chrisvoncsefalvay/vaers-outcomes huggingface dataset:
broken blood vessel in left eye; A spontaneous report was received from a consumer (patient's spouse) concerning 66-years-old  female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had broken blood vessel in left eye (eye haemorrhage).    No medical history was reported. No concomitant medications were provided.  On 17 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 014M20A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 07 Mar 2021, the patient had a broken blood vessel in left eye (medically significant).  The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event of broken blood vessel in left eye was unknown.  The reporter did not provide assessment for the event of broken blood vessel in left eye.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Right deltoid: redness, swollen, itchy and pain. Benadryl 25mg po PRN prescribed.
The patients parent was asked by the nurse which vaccine would you like. The parent stated J&J and the nurse administered the vaccine. The patient is under age and the patient shouldn't have received it.
STATES SHE HAS BEEN FEELING RUN DOWN AND SICK FOR SOME TIME. STATES SHE HAS COVID IN NOV 2020 AND HAS NOT FELT WELL SINCE THEN. MADE AN APPT WITH HER HEART DOCTOR FOR FOLLOW UP TO TRY AND SEE IF THEIR WAS ANYTHING SHE COULD FIND TO HELP IMPROVE HER FEELING. WENT ON 4/22 FOR APPT AND MD SENT HER STRAIGHT TO THE HOSPITAL. WAS ADMITTED THAT NIGHT WITH FINDING OF BLOOD CLOT IN HER LUNG. CLIENT REPORTS AFTER EACH VACCINE SHE HAS SEVERE WEAKNESS WITH CHILLS AND FEVER OF 99-100. FEVER CHILLS RESOLVED WITHIN 1-2 DAYS BUT WEAKNESS JUST PROGRESIVLY GOT WORSE.
Shot given at 4pm on 5/17/2021. By 10:30am on 5/18 I spiked 102.5 fever. My arm was so sore I could barely lift it. It wasn?t red or itchy, but was puffy and swollen. I had horrible body/joint/muscle aches. Fever came down over course of day but came back up at 3am on 5/19/21 to 103.3. I called my dr and he advised to continue with fluids and Tylenol today and tonight and to call him tomorrow.
SEVEN DAYS AFTER VACCINATION PATIENT GOT SKIN REACTION (RED/INLFAMMAED/RAISED AREA WARM TO TOUCH ABOUT 2INCH WIDE AND 3INCH LONG)
p/vax pt c/o n/v, pain in arm from elbow to shoulder;stated unable to lift arm;pt instructed to call family MD;called 24hr later & pain greatly decreased & other sx subsided;arm pain was localized;
Starting 12/23/2021, developed hives with no change in environment or diet. Still present as of 4/12/2022. Zyrtec taken as needed, generally 1 dose every 48 hours, to subside itching.
VACCINATION SITE PAIN/ ARM WAS SORE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfonamide allergy, and moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 15-SEP-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for moderate to severe rheumatoid arthritis.  On SEP-2021, the patient experienced vaccination site pain/ arm was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination site pain/ arm was sore. This report was non-serious.
Lost my sense of smell; Arm is a burning; Hot rash; 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 ANOSMIA (Lost my sense of smell), INJECTION SITE PAIN (Arm is a burning) and RASH (Hot rash) 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) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced ANOSMIA (Lost my sense of smell), INJECTION SITE PAIN (Arm is a burning) and RASH (Hot rash).   At the time of the report, ANOSMIA (Lost my sense of smell), INJECTION SITE PAIN (Arm is a burning) and RASH (Hot rash) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication provided. No treatment information provided. Case is from social media page with no further information as such.   Reporter did not allow further contact.
Mother called states pt awakened around 6:30 am complaining of abdominal pains bilaterally just under rib cage, then approximately 30min later vomited, continues not to feel well. Refuses to eat or drink anything. No fever.
