chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Next day, he felt awful; dizziness; anxiousness; fatigue; hot red spot the size of a silver dollar; arm was swollen and large/Next day, his arm felt the same; hot red spot the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Next day, he felt awful), DIZZINESS (dizziness), ANXIETY (anxiousness), SKIN WARM (hot red spot the size of a silver dollar) and PERIPHERAL SWELLING (arm was swollen and large/Next day, his arm felt the same) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced SKIN WARM (hot red spot the size of a silver dollar), PERIPHERAL SWELLING (arm was swollen and large/Next day, his arm felt the same) and ERYTHEMA (hot red spot the size of a silver dollar). On 09-Sep-2021, the patient experienced FEELING ABNORMAL (Next day, he felt awful), DIZZINESS (dizziness), ANXIETY (anxiousness) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (Next day, he felt awful), DIZZINESS (dizziness), ANXIETY (anxiousness), SKIN WARM (hot red spot the size of a silver dollar), PERIPHERAL SWELLING (arm was swollen and large/Next day, his arm felt the same), ERYTHEMA (hot red spot the size of a silver dollar) and FATIGUE (fatigue) was resolving.            No concomitant medications were reported. No treatment medications were reported.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL SODIUM for Pulmonary arterial hypertension and SELEXIPAG (UPTRAVI) for an unknown indication.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included WARFARIN for an unknown indication.   On 27-Mar-2019, the patient started TREPROSTINIL SODIUM (unknown route) .6 milligram per millilitre four times per day. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SELEXIPAG (UPTRAVI) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI- Email ack from reporter
Systemic: Allergic: Itch Generalized-Medium, Additional Details: mother called that said couple hours after vaccine had itching all over; gave benadryl going on for 2 days
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013203 and expiration date 28-JAN-2017, lot # L027067 and expiration date 06-APR-2017, exact doses were not reported, orally). The vaccines were exposed to temperature of 10.5C for 32 hours, 8 minutes and to temperature of 0.6C for 16 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a female patient who was vaccinated intramuscularly with the first dose of GARDASIL. Subsequently, the patient experienced a skin reaction or what was described as half a boiled egg and her skin was bubbling a little at the injection site. No medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Pt started with hives on trunk. On 2/3/01, by the end of day, had a temperature of 103F, increased hives and itching. Went to ER and they gave Benadryl, Tylenol alternating with Motrin. On 2/4/01, swelling hands and feet. On 2/5/01 to ER and referred and they think is Prevnar. If no better in 3 days, return.
4pm had swelling on top of arm, not around entire deltoid, described by patient as softball size. Also red and warm. No rash. 10/12/18 in morning, still red, swelling greatly decreased, some tenderness. Went to PCP and received rx for cephalexin x10 days. 10/15/18 All symptoms completely resolved per patient.
Was exposed to Covid 8/30/2021. Felt ill 9/1. Home rapid test negative. Saw personal care physician 9/3. Doctor indicated that if positive, I was eligible for antibody infusion. Test result positive 9/4, infusion done 9/6
Chest pain; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 23Apr2021 at 15:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The medical history included peripheral arterial disease (PAD) and antithrombin III deficiency. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included warfarin sodium (COUMADIN), atorvastatin calcium (LIPITOR), lisinopril (MANUFACTURER UNKNOWN) and 81 mg of unspecified medication; all for unknown indications from unknown dates and unknown if ongoing. On 25Apr2021 at 21:30, the patient experienced chest pain and shortness of breath. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain and shortness of breath were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
high fasting blood sugar; felt off; couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (high fasting blood sugar), FEELING ABNORMAL (felt off) and INSOMNIA (couldn't sleep) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus and Anxiety. Concomitant products included METFORMIN for Diabetes.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced HYPERGLYCAEMIA (high fasting blood sugar), FEELING ABNORMAL (felt off) and INSOMNIA (couldn't sleep). On 06-Feb-2021, HYPERGLYCAEMIA (high fasting blood sugar), FEELING ABNORMAL (felt off) and INSOMNIA (couldn't sleep) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Blood glucose increased: 180, 174, 179 (High) fasting blood sugars were "sky high", in the 180's, 174, 179.         Patient normal fasting blood sugar is around 107.  Patient wears a diabetic sensor. Patient noticed her blood sugar increased with both doses of the vaccine.  Treatment information was not provided.   This case was linked to MOD-2021-047827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: updated reporter contact details
10 minutes after injection patient developed generalized itching, chest tightness.   oral diphenhydramine 50mg;  administered, patient developed itchy throat, mild cough in another 10 minutes.  Continued monitoring with no progression of symptoms.  to treat outpatient with prednisone and diphenhydramine.
Patient complained of "burning in her left shoulder at approximately 0940.  Upon inspection, the back of her shoulder had a large red area with 3 raised hives, she also complained of shortness of breath at that time.  At 0943 50mg Benadryl was administered to her right deltoid.  The patient then began complaining that her throat felt scratchy and she started coughing.  Patient was placed on 2L O2 via nasal canula and was given an Epipen injection to her right quad.  911 had been called and the patient was transported to the ER.
