chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 4/26 around 4pm 2 Moderna vaccine doses were drawn up for immediate administration to patients with the evening appointments that day.  By 7pm the last 2 appointments did not show up. The pharmacist placed the 2 syringes in the fridge to report as waste the next day in inventory counts. This pharmacist did not work the next morning. On 4/28, the pharmacist working the afternoon shift thought the 2 drawn up syringes were from that morning and administered one to patient patient. Moderna manufacturer was contacted on 4/29 to advise on next steps and if re-vaccination was required since greater then 12 hours passed after puncture. They advised that the reason for the 12 hour window after puncture of the vial is because it does not contain preservative and to avoid potential infection it should be disposed of after 12 hours, however the vaccine is viable for 30 days in the fridge at manufacturer?s temperature. The vaccine administered was within the 30-day window, in date and remained in the fridge the entire time. The patient was called two times after their vaccination to check in for any adverse event or signs of infection. The patient said they were fine, only a sore arm for a few days, no signs of infection or other adverse reaction. The 1st dose was not re-administered. Patient was administered the 2nd vaccine on 5/26, 28 days later. The pharmacy updated their procedures for immediate vaccine disposal before leaving for the evening and other procedures such as clear labels and individual draws to avoid this same error. All staff were retrained.
Patient came in with large, red rash on arm.  Patient stated rash developed where she received the shot and eventually grew larger down towards her elbow. Patient also stated that it feels hard to the touch. Advised pt to see their PCP.
Patient received the vaccine although she is not 18 years old.   The questions at time of scheduling did ask if patient was in the appropriate group to receive vaccine but did not ask if the patient was 18 years old.   It was overlooked at time of administration as vaccinator asked if they were in the appropriate group but did not confirm age.
very bad headache; feels terrible/feeling bad; she was sick; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL4238, Expiration date: 30Apr2021), via an unspecified route of administration at site of right arm at 14:00 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing high cholesterol for several years. Concomitant medication included rosuvastatin calcium (CRESTOR) for cholesterol (had taken it for several years). The patient had a bad headache and feels terrible at 6 am on 07Jan2021, she wanted to know if she could take something for the headache. She got up at 6 am and feeling bad on 07Jan2021, she left for work and came home, and she was sick. Her feeling terrible started sometime during the night. She was feeling fine on 06Jan2021. These events were identified as non-serious by reporter. Vaccination Facility Type was in public health department. Vaccine was not administered at military facility. No history of all previous immunization with the Pfizer vaccine considered as suspect. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. No adverse events required a visit to emergency room. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. The outcome of events 'headache' was not recovered; of rest events was unknown.
Initial unsolicited misuse report received from LVN (Licensed vocational Nurse) on 18 May 2016. This case involves two-month-old male patient (reported as eight-weeks-old) who received 2 vials of ACTHIB diluents as dose 2, 0.4 percent of HIB (PRP/T) VACCINE (ACTHIB) (Diluent batch number: UI537AA, expiration date: 04 November 2017, dose was not reported), was vaccinated with first dose of PNEUMOCOCCAL CONJUGATE VACCINE (PCV 13) (Manufacturer: Pfizer, Batch number: M16259, expiration date and dose was not reported) and a first dose of PEDIARIX (Manufacturer: GSK, Batch number: 4922C, expiration date and dose was not reported) all by intramuscular route in the left thigh on 17 May 2016. Patients Illness at time of vaccination reported as well child visit and pre-existing physician diagnosed allergies, birth defects, and medical conditions were reported as none. On 17 May 2016, same day post vaccination, the patient had experienced redness and mottling around the left knee. It was reported that 2 ACTHIB diluents 0.4 percent vials was administered. It was also a case of product preparation error and product use issue. Laboratory investigations and corrective treatment were not reported. The patient was recovering from the events. It was reported that the evaluating physician stated the events may be a vaccine reaction. List of documents held by sender: none.
