chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of inadequate dose as they screwed on the needle tight but when they administered, a good amount squirted out the space where the needle was attached with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves 69 years old female patient who had administration of inadequate dose as they screwed on the needle tight but when they administered, a good amount squirted out the space where the needle was attached with no reported adverse event while receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Sep-2023, the patient received a total dose of suspect influenza quadrival A-B high dose HV vaccine (formulation, strength, dosage- not reported) (lot U8132DA, expiry date- 01-JUN-2024) via unknown route in unknown administration site for Immunization.  On 29-SEP-2023 the patient had administration of inadequate dose as they screwed on the needle tight but when they administered, a good amount squirted out the space where the needle was attached with no reported adverse event (incorrect dose administered) (latency- same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Pharmacist wants to know if there are any guidelines regarding revaccination FLUZONE HD QIV  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 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.
17 y/o female presents to er with cough, sore throat, headache and tactle fever at home since Friday, pt reports her mother tested positive for covid 19 yesterday. Today pt lost her taste. She denies sob. Pt has received covid 19 vaccinations
Two days after receiving the vaccine I awoke with major pain in my right big toe. It was swollen so badly I could not put on a pair of flip flops the swelling was cutting into my toes so badly. I waited two days before I contacted my doctor hoping the swelling would go down. I started reading and found that vaccines could cause gout. Once I went in to see my doctor, he did take x-rays to make sure I had not broken any bones. He did say I had gout, prescribed a methylprednisolone dose pack. The medication has started to help to alleviate the pain.
A spontaneous report was received on 17DEC2014 from the father of twins (age not provided) (see MARRS case # 1412USA009006 for second case) regarding a dose of PEDVAXHIB. The father reported "my twins were scheduled to receive their second dose of PEDVAX today but they were given both the second and third dose during the same visit and not with 2 month in between like the product literature says." No adverse effects were reported. The father made no mention of the first dose of PEDVAXHIB. The father reported he spoke with the physician. The father did not wish to provide specific information. No further information was provided. Additional information is expected.
Received 2nd dose Pfizer lot EL0142 in right arm on 1-13-2021.  Employee is experiencing body aches and cramping all over.
Patient was given high dose Fluzone (0.7mL) when under the age of 65 and should have been administered normal dose (0.5mL).
Patient stated that within two hours of receiving the Hepatitis B vaccination, she started having back pain. Symptoms later progressed to headache, generalized body ache, shaking chills, heartburn, nausea and vomiting. Advised to continue Ibuprofen and given prescriptions for PHENERGAN.
Four days after flu vaccine I had flu like symptoms followed by burning/pain in chest/back. I was diagnosed with espohgus erosion. The pain worsened and spread to right shoulder blade and right upper arm. The pain in my chest was so intense I thought I may be having a heart attack. I visited the local EMS office, they stated my heart rythms was good. I called my health care provider telling her I thought something else may be wrong. She acted though I was bugging her but, she ordered ultrasound on my belly. When she contacted me with results she said she was sticking to her diagonals. Within three days of talking to her I broke out with the shingles rash. This is the sickest I can remember being. Awake almost three nights now with intense pain.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. Over approximately the last 2 months, approximately since August 2013, on unspecified dates the patients were received improperly stored VARIVAX (Merck) injection subcutaneously (dose, frequency unknown, lot # H021799 was not valid for VARIVAX (Merck), expiration date 07-DEC-2013 that was exposed to "23 Fahrenheit since it was received in the facility about 2 months ago". No know adverse effects were reported. Additional information has been requested.
