chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt like I had a bad allergy attack (lots of sneezing and runny nose) friday night (the 18th). Saturday and Sunday I had chills and trouble regulating my body temperature (which in me is often a sign of a fever), though I do not own a thermometer so I can't say for sure. I also had headaches, fatigue and ongoing bad allergy symptoms that did not respond to antihistamines (claritin). I took claritin and ibuprofen over the weekend.   Since some of these are symptoms of covid I went to get tested on monday so I would know if I needed to self-isolate, but a nasal swab test came back negative for covid. And by next tuesday or wednesday I felt fine.
one week after injection I developed a red rash under the skin around injection shot. It extends approximately 3 inches out from injection. It is bumps under the skin rather than small bumps on top. It itches.
8-15-97-Arose -in A.M. with a fever of 102; blood shot eyes;crying, yelling that whole body hurt; some areas on fingers had small red spots;could not move because of pain in joints, knees, elbow, fingers, neck, toes; called Pediatrician, told me to give her Tylenol and an appointment tocome in.
Cellulitis of arm; Mother of child removed bandaid one day post vaccination and noticed the area to be red, warm and painful. Patient was taken Urgent care and diagnosed with cellulitis, rx for KEFLEX given.
Golf Ball Swelling and erythema with at deltoid fever now qod HA, Fatigue. Exanthem 1st set of vaccines/lifetime.
pt recv vax 25JUL96 & on 30DEC96 pt exp rash-full blown chicken pox;
Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m.
extreme fatigue starting on 3/10/21 and continues. back  pain between shoulder blades and chest pain . not sure if really muscle aches. reported tingling in right cheek and some numbness but this subsided quickly. both arms are weak and have been since 1 day after the shot. encouraged evaluation by primary care provider
CHILD STARTED BREAKING OUT WITH RED UNRAISED RASH ON BACK ON 5-11-04.  BY 5-13-04, ENTIRE BODY WAS COVERED WITH RASH, AND EYES WERE SWOLLEN HALF SHUT.  NO ITCHING EVIDENT, HOWEVER, PARENT STATED CHILD WAS VERY CRANKY.  FEVER DENIED BY PARENT.
Rash on arms and legs - not itchy, mild irritation.  No prior reactions to shots.  No treatment given.
The patient suffered NO adverse reaction to the vaccination. She should have been given a booster for the meningococcal B vaccine (TRUMENBA), but was given MENACTRA by mistake.
No additional AE/PQC; HCP calling to report a patient was given an expired vaccine on 5/2/2019.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-MAY-2019, the patient was vaccinated with first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot # L049316, expiration date 03-DEC-2017 (dose, route of administration and anatomical location were not reported) for prophylaxis (expired vaccine used). It was unknown if the vaccine had any prior temperature excursions. No additional adverse event was reported.
Headache, fever, chills, swelling of arm from injection site to elbow, arm hot, difficult to move arm due to pain/swelling, body aches, visited doctor 2x prescribed 2 different antibodics and prednisone.
following vax pt felt shaky;did not pass out but heard zooming noises & saw blackness;apparently remained seated, until lt w/father & step-mom;
This was pt 1st flu vaccine.  She c/o itching at injection site L Deltoid.  There was no redness or swelling- just itch-  The itching was intermittent but lessening- still present as of 10/30/08 evening.
Flu vaccine from last year that was inadvertently injected to a patient with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from other healthcare professional and transmitted to Sanofi on 09-Oct-2020 .  This case was linked with 2020SA283093 and 2020SA283092 (Same reporter).  This case involved a 37-year-old female patient who received a 0.5 mL dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number- UJ247AA, expiration date- 30-Jun-2020) via intramuscular route in left deltoid for prophylactic vaccination on 07-Oct-2020 (Expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medication was reported as none.  It was a case of actual medication error as expired vaccine was administered (Latency: Same day).  It was reported that 3 boxes of Fluzone QD NP (no preservative) which was from last year. Each box had 10 syringes.One box was open. There were 3 Flu vaccines from last year that were inadvertently injected to 3 different patients. One of the patient was a doctor.  At the time of reporting it was unknown if the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Erythema, firmness to arm, red area warm to touch, itchy no pain. Patient treated with course of antibiotics (Augmentin) for 10 days. Per follow up via phone conversation on 12/17/11, s/s resolving. Mom with no concerns.
Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraines). At the time of the report, MIGRAINE (Migraines) outcome was unknown.            No concomitant drugs are provided. No treatment.
Child "lethargic" with "froth at mouth" per parent, when tried to awaken from nap. Called 911, transferred per ambulance (O2 given during trip), to ER. In hospital given Tylenol. All symptoms resolved upon arrival. Consulted own physician, who recommended returning to our site for next shots, but give separately. On 9/29 gave Hib #2, PCV #2, no problems. On 10/6 gave DTaP #2 and IPV #2, no problems.
The vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022; No adverse event; Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022) 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. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Nov-2022, 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 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and vaccine administered on 18-Nov-2022).    Concomitant medication was not provided.  Reporter reported that the vial was individual vial and size was 2.5 ml. The vial was initially stored in the refrigerator on 18-oct-2022. The vial did not undergo any temperature excursions.  Treatment information was not provided.  This case contains information for the 9th of 14 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260: US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675268:
I began vaginal bleeding late July. Consistency, and flow started as light pink in varying degrees of amount but it was always flowing. Then, I began seeing what looked like clots and it was very thick. First appointment with the provider and he chalked it up to my cervix healing from a recent pap.  I continued to bleed through all of August. Late August/early September I began experiencing mild cramping and spurts of area specific pain. I was seen again and this time the provider decided to order labs and an ultrasound.  A day before the ultrasound I ended up in the ER because I was in so much pelvic pain and I felt extremely weak and lightheaded. I felt so much pressure in my uterine region I felt like it was going to fall out.
Mom reports the patient developed fevers with T-max 103F the day after she received her 12-month immunizations (MMR, varicella, and hepatitis A immunizations) on 11?29.  She has had intermittent fevers daily but no fever noted today.  She has been extremely fussy.  She is consolable at times but has been crying on and off throughout the day and night.  Parents noticed a faint pink rash on her trunk, chest, and extremities today.   Parents deny any face/mouth swelling, difficulty breathing, vomiting, diarrhea, lethargy.   Prescribed Tylenol and Motrin alternating every 3 hours to be taken at home after 4ml of Motrin was given in clinic.
heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case  was received from a consumer/non-healthcare professional.  This case involves a 49 years old patient  of unknown gender, who had heart attack, while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received influenza vaccine (produced by unknown manufacturer) (strength, formulation, dosage, lot number not reported) via unknown route in unknown administration site. Information on batch number was requested.   On an unknown date, the patient had heart attack (myocardial infarction) in locker room (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart attack).  At time of reporting, the outcome was Unknown for the event (heart attack).; Sender's Comments: Sanofi Company Comment dated 07-Feb-2022: This case involves a 49 years old patient  of unknown gender, who had heart attack, while receiving influenza vaccine. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Patient states feeling numbness from the area of the knee down. Also syncope, and being unable to get back up after falling in the middle of the night when going to the bathroom. Symptoms resolved the next day.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose02/05/21 2nd dose02/26/21 Diagnosed covid positive:09/14/21 Symptom onset:09/07/21 Exposure:travel Symptoms:fever,cough,fatigue,muscle aches,sore throat,chills
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date of 01/11/2023, lot #GJ6738. Patient has been notified. No adverse effects reported. Reports filed. -  ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into system prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and technical reconciliation o Training on how to enter information into monitoring system when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
Shingles : onset 11/23/22, diagnosis 11/28/22, Rx: Valacyclovir 1 GM Tab, lidocaine patch,  and 600mg ibuprofen.
Patient was vaccinated and within few seconds he was feeling disoriented, light headed and dizzy for over 10 minutes.  Pt did not loose his consciousness. He was sweating profusely and appeared pale.    Could have been possible syncope.   Called 911, paramedics arrived at the scene and checked his vitals.  Blood pressure was 117/ 70.  Pt was was feeling normal when paramedics arrived.  Paramedic  checked  his blood sugar using finger prick.( His blood sugar was around 150)  Pt  immediately fell little disoriented and dizzy and recovered in 2 minutes.   Pt was not admitted to hospital.   He was doing well when he left the pharmacy after 30 minutes or so.    Pt said that he had similar episode when blood was drawn for some lab tests in the past.
