chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in her left pointer finger along with black and blue discoloration that is moving down her finger; swelling in her left pointer finger along with black and blue discoloration that is moving down her finger; cant bend finger; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in Arm Right on 13Feb2021 15:00 (vaccinated at the age of 61-years old) as dose1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications were none. On 14Feb2021, the patient experienced swelling in her left pointer finger along with black and blue discoloration that is moving down her finger, cant bend finger. It was reported that it's odd to call about the Covid Vaccine. She had the shot Saturday after noon, then late yesterday her left pointer finger was swelling and turning blue, today it is still black, blue, and swollen. Today it has move it down the finger. It doesn't hurt, she notices that she cant bend it as much. She has not injured the finger some other way. initially on Sunday the blue color was on 1 inch from the tip on her finger, and this morning it has moved down to the 2nd crease in her finger, making it now 2 inches down the finger being blackish blue. Patient stated that the temperature of the finger feels normal, as well as her sensation in the finger was also normal, she was able to feel. She stated that the finger turning bluish black has worsened since she notices it has traveled down the. Doctors offices and urgent care are closed due to the weather, but nobody ever contacted her back. She has already reported this to drug safety. She has had no positive covid or antibody test. Her most recent test was 3 weeks ago, being negative. She has had no vaccines on the same day or the 4 week prior to the covid vaccine. Outcome of events was not resolved.  Follow-up attempts completed. No further information expected.
Menstrual period early by one week, with several days of spotting leading up to it.  Extremely heavy bleeding, extreme pain and vomiting.
-Fatigue - joint aches - swelling of knees, legs, ankles, and feet  Approx 2 days and no treatment
Pain in the arm. Can't raise it. Was going to doctors office at the moment of report.
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. The nurse reported that an unknown number of doses of VARIVAX (Merck) (dose, lot# and route not reported) that were improperly stored (outside of the range specified in the prescribing information) might have been administered. VARIVAX (Merck) was experienced freezer fluctuations of 7-9 F and possibly temperatures of 14-15F for 24 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
No adverse event; a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 12-Apr-2021 and Moderna COVID-19 Vaccine on 10-May-2021; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 23-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a 20-year-old patient whom received a bivalent Moderna COVID-19 booster from a vial intended for Bivalent booster vaccination of 6M-5Y).    No concomitant medicine were reported. No treatment medicine were reported.
Feelings similar to the start of a cold or flu.  Unusually warm.  Loss of appetite.  Sore right arm near injection site.
The  vaccine recipient complained of itching  and tingling around the mouth, face, and nose .   Per Dr. recommendation, pt. received 50 mgs of  PO Benadryl.   Three  set of vital signs were taken.  Water was provided .  Vaccine recipient was taken home by her husband  via wheelchair .   Initial vitals at 11:38: BP : 144/104, pule 72, RR: 20, O2 98%. 11:40: O2 99%, pulse: 72 1145: 99%, pulse: 68  1147: BP: 130/80, pulse: 68, 99%. 1200:  BP: 130/65, O2 99%, pulse: 65, RR: 18 1205: pt. denied any further symptom/itching.  Pt. was released to her husband via wheelchair.
waited in store for the required 15 minutes. Got in car to drive home . Stopped at light about 1030 and heart raced to 160 and very dizzy.  I am a nurse and brought with me the epipen, benadryl repetab kids 12.5mg and proair...just in case.   I was wearing my fitbit and it read 160.  I took 50 of benadryl and was able to get home safely, Still felt very dizzy and heart rate dropped to 110 within 15 minutes. Sat in chair with feet elevated above heart.  Then at around 11 started with severe chills that lasted about an hour. Obviously the benadryl knocked me out for about two hour. When woke up from nap my Heart rate was back in 70s chills gone.  injection site hurt for several days and had knot in left arm for a week.  I have type AB blood and have a PA1 stress hormone verified by specialty labs by doctor when I was pregnant in 2004.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. Since 01-APR-2015, the patients were vaccinated with doses of PEDVAXHIB (lot # reported as K05462, expiration date: 07-AUG-2017; lot # L014426, expiration date: 08-MAR-2018; dose and route were not provided). which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient was administered a 0.5 dose of moderna for a fourth dose, instead of 0.25 dose of moderna
8 days after vaccine developed red, warm,  itchy rash at injection site.  treating with topical hydrocortisone
Agitation & Myalgia Narrative:  Per nursing report: "took 2nd Moderna vaccine yesterday[1/26]. Last night [1/26] c/o feeling shaky, c/o throat feeling tight. C/o more soreness to left arm states than when received initial dose of Moderna. States feeling weak in lower extremities. Rates sore left arm and neck sided stiffness at level 7."
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 10/08/2021. PATIENT FULLY VACCINATED ON 02/12/2021.
IBS, digestive problems, body twitch, tremors. I never had these problems EVER before taking this vaccine.
