chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fever; Cough; Sore arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), COUGH (Cough), PAIN IN EXTREMITY (Sore arm) and PAIN (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), COUGH (Cough), PAIN IN EXTREMITY (Sore arm) and PAIN (Body aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Pyrexia, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm) and PAIN (Body aches) outcome was unknown and PYREXIA (Fever) and COUGH (Cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment includes Ibuprofen
Headache, chills, muscle aches, fatigue starting about 10 hours after vaccine was administered and lasting about 24 hours. After that, chills went away and headache improved. Muscle aches/fatigue continued for another 3-4 days.
Patient developed a quarter size rash on inside of elbow area 3 days after immunization. He felt may have been related. Obviously not at injection site. MD said not related to vaccine.
Fatigue; lightheaded; temperature around 99.3; This is a spontaneous report from a non-contactable consumer (patient himself). A 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9261; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 25Jan2021 14:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient had not any known allergies. Patient had not received any other vaccine in four weeks. Concomitant medications included levothyroxine, pregabalin, mirabegron (MYRBETRIQ), zinc and vitamin b nos (B-COMPLEX [VITAMIN B NOS]) taken for an unspecified indication. It was reported that on 29Jan2021 patient experienced fatigue, lightheaded and temperature around 99.3, required 2 days of bed rest. Symptoms began 4 days after receiving the first dose. Therapeutic measures were taken as a result of fatigue, lightheaded and temperature around 99.3 as patient had received paracetamol (TYLENOL) and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: around 99.3 on 29Jan2021. Patient was not diagnosed with COVID-19 prior and since the vaccination. The outcome of all events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; on the fourth day I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Apr2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2015, stop date: 20Aug2022. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 28Aug2022 at 10:00, outcome "recovering", described as "on the fourth day I tested positive"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Aug2022) Positive, notes: my symptoms returned three days after ending the Paxlovid, and on the fourth day I tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Additional information: Covid rebound: his symptoms returned three days after ending the Paxlovid, and on the fourth day he tested positive. Known allergies was reported as No. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fever, chills, upset stomach, headache, muscle ache  Note: I've provided Doctor information, but the show was administered at Pharmacy.
The night of the vaccination, I had a headache, dizziness, fever, chills, fatigue, and body aches. It lasted for 36 hours. I called out sick from work because of those symptoms. Later I started having a headache daily along with the fatigue. On 10/09/2021, I woke up with heavy menstrual bleeding and cramping. This was odd because previously my periods would be normal and occur for 4 to 5 days. Around this time, I was bleeding through 3 or 4 pads an hour. On 10/12/2021, I went to my doctor. I was prescribed with hormone therapy Microgestin. Eventually, my period stopped being extremely heavy, but I was still experiencing spotting. This was strange to me because I had my fallopian tubes removed in June 2021. On 10/15/2021 early in the morning, I woke up with chest pains, cold sweat, and I was nauseated. I thought I was having a heart attack. I went to the ER at Medical Center. I took many tests. The doctor checked to see if I had a pulmonary embolism - and I tested positive for it. I was given four aspirins. They released me from the hospital. I have to follow-up with my physician soon. Currently, I wake up with a headache, light headedness, and I am still dealing with menstrual spotting. I've been dealing with shortness of breath as well.
No additional AE details were provided and no additional AE's were reported; patient was administered a dose of VARIVAX after it was involved in a temperature excursion.; This spontaneous report was received from  the office manager and refers to a patient of an not reported age or gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 14-DEC-2022, the patient was vaccinated with an improper stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter, lot #W018825, expiration date: 14-JUN-2024, administered for prophylaxis (vaccination scheme and route of administration were not provided) following a temperature exception of 41 degree Fahrenheit for 7 hours and 30 minutes (product storage error), it was stated that no previous temperature excursion occurred and there was no additional adverse event reported.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. Other Case identifier(s): 2022NVX-US-000003254.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 2, single (Lot number: FK9894) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Vaccine breakthrough infection.  Clinical Course: On 29Aug2022, it was reported that a patient started treatment on 28Apr2022 with Pfizer at Dose 2 for unknown indication. It was reported the patient had COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive and Vaccine breakthrough infection. No further follow-up is anticipated.
