chrisvoncsefalvay/vaers-outcomes huggingface dataset:
People are having Bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (People are having Bell's palsy) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (People are having Bell's palsy). At the time of the report, BELL'S PALSY (People are having Bell's palsy) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. The caller reported that other people also had bell's palsy associated with the Moderna and Pfizer vaccine.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the non-serious expected of Bell's palsy which occurred on an unknown date and non reported onset latency with an unspecified dose number of mRNA-1273. No concomitant medication or treatment information was reported. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Sender's Comments: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the non-serious expected of Bell's palsy which occurred on an unknown date and non reported onset latency with an unspecified dose number of mRNA-1273. No concomitant medication or treatment information was reported. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Pt mother made appointment online to receive Pfizer covid vaccine. Online when mom filled out pts info, she put in DOB as 07/13/2008, pts correct DOB is 07/13/2009. The pharmacy was not told by mother, we went based on what was filled online as the correct DOB. Pharmacy went based on the DOB of 07/13/2008 per form. Pharmacy was  made known when we received an email regarding this. called and confirmed with mom that in face pts DOB is actually 07/13/2009 not 07/13/2008. Pt did not report any adverse affect, mom stated she did confirm dob with the state
Patient came in for a Pfizer COVID Bivalent booster vaccine. Was administered a Pfizer COVID (Not Bivalent) vaccine in error.
Itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and RASH (Rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Denosuaub v (got flu). Concurrent medical conditions included Seizure (under control for 30 years), Mitral valve disease, Osteoporosis and Raynaud's syndrome. Concomitant products included CARBAMAZEPINE (TEGRETOL), PHENOBARBITAL, CALCIUM, CENTRUM SILVER WOMEN 50+, VITAMIN D [VITAMIN D NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 30-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) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced PRURITUS (Itchy). At the time of the report, PRURITUS (Itchy) and RASH (Rash) outcome was unknown.            The patient reported that she had the first vaccine and there was no adverse event, she was fine.  The patient reported that She is going to get tested for autoimmune disease, not sure if she has.  She got tested for Sjogren's syndrome, but she does not have it.  Treatment details was not reported.  Consent for safety follow up given
This spontaneous report was received from a physician regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, (dose was not reported, lot # L020859, expiration date 19-JAN-2017). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
TERRIBLE SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced terrible side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20220609909.
Patient was see in ER on 8/17/13 with complaint of painful rash. Was given Acyclovir, Prednisone Clobetasol and PERCOCET. He is being treated with LYRICA and LIDODERM patches as of 9/29/13 symptoms of painful rash not resolved.
Dizziness, nausea, vomiting, chills, headache. Began at 5:00 am the day after vaccination and lasted approximately 4 hours.
fever of 100.6°F; tested positive for COVID-19; Congestion; sinus drainage; A spontaneous report was received from a Physician  concerning a 68-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events congestion, sinus drainage, fever of 100.6f, tested positive for covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K20A) Intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Jan 2021, the patient experienced the event congestion, sinus drainage. On 20 Jan 2021, the patient experienced the event fever of 100.6f,On 19 Jan 2021, the patient experienced the event tested positive for covid-19.  Treatment details included For the symptoms: Tylenol, Aspirin and Monoclonal infusion., Other: Lotrel for her blood pressure and Melatonin for sleeping., 09Feb2021. No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), congestion, sinus drainage, fever of 100.6, tested positive for covid-19 was unknown.
Information has been received from a nurse concerning a 12 year old female patient who on 16-JUN-2009 was vaccinated with a 0.5ml dose of VARIVAX (Merck) (lot #663536/0263Y) subcutaneously.  Subsequently, one day or 2 day after injection, the patient developed "redness and warmth" at the injection site.  The patient had sought unspecified medical attention.  No lab diagnostics study was performed.  The patient recovered on an unspecified date.  This is one of several reports received from the same source.  Additional information has been requested.
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 17:00 as dose 5 (booster), single (Lot number: GHQ703) at the age of 77 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 at 11:00 as dose 1, single (Lot number: EL9266), in left arm and on 11Apr2022 at 03:00 as dose 2, single (Lot number: FJ4991), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies and is healthy no diabetes, Hypertension etc. The patient received Paxlovid from 08Mar2023. No other medication in 2 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108400 same patient, different drug/event;US-PFIZER INC-202300108419 same patient/vaccine, different dose/event;
Severe back muscular and intestinal cramping lasting for about 8 hours.  Abdomen distention was pronounced.  Also  very fatigued  and lethargic for over 24 hours.
Pfizer & Biotech vaccine was administered to the patient and after the vaccine we asked them to have a sit for 15 minutes. During that time, patient experienced headache and nausea. Patient did mention that he usually eats right after waking up but on 3/31/21 he didnt eat anything in the morning. His parents gave him water and he felt a lot better. Pharmacist called 911 because we thought that his throat was closing up but it was just nausea and his spit was coming up. After the 911 came they checked him out and he was doing okay and felt much better and did not had to go to emergency room. He was okay and then left after 30 minutes of observance. I also called the patient at around 4 pm to make sure he was okay and patient said he was fine and was felling normal like before.
