chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness in the face , ears , cheeks and neck; Tingling at the tongue and lips; Red spots in the arms and legs; arm felt weird, bothered them, it hurt; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in the face , ears , cheeks and neck), PARAESTHESIA ORAL (Tingling at the tongue and lips), RASH MACULAR (Red spots in the arms and legs) and PAIN IN EXTREMITY (arm felt weird, bothered them, it hurt) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (Redness in the face , ears , cheeks and neck), PARAESTHESIA ORAL (Tingling at the tongue and lips) and RASH MACULAR (Red spots in the arms and legs). 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm felt weird, bothered them, it hurt). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. On 24-Feb-2021, PAIN IN EXTREMITY (arm felt weird, bothered them, it hurt) had resolved. At the time of the report, ERYTHEMA (Redness in the face , ears , cheeks and neck), PARAESTHESIA ORAL (Tingling at the tongue and lips) and RASH MACULAR (Red spots in the arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that patient had gone to a health care provider and an allergist for the symptoms being experienced, both providers recommended that the patient go ahead with the second dose even if it's late.  Patient was reported to be taking no daily medications.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up was received. Reporter's address was updated. Patient's DOB, relevant medical history, vaccination site, treatment drug-benadryl and event- Pain in arm was added.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-AUG-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 144 hours. The highest recorded temperature was 12 F. No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a regulatory associate (also reported as health care worker) refers to a 72 year old male patient. On 19-OCT-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J006242, expiration date 03-AUG-2014, dose, route not reported). On 19-OCT-2013, the patient experienced the area of injection was "swollen, red and hot". The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
The only side effect I had  from the first and second vaccine inoculations was a sore arm at the injection site. The pain from the shot was more profound with the first dose--developed several hours after the shot and lasted about 48 hours, then just disappeared.  With the second shot, I again had pain at then injection site that developed after several hours, but it was not as painful as the first shot. In both cases, the reactions were what I would consider mild and did not cause me any problems. I can relate it to soreness from lifting weights, but rather than your whole arm being sore from weight lifting,  the pain from the vaccine  was very centralized around the injection site.
No immediate reaction other than sore arm no swelling or redness until day 9. Injection site turned red, swelled up and was extremely hot. Some itching at onset.
Mother brought child to clinic due to apparent local reaction following vaccination. Large, circular, erythematous area noted to side of left thigh. Area of reaction approximate diameter of grapefruit, non-raised, warm to touch. Child non-febrile and in no apparent distress. Child was observed by APN. APN advised mother to give BENADRYL and if redness widens, call pediatrician. Mother marked area with marker. APN reviewed ER precautions with mother. Also advised cold compresses to area as needed.
got second more than 35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second more than 35 days after the first dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 042LFCA) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second more than 35 days after the first dose). On 22-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second more than 35 days after the first dose) had resolved.            Concomitant medications was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-378281 (Patient Link).
Arm pain for 7 days.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to dust, pollen, mold and dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced arm pain for 7 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm pain for 7 days was recovered on 15Apr2021 after a duration of 7 days.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EN9810), on 27Feb2021 as dose 2, single (Lot number: EN6203), on 19Aug2021 as dose 3 (booster), single (Lot number: FA7485) and on 22Mar2022 as dose 4 (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Nov2022, outcome "unknown" and all described as "Tested positive for Covid 19 after having the Covid 19 Vaccines and Boosters".
Prior to vaccine my last menstrual cycle was 12/12/21 and I received the vaccine on 12/20/21 so I was expecting my next cycle to be on 01/03/22 but it didn't occur, and I had negative pregnancy tests. I sought medical attention on 02/01/22 and I had labs and an ultrasound and they were normal. I had a cycle on 02/08/22 and it's been normal since then. My provider said she has had multiple women come in with the same issues.
