chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blisters around the nose and mouth; Pain in the back of the head; Arm was a little sore; Very Very high fever; A spontaneous report was received from a consumer concerning a of an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced high fever, blisters around her nose and mouth, arm was a little sore, and pain in the back of the head.   The patient's medical history and relevant concomitant medications were not reported.   On 30 Dec 2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient's arm was a little sore and developed a fever.  On 04 Jan 2021 the patient developed blisters around her nose and mouth and pain in the back of her head.  The patient took ibuprofen to treat the events.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events blisters around her nose and mouth, and pain in the back of her head were not reported. The outcome of the events arm was a little sore and fever were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pregnant while receiving first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant while receiving first dose) in a 38-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage and Preterm labor on 19-Mar-2019. Previously administered products included for an unreported indication: ALCOHOL (1 drink a week) until 01-Sep-2020. Concomitant products included PROGESTERONE for Preterm labor, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and FISH OIL (OMEGA 3 ELITE) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Sep-2020 and the estimated date of delivery was 02-Jul-2021. On 19-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant while receiving first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant while receiving first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 19 Feb 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. on 23 Feb 2021,She would like to be enrolled to the pregnancy registry.
pt says she got really tired about 4:30 in the afternoon after taking the vax.  She went to bed. Her fever went up to 101.  She took Tylenol.  It came down to 100 but went back up to 102.4 so then took ibuprofen.  It went down to 101.  She took her lorazepam to sleep.  Her fever broke during the night.  Today she has fatigue and a sore left arm.
improperly stored vaccine; No additional AE; This spontaneous report has been received from an allied health, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1, lot # T007035 with expiration date 01-MAY-2022 ((strength, frequency, route and anatomical location were not provided) for prophylaxis.    The vaccine was stored at a temperature of 60 and 34 Fahrenheit degrees, time frame of 85 hours and 18 hours with no previous temperature excursion. Digital Data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Inappropriate age at vaccine administration; No adverse events; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse events) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021 at 1:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse events). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved and NO ADVERSE EVENT (No adverse events) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not provided.   This case was linked to MOD-2021-011291 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up information received and contains No new information
Arthralgia, NauseaVomiting, CHILLS BODY ACHES SORE THROAT NAUSEA Narrative:
On 11/8/2022, I worked all day with no problems. At about 6 PM, I had a stomachache, though. I also had no appetite, plus I had worsening pain with vomiting. I went to the ER at around 10:30 PM. I underwent a CT scan and was diagnosed with appendicitis. The CT scan also detected a cyst near my right ovary. I underwent laparoscopic surgery at about 4:00 AM on 11/9/2022. I then went home that afternoon. Everything went fine after that, and I had no complications. On 1/6/2023. I had a scratchy throat, headache, head congestion, fever (101 or 102 degrees), and fatigue. I tested negative the morning of 1/7/2023 and positive the morning of 1/8/2023. I stayed home from work for about a week. I didn't take antivirals, but I may have taken some OTC medicines to treat my symptoms, but I don't remember for sure. After about three weeks, I still had lingering sinus headaches and sinus inflammation. I used FLONASE, which provided relief within about two days. On 3/29/2023, I underwent an endoscopy and colonoscopy, and I was diagnosed with eosinophilic esophagitis. My doctor prescribed PRILOSEC. I'm supposed to take 40 mg twice a day, but I can only take one dose, because the medicine makes me nauseous. I am due for a follow-up endoscopy on 7/11/2023. I saw my gynecologist about the cyst in late December 2022, and an ultrasound provided further confirmation of the presence of the cyst. I underwent another ultrasound in mid-April 2023, and it indicated that the cyst was still present and that there had been no changes. The gynecologist recommended that I undergo diagnostic laparoscopic surgery, which is scheduled for 7/24/2023. This may result in the removal of my right ovary.