ABDOMINAL PAIN AND CRAMPING; SWEATING; VOMITING; DIFFICULTY BREATHING; FATIGUE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072) dose was not reported, Vaccinated at on left deltoid once a total administered on 16-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021 01:30, the subject experienced abdominal pain and cramping. On 17-MAR-2021 01:30, the subject experienced sweating. On 17-MAR-2021 01:30, the subject experienced vomiting. On 17-MAR-2021 01:30, the subject experienced difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain and cramping, vomiting, difficulty breathing, and nausea on 17-MAR-2021, had not recovered from fatigue, and headache, and the outcome of sweating was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
T50.Z95A M54.2 R25.2 Right hand int no exam slight decreased hand strength rit vs lt Neurology Referral
Information has been received from a biller at a physician's office concerning a 65 year old male with hypertension, coronary artery disease, benign prostatic hyperplasia, hypothyroidism, hyperlipidaemia, gout and no known allergies who on 06-NOV-2007 was vaccinated IM in the left buttock with a dose of ZOSTAVAX (lot # 658395/0966U).  Concomitant therapy included indomethacin (INDOCIN (indomethacin)), allopurinol, atorvastatin calcium (LIPITOR), hydrochlorothiazide (+) valsartan (DIOVAN HCT) and metoprolol.  On 15-NOV-2007 the patient developed an erythematous purulent appearing nodular dermal lesion, a little reminiscent of herpes zoster on the left arm.  The patient had no history of shingles prior to vaccination.  Medical attention was sought, viral and bacterial cultures were performed, results were not reported.  On an unspecified date the patient recovered and was noted to be "fine".  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
This spontaneous report as received from a 45 years old male field representative refers to himself with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with 0.5 ml PNEUMOVAX23 (lot number, route not reported) on 08-OCT-2012. On 03-OCT-2012 he received the yellow fever vaccine (manufacturer unspecified) and also started taking a capsule every other day for 7 days as the typhoid fever vaccine (manufacturer unspecified). On 08-OCT-2012, he also got MENVEO (Novartis) and FLUZONE. Other concomitant medications included SINGULAIR, CLARINEX, AXIRON and Finasteride. The patient experienced pain at the injection site on 08-OCT-2012 and was not feeling well (with a headache) on 09-OCT-2012. On 10-OCT-2012 the patient developed rash. The patient talked to a pharmacist for medical attention. No treatment or laboratory diagnostics studies were given. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.
Information has been received initially from a licensed practical nurse and follow-up by a physician concerning a 6 year old female pt with no past medical history and no known allergies who on 05/14/1996 was vaccinated SC in her left arm with the first dose of varicella vaccine. Concomitant therapy on 05/14/1996 included the first dose of PPD. There were no other concomitant medications. On 06/22/2001, the pt's mother noticed that her child had developed chicken pox with greater than 250 papules. At that time, she contacted the child's physician. On 06/27/2001, the pt's mother reported to the child's physician that the child had chicken pox with greater than 260 papules and had developed intermittent fever of 101-102 deg. F. At that time the child was treated with Benadryl and Aveeno baths. On 06/27/2001, the physician placed the child on therapy with Zovirax for five days. The licensed practical nurse also discussed the experience of two other children after vaccination with varicella vaccine. Additional info has been requested.
Itching, injection site large circular bruise, stiff right arm muscle, itching in eyes, large rash on chest and legs and shoulder.
patient with DAH that resulted in ventilatory support/severe ards (now diagnosed with anca vasculitis)
Redness and swelling at site. One small red circle developed, with redness and heat surrounding it. Large patch was approx. 4" x 6" - hard, red, swollen. Smallest circle had some white flaky spots.
The patient received Fluzone High Dose instead of the Fluzone Quadrivalent, no AE; A 60-years-old patient was given Fluzone High Dose, no AE; A 60-years-old patient was given Fluzone High Dose, no AE; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case is linked to cases 2020SA253357, 2020SA253258 and 2020SA252226 (same reporter).  This case involves a 60-years-old female patient who received 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ453AB, expiry date 30-Jun-2021) once via an intramuscular route in the left deltoid for prophylactic vaccination, on 10-Sep-2020 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered, product administered to patient of inappropriate age and overdose).  Medical history, past medical treatments, vaccination and family history were not provided. Patient did not receive any concomitant medications. It was unknown if the patient was pregnant as the information was not obtained.   It is an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and it was a case of overdose (latency same day).  It was reported that the error occurred due to grabbing the wrong box, not paying attention and not looking at the box carefully. The facility contacted the patient on the day after the injection and is planning to follow up today after reaching out to the manufacturer.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Visual disturbance and right arm numbness lasting less than 2 minutes. Blood pressure 190/98.
Client presented for flu shot.  Flu Shot administered but afterwards complained of feeling faint and client looked slightly pale and clammy.  Nurse instructed client to put her head down between her knees which client did.  After a few moments she sat back up and said "I fell asleep." Had client remain in chair and encouraged to drink some water.  She said she had not eaten anything since lunch and did not eat much at lunch.  Dad said they lived about a block away and that he wanted to take her home.  Father volunteered that client's mother occasionally faints from shots. After about 10 minutes client was able to stand without feeling faint but she said she felt tired so her dad carried her from clinic site.
