chrisvoncsefalvay/vaers-outcomes huggingface dataset:
clogged ear; vertigo; tinnitus; Muscle fatigue; Unable to unplug hair dryer/ debiliatting enough to disable from walking, sitting upright, or even eating; vomitting; dizziness; injection site swelling; weakness; giant bump on injection site; Fever; chills/ shivering; muscle aches; headache on top of the head; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), VACCINATION SITE MASS (giant bump on injection site), DIZZINESS (dizziness), EAR DISCOMFORT (clogged ear) and VERTIGO (vertigo) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was given by the reporter.  Concomitant products included VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (weakness), VACCINATION SITE MASS (giant bump on injection site), PYREXIA (Fever), CHILLS (chills/ shivering), MYALGIA (muscle aches), HEADACHE (headache on top of the head) and VACCINATION SITE SWELLING (injection site swelling). On 27-Mar-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced EAR DISCOMFORT (clogged ear), VERTIGO (vertigo), TINNITUS (tinnitus), MUSCLE FATIGUE (Muscle fatigue), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to unplug hair dryer/ debiliatting enough to disable from walking, sitting upright, or even eating) and VOMITING (vomitting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (TYLENOL COLD + FLU SEVERE) at an unspecified dose and frequency. On 08-Feb-2021, ASTHENIA (weakness), VACCINATION SITE MASS (giant bump on injection site), PYREXIA (Fever), CHILLS (chills/ shivering) and MYALGIA (muscle aches) had resolved. At the time of the report, DIZZINESS (dizziness), EAR DISCOMFORT (clogged ear), VERTIGO (vertigo), TINNITUS (tinnitus), MUSCLE FATIGUE (Muscle fatigue), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to unplug hair dryer/ debiliatting enough to disable from walking, sitting upright, or even eating), HEADACHE (headache on top of the head), VOMITING (vomitting) and VACCINATION SITE SWELLING (injection site swelling) had not resolved.            This case was linked to mod-2021-090644 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: The Significant Follow up Information was received on 22-APR-2021.Events are updated. Patient demographics are added.  First dose information was added.
This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M005714, expiry: 03-OCT-2017; lot # L043214, expiry: 30-AUG-2017; lot # L026602, expiry date: 19-OCT-2017). The vaccines were exposed on following dates: 10-AUG-2016 at 28.9F for 3.8 hours, 11-AUG-2016 at 31.8F 1.7 hours and 26-AUG-2016 at 31.F for 3.75 for 3.75 hours. They were logged by a data logger and there were no prior excursions. Medical assistant reported that she has not been informed of any adverse effects. This is one of the three reports from the same reporter. Additional information has been requested.
Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, hands are swollen and have a spotted look on the underside.  Tried taking over counter meds, nothing is helping with pain.
I started to notice a tickle in my throat on 5/21. The next day I started to feel achy and developed a cough. My husband had tested positive for Covid a week before, so I did an at home Covid test on Sunday morning and it was negative but I felt achy all day so I went ahead and took another home test on 5/23 and that was positive. On Sunday, I began taking some vitamins, a B complex, vitamin D, vitamin C, zinc, and vitamin K on the advice of my husband who is a doctor. He also called a prescription in for prednisone and a Z-pak. Due to my small size, he advised that I start with a lower dosage of prednisone. On Tuesday, my symptoms began to subside and I was gaining energy. By Friday, the only symptom I was still experiencing was an occasional cough.
This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not provided. The patient inadvertently received SHINGRIX via subcutaneous injection, which led to inappropriate route of vaccination. No further information provided. The reporter preferred not to provide further information at the time of reporting.
Administration Error:  Patient is 17 years, 11 months, under 18 at administration
Pfizer Bivalent Covid-19 vaccine vial was first punctured on 05/23/2023 (unknown exact time) and left overnight at room temperature (up to 30 hours) with 1 dose remaining in the vial. The pharmacist-on-duty withdrew the last dose in that vial on 05/24/2023 and administered to the patient on the left arm. The pharmacy manager already contacted Pfizer manufacturer regarding the stability and safety of the COVID-19 bivalent vaccine and is currently waiting for the manufacturer's decision. The staff pharmacist already contacted patient on the following date regarding the incidence.
The morning after the vaccine, despite sleeping on my right side, I woke up with my vaccine arm (left) numb and tingling all the way down to the fingertips. It's a "pins and needles"-y feeling. The vaccination site itself wasn't unusually painful. The pins and needles feeling has diminished somewhat over the past three weeks but continues. It is not exactly painful and it does not affect my movement; it is more weirdly uncomfortable.
DTaP, Varicella given in left arm. HPV and Meningococcal given in rt. arm on 8-11-08. Presents on 10-22-08 with atrophy of left arm noticed very recently.
1st dose 08Sep2020, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 8th September 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments:  The reporter reported that a patient was late for the second dose.  The HCP did not have the lot number or expiry date.  The reporter was consented to follow up via email. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.  This case is linked with case US2023021215 reported by the same reporter.; Sender's Comments:  US-GSK-US2023021215:Same reporter.
