chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose (Moderna Vaccine) given 4 months after first dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose (Moderna Vaccine) given 4 months after first dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL and CLONAZEPAM for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose (Moderna Vaccine) given 4 months after first dose). On 15-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose (Moderna Vaccine) given 4 months after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications are provided.
Around shot area, swollen, warm and red about 5 inches down arm, and itching lasting 4 days. Today, red somewhat fading, arm still warm, and some swelling.
On April 28, 2022, I got hives on my elbows which were unbearably itchy. The hives became hives and a red rash and spread up my arms and my torso, especially on my right side.  Previous rashes had responded to Kenalog cream. This rash did not.  Went to dermatologist on May 11, 2022.  The physician?s assistant said she the uticaria was due to my second COVID booster, which I?d gotten about three weeks earlier, on April 4. She gave me a steroid injection (Kenalog) and a stronger steroid cream (Clobetasol, which is mixed with CeraVe cream).  This turned out to not be enough. On May 20, I called her.  She told me I could use the Clobetasol three times a day and she gave me a prescription antihistamine, Hydroxyzine Hydrochloride. I take  two pills at bedtime along with a Zyrtec.
post menopausal menstrual bleeding. light. some cramping.  Same occurred following 1st booster Moderna lot 939909 in November of 2021 but did not immediately connect event to vaccination. No menstrual bleeding following Pfizer 1st dose 03-02-2021 EN6198 or dose 2 Pfizer 03-23-2021 ER2613
belly button is red and inflammed , both upper thighs inflammed, stomach upset, issues swallowing
Patient received FLUZONE on 09/02 and on 09/04 she started developing a rash on her abdomen, she tried using hydrocortisone cream which didn't help, the rash started spreading on extremities she was seen by MD & prescribed a prednisone taper.
Gave vaccine 12/9/15, and a red, quarter-size area developed 12/10/15. As of today, 12/12/15, the area involved is much larger with one small whelp, but she says it is improving.
I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 11:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 11:12 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.11.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Chills, severe headache, fever (101-103) , fatigue, throwing up, nausea, heart palpitations and COVID Arm Rash. (still have rash)
shakes; cold; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), FEELING COLD (cold) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced TREMOR (shakes), FEELING COLD (cold) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GABAPENTIN (NEURONTIN) at an unspecified dose and frequency. At the time of the report, TREMOR (shakes), FEELING COLD (cold) and CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.
rash both arms 4 wks p/nausea (no diarrhea) hot flashs-sweaty; rash on back 11MAR93;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer (patient's wife) concerned a 40 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 09-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAY-2022, the patient experienced symptoms similar to his wife but were a bit more intense, at the beginning he went from no cough to fever and his fever lasted a little bit longer. The reporter (patient's wife) stated that her husband had covid (suspected covid-19 infection). On 22-MAY-2022, the patient tested positive on one of the antigen tests. Laboratory data included: COVID-19 antigen test Positive (suspected clinical vaccination failure). The patient did not seek care but stuck it out at home. The patient did not receive a booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint. This case, from the same reporter is linked to 20220610705.; Sender's Comments: V0-20220632754 -COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
ADMINISTRATION ERROR : Pt.'s Mother reports 11/14/2021 daughter was mistakenly given a 2nd dose of Phizer rather than Flu Vaccine Quad Injection. Received 1st dose of Phizer 11/09/2021. Communications with Primary waiting for recommendations. No noted Symptoms presented.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from Pfizer-sponsored program via contactable other health care professional (Patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number for both doses: EL0140), second dose via an unspecified route of administration, anatomical location was arm left on 12Jan2021 as single dose, first dose via an unspecified route of administration on 22Dec2020 as single dose for covid-19 immunisation.  Medical history included Epstein Barr (had a flare last year. She does not know how long she has had it.). There were no concomitant medications.  Patient has had both doses of the Covid-19 vaccine. The second dose was exactly 4 weeks ago after receiving second dose has tested positive for Covid on 10Feb2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
didn't feel good for a week;lt arm hurt from the time the nurse put it in, told her it hurt & lt arm still hurts where put it in;it aches deep lots of time;
fever, especially first day, over 102 Chills Muscle and joint pain high heart rate.  it was steady between 90 and 100 (normal in the 60's) insomnia Felt terrible
Red rash itchy right arm, back, chest, feet. Throat irritation, dyspnea. Patient seen in 3 days after injection. Treatment with prednisone and OTC antihistamines and OTC ranitidine.