Started on 10/17 with a dry cough which out worse throughout the night and now she has become horse. If she talks to long she has to keep her throat mosit.
Pt describes the onset of left sided neck pain the day after receiving the injection.  The pain is sharp and is in the area of muscle insertion at the base of the occiput and mastoid process.  Has tenderness to palpation over the SCM tendon insertion superiorly.  Notes that the pain increased with certain head movements.  Not associated with headache, fever, redness, or swelling in the area.  Also noted skin sensitivity over left cheek initially, however this has resolved.  Did not take any pain medication for this.  Has had pain for the past 3 days.
Syncope after getting vaccine. BP 95/60, P 100, O2sat 96%. Improved after 2 minutes but monitored for 20 minutes.
On yesterday, February 11th, day 7 after getting my 1st shot of Moderna Covid19 vaccine, I woke with an itching feeling just under the injection site. I thought I maybe had been bitten by a bug. As the day progressed it not only itched it became very red and hot in about a 2 inch area. I put an ice pack on it then cortisone cream on it yesterday afternoon and before bed time.  Today, Friday, February 12th, the itching is lessened but I still feel it. The redness has lessened slightly. I did not seek medical attention. I am only reporting it because I looked up on the internet if this was one of the side effects. The article suggested to report it.
Patient received a H1N1 shot at the school of nursing on the above date mid-morning. Patient began with difficulty breating and Shortness of Breathe approximately 3 yours post injection. Several hours post these difficulties patient went to local urgent care and recieved Benadryl, prednisone injection and proventil in addition to a prescription for proventil and prednisone. Patient to date continues to have wheezing and uses an inhaler daily.
Medication Administration Error. Patient received 0.25 mL of Moderna bivalent vaccine instead of 0.5 mL at office visit.  The patient was contacted immediately once error was discovered and returned the same day for an addition 0.25 mL for the full dose.
5/16 14yo Male with B ALL, in week 2 of consolidation therapy admitted for positive covid 19 infection (via at-home test) and uncertain hydration status. Pt was monitored for two hours following his PEG asparaginase administration, had no further complications and was medically cleared to be dc.
Swelling to 2? by 1.5? by .5? and pain lasting for about a week
Patient reports having a history of allergic reaction with first vaccine. Per patient she reports symptoms of hives, itching and syncope. Patient Pulse ox 98%, Hr 97, BP 114/68. Patient does have a history of allergies, POTTS. Patient felt itching, throat tightness, and cough after second vaccination (similar to first. Patient did not require EPI with first vaccin. On evaluation lungs sound clear, no edema. Patient took Benadryl 50mg and was provided Pepcid 20mg. Patient was observed for 30 minutes. Patient was discharged home with parent.
From initial information received on 05Jan04 from the pt's parent, who is also a physician, regarding an adverse event occurring, it was reported that a pt (gender, age and date of birth not specified) received a Fluzone SV 2003-2004 vaccination, lot number U129AA, administered IM in the anterolateral thigh on 08Dec03. Three days post vaccination, on 11Dec03; the pt developed a 104 degree F temp, cough,loss of activity and tonsillitis.  According to the physician the pt received "supportive care".  Reportedly the pt recovered from this experience. 10Aug04: No additional information has been obtained from the reporter. Case is closed. The reporter of this case is the same reporter of case number 2004-00024, 2004-00026 and 2004-00027.
positive covid test; Slight fever; sneezing; cough; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever), SNEEZING (sneezing), COUGH (cough) and COVID-19 (positive covid test) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PYREXIA (Slight fever), SNEEZING (sneezing) and COUGH (cough). On 27-Jan-2021, the patient experienced COVID-19 (positive covid test). At the time of the report, PYREXIA (Slight fever), SNEEZING (sneezing), COUGH (cough) and COVID-19 (positive covid test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) On Jan 27, Patient had a positive COVID test.   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.
Information has been received from a physician concerning a female teenager, probably between 17 and 18 year old patient who in May 2007, was vaccinated with a second dose of Gardasil. The patient developed amenorrhea after the second injection. The physician felt that amenorrhea was not related to therapy with Gardasil. It was unknown if the the patient sought medical attention. The outcome was unknown. Additional information has been requested.
Received shot 1 pm 3-16-04. Became nauseous 1 hr later. Started vomiting 32 hours later. Vomiting every 19 hours. Then diarrhea. To medical center ER, Saturday 3-21-04. Received IV fluids, blood work, urine test, abdominal x-ray & released. Sent home to gather stool sample. Lives alone, no one else sick.
pt recvd vax OCT92 & evening of vax exp burning when urinating; devel cystitis & pylonephritis & was thrown into diabetic stress & bleeding of colon; hospitalized & sx were felt to poss ATB; frozen shoulder; fasting blood sugar of 150;
Started cough that night, arm very sore and kept her awake at night, cough got worse and she went to walk in clinic and treated for bronchitis, never got better, went to her MD and they put her in the hospital with pneumonia, she was there for a week, and is now home but patient says the shot is to blame.  Patient states she still has tenderness and redness at injection site.
