chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; GARDASIL 9 was stored improperly and administered; Information has been received from a licensed practical nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 28-JUL-2020, the patient was vaccinated with an improperly stored dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# 1637651 and expiration date 09-JUN-2022 for prophylaxis (dose and route of administration were not reported).  On an unknown date, the vaccine experienced an excursion temperature of 50 degrees Fahrenheit for 1 hour and 46 minutes. The reporter confirmed that there was no previous temperature excursion. The call was placed because of a digital data logger.   This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA012054: US-009507513-2007USA012060: US-009507513-2007USA012061: US-009507513-2007USA012124: US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2008USA000307: US-009507513-2008USA000314: US-009507513-2008USA000326: US-009507513-2008USA000367: US-009507513-2008USA000370: US-009507513-2008USA000372:
Shingles flared up after the first vaccine, prescribed gabbapentin for shingles pain, did not help.  Epeditimytis (may have been linked to shingles, doctor's unsure).
On 10/01/2019 the evening of getting flu shot started having body aches by that night had a fever and chills along with body aches. Wednesday, October 2, 2019 symptoms got worse, Thursday, October 3, 2019 developed a rash all over my body, the rash is very itchy
Within 5 mins after, momentary hearing lose in both ears X 2  Day 2, began experiencing, extreme lethergy Day 2 began experiencing stumbling gate Day 2 symptoms lasted approx 3 weeks.
Area around injection site inflamed,  itches and stings slightly. Noticed evening of shot.  Had headache, mild fever, some body aches and sorness. Noticed about 20 hours after the shot. Took acetaminophen to counteract the affects. Injection site still inflamed.  Headaches, mild fever, aches resurfaced about 20 hours after taking acetaminophen.  Took another dose of acetaminophen.
Skin rash about 2x3 inches, no itching no pain. Rash is about 1 inch away from injection site.
super sore arm esp if lifiting or touching it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Oct2021 (Lot number: 301258A) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "super sore arm esp if lifiting or touching it".  Additional information: Patient has received dose 2 on 24Oct2021, at 10:45 AM, in left arm, with lot number Ff2590.  No follow-up attempts are possible. No further information is expected.
After receiving first COVID vaccine patient reported tasting metal, itchiness in right leg. Patient was monitored for an additional 10 minutes, no additional symptoms were noted during while being monitored.
No other AEs reported; administration of improperly stored VARIVAX; This spontaneous report as received from a physician refers to a 17-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 11-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, one time (route of administration and anatomical location were not reported) lot # T025944, expiration date: 30-JUL-2022 for prophylaxis. No adverse event was reported.  Administered dose of vaccine underwent the temperature excursion of 19.7 degrees Fahrenheit (F) max, 14F to 46 F for 2 hours, 6F to 14F for 40 minutes. Digital data logger was involved. There were no previous excursions reported.
symptoms: felt light headed, dizzy, low bp, flushed tx: water, controlled breathing and after 5- 10min gave 50mg Benadryl outcome: patient was ok after 30 min, felt fine and stood up with ease, husband was with her
The day after my 2nd dose, I developed pain in my ankles, shins, and calves. Very painful to move and just a general not feeling well. I did have the normal fever/headache etc. that people get after the shot and that cleared up but on this day later, the fever came back. Low fever, very tired.  Day 2 after the 2nd dose, I woke up in the night with horrible pain in throughout my legs, my left forearm, and areas of my face and neck. These areas were painful to the touch too. By late morning on day 2, I developed a big red mark on my left forearm, my fever went to 103.7 and after Tylenol only went down to 102.9. I decided to go to urgent care. My whole lower body, left arm, face and neck was extremely painful. They sent me to E.R. More red marks appeared in those painful areas on my legs, face, and neck. I was given Benadryl and steroids at the hospital. They did not work. Eventually they sent me home. The 3rd day after the 2nd dose, the pain went to my upper back and both my arms, hips, but pain started to subside a little in my legs. Fever was off and on and low. I went to the doctor to get something for the pain. He prescribed tramadol. That and tylenol did help some. Later on the 3rd day, my fever was back up to 102.7, my wrist and neck swelled. More red spots appeared on my face. Over the next few days, most of the red spots turned a bluish color but didn't feel like bruising. My fever was off and on and high or low for a total of a week from the night of the 2nd dose. The pain was there for a week and was slightly there after a week. I saw an allergist a few months later to talk about it. He diagnosed it as urticarial vasculitis. He doesn't believe it was an allergic reaction, but an autoimmune response to the 2nd dose. He thinks it's because of my autoimmune hepatitis. But, although the meds I take for the autoimmune hepatitis is also treatment for urticarial vasculitis, I still had this problem.
