chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No appetite; felt draggy; ached all over; fever off & on; mild pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), MOBILITY DECREASED (felt draggy), MYALGIA (ached all over), PYREXIA (fever off & on) and VACCINATION SITE PAIN (mild pain at the injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DECREASED APPETITE (No appetite), MOBILITY DECREASED (felt draggy), MYALGIA (ached all over), PYREXIA (fever off & on) and VACCINATION SITE PAIN (mild pain at the injection site). At the time of the report, DECREASED APPETITE (No appetite), MOBILITY DECREASED (felt draggy), MYALGIA (ached all over), PYREXIA (fever off & on) and VACCINATION SITE PAIN (mild pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
About 1-2 minutes after the patient received the vaccine, she reported she wasn't feeling well and then fainted while sitting in chair. Her husband and I proceeded to transfer her to the floor and elevate her legs. Patient resumed consciousness after 1 minute and had no recollection of what happened. Blood pressure was taken after 5 minutes (95/55) and again after 10 minutes (117/96). EMS was called because patient was still not feeling improvement after 10 minutes (reported shakiness, tingling feeling in hands and tongue). EMS cleared her as BP was normal and blood glucose level was normal.
Information has been received from a registered nurse concerning a female patient "in her 70s" with a chronic renal insufficiency, hypertension, type II diabetes mellitus, hyperkalemia, and "ASVD" who on 05SEP2003 was vaccinated "from a multi-dose vial" with a second dose of pneumococcal 23v polysaccharide vaccine . A prior vaccination in 1998 with pneumococcal 23v polysaccharide vaccine was "without any type of reaction". Concomitant medication included Pletal, Plavix, Lasix, Zoloft, Glucatrol, Toprol XL, omeprazole, and aspirin. On 05SEP2003, "later that afternoon", the pt developed "swelling from site to elbow", which now appears as a green bruised area. It as noted that the pt was not hospitalized, was not seen in the office but was seen each day by home health (treatment not specified). The reporter expressed concern about the particular lot of vaccine and mentioned that the "second and third pt received lot 0873M". Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that the pt had recovered. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and research and was released. The reporter also mentioned two other pts who were vaccinated with pneumococcal 23v polysaccharide vaccine and experienced similar reactions. Additional information is expected.
Dizziness, nausea, feeling "hot". Observed 15-20 min. Stable and released.
Acute renal failure superimposed on stage 4 chronic kidney disease. Treated and discharged. ED visit and hospital admission within 6 weeks of receiving the COVID-19 vaccine.
Feeling cold and chills; Bones hurting; Migraine; Rash on my arm where it swelled up, its red; starting to move from out of my arm to the underneath where my armpit is and to my breast area; Rash on my arm where it swelled up, its red; starting to move from out of my arm to the underneath where my armpit is and to my breast area; Feeling cold and chills; Fever on and off all of day; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number was not reported, NDC number, UPC number, expiry date: unknown) via an unspecified route of administration on an unspecified date (at the age of 43 years old) as dose 2, single for covid-19 immunisation. Medical history included that the patient was allergic to lot of things from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number- not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that the patient got her second shot on Tuesday, and she had bad reaction to it. She got it at 1 pm and her first side effect started at 9 pm that night with feeling cold and chills, her bones were hurting and then the following day she had 100.6 highest, the fever on and off all of day, with migraine that was bothering her. She also had rash on arm where it swelled up, it was red and started to move from out of her arm to the underneath where her armpit was and to her breast area as well. The patient underwent lab tests and procedures which included body temperature: 100.6 on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
complex febrile seizure - also received his 15 mos shots, but mom did not know which ones. 2 seizures and fever to 104 within 24 hours
Primary AE:  Involuntary muscle fasciculations throughout entire body, especially concentrating in legs and arms (Started 1/1/21 and continues to today...interrupts sleep and thus my ability to function normally, strength, and psychologically distressing given the length of time), Secondary AEs:  essential tremor at rest; new onset brain fog (trouble with words in simple conversation, remembering order of tasks...new since vaccine and continues today, arthritis in fingers - started few days after shot and has not resolved ; Short-term AEs that have resolved - arthritic "crunchy" ankles with painful walking - next day, resolved in 3 days
she is having diarrhea; This is a spontaneous report received from contactable reporter (Consumer) from medical information team.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 13:00 (Lot number: EM9810) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 29Mar2021, outcome "recovering", described as "she is having diarrhea".  No follow-up attempts are possible. No further information is expected.
Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 12:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (10May2022) Positive, notes: Rebound Covid infection, 10May. Therapeutic measures were taken as a result of drug ineffective, covid-19. other medication in 2weeks was No. Rebound Covid infection, 10May. This is one week after completing. Paxlovid 5 day dose age.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # reported as L017406, expiration date: 26-FEB-2017 (dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
her eyes are currently very puffy/swollen, watery and itchy; her eyes are currently very puffy/swollen, watery and itchy; her eyes are currently very puffy, watery and itchy; her eyes are currently very puffy, watery and itchy; She says she has the other normal side effects like a headache; This is a spontaneous report from a Pfizer-sponsored programt. A contactable consumer (the patient) reported that an 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number for second dose: EW0162 or EWO162, expiration date: 30Jul2021, NDC number: 59267-1000-02) via an unspecified route of administration in left arm on 14Apr2021 19:15 at age of 18-year-old at 0.3 mL, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No family medical history relevant to AE. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) in left arm on 24Mar2021 at age of 18-year-old at 0.3 mL for COVID-19 immunisation and experienced no event (reported as "no AE following prior vaccination"). The caller declines being sick at the time of vaccination. No relevant tests. She said her eyes were currently very puffy/swollen, watery and itchy, start date 15Apr2021 ongoing improved. She said she had the other normal side effects like headache, start date 15Apr2021 ongoing improved. She did not elaborate on any other side effects. She said she was wondering what to do about her eyes, they were still swollen. She said she took an allergy pill to help that the pharmacist told her to take, her eyes were still somewhat swollen. She asked if she should call her doctor. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Eye felt dry, tingling in tongue and face, could not chew, could not move left part of face.
10 days after receiving his first dose of mmr he woke up with a full body rash. Head to toes. Rash lasted 9 days. He was extremely uncomfortable and wouldn?t sleep for the first 2 days.  His doctor said there was nothing to do but monitor him and to watch for fever and gland swelling. We gave him Tylenol for 3 straight days to keep him some what comfortable. I also gave aveeno oatmeal baths  and used aveeno oat lotion to try and control the itching.
Back pain; Lump at injection site; Dry mouth; Not much of an appetite; Chills; Feels tired; Fever 101-103 F; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), VACCINATION SITE MASS (Lump at injection site), DRY MOUTH (Dry mouth), DECREASED APPETITE (Not much of an appetite) and CHILLS (Chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced BACK PAIN (Back pain), VACCINATION SITE MASS (Lump at injection site), DRY MOUTH (Dry mouth), DECREASED APPETITE (Not much of an appetite), CHILLS (Chills), FATIGUE (Feels tired), PYREXIA (Fever 101-103 F) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain), VACCINATION SITE MASS (Lump at injection site), DRY MOUTH (Dry mouth), DECREASED APPETITE (Not much of an appetite), CHILLS (Chills), FATIGUE (Feels tired), PYREXIA (Fever 101-103 F) and MYALGIA (Body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 101-103 (High) Fever of 101-103 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Employee states that on the third day after vaccination was administered she began to experience headache and woke up that morning with a rash under bilateral breast and neck. As the days progressed rash grew to the middle of abdomen. Employee also reports that the rash was painful, reddened and inflamed. Employee treated symptoms at home with cold compress, cortisol anti-itch cream and over the counter Tylenol. Employee reports that symptoms resolved 2 weeks after injection.
experiencing swelling in the armpit of the arm I was injected in; This is a spontaneous report from a contactable other healthcare professional, reporting for himself.  A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via an unspecified route of administration on 06Jan2021 at 15:30 (at the age of 56 years old) as a single dose in the right arm for COVID-19 vaccination.  Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included famotidine (Pepcid AC) for an unknown indication from unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of  BNT162B2, lot number: EJ1685 on 16Dec2020 at 11:00 AM in the right arm. On 08Jan2021, the patient experienced swelling in the armpit of the arm he was injected in. The patient did not receive treatment for the event. The event did involve doctor or other healthcare professional office/clinic visit. The clinical outcome of swelling in the armpit of the arm he was injected in was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
16 hours after injection: moderate injection site pain, severe fatigue/disorientation, mild nausea, moderate headache
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 21-MAY-2021, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
arm is still aching/right arm continues to throb; This is a spontaneous report from a contactable consumer (patient herself).  This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 19Jan2021 (at 16:00, at the age of 76-years-old) at a single dose on the right arm for COVID-19 immunization, administered at hospital. No other vaccine was received in four weeks. No relevant medical history was provided. Past drug history included allergy to sulfur. Relevant concomitant medications included losartan.The patient stated 'my arm is still aching/right arm continues to throb'. The patient had not recovered from the event.
