chrisvoncsefalvay/vaers-outcomes huggingface dataset:
off label use due to--inappropriate age for the product as per local labelling (with no reported adverse event); Initial information received on 31-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and this condition is off label use due to--inappropriate age for the product as per local labelling (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 MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) both for Immunisation.  On 30-Sep-2022, the patient received 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml dose 5 of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (Strength: standard) (Frequency: once) (lot number: U7526AA) (expiry date: 07-sep-2024) via intramuscular route in the left deltoid for Immunization or TB skin test. and this condition is off label use due to--inappropriate age for the product as per local labelling (with no reported adverse event) (product administered to patient of inappropriate age) (latency: same day).   Action taken: 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.
Pt. felt light headed and dizzy. Upon observation, she was pale and forehead was clammy.
Chest pains occurring about 27 hours after the vaccine. About 5 sharp pains, a few more less sharp ones. Pains stopped after about an hour. Had some subsequent lightheadedness.
Following the shot, my period completely stopped. By age 14 I had cysts rupturing on my ovaries and was hospitalized to determine what my pain was coming from. My period did not come back fully, but rather very lightly throughout the years. About 1-2 periods per year.  Garadsil is the reason I have PCOS!
Reports right deltoid, at site of Hep-B vaccine, fibrillated, starting 2 hours, post vax, until bedtime. By evening of the same day, she received vaccines, she noted "feeling of warmth" radiating down her spine, accompanied by arthritis-like aching. Her spinal discomfort disappeared after 1 week. The leg sensation persists and on 4/16/00, appeared also in right leg. The tendon under her right knee cap ached for 1 day, post vax.
During a review of the Local Health Dept. internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
pain at injection (left); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection (left)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at injection (left)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (pain at injection (left)) outcome was unknown. Not Provided          no concomitant medication provided.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Contact details updated.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included she thought it was her allergies, as it as starting to get bad in state. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 rapid POC test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. The case was associated with a product quality complaint number: 90000174423 The suspected product quality complaint has been confirmed to be voided: does not meet PQC criteria, based on the PQC evaluation/investigation performed.; Sender's Comments: V1: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
right upper arm was sore; awake from 1:30 AM until 3:30 4AM; This case was reported by a consumer and described the occurrence of pain in arm in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and sleep disturbance. On an unknown date, the outcome of the pain in arm and sleep disturbance were unknown.   It was unknown if the reporter considered the pain in arm and sleep disturbance to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. On 18th June 2020 at 11AM the patient received the Shingrix. On the same night, the patient experienced right upper arm was sore, the patient slept on stomach. The patient normally sleeps at 9 to10 hours per day with no issues. The patient awakes from 1:30 AM until 3:30 to 4AM. Could this be drug related, as it was not a listed side effect.
Onset of symptoms on June 15, 2021, shortness of breath, tightness in lungs, swelling and pain in right calf . Symptoms grew progressively worse over following week. June 24 ? extreme difficulty breathing, loss of consciousness. Ambulance to emergency room. CT Scan at ER revealed dual branch pulmonary embolisms.  Emergency Thrombectomy. Multiple blood clots between 1 and 6 inches long removed from both branches. Anticoagulants prescribed for one year and assisted oxygen.
Symptoms started the morning after (12/29/2020), the injection site is very sore. Sudden onset of headache.
cerebral blood clot three months after the Pfizer Covid Booster.; memory fog; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "memory fog"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "memory fog". The following information was reported: CEREBRAL THROMBOSIS (medically significant), 3 months after the suspect product(s) administration, outcome "unknown", described as "cerebral blood clot three months after the Pfizer Covid Booster."; MEMORY IMPAIRMENT (non-serious), outcome "recovered", described as "memory fog".  Clinical course: Patient had three Pfizer shots and no issues except some memory fog that lasted 6 weeks and then was gone. The patient developed a cerebral blood clot three months after the Pfizer Covid Booster. Stroke team of cardiologists and neurologists narrowed down the cause of the blood clot to the mRNA vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300013179 Same reporter, same patient, same product, different dose, different event.;
The next day 03/14/2021 I started having soreness and achiness in the morning.  About a 3 months later (June) I started having problems with my heart but it wasn't directly after I had my vaccine. . I did see a Doctor about my heart and they put my on a heart monitor and I haven't gotten any results from it yet. I did have a-fib one night. I have appointment with cardio tomorrow 06/25/2021. I thought it was odd because I never had a-fib before and now all of a sudden I do.
This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, feelings of weakness and fatigue. On an unknown date, the outcome of the fever, feelings of weakness and fatigue were unknown. It was unknown if the reporter considered the fever, feelings of weakness and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient was over 50 years. The age at vaccination was not reported. The patient experienced a feeling of weakness, fatigue and feverish. This event ran into the next day and the patient missed work as a result. The reporter agreed to follow up if necessary.
