chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches; Chills; Fever; Tiredness; Nausea; Muscle pain; General overall feeling ill; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 04Mar2021 at 10:30 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included cholesterol high, bladder and basal cell cancer and COVID-19 (which was diagnosed prior to vaccination). The patient did not have any allergies to medications, food or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) 20 mg, lactobacillus acidophilus (FLORAGEN ACIDOPHOLIS) and MULTIVITA; all for unknown indications, from unknown dates and unknown if ongoing. 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 05Mar2021 at 04:00, the patient experienced headaches, chills, fever, tiredness, nausea, muscle pain and general overall feeling ill. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headaches, chills, fever, tiredness, nausea, muscle pain and feeling ill were recovered at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Affecting her menstrual period , menstrual period came early; Weird side effects; Feeling more tired; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUATION IRREGULAR (Affecting her menstrual period , menstrual period came early), VACCINATION COMPLICATION (Weird side effects) and FATIGUE (Feeling more tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MENSTRUATION IRREGULAR (Affecting her menstrual period , menstrual period came early), VACCINATION COMPLICATION (Weird side effects) and FATIGUE (Feeling more tired). At the time of the report, MENSTRUATION IRREGULAR (Affecting her menstrual period , menstrual period came early), VACCINATION COMPLICATION (Weird side effects) and FATIGUE (Feeling more tired) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants were reported.  Patient felt it was affecting her menstrual period as the menstrual period came early. The period came one week later after the vaccination, but it was still early for her menstrual cycle.  Treatment medication was not reported.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with VARIVAX, and subsequently developed transverse myelitis. The patient was transferred to a children's rehabilitation facility. The reporting physician noted that the patient's parents had reported "that the physicians thought that it was related to VARIVAX. "The physician noted they have been unable to confirm this. Additional information has been requested.
Developed rashes at inner part of both legs after receiving the 1st dose of Moderna vaccine, rashes later localized to the left leg and its persisting; missed 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed rashes at inner part of both legs after receiving the 1st dose of Moderna vaccine, rashes later localized to the left leg and its persisting) and PRODUCT DOSE OMISSION ISSUE (missed 2nd dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Developed rashes at inner part of both legs after receiving the 1st dose of Moderna vaccine, rashes later localized to the left leg and its persisting) and PRODUCT DOSE OMISSION ISSUE (missed 2nd dose of vaccine). At the time of the report, RASH (Developed rashes at inner part of both legs after receiving the 1st dose of Moderna vaccine, rashes later localized to the left leg and its persisting) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed 2nd dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. Treatment medications included Steroid cream.
(Moderna) The day after the second dose of the COVID-19 vaccine patient had a fever of 102 Fahrenheit, body chills, aches, headache, loss of taste and smell, severe fatigue, and pain at spot of injection. All flu like symptoms lasted a full 48 hours after injection. Arm was warm to the touch and red in color for a few days.
CHILLS AND BODY ACHES-  TOOK IBUPROFEN DURATION ~ 6 HRS
High fever 5 days after vaccination. DTaP and IPV fever went up to 106 degrees.
Redness, irritation, may have started earlier than date above, reported to us on 10/4/16.
Shaking of arms, starting x 15 sec. No fever at the time. Pt has had similar events in the past not temporally related to vaccines.
This spontaneous report as received from a registered nurse, refers to seven unspecified patients of unknown age and gender. On an unknown dates, the patients received improperly stored VARIVAX (Merck) (dose and route were not reported, lot # K005177, expiration date: 10-APR-2016), exposed to -9.5 C for 20 hours. No adverse effects were reported. Additional information has been requested.
