chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delayed injection site rash beginning on 1/31/21; swollen lymph nodes, severe neck pain, fatigue, headaches, pain and itchiness at injection site followed. Swelling and pain in both hands that made it difficult to bend fingers and used hands developed over the second week. The hand pain began 2/2/21 but the very concerning swelling happened overnight from  2/5-2/7 on both hands, with the index and middle fingers especially affected. I went to the primary care doctor, with contact information listed above, on 2/8/21. Doctor's visit summary mentions: "Arthralgia of both hands; Reactive lymphadenopathy." She said if the swelling returns I should see my rheumatologist to rule out rheumatoid arthritis.
about 1 month after 2nd dose started feeling fatigue, 3 months later developed problem sleeping lying down, ankle swelling, sob, extreme fatigue 11/30/2021 went emergence room in at a HCF admitted with AFIB, CARDIOMYOPATHY, HEART FAILURE EJECTION FRACTION AT AROUND 23-25% admitted to hospital for 5 days released with digoxin, amiodarone, bumetanide, metoprolol and life vest worn for 4 months along with another heart monitor for 1 month ablation to correct AFIB 2 1/2 months later various medication adjustment off work for 4 months mild kidney failure
This spontaneous report was received from a female patient (age unknown) with back issues. The medical history included chickenpox. On an unknown date in 2008 (reported as 6 years ago, patient received ZOSTAVAX, unknown dose and frequency. Relevant concomitant medications were unknown. On an unknown date, the patient experienced rash on her back for which she was hospitalized on an unknown date for an unknown duration where she was diagnosed that the rash she had was because of the shingles (she had since an unknown date) after administration of ZOSTAVAX. Relevant laboratory data was unknown. The outcome of the events was unknown at the time of this report. Therapeutic measures taken in response to the reported events were not provided. The causality assessment was not provided. Additional information has been requested.
bruising all over body; swelling to the left side of face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling to the left side of face) and CONTUSION (bruising all over body) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced SWELLING FACE (swelling to the left side of face). On 10-Apr-2021, the patient experienced CONTUSION (bruising all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SWELLING FACE (swelling to the left side of face) and CONTUSION (bruising all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         No treatment information was reported.
Approximately 1 week after receiving the J&J COVID vaccine, the patient experienced a delayed rash that was red and itchy. The rash presented on their lower legs, underarms, back, hands, thighs and appeared to spread from place to place as time went on. The patient took Benadryl and could not tell if there was any symptomatic improvement. He did note that it wasn't getting worse, it was just moving to different sites on his body. Patient didn't report any systemic symptoms. At the time patient reported the reaction, he had experienced the rash for 1 day already.
A report has been received from VAERS concerning a 7 years old male patient. The patient's medical history included VSD, aortic annulus dilatation and recurrent otitis media. Concomitant medications were not reported. On 08-Oct-2010, patient received FLUMIST (intranasal). It was reported that illness began 20 days after vaccine administration with headache, visual changes, progressive weakness, fatigue, and bilateral upper and lower extremity pain. The patient required hospitalization. Multiple labs including CSF studies were obtained as well as a brain and full spinal MRI. The patient was diagnosed with Guillain-Barre Syndrome on 28-Oct-2010, for which he received IVIG. He had required pain control, NG feedings, and physical rehabilitation. He was currently still admitted at Hospital for rehab. Patient had laboratory investigation as initial CBC, CRP, CMP, CK all within normal limits. CSF showed elevated protein (52), normal glucose, normal gram stain, no growth on culture. Negative UA. Negative Enterovirus, HSV, Mycoplasma, EBV, West Nile virus, Lyme serology. Normal T4, TSH. Normal ESR. Repeat CSF studies showed elevated protein (73), normal glucose, gram stain. CSF culture no growth. CT head normal. MRI brain normal. MRI thoracic and cervical spine normal. MRI lumbar spine with enhancement of anterior nerve roots. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter considered the event of Guillain-Barre syndrome to be serious due to hospitalization and Required emergency room/doctor visit. Laboratory values and diagnostic test details are available.
ADMINISTRATION OF ONE DOSE OF THE JANSSEN COVID-19 VACCINE EXPIRED BY ONE DAY; This spontaneous report received from a pharmacist 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: 212A21A, expiry: 21-DEC-2021) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-DEC-2021, the patient experienced administration of one dose of the janssen covid-19 vaccine expired by one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of one dose of the janssen covid-19 vaccine expired by one day was not reported. This report was non-serious.
