chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain, swelling of joints, itching beginning 9/12/05 (noted when coming home from school) lasting for 7 days.  Seen by ER physician.  Noted swellling both elbows, one knee and one thumb. Blood work completed at hospital.  On Prednisone for one week.  Seen by physician for follow up in one week.
My arm was very sore and I can not raise it without severe pain. I also have problems laying on it without pain.
got the vaccine snd has gotten shingles every year since/suspected vaccination failure; has gotten shingles every year since / badly; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that his/her friend got the vaccine and has gotten shingles every year since badly. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Client had Moderna vaccine on 02/05/2021 but stated to nurse he had no prior covid injections
No Additional AE; HCP reports patient was administered  GARDASIL 9 ( not supported ) and VARIVAX ( supported) after TE.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot # W039688, expiration date: 13-DEC-2024 (strength, and route of administration were not provided); and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #w015188, expiration date: 06-JAN-2025 (strength, and route of administration were not provided). Those vaccines were administered for prophylaxis. Before administration those vaccines underwent temperature excuursion for 20 minutes. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in 0 Farenheit (F) and varicella virus vaccine live (oka/merck) (VARIVAX) in 32 Farenheit (F). No additional adverse events were reported.
Bright yellow urine; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient reported received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 25Jan2021 at 46-year-old. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient had bright yellow urine after second dose of COVID-19 vaccination taken on 25Jan2021. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
01/09/23 presents to ED for "chest pain". PMHx of "of severe depression, coronary artery disease"
9/6/21 presents with SOB, increased weakness with intermittent cough. Tested COVID + 9/1/21 per patient.
EXPERIENCED A TONIC CLONIC SEIZURE AT APPROXIMATELY 08:45PM THAT LASTED FOR JUST ABOUT 5 MINUTES
INJECTION SITE ITCHING; RASH; INJECTION SITE PAIN; This spontaneous report received from a patient via a company representative concerned an elderly female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 injection site itching, rash, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from injection site itching, and injection site pain, and had not recovered from rash. This report was non-serious.
Temperature excursion; This spontaneous non-serious safety report was received on 03-Dec-2021 via Fax by the reporter, from a nurse.  A source case was databased with the following number: MCM-002828.  Due to the nature of the event (temperature excursion only), the causality between the event and Vaxelis was not applicable.  No further information is expected.
Fever developed at 6:00 am on 6/29/12 (102.9) fussy, poor appetite, decreased urinary output.
Diminished smell persisting for a few weeks post vaccination.  Initially, had nausea, headache, skin pain, fever/chills, nasal congestion, ST, cough, fatigue that resolved within 2 weeks.   No noted change in sense of smell post COVID infection Aug, 2022 until COVID vaccine in October.
CHILD COMPLAINED OF PAIN. MUSCLE AREA WAS RED WITH GOLF BALL SIZED KNOT, WARM AND HARD TO THE TOUCH. REDNESS HAS SPREAD FROM SHOULDER TO ELBOW AND VERY WARM. COMPLAINS OF "ITCHY".
warm to the touch at the site of injection; itchiness at the site of injection; Redness at site of injection; Bad headache; Sore at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch at the site of injection), VACCINATION SITE PRURITUS (itchiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at site of injection), HEADACHE (Bad headache) and VACCINATION SITE PAIN (Sore at the site of injection) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch at the site of injection), VACCINATION SITE PRURITUS (itchiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at site of injection), HEADACHE (Bad headache) and VACCINATION SITE PAIN (Sore at the site of injection). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to the touch at the site of injection), VACCINATION SITE PRURITUS (itchiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at site of injection), HEADACHE (Bad headache) and VACCINATION SITE PAIN (Sore at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
Havent barely moved all day/''i'' just feel so unable to do anything; A pounding headache that wont go away; "My" left arm is really sore; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 02May2021 at 17:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid, anxiety, severe depression and lower back pain. The patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), buspirone (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN), naloxone hydrochloride, buprenorphine hydrochloride (SUBOXONE) and levynthor (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 22:00, the patient had not barely moved all day, had a pounding headache that would not go away, her left arm was really sore and she just felt so unable to do anything. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had not barely moved all day/she just felt so unable to do anything, a pounding headache that would not go away and her left arm was really sore was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
I have a history of ear infections - I have getting them since a child. I got an ear infection. Urgent Care - Hospital. They gave me ear drops - I think it was a steroid ear drop - and told me to put in ear for a week. That cleared it up. Immediately after the vaccine, I had fever, chills, body aches, nausea and those symptoms lasted for four days. No treatment.