Loss of taste - things don't taste normal; Loss of taste - things don't taste normal; This is a spontaneous report from a contactable nurse.  A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number=EK9231, intramuscular in right arm on 07Jan2021 at 08:45 (at the age of 62 years-old) as a single dose for COVID-19 immunization.  The vaccine was administered at a hospital. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included duloxetine (DULOXETINE), naproxen (NAPROXEN), ergocalciferol (VIT D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of the vaccine. On 08Jan2021, at 9:00, the patient experienced a loss of taste - "things don't taste normal". The patient was not hospitalized for the event nor received treatment. The clinical outcome of the events of loss of taste  things don't taste normal, was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 03-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant product use was provided.  Treatment details included 2 aspirins.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   Reporter did not allow further contact.
felt bad; no energy/out of energy, no desire to go out; had a fever of 100F; aching all over; chills; swelling on the arm; got really ill; upset stomach; arm hurt a tiny bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a tiny bit), PERIPHERAL SWELLING (swelling on the arm), ILLNESS (got really ill), ABDOMINAL DISCOMFORT (upset stomach) and VACCINATION COMPLICATION (felt bad) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurt a tiny bit). On 19-Oct-2021, the patient experienced PERIPHERAL SWELLING (swelling on the arm), ILLNESS (got really ill), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (had a fever of 100F), MYALGIA (aching all over) and CHILLS (chills). On 21-Oct-2021, the patient experienced VACCINATION COMPLICATION (felt bad) and FATIGUE (no energy/out of energy, no desire to go out). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 20-Oct-2021, PERIPHERAL SWELLING (swelling on the arm), ILLNESS (got really ill), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (had a fever of 100F), MYALGIA (aching all over) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt a tiny bit), VACCINATION COMPLICATION (felt bad) and FATIGUE (no energy/out of energy, no desire to go out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, Body temperature: 100 (High) fever of 100F.         No concomitant medication listed.   No treatment information provided.
Patient was given a Moderna COVID vaccine out of the recommended age. Vaccine given off label on accident.
FLUZONE HIGH DOSE to a 55 year old with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 55 year old female patient who received influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included tozinameran (Pfizer biontech covid-19 vaccine) for Prophylactic vaccination.  On 26-Jan-2022, the patient received a 0.7 ml dose, total of suspect influenza quadrival a-b high dose hv vaccine (lot UJ779AA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid as prophylactic vaccination.  On 26-JAN-2022 the patient developed a non-serious "fluzone high dose to a 55 year old with no reported adverse event (product administered to patient of inappropriate age)" following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported "Nurse states she gave the FLUZONE HIGH DOSE to a 55 year old female. What should they do? Pharmacist came on the line and wants to know if there is any information that the Fluzone High Dose would be needed in the under 65 age range? Additional Description of event Adverse events: Nurse states she gave a 55 year old consumer the Fluzone High Dose today. Product used : Used Still using product : No"  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (FLUZONE HIGH DOSE to a 55 year old with no reported adverse event).  At time of reporting, the outcome was Unknown for the event fluzone high dose to a 55 year old with no reported adverse 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.
I was experiencing some symptoms on 11/23/2022 and 11/24/2022. I woke up with body aches on the morning of 11/25/2022 and tested positive with a home COVID-19 test. I placed a call with my family physician and was prescribed and received two doses of Paxlovid on 11/25/2022. I also had a horrible cough and was given Benzoate cough pearls but did not have to use my rescue inhaler. I was also taking two extra strength Tylenol in the morning and evening and am still doing that. I was instructed to stop taking Pravastatin while taking Paxlovid.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 20th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, pruritus, tiredness and muscle pain. The patient was treated with ADVIL. On an unknown date, the outcome of the pain, pruritus, tiredness and muscle pain were recovered/resolved. It was unknown if the reporter considered the pain, pruritus, tiredness and muscle pain to be related to SHINGRIX. Additional information was provided as follows: The patient received first dose of SHINGRIX and experienced pain, itching, tiredness and muscle ache. She took ADVIL and she recovered within one day. The reporter did not consent to follow up. No further details were provided. For tolerance with 2nd dose of SHINGRIX, refer linked case US2018GSK233751.
