chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone high-dose was administered to a pediatric patient with no adverse event; Fluzone high-dose was administered to a pediatric patient with no adverse event; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer .  This case involved a 7-years-old male patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Lot number- UJ450AB, expiration date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (product administered to patient of inappropriate age) on 08-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.   It was a case of an actual medication error case due to inappropriate age at vaccine administration and it was also a case of overdose (Latency: same day).  At the time of reporting, the patient had no adverse 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 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.
A female reported that she received an injection of Flu Shield '00-'01 on 10/25/00 and subsequently developed redness at the injection site. As of 11/9/00, the redness persisted. No further information was available at the date of this report.
Patient had common  side effects on post-vaccination day 1 (body aches, fatigue, HA) which resolved within 24hr however patient then developed stabbing mid-sternal chest pain on the morning of 10/11 (3 days post-vaccination). Initial troponin level was 2.18 as well as CKMB at 19.6. Troponin peaked at 7.84 (roughly 24hr after symptom onset - 10/12@0400) then began declining that evening (10/12@1600). Chest pain was mild, intermittent and completely resolved within 12 hours of arrival after NSAID initiated.
Around 9pm on July 31, I began feeling feverish and having chills. My back also started hurting. I tried to go to bed and slept off and on all night. My upper left arm, which was where the shot was administered, was sore. The next day, August 1, I had a lessened fever with my skin still warm to the touch. I slept off and on throughout the day and drank vitamin flavored water and regular bottled water and ate small amounts of cinnamon applesauce and took Tylenol for the fever as the pharmacist at pharmacy had advised. I started feeling better that evening and attempted to eat some sliders around 7pm, only to feel nauseous and vomit three times after 9pm. My heartbeat was also irregular throughout the day. Today, August 2, I woke up with my skin still warm to the touch and irregular heartbeat. I took two naps at the time of this writing (7:47pm CDT). So far I have eaten cinnamon applesauce and Chicken-in-a-Biscuit crackers and drank vitamin flavored water and bottled water and have not vomited yet. I have also taken Tylenol and after the second nap, I woke up around 5:30pm CDT with a headache. I took some pharmacy brand Excedrin, which my body is used to for headaches, and ate some crackers and drank some water. I have also applied peppermint oil to my forehead, which is a standard treatment procedure I use for headaches. As of 7:49pm CDT, the time of this writing, my headache has subsided, along with any arm pain. I still feel slightly warm to the touch, though. The irregular heartbeats also seem to have slowed to normal pace/rate.
1/16/13: 6 hours after administration pt got tired & weak & next day felt fine. Then 1/21/13 about 7pm with left upper arm pain & swelling & warmth. Negative fever, better since yesterday better 1/22/13.
ZOSTAVAX vaccine was administered on 2/25/12. Patient said symptoms began 2/26/12 in the morning. She reported redness, swelling & itchiness at the injection site. She did not report any other AE. Did not have any trouble breathing or rash on any other part of body. Patient was told to take a dose of BENADRYL & follow-up with PCP if no improvement.
fully vaccinated with 5 of Pfizer's vaccines, including the latest one/third day with covid; fully vaccinated with 5 of Pfizer's vaccines, including the latest one/third day with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LORAZEPAM taken for hypertension; TEMAZEPAM taken for hypertension; CLONIDINE taken for hypertension; LISINOPRIL taken for hypertension. Patient is fully vaccinated with the Pfizer vaccine. Clarified as fully vaccinate with the Covid-19 Vaccine. Reporter stated he has taken five of our vaccines. He added he just received the new one, the most recent one to fight, the booster, the new Covid-19 Booster. He received the new one on 07Oct2022. Patient has taken five of our vaccines. This is the third day with covid.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering", COVID-19 (medically significant), outcome "unknown" and all described as "fully vaccinated with 5 of Pfizer's vaccines, including the latest one/third day with covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Bruises in the lower arm; This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bruising of arm. On an unknown date, the outcome of the bruising of arm was unknown.   It was unknown if the reporter considered the bruising of arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report.  No information was available data from patient. The batch number was not reported. The patient received Shingrix and experienced bruises lower in their arms. The reporter consented to follow up.
