chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives all over the body) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Skin reaction. Concurrent medical conditions included Parkinson's disease, Sulfonamide allergy (Had skin reaction to sulfa) and Penicillin allergy (Had skin reaction to penicillin). Concomitant products included LEVOTHYROXINE, VITAMINS NOS, LEVODOPA, CARBIDOPA and PRAMIPEXOLE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (Developed hives all over the body). In March 2021, URTICARIA (Developed hives all over the body) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication included Aceclopar and tremor medication.  The patient was not sure but think that the vaccine administered on the left arm. Then, 4 days after the second dose the patient developed hives all over the body. This lasted for a week and the patient mentions taking antihistamines for it.  Patient stated having same kind of skin reaction with other medicines like sulfa, penicillin and Thoudsand X.
Patient presented to ER after a syncopal episode at home.  She reports feeling lightheaded and fell to the floor, she is uncertain how long she was unconscious, but when she came to, she called 9-1-1.
Soreness at injection site, chills, rhinorrhea, fatigue Narrative:  Per nursing report: "C/o sore,swollen right arm,runny eyes, runny nose,chills and fatigue. "
At the time of vaccination, a part of the liquid contained in the syringe spilled prior to it being injected. Unclear how much of the dose truly administered. I felt minimal left deltoid injection site pain with the second vaccine than the first.
Patient is a 64 y.o. female patient of, CNP with history of DM type 2 without insulin use, HTN, HLD and depression who presented to Doctors Hospital with shortness of breath and hypoxia. Problem based management in the hospital is as follows:   Acute respiratory failure with hypoxia, resolved Covid-19 Virus Infection Date of onset of symptoms: 10/10 Symptoms present on admission: Fatigue and shortness of breath.  Date of covid positive test: 10/13 Vaccination status: vaccinated Imaging: CTPA showed severe multivessel coronary calcifications.  0.7 cm noncalcified nodule and anterior lateral right mid chest, 0.4 cm stable noncalcified nodule in posterior medial left lower chest.  A 1.4 cm hypodense nodule within the left lobe of the thyroid gland. Oxygen requirements on admission: 2 L Current oxygen requirements: Room air Medical therapy: remdesivir and steroids while inpatient, discharged on steroid taper Consultants following: ID were consulted Anticipated special isolation end date: 10/20   Elevated troponin Likely related to COVID-19 infection Troponin 30 then 24, delta -6 EKG with mild ST depressions in lateral leads otherwise unremarkable. Patient denies any chest pain No further inpatient work-up indicated   Chronic back pain and left hip pain Reports acute aggravation over the last week or so Has history of previous back surgery with a scar but she is unable to explain what kind of surgery was She takes gabapentin 600 mg nightly, changed to 200 3 times daily for now. Recommend continued outpatient follow-up with surgery  Hypokalemia, resolved K3.4 on arrival Replaced Recheck tomorrow   Lung nodules Noted on CTPA as above Recommend repeat CT chest in 6 months   Thyroid nodule Noted on CTPA as above TSH WNL Recommend outpatient thyroid ultrasound   DM Type II without insulin use or complications Uncontrolled.  Takes metformin at home Held oral meds and SSI for now   Benign Essential HTN Takes amlodipine, Hyzaar at home Continue home meds Continue monitoring   Mixed Hyperlipidemia Continued home dose statin    GERD Continued home PPI   Anxiety and depression Continued home BuSpar, Depakote and Zoloft   Insomnia Continued home Ambien as needed   After 2 days of hospital stay, patient was doing well so he was discharged in stable condition. Advised to f/u with PCP and spine surgery. All questions and concerns were addressed before discharge.
This case is a part of cluster of 5 cases and is linked with 2012-10398, 2012-10466, 2012-10467, 2012-10469 (same reporter, same events after administration of FLUZONE ID batch number: UT4468BA). Initial report received from a healthcare professional on 06 November 2012. A male patient (age was not reported) whose illness at the time of vaccination and medical conditions were unknown and concomitant medications were not reported, had received an intradermal dose 1 of FLUZONE ID vaccine (batch number: UT4468BA) in the deltoid region on an unspecified date of September 2012. On an unspecified date, 3 months after the vaccination, the patient presented stomach upset with fever, diarrhea and vomiting. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered. Documents held by sender: None.
Two days after I received the vaccine I noticed swelling and the site was simultaneously sore and itchy. It is now 5 days post injection and it?s  red and appears to be bruising, is still raised, sore and itchy, and I feel like I?ve lost strength in that arm. It just feels tired and weak as if my arm itself is fighting a virus. I am currently pregnant, was 27weeks and 2 days pregnant at the time of the vaccine.
