chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st in Oct2019, due to Covid never got 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments: This case is received from Shingrix. This case was reported by the patient. Due to Covid, the patient never got second shot of Shingrix in 2020.The patient asked what should be done now.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a 6-month-old subject of unspecified gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received the 1st dose of Engerix B (.5 units not specified, unknown).  On an unspecified date, less than one day after vaccination with Engerix B, the subject experienced injection site pain.  The reporter stated that the needle "went into the subject, but when the nurse pulled the plunger out to aspirate, the entire plunger came out".  It was noted that the needle was still in the subject "when the unit fell apart" (product quality complaint).  The needle was removed, and the subject required re-administration of the vaccine.  At the time of reporting the outcome of the events was unspecified.  Follow-up information received on 04 June 2007 indicated that per the reporter, the medical assistant was correctly using the vaccine when the plunger fell out.  No additional detail was provided concerning the outcome of the event.
Swelling and redness (about 9x9cm) of deltoid area at site of DTaP administration. Only mild tenderness.
Breakthrough COVID-19 case: I was exposed so I decided to test for COVID-19 on 05/16/2022 and the test came back positive. I did not experience symptoms until the following day. I developed a headache and a stuffy head, like a pressure feeling. I also started to have an upper sore throat. I experienced a stuffy nose. There was no drainage. I didn't really experience a cough, but if I did have one large cough I would expel a big sticky mucus discharge. I contacted my doctor and they told me I was qualified for their COVID-19 clinic and was prescribed Paxlovid. I started it yesterday and it seems to be helping. I only coughed once today and my sore throat seems to be getting better.
1/11/04 outdated Hepatitis B given on 3/1/04. Hep B readministered.
Area about the size of a 50 cent peice was swollen, red, and hot at Zoster injection site. No blisters or breaking of skin were present.
I had chills, fever, headache, extreme tiredness, almost passed out and  tingling on right side arm/leg. When I almost passed out felt like tunnel vision.
Fever reaching 100.5°F Aches muscle soreness in general. Swelling and redness at injection site (about7x10 inches,  very red, splotchy,  sticks out over an inch more than normal [big knot])
Seizures (generalized) poss due to inc temp, requiring extensive rescuscitation & intubation w/subsequent ICU care; seizure activity lasted approx 2 hrs through several cycles of anti-seizure meds;
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Agency (Reference number- 00653846) and transmitted to Sanofi on 23-Jun-2021.  This case involves a 28-year-old female patient who received a 0.5 mL dose of expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot C5638AA and expiry date: 19-Jun-2021) via an intramuscular route in the right deltoid for prophylactic vaccination on 23-Jun-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The patient did not receive any other medications or vaccinations.  This was a case of actual medication error due to expired vaccine used (latency same day).  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a 72 year old female patient with a drug allergy to penicillin and a history of open heart surgery who on approximately Dec 6, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The patient was concomitantly vaccinated with influenza virus vaccine. Subsequently the patient developed "severe pain and immobility in her left arm where she received the pneumonia shot and it is almost better now. The physician treated her with celecoxib (Celebrex) for the pain, but it did not help. He switched her rofecoxib (MSD) and it helped her pain. No further information is expected.
severe injection site pain in left arm. Started about 6 hours after the injection and lasted for approximately 36 hours. Burning and throbbing sensation in top of arm at injection site, could not lift or move arm without severe pain, severe pain also with touch or simple tasks like putting on a jacket.
Urticaria immediately after PROQUAD vaccine. BENADRYL given, rahs improved.
Patient came to get Pfizer 5-11 Pediatric Bivalent booster, but received Pfizer 5-11 Pediatric Monovalent booster
I became ill with chills and then severe sweating that evening after receiving them. Also had extreme pain, hot and red itching on my shoulder where one of the vaccines went in. The following day I was still not feeling very well and by the third day I was dizzy, felt faint and sweating. I was so bad the third day, I had to go home after being at work a short time.