Cheeks flushed bilaterally; front of legs flushed bilaterally w/sl raised rash; sx's occurred approx 24 hrs p/immun; assessed by MD t98.6 ax;
Starting the day after receiving the vaccine, I had a mild headache for about 2 months. Also, I had severe fatigue. After 2 months, the headache went away, but the fatigue persisted. I got nervous because it was not resolving and I'm normally not that fatigued. I knew something was off. I saw the doctor who said that he had seen similar reactions to mine but they never lasted as long as mine have so far. Its just now getting better where I will have a few days of feeling normal and then a day of feeling badly again. So, I am concerned on whether or not to get another vaccine/booster yet or to wait.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Secondary and concomitant therapies were not reported. Pharmacist stated that an unspecified patient that received ZOSTAVAX on an unspecified date presented with shingles four days after receiving ZOSTAVAX. Pharmacist was unable to provide any further information as the unspecified patient had returned at a much later unspecified date to provide this information. Outcome of shingles was not reported. Additional information has been requested.
One month post vax, the pt experienced intermittent vomiting. The pt was administered the third dose one month after the second dose. The intermittent vomiting continued. Approximately one year later, in October 1998, the pt received a fourth booster dose. The vomiting persisted. The pt was seen by a gastroenterologist and was dx with eosinophilic gastroenteritis. He was treated with tetracycline, prednisone, and Prevacid.
Around 9 hrs. after injection got a fever that eventually went to 103F. Lasted from 6PM till 5AM when the temperature came down to 100.1F. Back to normal by 9AM. No nausea or chills with the fever just very hot with loss of balance and strength Until early morning.
appears to look brusied; Redness in arm; Swelling in the arm; Arm hot to the touch; Lymphnode pain; Pain in the armpit; Pain in the right side of the body; Headache; Pain in the shoulder; Poke of pins and needles; A spontaneous report was received from other healthcare professional concerning a 48-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced poke of pins and needles (paraesthesia), pain in the shoulder(arthralgia), little bit of a headache, pain on the right side of the body (pain), pain in the arm pit (axillary pain), lymph node pain (lymph node pain), redness in the arm(erythema), swelling in the arm(peripheral swelling), arm hot to touch (feeling hot) and bruised (contusion).  The patient's medical history was not provided. Concomitant medications were not reported.  On 29 DEC 2020, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 29 DEC 2020, after receiving the vaccine, the patient felt different poke of pins and needles occurred at different parts of her body (fingers, toes and cheek) and experienced pain in the shoulder, little bit of a headache. During that evening because of the shoulder pain she could not get any proper sleep. On 03 JAN 2021, the patient developed a pain on the right side of the body and started to have pain in the arm pit, described as lymph node pain. On 04Jan2021 she developed redness and swelling in the arm which was hot to touch. On 05 JAN 2021, it was reported that the surface area that was red got much bigger, the swelling was more visible, and the pain was still there and to touch it was very hot. The circumference of the right arm was measured 2 centimeters bigger than the left arm. On 08 JAN 2021, the reddened area appeared to look bruised.   Treatment for the events included, topical cream clobetasol 0.05, IBU 600mg qTID.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of poke of pins and needles was considered resolved on 29 DEC 2020 and the outcome of the events, pain in the shoulder, little bit of a headache, pain on the right side of the body, pain in the arm pit, lymph node pain, redness in the arm, swelling in the arm, arm hot to touch and bruised were considered recovering.  Follow up was received on 07 Jan 2021. Events and treatment details were updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
2021-03-20 07:30 PM - chills, 11:00 PM - vomited, 11:30 PM- seen in the Emergency Department 2021-03-21 11:30 AM - fatigue, somnolescence, nausea 2021-03-22 08:00 AM - nausea, 11:30 AM - altered mental status, vision loss, headache, balance problems, numb left arm and hand, hypoxia (SpO2 < 50%), 01:00 PM - seen in the Emergency Department, 03:00 PM Creatinine > 6.8, eGFR < 10
Body aches, fever (101.5), swollen eye lids and beneath eyes, headache, upper back aches, chills
Immed, eye watering, nausea, dizziness, headache, weakness. Consulted with PA. Rest and ice to head.
Redness, swelling, and warmth at injection site. Dr. prescribed clindamycin because he thought it seemed infected.
