chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After my first dose of the vaccine my right eye twitched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 10:15 (Lot number: EN6202) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTIC [BIFIDOBACTERIUM LACTIS]. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "recovering", described as "After my first dose of the vaccine my right eye twitched". The event "after my first dose of the vaccine my right eye twitched" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of muscle twitching.  Additional information: Patient did not receive any other vaccines in four weeks prior to the COVID vaccine. The patient receive other medications in two weeks was Probiotic, Vitamin. Facility type vaccine: Other. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Had no known allergies.  No follow-up attempts are possible. No further information is expected.
Severe Headache; significant arm pain again -decrease ROM to less 90'; significant arm pain again -decrease ROM to less 90'; Body aches; significant joint pains-especially in hands and wrists; This is a spontaneous report from a contactable other-HCP (Nurse, patient herself). A 55-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN 6201) intramuscularly in right arm on 16Feb2021 11:45 as dose 2, single (at the age of 55-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Vaccination facility type was reported as Hospital. Patient did not receive any other vaccine in four weeks. Patient medical history were reported as liver injury from 1986 to 1986, blood transfusion for lacerated liver repair, seasonal allergy, allergy to cats and dogs (animal), various Trees and various Nuts. Patient known allergies included allergies to Synalgos, Zyrtec. The concomitant medications were reported as estrogens conjugated, progesterone, mesterolone (RESTORE) taken for an unspecified indication, start and stop date for all medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3246) intramuscularly in left arm on 26Jan2021 as dose 1, single for COVID-19 immunization. Patient experienced significant arm pain, with decrease ROM to less 90, chills, brain fog, felt agitated and unsettled, headache as moderate with the first dose which lasted 3 days. Patient experienced significant arm pain again, decreased ROM to less than 90, severe headache, body aches and significant joint pains especially in hands and wrists on an unspecified date in Feb2021 which lasted for 3 days. The patient did not receive any treatment for the adverse events. The outcome of the events was resolved on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
The patient was supposed to receive a second dose of COVID-19 (Pfizer) Monovalent vaccine.  Instead, a medication error occurred, and the patient received COVID-19(Pfizer) bi-valent.  No reactions noted or reported by patient or patient's mother.
received his second FLUZONE QUADRIVALENT vaccine only 3 weeks after the first with no reported adverse event; Initial information received on 04-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old male patient who received his second fluzone quadrivalent vaccine only 3 weeks after the first with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 18-Oct-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength and lot number not reported) via unknown route in unknown administration site for prophylactic immunization.  On 03-Nov-2022, he also received 0.5 mL dose of the same vaccine (lot UT7744NA) via intramuscular route in the left vastus lateralis for prophylactic vaccination.  On 03-Nov-2022, (latency: same day) the patient received his second fluzone quadrivalent vaccine only 3 weeks after the first with no reported adverse event (inappropriate schedule of product administration) 16 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was 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.
The patients mother came into the store and said her daughter had a reaction to her Moderna shot. She showed the Pharmacist pictures. The patient experienced red blotchy solid rash on arm and neck. Her toes were swollen and red and had a metallic taste in her mouth. Recommended to the mother to have her daughter go to Urgent Care. I have tried to reach out to the patient for more info but no one answered and there was no option to leave a voicemail.
5/17/21:  Left groin lymph node extremely tender and painful on touch.  Symptoms lasted about 5 days                        Skin/bumps eruption between buttocks, sore & itchy.  I applied OTC Cortisone.  Symptoms lasted 7 days.                        Ear ache, itchy, clogged, moist.  Applied previously prescribed drops:Fluocinolone Acetonide oil                        Fatigue (only lasted one day)                        * Irregular heartbeat.  Heart muscle gradually tightening then a thump followed by heart skipping a beat and then  light   palpitations.  Lasted 5 days.  On and off throughout the day and night.  No pain.                           Tingling left side of neck w/ muscle soreness; traveled down to shoulder and up to behind right ear.  Symptoms continuing                         to present day.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II [Lot# K026366 and Expiry date: 15-DEC-2016; Lot# L008684 and Expiry date: 13-MAR-2017; Lot# L023385 and Expiry date: 25-JUN-2017; Lot# L020189 and Expiry date: 03-JUN-2017; Lot# L019989 and Expiry date: 01-JUN-2017; Lot# L009214 and Expiry date: 17-MAR-2017; Lot# K009957 and Expiry date: 14-JUL-2016). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sick for 2 days; Tiredness; headache; nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 2 days), FATIGUE (Tiredness), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (Muscle aches) in a 40-year-old male patient 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 ILLNESS (Sick for 2 days), FATIGUE (Tiredness), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (Muscle aches). At the time of the report, ILLNESS (Sick for 2 days), FATIGUE (Tiredness), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  Treatment medication were not provided.   This case was linked to MOD-2021-087237 (Linked Report).; Sender's Comments:  MOD-2021-087237:same reporter US-MODERNATX, INC.-MOD-2021-087237:Same reporter
the area is tender to the touch; 4x4 inch are with several colors pink/red/lavender/yellow, pale in shade and it fades to the edges; wabbled around the house for the first two days, she was conscious of what she was doing but could not settle down to anything; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (the area is tender to the touch), ERYTHEMA (4x4 inch are with several colors pink/red/lavender/yellow, pale in shade and it fades to the edges) and GAIT DISTURBANCE (wabbled around the house for the first two days, she was conscious of what she was doing but could not settle down to anything) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid disorder.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced GAIT DISTURBANCE (wabbled around the house for the first two days, she was conscious of what she was doing but could not settle down to anything). On 31-Mar-2021, the patient experienced TENDERNESS (the area is tender to the touch) and ERYTHEMA (4x4 inch are with several colors pink/red/lavender/yellow, pale in shade and it fades to the edges). On 26-Mar-2021, GAIT DISTURBANCE (wabbled around the house for the first two days, she was conscious of what she was doing but could not settle down to anything) had resolved. At the time of the report, TENDERNESS (the area is tender to the touch) and ERYTHEMA (4x4 inch are with several colors pink/red/lavender/yellow, pale in shade and it fades to the edges) outcome was unknown.            Concomitant medications include: Thyroid medication. No treatment  medications were reported.  Action taken with mRNA-1272 with respect to events was Not Applicable.