Distorted Vision; Itching; This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (Distorted Vision) and PRURITUS (Itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Neomycin) and Drug allergy (Pencillin).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced METAMORPHOPSIA (Distorted Vision) and PRURITUS (Itching). On 28-Feb-2021, METAMORPHOPSIA (Distorted Vision) and PRURITUS (Itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported  Treatment information was not provided
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-MAR-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
the morning after my 2nd pfiizer vaccine dose --3/21-2021 -  i experienced hearing loss and non-stop tinnitus.  after 29 days of 24/7 ear-ringing I finally went to an ear specialist on 04/19/2021.  i was adinistered a hearing test and an ear exam.  was told i have lost 'approximately 35% of my hearing in both ears." the ear specilist did not discuss the fact that i had ZERO hearing loss and ZERO tinnitus prior to my 2nd vaccine dose.  The ear speciaiist simply  advised me to either puchase hearing aides or download some white noise apps to play overnight.    there was no advice or insight as to how the vaccine did this to me.
Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emergency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, hight headedness, headhache, and myalgias. In the emergency department vitals stable and within normal ranges, including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted. Patient administered intravenous fluids with symptom improvement. Discharged home stable.
Local reaction at site, red, warm to touch 50 x 60 mm Treatment: Claritin, Ice, Motrin
Discovered itchy rash/spot on left hand after receiving flublok vaccine on 10/31. Applied alcohol and hydrocortisone to help relieve itchiness.
Narrative:  Fully vaccinated, admitted of dyspnea due to COVID infection, did not require treatment
Pt received both a flu and covid vaccine and passed out immediately after. No history of passing out after vaccines. Only passed out once after a blood draw.
arm was sore; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself).   A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's arm was sore on an unspecified date (reporter was uncertain for the event duration reported as "maybe an hour or 2").  The patient underwent lab tests and procedures which included body temperature: 97.4 degrees Fahrenheit and 97.6 degrees Fahrenheit on an unspecified date. The outcome of the event was recovered on unspecified date.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Initial report received on 09 February 2010 from a consumer. A 55 year old female patient with a history of hypertension and allergies to codeine and penicillin developed a knot under her right arm one week after she received an intramuscular right deltoid injection of TETANUS TOXOID (lot unknown) on 21 September 2009. She also had body aches which were relieved with Prednisone and then would return when the Prednisone was stopped. The patient required a doctor's visit, however the date was not reported. The patient was not recovered at the time of the report. Concomitant therapy included DIOVAN, "DYPAMINE",  NORVASC, and PREMARIN. List of Documents held by Sender: none.
At approximately 0845, patient began to complain about a tightness in her throat and chest. This was 13 minutes after receiving her COVID vaccination while sitting in post vaccination waiting area. Was escorted to the Clinic  where she was assessed by medical provider, and EMS was called. Pulse oximeter showed 100% oxygenation. EMS arrived approximately 0920 and transported patient via ambulance to Emergency Room.
Patient reported feeling faint and then passing out approximately 12-18 hours after vaccination.  She went to local hospital emergency room to be treated for head wound.
Sore Arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. Not Provided          No concomitant medication was provided. No treatment drugs was included.   This case was linked to US-MODERNATX, INC.-MOD-2021-051613, MOD-2021-052287 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051613:1st dose MOD-2021-052287:Patient information
Leg weakness resulting in fall. Weakness and paralysis moved to arms. Speech, swallowing and breathing all affected adversely.
Patient received the Moderna vaccine (dose 1) and reported numbness and soreness in the kidney/back area that lasted 30 minutes later that night; she also reports pressure in that same area for a few days after. She also reports low urinary flow starting the night after getting the vaccine. She also has throat dryness at night, but feels fine during the day. She reports drinking plenty of water. She will follow up with her PCP in a few days.
6/20/12 - Mom reports "blotchiness" on face. 6/21/12 - Dad reports "rash all over body" BENADRYL/CLARITIN/ZYRTEC. * Also known hx of increase use hair conditioner as lotion on body.
DEATHLY ILL; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history 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, per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced deathly ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deathly ill was not reported. This report was non-serious.