Information has been received from a pharmacist referring to a 61 years old female patient who was not pregnant. The patient had no pertinent medical history nor drug reactions/allergies. Concomitant therapies included fish oil, daily multi-vitamins and OS-CAL. On 20-SEP-2016, the patient started a prescription for amoxicillin and PROAIR for respiratory congestion. The patient was not running fever at the time she was prescribed the amoxicillin and PROAIR. On 20-SEP-2016, the patient was vaccinated with ZOSTAVAX (0.65 ml, lot # reported as M030140, expiration date 18-AUG-2017) subcutaneously in the right arm. On the same day, the patient also received PNEUMOVAX 23 (dose, lot #, expiration date and route not reported) at physician's practice. When the patient was vaccinated with ZOSTAVAX, the patient also vaccinated with AFLURIA during the same vaccination session. In the evening of 20-SEP-2016, the patient experienced ZOSTAVAX injection site pain. In the evening of 21-SEP-2016, the patient noticed that her ZOSTAVAX injection site was silver-dollar sized. On 22-SEP-2016, the ZOSTAVAX injection site was 4 inches in diameter, warm, indurated, but not itching. The patient was experiencing a fever of 101 degree Fahrenheit. The pharmacist stated that the injection site area appeared to be developing white bumps inside the pink area and the pharmacist referred to these bumps as a rash. On the same day, the patient called her physician who referred her to the pharmacy for treatment guidance. No treatment was given for the events. No laboratory test was performed. The outcome of the events was reported as not resolved. The causality between suspect therapies and the events was not provided. Additional information has been requested.
F/U type symptoms 24 hours post shot, 12 hours swelling in right arm, approximately 2 inches across, tenderness, erythema.
At site of injection left ant thigh erythema, swelling, induration -3 cm. Questionable vesicular presentation in area of erythema. Sxs developed last 48 hours.
Redness appeared at the vaccination location (left upper arm) 9 days after vaccination was administerede
1/24/22 Chief Complaint Patient presents with o HOT o Respiratory Distress     Per EMS called resp distress, low-mid 80s on10L pt diagnosed with covid on 1/11. Pt increased WOB. hx of colon ca. 75 yr/o male who presents with abdominal and chest pain.  He was recently diagnosed with Covid.  His wife says that he has been confused since Thursday of last week.  His O2 sats have been low at home.  He was complaining of abdominal and chest pain and EMS was called to transport the patient to our facility.  He was vaccinated against Covid, including a booster. Admission Diagnoses: Acute respiratory failure due to COVID-19    Hospital Problems:  Principal Problem:   Acute respiratory failure due to COVID-19  Active Problems:   S/P thoracic aortic aneurysm repair (4/19/2012)     Chronic anticoagulation (3/12/2015)     CKD (chronic kidney disease) (5/20/2018)     Malignant neoplasm of urinary bladder    Discharge Diagnoses: Acute hypoxic respiratory failure secondary to COVID-19 PNA                                         Sepsis, POA                                         Acute on CKD III                                         Hx of bladder cancer    Hospital Course: 75 y/o male with hx of bladder cancer, who was vaccinated against COVID-19, was admitted to the hospital for acute hypoxic respiratory failure secondary to COVID-19 PNA.  He was placed on high flow oxygen and started on IV Abx and IV steroids.  On the evening of 1/25, he kept pulling off his oxygen and made it clear to me that he didn't want to fight anymore.  I talked to him and called his wife.  We discussed options of continuing aggressive medical care with DNR order vs transitioning to comfort care.  Patient said he just wanted comfort care.  He was started on prn IV dilaudid and versed.  His family arrived, he was kept comfortable, and passed away at 14:45 on 1/26/2022.  Cause of death is acute hypoxic respiratory failure secondary to COVID-19 PNA.
Redness, tender to touch. Abscess/cellulitis. BACTRIM DS one PO BID x 10 days.
Fever 100.9; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 12May2021 at 08:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 21Apr2021 at 08:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 13May2021 at 00:30, the patient experienced fever, diarrhea and nausea. On 13May2021, the patient underwent body temperature test and the result was 100.9 with units unspecified. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events fever, diarrhea and nausea. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events fever, diarrhea and nausea were unknown at the time of reporting.  No follow-up attempts are needed. No further information is expected.
A few hours after the new Comirnaty vax from Pfizer, I began to get flu-like symptoms and felt so tired I could barely move from Friday night-Monday morning. I haven't felt "back to normal" since the vax (my 5th Pfizer vax), and my blood pressure has been higher since taking it.
PATIENT RECEIVED 2ND BOOSTER SHOT BUT DID NOT MEET THE CRITERIA TO BE ELIGIBLE (50 YEARS OR OLDER, IMMUNOCOMPROMISED, OR RECIEVED J&J FOR FIRST 2 SHOTS).