Arm pain, mostly in shoulder, when raising it or lifting things. Started immediately after shot, and has increased in intensity over 3 weeks. Injection was very high up on arm.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unknown number of patients of unknown gender and age. On an unknown date, the patient were vaccinated with an unknown number of doses of VARIVAX (Merck) (lot/batch number, expiration date, route, dose, dose number and frequency were not reported) that were exposed to temperatures of -14 Celsius (C) for 5 minutes. No adverse effect were reported. No product quality complaint (PQC) involved. Additional information has been requested.
(R) upper arm cellulitis - Itching and stinging the day after immunization 9/17/09.
Pt states with 2 day hx of extremity numbness/tingling and weakness.  Pt states 2 days ago started to have tingling in fingers.  Pt states still with muscle control at that time.  Pt states progressed until this am with difficulty with controlling hands and legs.  Pt states now with mild difficulty breathing.  No fever or chills, no hx of immunizations in last 1 week. Trasferred to the ED, the chief complaint is: Extremity numbness and tingling. He reported: Feeling terrible.  Previously well, no fever, no chills, and no night sweats. Quadriparesis, limb weakness causing difficulty lifting, limb weakness causing difficulty climbing stairs, and upper limb weakness descended to the legs. Poor right upper extremity coordination, poor left upper extremity coordination, tingling of both arms, of both forearms, and of both hands.  9/23/2008 Er records received for DOS 8/28/2008 with transfer DX:  Ascending Paralysis. Pansinusitis. Pt presented to ER with c/o dizziness and weakness of all 4 extremities, arms & legs which began 1 day prior. Also c/o numbness in arms and from knees down, tingling, SOB, malaise, loss of strength and intermittant sharp pains. On PE pt had unsteady gait.  Unable to lift legs without strain. Transfered to higher level of care with DDX:  Demyelinating Encephalitis. GBS.  Myesthenia Gravis.  MS. 11/24/2008 Clinical Summary received. Pt admitted 8/28-9/5/2008 with DX: Guillain-Barre Syndrome-acute demyelinating polyneuropathy. During hospitalization, pt became progressively weak and lost tendon relexes. Respirations and swalling intact. Tx with IVIG and transferred to rehab. By late October 2008 pt had not returned to normal state of health. 01/26/2010 Follow-up: Still noticing numbness in 4th and 5th digits. Is being followed now.
COVID - Dec 2020. Chest tightening (stabbing pain), Was diagnosed with Pericarditis and Myocarditis. Was put on Colchicine for inflammation.
pain daily kidney area up to my shoulders to mid back; pain daily kidney area up to my shoulders to mid back; pain daily kidney area up to my shoulders to mid back; Headache; pain; exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old [non-pregnant] adult female received the second dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose in the left arm on 12Apr2021 at 11:15 (at 55-years-old) for COVID-19 immunization. Relevant medical history included endometriosis, cysts, tumors, food allergy (bell pepper) and drug allergies (ciprofloxacin and nitrofurantoin). Concomitant medications included letrozole from unspecified date for an unspecified indication; and unspecified thyroid medications. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose in the left arm on 22Mar2021 at 11:15 (at 55-years-old). The patient was not pregnant at the time of vaccination and the patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within four weeks of this vaccine. The patient reported that on 13Apr2021 at 06:00 she experienced headache, pain, and exhaustion. The patient explained that now she has pain daily in the kidney area up to her shoulders and mid back. The patient stated that she is currently on an anti-inflammatory intravenous (IV) serious to try to stop the pain. The patient reported the events resulted in visit to doctor's office though denied that the events resulted in death, was life-threatening, caused/prolonged hospitalization, was disabling/incapacitating or resulted in congenital anomaly/birth defect. The outcome of the events headache, pain, exhaustion, and pain daily in the kidney area up to her shoulders and mid back was not recovered.   Information regarding the lot/batch number has been requested.
This spontaneous report was received from an office manager via a company representative concerning a daughter of a co-worker. The patient's age was unknown. The patient's pertinent medical history and concurrent conditions were not provided. In January 2015 the patient was vaccinated with an unspecified dose of GARDASIL (lot# and route not provided). The office manager reported that her co-worker stated that her daughter experienced amenorrhoea reported as "had not had her period" since receiving GARDASIL in January 2015. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Arm broke out in terrible itchy rash. Rash is getting a bit worse everyday.