SEVERE SHORTNESS OF BREATH; DRYNESS OF MOUTH; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart surgery back in 2011, and stent placement in 2012, and concurrent conditions included cipro allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, vaccination on left arm administered on 31-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ticagrelor for heart surgery. On 01-APR-2021, the subject experienced severe shortness of breath. On 01-APR-2021, the subject experienced dryness of mouth. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe shortness of breath, and the outcome of dryness of mouth, nausea and fever was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
On 10/27/21, 54 yo immunocompromised M was admitted after experiencing hypotension during an outpatient procedure. On 10/28 at 1223, pt was administered booster dose of COVID-19 vaccine (PFIZER-BIONTECH COVID-19 VACCINE) 0.3 mL IM. Pt had no prior cardiac history. On evening of 10/28, pt developed chest pain with elevated troponins and new T wave inversions on EKG. On 10/29, pt underwent LHC and TTE showing new evidence of RV systolic dysfunction. with Wells Score 3.5 (active malignancy, surgery, hemoptysis). Pt was started on atorvastatin 40 mg PO daily and aspirin 81 mg PO daily. MD unclear of cause of cardiac symptoms and whether COVID vaccination was contributory. Evaluation ongoing. Pt was discharged home on 10/31 with plans to follow up in Cardiology clinic in 4 weeks.
Itchiness and rash appeared on arm 8 days after vaccination.  Slightly red and swollen but overall minor so far.
19MAY98 mom reported fever 103 noc p/vax-unresponsive to APAP dec temp p/tepid bathe;fever off & on for a day;crying episode >3hr;needed inc distraction to dec crying until next day;
Severe headache, arm soreness at injection site, vomiting in first 24 hours, nausea, fever up to 102 but consistently at 100 for approximately 48 hours, weakness and fatigue. Headache lasted to third day but less severe.
1st day p/vax father describes upper body/eyes in a trance occurred several times a day, last 1-2 sec for 4-5 days;
This case was reported by a healthcare professional and described the occurrence of arm tingling in a female subject of unspecified age who was vaccinated with Influenza vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose if Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced arm tingling that went away 4-5 hours after the vaccine was administered and minor soreness for a couple of days. At the time of reporting the outcome of the events were unspecified.
The patient was discharged from the facility on 1/4/2021 and was re-hospitalized on 1/8/2021, currently in the MICU. Hospital feels that current admission is due to a reaction to the COVID vaccine but not specific with the presenting symptoms.
The 3 doses of the anti COVID vaccine; After taking the 3 doses of the anti COVID vaccine, unfortunately I got the virus; After taking the 3 doses of the anti COVID vaccine, unfortunately I got the virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 3 (booster), single, via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 2, single, and via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported IMMUNISATION (medically significant), outcome unknown; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown. The patient was currently not working.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I had stomach pain on my lower left side accompanied with nausea. I went to my local urgent care where they ran a CAT scan and blood work. They surmised that I have diverticulitis and prescribed antibiotics. I am feeling a lot better.
Fever (101 - 102 degrees) duration 6 hrs. Twitching of right extremity (duration 6 hrs). No treatment (physical examination at doctor's office). Dx: (Myoclonus).
The bone in the opposite arm began to hurt the following day in the morning. Patient cannot carry any heavy objects or lift the arm. Pain has lasted over 1 month.
felt like she was on steroids; facial flush; increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was on steroids), FLUSHING (facial flush) and BLOOD PRESSURE INCREASED (increased blood pressure) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like she was on steroids), FLUSHING (facial flush) and BLOOD PRESSURE INCREASED (increased blood pressure). The patient was treated with CLONIDINE at a dose of UNK UNK, q4h for a month. At the time of the report, FEELING ABNORMAL (felt like she was on steroids), FLUSHING (facial flush) and BLOOD PRESSURE INCREASED (increased blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Increased.         No concomitant medication were provided.   This case was linked to MOD-2022-648649 (Patient Link).