This case was reported by a health professional and described a 39 year old male who had a decreased response to the hep B vaccine recombinant (Engerix B) immunization series. The pt's medical history, concurrent conditions, and concurrent medications were not reported. The pt received injections of Engerix B on 9/25/01 (5239A4), 10/22/01 (5235A4), and 4/1/02 (5242A2). On 5/20/03, a hep B surface antibody titer measured 5.4.
rash on legs, scalp, buttocks that is itchy after vaccines administered, still has rash
Moderna COVID-19 Vaccine EUA dose given 30 days after BUD for refrigeration
New side effects keep coming. Should I be concerned about an allergic 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 VACCINATION COMPLICATION (New side effects keep coming. Should I be concerned about an allergic 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. In 2021, the patient experienced VACCINATION COMPLICATION (New side effects keep coming. Should I be concerned about an allergic reaction). At the time of the report, VACCINATION COMPLICATION (New side effects keep coming. Should I be concerned about an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information is not given.
Low hemoglobin detected when attempting to donate blood.    Completely asymptomatic, but was rejected from donating blood today because of a fingerstick Hgb 11.7 gm/dl.  This result was duplicated when the fingerstick was redone.  I've never been told that I am anemic before.
Child received 1Z 3/8/07 exam 3/10/07 received redness, swelling, mild tenderness, warmth L thigh 7.5 x 12 cm, R thigh 16.5 x 19.5 cm no evidence of cellulitis.
Pt. states that after receiving the 3rd dose of Moderna 01/06/2022, started experiencing symptoms 01/10/2022 of chest, shoulder, and back "hive-like" rashes. Self-treating with Hydrocortisone with persistent. No noted Primary visit/communications.
07/14/2010 MODERATE other. PAIN, SWELLING, REDNESS X 5 DAYS, FEVER 99.5 X 1 DAY.
Migraines every 1-2 weeks. Sleep, nsaids, adequate water, etc do not help and have to let the migraine take its course until done. Usually about 3 days to subside.  Never had migraines prior to the Covid vaccine being administered.
stroke; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, first dose) intramuscular on 01Feb2021 (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 05Feb2021, four days after vaccination, the patient had a stroke. The outcome of the event stroke was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
severe headache after that happened otw home lasting several hours; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration, administered in arm left on 22May2021 as 1st dose, single (age at vaccination was 48 years and was not pregnant) for COVID-19 immunisation. Medical history included migraines, arthritis, and fibromyalgia (chronic pain), and had known allergies to Codine, Theoflyine, Minocycoline, Bactrim DS, Flexril, and latex. The patient's concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced severe headache after that happened otw home lasting several hours on 22May2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
mild injection site swelling more than just wheel and flare; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to case 2020SA272580 (same reporter).  This case involves a patient who experienced mild injection site swelling more than just wheel and flare (vaccination site swelling), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history included DT containing vaccines that sometimes caused limb swelling, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious mild injection site swelling more than just wheel and flare (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on lot number for this case.
"Patient had her 2nd SHINGRIX vaccine on July 25, 2018. She then drove up to the mountains where they have a house there. On the way she had some arm pain. In the middle of the night she woke with chills and feeling cold. She got up to get a blanket and then had a syncopal episode, falling in her closet and striking her lip, sustaining a laceration through and through. She was seen at Hospital. A CT scan of the head was done with no abnormalities as well as CT of the cervical spine. Her wounds were sutured. She was placed on clindamycin. The wound is healing extremely well. She also saw her dentist because she had some lacerations of her gum line. She was reassured that healing well also. She is applying MEDERMA. There was an incidental finding of a nodule on the epiglottis on the CT scan. She was referred to ENT for consult. That is pending, probably in September. She does not have any hoarseness. No voice changes. She does have chronic mucus drainage in the posterior oropharynx and a history of allergies."
Erythema and edema to injection site (mild - mod). Pt prescribed BENADRYL 125/5.