Mom called on 13MAR92 saying that pt had fever 104 on 12MAR92; pt had some vomiting & diarrhea; no rash or swollen glands;
Patient passed away on 05/06/2021, 16 days after the first Pfizer injection. He was a healthy 34 year old. Autopsy report showed no organ or other physical abnormalities. The autopsy report stated his cause of death was an hemopericardium (acute dissection of proximal thoracic aorta / fatal cardiac tamponade / rupture into pericardial sac).
11/20/2021 headache, chills, fever, aches, soe muscles, shallow cough, twinges, dizzy, nausea, fatigue. Much worse than either of the first two doses of the Pfizer vaccine. All day, all night.  11/21/2021 at approximately 6am nausea, need to have BM without success, profuse full-body sweating. Went to ER. Had a heart attack. Emergency heart surgery found blood clot in the RCA. Implanted two stents in the RCA. Recovered in coronary ICU. Given aspirin, heparin, ticagrelor, metoprolol tartrate, plus some sedative during surgery. 11/22/2021 moved from ICU to coronary ward, recovery continued 11/23/2021 echocardiogram, lipid, and EKG results sufficient to release from hospital. New prescriptions set up - continued Prescribed metoprolol tartrate 25mg daily, repatha 1ml every 14 days, ticagrelor 90mg 2 times a day, aspirin 81mg daily, cholecalciferol 25mcg daily, nitroglycerin PRN. Prescribed 12 weeks of 3x/week cardio rehabilitation. 11/24/2021 recovering at home. Sore, fatigue, but no chest pain. Skin of legs and arms burning.  I got my seasonal flu vaccine at the pharmacy and got the standard quadrivalent shot. I am assuming that it was the Afluria Quadrivalent but I do not have the paperwork any longer. I assume the records could be obtained from the pharmacy is needed. I got the flu vaccine 15 days before the booster COVID vaccine.
High fever, chills, nausea, headache, during 12-24 hrs after injection. Treated with (1) Acetaminophen (500mg) every 6 hrs (2x total) .  Periodic sharp pains in legs (calves) about 25-27hrs causing awakening from sleep.  Took 320 mg aspirin, symptoms alleviated.
48 hours after injection, deltoid swollen (size of a baseball). No redness, fever last night per parent. No treatment; may ice shoulder.
Immediately after first doze, experienced drop in blood pressure from 138/79 to 115/60, this lasted about 24 hours, I felt completely knocked out and slept for 24 hours. Blood pressure went back to my normal which is around 138/79, it has been steady at this level for the past 10 years. Starting about 2 weeks after second dose administered 5/12/2021 a series of complications started appearing: 1. Elevated heartrate at night, I could hear my heartbeat.  Pulse was high and regular similar to what I experience walking up 5 flights of stairs.  Sitting up/Walking, drinking water seems to calm things down within about 15 minutes.  This happened once or twice a week tapering off in frequency over 6 months, the rate of occurrence is now about once every 3 weeks. 2. Insomnia, Early frequency once or twice a week tapering off in frequency over 6 months, the rate of occurrence is now about once every 3 weeks. 3. Daytime, phantom nerve sensations resembling having a cockroach crawling under your skin.  Early frequency, 2-3 times weekly, most common in legs, face, neck.  Heavy rubbing of the area affected resolves the symptom. This symptom appears to taper off and is now increasingly rare (once every 2-3 weeks) six months later. 4. Muscle joint and tendon pain/weakness, very slow recovery.  First observed in right arm/shoulder after coaching little league and softly tossing some balls to the kids. This is a similar experience that I would normally have 2 days after a very heavy workout.  This first occurred in right arm / shoulder severe (injection was in left) this prevented me from any sports such as little league coaching softly tossing balls to my 10yr old. Recovery about 4 months.   It feels like a light workout could cause severe damage to tendons/joint and that these injuries heal very slowly compare to what is normal for me. Several additional places of injury, elbows (both), thig/groin area got injured over the past 6 months.  This symptom does not appear to taper off. I feel fragile.
She developed symptoms of fever and chills. Then it developed into congestions, fatigue, and shortness of breath. On 2/4/2022, she got a positive COVID-19 test. It eventually developed into pneumonia. She had a telehealth visit and was prescribed medications. The major symptoms lasted approximately 1 week. She still has muscle fatigue and shortness of breath with scarred lungs.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Nausea-Medium, Additional Details: Flu and COVID vaccine were given in the same arm the same day.