Mid-May (one month after 2nd dose), experienced racing heart (suspected tachycardia) while walking (for fitness), above 130bpm. 9/1/2021 -- experienced first near-syncope around 5pm while standing; resolved itself after several minutes. 9/16/2021 -- experienced second near-syncope around 9:30am while sitting at desk; went to Emergency Center at Hospital. EKG performed, no treatment. No further events. 9/25/2021 -- experienced third near-syncope around 7:30am, while standing (and collapsed to floor this time). Opted not to head to EC at hospital again, at the time. 9/25/2021 -- experienced fourth and fifth near-syncopes around 2pm, while seated. Opted to head to EC at hospital, had sixth near-syncope while riding to EC. Kept in EC while waiting to be admitted to hospital. 9/26/2021 -- diagnosed with right bundle branch block. 9/29/2021 -- cardiac pacemaker implanted (hospital, MD)
Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023.; No adverse event; 12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date), PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023. ) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023. ) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date), PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 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 (12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023. ).    No relevant concomitant medications were reported. Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was on 12 Jun 2023. The vial haven't undergone any temperature excursions. No treatment medication reported.  This case contains information for the 8th of 12 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Follow up received contains No New Information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Master case
Please note, vaccine was not administered at doctors office. Not clear what was being asked in previous page for address - of doctor or vaccination site. I had vaccine at 730-740am and by 430pm, I had heavy onset symptoms of body aches, chills, fever etc. I took 1000mg of Tylenol and began feeling better. Still exhausted so I went to bed around 630pm but because I was pushing so much fluid, I kept getting up to pee. I was still freezing. Around 940pm, I woke up to pee and again freezing still. I sat on the toilet and started having full body convulsions and the next thing I remember is waking up on the floor. My husband found me passed out, face first on the tile floor with my pants still down. I hit the left side of my face very hard. My husband helped me to bed where I took more ibuprofen and tremored for the next hour before I fell asleep. I woke up completely drenched and sweat and with a headache.
Dose administered after allowed time after first vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture) 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 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, 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 experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
This spontaneous case reported by a consumer, describes the occurrence of asthenia (low energy) and nausea in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 14, 2021, patient experienced asthenia (low energy) and nausea. At the time of the report, asthenia (low energy) and nausea outcome: unknown. No concomitant medication or treatment information provided. Action taken with mRNA-1273 in response to the event: not applicable.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-AUG-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L029266; strength, dose, route and site of administration were unspecified). This one of several reports received from the same source. Additional information has been requested.
Numbness in "my" right arm and hand for 3 days; Tremors in right arm and hand and also on left side. Tremors in right leg at night; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Jul2021 at 15:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Jun2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 01Jul2021 at 15:15, the patient experienced numbness in her right arm and hand for 3 days, tremors in right arm and hand and also on left side and tremors in right leg at night. On 02Aug2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. On an unknown date, the patient also underwent magnetic resonance imaging(MRI) and electrocardiogram(EKG) and the results were not reported. The adverse events resulted in emergency room/department or urgent care. Non-therapeutic measures were taken as a result of reported events included rest. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events numbness in right arm and hand was resolved with sequelae on 04Jul2021, while the clinical outcome of event tremors in right arm and hand and in right leg were resolved with sequelae on an unknown date in 2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Got really sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got really sick after his/her shingles shot. The patient stated could not do another one. Additional Supportive Information: Follow-up would not possible as no contact details were available.
I woke up just after midnight scratching furiously my entire body though mostly from the waist down. I noticed breaking out in hives on my legs. I had scratched so hard while sleeping that I broke the skin and was bleeding. Through a combination of benadryl and topical otc lotions the hives went down after 8 hours and gone within 24 hours. I still have moderate itching from the waist down which I never experienced prior to my second shot. I use otc lotion throughout the day and still continue to itch. I will at times use benadryl is the itching gets uncontrolled.
No adverse effects from 4 previous Pfsier covid shots. 9/18/2022 4 AM Face flushed Hands and feet hot Hands and feet pain level 10 Pain subsided after about 45 minutes Temp 98.3 BP 128/64 Flu like symptoms remainder of day, headache, eyes hurt, no appitite 9/19/2022 Returning to normal
60 hrs later child developed fever 20 min after fever was noted by parents the child  began shaking, stiffened muscles, blue lips, pale skin, taken to ED dx febrile seizure
Received Tdap 8/7/09. About 12 hours later noted erythema swelling & aching. Next day stated arm above elbow to shoulder was swollen, indurated, warm & erythematous x 5 days. Felt Feverish, (+) perspiration (+) aches x 5 day. states she was treated with AUGMENTIN & BACTRIM. No official record of treatment. Advised her PMD not to take Tdap again.
This spontaneous report as received from a physician via a company representative concerning her unknown age son who on unknown dates was vaccinated with 2 doses of VARIVAX (Merck) (doses, route and lot numbers not provided). The physician stated that on an unknown date a titer was done to her son after the second dose of VARIVAX (Merck) that showed her son had no titer. The outcome of the event was unknown. The patient sought medical attention with his physician. Additional information is not expected.
tingling & numbness in Right side of face lasting throughout the day. Subsided by end of day. Shingrix in IM right Deltoid.
