chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Edema under left armpit/ Edema is not lymph node, it is generalized and larger than a deck of cards but soft.; Muscles in left shoulder were painful; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 04Nov2021 at 11:30 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, obesity, heart arrhythmia and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. On 07Nov2021 at 11:00, the patient experienced edema under left armpit (vaccine was administered in left shoulder), muscles in left shoulder were painful for 2 days but reduced. The patient reported that edema was not lymph node, it was generalized and larger than a deck of cards but soft. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscles in left shoulder were painful was recovering while of the event edema under left armpit (vaccine was administered in left shoulder), edema was not lymph node, it was generalized and larger than a deck of cards but soft was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Horrible headache, horrible nausea, fever (100.3), joint/muscle pain, mouth/gums and jaws hurt, chills, arm pain at injection site. My checks seemed a little swollen. I had an awful metal taste in my mouth for a day. I felt like I had been poisoned.
Patient did not take the second dose within the recommended dosing window; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not take the second dose within the recommended dosing window) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not take the second dose within the recommended dosing window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not take the second dose within the recommended dosing window) 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 medication not reported.  Treatment information not reported.
developed a large red spot not at the injection site; This case was reported by a other health professional and described the occurrence of localized erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was unknown.   It was unknown if the reporter considered the localized erythema to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient experianced large red spot after every shigrix vaccination . The large red spot not at the site of administration but red spot at few inches from site of administration.  The patient was fine but think about red spot which are not at site of administration. The reporter consented to follow up.
Administered influenza and bivalent covid vaccines to patient on 10/14/22 at senior living facility. In error, the same vaccines were administered to patient again on 11/9/22. Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Administered influenza and bivalent covid vaccines to patient on 10/14/22 at senior living facility during a Covid/Flu vaccine clinic for residents and employees. Facility requested a second Covid/Flu vaccine clinic for more residents and employees.  On 11/9/22, our pharmacy went to administer vaccines and in error, the patient was received a repeated Influenza and bivalent covid vaccine (in <1 month).  Alerted Director of Nursing at facility and patient's physician when error was discovered (11/9/22).
Likely gave a patient a partial dose, liquid was dripping out on the patients arm; the needle became disconnected and liquid was dripping out on the patient's arm; A spontaneous report was received from a health care professional concerning a patient (unknown age and gender) who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced partial dose given and device use issue.   The patient's medical history was not provided.  Concomitant medication were not provided.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   On an unknown date, during administration, the needle became disconnected from the syringe and liquid was dripping out on the patient's arm. It was reported that the patient likely received a partial dose. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event is considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and device use issue for mRNA-1273 (lot # unknown). There were no reported AEs associated with this case of incorrect dose administered and device use issue.
12 hours post injection, my blood pressure dropped, I almost passed out and my hands and feet turned blue. Chills lasted for about an hour and a half.
K92.2 - GI bleed I26.99 - Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (CMS/HCC)
the second dose ofGARDASIL9 "not intramuscular and was given at the top of her shoulder ahnost parallel bra strap; redness at the injection site; This spontaneous report was received from a registered nurse and refers to a 32-year-old female patient. The patient's concurrent conditions included allergy to acetaminophen (+) oxycodone hydrochloride (PERCOCET), ibuprofen and pseudoephedrine hydrochloride (SUDAFED). The patient's historical drug included acetaminophen (+) oxycodone hydrochloride (PERCOCET), ibuprofen (manufacturer unknown) and pseudoephedrine hydrochloride (SUDAFED). It was reported that the patient did not have any concomitant medications or pertinent medical history.  On 03-DEC-2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, (strength, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 13-FEB-2020, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R028386, expiration date 27-APR-2021. The patient received a second dose of the vaccine not intramuscularly and it was given at the top of her shoulder almost parallel bra strap. On 14-FEB-2020, the patient contacted the office to report redness at the injection site. She sought medical attention to see the nurse however no treatment was given. The outcome of injection site erythema was reported as recovering.  The causality assessment was not provided.
Narrative:  75yo male died during inpatient hospice admission from Metastatic hepatocellular carcinoma. Pt had received one covid vaccine on 3/30/2021 (J&J). This death caused by cancer and covid vaccine is not related to death.
