chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days later after first dose received the second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 days later after first dose received the second dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 days later after first dose received the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 days later after first dose received the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  No treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUNE-2021 and contains no newinformation; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Rt leg is red & swollen w/white spot @ inject site per moms report. Mom states white spot is pus. Seen by MD 22JAN91 felt it was allergic rxn and re: Benedryl.
1 Day after vaccine, left shoulder and upper arm developed swelling, erythema, warmth, itching. Pt/Parent was advised on warm compress, Prednisone 15mg/5mL: take 5mL by mouth BID prescribed, and return to office if no improvement or symptoms worsen.
Feeling tired; rash red, stinging and hot; rash at injection site extending to elbow; Itching rash; headache; chill; throwing up/ vomitting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chill), VOMITING (throwing up/ vomitting), INJECTION SITE RASH (rash at injection site extending to elbow) and PRURITUS (Itching rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (headache). 05-Mar-2021, the patient experienced CHILLS (chill), VOMITING (throwing up/ vomitting) and PAIN IN EXTREMITY (sore arm). On 07-Mar-2021, the patient experienced INJECTION SITE RASH (rash at injection site extending to elbow), PRURITUS (Itching rash) and RASH ERYTHEMATOUS (rash red, stinging and hot). On 08-Mar-2021, the patient experienced FATIGUE (Feeling tired). At the time of the report, HEADACHE (headache), CHILLS (chill), VOMITING (throwing up/ vomitting), INJECTION SITE RASH (rash at injection site extending to elbow), PRURITUS (Itching rash), FATIGUE (Feeling tired), PAIN IN EXTREMITY (sore arm) and RASH ERYTHEMATOUS (rash red, stinging and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include blood pressure medicine. Not provided the name.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Child had DTaP to L leg and next day came here and area is 3in x 3in red, raised, warm to touch. Using ice pack prn.
Patient received First Dose Moderna lot #030B21A  Patient vaccinated without incident and sent to observation lot., RN in the observation lot greeted patient on arrival. Patient stated she was feeling "weird and a little dizzy" Jonetta had her recline her seat and open her window for air. She reported worsening dizziness and called APP (who happened to be very close).  APP arrived to car and asked for observation / emergency supply cart. Found patient reclined in passenger seat c/o feeling weird and dizzy. APP noted increased respiratory rate and patient said she felt faint. She then slumped in seat and appeared to lose consciousness for a few seconds. She was breathing although breathing appeared mildly labored. She opened her eyes after a few seconds and began to shiver significantly. Pre-epinephrine assessment by APP: BP WNL, tachycardia and elevated respiratory rate. Skin cold. No wheezes.  APP administered 0.3mg of epinephrine IM at 1237 to right thigh through jeans. Patient tolerated well. Vital signs post epinephrine showed an initially high BP and heart rate and then returned to within normal limits 5-10 minutes later. Patient feeling much better after epinephrine.  I was assigned clinical site lead, I arrived on scene 3-4 minutes after APP. I called 911 and ambulance arrived within 3-4 minutes. Patient did not want to go to hospital but agreed to get in ambulance for 12 lead EKG and vital signs, all of which were stable. Patient refused hospital. Husband drove her home at approximately 1:30pm.  APP called MD on call, they called patient at approximately 2:30pm and reported to APP that she was at home with no further symptoms
sore arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included Polyps (bile duct removal by surgery) in October 2019 and Surgery (bile duct removal by surgery (because of polyps in duodenum)) in October 2019. Previously administered products included for Drug use for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Drug allergy (Aleve allergy), Drug allergy (Codeine allergy), Drug allergy (allergic to Opioids), Cholesterol, Anxiety, Restless leg syndrome, Acid reflux (esophageal), Insomnia, Osteoporosis and Hypothyroidism. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), HYDROXYZINE HYDROCHLORIDE (ATARAX [HYDROXYZINE HYDROCHLORIDE]) for Allergy, CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, COLESEVELAM for Cholesterol and Bile duct obstruction, LEVOTHYROXINE for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, CLONIDINE for Restless leg syndrome, ZOLPIDEM TARTRATE (AMBIEN) for Sleeplessness.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (Rash). At the time of the report, PAIN IN EXTREMITY (sore arm) and RASH (Rash) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient has completed the vaccination series and has received 2 booster doses. she got her booster dose about 3 weeks ago.  Patient stated no changes in medical history after vaccination.  No treatment information was reported.   This case was linked to MOD-2022-553214, MOD-2022-553294, MOD-2022-553295.