He is a 82 y.o. male patient of DO with history of past medical history of CAD status post stenting, BPH, hypertension, insulin-dependent type 2 diabetes mellitus, GERD, chronic tremor (on chronic primidone), and heart failure with preserved ejection fraction.  He is admitted on 12/14/2022 with generalized weakness and cough, found to be COVID-19 positive in ED.   Covid-19 Virus Infection: Date of onset of symptoms: 12/13/2022 Symptoms present on admission: Cough, decreased appetite, weakness Date of covid positive test: 12/14/2022 Imaging: Chest x-ray 12/14/2022 without acute disease Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: Steroids not indicated, started on Remdesivir -treatment completed Consultants following: Infectious disease consulted-will follow outpatient in 2 weeks Anticipated special isolation end date: 12/24/2022 T-max 101.8, afebrile for 48 hours   Mucinex 600 mg BID  Continue Remdesivir day 5/5 - completed Sputum Cx-negative Blood Cx-no growth  AKI on CKD Dehydration Diarrhea-resolved  Baseline creatinine 1.4-1.5, suspect most likely prerenal in the setting of COVID-19 illness, diarrhea, and decreased oral intake Creatinine 1.61-- >1.72-- >1.61-- >1.57-- >1.42->1.34 >1.30>1.31 Trend chemistry, avoid nephrotoxins  Generalized weakness: Fall Trauma survey in the ED including CT cervical spine and CT head without acute pathology.  Suspect generalized weakness due to COVID-19 illness PT/OT consulted, Low AM PAC score, continue therapy  Case manager consulted to assist with discharge needs Management of COVID-19 as above.  Hypertension: Hold home lisinopril and hydrochlorothiazide in setting of AKI Continue home metoprolol, amlodipine, and Imdur. Will increase Norvasc to 10 mg daily at this time, hold metoprolol, patient has been having elevated blood pressure readings with low heart rate, if kidney function stable tomorrow can likely resume home Lisinopril    Chronic normocytic anemia: No signs of bleeding on admit. Iron studies show iron deficiency  Will Start Iron supplementation  Chronic tremor: Continue home primidone  Insulin-dependent type 2 diabetes mellitus: Hold home glimepiride in the setting of AKI Home glargine reduced to 15 units from 30 given acute illness and decreased intake Sliding scale insulin Glucose stable   GERD: Continue PPI  CAD status post stenting: Heart failure with preserved ejection fraction Warm and dry on time of admission without signs of acute decompensation Continue home metoprolol Continue home Plavix and statin Not on home diuretic
Patient reports pain in both thumbs, both wrists, both rotator cuffs, back, both thighs near groin and both hip bone areas. Patient has a history of bilateral torn rotator cuffs. Patients reports no decrease in pain since vaccine administration. Patient has been suffering from pain since the vaccine administration, difficulty sleeping and working due to pain.
Fever. Had fever dreams that I was gnawing on a severed human head, then walking a pet pig.   Sweating, and the sweat was thick and greazy. My face felt like wax.   Total energy depletion. Malaise. Fatigue.   Loss of sense of time.    Confusion. I thought I was a fly on a head.   Muscle pain all over.   Took aspirin and ibuprofen. Drank pineapple juice. Ate soup.
8/8/21: Presents to the ED with 4-day complaints of progressive shortness of breath with associated generalized body aches, fatigue, weakness, fever and chills.  Patient endorses that he lives alone and he is unable to take care of himself under this condition.  He can barely get out of bed without gasping for air. Upon ED arrival, patient was febrile, tachypneic, tachycardic, hypoxic, and was put on a nonrebreather with improvement of O2 saturation. Upon eval, patient tested positive for COVID-19 following admission.  Of note, patient received Pfizer COVID-19 vaccine, last dose administered in March 2021.  8/16/2021: Patient still admitted as of this report submission
Myalgia sore throat, aches Narrative:  Per pt. report: "As with the first vaccine, I am experiencing symptom of a cold but without the mucus, to include upper body aches, with the second vaccine. Not serious, however, just uncomfortable."