joint pain and intense itching; intense itching; redness; This spontaneous case was reported by an other and describes the occurrence of ARTHRALGIA (joint pain and intense itching), PRURITUS (intense itching) and ERYTHEMA (redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product OBETICHOLIC ACID (OCALIVA) for Primary biliary cirrhosis.    Concurrent medical conditions included Primary biliary cirrhosis, Hypertension, Perfume sensitivity and Child-Turcotte-Pugh class A. Concomitant products included URSODEOXYCHOLIC ACID for an unknown indication.   On 20-Dec-2019, the patient OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram once a day. On 12-Jan-2020, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram once a day. In July 2020, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to dosage form. On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started OBETICHOLIC ACID (OCALIVA) (Oral) 5 milligram once a day. On 25-Mar-2021, the patient experienced ARTHRALGIA (joint pain and intense itching), PRURITUS (intense itching) and ERYTHEMA (redness). At the time of the report, ARTHRALGIA (joint pain and intense itching), PRURITUS (intense itching) and ERYTHEMA (redness) outcome was unknown.            Reporter did not allow further contact
January 1, 2021 about 7:00 p.m. Patient experienced sudden onset of "sciatic pain."  Pt normally has recurring similar pain, but describes this as more severe.  Pain extended from R hip to neck. On the morning of January 2nd, painful muscle spasms extended from lower back, mid back, between shoulder blades  and neck spasm on right side, radiating to spine.  Patient used ibroprofen and Tylenol.  Tylenol provided some relief.  Pain so severe, patient reports difficulty breathing due to spasm pain.  No further respiratory distress.    January 3, 2021 in the afternoon, patient reported to Emergency Department for evaluation.  Was given toradol.  Prescriptions for  Flexeril and hydrocodone were given.  As of 1/6/2021, patient is still on meds and reports improvement.   However, 1/5/21 significant swelling  and slight pain began  in Left knee, restricting range of motion.
Client is elderly and has reduced mobility status. Client was ushered up into the bleacher seating at the vaccination site following the dose administration, and upon sitting down was experiencing shortness of breath (reported by the client to be from walking up the stairs). Client pulled out personal inhaler (albuterol) and self-administered a dose. Responder noted pallor and increased difficulty with speaking for the client, but client's breathing returned to a regular rate and rhythm in the minutes following albuterol administration. Client's pallor resolved. The client refused emergency medical services twice, and refused having his vitals taken. The client was monitored visually by responder until deemed appropriate for discharge from the observation area. When the client ambulated down the stairs, Responder noted unsteadiness in gait. Once the client was safely at the bottom of the stairs, a wheelchair was retrieved for the client so that the client could safely exit the facility. Client accepted the wheelchair at this time. Client refused a vitals check a second time at the checkout station, per responder.
pt had insomnia the night after taking the vax and experiences insomnia everyday since then.  She feels like she has electricity in her brain and is also in her neck and going down her spine. Then she experiences tachycardia with HBP.  These symptoms are worse at night and keep her from sleeping because her body starts jerking.  On 5/25/2021 she felt like her heart was pumping very fast and she was dizzy so she went to Urgent Care.  She had an EKG- normal w/ tachycardia, BP was high, and heart rate was high about 100.  She was given an injection and prescribed clonazepam to go along with the HBP medicine she was prescribed after taking the 1st dose of the covid vax.  She was told to FU w/ Cardiologist. She went to Cardiologist on 5/27/2021 and was told to continue the medication she was on and to FU in one month.  She went to her Psychiatrist because she was still having trouble sleeping and was told to double up on the medication she was currently taking.
Swollen upper lip. Red and itchy eyes. Scratchy throat. Low grade fever. Shaking and chills. Elevated heart rate of 152. Flu like symptoms for 3 days. Swollen upper limb went away on its own within 4 hours. Treatment: IV fluids and TYLENOL.
Approximately 15 minutes after vaccination, recipient developed tightness in throat. Taken into ambulance by EMTs. Seen by doctor at 20 minutes post vaccine. Patient developed stridor and shortness of breath. Treated for anaphylaxis- IM epinephrine x2, IV dexamethasone, 250 mL normal saline bolus. Transported to emergency department by EMS.
Stiff neck, left side.  From left shoulder across to neck.  Lasted about 15 minutes.