Developed a temperature of 102.3  and had a one minute seizure on Day 3 after vaccines.  Was limp afterwards, went to ER
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient send swelling to baseball size, with pain and discoloaration. Counsel if it get worse in pain, swelling, color, and it start spreading to seek medical attention
Significant local reaction at injection site with significant redness, warmth & pain for 2-3 days.
Onset of red rash at injection site. Spread over 1-2d, also blotchy rash at other sites. Seemed itchy. ER dxed as erythema multiforme. Twin brother w/ similar prodrome, similar rash.
administer the vaccine from a vial that stay >24 hours at room temperature; administer the vaccine from a vial that stay >24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine from a vial that stay >24 hours at room temperature) and PRODUCT TEMPERATURE EXCURSION ISSUE (administer the vaccine from a vial that stay >24 hours at room temperature) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033k21-2a and 033h21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Recent change in status such as improvement or worsening really high on diabetes).   On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2022 at 2:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine from a vial that stay >24 hours at room temperature) and PRODUCT TEMPERATURE EXCURSION ISSUE (administer the vaccine from a vial that stay >24 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine from a vial that stay >24 hours at room temperature) and PRODUCT TEMPERATURE EXCURSION ISSUE (administer the vaccine from a vial that stay >24 hours at room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  It was reported that they left a vial open on 21 Feb 2021 at 1:19PM and on 22 Feb 2022 at 2:10 PM they administered the vaccine from that vial. Initially the vial was stored in the refrigerator on 18 Feb 2022. The vial were moved from freezer to refrigerator on 21 Feb 2022. Total amount of time the vial was exposed to room temperature ranged 25 hours 8 to 25 degree Celsius/46 to 77 Fahrenheit. The vials were returned to the maintained at room temperature.   This case was linked to MOD-2022-492698 (Patient Link).
the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 23-Jul-2023; no adverse event; dose was given after the beyond used by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after the beyond used by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 23-Jul-2023) and NO ADVERSE EVENT (no adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     Patient's medical history was Unknown. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 23-Jul-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 23-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after the beyond used by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 23-Jul-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after the beyond used by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 23-Jul-2023) 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), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose was given after the beyond used by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-Jun-2023 and the vaccine was administered on 23-Jul-2023).    No concomitant medications were provided. Dosage text for suspect product was reported as unknown. It was reported that patient's 1st dose was unknown, 2nd dose was unknown, 3rd dose was unknown, 4th dose lot number was 060A22A administered on 21-Jun-2022 and 5th dose was unknown. It was reported that 4 doses was given after the beyond used by date. The BUD  was reported as 22-Jul-2023. 1 Intact carton Remaining vials has been discarded. Vial size was 2.5 ml. Vial did not undergo any temperature excursions. The expiry date was reported as 14-Oct-2023. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-734899, US-MODERNATX, INC.-MOD-2023-734913, US-MODERNATX, INC.-MOD-2023-734932 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734913:Same reporter US-MODERNATX, INC.-MOD-2023-734899:Same Reporter US-MODERNATX, INC.-MOD-2023-734932:Same Reporter
Widespread hives,  itching within 24 hours after vaccination.  It is now about 36 hours post vaccination and he has hives on his face, left upper arm, right palm and bilateral lower legs.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 26-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
I woke up the next morning after receiving the vaccine with a rash on my stomach. I thought it was my allergies from playing outside with my son. By Thursday I noticed it was spreading and made an appointment with the local clinic for Friday and there was diagnosed with shingles. I was advised to use over the counter lidocaine cream. The blisters are gone my skin is just a little discolored.
The day after the second vaccine, I experienced elevated morning heart rate (HR) and lowered heart rate variability (HRV). Initially, this was not unexpected; however, my HR and  HRV remained abnormally high and low, respectively, with no clear cause. I am an athlete, so I pay very close to these metrics on a daily basis.  My mean morning heart measurements 40 days prior to the second vaccine: HR = 68.5 bpm, HRV= 8.0 .  Mean Morning heart measurements 30 days post vaccine: HR = 82.7, HRV = 7.2
Information has been received from an office manager concerning an 18 year old female who on 05-AUG-2008 was vaccinated with a second dose of GARDASIL (route and administration site not reported).  Immediately post the vaccination the patient fainted and had convulsions and seizures which lasted for approximately 1 minute.  Subsequently, the patient recovered from seizures and faint.  The adverse events happened in the office.  Upon internal review the seizure was considered to be an other important medical event.  Additional information has been requested.  This is one of several reports from the same source.