All over the left side of my chest and down my left arm, you can now see a lot of my veins (dark blue). You couldn?t see them before injection and you can?t see them at all on my right side. The area, including my underarm and chest are sore.
The pt developed localized tenderness and redness over the site of vaccinia vaccination with lymphangitis to axilla; treated with 5 days of Augmentin, 875mg BID.
My son got shingles after his second covid dose.  He did have the chicken pox vaccine when he was young and the doctor said that's why the shingles wasn't as bad as it could of been.  I have read that the covid vaccine can cause a shingles flare up, but how can he have a flare up when he's never had shingles.  Now, the question is, will he have flare ups for the next 21 years until he can get the shingles vaccine?  Location of the shingles were located on his side, back and hip and lasted 2 months.
About 13 hours after vaccine had uncontrollable shaking of all limbs, hands and feet for about 4 hours. For 42 hours I could not be upright due to feeling like I would pass out. Was flat out in bed for 42 hours starting 13 hours after vaccination. Other symptoms:fever, body aches, headache, exhausted.
Fever 101.6F, chills, body ache, pain at injection site, brain fog, rash
Patient developed redness and swelling of right anterior lateral thigh on the evening of 5/29/07 after receiving DTaP injection earlier that day. Seen in office 5/31/07 with 7cm area of edema and erythema was advised to take Tylenol or Ibuprofen and apply ice to site.
Patient received Moderna Covid 19 vaccine. Immediately following administration she experiences chest pressure, shortness of breath, flushing. She was seen in urgent care and found to have hypertension and tachycardia. Symptoms attributed to allergic reaction to the vaccine. Treatment in urgent care with Benadryl and extended observation with resolution of symptoms.
Information has been received from a health care professional concerning a study. An investigator reported that a 12 month old male on 23-AUG-2007 was vaccinated subcutaneously in the left arm with the first dose of ProQuad. Concomitant therapy included fourth dose (intramuscular, left thigh) ACTHIB and a fourth dose (intramuscular injection, right thigh) of PREVNAR. Study product was not administered. On 31-AUG-2007 the patient developed a fever and subsequently experienced a febrile seizure. The patient also experienced a rash (onset date not reported) that the reporting investigator felt was consistent with ProQuad. The reporting investigator felt that febrile seizure was related to study therapy. Treatment included TYLENOL for fever. Subsequently, the patient recovered from febrile seizure, fever and rash and continued in the study trial. Febrile seizure was considered to be an other important medical event. No further information is available.
Patient reported nausea following 1st dose administration of moderna covid vaccine. Nausea resolved without intervention.
pt recv vax & exp numbness & dec motor function in lt arm;dx of brachial plexopathy was made;
Patient came in for booster dose today on 12/13/2021 and stated that for her 1st Pfizer Covid Vaccine she had bruises on multiple areas of her body and for her 2nd dose her left breast was enlarged and pain under her left arms. She noticed it got worsen after 3rd day of getting the vaccines. She was told by her physician to take tyelnol and benadryl and rest. She was better after 2 weeks.
patient received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 20th June 2022, the patient received Havrix. On 20th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: Pharmacist reported a patient received an expired dose of Havrix. The health care professional declined to provide patient demographics.  The health care professional declined follow up and did not want any contact details provided. The reporter did not consent to follow up. Additional Supportive Information: The patient received expired dose of Havrix which led to expired vaccine used.
Patient's arm swollen and red the following day. Treated with ice and MOTRIN. Symptoms subsided but patient went to MD on 12/26 with recurrent symptoms and shoulder pain.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Yes the patient received vaccine. No other medication received in 2 weeks.  No follow up attempts are needed. No further information is expected.