**Note: I believe patient is having symptoms of illness plus possible adverse events to the vaccination. On 4/26/21, occasional sneezing began. 4 days ago, +pain in throat with swallowing (present before vaccination). She received second dose of COVID-19 vaccine (Moderna) in right arm on that same day (4/29/21). On 4/30/21, +cough, body aches, chills, sweating, headache, nasal congestion/runny nose, nausea, fatigue, loss of appetite, on and off lower central abdominal pain, right arm injection site pain. On 5/1/21, symptoms continued except throat pain, body aches, sweating, and chills. Also, right arm pain began to improve. Yesterday, no more right arm pain and fatigue improved. Today, only had some abdominal pain this morning, still with nausea, loss of appetite, nasal congestion, cough. All other symptoms have resolved. No subjective fevers. No shortness of breath, loss of smell/taste, vomiting, diarrhea, rashes. Patient is currently pregnant (no complications with pregnancy). Patient took acetaminophen as needed for some of these symptoms.
Caller has allergies; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient took 1st dose of Covid vaccine today (02Feb2021). She has allergies and would like to know if she can take something for them. Clarified that patient had allergies before taking vaccine. Unknown if vaccine affected allergies. The patient experienced allergies (drug hypersensitivity) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient has had a headache since vaccine was given. Patient diagnosed with generalized headache during sick visit 3/1/17 following vaccine admin 2/28/17. Still has headaches.
pt presents with mid epigastric chest burning x1 hour after breakfast, 21 yo M w/ no known chronic medical conditions, presents w/ 2 hours MEG/central chest burning. Initial a/w mild SOB and LH; by time of my eval, LH/SOB had resolved and CP was 4/10. Pts sx completely resolved w/ GI cocktail. No exertional sx. No recent infectious sx.  VS w/o acute abn. Well-appearing, NAD. Normal CV exam; no edema. LCTAB.   PT  transferred for troponemia.
Burning sensation in legs; Tingling sensation in fingers; Arms got swollen up; Pain in the hips; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in legs), PARAESTHESIA (Tingling sensation in fingers), PERIPHERAL SWELLING (Arms got swollen up), ARTHRALGIA (Pain in the hips) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced BURNING SENSATION (Burning sensation in legs), PARAESTHESIA (Tingling sensation in fingers), PERIPHERAL SWELLING (Arms got swollen up), ARTHRALGIA (Pain in the hips) and HEADACHE (Headache). At the time of the report, BURNING SENSATION (Burning sensation in legs), PARAESTHESIA (Tingling sensation in fingers), PERIPHERAL SWELLING (Arms got swollen up), ARTHRALGIA (Pain in the hips) and HEADACHE (Headache) had resolved.            Concomitant medications include BP Medication, Acid reflux Medication, Cholesterol Medication. No treatment medication were provided   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR received and updated events onset date and events outcome.
SIGNIFICANT SCARRING NOT GOING AWAY AFTER 2 WEEKS BUT GETTING WORSE
Left arm has redness, swelling , itching at sight and feels hot - symptoms have also travelled beyond the injection site - new swelling and redness and itching is now 3 inches around and appears to be spreading.  I have had these symptoms for 9 days now and they do not appear to be getting better.
I was walking in the evening and walked about a block and a half. All the sudden I had excruciating pain form my hip to my leg and had to basically drag myself home. It was like that for over a day so I called my doctor and they had me come in. They did hip X-rays of both hips. They couldn't see anything so he did a physical exam and found the most pain in my bursa and it's causing sciatica down my leg.  I sued to be a morning person and now I wake up tired and need coffee. I feel 80 years old when I wake up and it takes a lot of walking around and stretching to feel okay again. After a few weeks, I was still in pain everywhere so my doctor referred me to an Orthopedic doctor who gave me a cortisone injection in my hip. The next morning I was able to walk like a normal person again. My doctor explained that a pain somewhere in the body can go through your joints and cause pain all over. I got 600mg Motrin but I don't like to take medication. He told me it would heal in a few weeks. He also gave me physical exercises to do to help heal it. I am still waiting to feel like myself again and it's been three months. I am still having issues. A few weeks ago , I also started spotting. I haven't had my period in many years so it was freaky. Now, they want to do a biopsy. I didn't have any other symptoms but the spotting lasted about 3-4 days. My doctor did an ultrasound and found the lining of my uterus was thicker than normal.
pain at injection site and weakness limited by pain. resolved several days after receiving a course of oral methylprednisolone dose pack.