Intense ?coffee grind vomit? 12 days no food/water Chest racing Feeling of hollowness in chest   Zofran for a few crackers during two separate 15 days total hospitalization 6/7/15 hospital and 10/28-11/2 other hospital  No fluid while hospitalized had iv and now I have no veins left from weeks with many iv
AT 0900, patient complained of left hand and finger numbness. Patient stated this has happened before. Staff continued and to watch for additional 5 minutes. Patient went home after additional 5 minutes and told to go to the emergency room if any symptoms returned.
UrticariaPruritus Narrative: Mild reaction R Arm and Left leg w/mild urticaria. Treated with 25mg Benadryl oral, observed for additional 30 minutes and released to home feeling well
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Tested positive for COVID/She has no symptoms; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 31May2022, outcome "unknown", described as "Tested positive for COVID"; ASYMPTOMATIC COVID-19 (medically significant) with onset 31May2022, outcome "unknown", described as "Tested positive for COVID/She has no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) positive, notes: tested positive for COVID on 31May and 30May respectively.  Additional Information: Patient was vaccinated with Pfizer COVID vaccine. Reporter asked for pics of their COVID cards and will send shortly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe abdominal pain, vomiting, diahrea, chills, headache, body aches, pain in wrist, these lasted about 2 days.
Patient came back when he was shopping one day and told me he had had some reactions to the shot. He went on to explain: redness at the injection site (no itching) that lasted several days and dizziness and mild fever with chills that lasted a few hours after the shot.
Arm that was injected feels weaker with muscle twitching over 1 week after vaccination; Arm that was injected feels weaker with muscle twitching over 1 week after vaccination; menstrual cycle was lighter and shorter than usual; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 10Jan2021 (at the age of 27 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included GERD. The patient previously received the first dose of BNT162B2 on 20Dec2020 at 02:30 PM (at the age of 27 years old) as a single dose via intramuscular route of administration in the left arm for COVID-19 IMMUNIZATION. Concomitant medications included vitamin D3, cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), and fluticasone propionate (FLONASE). The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021, the patient experienced her arm that was injected feels weaker with muscle twitching over 1 week after vaccination and her menstrual cycle (that is usually regular each month) beginning 17Jan2021 was lighter and shorter than usual. The patient did not receive any treatment for these events. The outcome of the events arm that was injected feels weaker with muscle twitching and menstrual cycle was lighter and shorter than usual was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Information has been received from a nurse concerning a currently 1 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001065: US-009507513-1704USA001070: US-009507513-1704USA001067: US-009507513-1704USA001068: US-009507513-1703USA012554: US-009507513-1704USA001064: US-009507513-1704USA001066:
MD reported that patient received vaccination within 2 years of previous shot and had diffuse immunological reaction to left arm with red swollen tender hot area,  "immunological memory".  6/16 arm better; less red, less swollen; positive antineutrophil cytoplasmic antibody
Patient was given dose 1 of MMR intramuscularly in the right deltoid muscle instead of subcutaneously.
RECEIVED JANSSEN COVID-19 VACCINE THREE TIMES; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced received janssen covid-19 vaccine three times, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received janssen covid-19 vaccine three times and off label use was not reported. This report was non-serious.
Bilateral lower leg mild swelling and moderate pain, pain worse to right leg Pt is taking Tylenol and ibuprofen with good pain relief Pt is raising legs while sleeping at night which helps reduce the swelling
Extreme itching on bottoms of feet and palms of hands-extending to tops of feet and tops of hands- began 2nd day after 2nd shot
My heart started feeling funny. I walk a lot and we usually walk four miles 4 or 5 days a week. I told her my chest felt funny. It didn't funny. It felt like heart was pounding. I waited about a month before I went to doctor - never had it in my life this kind of thing. It beats out of whack ( my heart) - I feel it mostly at rest. If I lie down I can hear heart beating in my ear. It is still occurring. The next step would maybe be to take beta blockers but haven't tried that yet. My doctor can hear it. It's constant - it is always is doing it. When I stop and slow down, I hear that it's beating irregular.
2 DAYS AFTER INJECT PT COMPLAINED OF PAIN- THROBBING TYPE, AND FEVER AT SOI. WHEN SEEN BY NURSE PT HAD DISCOMFORT /W/ LG ERYTHEMA FROM SOI-LEFT DELTOID TO ELBOW.