Jansen COVID-19 Vaccine EUA Severe pain under left shoulder blade radiating down upper arm. 5 days later (4/4/21) still in severe pain AND numbing of the pinky and ring finger on left hand. Tried Tylenol with no relief.  4/5 numbing extends to palm area below those 2 fingers.  Began taking ibuprofen with some relief.  4/6 pain and numbing go from left shoulder blade all the way down left arm to hand but only on the outer side of arm.  Pain is increased and appointment is made for dr. for 4/7. Prescribed Meloxicam 15mg on 4/7 and began taking that night. Minor relief of pain. No effect by 4/12 on numbness.
HEADACHE & JOINT PAIN-STARTED 3 DAYS POST VACCINATION LASTED A COUPLE OF DAYS, HEADACHE, DIARRHEA, LIGHT SENSITIVITY, FEVER 101-10 DAYS POST VACCINATION. RASH ON NECK, FACE, & TRUNK APPEARED 2 WEEKS POST VACCINATION.  HEADACHE & JOINT PAIN RETURNED 10 DAYS POST INJECTION, SXS WORSENED.  PT SELF MEDICATED WITH MOTRIN 800MG
The pt experienced swollen hands, swollen joints of hands, extremely painful. Acute pain in shoulders, hands and legs. Stiffness in hands, arms, legs, neck. Fingers became distorted. Joints locking, and shoulders locked. Problems remain. The follow up stated that the pt has been experiencing more severe neck pain and stiffness coupled with severe headaches. In addition, the symptoms include stiffness, pain, numbness in the lower arms. He recently on 06/11/2001 was a walk-in pt at primary care and saw a physician because he could not get an appointment with his primary care physician within the same group. The physician prescribed CEFTIN 500 mg two times a day which seemed to help his neck pain. He also states that he is planning to see a Lyme disease specialist on 06/18/2001 and he will forward another release form for the new specialist. More severe neck pain and stiffness. New onset HA, stiffness, pain, numbness in low arms, hands, shoulder and legs. Neck pain helped with Ceftin
pt recv vax & w/in 1 day post vax pt exp urticaria;tx DPH MD has not seen the pt since 20JUL96;no further details are available;
stated that while she was getting her 2nd shot, that she called the HD to report swelling of her right hand and development of blisters.  States that the employee told her that was not a side effect and told her to move her arm about to increase absorption.  She mentioned that blisters formation and later popped with refness and pus drainaing from her left hand.  MD was consulted who was concerned about a blood clot but doppler was negative.  Today, remnants of that swelling persists but the redness has gone away.  blister is dried and healing with no s/s of redness, drainage, however, top part of hand is swollen.  Encouraged to elevate left arm to promote return to normal size of arm.  Notified to call HD a
Starting about 9 hours after vaccination, started to get chills, bodyaches ,nausea dizziness and approximately 6 episodes of vomiting.  This resolved around 16 hours after vaccination.  continued to have fatigue and bodyaches until about 24 hours after vaccine but then started to get painful axillary LAD on the side of injection (left).  LAD resolved 3 days later.
Swollen lymph node sub-clavicle on left side. Notice on 1/04/2021 around 8:00 PM. Lymph node continued to get bigger through the night and is sore to touch
Initial report received from a health care professional on 30 December 2010. A 16-year-old female patient received on 22 September 2009 an injection (route and site not reported) of MENACTRA, lot number U2874BA. The patient's medical history and concomitant medications were reported as unknown. On 30 December 2010, the patient was not feeling well. The next day she was found unresponsive with a rash on the body. She was taken to the hospital. The patient had a spinal tap at the hospital which was reported as "Did not look good". The outcome was reported as not recovered. Documents held by sender: None.