On 11/7/00, the pt experienced an unrelated viral illness and was hospitalized overnight with dehydration and he was feverish with a fever of 101.6.The child was hydrated. On 11/7/00, liver function tests were taken and the results were mildly elevated.  Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a 35 year old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II, subcutaneous, for prevention of measles, mumps and rubella (dose, lot # and expiration date were not reported). The patient was asking for revaccination with M-M-R II, due to positive titers only for mumps and rubella. It was reported, that measles failed to seroconvert. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided.
Arm severly painful.  4-6 hours later hives, red itchy on affected arm, chest and back on same side as vaccine given.  7 hours later abdominal pain which increased in severity lasting 24-48 hours.  Nausea and small amount diarrhea 8 hours after.  Slight fever 100.  Achy all over.
Adverse event NOS; This spontaneous case was reported and describes the occurrence of ADVERSE EVENT (Adverse event NOS) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event NOS). At the time of the report, ADVERSE EVENT (Adverse event NOS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported.  No treatment information was reported.   Case was received via email with limited information.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vaccines were stored in freezer and required vials were taken out to place in fridge as needed.  No treatment medications were reported.
pt recv vax 15OCT96 & 2 days post vax pt devel a small red are @ inj site & a large 7x8cm raised erythema w/satellite vesicles around a huge wheal;also devel fever to 102;severe local rxn;
Breakthrough case admission after 2 vaccines Moderna 3/18/21 Lot# 002B21A;  Moderna 4/15/21 LOt# 040B21A
Terrible migraine; Eye ball pain; Woke up with the sweats; Vomiting; Blurry; Rash; Sensitivity with teeth; Headache; Fever, high as 101 for about three days; Muscle soreness/Muscle pain; Nauseous; Still in a fog.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration, administered in the left arm on 09Aug2021 at 11:00 (at the age of 49-years-old) (Lot Number: FA7484) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure high, had COVID on 22Jun2020 to an unknown date, and ongoing migraine. Concomitant medications included olmesartan (strength: 20 mg) taken for hypertension from an unspecified start date and ongoing and hydrochlorothiazide (strength: 12.5 mg) taken for hypertension from an unspecified start date and ongoing. On 09Aug2021, the patient experienced headache, muscle soreness/muscle pain, fever, and sensitivity with teeth (reported event onset time was at 11:00). It was reported that the patient used kinesiology tape regarding her muscle soreness/muscle pain. On 10Aug2021, the patient had a terrible migraine, was having eyeball pain, woke up with the sweats, vomiting, had blurry feeling, and rash. On an unspecified date, the patient experienced nauseous and still in a fog. Events were treated with Tylenol Extra Strength. The patient underwent lab tests and procedures which included antibody test: 500+ on an unspecified date in Aug2021 and body temperature: 101 on 09Aug2021. It was as high as 101 for about three days. The outcome of the events migraine, fever, muscle soreness/muscle pain, sensitivity with teeth, nauseous, blurry, headache, and still in a fog were not recovered/not resolved. Outcome of the event sweating was unknown. The outcome of the event eyeball pain was recovered on 12Aug2021, outcome of the event vomiting was recovered on an unspecified date in Aug2021 and outcome of the event rash was recovered/resolved on 11Aug2021.  No follow-up attempts are possible. No further information is expected.
About a week after I started to break out in hives / dermatographia. It?s been a daily occurrence since January and it is now June. Antihistamines help slightly but don?t make them go away. Constant hot itching and rashes daily.
Local erythema, warmth, tenderness worsening for 6 days when evaluated today.
Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
Breakthrough case admission after 2 vaccines Moderna 3/3/2 Lot# 023M20A;  Moderna 3/31/21 Lot# 028B21A
Within 24 hrs of vaccination, there was significant discomfort in the shoulder and clavicle area on side of injection. The lymph nodes in the area above the clavicle were felt as hard round lumps and tender to the touch.  Discomfort continued for 5 days with swelling of nodes slowly decreasing over that time.   Acetaminophen and Naproxen were used to control discomfort with questionable success.