PATIENT DID NOT HAVE AN ADVERSE EVENT BUT DID RECEIVE AN ADDITIONAL DOSE OF THE MODERNA BIVALENT VACCINE
Extremely Fatigued, Muscle aches all over, fever, chills, headache, runny nose, injection site red, swollen and itchy
12 hours after 2nd vacccine, I started experiencing severe headache, severe bodyaches, climbing temperature that got up to 102.1 at 7pm that evening. I was extremely tired and slept for 24 hours.
fever; reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION SITE REACTION (reaction) 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, 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 experienced PYREXIA (fever) and VACCINATION SITE REACTION (reaction). At the time of the report, PYREXIA (fever) and VACCINATION SITE REACTION (reaction) outcome was unknown.            This case was linked to MOD-2021-031890, MOD-2021-032177 (Patient Link).
pt recv vax 1995 & pt exp fever & a strange red rash @ the inj site;
12 year old male was administered Pfizer 5-11 0.2 mL dose instead of Pfizer 12+ 0.3 mL dose for 2nd dose. Patient waited with parent for 15 minutes under observation. No adverse events/symptoms occurred during observation period. Patient and parent left after 15 minute observation.
Covid vaccine was not reconstituted - Observed for 30 minutes before leaving the clinic. No side effects noted.
Red, itchy patch underneath vaccine site appearing day after vaccine administration. First time for patient to receive high-dose flu vaccine.
Brought to ED for stroke like symptoms. Chronic cough for > 1 month and generalized weakness. Treatment includes observation, fluid and electrolyte replacement.
Legs and feet swelled suddenly and dramatically.  Cardiologist described it as possible myocarditis and congestive heart failure.
itchy rash on her upper back; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 45 days after receiving Shingrix, the patient experienced itchy rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, about 1.5 months later, the patient developed an itchy rash on her upper back. The rash lasted for about 1 month and she finally saw her health care professional and got a steroid injection and oral steroids. This case is linked to the case US2020AMR014194, reported by the same reporter.
Lump between shoulder and neck on both sides; Tired/sleepy; Arm pain; Dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), FATIGUE (Tired/sleepy), PAIN IN EXTREMITY (Arm pain) and MASS (Lump between shoulder and neck on both sides) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DRY MOUTH (Dry mouth) and PAIN IN EXTREMITY (Arm pain). On 27-Feb-2021, the patient experienced FATIGUE (Tired/sleepy). On 03-Mar-2021, the patient experienced MASS (Lump between shoulder and neck on both sides). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 27-Feb-2021, DRY MOUTH (Dry mouth), FATIGUE (Tired/sleepy) and PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, MASS (Lump between shoulder and neck on both sides) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include, Blood Pressure medication.
this actually started with the first does given at my doctors office july 24, 2021. but there was only slight pressure. the 2nd does of Pfizer was given at the Pharmacy the symptoms got worst.. more pressure then ringing in my air mostly when there is ambulation.
Symptoms: patient experiencing left arm pain with full range of motion, but muscle soreness and muscle pain status post 5 days after the Bexero was administered. Patient c/o of immediate area surrounding the vaccine administration was "feeling slightly firm". The greater region around the injection site was "extremely sensitive to touch". Patient denied symptoms of: fever, redness or warmth, red streaks down the arm, decreased mobility of the arm, or numbness or tingling in the arm or hand.
Anaphylactic reaction. BP 98-70, P 92. Pale, clammy, lethargic, throat constriction. Epi-Jr. 0.15mg given. 911 called. Taken to Hosp via rural metro ambulance.
POTENTIAL ADMINISTRATION ERROR; FREEZING EXCURSION OF 20 UNPUNCTURED VACCINE VIALS; This spontaneous report received from a health care professional concerned multiple patients.  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, and batch number: 202A21A expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the patient experienced freezing excursion of 20 unpunctured vaccine vials. On an unspecified date, the patient experienced potential administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential administration error and freezing excursion of 20 unpunctured vaccine vials was not reported. This report was non-serious.