Patient given FLUARIX QUADRIVALENT vaccine at approximately 930am on 10/25/16. At approximately 935am patient noted to have seizure (left arm shaking, fell to floor convulsing, then unconscious for approximately 30-40 seconds). Regained consciousness about 2 minutes after seizure starts. Paramedics transport patient to Emergency at approximately 950am. Patient denied hx of seizures.
The next day I had high blood pressure, muscle pain, stiffness, annoyance of the noises and light, headache, nausea, chills, the next day low blood pressure and the other symptoms not so intense, then they decreased
17y female (almost 18y) with Hashimoto's Thyroiditis on levothyroxine and major depressive disorder on setraline who was at baseline who received 1st booster on 1/06/22 around 5pm without problems then around 1am midnite the following day (approx 8 -9 hours later) she woke up with chest pain lying in bed. It was not improved over the following 3 days. She noted chest pain with mostly lying down, alleviated by sitting/standing. With lack of improvement she sought further care to ER
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 10-AUG-2018, the patient was vaccinated GARDASIL 9 lot number N025428 and expiry date 19-JUN-2020 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36 to 46 degrees Fahrenheit (°F) (35.9 °F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36°F to 46°F for 10 hours and 25 minutes; and 32°F up to 35°F for 3 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of thirteen reports from the same reporter.  Sender's Comments: US-009507513-1811USA008122: US-009507513-1811USA008130: US-009507513-1811USA008124: US-009507513-1811USA004452: US-009507513-1811USA008126: US-009507513-1811USA008127: US-009507513-1811USA008128: US-009507513-1811USA008129: US-009507513-1811USA008121: US-009507513-1811USA008120: US-009507513-1811USA008119: US-009507513-1811USA008123.
no adverse effects reported; vaccinated with improperly stored Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-JAN-2019, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin) (PROQUAD) injection, lot # R020678 with expiration date: 15-JAN-2020, (dose, frequency and route of administration were not reported). The suspect vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # N035970, expiration date 30-APR-2020). No adverse effects was reported. The vaccine was stored in 16.5 Fahrenheit degrees for 1 hour and 44 minutes. There was no previous temperature excursion.. Digital data logger was involved. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003435: US-009507513-1904USA002106: US-009507513-1904USA003434:
GOT RED ITCHY SPOTS ON BODY AFTER 4 DAYS OF GETTING 2ND DOSE OF SHINGRIX
67 year old female with PMH anemia, HTN, HLD presents with headache, dizziness. Reports headache for 15 days, occipital, non-radiating, worse with bright lights and loud noises. Also reports associated dizziness, feels like the room is spinning, worse when she moves or head or tries to stand up. Reports intermittent paresthesia of right arm, no symptoms currently.
19:00 (11th) - Odd ear pain that wasn't relieved by OTC pain medication 1:00 (12th) - Intense chills and extreme nausea. Vomited at this time. Still had chills with heated blanket on after.  7:30-present (12th) - Ear pain, intense headache, fatigue, nausea.
pt recvd vax & began to feel dizzy, nauseated, weak, had chills x 1 1/2 hrs; also h/a, muscle aches; eventually went home but did not see MD;
Received booster shot twice about a month apart. When receiving accidental booster, also received flu shot. No adverse reactions to date.
Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
On 5/3/2021, patient called hospital call center to report side effects experienced 4/17 from 1st dose Pfizer vaccine. Patient denied emergency symptoms at time of call. Patient only wanted to report symptoms experienced in the past. Advised by PCP to report side effects. 3 days after 1st dose Pfizer vaccine on 4/13, patient reported having pain and numbness in both arms and hands, pain in legs after walking and chest pain. Patient states he did not seek emergency attention on 4/17, but later scheduled an appointment with his outside PCP. Patient underwent blood tests and reports being prescribed a stronger dose of Ibuprofen for 2 weeks.
Pressure in ear and ears are popping; Pressure in eye; Sinuses draining; Herpes inner lip; Opposite arm that received the injection hurts; Tinnitus; Immediately Dizzy; Allergic reaction; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Immediately Dizzy), ALLERGY TO VACCINE (Allergic reaction), TINNITUS (Tinnitus), EAR DISCOMFORT (Pressure in ear and ears are popping) and OCULAR DISCOMFORT (Pressure in eye) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Immediately Dizzy), ALLERGY TO VACCINE (Allergic reaction) and FATIGUE (Tired). On 19-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced EAR DISCOMFORT (Pressure in ear and ears are popping), OCULAR DISCOMFORT (Pressure in eye), SINUSITIS (Sinuses draining), ORAL HERPES (Herpes inner lip) and VACCINATION SITE PAIN (Opposite arm that received the injection hurts). At the time of the report, DIZZINESS (Immediately Dizzy), ALLERGY TO VACCINE (Allergic reaction), TINNITUS (Tinnitus), EAR DISCOMFORT (Pressure in ear and ears are popping), OCULAR DISCOMFORT (Pressure in eye), SINUSITIS (Sinuses draining), ORAL HERPES (Herpes inner lip), FATIGUE (Tired) and VACCINATION SITE PAIN (Opposite arm that received the injection hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-May-2021 contains non-significant information.