My right knee became filled with fluid. No known injuries. I went to Rheumatologist, checked for rheumatoid arthritis and lupus. No tears or anything. I had to get fluid drawn off the knee. Everything looked fine pathology-wise. At this point, I have not followed up with rheumatologist - it swells and goes down and swells and goes down - the fluid in the knee. Two weeks ago - I have  a mass on my breast. I was scheduled for Mammography and an ultrasound. I am set up with Breast Biopsy now with a Breast Specialist.  He was concerned where I had my COVID vaccine. On the 18th of this month will be the Biopsy - that will be done at the hospital.
Within 25-30 minutes I felt a very sore area on my right side just up from the bottom of my rib cage. I reached for it and I could touch the exact spot with one finger. It was almost like if you had run into the corner of a table really badly. It came on fast. Within less then 10 min later it felt like a small balloon was getting inflated with the sore spot right in the center expanding. The soreness was not that big just this strange feeling like that area was expanding just like a balloon. I would say it was about an 8" circle. This strange feeling and soreness lasted all evening. It even woke me up in the middle of the night. It was slowly gone by the end of the next day. The next day I only felt a little tired and not well. Nothing major. I have not heard of anything like this. I have no doubt this was from the shot. I had only gotten in my car to drive home. As soon as I pulled in my garage it came on very suddenly. No other reason for this.
Shingles. Symptoms started 5/17/2021,  Diagnosed 5/19/2021. Prescribed valacyclovir & gabapentin.
chest pain. Sharp, left sided CP with SOB x 3 hours; continuous, no radiation; mvmt increases pain, started while sitting today; HX PTX x 2 with VATS surgery 5 years ago.
Significantly increased hair shedding and alopecia aereata. Hand and foot skin tightness, swelling in hands and feet. Later diagnosed with scleroderma.
Soreness at injection site initially which progressed to mediate pain, like a knot in the arm that was painful.   Also, around 4 hours after the injection, extreme fatigue set in  and it felt like I was getting sick, like I normally do with a cold or flu.  After 12 hours of sleep from the tiredness, I felt normal the next day, but site where shot was in the left arm was very sore and painful.
Patient was administered second dose Pfizer after receiving first dose Moderna for the first dose at a different provider.
No adverse event; Given 10 mcg moderna bivalent instead of 25 mcg; This spontaneous case was reported by a non-health professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Given 10 mcg moderna bivalent instead of 25 mcg) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No known allergy.  Concomitant products included PENTACEL, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 05-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 10 microgram. On 05-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (Given 10 mcg moderna bivalent instead of 25 mcg). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Given 10 mcg moderna bivalent instead of 25 mcg) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The patient age reported as 0.50. The vaccination site reported as RL. Treatment medications were not reported.
Developed red hives around neck and chest at 4 minutes post vaccination.  Gave  25 mg tablet Benadryl PO.   At 7 minutes post vaccination had c/o feeling warm and having a headache.  Vitals taken,  vitals repeated 5 minutes later,  still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back.  At 11:15 an additional 25 mg tablet of Benadryl PO was given.
Severe convulsions, harsh chills, 102 fever, sweating, and migraine headache around 9 hours after vaccination. I have had a strange and non-stop headache ever since that day, and my entire body feels like I had went to the gym and did hardcore aerobics. Those are the main two symptoms I still have as of now. I am afraid my body is being set up for a blood clot.
Patient received the first dose of the COVID-19 Moderna vaccine. One week later developed left calf pain. At the time was in a boot for tendonitis. Described pain as new and aggravated by ambulation or pressure.  No alleviating factors.  She was sent by podiatrist for vascular study which was positive for DVT to the left distal popliteal vein and posterior tibial veins. Patient was seen at the ED and prescribed rivaroxaban.
Felt poorly with myalgia, weakness and chills on first day after vaccine that did not resolve. Developed severe shortness of breath and chest pain on day 9 after vaccine and found to be in atrial flutter with rate of 160 on day 10 after vaccine. Has long ho diabetes, but no cardiac history.