chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 0U9C21A and D39A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). On 04-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Anaphylactic reaction, at a dose of solumedrol steroid injection; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of Medrol steroid pack. At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) and URTICARIA (Hives) outcome was unknown.            Concomitant medications were not provided.  Company Comment: This is a spontaneous case concerning a 31-year-old, male patient with no medical history, who experienced the expected serious event of Anaphylactic reaction and non-serious event Utricaria. The event Anaphylactic reaction occurred on an unknown day and event utricaria occurred 8 days after the third dose of mRNA-1273 vaccine. Patient was treated with Methyl prednisolone, Clarithromycin, Benadryl, prednisone and Medrol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-422917 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 31-year-old, male patient with no medical history, who experienced the expected serious event of Anaphylactic reaction and non-serious event Utricaria. The event Anaphylactic reaction occurred on an unknown day and event utricaria occurred 8 days after the third dose of mRNA-1273 vaccine. Patient was treated with Methyl prednisolone, Clarithromycin, Benadryl, prednisone and Medrol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Mom called starting 5/18 that Pt has a rash on arms + legs, no fever.
Called to car approx 10 min post vaccination where PT reported "my nose and mouth are itchy" "my throat and eye feel itchy". VSS. Offered benadryl po 25mg. PT accepted. 15 min later, pt reported "my throat is tight" "some trouble breathing ". Breath sounds clear bilat. Sao2 = 96 - 99. As precaution, EMS on site consulted. Advised pt that "she looked stable" and gave her options for further obs or d/c home, calling 911 if there was further distress. PT reported feeling better and opted for d/c home. Vital signs stable throughout.
Erythema, swelling and severe pain to R Deltoid area.  Afebrile.
headache; fever for 10 to 12 hours; very weak; any time she walked, she felt like she was going to die in the walk; tightness in the chest; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), FEELING ABNORMAL (any time she walked, she felt like she was going to die in the walk), CHEST DISCOMFORT (tightness in the chest), HEADACHE (headache) and PYREXIA (fever for 10 to 12 hours) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Asthma, Hypertension, Arthritis and Allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) and CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for Arthritis, OMALIZUMAB (XOLAIR) for Asthma, RAMIPRIL for Hypertension, THYROID (ARMOUR THYROID) for Hypothyroidism, CALCIUM, VITAMIN D NOS, LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ASTHENIA (very weak), FEELING ABNORMAL (any time she walked, she felt like she was going to die in the walk) and CHEST DISCOMFORT (tightness in the chest). On 25-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever for 10 to 12 hours). On 26-Mar-2021, HEADACHE (headache) and PYREXIA (fever for 10 to 12 hours) had resolved. On 26-Apr-2021, ASTHENIA (very weak), FEELING ABNORMAL (any time she walked, she felt like she was going to die in the walk) and CHEST DISCOMFORT (tightness in the chest) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Electrocardiogram: normal (normal) normal.Symptoms: It was reported that she thought all the symptoms are due to vaccine, she visited to doctor and ER but couldn't find anything wrong, also she visited to heart specialist and by that time all her symptoms were gone, she reported to fear getting booster dose of vaccine. No treatment medications were reported.This case was linked to MOD-2021-365216 (Patient Link).
Headache, Myalgia, Fever, NauseaVomiting, Pain/Discomfort at injection site, chills Narrative:
Persistant seizure observed in Emergency Department, requiring hospitalization. (Time may be incorrect). Child presently in hospital.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 24-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001558: US-009507513-1806USA001557: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103:
extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 25May2021 at 11:00 as an unknown dose number, at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme headache resulting in fainting and twitching while unconscious on 25May2021 at 20:00. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received 2nd Pfizer COVID vaccine 5/9.  On the evening of 5/10 he awoke with severe 7/10 CP located centrally and radiating down both arms.  Not a distinct pain such as sharp, stabbing, burning, throbbing but located in center of chest and was really uncomfortable.  No other associated CV symptoms (palpitations, SOB, syncope).  Pain slightly worse supine.  Pain self-resolved but recurred on 5/12.  he had no symptoms of COVID disease.
Arm pain on 30 April, 1 May, 2 May started to go away but by end of 7 May returned, sleep disrupted on May 8, Today, 10 May, stiff and achy, hard to lift easily.
From telephone contact received on 3/27/02, it was reported that a 17 month old male pt received a Tripedia vaccination on 3/14/02. Reportedly, 1 1/2 days later, the pt developed a 103F fever, became pale, limp and unresponsive with eyes rolled back in his head. The pt was taken to the ER; treated and released. The symptoms resolved. These events were considered to be "Other Important Medical Events".
