chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a male 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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information received on 27-APR-2021 contains non-significant information: Corrected first name of reporter.
Dose administered from vial outside of BUD labeled on product. Dose determined to be valid by Moderna.
Elevated B/P and lethargy, upon assessment, patient was observed with fever (T 103), hypoxia (O2Sat 85 - 88), and tachycardia (HR 115),
Abdominal cramping Diarrhea  Nausea & vomiting Light headed & dizziness
dizziness; experiencing the rash and it's still itchy; took the first dose on 26Feb2021 and took her second dose  on19March2021; fatigue; rash in left arm  at the injection site that spread to right arm and leg; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), RASH PRURITIC (experiencing the rash and it's still itchy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the first dose on 26Feb2021 and took her second dose  on19March2021), FATIGUE (fatigue) and VACCINATION SITE RASH (rash in left arm  at the injection site that spread to right arm and leg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EN6204 and EL9265) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included SIMVASTATIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (dizziness), RASH PRURITIC (experiencing the rash and it's still itchy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the first dose on 26Feb2021 and took her second dose  on19March2021), FATIGUE (fatigue) and VACCINATION SITE RASH (rash in left arm  at the injection site that spread to right arm and leg). The patient was treated with TRIAMCINOLONE for Vaccination site rash and Itchy rash, at a dose of 1 dosage form. On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the first dose on 26Feb2021 and took her second dose  on19March2021) had resolved. At the time of the report, DIZZINESS (dizziness) and FATIGUE (fatigue) outcome was unknown and RASH PRURITIC (experiencing the rash and it's still itchy) and VACCINATION SITE RASH (rash in left arm  at the injection site that spread to right arm and leg) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient also took unspecified blood pressure medications and antidepressants.
1 1/2 hrs p/MME devel red, swollen, blotchy, patches, changing into areas of peeling crusting skin;
Pt. rec'd 5 yr imm. at WCE 10/01/14. Developed (R.A.) 6 cm x 7.5 cm area erythema, warmth and pain 10/03/14. Afebrile. Seen in office 10/03/14 and tx'd with ice, ibuprofen.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 10 weeks old patient of unknown gender. On 12-SEP-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Patient has not received her second dose yet.  Scheduling team had not contacted patient to schedule her for the second dose.  Pt is now scheduled to receive her dose Friday 12March which will be 60days after initial dose.
Started low grade fever Thursday afternoon. Still wanted to eat and play. Friday early in the day he was warm to the touch but still playing and eating and drinking. Complained of headache about 4pm. The fever was still present - measured 101.F around 5pm. And glands in neck looked swollen. Overnight felt very hot. Woke up and gave Tylenol. Saturday the fever was still present yet low grade (100F) still eating, drinking and playing. Saturday evening around 7pm the fever spiked to 104F. Put in a tepid bath. Gave Tylenol and ice water. Cool washcloths and layed on couch together. He was responsive yet complained of dizzy. Sunday a.m. - fever still present. He was tired and general malaise. Not wanting to eat or drink much. Not very active. Temp varied throughout the day between 100F and 103F. Alternating Ibuprofen and Tylenol every 4 hours. Pushing fluids, and he showed me a sore in his mouth on the inside of his lip that looked like a cold sore. Glands in neck swollen. Sunday night still fever overnight. Still using Tylenol and ibuprofen alternating every 4 hrs. Monday morning I called the doctor. Child didn't want to eat or drink. Said his belly hurt. Still fever. 11:45am appt with pediatric NP.  She was not convinced this was vaccine related, although the Strep test was negative. His ears looked good. No coughing, no sneezing, no vomiting or diarrhea. Urinalysis was normal. Temp measured 101F in office. Blood drawn for CBC to look at WBC and rule out bacterial infection. Went home to continue nursing care of fever. Gave Tylenol after he ate some apples and drank milk. The temp was 102F. Waited for Dr office to call. At 4pm I was told that the CBC was normal. And, no other signs of bacterial infection.  Again, I asked if this is vaccine related given I have read the package insert for the MMRII vaccine and been on the CDC website indicating this as a side effect. The NP said she wasn't sure, and that if the fever hadn't broke by lunch time on Tuesday that she would need to re-evaluate him. As it is, Monday evening he did drink and eat and played. Temp was 100F with Ibuprofen on board. At bed time, he felt low grade fever, but we woke up at 3am to a 103.7F fever. Gave Milk and Tylenol. Some ice water. A cool cloth on forehead.  I am convinced this is vaccine related.
Elevated blood glucose levels for the past 48 hours,today being far worse than the previous.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 12Apr2021 at 14:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergic to medications, food, or other products.   Concomitant medications included insulin aspart (NOVOLOG), amlodipine (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), escitalopram (MANUFACTURER UNKNOWN) and insulin glargine (LANTUS) all taken for unknown indication on unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955,) via an unspecified route of administration in the left arm on 15Mar2021 at 14:15 as a single dose. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 17:00, the patient experienced elevated blood glucose levels. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with insulin.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event elevated blood glucose levels was resolving at the time of this report.     No follow-up attempts are needed. No further information is expected.