Information has been received from a company representative and a nurse concerning a 11 year old female who was vaccinated with a 0.5 ml dose of Gardasil. The patient developed a fever and missed at least one day aft school. The interval between administration of the vaccine and the onset of the fever is unknown. The nurse mentioned that the patient also received four additional injections at the same office visit. Subsequently, the patient recovered from the fever. Unspecified medical attention was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a nurse and a physician concerning a 12 year old female who had no illness at the time of being vaccinated. On 10-APR-2007, the patient was vaccinated with a first dose of GARDASIL (lot # 656049/0187U) 0.5 ml, IM in the right upper arm. Also on 10-APR-2007, the patient was vaccinated with a first dose of ADACEL (lot # C2688AA) IM in the left upper arm; a first dose of VAQTA (MSD) (lot # 656993/0001U) IM in the right upper arm; and a first dose of MENACTRA (lot # U1922AB) IM in the left upper arm. On 11-APR-2007, at HS, the patient developed a fever for 24 hours. The patient sought medical attention. She also experienced a headache which was not resolved with MOTRIN and missed school on 12-APR-2007. On 13-APR-2007, the patient recovered. No additional information is expected.
Patient presented to pharmacy 3 days after immunization asking for an evaluation on her arm. Her arm was visibly bruised with a localized erythema around the injection site. She stated that the reaction started the day after receiving the injection. The skin was warm to the touch where red, and painful. She stated the pain had not improved, nor worsened since the onset, and no other symptoms had appeared since the onset of symptoms.
Late/Irregular period; This is a spontaneous report from a non-contactable consumer (patient). A 21-years-old female patient received bnt162b2 (BNT162B2) at the age of 21-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 23May2021 (Batch/Lot Number: TW0187) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 (Batch/Lot Number: TW0196) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient medical history was not reported. The COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced late/irregular period on 2021 with outcome of unknown. Reported Event: Late/Irregular period (she had tracked period for years, so she can tell when it should have come, and that there are no other factors that would cause this sudden change). No treatment was received. The report was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts possible. No further information expected. Information about batch number has been obtained.
Received DTAP and HEP A #1 in left thigh on 11/09-on  11/12 developed urticartial papular rash mostly left leg and low grade fever.
Presented emergency department with difficulty ambulating on 2/23/22.  Reports having multiple falls, over the last 2 days associated symptoms include multiple episodes of hypoglycemia. in the emergency department  On admission patient was found anemic; hyponatremia (132); hypoglycemia (37-44-55-73); elevated kidney function; elevated troponin; transaminitis; CT of the brain on 02/23/2020 to admission showed small subdural hemorrhage along margins in the right cerebral tentorial leaflet. Old compression fracture at T12.  Chest x-ray shows normal single-view chest x-ray.  Pt tested positive upon transfer screening for Rehab 2/25/22. Pfizer 2/17/21 & 3/11/21
patient received expired dose of the monovalent vaccine instead of Bivalent booster; No adverse event; patient received expired dose of the monovalent vaccine instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster), WRONG PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster), WRONG PRODUCT ADMINISTERED (patient received expired dose of the monovalent vaccine instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   The vial was initially stored in the refrigerator on Nov 29 2022. The vial did not undergo any temperature excursions. HCP realized that the vaccine that was intended to be given was the bivalent booster, but the patient received expired dose of the monovalent vaccine. All other details of the expired dose given was accurate. HCP mentioned 2 adult patents received the expired vaccine.   This case was linked to MOD-2022-682308 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live Follow-up  Significant information accepted : Added event and updated narrative
This case was reported by a physician and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received primary course of Hepatitis B vaccine (dosing was not specified). It was indicated that the subject received a "series", however, the reporter was not sure if the series was Engerix-B or another manufacturer's product. The series was not given in the reporter's office. The subject was not responding to therapy (negative titer test). No additional information is available.
Red, itchy, small cucumber-sized swelling at site of injection 3 day after administration. Applied hydrocortisone cream.
This spontaneous report as received from a Licensed Practical Nurse (via company representative) refers to a patient of unknown age. On  09-JUN-2016 the patient was inadvertently administered an expired dose of VARIVAX (Lot # K007976, Expiry date: 03-JUN-2016) subcutaneously (expired product administered). No adverse effect report. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
bronchospasm, angioneurotic edema upon arrival to clinic @ 254PM;DPH given;
itchy; Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (Rash all over body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRURITUS (itchy) and RASH (Rash all over body). At the time of the report, PRURITUS (itchy) and RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were provided.  No Treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non Significant- TCR attached.