Rash on left flank onset abruptly on 1/21/17. Rash was papulovesicular, red, swollen, and exquisitely tender. Pt was also febrile.
observed slurred speech, drooping side of face, says he was diagnosed by hospital on 5/18/21 with bells palsy
Initial report received from a consumer on 20 October 2010. A female patient (birth date declined) received on 19 October 2010 a right deltoid injection (route not reported) of ADACEL, lot number unknown. On 20 October 2010 the patient woke up with severe bilateral jaw pain, face tingling as though NOVOCAIN wore off, severe arm pain, and bilateral stiff neck. The patient had called her physician. The patient declined to give any further information. The outcome was reported as not recovered. Documents held by sender: None.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L044475, expiry date 12-MAY-2017; lot # L019297, expiry date: 18-AUG-2017; lot # L026602, expiry date: 19-OCT-2017; lot # L043213, expiry date: 28-AUG-2017; lot # L019297, expiry date: 08-AUG-2017). Nurse reported that the vaccine underwent a temperature excursion at 11 degree Celsius in a large refrigerator for a time frame of 1 hour 18 minutes which came back to its temperature range. She reported that the vaccine also underwent 2 temperature excursions previously on an unknown date: at 0.2C as minimum for 96 hours plus a second exposure at 1.5C for 7 hours 22 minutes (evaluating 0.2C for cumulative time of 103 hours, 22 minutes). No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Today I had a rash on my leg. My doctor, told me to use Impoyz  cream, twice a day for 10 days then call if not better.
Extreme amount of pain in both breasts; swollen and full of lumps; swollen and full of lumps; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 12:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included tetanus vaccine (MANUFACTURER UNKNOWN) for an unknown indication received on 25Feb2021, atorvastatin (MANUFACTURER UNKNOWN) for an unknown indication and levothyroxine sodium (SYNTHROID) for an unknown indication received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient received other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 12:00 the patient experienced extreme amount of pain in both breasts and they were swollen and full of lumps. The patient reported as extreme amount of pain in both breasts for ten days following the first shot and any amount of movement caused pain and they were swollen and full of lumps that were not normally there for ten full days, which started on day 2 post shot. The patient underwent nasal swab COVID-19 PCR virus test on 22Mar2021 and was tested negative. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care'.  The clinical outcome of extreme amount of pain in both breasts, swollen breasts and breast lumps were resolving.    No follow-up attempts are needed; information about lot number cannot be obtained.
I developed intense joint and muscle pain the day after my second COVID vaccine and had a low grade temp. Most notable was intense pain in my feet that never went away. The pain was on the top of both feet and some days, I could barely walk due to the pain. After 3 months with no resolution, I went to see a nurse practitioner on April 22, 2021. She did routine labs and discovered my creatinine was slightly elevated, my GFR was decreased,  my BUN was elevated, and my Vitamin D3 was very low. She recommended hydration and return in 3 months to recheck my kidney values. She also put me on CoQ10, magnesium, zinc, fish oil, Vitamin D3 5,000 units daily, B12, B complex, and Vitamin C. I returned for labs on July 20, 2021. My Vitamin D3 and BUN were now normal but creatinine and GFR were unchanged. She subsequently sent me for a renal ultrasound on 7/23 and I consulted with a nephrologist on 7/29/21.
Information has been received from a consumer concerning his 6 month old child who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 instead of flu vaccine (date, strength, route were all unknown). On an unspecified date, the patient experienced symptoms including fever, nausea and vomiting. It was unknown if the patient sought medical attention. At the time of the report the patient's outcome was unknown. No further information is available.
Flare up of Ebstein Barr Syndrome, sores on lips, exhausted, inability to exert physical insertion,
This patient received zoster vaccine on 4/27/17 on Rt. arm subcutaneously and developed Rt. arm redness, mild edema, warmth, and itchiness on injection site. Patient denies pain, discharge.
Patient was inadvertently given Pfizer COVID-19 vaccine for his 2nd dose instead of Moderna COVID-19 vaccine. The Moderna COVID-19 vaccine was given on 1/20/2021 and the Pfizer COVID-19 vaccine was given on 2/24/2021 (so there was at least 28 days between the 2 doses).
Nausea, dizziness, lightheaded. BP 113/78 (pulse 100), 96% O2 sat. Final BP 109/75 (pulse 64), O2 sat 97%.
This spontaneous report was received from a consumer referring on her son, a male patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL dose 1, 1 single shot, for HPV vaccine. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The reporter stated that after her son had had many of the same symptoms that her daughter (case # 1405USA002064) that also began after his first GARDASIL dose. He additionally had "swelling of the eyes" and loss of hair (on an unknown date). The reporter did not indicate that he had developed any heart condition. Reporter's son received his second dose of GARDASIL. At the time of the report the outcome of the events was unknown. This is one of two reports from the same source. Additional information is not expected.