No Adverse event; Monovalent vaccine for 6mo-5yo administered to a 12yo patient instead of the Bivalent Booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6mo-5yo administered to a 12yo patient instead of the Bivalent Booster dose) and NO ADVERSE EVENT (No Adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6mo-5yo administered to a 12yo patient instead of the Bivalent Booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6mo-5yo administered to a 12yo patient instead of the Bivalent Booster dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6mo-5yo administered to a 12yo patient instead of the Bivalent Booster dose).    No concomitant products reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the monovalent vaccine for 6 months to 5 years administered to a 12 year patient instead of the Bivalent Booster dose. The patient needed to receive the booster dose caller did not know if it was going to be the initial booster or an additional booster.  No treatment products reported.
BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER WITH MODERNA VACCINE. DX Acute hypoxic respiratory failure secondary to covid-19 PT REQUIRED INTUBATION. PT LATER DEVELOPED RLE DVT POSITIVE. 65 yo male known to Dr. with a h/o bladder cancer diagnosed in 2018 s/p cystoprostatectomy with neobladder formation with positive margins and lymph nodes. He received adjuvant chemotherapy. In 2019, he developed bony metastasis.  19. DISCHAREGED TO HOSPICE.
Swollen eyes; Pain in the eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swollen eyes) and EYE PAIN (Pain in the eyes) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 20-Apr-2021, the patient experienced EYE SWELLING (Swollen eyes) and EYE PAIN (Pain in the eyes). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Swollen eyes) and EYE PAIN (Pain in the eyes) had not resolved. Not Provided          No concomitant product was reported.
Following day after vaccine (Saturday) fatigue, extreme soreness at injection site, 102° fever, headache, chills, and body aches. Stayed in bed entire day. Day 2 following vaccine, Covid arm, and still very painful at injection site.
Began with general malaise, later:  SOB with exertion, at general physical on 9/15/21, found to have irregular HR, blood work showed hyperthyroidism
day after 1st vaccine had hives on back and hips.  they went away later that evening
Felt Winded with chest pain the day of the vaccine. H/O of PVCs but this was different more frequent. 4 days after the vaccine began feeling pain pinky finger and then it became excruciating with swelling and spread to the ring finger on the left hand. Was seen by PCP who sent Employee to the ER to be seen by a Hand Specialist MD. Admitted to the hospital for high dose steroids', and lymphadenopathy discovered and diagnosed. Parsonage Turner syndrome diagnosed secondary to the Covid-19 Vaccine. Discharged the next day to be followed outpatient, 2 weeks of steroids and nerve medication as of now. Unknown if the damage will be permanent.
pt recv vax; grandma found pt weak & staring & was not able to stimulate pt;to er & was adm;reported to have sz;to hosp for intensive care;
Petechiae running down left arm into hand and left chest. Noticed at approximately 10am 1/7/2021 progressively got worse at about 12:00pm contacted vaccine clinic. They told me I should go to the Emergency Room. Went to Emergency Room and had multiple blood tests performed, all came back okay. They told me to come back if it gets worse. 1/8/2021 petechiae seem to be resolving. Just interesting that it was just on the left side of my body where I received the vaccine.
low grade fever (normally 97 point something and yesterday it was 99.5°F); really high erratic heart beat/ heart rate was over 120. At one point 150 and, while walking up the stair, 170/heart rate is 127; didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (really high erratic heart beat/ heart rate was over 120. At one point 150 and, while walking up the stair, 170/heart rate is 127), FEELING ABNORMAL (didn't feel well) and PYREXIA (low grade fever (normally 97 point something and yesterday it was 99.5°F)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068J21A, 019B21A and 016C21A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL (ESTROGEN) and PROGESTERONE for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced HEART RATE INCREASED (really high erratic heart beat/ heart rate was over 120. At one point 150 and, while walking up the stair, 170/heart rate is 127) and FEELING ABNORMAL (didn't feel well). On 28-Dec-2021, the patient experienced PYREXIA (low grade fever (normally 97 point something and yesterday it was 99.5°F)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 28-Dec-2021, PYREXIA (low grade fever (normally 97 point something and yesterday it was 99.5°F)) had resolved. At the time of the report, HEART RATE INCREASED (really high erratic heart beat/ heart rate was over 120. At one point 150 and, while walking up the stair, 170/heart rate is 127) and FEELING ABNORMAL (didn't feel well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Body temperature: 99.5 degree f (High) High; 99.5 degree F. On an unknown date, Heart rate: 71-72 (normal) Resting heart rate; 71-72, 120 (High) Heart rate while riding bike: 120, 120-150 (High) Heart rate while sleeping: 120-150, 170 (High) Heart rate when going up stairs: 170 and 127 (High) 127; High.         Patient would not have noticed the heart rate if it was not for the watch   This case was linked to MOD-2021-431997 (Patient Link).
Arm swollen in a 3-4 inch band all the way around injection site, nausea & vomiting, diarrhea, fever, chills, weakness.