chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She experienced dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She experienced dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (She experienced dizziness). At the time of the report, DIZZINESS (She experienced dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Severe heart palpitations, anxiety, nausea, weight loss, sweating of hands and feet
Rash on right arm that spread to left arm also. Patient received Engerix vaccine in left arm but has had vaccine in past with no issues so they know it was caused by Shingrix
Dime-sized pustular lesion at site of varicella injection on left anterior thigh. Low-grade fever at home. Faint, red bumps on left foot and posterior scalp. Recheck lesion on 4/21/1 to ensure no secondary infection.
SORE IN ARM; Headache; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and marijuana use, and other pre-existing medical conditions included the patient had no medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced sore in arm. On 02-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and was recovering from sore in arm. This report was non-serious.
I recently got my booster; Dose 2 30Aug2021/Dose 3 09Dec2021; my period to start in severe pain. I have never had such painful periods in my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: FJ8762) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Known allergies: Gadolinium contrast" (unspecified if ongoing), notes: Known allergies: Gadolinium contrast. Concomitant medication(s) included: CLONAZEPAM; PAROXETINE; ROSUVASTATIN. Vaccination history included: Bnt162b2 (lot: EW0193, vaccine location=Left arm), administration date: 10Apr2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "had awful cramps and bleeding"; Bnt162b2 (lot: EW0193, vaccine location=Left arm), administration date: 10Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "had awful cramps and bleeding", "Ever since the first 2 shots my period was delayed"; Bnt162b2 (lot: EW0171, vaccine location: Left arm), administration date: 30Aug2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "had awful cramps and bleeding", "had awful cramps and bleeding", "inappropriate schedule of vaccine administered", "Ever since the first 2 shots my period was delayed". The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "I recently got my booster"; DYSMENORRHOEA (non-serious) with onset 2021, outcome "recovering", described as "my period to start in severe pain. I have never had such painful periods in my life"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Dose 2 30Aug2021/Dose 3 09Dec2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysmenorrhoea. Additional information: Patient recently got booster and was waiting for period to start in severe pain. She never had such painful periods in life. She took pills for the pain and nothing worked (as reported, also reported as recovering). So painful, she ended up googling if this was happening to others and it was. She was like she knew she wasn't the only one. She was done getting the shots and cannot go thru all the pain anymore. It can't be good for this to be happening.  No follow-up attempts are possible. No further information is expected.
pt admitted to hosp after being tested in assisted living for COVID - test was positive; c/o increasing SOB and generalized weakness; placed on O2 therapy, dexamethasone and remdisivir; dc'd remdisivir due to AKI; placed on BiPAP for a period of time, but was able to go back to HFNC; pt not responding well to therapy; palliative care discussed; pt placed on comfort care measures; she passed away in the hospital
Redness, warmth, Rash, itching to arm from top of shoulder to elbow with golf ball size knot at injection site Reaction lasted until February 3rd
Patient received dose 1 of Moderna and reported feeling dizzy and then blacked out. Ambulance was called and then EMS came and spoke with the patient. The patient did wake up and was conscious when the EMS was here with her.
Pfizer 6m-4yo bivalent  covid vaccine given to patients for their third dose who received two moderna doses for their primary series. No adverse effects. Per disease control they said patients do not need to be revaccinated and are still considered up to date.
shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had shingles and pain. The reporter asked could Shingrix cause a shingles pain 3 weeks after the 1st shot.
Patient got MMR (#2), DTaP (#5), IPV (#4) in office in AM.  Came back to office at 3:10PM with Havey and eyelid swelling but no oral or pharyngial anedara, no sensoring change, no dysphiaga or soreness, no borpatia, no wheeze, and no blood pressure change.
Portal vein thrombosis extending to superior mesenteric vein, jejunal/ileal branches and splenic vein Inpatient hospitalization IV heparin
Soon after receiving the covid 19 vaccine patient felt faint, cold, and weak.   VSS.
pt taken to ER about 7PM c/o swelling around mouth & eyes; pt was given DPH & observed in ER: no labwork done; pt was released to home;
pt seen in ER 25MAR97 for sx w/fever felt to be first feb sz;pt ha multiple partial sz, stare, unresponsive;pt on tegretol;EEG nl;MMR given 8 dasy prior to first sz episode;
For a week after my first Moderna  shot I was extremely nauseous, aches pains all over my body, extreme fatigue and chills and sweating.