I received my first shot around 9am of 8/14/21. I ran a few errands and went home. Some time around 1-2pm that same afternoon, I was hit with excruciating pain in my left flank area that totally encompassed my upper thigh. This was the worse pain I have ever experienced, ever. I have had children, surgeries, etc. and have not had this severity of pain. I was outside in my yard when the pain started. I tried walking around some to see if that would help, but the pain became so unbearable, it was all I could to to walk into my house and lie on the floor. I did everything I could to try and relieve the pain but nothing helped. And what made it so unbearable was that the pain was nonstop; it would not let up no matter what I did. I tried different positions, etc. I finally half walked and half crawled to our extra bedroom to lie down on the bed. Again I tried multiple positions to try and help. I was in bed in horrible pain from Saturday afternoon until Tuesday.  At some point late Monday or early Tuesday, the pain started radiating down into my lower right leg and foot and toes. I was alternating aleve and tylenol (normally I take Advil for any pain but the nurse that gave me the shot that morning specifically told me not to take any Advil because there are studies or something that indicate Advil may affect the effectiveness of the shot so I specifically had my husband go get aleve and tylenol).  After much online searching and discussions with my daughter and husband, we came to the conclusion that I most likely was having severe sciatica. I have never had this before, never had back pain that was so relentless to never let up.  I have had minor aches and pains, but again, nothing this debilitating. Finally by Wednesday morning, I was able to walk and sit just enough through the pain to go see Dr., my internal medical family practitioner. I explained my symptoms and I did tell her that I had the shot Saturday morning around 9 and my pain started 4-5 hours after the shot.  She told me she believed what I have is classic sciatica and she prescribed prednisone. I was able to start doing the child pose almost all day off and on for the next several days and taking the prednisone. Initially, the child pose was the only thing I could do to help alleviate some of the pain. And I was only able to feel well enough to do that on Wednesday. I am on day 5 of the prednisone and am almost finishing it up by tapering off.  My pain is much better now. I was able to return to work this week.  I was out of work the entire last week.
Information has been received from a health professional concerning a patient (5 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F). It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day. Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the agency and was released. Additional information has been requested.
Large red raised welts, tender to the touch but not itchy on my left arm where injection was given. Not near the site but in front of upper arm.  Appeared Tuesday April 13 at around 9pm.
Increased menstrual bleeding that soaks a overnight pad every 30 min for 24 hours. This is uncommon for her.  Possible anemia.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N008824 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. Sender's Comments: US-009507513-1708USA013604: US-009507513-1708USA013605.
This case was reported by a health professional and described a 28 year old female subject who did not respond to immunization with hepatitis B vaccine recombinant Engerix B. The subjects medical history included allergy to erythromycin, asthma, gastroesophageal reflux disease, tobacco use, and social drinking. Concurrent medication included fluticasone propionate + salmeterol xinafoate (Advair) to treat asthma, esomeprazole (Nexium) to treat gastroesophageal reflux disease, and zolpidem (Ambien) for an unspecified drug indication. On 3/1/2004, 4/5/2004, and 9/17/2004, the subject received three dosed of Engerix B (lot number not specified). Approximately seven months later, on an unspecified date on or before 4/25/2005, a hepatitis B surface antibody titer was negative. On 4/25/2005, the subject received a booster dose of Engerix B (lot number not specified.
RASH ON RIGHT ARM, AROUND SITE AREA. NO ANAPHYLAXIS OR HIVES. PATIENT CONTACTED MD AND BENADRYL WAS NOT NECESSARY AT THIS POINT
Stiff neck, headache and lethargic initially, at 2:00 AM on 09/25/2015, developed fever 100.2. Brought to Emergency room at 11:30 AM on 09/25/2015 per Dr's instruction. Cat Scan, blood work, x-rays and spinal tap performed. Released at 4:45 PM on 09/25/2015. At 5:00 AM on 09/26/2015 had temperature of 100.7. Still stiff and lethargic. Treatment recommended by Doctor, warm compress on neck and children's Ibuprofen for fever and pain.
Wrist and fingers became achy and numb on 6/14/08. Pain continuous fluctuating from mild to severe pain. Pt went to MD who took blood tests. Now getting deep tissue massage a week and icing it. Also sees chiropractor.
Headache, body aches, fever 102.47, pain and swelling and injection site. I'm using tylenol  1,000mg every 6 hours and it brings the fever down to about 100
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 16-AUG-2016, the patient was inadvertently administered an expired dose of PROQUAD (expiration date 14-AUG-2016, lot number, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient admitted with Pneumonia of left lung due to infectious organism treated with to ceftriaxone and doxycycline for suspected pneumonia.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The lot or expiration date of vaccine was unknown. The patient received a dose of SHINGRIX about 2.5 months ago just above deltoid and wanted to know if the dose would be effective, which led to incorrect site of administration. The patient had mild pain at the injection site, since receiving SHINGRIX and wanted to know if this was normal and if he should have it treated with a cortisone shot or if it would go away. The vaccine was administered at a pharmacy. The reporter gave consent to follow up.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium
Pfizer covid vaccine 5-11yr was not diluted and was given to the patient.