Started uncontrollable crying for hours hour 4-5 days following vaccines. Began about 3-4 hours after vaccines. Mild low grade fever 99.5. Began having trouble nursing approximately 3 days following. Developed high tone and increased hip tightness. Went to emergency on 7/8/18 for non stop crying.
Subject received HPV vaccine dose #1 on 10/30/15. On 10/31/15, subject developed severe cough, vomiting and fever to 104 degrees F. Subject seen in ER and diagnosed with pneumonia, received IV antibiotics and fluids and discharged home. On 11/1/15, subject continued to experience fever (to 103 degrees F) , severe cough and vomiting; she took prescribed oral antibiotics and over-the-counter cough medications and remained at home. On 11/2/15, subject continued with fever to 102.7, severe vomiting and cough, and developed severe diarrhea. Subject's mother advised to return child to the ER for further evaluation and management.
This spontaneous report as received from a physician via field representative refers to female patient who was more than a 70 years old. On an unknown date approximately in 2007 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot #and expiry date unspecified). The physician reported that an anonymous patient developed rash and shingles (date unspecified) after receiving ZOSTAVAX. The patient sought medical attention by seeing the doctor. The events were reported to be not recovered. Reports causality was not provided. No product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to two unidentified patients of unknown age and gender. It was reported that on an unknown date the patients were vaccinated with an improperly stored VAQTA (lot number and expiration date not reported) (dose and route not reported), that were stored as low as 30F on multiple occasions. Concomitant therapy was not reported. No adverse effect reported. This report is linked to MARRS 1305USA002431. Additional information has been requested.
This spontaneous case, initially received on 05-Dec-2016, was reported by a health professional and concerns a(n) female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported. Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date after vaccine, the patient experienced Guillain Barre Syndrome (Medically Significant, outcome: Not Reported).
headache; Slight sore throat; Chills; fever 101.4 F; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever 101.4 F), PAIN (body aches), HEADACHE (headache) and OROPHARYNGEAL PAIN (Slight sore throat) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (fever 101.4 F) and PAIN (body aches). On 24-Feb-2021, the patient experienced HEADACHE (headache) and OROPHARYNGEAL PAIN (Slight sore throat). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and HEADACHE (headache) had resolved, PYREXIA (fever 101.4 F) had not resolved and PAIN (body aches) and OROPHARYNGEAL PAIN (Slight sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia: 101 f 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided.   Reporter did not allow further contact
Patient was given Moderna booster (0.25 ml) instead of full 2nd dose (0.5 ml). Mistake was realized after patient left the pharmacy and he returned the following day for the other 0.25 ml
23 yo male with no known cardiac history reports being awakened at 4:00 am with severe, sharp chest pain and shortness of breath ("I couldn't breathe") 9 days after receiving smallpox and anthrax vaccinations.  No associated fevers or other symptoms.  The CP lasted 2 hours and he went to the ER around 6:00 am.  Per patient report, EKG, cardiac enzymes, and CXR were all normal.  Auscultation of heart was normal.  He was treated with Motrin with improvement in the pain (although he specifically notes that the pain was not reproduced upon palpation of the chest).  He was observed in the ER for several hours and discharged at 4-5pm.  He has had no episodes of chest pain since then but does report some weakness and fatigue.  He was seen by the MD who reports that the patient looked well and had a normal PE.  He did encourage the patient to keep an upcoming visit he has scheduled with a doctor.  The MD and I both suggested that the patient have an echo.  I have reported the case to another MD.
Muscle aches and fever. Same reaction that I had after the first shot on June 14, 2019., which lasted for about 2 days back then. I am taking Acetaminophen and Ibuprofen to alleviate the symptoms
Swollen neck lymph nodes, low grade fever, sweats, fatigue, mild diarrhea. Hard, hot, red, tender itchy lump and bruise at site of vaccination. Neurological symptoms ("zooming, like withdrawal from" SNRI). Doctor prescribed Benadryl. Also took Aleve or Aspirin for pain and fever. Couldn't get out of bed for 3 days. Symptoms began subsiding after 7 days. Still have swollen lymph nodes in neck and itchy lump at site.
My 1st shot I did not feel anything. The 2nd one was brutal. It hurt instantly. I felt stinging, then a flaring affect. My arm was so swollen by 11am , still today I can?t lift my arm or sleep on that side.
Rash, redness and infamation  at the innoculation site and extending around the upper arm. This rash has persisted and gotten worse since appearing.
beginning 8 days following vaccination: redness, itching, swelling at injection site.  Lessening in severity 4 days following vaccine
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. It was reported that the patients have been administered doses while the temperature excursion assessment was ongoing and reported that no adverse reactions were reported by any patients.  No treatment medications were reported.