chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; Chills; Fever; Injection site was red; Injection site was swollen; Injection site was hurts to touch; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PAIN (Injection site was hurts to touch). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 18-Mar-2021, VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PAIN (Injection site was hurts to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up included non-significant data: Reporter e-mail id added.
Severe lymphadenopathy which persisted for weeks. Primary symptoms: swollen glands, painful and tender glands, body ache, malaise, loss of appetite, blurred vision.  Right arm and right torso, right side of neck area were the most affected, and the pain was over my whole body.
After the 2nd covid vaccine she noticed her left armpit swelling and read that was happening so that is why all subsequent ones she does on her left arm; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 74 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose administered on 20Feb2021 with lot EN6198 to left upper arm left deltoid and she was asked but did not state dosage; patient card does not have expiry dates or NDC numbers written on it), administration date: 20Feb2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "the arm swelling after the first two vaccines", "COVID-19", "COVID-19"; BNT162b2 (2nd dose administered on 12Mar2021 with lot EN6208 to left deltoid), administration date: 12Mar2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "After the 2nd covid vaccine she noticed her left armpit swelling", "COVID-19", "COVID-19".  The following information was reported: SWELLING (non-serious), outcome "unknown", described as "After the 2nd covid vaccine she noticed her left armpit swelling and read that was happening so that is why all subsequent ones she does on her left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling.  Additional information: After the 2nd covid vaccine she noticed her left armpit swelling and read that was happening so that is why all subsequent ones she does on her left arm and it just feels different under her arm now and is swollen; her doctor sent her for an ultrasound and nothing was detected as amiss but the swelling is ongoing now and is squishy and feels different than the other side. The ultrasound as nothing swollen for nodes or lymph nodes at that time and she does not remember when the ultrasound was but it was probably a couple of months after the doses of vaccine. Had no treatment for the reported event but just had the ultrasound for the arm swelling after the first two vaccines and that was it just to make sure that it was not cancerous lumps.
Received vaccine on 3/16/2021 at about 10 a.m.  Right arm sorness for the next two days - 3/18/2021 Fatigue started on 3/17/2021 and last through 3/20/2021 -- although today is the 21st, in the morning, so may still have some fatigue Muschel aches started about 3/18/2021 through at least the early morning of 3/21/2021 Cough started on 3/20/21 and is continuing at present.  Productive Cough with phlegm
had the shot and then got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's brother/sister. The age at vaccination was not reported. The patient had the shot and then got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
10:00 AM Sore at injection site.  10:40 AM Dizzy and sleepy 10:50 AM vomiting  12:10 AM Ran 99.9 fever 3:00PM Same symptoms swelling at injection site. Took 600 mg Ibuprofen  5:30 PM Same symptoms, swelling from arm to neck. Fever at 100.2. Took 2 Tylenol PM  tablets.  8:30 PM Vomiting and same symptoms as all day. L/Side Neck and Left arm sore. Very intense headache. Took 2 Tylenol PM tablets.  3:30AM Same and very sore arm and head ache 11:00 AM
Mom states pt slept constantly x/for being awake to eat; sleep pattern altered; Despite APAP maintained temp of 100 to 101 ax; Notified MD who told to give pt APAP & call if temp not down in 1-2 days;
Patient received vaccine on 3/12/2021, left with no events. Patient called today stating she felt very fatigued, had a fever that was on downward trend, injection site soreness, and headaches.
Had COVID shot on 2/10/21, Redness on injection site.  Started a rash 2/11/21.  Went to Urgent Care per doctors office.  Gave a Prednisone Shot and prescription for prednisone.