In the morning eight days after receiving the first vaccination, I had a rash around and mostly below the injection site about 3 inches in diameter. (A Google search said that this was a rare but harmless reaction to the vaccine.) The paperwork I received at the time of injection said to report any reaction.
Only 1 vaccine dose; weakness; severe rash on the left arm and underarm, rash spread on right arm and shoulder; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), PRODUCT DOSE OMISSION ISSUE (Only 1 vaccine dose), ASTHENIA (weakness) and RASH (severe rash on the left arm and underarm, rash spread on right arm and shoulder) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included AMLODIPINE, SOTALOL, LEVOTHYROXINE SODIUM (SYNTHROID) and APIXABAN (ELIQUIS) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog). On 09-Mar-2021, the patient experienced ASTHENIA (weakness) and RASH (severe rash on the left arm and underarm, rash spread on right arm and shoulder). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only 1 vaccine dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and AVENA SATIVA FLUID EXTRACT (AVEENO) at an unspecified dose and frequency. On 13-Apr-2021, FEELING ABNORMAL (brain fog) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Only 1 vaccine dose), ASTHENIA (weakness) and RASH (severe rash on the left arm and underarm, rash spread on right arm and shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
11:00 vaccinations given, by 4:00 pt had t103.8R p/APAP given; pt was very lethargic & taken to ER: pt observed & then released by 19AUG94 pt was fine;
severe chills, severe body and muscle aches, fever, severe headache for about 10 hours commencing 12 hours after vaccination.  swollen and painful lymph nodes in armpit of injection arm (ongoing for 4 days)
Patient stated she felt clammy.  At 1013 am: BP= 117/75, O2 Sats RA= 100%, HR= 120, Temp= 35.8; at 10:45 am BP= 128/84,  O2 Sats RA= 198%, HR= 88, Temp= 35.8.  After about 30 minutes, patient stated they felt fine and left the facility
patient being administered only the DTAP-IPV component of PENTACEL without being reconstituted with the lyophilized ACTHIB component with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old male patient who being administered only the dtap-ipv component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without being reconstituted with the lyophilized acthib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine and Pneumococcal Vaccine CONJ (Pneumococcal Conjugate Vaccine) for Immunisation.  On 09-Mar-2023, the patient received dose 1 at 0.5mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (strength: standard) (lot number: UJ876AA; expiry date: 19-MAR-2024) via unknown route in unknown administration site for immunisation.  On 09-Mar-2023 the patient being administered only the dtap-ipv component of pentacel without being reconstituted with the lyophilized acthib component with no reported adverse event (product preparation issue) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  It was reported as Caller states that a medical assistant administered the liquid component (DTAP-IPV) of vaccine without reconstituting it with the powder component (lyophilized ACTHIB vaccine).   No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Burning rash, particularly waist down but on arms, back as well. Not related to injection site.
Breakthrough case of COVID-19: I felt like I had a horrible case of hay fever, I am coughing, sneezing, runny nose. I called the doctor to see how long I needed to quarantine. I was given dietary recommendation and told to watch my Oxygen levels. I was not given a specific timeframe to quarantine.
The patient is a 52 year old male. Patient received ANTHRAX #6, Hepatitis B #2 and Typhoid vaccines on 16 Apr '09. He was clinically well at the time and had no previous reaction to vaccinations. On 14 May '09 he was seen for tempr 103.3, myalgias, arthralgias, rash and 'erythematous nodules' on hands, elbows and knees, and "red fingertips". He had an elevated CRP and ESR. Due to concern for vasculitis, patient was immediately sent for dermatology evaluation and started on prednisone, and LEVAQUIN. A biopsy on 18 May '09 showed a "neurotrophillic, granulomatous and mixed dermal inflammatory infiltrate", and was subsequently diagnosed with Sweets Syndrome. This syndrome can be associated with a medication, infection, illness or vaccination. Symptoms: fever, rash, oth nonspecific skin eruption, joint pain.