Monday morning 5am i had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness; Monday morning 5am i had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness; Monday morning 5am i had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness; Within 24 hours i felt dizzy.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included venlafaxine hydrochloride 150 milligram (EFFEXOR) and naloxone hydrochloride, buprenorphine hydrochloride 16 milligram (SUBOXONE) both from unknown date for unknown indication. 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. Within 24 hours on 10Apr2021, the patient felt dizzy. On Monday morning, 12Apr2021 at 05:00 the patient had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events within 24 hours felt dizzy, Monday morning at 05:00 the patient had very bad chest pains, slight heartburn, cold sweats in addition to the dizziness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fainting - immediately, shaking, nurses administered aid she was down for about 15 minutes.
injection site arm is itchy; injection site arm is red; injection site arm is hard; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (injection site arm is itchy), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE INDURATION (injection site arm is hard) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (injection site arm is itchy), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE INDURATION (injection site arm is hard). At the time of the report, VACCINATION SITE PRURITUS (injection site arm is itchy), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE INDURATION (injection site arm is hard) outcome was unknown.            Concomitant medications details were not reported by the reporter.  The patient received first Moderna Covid 19 vaccine primary series on 4-FEB-2021. The patient received second Moderna Covid 19 vaccine primary series on 2-MAR-2021. The patient received first Moderna Covid 19 vaccine booster dose on 5-NOV-2021. Patient reported no Adverse reactions after first booster. The patient received second Moderna Covid 19 vaccine booster dose on 29-APR-2022.   Treatment details was not reported by the reporter.   This case was linked to MOD-2022-661563, MOD-2022-661585, MOD-2022-661589 (Patient Link).   Reporter did not allow further contact
No adverse affect, patient had already had a tetanus booster which was discovered after this booster given.
day 1 following vax rt arm edematous, red, hard & painful to elbow; t101 for 4 days; warm compresses applied; taken to MD x2; given DPH, duracef & Motrin;
Severe chills & shaking, low grade fever, muscle aches,  headache, extremely tired, temporary paralysis in legs (unable to move legs while trying to walk normally).
Headache, Myalgia, Arthralgia, fatigue, inj site pain Narrative:   Other Relevant History:
Moderna COVID-19 Vaccine EUA  Have a bad rash all over the body,  looks like hive which I had before. Took Claritin, yet hives continue
been having recurring outbreaks since the 2nd dose/suspected vaccination failure; shingles; missed 3 weeks of work due to the shingles outbreaks; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had shingles at age of 16).   On 7th March 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and activities of daily living impaired to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: The patient was the reporter. The patient was not immunocompromised. The patient had her first shingles outbreak when she was age 16. She said it was on both sides of her head. Once or twice a year every since then (since age 16) she had been getting shingles outbreaks. The outbreaks were usually on the left side. The patient stated that she had the second dose of shingrix on 7th March but facing recurring outbreaks since the 2nd dose. The patient asked if it  was normal. Since getting Shingrix shots she had been getting repeated shingles outbreaks/breakouts more often (more frequently) and they last longer. The patient had missed 3 weeks of work due to the shingles outbreaks. She did not have the lot number of the Shingrix shot(s) administered to her. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles not provided.
Overall numbness of the left cheek from lower jaw and to the eye; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Overall numbness of the left cheek from lower jaw and to the eye) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history reported.   On 27-Jan-2021 at 5:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 5:30 AM, the patient experienced HYPOAESTHESIA (Overall numbness of the left cheek from lower jaw and to the eye). At the time of the report, HYPOAESTHESIA (Overall numbness of the left cheek from lower jaw and to the eye) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications have not been provided.  Treatment information has not been provided.
I got pneumonia; I got pneumonia; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as 1st dose, single and 2nd dose, single, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got pneumonia after 30 days of vaccination in Apr2021. Patient was taking many mediations. Patient was fine before the vaccine. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Hospitalization: 9/23/2022 - 10/1/2022 Presentation to the ED: SYNCOPAL EPISODE, HYPOTENSIVE. COVID + date: 9/30/22. Treatment: Zosyn and Vancomycin.  Discharge to: SNF.
Since March 8, 2021,  I developed Severe diarrhea, headache, extreme fatigue, stomach ache.