At approximately 9:30pm I became chilled and experienced overall body ache. Later when taking my dog out my right leg locked up and once I got into bed I began convulsing, could not breath and was unable to communicate with my husband.  Initially the paramedics felt it was a panic attack.  Vital signs, CBC and Metabolic panel showed no abnormal results. Medical Center ER doc also initially indicated he also suspected a panic attack, however conceded it was possibly an adverse reaction.  I spent 9-31-2021 resting and on 10-1 feel back to normal.  I do not believe it was a panic attack.  After the first dose of the Pfizer vaccine (EL9269)  I was aware of underarm gland swelling.  Now after the third dose it is more pronounced.
Patient describes got reaction like flu symptoms for almost 1 week, chest congestion, fever, body aches, shaking.
Loss of sight in left eye evening of shot.  As if a black construction paper was put in front of my eye. through the night.  Blurred vision for several days after with periodic episodes of blurriness to present. Eye Doctor: stated she thought it could be Ocular Migraine (never had one before) General Practitioner: stated he thought it may be a mini stroke. Gradual locking up and pain of muscles on right side of body from neck to foot.  Continuous discomfort and pain in muscles on rt side of body. Multiple doctor visits to: Orthopedic foot/ankle  Knee Specialist Pain management Neurologist Accupucture  Massage Therapist Chiropractor
Fatigued; Elevated heart rate; Broke out into a full body rash, everywhere, but my palms and soles, and face on 4/7; Hives; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 08:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included emtricitabine, tenofovir alafenamide fumarate, bictegravir sodium (BIKTARVY). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 14Mar2021 at 15:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation.  On 07Apr2021, the patient experienced hives and broke out into a full body rash, everywhere but her palms, soles, and face were 4/7. The patient was given prednisone to stop the hives, but they came back the same night. On 08Apr2021, the patient was fatigued, and had an elevated heart rate. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event hives and included treatment with prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the events broke out into a full body rash, everywhere, but her palms, soles, and face were 4/7, hives, fatigued and elevated heart rate was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Myocarditis Bucal cord paralysis Shingles ? Herpes Zóster And all the symptom fron april until toda july 18th 2021
Pt recv vax on 10/22/98; on same day pt exp wooziness, hot face, dizziness, nausea
Pfizer Biotech COVID-19 mRNA given instead of Pfizer COVID-19 Bivalent
FEELS WIRED; TINGLING ON LEFT ARM/TINGLING FROM ELBOW DOWN TO FINGER TIPS/TINGLING IN FEET/FEELING THE TINGLING AGAIN IN LEFT HAND AND RIGHT HAND (FEELS IT IN THE OUTER SIDE OF HAND); This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known drug allergies and no reported medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 20-OCT-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 20-OCT-2021, the patient experienced tingling on left arm/tingling from elbow down to finger tips/tingling in feet/feeling the tingling again in left hand and right hand (feels it in the outer side of hand). On 21-OCT-2021, the patient experienced feels wired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling on left arm/tingling from elbow down to finger tips/tingling in feet/feeling the tingling again in left hand and right hand (feels it in the outer side of hand), and feels wired. This report was non-serious.
2nd hand, after pt had left vaccine site and returned to work they experienced trouble breathing. and ambulance was called. pt told them they had asthma and they did start breathing better but then began vomitting so they were transported to the hospital. current condition unknown
FEVER OF 104.2, SHAKING, CRYING FOR 2 HOURS & 10 MINUTES, SEIZURES.
Employee received vaccine and had no signs of adverse reaction after vaccination. Employee went to eat something and fainted. Shortly after employee had an emesis as well. Felt fine afterward and vitals were within normal limits.
"Ache" in throat. No further signs of allergic reaction. Patient reports anxiety surrounding getting vaccinated.
Pt developed erythema of upper arm equaling 2/3 of medial bicep/tricep area. Pt also experienced pruritus. No shortness of breath was noted.  Follow up 10/25/2000: "Patient partially recovered from adverse event.  I have a tingling feeling down my left arm to my 4-5 fingers on my left hand.  Every morning I have to massage my left arm to regain feeling in my left hand and fingers.  Patient did not receive any more shots since the reported event."