I had intense bone and muscle aches. I had a lot of pain in my hips as well. I was thinking that had Arthritis. This continued to progress, and I started to have this in my arms, legs, knees, and all over. My hip was hurting so bad that I went to an urgent care clinic, and she did an X-Ray and said I had an old hairline fracture and prescribed 7 days' worth of steroids. I started taking a supplement for joint pain and my heartrate skyrocketed. I went to the ER, and they admitted me because my Thyroid went crazy. I had to stay in the hospital for 4 days. That happened in April. They put me on a Beta Blocker to slow my heartrate. I explained to the doctor why I started taking the supplement and this started happening shortly after taking the supplement. The doctor seemed to think that this could have been booster related. Now, am I seeing an Endocrinologist.
pt recvd vax;labyrinthitis w/ sx like benign positional vertigo;subjective sx of imbalance w/ limitation;neurologic exam nl;
Info has been received from an RN concerning a 25 year old female who in 12/05, was vaccinated with a dose of varicella virus vaccine live (lot 648298/0186F). Subsequently, the pt experienced a rash. Unspecified medical attention was sought. The pt subsequently recovered. The pt was planning to receive her 2nd dose. There was no product quality complaint involved. Additional info has been requested.
Client received her first Pfizer-BioNTech COVID-19 Vaccine at about 12 noon on 04/09/2021 with lot number ER8731 exp. 07/2021.  Client's daughter reported to EMT that her mother's arm was twitching at the site of the injection. Patient has a history of Carpal tunnel syndrome for the last 10 years, stroke in 2010, and asthma requiring an albuterol inhaler. Vital signs at 1232pm revealed: blood pressure of 172/120, pulse of 64, and respiratory rate of 16 breaths per minute. Vital signs at 1242pm were 168/132, pulse of 62. Blood pressure at 1256pm was 190/110. EMS was offered to client but was declined, client was alert and oriented. No medications or interventions were indicated or administered. Client stated would follow-up with medical provider on own. At 1300 client and daughter left the site, reporting feeling fine, however, symptoms noted were not resolved. Client stated would go to  Hospital for further evaluation as that is where medical records are.
Patient presented to the pharmacy for her second vaccination and was concerned because she had side effects from the first vaccine. She showed a picture of her swollen right breast (mastitis) and she stated she was taking antibiotic for after consulting her OB/GYN about the problem. She stated her doctor has seen this reaction from another patient and she stated her cousin had a similar reaction to the COVID 19 vaccine.
Patient received flu injection yesterday at office. Noticed while she was driving from office that her arm started to swell, become warm, developed itching. She pulled over to the side of the road. Stated that the swelling came to the size of a golf ball. She was able then to drive home. She took Benadryl when she got home which brought the swelling down and relieved some of the itch. She had no respiratory distress or anaphylactic symptoms. Today she slept until 11 am. She has full use of her arm. She spoke with our nurse today who advised her to monitor symptoms and apply ice if needed to the swelling. Physician was advised for further recommendations.
Fever 102.3, chills, muscle cramps, soreness at injection site, mild cough, fatigue beginning all starting 9 hours after vaccine.
Severe headache, flushed hot face, pain in arms and legs, weakness for 36 hours.
Per mom, Patient, about 3 hours or so after she got the vaccine she started with a headache, blurred vision, shortness of breath and fatigue.  These symptoms lasted about 48 hours.   Mom gave her some Benadryl and that helped. Mom also stated that she did have similar (minor) symptoms after her 1st Men B on 8-5-2020, but thought it was due to her period at the time.
patient called to state that she experience one day of flu like symptoms (fever, chill, lethargy) beginning the day after her vaccination and resolved by the next morning.
The patient reports the day of the vaccine he had swelling of left side of lips and cheek. Additionally he started having superficial abdominal discomfort on the LUQ that radiated to the back. Abdominal pain is described as a superficial, pinching. Not stabbing or visceral.  The lips and cheek swelling has resolved since day of exam (3 days after the vaccine) - he took cetirizine on Sunday and Monday  The abdominal discomfort is improving- using ice & naproxen as needed to alleviate it.
Swollen under my eyes.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 30Apr2021 at 10:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included dermal fillers a couple of months back and the patient reported no other relevant medical history. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN), both taken from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 09Apr2021 at 00:00 as single dose for COVID-19 immunisation. 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 01May2021 at 08:00, the next day after the vaccination, the patient experienced swollen under her eyes and the patient called her doctor. Therapeutic measures were taken as a result of swollen under the eyes and included treatment with benadryl and ice as suggested by her doctor. The clinical outcome of the event swollen under her eyes was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Came in for a vaccine shot, I greeted him and asked if he was getting his first or second vaccine and he stated that he was getting his second shot and I asked if it was Pfizer he said yes and i directed him to an open nurses station and administer the vaccine once the scribe was done taking his info. the person answered all the questions and then received the shot ,once receiving his vaccination card he said he thinks he took Jansen (J&J) the first shot . at that point he was instructed by the pharmacist of what he could expect for side effects being he got Pfizer on top of J&J. and what to do about the side effects.