A few days after my vaccine, I noticed under the pad of my big toe, there was a yellowish fluid-filled lesion that took about a month to 2 months to resolve. I also had redness on the tip of a couple of my toes and the end of my toes. That was on my left foot. I also had redness on the tip of my toes on my right foot.  I saw a dermatologist one month (03/01) after my adverse effects started, he diagnosed it as permio / chill blaines. (covid toe).
This spontaneous report as received from a registered nurse refers to a identifiable adult patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On December 2017, the patient was vaccinated with pediatric dose of VAQTA lot # N017094 expiry date 31-AUG-2018 by intramuscular route for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1802USA012041: US-009507513-1802USA012042.
She received COVID 19 vaccine #2 on May 16th in her Right deltoid (IM).    Patient reports the following post-vaccine #2: During 30 minute wait began to feel "tightness" in face.  Waited an additional 40 minutes without progression therefore started to drive home. On the drive home, began to experience  "HA, fogginess, R eye cloudy vision sensation" Tightness sensation spread over face (Right) and neck and down chest.  Tightness turned to numbness No issues with eating/drinking (swallowing) however doe have some nausea. Went to ED and observed there.  Nausea increased however no vomiting.  Patient describes severe headache and she was treated symptomatically (Tylenol 975mg, Zofran 4mg). Reassuring exam documented and patient was discharged home.  From May 16th (day of vaccine to now) patient reports the following: Numbness sensation on face, neck and down upper right chest has decreased and involved area has decreased/shrinking down to include only her R eye (patient points directly over her globe).  Patient does not describe weakness.   Headache decreasing in severity and frequency.  Using prescribed acetaminophen PRN, which dulls HA to 2/10 (points to entire head) however never fully resolves.  Denies sensitivity to light, sound. No vomiting.   Left chest wall pain flared to 4-5/10 while exercising (jogging) speed 5 on treadmill for 5 minutes.  Experienced sharp/stabbing pain in location of previous pain.  With rest, reduced back to baseline 1-2 pain.  No associated dizziness, light-headed sensation, SOB, dyspnea.  No palpitations during exercise however patient has had palpitations post each vaccine.   New rashes developed and areas of previous rash on leg flared.  Specifically, rash on left posterior lower leg became fluid filled blister.  Developed ~4 lesions on her bilaterally upper extremities on the day of vaccine (May 16th) and continues to have new rashes developing over the past week.  Newest lesion is located in the right axillary region; described as itchy and painful 1-2/10.  This rash began 3 days ago and has not yet developed a blister.  All blisters have started to scab over  CURRENT TREATMENT: PRN acetaminophen PRN topical corticosteroid ongoing evaluation with A/I, dermatology, neurology
my heart was pounding; metal taste, kind of like a fuzziness, in my tongue; heartburn; chills; random rashes on my body and it disappears in 15 minutes; felt tightness in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (felt tightness in chest), PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dermographism. Concomitant products included ATORVASTATIN, CALCIUM CITRATE, ZINC, MULTIVITAMINS [VITAMINS NOS], ALPRAZOLAM, PROBIOTICS NOS and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHEST DISCOMFORT (felt tightness in chest) and RASH (random rashes on my body and it disappears in 15 minutes). On 26-Feb-2021, the patient experienced PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn) and CHILLS (chills). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK dosage form. On 25-Feb-2021, CHEST DISCOMFORT (felt tightness in chest) had resolved. At the time of the report, PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn), CHILLS (chills) and RASH (random rashes on my body and it disappears in 15 minutes) 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 03-May-2021: Contact information & new AE added