Ever since there is the redness about 3 inches, 5, 6 inches and that hasn't gone away; its warm to the touch kind of hard; its warm to the touch kind of hard; It's warm and hard to the touch and sore; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 55-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for autoimmune disorder. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Ever since there is the redness about 3 inches, 5, 6 inches and that hasn't gone away"; VACCINATION SITE PAIN (non-serious) with onset 14Apr2022, outcome "not recovered", described as "It's warm and hard to the touch and sore"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 14Apr2022, outcome "not recovered" and all described as "its warm to the touch kind of hard".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RASH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
Had Tetanus shot on 6/29/07- soreness in shoulder resulting in swelling and soreness in soft tissue around clavicle.
Lost of consciousness and syncope; headache; Initial information received on 02-May-2019 regarding an unsolicited valid serious case received from a Nurse.  This case involves a 16 years old male patient who experienced lost of consciousness and syncope, and headache, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BUXSERO].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided.  On 29-Apr-2019, the patient received a 2nd dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6204AA and expiry date: 08-May-2020 via intramuscular route in the right deltoid and a dose of Buxsero (details not reported).  On an unknown date, within 8 hours of the vaccination the patient experienced loss of consciousness and syncope and headache. Syncope was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was syncope, loss of consciousness and headache.  It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as recovered on an unknown date.  List of documents held by sender: none.; Sender's Comments: This case involves a 16 years old male patient who presented with syncope with loss of consciousness and headache 8 hours after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information, the role of the vaccine cannot be assessed.
Patient awoke in the middle of the night with extreme chills and vomiting, flu like symptoms during and the next day
Expired Dose Administered; Initial Report Received on 13-DEC-2022, 14-DEC-2022  This is a spontaneous report, received from an office coordinator at an Internal Medicine Office regarding a 39-year-old male patient who received HEPLISAV-B for hepatitis B immunisation.   Medical history was reported as an allergy to naproxen (rash).  Concomitant medications were not reported.  On 12-DEC-2022, a dose of HEPLISAV B (Lot # 934975, expiration date 13-AUG-2022, NDC # 43528-003-05), route and site not specified, was administered for hepatitis B immunisation.    The dose of HEPLSIAV B administered was reported as expired.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine given 2010 - developed MS inflammatory joints w/in 2 weeks.  Resulted frozen shoulder x 1 yr. 11/21/11 - vaccine 2011 - developed MS inflammation w/in 2 weeks - continued for almost 4 months. Then mostly resolved still residual (R) hip knee.
Severe headaches; Fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 16Sep2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Sep2021, the patient experienced severe headaches and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unspecified medications, neurological evaluation and blood work. Since the vaccination, the patient had been tested for COVID-19. On 30Sep2021, the patient underwent SARS-COV-2 test (nasal swab) and the result was negative. On an unknown date in 2021, the patient underwent neurological examination and blood test and the results were unknown. The clinical outcome of the events severe headache and fatigue was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 16-Oct-2018, the patient was administered FLUAD (TIV) [ batch number: 250796, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805540 was crossed linked to original case 201804863 due to same reporter.
10/1/07 Mother called. Child developed Varicella like rash. to watch and if worse call again. 10/3/07 Mother called. Rash increased in area and itching increased. Getting open sores where she scratched. Referred to Pediatrician.
Patient received Flu and Pneumovax in right arm and then he got a large red knot at sight of injection. Patient went to emergency room and the doctor draw a circle of the red area and said it was 9 inch around. The doctor said if the red area went outside the circle to get script filled. The next morning the patient was not any better (red had not gotten bigger) and he decided to get script filled.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past expiration date) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. Patient didn't received other vaccines within one month prior Moderna vaccination. Patient didn't had adverse event following previous vaccination. Concurrent medical conditions included Penicillin allergy, Chronic kidney disease stage 3, Diabetes mellitus, Hypertension and Parkinson's disease. On 23-Mar-2022 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant Products were reported. Vial didn't undergo any temperature excursions. Patient didn't experience an adverse event. No Treatment information was reported.
Have a lump on my arm the size of a fifty cent coin tender and sore still after 4 weeks.