Information has been received from a physician concerning a 12 year old male who in 2007 was vaccinated with the second dose of VARIVAX (Merck) injection. On 01-JUN-2010 the patient came into the office and the patient presented with chickenpox. Titer test was performed but the result was unknown. At the time of report, the patient had not recovered. Additional information has been requested.
Burning sensation during administration with flu like sx x 2 days along with numbness, tingling, heaviness and weakness in arm.
not feeling good; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205), via an unspecified route of administration, on 05Mar2021, at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose on 05Mar2021 and she was not feeling good after that one on an unspecified date in 2021, but it was not bad. The outcome of the adverse event was unknown.
first dose of shingrix january 3rd, 2021/ has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd January 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (circular red area on her arm at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (circular red area on her arm at the injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm was sore). At the time of the report, VACCINATION SITE PAIN (arm was sore) had resolved and VACCINATION SITE ERYTHEMA (circular red area on her arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reporter that the area of injection site is about 2 inches in diameter. It was red, but did not hurt and not rashy. Concomitant medications were not provided. Treatment information was not reported.
School nurse - called to have me take child to hospital immediately. I took her to clinic to see Dr. She was wheezing uncontrollably. She could not catch her breath. She had trouble speaking this happened 09/15/09. At around 2:45 or so Dr. said she had a physical activity related asthma attack. He prescribed ADVAIR & PROAIR. 11/23/09 Medical records received for date 9/15/09. DX: asthma Presents with asthma symptoms increased. Pt states worse with exercise. Assessment: (+)wheezing.
Itching accompanied by small raised red dots on skin, mostly on hands and arms, bilateral, not near injection site. Minor discomfort, treatment not initiated.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program . The male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 04Jan2021 at SINGLE  DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He received the Pfizer BioNTech COVID-19 vaccine on 04Jan2021 and tested positive for COVID-19 on 11Jan2021. He said he is already back to work and is scheduled for the second dose on 25Jan2021. He asked if he should go forward with the scheduled dose or should he wait 6 more weeks for the second dose. The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
This spontaneous report as received from a consumer refers to a 73 years old female patient with high cholesterol and penicillin allergy. On 27-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose were unspecified) subcutaneously. Concomitant medications included CRESTOR, SYNTHROID, omega-3 marine triglycerides (fish oil), calcium (unspecified) and aspirin (Baby aspirin). On 30-NOV-2012, the patient experienced itching on her back. The patient stated that the event was not bad and she would advise her doctor. It was unspecified if the patient sought medical attention. No treatment was given. The outcome of itching on her back was unknown. Additional information is not expected.
I tested positive the COVID-19; I tested positive the COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 28-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested positive the COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Patient is an orthopox virus lab worker vaccinated per IND.  Had major reaction to vaccine.  On post vaccination day 145 was exposed to cowpox-infected calf tissues.  On post exposure day 9 developed erythema and pruritis at vaccination site.  Two days later developed 2-3 vesicles at the site.  Appearance of vesicles concurrent with sunburn.
Shingles vaccination is HORRIBLE!! I GOT SOOO SICK; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-JUN-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient stated that shingles vaccination was horrible and got sick. The patient did not recommend it. Additional Supportive Information: Follow-up would not be possible, as no contact details were available.
Narrative:  Patient tested positive for COVID-19 and was hospitalized despite full vaccination. Pt received Pfizer (2 doses) last one on 02/16/2021. No booster dose was received.
Left deltoid swollen, hot to touch. No redness. Localized reaction. Afebrile, tender to touch.
5 min- blurred/wavy vision 10 min- lightheaded 15min - body shakes, stiffened and painful spine. Over next hour, went through 10 min waves of feeling hot and cold. 30 min- given 25mg Benadryl; no effect At 45 min- Pharmacy called 911.  Taken to hospital/ER.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition and medical history was not reported. On 02-MAY-2016 the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L044528 with expiration date of 09-FEB-2017, dose and route unknown). No adverse effect was reported. Additional information has been requested.
Information has been received from a health professional concerning an approximately 13 year old patient who on 29-DEC-1998 was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). On approximately 12-MAY-2008 the patient developed 50 lesions. At the time of the reporting, the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.