Patient awakened with a c/o sharp substernal chest pain 5/10 in intensity and shortness of breath and some lightheadedness. He was admitted to the hospital for less than 24 hours and was discharged on NSAIDs and Colchicine. Symptoms rapidly resolved over the next few days and patient denies any recurrent or prolonged symptoms.
I received the pfizer COVID vaccine Wednesday 12/16. I noted an erythematous raised warm painful confluent blanching rash on 12/18.   So far I have not has SOB, fatigue, N/V - any other systemic sx.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07May2021 11:35 (lot number and expiration date not reported) as UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer COVID-19 vaccine yesterday (07May2021) on 11:35 and the patient wanted to report some possible side effects, after that last night (07May2021), the patient's body temperature got a little bit up, but there was no problem, then this morning (08May2021) at about 5:00 am, the patient suddenly felt uncomfortable so, the patient got up and went to the bathroom, and then the patient suddenly felt like the patient's body temperature kind of dropped and the patient just felt like the patient was going to faint, and then according to the patient, "I found myself, I possibly loss conscious, I am not sure but I found myself on the bathroom floor. And then after 7 minute I just felt fine again, but it was kind of that the body temperature suddenly dropped and the I totally lost conscious, I am not sure." Outcome of 'possibly loss conscious/the patient totally lost conscious' was recovered on 08May2021, while outcome of the remaining events was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Immediate intense internal heat with excessive sweating; nausea; light headed; faintish; severe dizziness.  After 40 minutes, the lightheadedness, faintish and dizziness subsided.  However, the intense heat, sweating and nausea continued.  By the evening an intense migraine started and by 4/10/21 my sister vomited and started running a fever 100.5.  Complete muscle aches, overall feeling extremely ill, totally bed ridden and a migraine that cannot be controlled at all.
day of vax flu vax devel complete flu like sxs-lasting 2 days;
R arm injection site became swollen and warm to touch, rash developed over body. Cheeks were flushed. Physician MD told to give 1/2 tsp Zyrtec and pt was observed x 30 min. Pt stable at 30 mins and sent home with instructions to cont. w/ Zyrtec 1/2 tsp QD x 2 days. 11/26/02 spoke with mom and pt cont. to be stable.
Subsequent to receiving one dose of varicella virus vaccine live and one dose of MMR the pt broke out in a rash with small, raised lesions on her arms, legs and a few on her chest and buttocks. Pt was seen by her physician.
12/27 She came in for evaluation of shortness of breath and cough and was found to be covid positive. She had a single episode of torsades de pointes. 12/28 stable at this time on nasal cannula oxygen 12/31 Sinus bradycardia in the setting of are COVID-19 and one dose of remdesivir.  Heart rate in the 40s.  Blood pressure stable 1/2 Pt seeing Rapid resolution, due to immunized status 1/3 Op: LEFT HEART CATH, CORONARY ANGIOGRAPHY  Procedure 1/4 Pt recovering well 1/7 Pt discharged ...
very dizzy since this morning, couldn''t get up from the bed; blood pressure is very low; This is a spontaneous case received from a contactable consumer (patient). A female patient of unspecified age received third dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered on 30Sep2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose and second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered on an unspecified date for COVID-19 immunization. On an unspecified date in 2021, the patient reported that she was very dizzy since morning and could not get up from her bed and her blood pressure is very low. The patient underwent lab tests and procedures which included blood pressure: blood pressure is very low on an unspecified date in 2021. The outcome of the event very dizzy since this morning and could not get up from her bed was not recovered and event (hypotension) was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Patient got really dizzy and was sweating profusely about 3 minutes after receiving his vaccine.  This lasted about 15 minutes.  He then felt cold and had the chills once he stopped sweating.  He was soaked with sweat.  I made him stay for another 15 minutes to observe him.  He felt normal once he left.
Significant sudden lost of vision on left eye.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0150), via an unspecified route of administration, administered in right arm on 30Mar2021 02:30 as single dose for COVID-19 immunisation. Medical history included remitting multiple sclerosis (MS). The patient had no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), latanoprost, timolol and glatiramer acetate. On 10Apr2021 09:30, the patient experienced significant sudden lost of vision on left eye. Previous day/night vision was normal then all of the sudden, after a week and a half from first dose of Covid-19 vaccination, vision in his left eye deteriorated 90 percent. The event resulted in disability or permanent damage. The patient did not receive therapy for the event. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.