Information has been received from a 62 year old female with no known drug reactions/allergies who on 25-APR-2008 was vaccinated with the 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID, ACTONEL, BENICAR and albuterol. On 29-JUL-2008 the patient developed shingles. The patient's outcome was unknown. Unspecified medical attention was sought. Additional information has been requested. Additional information has been received form a health professional concerning the 62 year old female with sulfonamide allergy, asthma, emphysema, chronic obstructive pulmonary disease, house dust allergy and mycotic allergy and a history of measles, mumps and chickenpox as a child who on 25-APR-2008 was vaccinated with ZOSTAVAX (Merck) (Lot# 659760/0159X) in the right arm. Additional concomitant therapy included ZEFTA, VERAMYST. The patient was seen in the physicians office on 29-JUL-2008 with complaints of rash, skin feeling tender, joint pain, back pain. There were 3 small vesicles at the site of orgin of pain. The patient complained of constant right sided abdominal pain that occacionaly radiates to the left and down the leg at site of pain, right side back, bottom, upper quadrant. The patient was also noted to have neuralgia/neuritis. The patient had a gall bladder ultrasound (results not reported) and a HIDA scan was ordered. On 09-OCT-2008 the patient reported her shingles were gone. Additional information has been requested.
Patient reported a localized redness and swelling over a large area of her arm that remained unresolved for 2-3 weeks after vaccination. She also reported back pain that began the day following her vaccination and has continued thru the present time.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated intradermally with 0.1 ml of PNEUMOVAX 23 (lot# H013847; exp date March 2014). No other co-suspects were reported. No concomitant medications were reported. On 10-OCT-2012 the patient experienced an unspecified localized reaction. The patient sought unspecified medical attention. She was given TYLENOL and applied cool compresses for the treatment of localized reaction. No lab diagnostic tests were performed. The outcome of unspecified localized reaction was reported as recovering. The relatedness for unspecified localized reaction was not provided for PNEUMOVAX 23. Additional information is not expected.
Pt. received second dose of Pfizer vaccine on 2/24/2021, on 2/25/2021 at 12:30 pm she stated she became flushed and was nausea's.  Went to put her head down on desk, head hit desk and she fell to her knees.   Pt. unsure if she lost consciousness.  She described going form extremely hot to cold.  Ambulance called and taken to ER
arm swelled 12x6 cm induration itching & pain (5cm erythema at center painful & hot);
Generalized urticaria, vomiting, bronchospasm - coughing, wheezing. Treated with Orapred, Albuterol nebulizer.
This spontaneous case reported by a nurse (subsequently medically confirmed), describes the occurrence of pruritus (deep itching), rash (generalized rash) and pyrexia (temperature got up 102°F) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 02SL209) for COVID-19 immunization. The patient's past medical history included eczema and psoriasis. On Dec 30, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pruritus (deep itching), rash (generalized rash) and pyrexia (temperature got up 102°F). The patient treated with Cipro 1A Pharma (ciprofloxacin hydrochloride) at an unspecified dose and frequency. At the time of the report, pruritus (deep itching), rash (generalized rash) and pyrexia (temperature got up 102°F): resolved. Diagnostic results: On an unknown date, body temperature: 101°F (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medications.
Injection on WED,  just sore near injection site for about 48 hrs, but then awoke on Day 3 with acute Muscle/Joint pain near injection site that extended into elbow /forearm - and right knee (site of surgery 18 months prior that has never healed right).  This quite bad pain lasted 2 days before it began to fade.    So - a bit 'delayed' onset before pain really began.  It was quite bad in shoulder / knee that already has arthritis
Started to have body aches, headache and fever 18 hours after  shot.  By 4:30 my fever was 104.2, severe headache, I was light sensitive. I also hurt all over really bad. I felt as sick as I was when I had COVID in Dec..  2 days after shot the fever was down enough that I could control it to around 99.6 -100.4 3 days  after shot I still had a headache, most of body aches were gone and fever down below 99.2 without medication.