I was massively sick. Could not get out of bed. Two weeks later, I started feeling better. About two weeks later, my chronic issues got worse. The conditions was under control until after the booster. The mast cell disease is not under control. I have much looser muscle tone. Muscle lost from my feet going up to my hands, fingers and not as functional. Prior to booster I could walk up three flights of stairs and now it is very difficult. My Neurologist sent me to the ER due to my declining status.
AIOU needle used for vaccination.   During administration the needle and hub broke off from the syringe and unknown amount of vaccine squirted out onto patient?s arm.  Unsure how much administered.  Needle and hub removed from arm.  NO adverse effect for patient.  Dr. contacted and advised to re-administer vaccine.
Red itchy rash that appeared 10 days after she received the Tdap. Rash only present at site of injection.
This spontaneous report as received from a Physician assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 15-APR-2016 the patient was vaccinated with expired dose of ZOSTAVAX lot # K018176, expiration date 10-JAN-2016. No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 15 month old patient. On 12-DEC-2013 the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneously. Other suspect therapies included PROQUAD (Merck). On 12-DEC-2013, the patient was inadvertently administered a 0.5 ml SQ dose of PROQUAD and a 0.5 ml SQ dose of VARIVAX. The outcome of event is unknown. No adverse effect was reported. Additional information has been requested.
p/vax pt c/o soreness in that area on 10/15/99 but no redness;c/o redness & soreness;10/17/99 knot in area;mom noticed a large pimple in are on 10/23/99;states stuck it w/a needle & cleansed it well& applied ATB ointment;size of quarter;
Case number PHEH2014US019456 is an initial spontaneous report received from a nurse on 25 Sep 2014. This report refers to a patient of an unspecified age. Past medical history and concomitant medications of the patient were not reported. The patient received the Men A lyophilized powder component of MENVEO (batch number: M14042) intramuscularly which was reconstituted with another unspecified diluent instead of Men CWY liquid conjugate component on an unspecified date. No adverse events had occurred following this medication error (wrong solution used in drug reconstitution).
Hep A, MCV-4 & HPV-4 given together (sep injections) 11-26-07.  Parent called 11-28-07 to report patient experienced headache, neck pain on Rt side of neck, nausea, dizziness, aches & generalized body pain.  "Anything that touches me hurts me".  She missed 2 days of school.  Temp approx 100 degrees.  She did recover.
He had sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) of an unspecified age received This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable male consumer (patient) of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as unknown as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient mentioned that he had sore arm while he was reading "ISI", on an unspecified date. The patient wanted to know more about the components of the COVID-19 vaccine. The outcome of the event was unknown.  It was unknown if the reporter was a health care professional. It was unknown if the reporter was the prescribing HCP.  Follow-up attempts are completed. No further information is expected.
Vertigo; This spontaneous case was reported by a health care professional and describes the occurrence of VERTIGO (Vertigo) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VERTIGO (Vertigo). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo) outcome was unknown.        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.   No concomitant medication was reported.
Patient developed hoarseness and swelling of face several hours after receiving the Prevnar vaccine.  He had similar episodes after receiving the vaccine at 2 and 4 months of age.  He was evaluated by an allergist for this reaction and underwent skin prick testing for Prevnar vaccine as well as to the Pediarix and Hib vaccines and gelatin.  The allergy testing showed no reactions.  The mother elected continuing with vaccinations but only giving one at a time on a weekly basis.  He recieved DTaP, IPV and Hep B as individual vaccines with out any problems.  When given the Prevnar, he had a reaction.  It was not immediate and occurred after several hours,  similar to the first two episodes in description and timing of the event.
A week and a half following her first dose of the COVID 19 vaccine the patient reported a swollen rash that covered almost the entire upper half of her left arm.
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L010598, expiration date: 16-AUG-2016, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial Vital Signs: Pulse: 84 - B/P: 100/65 - Breaths: 20/min An 8-year-old female patient, after 12 minutes of observation, refers "her eyes feel swollen", she proceeds to notify the Nursing Leader and goes to the evaluation area. Initial vital signs are assessed. The patient does not present edema, saturation in 99%, alert in time and place, equal and reactive pupils. There is no rash, rash or spots on the skin. At 4:52 pm he is given 25 mg of Benadryl PO. Re-evaluation 5:10 pm: patient with puffy eyes and less itchiness. Reassessment of Vital Signs: B/P: 100/65 - Breaths: 20 - SPO: 99%
1/18/21: At site of the injection: Itchy, red skin, skin hot to the touch.  Spot was about 3"long by 2 " wide. Today, 1/24/21,  spot is 6? long by 5? across, and then a tendril going down that is 2? by 2.5?.   The top of the spot is less red and itchy and hot than it was on 1/18.
One minute of fine tremor all extremities. w/closed eyes, and not responsive - occurred approx 25 min post vax. Appeared mildly lethargic for 5 min after event then completely norm. temp of 99.5