I started with hives about 15 minutes after leaving the pharmacy. I went to the walk  in clinic that night. My feet were also feeling weird.   The hives ere present Saturday but  we?re full blown on Saturday night / Monday morning ( about 3 am I woke up and was covered ). My feet were also tingly.  I called off work Monday and went to another doctor and received a steroid shot, and steroids to take by mouth this week. He also prescribed  oral medicine for the itching. I currently still have hives and blisters on my feet and toes.
received only the Shingrix diluent without reconstitution with powder; received only the Shingrix diluent without reconstitution with powder; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number Y37L9, expiry date 10th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the Shingrix diluent without reconstitution with powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case had been linked with US2021126507, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021126507:Same reporter
Patient received Menquadfi vaccine at approximately  9:35am.   Vaccine received well and patient voiced relief she had gotten it over with and it was not as bad as she thought it would be.  She walked out of clinic room and down hall where record was given without difficulty or complaint.  Once patient in waiting room with stepmom, they stopped to get  a drink out of Coke machine and patient  stated to stepmom she was feeling dizzy.  Stepmom states before she can ask her any further questions or turn around from getting drink from machine, patient falls to the floor hitting her as she was faced away from her.  Staff was seated in clerical area and heard fall, looked up and noticed patient on floor. Staff had clerk call for help. All of this occurring at 9:40am.  When nurses arrive out to lobby, patient is lying face down on floor unresponsive initially but breathing.  Patient was gently log rolled onto back.  First vitals at 9:41am,  BP 102/56. Patient pale and bruising noted to left side of face as well as bleeding noted to left upper and lower lip. Patient slowly began to open eyes.  BP at 0946 110/60.   Slowly raised up to a 45 degree position but rested against nurse, being unable to hold herself up.   Patient did become more responsive and verbal.   Asked patient what she had for breakfast and quietly responded that she had cereal and the kind of cereal she had.  Pulse at 0951 -76 slightly weak but regular.  BP at 0952 106/58.   Continued to support patient in seated position and patient was verbal when asked questions but kept eyes only slightly opened and closed most of the time.  0958 called patient's pcp and spoke with staff giving all details of episode thus far. He suggests to have patient evaluated at ER since patient did hit her head.   Stepmom present and agrees this is what she wishes as well.  BP at 0956 122/70 and pulse strong and regular.  Patient remains  verbal, but only when spoken to, and supported to sit by nurse. Patient's left leg began to shake and patient verbalizes she felt she was shaking all over as well.   Ambulance notified of need for transport for further evaluation at 1001 and arrives by 1006.  Verbal report and form copy given to ambulance personnel.  Patient transported via ambulance at that time for further evaluation.
It was reported that a 17 month old female pt received a Tripedia vaccination on 4/4/01. Reportedly, that same day, the pt developed a local reaction of swelling, redness and ecchymosis. Physician dx'd as cellulitis and treated with Augmentin.
A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporters causality assessment. Follow up pending.
Patient noticed red area and heat at injection site. The red area is approximately 4" x 6" on arm encircling the injection site.  Patient says if area does not clear in a couple days she will go to the doctor.  No treatment at this time.
a bit of a headache for the second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization and experienced slight swelling. The patient had taken both doses of the Pfizer COVID vaccine and did not experience any side effects like the everybody else. She stated that she is concerned since everyone she had talked to who received the vaccine experienced some kind of side effects (fever, chills, body ache) and was wondering if the vaccine might not be working. She only experienced a bit of a headache for the second dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Upon administering the typhoid vaccine (which was the second vaccine being given in the arm that day following the flu vaccine) the patient began to lean forward in her seat toward her lap. It appeared she was in the process of fainting. When her upper body approached her laps she began to jerk as though she was having a mild seizure. Her mother held her upper body up while calling out to her for a response. When she regained consciousness she couldn't remember what happened because she asked "what happened?" She then said that her belly hurt. Her mother then sat her on her lap for a few minutes and then carried her out of the pharmacy to take her to a clinic for an evaluation.
pt recv vax 25AUG97 & 28AUG97 pt exp tremor, resting & intentional tremor of rt upper extremity & dec strength in that extremity;
Approximately 9 pm on 5/15/00 upper left arm began to turn red and swell at injection site. Swelling became worse today on arm from elbow to shoulder red, painful and swollen. Unable to use left arm. Denies fever at this time.
