chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question; No adverse event; Doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-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 20-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) 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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question).    No concomitant medication was reported.  Reportedly, temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction.  No treatment information was provided.
Covid club where he can not use his arms and  just hang there; Could not lift leg or hips up; vaccination complication; could not lift hips up; Bedridden; A lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Covid club where he can not use his arms and  just hang there), LIMB DISCOMFORT (Could not lift leg or hips up), VACCINATION COMPLICATION (vaccination complication), MUSCULOSKELETAL DISCOMFORT (could not lift hips up) and BEDRIDDEN (Bedridden) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Covid club where he can not use his arms and  just hang there), LIMB DISCOMFORT (Could not lift leg or hips up), VACCINATION COMPLICATION (vaccination complication), MUSCULOSKELETAL DISCOMFORT (could not lift hips up), BEDRIDDEN (Bedridden) and PAIN (A lot of pain). At the time of the report, HYPOKINESIA (Covid club where he can not use his arms and  just hang there), LIMB DISCOMFORT (Could not lift leg or hips up), VACCINATION COMPLICATION (vaccination complication), MUSCULOSKELETAL DISCOMFORT (could not lift hips up), BEDRIDDEN (Bedridden) and PAIN (A lot of pain) outcome was unknown.            No concomitant medications were reported.     Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up (TCR)  received on 30-Jun-2021 contains No New Information.
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided
Woke up night after the injection about 1am with excrutiating debilitating pain in all joints on the right side of body. Up through bone behind ear, down to elbow, wrist, hand on right side. Through middle back, rib-cage, breast, down to hip on right side. Could barely move - considered emergency room visit. Symptoms continued through the night adding nausea around 3am. Next day 12/8/2021 still in excrutiating pain on right side mid back and all joints on right side of body. Sought chiropractic and massage treatments 12/8/2021 to try to remedy the pain. Hot steam shower night of 12/8/2021. Tylenol every 4 hours from 1am on 12/8/2021 through 12/9/2021 barely took the edge off of the pain. By 8am 12/9/2021 most of the symptoms had resolved except for some minor burning sensation in right arm. Able to move body more freely and without excrutiating pain.
Pt recvd Recombivax-HB 14DEC89, 26JAN90 & 11JUL90 & did not respond p/a booster dose; currently receiving 2nd round of vax;
Lower legs/shin/ feet went numb a couple of days after vaccination and full numbness lasted for close to a week, over a month later and full feeling in lower shin still isn't back
Patients mother called the office stating  " Her Left upper arm is swollen red and warm to touch. She complains about it being sore. She is experiencing dizziness, headache, chills, mild fever, fatigue and pain going down the arm.
Patient described fever, chills, malaise and severe arm pain for 3 days that was beyond the normal potential side effects. Patient states that she was in bed for the entirety of that time.
Gardasil 9 was inadvertently administered to a 15 month old child; Gardasil 9 was inadvertently administered to a 15 month old child... MA was supposed to give HIB vaccine, she accidentally gave HPV (Gardasil) instead.; No adverse event experienced; This spontaneous report was been received from a healthcare professional, concerning a 15-month-old male patient. The patient's pertinent medical history, concurrent conditions, and drug reactions/allergies were not provided.   On 01-FEB-2021 the patient was supposed to receive a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown), however, the medical assistant accidentally administered to the patient the wrong vaccine and he received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 0.5 milliliter, intramuscularly, in the left thigh, lot # T007035 and expiration date 01-MAY-2022, for prophylaxis. On the same date, the patient also received a first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot # S039311, expiration date on 04-DEC-2021, subcutaneously, left arm; a fourth dose of diphtheria toxoid, Hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) (Lot # UJ1355AA, expiration date on 26-FEB-2021, intramuscularly, on right thigh; and a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot # DN4219, expiration date on 31-JAN-2023, intramuscularly, left thigh.   After the administration of the wrong vaccine, the family was notified. No laboratory tests were necessary. The parent was informed to monitor the patient and inform to the clinic of any side effects or adverse reaction. At the time of the report, the patient had not experienced any adverse reaction/adverse event. The medical assistant was re-educated. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided. Date of refrigeration was reported as 07-May-2021
Patient developed temp of 101 and inconsolable crying for three hours resulting in patient being taken to the ER.