Extreme headache; lethargy; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203), via an unspecified route on the left arm on 28Feb2021 as 2nd dose single for COVID-19 immunization. Medical history included osteoporosis and hypothyroidism. Concomitant medications included levothyroxine, alendronate sodium, vitamin D NOS and melatonin. Historical vaccine included first dose of BNT162B2 as a single dose for COVID-19 immunization. Patient has not taken any other vaccine within four weeks. The patient had no COVID-19 prior vaccination and the patient had not been tested for COVID-19 post vaccination. On 28Feb2021, patient experienced extreme headache for 24 hours and lethargy into second day. No treatment was received for the events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Pt started running an elevated temperature in late afternoon on 8/29/01. He then began to have small jerking movements of arm, head and tongue stuck out. This lasted for a while. At 01:00, on 8/30/01, temperature was 102.5F (ax); no jerking. Mom did not check temperature on the afternoon of 8/29/01. Today he is fine with no temperature; no jerking and is playing.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine date was 08-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Reactions on the arm at injection site: Tenderness, Redness, Warmth, Itching, Hard Nodular Lump, Muscle aches and temporary limitation of arm movement; Headaches; Fatigue; Heart Palpitations.
A redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A redness around the injection site) in an 86-year-old female 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) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (A redness around the injection site). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (A redness around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter was calling on behalf of their mother who received the vaccine 2 weeks ago and developed a redness around the injection site. Reportedly, on 15-Mar-2021, it became larger.  No Concomitant product use was reported.
Pfizer Covid vaccine: 1st dose gotten 12-22-20, had some expected side effects but didn't do anything about it then. However, within 2 weeks, reactivation of my shingles neuralgia and zoster on my lip that has persisted for 4 MONTHS now. This is not normal for me, although at times I would get a sore on my lip or feel burning on my right flank (for a day or 2) every few years or so. This continual burning pain and zoster sores on different areas of my lips is very unusual and getting a sore after sore after sore each week or two is getting rather ridiculous. Normally a sore would last a week or so and be gone for long periods of time. I have no serious other medical conditions. Nothing else has changed: sleep, diet, stress, etc. I feel this is completely related to the vaccine. I did not get the 2nd dose.
Seen several patients who also developed vertigo after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Seen several patients who also developed vertigo after receiving the vaccine) in a patient of an unknown age and gender 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 VERTIGO (Seen several patients who also developed vertigo after receiving the vaccine). At the time of the report, VERTIGO (Seen several patients who also developed vertigo after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent (MERCK). On 16-MAY-2018, the patient was vaccinated with an inappropriate storage dose of PROQUAD 1 dosage form (strength and route of administration were unknown) with lot # N023965 and expiration date of 28-FEB-2019 for prophylaxis, which was stored at temperature ranges from 6 Fahrenheit degrees (°F) to 14°F for 2 hours and from 15°F to 46°F for 30 minutes. There was a digital data logger involved. Previous temperature excursion was from 15°F to 46°F for 78 hours and 51 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA007992: US-009507513-1805USA008117.
RN administered vaccine in Right Thigh. When RN pulled needle out, pt.'s swiped hand at needle and caused a shallow approx. 1 inch scratch to thigh with needle. RN cleaned the scratch with an alcohol swab and bandaged it.
Flu vac administered 11/25/15 (Lt) deltoid pt noted pruritic rash at bra wire line 11/27/15 spread to torso, axilla, abd and inner thighs.
A non-serious spontaneous report of asthma attack and accidental exposure has been received from a Registered Nurse concerning a 33-year-old female. Medical history included asthma (since childhood) and colitis. The patient (nurse) takes azathioprine for her colitis and salbutamol for her asthma. The reporter is a RN who works in a community health center and administers FLUMIST. The nurse did not receive FLUMIST herself. The nurse reported she has an asthma attack after she administers FLUMIST to a patient. She clarified that she has had 15 asthma attacks this flu season beginning in 2008. These attacks have occurred about 5-10 minutes after she administers the FLUMIST. The nurse has had to increase her asthma medication, and on occasion had to use a nebulizer (as well as her salbutamol inhaler). No attack has resulted in a hospitalization. Per the reporter "after treatment she recovers but the event always returns."