Pt was receiving her routine 2 month vaccines, and after getting her PREVNAR and Hib (PEDVAX) she immediately broke out in a rash around the injection site. The doctor instructed the pt to wait for 20 minutes. Pt waited for the 20 min and when examined the rash had faded tremendously and the doctor allowed the pt to go home. Dr. has referred the pt to see an Allergist.
Breakthrough case admission after 3 vaccines Pfizer 2/5/21 Lot# EL9261;  Pfizer 2/26/21 Lot# EL9267;  Pfizer 10/21/22 Lot# 30125BA  This is the lot number listed in the database
She got sick from COVID-19 vaccine (Moderna); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She got sick from COVID-19 vaccine (Moderna)) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 ILLNESS (She got sick from COVID-19 vaccine (Moderna)). At the time of the report, ILLNESS (She got sick from COVID-19 vaccine (Moderna)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
severe arm pain, swollen lump in arm, feverish with no fever, chills, headache
Rash, UrticariaPruritus,  Tenderness at injection site, rash to site 4"x6 "  Narrative"
Extreme headache, extreme shaking/tremor, extreme chills, nausea, fever all starting the evening of the injection (5/22/19) and lasting until 5/25/2019. She had a small extreme injection site  redness night of injection and it got gradually worse, bigger, itchy, and hot by 5/25/19 causing her to come in the pharmacy and inquire about visiting the doctor. She did go to an urgent care and got a Keflex prescription to fill  if injection site continues to worsen.
approx. 40% temporary hearing loss in left ear that lasted for 15 seconds; Significant fatigue; Severe joint pain (hands, elbows, shoulder); Severe joint pain (hands, elbows, shoulder); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Jan2020 16:00 (Lot number: EL1284) at the age of 59 years as dose 1, single for covid-19 immunisation. Facility type Vaccine was Workplace clinic. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing); " Known allergies: Raw carrots, Raw celery, Raw Almonds" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; LISINOPRIL; GLIPIZIDE; METFORMIN. Within 24 hours of 1st dose, the patient had approx. 40% temporary hearing loss in left ear that lasted for 15 seconds. This has NEVER happened before. In past year it has happened approx. 8 times and included BOTH ears. Severe joint pain (hands, elbows, shoulder) that lasted approx. 10 month (no prior pain before injection). Significant fatigue. ALL these side effects occurred started within 24 hours of first dose.The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 10Jan2020 13:00, outcome "unknown", described as " approx. 40% temporary hearing loss in left ear that lasted for 15 seconds"; FATIGUE (non-serious) with onset 10Jan2020 13:00, outcome "unknown", described as "Significant fatigue"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 10Jan2020 13:00, outcome "unknown" and all described as "Severe joint pain (hands, elbows, shoulder)". The events "within 24 hours of 1st dose, i had approx. 40% temporary hearing loss in left ear that lasted for 15 seconds.  this has never happened before.", "significant fatigue", "severe joint pain (hands, elbows, shoulder)" and "severe joint pain (hands, elbows, shoulder)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test BinaxNOW: (Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of deafness unilateral, fatigue, arthralgia, pain in extremity. The patient administered second dose of bnt162b2 in arm right, on 31Jan2020 10:00 (Lot number: EL3297) as dose 2, single for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
has not been feeling weel; running a fever of 100 degrees; had a "sore arm" from the injection; the "GARDASIL 9 did hurt; This spontaneous report as received from a company representative and refers to her daughter, a 11-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified); (exact doses, routes of administration, anatomical locations, lot # and expiration date were not reported for any of them); all for prophylaxis.     On the same date, she experienced vaccination site pain (reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did hurt) and she had "a sore arm" from the injection. Since 04-FEB-2021, she was not feeling well and had a fever of 100 degrees (units not provided). The outcome of the events was reported as not recovered.  The reporter considered vaccination site pain to be related to hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The causality assessment between the rest of the events was not reported.     This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2102USA003519:
This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant), PERIPHERAL SWELLING (leg swollen) and CHEST DISCOMFORT (pressure in chest). At the time of the report, THROMBOSIS (blood clots), PERIPHERAL SWELLING (leg swollen) and CHEST DISCOMFORT (pressure in chest) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) Blood clots. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On an unknown date, a couple weeks after vaccination, the patient experienced THROMBOSIS (blood clots) (seriousness criteria medically significant), PERIPHERAL SWELLING (leg swollen) and CHEST DISCOMFORT (pressure in chest). Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
pt recvd vax & exp pain; became numb & felt tingling down to the hand;