Numbness and tingling on the right side of the face. Advised to go to ER if symptoms persist or get worse.  Contact physician.
pt recv vax 12NOV98 & reported that pt went to ER @ 3PM that day for treatment;in ER MD treated pt w/the dx of acute allergic rxn;c/o heaviness in chest, diff breathing & soreness in lt arm;tx IV solumedrol, DPH, tagamet;
This spontaneous report as received from a physician refers an unknown number of patients of unknown age. The physician reported that the unknown number of patients might have received improperly stored PNEUMOVAX 23 from 21-JAN-2011 to present. No adverse event reported. This is one of several reports from the same reporter (Other MARRS# 1305USA009039, 1305USA010280, 1305USA010282, 1305USA010283). Additional information has been requested.
Fever started 02/13/09, highest was 102.8F, parent noted redness, not wanting to use her right leg. Seen on 12/14/09, afebrile after ibuprofen, 1cm X 2cm area of erythema, 2cm X 3cm area of induration noted on exam.  Treated with Duricef 250/5, 1/2tsp BID X 10 days for cellulitis.
One month following bivalent vaccine was diagnosed with high level of proteinuria, GFR normal, kidney biopsy pending
Patient stated that the syringe was leaking during administration and she may have received an incomplete dose. Caregiver administering vaccine stated that a small drop leaked after which she tightened the needle to the syringe and complete administration.
Hair fail out; Sores all over my head; Felt like thing's were crawling over my scalp; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hair loss in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hair loss (Verbatim: Hair fail out), skin ulcer (Verbatim: Sores all over my head) and crawling sensation of skin (Verbatim: Felt like thing's were crawling over my scalp). The outcome of the hair loss, skin ulcer and crawling sensation of skin were not reported.   It was unknown if the reporter considered the hair loss, skin ulcer and crawling sensation of skin to be related to Shingles vaccine.     It was unknown if the company considered the hair loss, skin ulcer and crawling sensation of skin to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced bad reaction his or her hair fail out and got sores all over his or her head and it felt like things were crawling over his or her scalp. Follow-up would not possible as no contact details were available.
reports getting COVID after vaccine;  reports getting COVID after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 72-year-old male patient received BNT162b2 (BNT162B2), 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 "DR reports getting COVID after vaccine".  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
localized pain and swelling to deltoid with ct showing multiple fluid collections concerning for abscess or fluid collections. required iv abx, admission and possible drainage.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; GUANFACINE; HYDROXIZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Feb2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Positive test six days after testing. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: Positive test six days after testing. Minor symptoms of sniffling and sneezing prompted test. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient presented with chest pain, elevated troponin and was diagnosed with myocarditis. Treated with IVIG 2g/kg (12/2), ICU admission (12/2-12/5), stabilized and transferred to the peds floor 12/5.  Admission date 12/2/2021 to present.
Enlarged Lymph Nodes, for a week.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN; Lot Number: EW0151) via an unspecified route of administration in the right arm on 05Apr2021 at 10:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and penicillin allergy. It was reported that the patient was allergic to chick pea. Concomitant medications were not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, the patient experienced enlarged lymph nodes, for a week. Therapeutic measures were taken as a result of enlarged lymph nodes and included treatment with oxicodone, ibuprofen, dorflex pain pills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event enlarged lymph nodes, for a week was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
8 days post vax petechiae around both eyes, bruised very easily even if touched per mom; Seen by MD 28AUG91, sent to Hosp for CBC & platelets (8,000); Bone marrow normal; disposition: virus p/DTP; given IV GG; platelet count improved;
Shot was administered with immediate pain in left arm. Pain has progressively increased and now radiates from arm up to shoulder. Pain is regular, increasing and now impacting range of motion and use of left arm.
MMR II was indavertently administered via the intramuscular route.; no adverse effects reported; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's relevant medical history, previous drug reactions or allergies, concomitant medications, and concurrent conditions were not disclosed.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), lot # R036582 and expiration date 17-DEC-2020, inadvertently administered via intramuscular route (incorrect route of product administration) for prophylaxis (strength, dose, frequency and anatomical site of injection, were not reported).         By the time of this report, there were no adverse effects reported.
Swelling, redness, soreness at injection site lasted five days. swelling was hard lump the size of a golf ball. no other symptoms.