215PM MMR given 220PM pt in waiting room, c/o nasal stuffiness; 230PM c/o watery eyes nasal congestion, choking feeling, local redness & swelling @ inject site; No wheezing or obvious tongue swelling; Epi, DPH given;
PFIZER-BIONTECH COVID-19 VACCINE EUA.    PATIENT REQUESTED ADMINISTRATION OF MIXED SERIES DUE TO EXCEPTIONAL CIRCUMSTANCES.  PATIENT RECEIVED 1ST DOSE OF COVID-19 VACCINE WITH MODERNA PRIOR TO BEING ADMITTED TO NURSING FACILITY.  PATIENT CANNOT BE TRANSPORTED ELSEWHERE AND ONLY PFIZER COVID-19 VACCINE AVAILABLE TO COMPLETE SERIES.
Patient reports pain at injection site and continued pain and soreness of muscle. Arm muscle is still hurting 6 weeks after injection. Has seen primary physician but has not received any treatment.
Approximately 3 cm area of redness, warmth around vaccination site with 3-4 smaller similar areas extending 3-4 inches distally on right upper arm. No fever, pain or systemic symptoms. Mildly pruritic.
Child (2 mo) adm. expired dose of ROTATEQ on 12-30-10 per order of Dr. parent to be called for redose 4 wks later on 1-30-11 or after.
Patient was administered his second HPV vaccine today and directly after the injection, patient turned pale in the face and said he didnt feel good. He lied down on table for approximately 15 minutes and then he said he felt better and he had color back in his face. The provider took his blood pressure and released him, telling the mother to call us if he started feeling bad again, got a fever or a local reaction such as swelling or swelling.
angioedema by hx, later devel urticarial types of diffuse erythema;eye swollen then somnolence;mom felt poss sz;then pt spazzed & jerked & stiffened briefly;poss allerg rxn to vax;
Medication error: The patient's first vaccine was Moderna but received Pfizer for the second dose.
This spontaneous report was received from a nurse practitioner concerning a 22 months old patient of unknown gender. The patient's historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patient was inadvertently vaccinated with a dose of PROQUAD reported lot number R002932, expiry date 29-JUL-2019 (strength, dose and frequency were not reported) and VARIVAX (strength, dose, route, frequency, lo number and expiration date were not reported) both vaccines for prophylaxis (Accidental overdose). It was also reported that the patient's sibling was vaccinated on the same date with the same vaccines (refer to case 1809USA008265). The nurse practitioner reported that it was a medication error as well as a product confusion (Product appearance confusion). She stated that the PROQUAD was confused with M-M-R II, and that "the nurse who administered these vaccines did not realize that the PROQUAD (MMRV) was not M-M-R II, as the PROQUAD also contained measles mumps and rubella" (Wrong drug administered ). It was unknown which dose in the measles mumps rubella and varicella vaccination series the dose of PROQUAD or VARIVAX was. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1809USA008265: Patient's sibling.
24 hours, post vax, had rash on arms and legs. Had low-grade temperature, later on 8/11/00. Lethargy and no oral intake from 8/16/00 to 8/18/00. IV hydration in ER on 8/18/00 AM. Still has rash on neck and back.
No adverse effect.  Patient potentially received Moderna COVAX 0.5 mL versus the correct dosage of Moderna COVAX 0.25 mL. The Moderna COVAX 6mos to 4yrs old is clearly labeled as ?0.25 mL single dose vial? however I did the investigation and found that the single dose vials we have on hand indeed have 0.5 mL inside of it.
Gave 2nd Hepatitis A vaccine 3 months too early. No problems noted to patient.
Shortness of breath. Throat tightening. Dizzy. Patient called covering MD. Told to go to ER with worsening symptoms.
Swollen lymph glands under left arm (same as shot). Went to physician who prescribed Naproxen.
Vaccinated with MMR for neg. Rubeola titer (7/12/16). Reported hives/itching 30 minutes after vaccine up to 4 days. Self-medicated with BENADRYL and ZANTAC. Sought medical attention on 9/24/16 in local ER due to rash and fever. Diagnosed by ER MD and Health Dept with adverse reaction to measles vaccine. Subsequent Rubeola IgG neg. on 9/30/16, 10/4/16. IgM negative 10/4/16. Rash subsided by 10/4/16.
Diarrhea; Urinary tract infection; Weakness; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), URINARY TRACT INFECTION (Urinary tract infection) and ASTHENIA (Weakness) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No Adverse Events.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 21-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), URINARY TRACT INFECTION (Urinary tract infection) and ASTHENIA (Weakness). At the time of the report, DIARRHOEA (Diarrhea), URINARY TRACT INFECTION (Urinary tract infection) and ASTHENIA (Weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   there is no lab data given by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Email response
Outbreak of itchy bumps from wrist to elbow on both arms about 8hrs after shot. Rash is still there after 30hrs but itching has subsided.
(L) deltoid area shot given. Pain and limited range of motion 1 month later.
Breakthrough case admission after 4 vaccines Moderna 1/48/21 Lot# 039K20A;  Moderna 2/1/21 Lot# 012L20A;  Moderna 11/10/21 Lot# 013F21A;  Modern a4/27/22 Lot# 056A22A
"been in bed all day"; nausea; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ("been in bed all day"), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure management, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced MALAISE ("been in bed all day"), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE ("been in bed all day"), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.