Pfizer-BioNTech COVID-19 Vaccine EUA  High heart rate (138 bpm) at rest
No adverse events reported by the patient. Expiration date for the vaccine is 04/01/2022
sore arm; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old female patient (who happened to be a pharmacist) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a sore arm following administration of Covid 19 vaccine on an unspecified date with outcome of unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
10/27/2006 generalized rash began on face and progressed throughout body. Enlarged lymph nodes and painful joints. Saw Dr on 6/28/06 no treatment.
Sore spot at injection, the next morning pinching feeling at sight of injection, at 9am 5/6/11 the sore red spot was the about the size of the back of a spoon, at 9pm 5/6/11 it was the diameter of a coke can, at 12pm 5/7/11 it was the diameter of a baseball, at 8:30pm 5/7/11 it was the diameter of a soft ball.  My arm is very sore and tender and hard to move at times.  I'm nauseated and light headed.
Initial report received from a healthcare professional 14 October 2013. An 11-month-old male patient had received an intramuscular dose of FLUZONE vaccine (lot number: U4697CA, dose number was not reported) in the left thigh on 14 November 2013. On 22 April 2013, the patient had received an intramuscular dose 1 of DAPTACEL vaccine (lot number: C4378AA) in the right thigh and patient developed blotchy rash on thigh at injection site and had superficial rash, facial flushing. In 20 minutes the symptoms were resolved and patient had no other symptoms. On the same day the patient had also received ActHIN, IPOL, PREVNAR and ROTATEQ vaccines (lot number, dose number, route and anatomical site of administration were not reported. On 24 June 2013, the patient had received an intramuscular dose 2 of DAPTACEL vaccine (lot number: C4383AA) in the left thigh and patient developed blotchy rash at injection site. In 20 minutes the symptoms were resolved and patient had no other symptoms. On the same day the patient had also received Hepatitis B and ROTATEQ vaccine (lot number, dose number, route and anatomical site of administration were not reported. On 14 November 2013 same day after vaccination immediately the patient had developed blotchy, rash and swelling at injection site. Laboratory investigation was and corrective treatments were not reported. On the same day 20 mins after, the patient had recovered from events. Documents held by sender: none
Stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 30 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Plavix, reaction(s): "Known allergies: Plavix", notes: Known allergies: Plavix. Vaccination history included: BNT162b2 (lot number: EP7534, administration time: 10:00 AM, dose number: 1, vaccine location: Left arm), administration date: 20Mar2021, when the patient was 29-year-old, for COVID-19 Immunization; BNT162b2 (Lot number: ER8729, administration time: 10:00 AM, dose number: 2, vaccine location: Left arm), administration date: 10Apr2021, when the patient was 29-year-old, for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant, life threatening) with onset 12Dec2022 at 23:00, outcome "recovering", described as "Stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Uknown results, notes: Covid test type post vaccination: Unknown. Therapeutic measures were taken as a result of cerebrovascular accident (Hospital stay and loop recorder implant). Additional information: Patient did not have COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 14 month old white male who on 26Sep05 at 11:00AM, was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot 651044/0323R). On 15Dec05 the child had breakthrough chickenpox that was mild with about 20 vesicles. It was reported there was no hospitalization and no long term problems. Additional information has been requested.Follow up information from the physician indicated that the patient had 20-30 breakthrough varicella lesions. She indicated that there was one residual scar on the back of the scalp. The patient recovered on 20-DEC-2005. Additional information not expected.
Client's mother came in with child.  Child's left arm is very swollen and has 2 blisters at sight where shot was given.  Unsure whether this could have been caused by the vaccine, alcohol swab, or band-aid.  Child has never had a reaction to any previous vaccinations.
rash and itching on both eyes. Administered Benadryl IM 50mg as ordered by doctor. Was kept under observation for 15 min. Patient left in stable condition.
The COVID-19 vaccine administered through Catalent's vaccine administrator between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.