Patient is a 63 year old male with history of HTN, HLD, prostate CA (Gleason 7) who presented with acute onset left sided facial swelling. He arrived on 09/19/13 to get his flu shot at 11:00am and follow up with Urology for his prostate cancer. At 2:30pm the patient noted the sudden onset of left sided facial swelling that continued to worsen. He then presented to the ED for further management. He denies any difficulty breathing or difficulty swallowing. He denies any pain, numbness, or tingling. No mouth ulcers or sores. No recent illnesses, fevers or chills. Patient was also taking lisinopril since 05/26/2010. In the ED, facial swelling attributes to angioedema from lisinopril versus a reaction to the influenza vaccine. Ranitidine 50 mg once, methylprednisolone 125 mg once, diphenhydramine 50 mg once.
CHILD'S DATE OF BIRTH WIRITTEN AS ON FIRST PAGE OF CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER.  CHILD'S DATE OF BIRTH IS WRITTEN ON THE BACK OF THIS PAGE WHICH IS THE "COVID-19 VACCINE ELIGIBILITY CHECKLIST", SIGNED BY THE SAME INDIVIDUAL. CHILD IS TOO YOUNG TO RECEIVE VACCINE ON THIS DATE BUT PER CONSENT IS RECEIVING HIS SECOND PFIZER DOSE.  POSSIBLE IMMTRAC # IS 256519977
Patient experienced brusing several days after her vaccination, noticed when she went to go have a flu vaccine in the same arm.  The vaccinator at that time used her opposite arm.
Covid Bivalent vaccine was give as well as a Seqirus FluAd Quad vaccine lot # 942394 in 5h3 right deltoid as well.  Unknown which vaccine caused reaction within 15 minutes of coughing, throat irritation,& vomitous. Patient was given 50 mg benadryl and 20 mg of prednisone in office with resolution of symptoms within 10 minutes.   It is known that she drove home safely after above treatment
Felt horrible; inflammatory Lymph node; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced feels awful (Verbatim: Felt horrible) and lymph node inflammation (Verbatim: inflammatory Lymph node).  The outcome of the feels awful and lymph node inflammation were not reported.   It was unknown if the reporter considered the feels awful and lymph node inflammation to be related to RSV vaccine.     It was unknown if the company considered the feels awful and lymph node inflammation to be related to RSV vaccine.   Additional Information: GSK receipt date: 09-SEP-2023 This case was reported the patient via interactive digital media. The patient regretted of taking the RSV vaccine and felt horrible after and had an inflammatory lymph node. Follow-up not possible as no contact details provided.
Patient received 1st Pfizer vaccine (booster) 1/13/22.   Patient had previously received 1 J&J COVID vaccine.    Patient experienced flushing and itchy throat approx 15 minutes after vaccination.  Patient was in observation room and reported symptoms to  Paramedic who was monitoring observation room.  Paramedic notified Health Dept nurses. Paramedic administered 50ml oral Benadryl to patient. Patient's symptoms resolved.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-363763, MOD-2021-363032 (Patient Link).
got the flu; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced got the flu, when received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine for prophylactic vaccination with reaction Influenza .   The patient's medical history, past medical treatment, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got the flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
This spontaneous prospective pregnancy report as received from a nurse refers to a 25 year old female patient. The patient had an allergy to nickel, with allergy to metals. The patient's pertinent medical history included type one Herpes simplex virus (reported as "type one HSB"). On 08-MAR-2017, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly (lot # M032650, expiry date 31-FEB-2019, dose not provided) when she was 3 weeks pregnant. Concomitant medications included unspecified pre-natal vitamins. Last menstrual period was calculated to 15-FEB-2017, estimated conception date was 01-MAR-2017 and estimated delivery date was 22-NOV-2017. The pregnancy outcome was pending and fetal outcome was unknown. Exposure to GARDASIL 9 occurred in the patient's first trimester. Additional information has been requested.
I had fever of 102 to 103 for 5 days. Relieved by ADVIL. Then temperatures of 101. Weakness. Total body ache.
Information has been received from a 27 year old female with no allergies who had no problem with her first dose of Gardasil. On 27-FEB-2007 the patient received her second dose of Gardasil via injection. Concomitant therapy included "YAZ" (therapy unspecified). On 01-MAR-2007 the patient experienced bumps and itchiness where she received her Gardasil shot. The patient did not seek medical attention. As of 02-MAR-2007 the patient was not recovered. Additional information has been requested.