Pt.'s Daughter states that after receiving the 1st dose of Pfizer 12/20/2022 (Booster - Previous J&J 01/15/2021), started experiencing symptoms 01/28/2022 of fatigue, fever, and weakness. Urgent Care 01/29/2022 visit/ tested for Flu & Covid = Negative. 01/31/2022 Confusion, fever, difficulty walking and communicating/ Transported to Hospital admitted for Viral Meningitis, IV treatment followed with Discharged 02/05/2022 to Rehabilitation 02/05/2022 - 02/11/2021 discharged. Primary visit 02/17/2021 protein and calcium levels low. Infectious Disease appt. 03/01/2022.
Arm started to burn; Intense itching on her face, chest, and all over her body; Diarrhea; Bumps; Very red; Painful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (arm started to burn), PRURITUS (intense itching on her face, chest, and all over her body), DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (bumps) and VACCINATION SITE ERYTHEMA (very red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (allergic reaction to the vaccine).    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced BURNING SENSATION (arm started to burn), PRURITUS (intense itching on her face, chest, and all over her body), DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (very red) and VACCINATION SITE PAIN (painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 08-Jun-2021, VACCINATION SITE PAIN (painful) had resolved. On 09-Jun-2021, BURNING SENSATION (arm started to burn) and VACCINATION SITE ERYTHEMA (very red) had resolved. On 10-Jun-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, PRURITUS (intense itching on her face, chest, and all over her body) and VACCINATION SITE SWELLING (bumps) 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.   Patient is not on any concomitant medications currently.  Patient received the shot on her right (dominant) arm. She states that as soon as the needle came out after administration, her arm started to burn and became very red and painful. She put ice on her arm for 20 minutes and repeated it throughout the day. In about 24 hours, the redness and burning were gone. She says that on the same day she received her shot, she started experiencing intense itching on her face, chest, and all over her body. She says that there is no visible rash but she does feel some bumps.   Patient has been taking Benadryl for itching, but it does not seem to help. She also experienced diarrhea which started on the same day as receiving the 1st dose. She had diarrhea for two days and says that it has improved today on 10-Jun-2021.  She has not taken any medications for the diarrhea but has kept herself hydrated. She is hesitant to receive her 2nd dose due to these reactions.
PATIENT RECEIVED VACCINE ON 08-09-2017, PATIENT CALLED 08-11-2017 SAID THAT NIGHT HER ARM GOT SWALLOW AND RED FROM DELTOID TO ELBOW. SHE SAID IT WAS STARTING TO GO DOWN BUT IT WAS STILL RED BY HER ELBOW. I ADVISED HER TO CONTACT HER DR AND THAT SHE COULD TAKE BENADRYL TO HELP WITH SWELLING/REDNESS.
No adverse effects; inadvertently received one dose of PNEUMOVAX 23 but were supposed to receive GARDASIL 9; This spontaneous report was received from a health professional (medical assistant) refers to a 12 year old female patient. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 05-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dosage information, route of administration and anatomical locations were unknown) of lot # S004548, expiration date 12-AUG-2020 for prophylaxis but was supposed to receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, lot#, expiration date, dosage information, route of administration and anatomical locations were unknown) (wrong product administered). No adverse effects reported. The reporter described the patient as a health, normal patient, not indicated for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of wrong product administered was unknown. No product quality complaint (PQC) reported.
The patient experienced no symptoms; The patient was administered an unspecified hepatitis A vaccine on an unspecified date in 2017. The pharmacist reports that the patient received a dose of VAQTA on 9/25/2019; This spontaneous information has been received from a pharmacist, concerning an adult patient of unknown gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unspecified date in 2017, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (manufacturer unknown) (strength, route of administration, anatomical location, indication, lot number and expiration date were not reported).  On 25-SEP-2019, the patient received a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection as prophylaxis (strength and anatomical location were not reported; lot number and expiration date were unknown by the reporter) (inappropriate schedule of drug administration).  The patient experienced no symptoms.
Menstrual cycle became very irregular. Started having a period every 2 weeks for 2 months
Initial reaction (two weeks) was a reduction in Blood Pressures, followed by Myocarditis/Pericarditis and Pulmonary Edema (8 weeks-diagnosed CHF), followed by Angina & Congestive Heart Failure (Death).
redness @ inj site of inj lt arm voiced inability to use arm;also recv TD in lt arm IM;sx began w/in 24hr of vax;
Headache unlike anything I have felt before. It comes back several times a month. Its a sharp pain in my front left brain and then it turns into an ache and feels like its constricting for about 30 seconds.
Pt. seated while receiving vaccine, after pt. given vaccine, pt. got up sat in different chair. Pt. then stood up walked to desk area in clinic room, while standing and reading out loud, pt. suddenly fainted, falling backwards hitting back of head on floor. No bleeding noted, body became rigid momentarily, pale skin color noted. Pt. then became more alert, skin color improved. Pt. remained in clinic about 40 minutes after event, walked out with no difficulty.