Verbal report from employee: Diagnosed with Brachial Neuritis. Has stiff neck and arm, nerve pain and spasms. On steroids and FLEXERIL.
3-26-2021 Fell tried to stand and fell again. Lack of equilibrium. Not dizzy, not vertigo just could not stand. Had periodic vertigo after that and vertigo. Had common side effects next couple days, fever, chills, nausea next couple days but periodic loss of equilibrium, stumbling fell couple times. Poor short term memory. 5-5-2021 TIA or small stroke, Driving difficulty staying in lane, could not park car, stumbling and catching self by grabbing something, at doctor office left side neurological symptom, Left arm drift and left heel to right leg abnormal. Change in cognition.
After receiving 1st dose of of J&J, client sat down post vax to be monitored, requested for water and when water was given, client suddenly lost consciousness. 1st VS 12:44-BP: 98/56, 55, 99% RA. 2nd VS: 120/80, 59, 99% RA. EMT/Fire Department called and notified. Arrived to site, BP taken, normal. BS: 79. Per EMT, client had a vasovagal response from the injection. Client refused to be transported to higher level of care. Client went home in stable condition.
This spontaneous report was received from a pharmacist refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were inadvertently vaccinated with improperly stored doses of VARIVAX (Merck) (dosage and route were not reported) lot# L026412 expiration date: 15-JUL-2017. No adverse effects were reported. Concomitant therapy was not reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because there is not permission to contact physician.
Patient's appointment was for a fluarix vaccine and a Pfizer COVID booster.  The patient was accidentally given two fluarix vaccines, both in left arm.  It was discussed with patient and her parents that were also present in the room with her.  After discussion, she was given the COVID vaccine she was expecting as well. Patient was advised to watch for increased symptoms/side effects from the flu vaccine.  Contacted patient today to check in, only reported redness at the injection site.  I told patient to contact me if it worsened or any other issues.
This is a spontaneous report from a contactable calling on behalf of a doctor. A patient of an unspecified age and gender (a student) received  the first dose of TRUMENBA for immunization at 0.5ml single dose on unknown date via an unspecified route. Medical history and concomitant medication were unknown.  On unknown date the patient had a temperature of 103 Fahrenheit. The outcome of the event was unknown.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  Company comment- This case concerns a 59-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a 59-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Headache, Myalgia, Diarrhea, NauseaVomiting, right arm soreness, cills Narrative:   Other Relevant History:
NauseaVomiting Nausea only Narrative:  Other Relevant History:
No symptoms until 1/7/21 when my arm was itchy, pink, and raised. It was same temperature as my arm, but it was approximately 3 inches wide and 2 inches long, and pretty much an oval where I had the vaccination.
1st dose a year ago, 2nd late; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over an year ago).   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 case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient was asking what could be done about the 2nd dose.
1:15 PM: pt received vaccination. 1:18 PM: pt states her throat feels "thick" and "uncomfortable to swallow".  Oxygen saturation: 100% and HR: 85.   1:30 PM: Oxygen saturation : 98%, HR: 69 1:35 PM: Oxygen saturation: 98%, HR: 70.  Reports feeling better.  Sensation is improving. 1:40 PM: Oxygen saturation: 99%, HR 65, pt reports she feels okay 1:45 PM: Oxygen saturation: 98%, HR 67. 1:50 PM: Oxygen saturation: 98%, HR 70.  Pt states she is ready to go and is feeling better.  She had no difficulty talking or breathing.
Gardasil used for condyloma accuminata; This literature marketed report was received from the authors of a published literature article, titled as stated below, and refers to a 9-year-old male patient. On an unreported date, the previously healthy boy presented to dermatology with his mother for a lesion on his penis with a recent history of itching and bleeding. On exam, there was a 6x7 mm brown papule on the shaft of his penis surrounded by smaller papules. The area was biopsied and pathology reported condyloma accuminata positive for Human Papillomavirus (HPV) 6 and 11, and negative for HPV 16 and 18. Upon further questioning, the patient's mother reported that she was serum positive for HPV; however, she and the patient's siblings were not clinically affected. The mother was educated on routes of transmission of HPV and denied any knowledge of prior sexual abuse. Laboratory Sexually Transmitted Infection (STI) studies were ordered and the patient was returned to primary care for further care and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination.   A copy of the published article is attached as further documentation of the patient's experience.
During her 15 minute monitoring post COVID vaccine, patient began to feel dizzy, light headed, waves of nausea and blood pressure started to climb
episodic acute heart pain, erratic pulse, lightheadedness, shortness of breath - symptoms would subside with rest - no treatment.
Left deltoid 1.5 x 1.5 in area of redness, erythema, non tender no inflammation.