaction included redness, swelling and pain and occurred within a few hours of vaccination. The systemic reactions were within 24 hours and included fever and myalgia. The patient was told to use ice and TYLENOL. The patient was seen last week for his symptoms and was told to call the office if he did not get better. The physician had not heard from the patient since. At the patient's appointment on 14-Jul-2008, the patient could not remember whether or not he had received a dose of PNEUMOVAX (lot # not provided) previously but is was later found out after vaccination that he had received one dose approximately 2 years ago. The patient's outcome was not known. This is one of two reports from the same source (WAES# 0807USA04021). Additional information has been requested.
15-20%less than full dose administered; When the syringe was removed from his arm, his arm was all wet; his arm hurts less than usual; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his arm hurts less than usual), UNDERDOSE (15-20%less than full dose administered) and DEVICE CONNECTION ISSUE (When the syringe was removed from his arm, his arm was all wet) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced UNDERDOSE (15-20%less than full dose administered) and DEVICE CONNECTION ISSUE (When the syringe was removed from his arm, his arm was all wet). In November 2021, the patient experienced PAIN IN EXTREMITY (his arm hurts less than usual). On 11-Nov-2021, UNDERDOSE (15-20%less than full dose administered) and DEVICE CONNECTION ISSUE (When the syringe was removed from his arm, his arm was all wet) had resolved. At the time of the report, PAIN IN EXTREMITY (his arm hurts less than usual) outcome was unknown.            No Concomitant and Treatment medication were reported.
Patient is a 54-year-old female who presents for evaluation of right arm injection site. Patient reports she had the influenza and hepatitis A vaccination injections on 10/3/18. Patient states and proximal right upper extremity near injection site, she noticed a small "dot". States she has used rubbing alcohol on the area. Rates pain 1/10. In patient's proximal left upper extremity she reports some pain, which she describes as itching and burning. Patient denies noticing any lesions in her proximal left upper extremity. Denies any drainage or erythema of either arm. Denies any fever, sweats, chills. Denies being on any antibiotics. Follow-up PRN.
father states pt awoke on 28OCT97 w/elevated temp of 102;APAP given;3PM cont to have fever so took child to MD;fever remained elevated to 101-102;30OCT97 devel a gen body rash;
This spontaneous report as received from a nurse practitioner who is also the 61 year old female patient with gastroesophageal reflux disease secondary to non steroidal anti-inflammatory drugs, hypertension, low potassium, fibromyalgia, sensitive to latex and has drug reactions/allergies to sulfa. The patient's medical history included back soreness, joints aching and recent back surgery repair. On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX in the left arm. Dose, expiry date were not reported. Concomitant therapies included NORCO. The patient had received vaccine in her left arm, not in deltoid, below deltoid, toward later, above elbow and it was a funny angle to get there. Within 24 hours (02-DEC-2013 approximately), she developed a baseball sized local reaction. The patient said though she had fibromyalgia, last night and day before (03-DEC-2013 approximately) she experienced joints aching, back soreness much more than she had before. The patient took TYLENOL and MOBIC as treatment and informed that she did not normally take these medications. The patient had contacted her physician regarding the reaction. The patient informed that last 2 days had been horrid and had started to itch last night (04-DEC-2013) but not quite as red as it was initially and there was no other rash anywhere on her body. The event of redness was resolving at the time of report, outcome of joints aching and back soreness was unknown and outcome of rest of the events were not resolved. No lab studies were performed. Additional information has been requested.
Body Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Body Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced CHILLS (Body Chills). At the time of the report, CHILLS (Body Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment medications 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.   This case was linked to MOD-2022-624376, MOD-2022-624175 (Patient Link).
Dermatographia Typical case - any minor scratch anywhere on my body causes hives. Zyrtec and Benadryl help a ton.
Severe shoulder pain in left arm (the arm in which the shot was given), pain radiating to left forearm, fever up to 101.0F (no fever as of 10/14 10:00 AM), dizziness, ringing in ears which turned into sound of sand pouring into a plastic container (lasted 10 mins), kidney pain, side pain, left eye pain when I look around or press on it it hurts (this pain is still here 10/14 8:30pm). No treatment taken.
pt called stating her arm is swollen from  her shouler almost to her elbow and warm to the touch  her had the PPV23
sleepiness; Minor ache at shot site; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in right arm on 19Mar2021 at 14:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. 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 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Mar2021 at 19:00, the patient experienced minor ache at shot site and mild sleepiness. No treatment was received by the patient for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain and sleepiness was resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected.
Patient received (FLUZONE HD) vaccination. After approximately 30 seconds patient stated was not feeling good. Patient was clammy and was having trouble breathing. Immediately called 911. Patient never lost consciousness, but was evidently in respiratory distress. Patient's breathing recovered, paramedic arrived.