Patient received Moderna Covid-19 vaccine after beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after beyond use date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 038c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were not provided.   This case was linked to MOD21-091094 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Patient's race and ethnicity added, second dose details added.; Sender's Comments:  MOD21-091094:Same reporter, different patient
Pt got flu shot on 9/25/15. He reported on 10/2 that he went to ER with heart palpitations and low potassium levels. Has seen 2 cardiologist, was placed on Holter monitor on 10/1/15. He went to ER on 9/30/15. He still as of 10/6/15 has heart palpitations in the AM. He wld like this incident reported but can't pinpoint if it was due to Flu shot.
Night of vaccine, minor headache and sore. Day 2 lump at the injection site and more sore. Day 3 and 4 lump lessened and some pain in the lymph nodes but did not appear swollen. All symptoms seemed to subside by day 5. On day 9 woke up to a lump, abnormal shaped redness at the injection site and extremely itchy. Day 10 the area of redness doubled. Went to the doctor. He said to take Benadryl and ice it.  Said to follow up in a couple days if worsened. Two days later it appeared to be clearing a bit and the redness had lightened. That was Friday April 2nd.  By Monday morning, April 5th, the redness had come back and the area seemed to be growing again. Went back to the doctor, seeing a different doctor in the same office. She put me on a 1% steroid cream twice a day. I am following up today because it seems to not be improving.
Rec. Vac. 4pm 10/15/2008.  At approx 8pm started having a cough with some wheezing (mild).  At 10:30pm upper lip became swollen and numb.  By 12 mn had extreme eye redness, fever, chills & generalized aches.  It resolved without treatment in 24 hrs.  Yrs. ago, had 1 episode of fever & chills 8 hr after flu vac which resolved overnight.  0 food allergies. Did not eat evening of 10/15/2008.
Fatigue; Headache; Chills; Left arm sore; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 at 18:30 (Lot number: 33030BD) at the age of 27 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP6955; Anatomical site: left arm; Route of administration: unspecified), administration date: 18Mar2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EP6955; Anatomical site: left arm; Route of administration: unspecified), administration date: 08Apr2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 18:30, outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious) with onset 03Dec2021 at 07:00, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 03Dec2021 at 07:00, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 03Dec2021 at 07:00, outcome "recovering", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 03Dec2021 at 07:00, outcome "recovering", described as "Left arm sore". Therapeutic measures were not taken as a result of fatigue, headache, chills and pain in extremity.  No follow-up attempts are possible. No further information is expected.
pt recv vax 18MAR97 & on 27MAY97 pt devel full blown chickenpox from head to toe;
no painful  itchy rash on back  near left shoulder in straight line raised bumps, used Benadryl cream  last night mild relief
24 cm of red, inflamed, edema, itchy, painful, local reaction (R) upper arm at injection site.
A non-serious spontaneous report of inadvertently administered FLUMIST to a 50-year-old female was received from a registered nurse/health professional. Neither medical history nor concomitant medication was reported for this patient. On an unknown date in 2010, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
pt recv vax 10MAY95 & 10JAN96 exp severe case of chicken pox w/over 200 lesions;MD called it a vax failure;MD uncertain whether or not the pt had been exposed to varicella;
Angioedema 3 days after flu vaccine. Has a history of angioedema (not related to vaccines). He is also on Lisinopril. Stopped lisinopril, started prednisone taper, ZYRTEC, PEPCID, BENADRYL, EPIPEN PRN.
Patient felt dizzy approx 10min after vacciantion. Patient drank some water and layed down for 15min and sx resolved.
THROAT CLOSED UP, COUGHING NOSE RUNNING AND ACHED ALL OVER.
DEVELOPED FACE AND THORAX PRURITIS AND ERYTHEMA. ON 1/26/2021  3:35PM. WAS GIVEN SOULMEDRO 125MG IVP, BENADRYLS 50MG IV SLOWLY
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with doses of (Merck) VARIVAX, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Day 1 no symptoms. Day 2 redness extending from injection site out 2.5 inches, warmth, swelling, hardened area, painful to the touch. Radiating pain/aching from injection site to elbow. This lasted approx 7 days. Then area was no longer swollen or hard but still reddened and itchy. The redness and itching lasted until day 14. After day 14 no further symptoms.
Thank you for providing an opportunity to describe the adverse effects.  My face broke out in five boils, redness and crustiness above the right eyebrow, and right side of mouth.  I had a consistent temperature of over 100 degrees for at least three days.  I was lethargic and even now one boil on my face has not healed.  I developed pressure on the left side of my head that has lasted for more than a week.  I am taking an antibiotic for it.  I will never get a flu shot again.  The shot they gave me was 4 strains.
Flu shot, fever/chills, myalgia, nauseated, headache and flushes.