7 patients in received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients in received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 patients received vaccine after its expiration date).    Concomitant product use was not provided by the reporter.  Limited Adverse Event reported on 5 patients of the 7 patients that received vaccine past it expiration date. Information on two patients was collected.  Treatment information was not provided.  This case contains information about patient 6th out of 7 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
After receiving Tdap patient felt nauseated,dizzy,fainted 30 seconds, rapid breathing, low blood pressure, shaky, weak pulse. Patient did not eat or drink anything today. 2 liters oxygen placed on patient, ammonia inhalent used. Paramedics were called. Arrived around 9:55am. patients Bp was 60/50 pulse 60 weak. Blood sugar 125. Bp rechecked at 10:00am 78/50. Pulse 60.  Patient drank juice, started feeling better BP 90/60 Pulse 60 strong upon discharge 10:45am.  Patients mom signed refusal to be transferred to ER form from the paramedics.  Patients stated she felt much better and was discharged home with mom via car.
Rise in blood pressure 150/119; nauseous; This spontaneous case was reported by a physician and describes the occurrence of BLOOD PRESSURE INCREASED (Rise in blood pressure 150/119) and NAUSEA (nauseous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On 13-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Rise in blood pressure 150/119) and NAUSEA (nauseous). At the time of the report, BLOOD PRESSURE INCREASED (Rise in blood pressure 150/119) and NAUSEA (nauseous) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood pressure measurement: 150/119 (High) 150/119.     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.   No concomitant medication was reported.  No treatment medication was reported.
tested positive; tested positive; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received his first shot a couple of weeks ago but tested positive later that day. The patient wanted to know how effective the vaccine was. The patient underwent lab test and procedure which included COVID: positive on unspecified date. Outcome of the event was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: There is not a reasonable possibility that event "tested positive" is related to BNT162B2.  The event occurred on the same day the patient got vaccination, when the vaccine is not expected to achieve the protection.  The event is most likely intercurrent medical condition.
Within 10 minutes I had inflammation surrounding the shot site and had hives all over. The nurses who were administering the shots told me to place a cold compress on the site and take Benedryl. Once I did that the hives went away. Then, again the next afternoon I got another case of hives on the arm where I got the shot.  I have no known allergies, so this was quite unexpected for me. I've also gotten flu shots over the years with no reaction.
Shingles type rash developed 6/10/14 under (R) breast radiating to (R) back tingling sensation - Dr Dx - shingles with rx for acyclovir.
This spontaneous case, initially received from a pharmacist on 11-Sep-2018, concerns a female patient of unspecified age. The patient's medical history and concomitant medications were unknown. On 10-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). On an unspecified date in Sep-2018 after vaccination, the patient developed a rash. The patient was given 2 1/2 percent hydrocortisone cream and the rash resolved within 1 to 2 days (recovered). The reporter assessed the causality of the event as related to the suspect vaccine. Follow up received on 04-Oct-2018: the outcome of the event 'rash' was changed from unknown to recovered. It was reported that, the patient was given 2 1/2 percent hydrocortisone cream. Narrative and case comment were amended accordingly. Update received on 02-Nov-2018: Non-significant case correction (IRD: 04-Oct-2018): The date in the case comment was removed and the cases comment was amended.
bad cold; feeling tired and significant fatigue; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2, via an unspecified route of administration, administered in right arm on 12Mar2021 11:30 (Batch/Lot Number: EL3247) at 46 years old as 2nd dose, single dose for COVID-19 immunisation. Medical history was none. No known allergies. No COVID prior vaccination. Not COVID tested post vaccination. There were no concomitant medications; no other medications in two weeks and no other vaccine in four weeks. The patient previously took BNT162B2 on 19Feb2021 (Batch/Lot Number: EL3247) as 1st dose (right arm) for COVID-19 immunisation. On 13Mar2021 07:30 (the next day), the patient was feeling tired and significant fatigue. He felt like he had a bad cold. No treatment provided. Outcome of events were recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
CLOTTING DISORDER; CHILLS; HEADACHE; FEVER; FATIGUE; UNDESCRIBED RESPIRATORY RATE; DIZZINESS; This spontaneous report received from a parent concerned a male of unspecified age. 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: Unk) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced undescribed respiratory rate. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced fatigue. Laboratory data included: Respiratory rate (NR: not provided) undescribed. On an unspecified date, the subject experienced clotting disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, fever, and undescribed respiratory rate, had not recovered from dizziness, and fatigue, and the outcome of clotting disorder was not reported. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of red blotches in a 65-year-old female patient who received SHINGRIX (batch number TZ9L5, expiry date 22nd November 2020) for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced red blotches and injection site reaction. On an unknown date, the outcome of the red blotches and injection site reaction were unknown. It was unknown if the reporter considered the red blotches and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The health care professional stated the patient received SHINGRIX on left arm and experienced a red blotch where SHINGRIX was administered on her left arm. The health care professional was not sure if she received it subcutaneously or intramuscularly. This case was reported by her friend to the HCP a day before reporting so the red blotch occurred within the 48 hours after injection. The health care professional was not sure if the patient was still experiencing the red blotch.