Tightness in chest and cough, fatigue for 6 days. Occasional cough only lasted 3 days. Pain streaks traveling down in left arm and left leg for 3 days. At this time I have occasional discomfort in left and right leg.  I have not seen a doctor, I am resting and going about my day as usual but with less energy.
Fever x 2 days, decreased appetite, very fussy, swollen and painful abdomen, ER visit.
Last night after showering I noticed a red rash  about 4" by 4" at and below the injection site.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 09:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The pt received a dose of Engerix-B vaccine (lot ENG239A2) on an unknown date. On 12/10/2003, the pt's attorney alleged that the "thimerosal contained in the vaccines administered to the children (child) contributed to and/or caused their deaths." No further info regarding the specifics of the claim was available at this time. The cause of death is unknown at this time. It is unknown whether an autopsy was performed.
patient experienced: Allergies: Swelling; patient experienced: Allergies: Swelling; This spontaneous report was received from a health care professional (HCP) referring to a 58-year-old (at reporting time) female patient. The patient's past medical history, historical medication, and concurrent medical conditions were not provided. Her concomitant medication included mycophenolate mofetil (CELLCEPT), albuterol sulfate (manufacturer unknown) (HFA), albuterol, alprazolam (XANAX), betamethasone dipropionate (DEL-BETA), budesonide, formoterol fumarate (SYMBICORT), cetirizine hydrochloride (ZYRTEC), cholecalciferol (reported as "Vit D-3"), doxepin hydrochloride (SINEQUAN), filgrastim (NIVESTYM), folic acid (FOLVITE), hydroxychloroquine sulfate (PLAQUENIL), levofloxacin (LEVAQUIN), losartan potassium (COZAAR), megestrol acetate (MEGACE), metformin hydrochloride (GLUCOPHAGE), mometasone furoate (NASONEX), montelukast sodium (SINGULAIR), omeprazole (PRILOSEC), ondansetron hydrochloride (ZOFRAN), thyroid (ARMOUR THYROID), tramadol hydrochloride (ULTRAM), and valsartan (DIOVAN).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (formulation, concentration, administered dose, dose number, vaccination scheme frequency, route of administration, anatomical location of vaccination, lot number, and expiration date were not provided).   On an unknown date, the patient experienced "allergies: swelling" (hypersensitivity and swelling). The outcome of the reported event was unknown.  The causality assessment for hypersensitivity and swelling regarding pneumococcal vaccine polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Temp range 100-105 x 3 days p/inject; Highest 30-36 hrs post inject; Irritable-no rxn @ inject site; Seen by MD 18MAR dx strep throat; Tx antibiotics;
hives; rash; chills; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), RASH (rash), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 05-Apr-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). On 08-Apr-2021, the patient experienced URTICARIA (hives) and RASH (rash). On 10-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 07-Apr-2021, CHILLS (chills) and FATIGUE (fatigue) had resolved. At the time of the report, URTICARIA (hives) and RASH (rash) outcome was unknown.
This is a spontaneous report from a contactable nurse via a Pfizer-sales representative. A female patient of an unspecified received the first dose of TRUMENBA, at the age of 17, via an unspecified route of administration from 15May2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized for three days after complaint of lethargic, aching, nausea, and dehydrationon an unknown date after the first dose of meningococcal group b rlp2086. Outcome of the events was unknown. Information on batch number has been requested; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Inappropriate Schedule of Vaccine; This non-serious case was reported by a consumer and described the occurrence of drug dose administration interval too long in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd May 2018).   On 09-MAR-2019, the patient received the 2nd dose of Shingrix (unknown arm). On 09-MAR-2019, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-MAY-2023. The reporter was patient, she and her husband received the first and second dose of Shingrix in an unknown arm. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case had been linked with US2019GSK043866 due to same reporter and different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019GSK043866:Husband case