Covid Arm; Rash went all the way around her arm; Fever 100.1F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm), PYREXIA (Fever 100.1F) and RASH (Rash went all the way around her arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PYREXIA (Fever 100.1F). On 12-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm) and RASH (Rash went all the way around her arm). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Covid Arm), PYREXIA (Fever 100.1F) and RASH (Rash went all the way around her arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.8 (High) 100.8 DEGREE FAHRENHEIT.         Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided.
severe joint pain in left hip, headache, all over muscle soreness, bad headache. Shot given 8/24/23, As of this morning 0n 8/26/2023, the joint pain is controlled by 800mg tabs of Motrin every 6 hours to lessen the  pain, but it is still painful. All over muscle soreness persists.
p/ pt recv vax approx 15 days later exp rash w/a total of 37 lesions, 2 days later rash had faded
Patient described an almost immediate feeling of warmth and tingling in shoulder and up into the left side of her neck following administration.  This feeling increased over a few days and became painful in shoulder and neck.  She has difficulty lifting her arm above her head.
Patient reported immediate left arm pain/burning sensation with radiation down to hand, unable to lift/move arm due to pain. No numbness/tingling. Called the after hours on call, Dr, and was directed to ED. Rx for abx. Today, pt feels improved, can move arm. Pt reports still has some warmth, swelling of the injection site, but better than last night. Took ibuprofen and Tylenol, iced x 1. She was advised to take her abx, ice her arm for 15 min 3 x 1 day, closely monitor the area and contact us for a face to face encounter if not improving or worsening.
Severe injection site soreness- Start: 0100 12/23- end: 0800 12/24  Fatigue- Start: 1200 12/23- end: 0800 12/24 Nausea- Start: 1700 12/23- end 1900 12/23
pt recv vax & 2 days later devel pain in lt elbow & the next day devel a 2x2" swelling in lt elbow radiating to axilla;consulted MD next day & prescribed ATB for ?abscess;
About 5 minutes after receiving the vaccines, pt said his throat felt like it was closing. He also appeared somewhat dazed and had redness of his hands and face. He had no respiratory distress and no hives. He was observed carefully in the office while EMS was called to transport him to the hospital. He was given BENADRYL. In the hospital ER he was observed for several hours. An EKG, serum glucose and urine drug screen were done and were normal. He improved and was sent home on BENADRYL. By the following morning all symptoms completely cleared and did not recur.
Pharmacist realized later in the afternoon, the Pfizer pediatric vial was undiluted and the patient received 0.2ml dose.  The pharmacist attempted to notify the parents but had to leave a message.  No adverse events reported at the time.
Redness, warmth, swelling and pain 3 inches below injections site. Started as two circles the size of dimes and progressed to the size of almost a dollar bill, rectanglish in shape. Lasted for over 1 week.
Immediately following administration, localized swelling was noted on the left arm of the injection site. The patient stated he felt dizzy and faint. He knelt down with his head between his legs for about 1 minute and stated he felt like he was having a panic attack. The patient was monitored for an additional 15 minutes and felt fine upon leaving. Patient requested a cup of water. No other side effects were noted.
After receiving my second dose of Moderna Vaccine on April 04, 2021, on April 05, we drove back about 3 hours to  go home.  The following day on Tuesday my left knee area began to hurt.  It was pretty severe pain, it still today hurts somewhat.    I waited until the weekend, and that Thursday I called my primary care at Family Medicine for a Tele-Visit but I had to see another doctor who wanted me to come in on Monday.  My knee got some what better on Monday so I cancelled the appointment.  I got up this morning around 4 am to walk my puppies when I herd the talking about the J&J issues which included knee, and leg issues, I'm now having pain in my right lower leg above my foot.  I did call my primary care again today.
Pt received flu vaccine in RD IM on 10/02/06. Right arm sore since then. Advised pt to put ice on it and take Tylenol. Go to private DR if not better. Pt to call Dr today.
patient had no reported side effects; expired dose of ROTATEQ was administered; This spontaneous report was received from a nurse referring to a 6 month old patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 11-MAR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), for prophylaxis, a dose of 2 milliliter, orally, lot # P028132, which expired on 22-FEB-2022 (expired product administered). The vaccine had had no known temperature excursions.  The patient had no reported side effects.
Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on approximately 14-MAR-2007 ("approximately 2 months ago"), was vaccinated with the first dose of Gardasil (dose not specified).  The day following the vaccination, the patient called the physician to report she had developed a rash on her arm, though not at the injection site, as well as on other parts of her body.  The patient presented to the office 2 or 3 days later, and a cream (unspecified) was prescribed as treatment.  At the time of this report, it wan unknown if the patient had recovered from the rash.  Additional information has been requested.
Headache, Myalgia & NauseaVomiting Narrative:  1 hour after the vaccine felt flushed, tired. The next day had ha, body aches, chills, spent the whole day in bed. Today she is feeling more tired than usual, ha, body aches, vomiting on Sun. She reported that she called off 1/25/21 for still not feeling 100%. EE reported that will be back into work on next scheduled shift.
Woke up at 3:30am to pain at injection site, headache, muscle pain over entire body, chills, throwing up, feeling tired.  This continued  throughout the day and the following night.