Extremely heavy period.  Haven?t had one in 18 months due to pregnancy and breastfeeding.   This is my 4th child and I never have a period while breastfeeding.    This period was non stop bleeding for more than 24 hours.   Bright red which is unusual because it shouldn?t be fresh blood since it?s been 18 months.  Happened almost 2 weeks after second shot.   I also had a lot of post vaccine symptoms after second shot which include fever, chills, aches and breathing issues. Those lasted a week.   Tested for coronavirus during that timeframe and was negative.  Still bleeding, on 3rd  day, still bright red but not gushing like it was.
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old female patient who was vaccinated with 0.5 ml expired dose of PENTACEL (lot C5439AA and Exp. Date 30-OCT-2018) via unknown route in the left thigh on 21-Nov-2018.  The patient's medical history was not reported and concomitant medications included PNEUMOVAX 13; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization. It was an actual medication error due to expired vaccine used. The patient did not experienced any symptom. 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. List of documents held by sender: none
Received Jansen shot on 8/11/21 with no significant adverse effects. Opted to receive Moderna booster on date of listed in this report. I had mild but distressing symptoms: extreme fatigue (could not get out of bed for 24 hours), general malaise, some aches in joints and muscles, no appetite. No fever.  Took Benadryl as a precaution 3 times during 24 hours, then felt fine. 10 days after the shot, I started getting random hives on hands, arms, chest, neck, buttocks, and stomach. I thought I was exposed to a known allergen and tried to find the source of the reaction. I determined all toiletries and foods were safe (no changes or contaminations). Hives got worse. They are worse at night, and more crop up as others go away. I have been diagnosed with dermatographia, as well. Any minor abrasion (the edge of a pen cap, rough seam on clothing, scratching an itch) and I get wheals in the shape of the scratch. I?ve been on one 6 day course of prednisone, which helped until 2 days after the steroids finished, when hives came back as they had before steroids. I am taking additional allergy meds plus my usual meds and I still have mild hives.
I received the dose approximately 7:15pm. Within about 8 minutes of receiving the Pfizer COVID-19 vaccine I experienced pins and needles sensation on the left side of my body in my left arm and strong muscle pain in my left neck. I felt nauseous intermittently.  The nurse stated that my skin looked a little blotchy on my chest. Joint pain in my left knee and left arm was intermittent as well as intermittent pins and needles sensation in my left ear and burning in my left fore arm. I felt somewhat lightheaded. This lasted for about 15-30 minutes on and off. The nurse measured my BP and oxygen saturation which were in acceptable ranges. I kept moving my arm to relieve the strong and at times painful muscle cramping sensation in my neck and massaged my neck. By about 8pm the light headedness and nausea passed enough that I could drive home. On the way home the left side of my throat felt thick and somewhat swollen but not enough to prevent me from driving or breathing in any way. At home I focused on drinking a lot of water and gently moving my arm to relieve the pins and needles sensation. After eating dinner and hydrating I felt some improvement and most pins and needles sensation and neck soreness/throat thick sensation was resolved by about 11 pm. I was able to rest fairly well through the night until 7am the next morning when pain at the injection side woke me up. Soreness at the injection site, headache, fatigue, nausea, and mild chills are what I noticed today which appears to be more typically expected from the vaccine.
This spontaneous report as received from a pharmacist refers to an unknown number of patients. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patients might have been vaccinated with VARIVAX (Merck). Concomitant medications were not reported. The reporter mentioned that VARIVAX (Merck) might have been stored in the refrigerator for an indefinite amount of time. No adverse events were reported. This is one of the several reports of the same source. Additional information has been requested.
PATIENT RECEIVED VACCINATION AND APPROX 1HR AFTER SHOT BEGAN HAVING SHOOTING PAIN IN LEFT WRIST AND FINGERS.  PATIENT REPORTED HAVING DIFFICULTY RAISING ARM  WITHOUT ASSISTANCE FOR SEVERAL DAYS FOLLOWING INJECTION.  PATIENT REPORTED PAIN INITIALLY BUT ATTRIBUTED TO NORMAL REACTION TO FLU SHOT.  PAIN CONTINUED FOR 3+ WEEKS AND THERE CONTINUED TO BE PAIN WHEN RAISING ARM ABOVE HEAD DESPITE TAKING ANTI-INFLAMATORY MEDICATION FOR AN UNRELATED CONDITION.  PATIENT REFERRED TO WORKERS COMP DOCTOR WHO EXAMINED AND PRESCRIBED MEDICATION BUT PATIENT HAS NOT FILLED PRESCRIPTION.  PATIENT IS RECOVERING WELL ALTHOUGH STILL EXPERIENCES SOME PAIN AND DISCOMFORT.
pt recv vax 1AUG95 & 25JAN96 pt presented w/chicken pox;had gen lesions, fever, & nausea;