exhibited symptoms of fatigue, fever/underwent a positive COVID-19 test (nasal swab); exhibited symptoms of fatigue, fever/underwent a positive COVID-19 test (nasal swab); This is a spontaneous report from a contactable consumer. A 73-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 15Feb2021 12:00 (batch/lot number and expiry date unknown) at 73 years of age as dose number unknown, single for covid-19 immunization in facility. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior vaccination. The reporter informed that the patient exhibited symptoms of fatigue, fever on 27Aug2021, and underwent a positive COVID-19 test (nasal swab) on 30Aug2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent a monoclonal antibody therapy treatment on 31Aug2021 and was currently recovering.   The lot number for BNT162B2 was not provided and will be requested during follow up.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M039317, expiration date: 20-SEP-2018; lot # M034583, expiration date: 27-JUL-2018; lot # M028546, expiration date: 07-JUN-2018); exact doses and route of administration were not reported). Concomitant therapy included well-stored sterile diluent (MERCK STERILE DILUENT) used to reconstitute doses of VARIVAX. The reporter stated that the administered doses of VARIVAX were stored at temperature between 15 to 46 degrees Fahrenheit (F) for 9 hours on unknown dates. Data logger was used to detect temperature excursions. There were no previous excursions reported. The physician stated that the sterile diluent (MERCK STERILE DILUENT) did not undergo a temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004392:
Pt began having stridor after vaccine. Monitored and went to E.R. Currently no Rx.
Expired-5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given at that point) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 3:33 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022 at 3:33 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 16-Dec-2021 Moderna vaccine was pulled from freezer. Beyond use date (BUD) of 15-Jan-2022 was printed in red and taped to the top of the boxes. The patient was notified of the error and patient denied adverse effects.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received. IRD changed (25-feb-2022 to 24-Feb-2022).
Cellulitis of the left arm. Given cefdinir suspension 250mg/5ml once a day for 10 days
Diffuse macular rash over trunk and extremities. Occurred one day after first immunization with HIB and IVP.  Pt seen 2 days after and rash persisted unknown if r/t immunizations or not.
Patient was given DTaP, Flu vaccine, IPV, MMR & VARIVAX at nurse visit 10/9/12 approximately 9:50AM. Mother took child to medical daycare. She was fine on arrival at medical daycare. Medical daycare called office at 12:12PM child developed flushed face, swollen eyelids, swelling over bridge of nose, red itchy neck. No respiratory symptoms. 1 tsp BENADRYL given via G-tube - symptoms improved within 10 min.
FOUR DAYS AFTER RECEIVING THE FIRST DOSE I NOTICED I WAS FEELING WARM. AS TIME HAS PROGRESSED I BEEN GETTING SEVERE NIGHT SWEATS AND HOT FLASHES. THE NIGHT SWEATS AND HOT FLASHES HAD BEEN UNDER CONTROL AND NON-EXISTENT FOR THE PAST YEAR BY THE USE OF THE HORMONE REPLACEMENT MEDICATION PREMPRO.
I had redness and swelling in my arm the size of a softball, warm to the touch, hot and very sore. I was put on steroids.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  CARDIOGENIC SHOCK 5/16/2022 -- RECURRENCE OF SAME SYMPTOMS
Muscle soreness at injection site for ~24 hrs after injection; This is a spontaneous report from a non-contactable consumer reported for self. This 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3248) at single dose in right arm on 12Jan2021for COVID-19 immunization. Medical history was not reported. Concomitant medications included amlodipine besilate (NORVASC), lisinopril, potassium/calcium supplements. There was no other vaccine in four weeks. There was no covid prior vaccination; no covid tested post vaccination. Patient experienced muscle soreness at injection site for 24 hrs after injection (in Jan2021). The outcome of event was recovered (in Jan2021).   No follow-up attempts are possible. No further information is expected.
Pt received the vaccine FLUZONE HD at 4:30PM on 10-6-10. At 08:00PM he developed many symptoms including a fever of 101 degrees, headache, joint pains, back pain, mucus production, and some breathing problems.