Information has been received from a third party claims administrator for a pharmacy concerning a female patient of unknown age. On an unspecified date the patient was vaccinated with ZOSTAVAX and PNEUMOVAX23 (lot#H021941, 11JUL2014). On 20SEP2013 the patient experienced an adverse reaction (NOS). The outcome of adverse reaction is unknown. Additional information has been requested.
Within five minutes of the vaccine, patient acutely developed severe periorbital and lip swelling,  with solitary hive and voice changes.  Noted to be tachycardic and inconsolable. Pt treated for anaphylaxis with Epinephrine, Diphenhydramine and Prednisolone with improvement.  Transferred to hospital for monitoring.
.  He received his second Moderna vaccine on 04/15th.  He did have localized pain in his arm and the following day, had some headache and neck stiffness.  Yesterday evening around 5 o' clock he developed left chest pain that has persisted.  It has waxed and waned, but not disappeared.  It reached an intensity of 7/10 prompting him to get a ride to the emergency room for evaluation.  He was found to have myocarditis, with troponin elevation to 37 ng/mL, and globally reduced ejection fraction 45%.  His care is ongoing.
arms & shoulders felt tired, achy & cold for about 2wk then on 5OCT97 4AM awoke w/both arms numb, cold & paralyzed;felt disoriented like was drugged & on anesthesia;had bad h/a 2 days a/this;
the patient was negative for immunity to measles; patient was administered a dose of M-M-R II after each of the three pregnancies; positive for immunity to mumps and diphtheria; positive for immunity to mumps and diphtheria; patient was administered a dose of M-M-R II after each of the three pregnancies; This spontaneous retrospective pregnancy report was received from a physician referring to a 38 years old female patient. The patient had a history of 3 previous pregnancies and 3 live births. The patient's pertinent medical history included long-standing essential thrombocytopenia. The patient's current condition included pregnant. Information about concomitant medication and drug reaction/allergy was not provided.  On an unknown date, the patient's obstetrician drew bloodwork to check titers, and the results showed the patient was negative for immunity to measles (measles antibody negative), the titers showed the patient was positive for immunity to mumps and diphtheria. So the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (vaccine exposure during pregnancy). Sterile diluent for the vaccine (lot # and expiration date were not reported) was also reported as suspect therapy.   On an unknown dates, the patient had the second and third pregnancy, the patient's obstetrician drew bloodwork to check titers, and the results showed the patient was negative for immunity to measles (measles antibody negative), the titers showed the patient was positive for immunity to mumps and diphtheria. So the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot # and expiration date were not reported) each of the pregnancies for prophylaxis.   In May, 2019(reported as about a month ago), the patient's titers were most recently rechecked, following the three doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and showed the same results - negative for immunity to measles but positive for immunity to mumps and diphtheria.    The physician reported that all of the patient's other immunoglobulins and IgG subclasses are normal and that the patient did not take any immunosuppressive medications and did not have any history of infections, so he believed the patient's measles immunoglobulin could be extraordinarily high and the negative titer result was spurious.  The LMP and EDD was not known. The pregnancy outcome was live birth.  The outcome of measles antibody negative was reported as not recovered. The outcome of rest events was unknown. The causality of the events was not provided.
having COVID; having COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "having COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.