Information has been received from a physician concerning a 12 year old female who 3 years ago, in approximately 2000, was vaccinated with a dose of varicella virus vaccine live. On 10/31/03 the physician reported that two days ago the pt was brought in with a breakthrough varicella rash. It as noted that the pt did not have a fever but she did have 25 lesions that itched. The pt was given with acyclovir to treat the varicella.  A product quality complaint was not involved. Additional information has been requested.
I have a son in law who took the Vaccine and almost died from it; This is a spontaneous report received from contactable Consumer or other non HCP for a Pfizer sponsored program (149602).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant, life threatening), outcome "unknown", described as "I have a son in law who took the Vaccine and almost died from it".  The lot number for bnt162b2 was not provided and will be requested during follow up.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Received 5 Engerix-B vax. @ 1st 3 doses "grossly overweight" now normal wgt. Did not develope HBSAB titer. Second booster given but was delayed because underwent a cholecystectomy.
Swelling in left cornea transplant. Noticed decrease in vision over 2 or so weeks, doctor confirmed May 7, 2021.
14APR92 mom called MD office pt exp shaking exp & r/o sz, getting EEG & tests; no pertussis till further notice; MD does not think vax related per MD office;
Noticed large lump near left breast, underarm area. Reported to my primary care dr. on July 13. Dr. referred me to surgical specialist for a consultation, appointment on August 4 2021. Surgeon referred me to the breast center for a mammogram and ultrasound of the area.  I had already had my routine mammogram earlier in the year.The technician asked me for the dates of my covid vaccines and what arm I had them in. After giving her the information, she said that my lump was a reaction to the vaccine and that they had to report it as such because others were having this reaction. Sept. 13, 2021 had an appointment with breast surgeon who read my report and all is fine. The lump could be a reaction to the vaccine. No further treatment needed
Arm: intense local soreness lasting 3 full days, minor residual soreness 4th day. Fatigue; intense feeling of cold including ice cold hands and cold feet despite warm indoor temp and full assemblage of layered clothing (my body temp measured 98.4º; and chills (the risk advisory form refers to "shivering", a term I've never used). These lasted 3 full days, then abated on the 4th day.
Within minutes after receiving Prevnar #1, mom noted child's right temporal and parietal regions of scalp pale and dusky. No changes in behavior. Rest of physical exam normal. Mom had child in clinic for around one hour. No further changes. Decided to home with consultation with newborn ICU.
This patient received 2 Flu vaccines in the month of November.  One Flu vaccine was administered 11/02/2023 and the other Flu vaccine was administered 11/15/2023.
No additional AEs reported; a patient was administered PNEUMOVAX 23 that expired on 01JUL2021.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies was provided.  On 13-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in prefilled syringe, lot #S034299, expiration date: 01-JUL-2021, 0.5 milliliter (injection site and route of administration were not provided) for prophylaxis (expired vaccine used). No additional adverse events were reported.
sickness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 ILLNESS (sickness). At the time of the report, ILLNESS (sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), on Mar 26, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), for COVID-19 immunisation. The patient had lymphadenopathy/swollen lymph nodes, onset Mar 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This spontaneous report as receive from a other health professional refers to a 61 year old female patient. On 29-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot # unknown). Other suspect therapies included (Oka/Merck) VARIVAX. The patient was scheduled to receive her second dose of (oka/Merck) VARIVAX on 29-OCT-2014 but received a dose of ZOSTAVAX. The healthcare worker believed that the error occurred because the patient is of the age-range to receive ZOSTAVAX, and the error probably did not occur due to medication confusion. The patient had not reported or demonstrated any adverse effects. The outcome of events was unknown. Product quality was not reported. Additional information has been requested.
Pain and swelling in arm and lymph nodes under arm.  Chills and body aches next day. Including a  slight headache and back ache.