S/P COVID19 vaccne today, pt was monitored in obs. unit. After 15-20 minutes, she c/o itching on her Left arm (injected arm). No rashes or hives on arm/trunk. No swellimg. Lungs clear to auscultate. VS stable. Benadryl 25mg po given and improvement. BP 119/79 - pulse 64 - 100% RA
Large white circle on skin on the underneath side of injection site just below the tricep muscle; swollen lymph node in armpit with extreme pain and restricting movement
fever; chills; body aches; terrible nausea; headache; very tired; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 3248), via an unspecified route of administration in left arm on 24Mar2021 at 10:00 AM (at the age of 56 years old) as single for covid-19 immunisation. Medical history included underactive thyroid, covid-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications patient received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID) 0.50 mcg for hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 24Mar2021 at 23:00, after 1st vaccine woke that night at 11 with fever, chills, and body aches. On 24Mar2021 patient also experienced terrible nausea and headache. Was in bed 4 days - very tired, extremely nauseous on 24Mar2021. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 3248), via an unspecified route of administration in left arm on 14Apr2021 for covid-19 immunisation. The patient did not received treatment due to the events. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
severe headache; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 19Mar2021 at 11:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, osteoporosis and penicillin allergy. Concomitant medications included alendronate sodium (FOSAMAX) and sertraline hydrochloride (ZOLOFT). The patient previously took clindamycin and had an allergy. 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 vaccination. On 24Mar2021 the patient experienced a severe headache which was moderate to severe headaches continuing for more than two weeks after vaccination. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe headache was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
UPSET STOMACH; PLANTAR FASCIITIS IN LEFT HEEL; HEADACHE; This spontaneous report received from a patient concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced upset stomach, plantar fasciitis in left heel, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upset stomach, and headache, and was recovering from plantar fasciitis in left heel. This report was non-serious.
Mom & pt left clinic & mom noticed pt breaking out in "hives", mom stopped car & gave pt dose of DPH & returned to clinic; pt had large red blotchy areas on both thighs & in inner aspect of rt forearm; large, red, raised patch covered arm;
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-APR-2015 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) for the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 08-FEB-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak, mental and emotional distress, physical limitations and vaccination failure were reported to be disabling. Additional information has been requested.
pt recvd vax 29NOV94 then reported to sick call 2DEC94 w/ c/o rash, swollen throat/tightness; tx Ataxax;
hurting in the first few days; Red dot on the injection area; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red dot on the injection area) and INJECTION SITE PAIN (hurting in the first few days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Red dot on the injection area). On an unknown date, the patient experienced INJECTION SITE PAIN (hurting in the first few days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (Red dot on the injection area) and INJECTION SITE PAIN (hurting in the first few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Blood thinners and Diabetic medication.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in 2014 (reported as "since 28-OCT-2014), an unspecified number of patients were administered with GARDASIL (doses, routes of administration, lot numbers and expiration dates were not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm soreness  1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next day, still experiencing fatigue and body aches but not as much. 1/12/21 feeling flu type symptoms again body aches, muscle, nausea, chills, severe sweating during night sleeping awoke several times . 1/13/2021 feeling flushed and sweating again while working, stomach cramps, nausea and then vomited x1. Tiredness and extreme fatigue, almost hard to walk, heavy head, chills, fever 100.  Has taken Tylenol some relief
Severe body aches, skin discomfort, fever, chills, headache, dizziness
Right arm was red around injection and went down the inside of arm almost to elbow. Warm to touch. Advised to take BENADRYL as directed and use a cold compress.
Swelling and redness at injection site, worsening over several days, joint pain, upper respiratory symptoms, general malaise, symptoms worsened over several days and then began improving by day 4 after immunization.
This spontaneous report as received from a consumer refers to her mother-in-law of unknown age. The patient was vaccinated with ZOSTAVAX on an unknown date. Lot # and route were unspecified. The patient developed shingles on her neck while she was in hospital after having a surgery to take out her uterus. The outcome of patient was unknown. Additional information is not expected.
Cellulitis treatment sulfa/trim 800-160 bid x 5 days.
Initial report was received from a consumer on 11 Dec 2009: This patient (3 year old) inadvertently received FLUVIRIN 0.5 ml, intramuscular on 10 Dec 2009. No adverse events were reported upon administration.
Patient reports having an MMR vaccine 90 days before conception of pregancy. No complications from the vaccine were reported. Fetal sonogram detected a unilateral absent hand at 20 weeks gestation.
woke up two days after with 100% hearing loss in right ear and 70% impairment in left ear.  Prior to vaccine, hearing was superb.
Information has been received from the registered nurse. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 18-MAR-2013 was administered a dose of GARDASIL (lot # and expiration date were not reported) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Information has been received from a PA concerning a 5 year old male pt who on 6/13/00 was vaccinated with Hep-A virus vaccine inactivated. The same day of vaccination, the pt had a tuberculin skin test (results not reported). On 6/15/00, the pt presented with an "itchy, generalized rash all over his body with pustules on his chin." Unspecified medical attention was sought. Additional information has been requested.