Prevnar 13 was the vaccine that was ordered by the physician and was to be administered. Medical assistant administered Pneumovax 23 in error. Mother was notified while still in the office of the vaccine error. Mother was instructed to monitor for any symptoms in the next 24 hours including fever or fussiness or diminished appetite. No adverse reaction has been reported by the mother.
Patient stated that day after receiving vaccine, he started having some swelling with tenderness of the neck, jawline, axilla and pain of lower back. Injection site has no redness, warmth or swelling at this time.
Cannot get dose within the recommended time period; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Cannot get dose within the recommended time period) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Cannot get dose within the recommended time period). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Cannot get dose within the recommended time period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-311336, MOD-2021-311212 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Non-Significant Follow up on 13-SEP-2021 contain Race information and Ethnicity were added
3" x 3.35" redness and swelling medial to Dtap  injection, slight warmness, tenderness
Information has been received from a physician via a company representative, referring to a 14 year old female patient not pregnant. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M034780 with an expiration date in April 2019, intramuscularly (strength, dose and anatomical location were not reported) for prevention of Human papillomavirus (HPV). On 09-JAN-2017 (reported as "11 days after receiving the first dose of the vaccine"), the patient experienced "clavicle enlargement". It was reported that the patient contacted the physician due to the event. The outcome of the "clavicle enlargement" was unknown and the causality between the vaccination with GARDASIL 9 and the event was not reported.  No product quality complaint (PQC) was involved. Additional information has been requested.
pt recvd flu vax & devel redness & swelling @ the site of inject;
severe hot flash; felt weird; upper lip was sweating; Blood pressure was high; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (severe hot flash), FEELING ABNORMAL (felt weird), HYPERHIDROSIS (upper lip was sweating) and HYPERTENSION (Blood pressure was high) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included METOPROLOL TARTRATE and CLOPIDOGREL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HOT FLUSH (severe hot flash), FEELING ABNORMAL (felt weird), HYPERHIDROSIS (upper lip was sweating) and HYPERTENSION (Blood pressure was high). On 29-Jan-2021, HOT FLUSH (severe hot flash), HYPERHIDROSIS (upper lip was sweating) and HYPERTENSION (Blood pressure was high) had resolved. On 04-Feb-2021, FEELING ABNORMAL (felt weird) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on blood pressure and blood thinner medication. The patient was afraid to get heart attack, not sure if she should get second dose. The patient could smell medicine in face mask. Treatment information was not reported.
Started with a headache almost like a migraine. Looks like a rash, blotchy at the injection site. It has grown in size, really hard and sore, red, hot to the touch. The redness area seems to getting bigger, like a big bump. Had a fever this morning, 101.6. Took a rapid COVID test this morning, results negative.
Post rabies # 1 - some red dots late that pm. Within 24-48 of second dose she developed hives that do not come and go. The red dots would continue to appear and coalesce into the hive. With the third dose she developed more red dots and the hives got bigger. Other than itching she has no other complaints. She has tried BENADRYL but had no relief. Rash and oth nonspec skin eruption.
ED visit for COVID symptoms. Given Regeneron antibodies in ED. Fully vaccinated April 2021.
01/04/2022 I was diagnosed with Covid-19. They did a chest x-ray and discovered I had a collapsed lung and enlarged heart.
This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 98.8. On 25-MAY-2021, the subject experienced possible sinuses acting up. On 25-MAY-2021, the subject experienced sneezing. On 25-MAY-2021, the subject experienced coughing. On 25-MAY-2021, the subject experienced pressure on ears. On 25-MAY-2021, the subject experienced blowing nose. On 25-MAY-2021, the subject experienced sore throat. On 25-MAY-2021, the subject experienced cramps. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced headaches. On 25-MAY-2021, the subject experienced temperature/fever. On 25-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sneezing, coughing, headaches, pressure on ears, sore throat, chills, temperature/fever, cramps, nausea, possible sinuses acting up and blowing nose was not reported. This report was non-serious.
02/28/22 presents to ED for "abdominal pain and dysuria". PMHx of "HTN, epilepsy, cardiac arrest/CMP (s/p ICD placement 2008), and recent diagnosis of stage IV metastatic carcinoma (unclear source pancreatic vs gastric vs gallbladder) w/L hydroureteronephrosis s/p nephrostomy tube (removed) w/stenting and biliary obstruction s/p biliary drain".
(L) arm had raised, warm, reddened area, 9 cm in diameter, pt was given Rx for KEFLEX 500mg 2 PO BID x 10 days.