Sore left upper arm for a few days, aching in shoulders and neck 1st 24 hours,  very slight headache
This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.
booster dose; I cannot lift my arm./I have have been icing my arm since I received the vaccine; pain at injection site.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 12:00 (Lot number: FJ1611) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Allergy", notes: known allergies levaquin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWb158, Location of injection: Arm Right), administration date: 15Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205), administration date: 25Mar2021, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster dose"; LIMB DISCOMFORT (non-serious) with onset 15Nov2021, outcome "not recovered", described as "I cannot lift my arm./I have have been icing my arm since I received the vaccine"; VACCINATION SITE PAIN (non-serious) with onset 15Nov2021, outcome "not recovered", described as "pain at injection site.". Therapeutic measures were not taken as a result of events.  Clinical course:The patient had no  covid  prior  to vaccination and not  tested covid post vaccination. No other vaccine  received in four weeks. It was reported that no results in death, life threatening, Caused/prolonged hosp, Disabling/Incapacitating, Congenital anomaly/birth defect. The patient waited 30 minutes after injection. It has been over 24 hours since the patient had the vaccine and she cannot lift her arm. The patient was awakened last night at 3:00am due to pain at injection site. She have been icing on her arm since she received the vaccine.  Follow-up attempts are completed. No further information is expected
Felt like scraping; sticky; Swollen Eyelids; Up all night; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Swollen Eyelids), INSOMNIA (Up all night), SKIN ABRASION (Felt like scraping) and STICKY SKIN (sticky) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced SWELLING OF EYELID (Swollen Eyelids) and INSOMNIA (Up all night). On 25-Feb-2021, the patient experienced SKIN ABRASION (Felt like scraping) and STICKY SKIN (sticky). On 23-Feb-2021, INSOMNIA (Up all night) had resolved. At the time of the report, SWELLING OF EYELID (Swollen Eyelids), SKIN ABRASION (Felt like scraping) and STICKY SKIN (sticky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
extremely painful injection site; redness upper arm; fever 101.2, chills self treated with fluids and acetaminophen
Hospitalized 1/5/22-1/10/22 Weakness, dysuria, UTI, sepsis w/ septic shock, cough, SOB, bacterial PNA, dizziness, lightheadedness
Myalgia, fever, hoarse voice, red/watery eyes & hyperaesthesia - sore throat/nausea tx: DEPO-MEDROL 80mg & BENADRYL 25mg. IM ZYRTEC 10 mg & PATANOL eye drops.
Staff member complained of a stiff arm. Was seen by Dr. and advised to see personal physician if problem persists. Stuff arm went away.
It appears to be an allergic reaction: red from injection site and down 8 inches past elbow, itches, swollen.
Case  number PHEH2014US021302 is an initial spontaneous report received from a consumer on 20 OCT 2014. This report refers to a 63 year old female patient. Her past medical history and concomitant mediations were not reported. On an unspecified date, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly. On 18 OCT 2014, her shoulder through elbow seemed to be radiating pain and was very stiff. She was unable to lift her arm up. The outcome of the events was not reported. The seriousness and causality of the events was not reported.
Medication Administration Error. Patient was given Moderna monovalent vaccine instead of Moderna bivalent vaccine as booster during visit. The patient was informed of error and given the option to return to the clinic after 2 months to receive the bivalent booster.
On 6/22/05 Pt c/o nausea, diarrhea, severe fatigue, joint pain and fever. On 6/25/05 states found three red marks about the size of a dime on inner Lt thigh states then a rash started spreading on both thighs, back, stomach and armpits. States rash only itched on thighs. Started taking Benadryl 25mg for itching a calamine lotion . Symptoms lasted for about 7-8 days. States rash started clearing up by 6/29/05.
2 inch diameter redness of the skin at the injection site, mild blistering. itching for next 10 days