he could sleep little but not properly at night; patient will not be getting second dose; suicidal thought came in his mind when he was going through all these but he is not a depressed person at all it was just a thought in his brain; he couldn't speak, he couldn't get the words to make any sense at all; right arm wasn't performing properly,he felt like it was more neurological problem; he was dizzy; Patient started losing his balance after receiving 1st dose; A spontaneous report was received from a consumer concerning a male patient of 74 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events suicidal thought came in his mind,started losing his balance, he couldn't speak,dizziness and right arm not working properly related to neurological problem and Insomnia.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 04 Mar 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 001A21A) vaccine intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, he experienced balance disorder(Started losing his balance).  On an unknown date patient experienced insomnia. and on 11 Mar 2021 patient decided not getting second dose (Intentional dose omission ).  On 07 Mar 2021, he experienced slurry speech,dizziness, Monoparesis, suicidal ideation.On 11Mar2021, he is about 90% better.  The event suicidal thought was considered to be medically significant based on IME list.Seriousness of other events are not reported.  Treatment medications include Aleve, Aspirin.  Action taken with the mRNA-1273 in response to the event was unknown.  The outcome of events slurry speech, dizziness,Monoparesis, suicidal ideation,balance disorder was considered to be recovering/resolving.  The outcome of events insomnia, intentional dose omission was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This report also refers to a case of Intentional drug omission for mRNA-1273, lot number 001A21A.
fever (took Tylenol after onset), malaise, myalgia, sustained tachycardia at rest to 180s, short of breath (O2 saturations low 90s), hypotension (unable to stand for lightheadedness), nausea; gradual onset 8 hours after vaccination, peak 10-14 hours after vaccination, much better 24 hours after vaccination.  Also mild allergic conjunctivitis (as with first dose of vaccine), for which I took fexofenadine.  No recurrence of arm rash on day 8 (as with first vaccine).
Patient came in for Covid 19 booster dose today. Staff that was preparing the vaccine did not dilute the vaccine prior to giving it. 0.2 mL IM was given, but not diluted, thus resulting in getting a larger dose than intended. MD was notified, pfizer was contacted for adverse reaction information to watch for, family was notified. Family was told to watch for local/systemic adverse reactions to higher dose, call clinic and be seen if any concerns. Staff was re-educated on proper dilution of vaccine, variance was done, program point of contact notified, report made with Pfizer, and VAERS forms completed. Patient reports no adverse effects at this time. If adverse effects occur, VAERS will be notified by clinic staff.
A large itchy rash with a raised border appeared on my left arm where I received the vaccine.  The rash appeared on 3/18/21 which was 12 days post the first dose of the vaccine.  I received the vaccine on 3/6/21.  My left arm has been ichy the past couple of days but there was no rash present at that time.
Single umbilical artery; Fetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 10-Oct-2019, concerning a foetus subject of unknown gender, whose mother was a 20-year-old female of body weight 175.5 lbs, height 63.2 inches and body mass index (BMI) 30.8, enrolled in a prospective observational safety study. The subject's father was 23-year-old.  The mother's medical history included asthma. Concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) and Albuterol HFA (salbutamol).   The mother's obstetrical history included one previous pregnancy which ended with spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 16-Apr-2019 and type of pregnancy was singleton. The estimated date of delivery (EDD) and corrected EDD (CEDD) of subject's mother was reported as 21-Jan-2020.   On 24-Jun-2019 and 27-Aug-2019, the subject's mother underwent ultrasound scan and no MCM was noted.   On 24-Sep-2019, at approximately 23 weeks of gestation, the mother was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine, batch number: P100118566, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   On an unknown date, after vaccination, the subject experienced single umbilical artery (reported as pregnancy complication) .  At the time of initial reporting, the outcome of the events was not reported.   This case is linked to the case 201905215 (the corresponding mother case).  The case was assessed as serious. The reporter did not provide causality assessment to Afluria QIV.; Sender's Comments: The subject experienced single umbilical artery after foetal exposure during pregnancy with the suspect product Afluria QIV. Vaccination of the mother occurred at approximately 23 weeks of gestation. Foetal exposure during pregnancy is assessed as not related per company conventions. Umbilical arteries form by the end of 5th week of gestation so causal role of the suspect product is assessed as not related.
This spontaneous report as received from a medical assistant refers to a 30 year old female patient. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent. On an unspecified date in May 2018 (reported as "last month"), the patient was vaccinated with a dose of PROQUAD (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis to vaccinate to attend college. On 08-JUN-2018, the patient was revaccinated with M-M-R II with lot number N014635 and expiration date of 11-MAY-2019 (strength, dose and route of administration were unknown) and VARIVAX with lot number M032495 and expiration date of 06-JUL-2018. No adverse effects were reported.
approx 5min p/vax pt devel urticarial rash on face, arms & legs;no resp distress;vital signs were nl;pt recv prelone & DPH;
Local redness, swelling, itching, heat, rash, pain "sore throat".
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 23-year-old female. Neither the patient's medical history nor concomitant medications were reported. The reporter indicated that she was not sure whether they received the FLUMIST IV or not. The product expired on 18-Dec-2011. On 19-Dec-2011, the patient inadvertently received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 30-Jan-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Next morning I had a static or whooshing noice in my left ear only. Sometimes it is worse than others.I thought it wasn?t cell phone problem and went to repair outlet. It wasn?t that . The sound / ringing in left ear is bad enough that I can?t have a conversation. My right ear is fine.
Left arm swollen from shoulder down to the wrist, itching, burning, red stripes down arm, injection site swollen and red, warm to touch.