A lot of pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A lot of pain in her arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy (she had a hysterectomy six weeks ago.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (A lot of pain in her arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (A lot of pain in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
This spontaneous report has been received from a medical assistant referring to a currently 4 years old male patient. Information about medical history, concurrent conditions concomitant medication and drug reactions/allergies was not provided. On an unknown date the patient received an improperly stored dose of PROQUAD (rHA (recombinant Human albumin)) (lot number: R012413; expiration date: 28-OCT-2019; dose detail, strength and route were unknown) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent. The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported.
pt recv vax 9APR96 & 5MAR97 pt exp chickenpox;
Itchy rash at injection site.  Red skin about 2x4 inches in area .  Some swelling that dissipated after 8 hrs but rash still there
Fever, Chills, Runny Nose, Lost taste and smell, Headache, Fatigue, Cough, Shortness of Breath, Chest Pain, Nausea & Vomiting, Diarrhea
Pt had a brief LOC after he was alert approx 20 min. after he received 3 vaccines. He was observed for another hour. Grandma called on 6-15-11 to report that the pt had experienced CP 3 days ago after running. Reassurance provided. Pt's caregiver was instructed to come in if persistent C.P.
Swollen arm; Little warm; Itches really bad; Red spot at the injection site, Red area about size of a pea; Sore arm; A spontaneous report was received from a 35 year old, female consumer who was participating in the mRNA-1273 Program and experienced red area on her arm, sore and swollen arm, injection site redness, warmth and itchiness.   The patient's medical history, as provided by the reporter, included hypertension, increased cholesterol asthma, and low estrogen. Concomitant medications reported included atorvastatin, estradiol, fremanezumab vfrm, oxymetazoline hydrochloride, omeprazole, HCTZ, and betamethasone.    On 5 Jan 2021prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 5 Jan 2021, after receiving the vaccine, the patient experienced a red area on her arm about the size of a pea and arm soreness. On 6 Jan 2021, the patient experienced swollen arm and an increasing in size red spot at the injection site. Patient reports the red spot is warm and itches really bad. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, experienced red area on her arm, sore and swollen arm, injection site redness, warmth and itchiness, were considered unknown.  Follow up:  Follow-up received on 07 Jan 2021 included updated symptoms to include sore and swollen arm, increasing in size red spot at the injection site and warmth. Also added concomitant medications estradiol, fremanezumab vfrm, and oxymetazoline hydrochloride.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
has a problem today not good; fever; headache; teeth ache; felt bad; arm can't lift up; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age reported for himself that he received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hepatitis disease of liver and constipation; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient had a problem, reported as today, not good and had fever last night, headache and teeth ache. The patient could not go to walk. He stated that when he felt bad last night with fever, headache, and teeth ache, he took Tylenol but it did not help. The patient stated he had hepatitis disease of liver and had constipation and he told his doctor but they said that was ok no problem his doctor told him ok you wait until you're strong and then go to get vaccine. The patient stated when he told then he was not feeling good and asked if he had medicine which he could have that sounds good for headache, teeth ache and arm can't lift up. Therapeutic measures were taken as a result of fever, headache and teeth ache. The outcome of the events fever headache, teeth ache was not recovered while other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Double vision within 15 minutes after first primary dose; Dizziness within 15 minutes after first primary dose; This spontaneous case was reported by a patient and describes the occurrence of DIPLOPIA (Double vision within 15 minutes after first primary dose) and DIZZINESS (Dizziness within 15 minutes after first primary dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Hypertension for the past 30 years controlled with medication Zestril 5mg once a day.) and Diabetes (for the past 2 years and it was being controlled with diet & exercise.). Concomitant products included LISINOPRIL (ZESTRIL) for Blood pressure high.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced DIPLOPIA (Double vision within 15 minutes after first primary dose) and DIZZINESS (Dizziness within 15 minutes after first primary dose). The patient was treated with GLUCOSE on 04-May-2021 for Double vision and Dizziness, at an unspecified dose and frequency. On 04-May-2021, DIPLOPIA (Double vision within 15 minutes after first primary dose) and DIZZINESS (Dizziness within 15 minutes after first primary dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient experienced double vision and dizziness within 15 minutes after vaccination. The pharmacist gave glucose tablets for the events and it went away within 1 hour.   This case was linked to MOD-2022-670217, MOD-2022-670221 (Patient Link).
Severe abdominal pain, especially in upper right side. I went to the emergency room where they thought I would need gall bladder surgery. After a cat scan and sonogram and EKG and blood tests it was determined I had a urinary tract infection, but nothing was wrong with my gall bladder, kidney or appendix.