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from contactable physician. This physician reported similar events for 11 patients. This report is for 7th of 11 patients.   A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the known product safety profile and plausible temporal relationship, a possible contributory role of the suspect product BNT162B2 to the reported COVID-19 cannot be completely excluded. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Rapid heart beat  Raising temperature  Could not cool down  Problems breathing  Rash Period was came back on.
Urticaria starting morning of April 22nd, 10 days post 1st Pfizer shot in left arm. Worse in left forearm, but also on right forearm, chest, back, and neck. Suspect new food allergy or possibly recent viral illness.
Patient reports that he lose the use of his legs about 18 hours after receiving the vaccine.  He was unable to move them but had feeling in them. He also reports having a fever of 102F.   Patient also reports that this happened when he had COVID, but no records from the hospital note this.
In March I had a grade 2 or 3 ankle sprain. The sprain happened while I was sleeping. On my ankle there was bruising and swelling and I was unable to put weight on it. I was able to put myself in an ankle brace and wore that for 2 weeks.  In  April I had a right shoulder subluxation (happened while I was sleeping and rolled over), a left pinky dislocation, and a right knee subluxation (this happened twice). In May, I had another left pinky dislocation. I am a physical therapist so I treated myself for all of this.
Vaccination was given 10 Feb 2008. Pt is expierencing itching and has bumps where vaccination was given. Bumps look like a mosquito bite and itchs like one. Bumps persist during and after physical activity and during bathing.
Injection site-soreness and pain. Systemic-muscle pain, malaise, chills, fever (101.2).
Reactivation of Shingles (varicella-zoster virus). I decided to report this information just in case you are tracking potential correlations between COVID-19 and delayed impact on immune system for things like Shingles reactivation.  My first episode with Shingles was in 2006.
Sore and swollen lymph nodes in left armpit area started about 28 hours after the shot and have continued since.
I got booster on oct 1, 2021,  4 days later got vertigo. I have dizziness still on oct 29. Saw dr 2 times. Took 2 antihistamines, no help. Antibiotics no help. Still dizzy.  Doing head exercises for Bppv still dizzy. Dizzy during day and mostly when go to bed and turn head. Off balance sometimes.
MINOR HEACHACHE BEFORE VACCINATION. POUNDING SEVERE HEADACHE SHORTLY AFTER IMMUNIZATION. SEVERE FATIGUE LASTED 4 DAYS AFTER IMMUNIZATION. SENSITIVE EMOTIONALLY/ FULL BLOWN PMS FOR 1 WEEK AFTER VACCINATION.  ON MARCH 22ND, HAD BREAK THROUGH BLEEDING ON DAY 19 OF CYCLE. BREAK THROUGH BLEEDING LASTED 1 DAY, IN THE MORNING, FEELING PRESSURE SIMILAR TO UTI, OR DEHYDRATED.  TOTAL OF 3 TIMES FELT PRESSURE ON BLADDER LIKE HAD TO URINATE. MENSES ON TIME NOW, APRIL 1ST PERIOD STARTED NORMALLY.  PATIENT HAD SEVERE NAUSEA ON FRIDAY 3/26 FOR A FEW HOURS THEN NAUSEA REAPPEARED NEXT DAY FOR 15 MINUTES. PATIENT IS NOT PREGNANT.
The pharmacist did not put the shot in the muscle - it was very high on his shoulder and the pain immediately went down his arm.  It was apparently injected into the tendon.  Six months later he is still using painkillers, physical therapy sessions 1-2x week, icing every day.  He still can't sleep flat on his back and does not have full range of motion in that arm.
Chills; Runny Nose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and RHINORRHOEA (Runny Nose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced CHILLS (Chills) and RHINORRHOEA (Runny Nose). At the time of the report, CHILLS (Chills) and RHINORRHOEA (Runny Nose) outcome was unknown. Not Provided          No concomitant medication was reported.  The treatment information was unknown.  Action taken with mRNA-1273 in response to the events were not applicable.
NO ADEQUATE PROTECTION FROM JOHNSON & JOHNSON COVID-19 VACCINE; This spontaneous report received from a patient 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, and batch number were not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reporter stated that she does not feel like she has adequate protection from Covid-19 after receiving Johnson & Johnson Covid-19 Vaccine and would not want a booster dose of the same vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no adequate protection from johnson & johnson covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210834826. This report was associated with product quality complaint.; Sender's Comments: V0. 20210860735-COVID-19 VACCINE AD26.COV2.S.- no adequate protection from johnson & johnson covid-19 vaccine. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Evening of immunization had nausea and could not eat. Next evening face was red, had chills, stiffness and lower back/knee pain next evening sweaty face, red and puff, dark color to urine - acidic smell went to Dr. next day.
pt recvd vax; pt devel pos antigen 2 days after vax;
Patient contacted pharmacy 3.26.19 - Patient reported redness spreading from elbow to shoulder, warm to the touch, itchy. Patient has tried applying an ice pack with no relief. RpH on duty advised the patient to contact their PCP, no further info reported as of 3.26.19 at 1140.