Headache, violent chills, low-grade fever, nausea, and whole-body hives, which I still have
First injection was 01/06/2019 and second injection was 03/09/2019.  Starting 04/14/2019, I started having spasms.  First strong, jerking spasms in my abdomen.  Then they started happening all over my body at varying intensities (jerk, twitch, flutter).  They usually happen when I'm resting or sleeping, but can happen any time. They usually happen quickly (one to three times) and then stop.  Spasm intensity has been improving over time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 63 years, in left arm 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 had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
fever of 103 for 28 hours, with continued redness of injection sight, 48 hours later started wheezing, gasping for breath and coughing continued for 36 hours (present) was seen in ER on 8/17/09 and given steroid to open airways
Pt devel arthralgia of neck & shoulders approx 22JAN92; rotation of neck dec to one half nl; sx peaked in severity @ wk 3; pt is almost back to nl w/95% recovery; no tx given;
On the day of the injection, 3 hours after I felt very lethargic, my pupils dilated, body felt incredibly tired, headache for 3 days to follow. Redness and irritation at injection site however that could have been the bandaid  2/11 - Itchy arm, bump/nodule under skin, pain when you touch bump
Day following vaccine, woke to very sore arm, fatigue, headache.  Hour after waking - chills, low grade fever,  and exhaustion, nausea.  Slept for 3 additional hours then woke with very little appetite and extreme fatigue.  Took Tylenol for headache... ate small lunch.  Did not move for the duration of the day at small dinner  & had multiple mugs of herbal tea throughout the day, then took additional Tylenol to take pain away before going back to bed for the evening.  Following day - 1/2 energy, mild pain at site of injection, some nausea in the morning.  Noticed a mild rash across entire chest and stomach, though no pain or discomfort.  Day three I felt back to normal.
Symtoms began approx. 6 days following vaccine.  Symtoms include straining cough, fever ranging from 100.2-103.3, general fatigue.  Ibuprophen 200mg. 4-6 times to help reduce fever.  Ice applied to head and neck to hel lower temperature.
Narrative: Pt followed with Clinic Mental health for suicidal ideation. Pt died 5/19/21 via self inflicted gun shot wound. Reporting death as within 42 days of covid vaccination
Headache; nausea; injection site pain; This is a spontaneous report from a contactable 43-year-old female Other HCP reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EU9231), via an unspecified route of administration on 18Jan2021 at 09:00 am in left arm as single dose for covid-19 immunization. The patient's medical history and concomitant medications not reported. Historical vaccine included bnt162b2 on 28Dec2020 (lot number=EJ1685, vaccine location-left arm, dose number-1, administration time-09:00 AM) for covid-19 immunisation. On 18Jan2021, the patient experienced headache, nausea, and injection site pain. The patient did not take treatment for the events. The outcome of the events was recovered on an unknown date.   Follow-up attempts are completed. No further information is expected.
Extra doses given. 3ml instead of 0.3ml. Reported to Poison Control, representative of which is filing this report.
WITHIN AN HOUR, TOTAL BODY ACHE, BAD HEADACHE, START OF FEVER CLIMBING TO 105.1 8 HOURS AFTER DOSE ADMINISTERED, DROPPING OVERNIGHT TO 101.1 BY 8AM NEXT MORNING.  DURING THE INITIAL PHASE BODY ACHE, HEADACHE AND CHILLS.
Sick on the stomach; Heart was racing at times; Sweating a little; Bad headaches; Feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick on the stomach), HEART RATE INCREASED (Heart was racing at times), HYPERHIDROSIS (Sweating a little), HEADACHE (Bad headaches) and NAUSEA (Feeling nauseous) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Sick on the stomach), HEART RATE INCREASED (Heart was racing at times), HYPERHIDROSIS (Sweating a little), HEADACHE (Bad headaches) and NAUSEA (Feeling nauseous). At the time of the report, ABDOMINAL DISCOMFORT (Sick on the stomach), HEART RATE INCREASED (Heart was racing at times), HYPERHIDROSIS (Sweating a little), HEADACHE (Bad headaches) and NAUSEA (Feeling nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported. Treatment information were not provided.
PT presented to ED after a fall admitted 4/8/21. SARS-COVID-19 resulted positive 04/09/21 00:42. Patient surpassed the two week post vaccination. Pfizer dose 1 Lot EL0140 received 1/15/21, dose 2 received 2/22/21. PT documented to be asymptomatic
24 hrs p/immun w/HIBTITER devel low grade fever; redness, swelling & induration @ inject site measuring;
Two days later participant woke up with a lot of pain and swelling in left arm. Also had Lymph node swelling. Next became very lightheaded and dizzy. Oxygen level dropped.