Started with hives on leg that rec'd Hep A. Spread to abdomen and arms. No breathing problems or other issues.
day p/vax pt exp red, swollen 10x12cm area over leg. treated w/benadryl, ice pack, diproline gel
This spontaneous report as received from a physician refers to a 38 year old adult female patient. The patient's concurrent condition included allergy to penicillin. On 18-FEB-2010, the patient was vaccinated with M-M-R II (lot #, expiry date, route of administration not reported) (0.5 ml dose) as she was health care worker. No concomitant medication was reported. The physician reported that the patient's titer drawn on 12-SEP-2014 showed that the patient was not immune to mumps. On 24-SEP-2014, the patient was administered another 0.5ml dose of M-M-R II (Lot# J014876, unspecified expiry date). The patient sought medical attention and consulted the physician. The outcome of event was unknown. No further information was reported. Additional information has been requested.
Medical assistant called stating that diluent or liquid portion of PENTACEL is missing so lyophilized portion was diluted with a normal saline diluent with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient to whom administered the diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)] and reporter stating that diluent or liquid portion of pentacel is missing so lyophilized portion was diluted with a normal saline diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine Suspension for injection (strength: not reported, Expiry date: 09-Oct-2023, lot UJ790AA) via unknown route in unknown administration site as Immunization and medical assistant called stating that diluent or liquid portion of pentacel is missing so lyophilized portion was diluted with a normal saline diluent with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Lupus/ about 1 week after getting the 2nd dose of the vaccine; she got her 1st dose in May2021/ Her 2nd dose was in Dec2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2021 (Batch/Lot number: unknown) at the age of 20 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Diagnosed about 4 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Anatomical Location: Left arm), administration date: May2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "She was so sick", "symptoms of Lupus". The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus/ about 1 week after getting the 2nd dose of the vaccine"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Dec2021, outcome "unknown", described as "she got her 1st dose in May2021/ Her 2nd dose was in Dec2021". The event "lupus/ about 1 week after getting the 2nd dose of the vaccine" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results. Clinical course: It was reported that, patient did not had lupus before she got the vaccine but, 2 weeks ago, she was diagnosed with Lupus, which was about 1 week after getting the second dose of the vaccine. She started to get symptoms after she received the first dose of the vaccine in May2021, but she wasn't diagnosed with Lupus until just recently. She reported that she waited all that time to get the second dose because she was so sick. She decided to finally get the second dose due to the Omicron strain, but she was still sick and was going to doctors to try to figure out what was wrong, so she doesn't know if it was the first dose that did it or the second dose. She confirmed that the doctors don't want to link this to the vaccine, but she feels that it's related.   The lot number for bnt162b2 was not provided and will be requested during follow up.
arm  swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  swelled up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection. Concomitant products included CEFDINIR for Urinary tract infection.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm  swelled up). At the time of the report, PERIPHERAL SWELLING (arm  swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Telephone contact report received
103 degree fever for 14 hours, severe body aches, nausea,  night sweats
Pain lower left abdomen at first. Then radiation to lower back. Then trip to ER.  Diagnosed with pancreatitis.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Mild difficulty breathing), HEART RATE INCREASED (Had a fast hearbeat (strong palpitations)), HEART RATE IRREGULAR (Heart beats irregular), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Mild chest pressure) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal cord disorder, Back pain, Muscle pain and Heart attack.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced DYSPNOEA (Mild difficulty breathing), HEART RATE INCREASED (Had a fast hearbeat (strong palpitations)), HEART RATE IRREGULAR (Heart beats irregular), PALPITATIONS (Palpitation), CHEST DISCOMFORT (Mild chest pressure) and VACCINATION SITE PAIN (Arm is still a little sore from vaccination). On 10-Jan-2021, the patient experienced BACK PAIN (Backache) and MYALGIA (Muscle aches). On 09-Jan-2021, DYSPNOEA (Mild difficulty breathing), HEART RATE INCREASED (Had a fast hearbeat (strong palpitations)), HEART RATE IRREGULAR (Heart beats irregular), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Mild chest pressure) had resolved. At the time of the report, BACK PAIN (Backache) and MYALGIA (Muscle aches) outcome was unknown and VACCINATION SITE PAIN (Arm is still a little sore from vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Administered an Expired Dose; Initial Report Received on 22-Apr-2022  A pharmacist reported that patient (age, gender, race, and ethnicity unknown) was administered an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   No concomitant medications at the time of vaccination were reported.  On 21-Apr-2022, the patient was administered a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown). The reporter thought the HEPLISAV-B vaccine expired 8 days ago.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.