Skin around injection site turned yellow and it spread  to about 4 inch area on her Right Arm.  Injection sight was slightly warm to touch. It was not tender though. Patient was advised to seek medical help. I did call and fax her PCP as well as spoke to on call MD to see if Cephalexin will be viable option with patient being diabetic. On call MD suggested to go to urgent care if it is severe and she will f/u with Dr next day . Followed up with patient and she declined to go to urgent care as she was seeing her PCP in next 48 hours.  Next day (03/03) Patient did go to ER due to discomfort. ER MD advised to ice injection site and did not prescribe any antibiotics. Discoloration has decreased in last 24 hours and her arm is feeling much better per patient.
pt came to hlth dept approx 3hr p/vax c/o severe pain in rt shoulder;no erythema noted & only sl warmth noted @ the inj site;
Pt in office for well child exam and vaccines, pt fainted within 2 mins after being injected with MENACTRA and Tdap vaccines. Recovered within 15 mins. No complaints/symptoms when patient left office.
This spontaneous report was received from a pharmacist refers to a 68 year old female patient. The patient's current condition included nerve pain, high blood pressure, acid reflux, seasonal allergies, cholesterol, thyroid dysfunction and diabetes. The patient's historical medication (last year) (unknown date in 2017)) included PREVNAR13 (Pfizer/Lot R48403 and expiration 01-MAR-2018) and patient developed skin warm, peripheral swelling, malaise and pyrexia. The patient's historical conditions included malaise, pyrexia, skin warm and peripheral swelling. Concomitant therapies included gabapentin, carvedilol, potassium (unspecified), omeprazole, furosemide, montelukast sodium (manufacturer unknown), isosorbide, lovastatin (manufacturer unknown), lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 03-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (anatomical location not reported) (lot # N022303, expiration date 01-MAR-2019) intramuscularly for pneumonia prevention. It was reported that the patient called and visited pharmacy on 04-MAR-2018 to report that on 04-MAR-2018 she had woken up this morning with a swollen left arm that felt hard and warm to the touch (peripheral swelling and skin warm). It was also reported patient had a fever. The patient called the pharmacy on 05-MAR-2018 to report not feeling well (malaise) and the entire left arm was swollen. It was reported that the patient would see an unspecified physician on 05-MAR-2018. The patient was treated for the events. The patient sought medical attention: called and visited pharmacist on 04-MAR-2018, would see physician on 05-MAR-2018. There was no intervention to prevent serious criteria. The outcome of the events was reported as not recovered/not resolved. The reporter did not assess the causality of the events. The reporter considered the events skin warm and peripheral swelling to be serious due to disability as the patient had difficulty using left arm.
Patient said she felt a little dizzy while walking down the hallway in the hospital. She had to have blood work drawn and during this she felt nauseous. At this time she became very pale and blotchy, her eyes rolled back in her head, body stiffened, hands and feet contracted. This seizure like activity lasted about 3-5 seconds per mom. Phlebotomist called ambulance. Paramedics checked blood pressure which was 151/80, they said she was alright. Per mom paramedic did not recommend going to Emergency Dept. Patient and mother left lab, was nauseated on the way home. Today 5/13/2020 patient has complaints of headache.
Headache, fever/chills, nausea. Lasted for about 13 hours
Discharge Physician: Medical Doctor Primary Care Clinician at Discharge: FNP Admission Date: 8/18/2022 Discharge Date: 8/19/2022   PRESENTING PROBLEM: Hyponatremia Fall, initial encounter COVID-19 virus infection   HOSPITAL COURSE: The patient is an 82 y.o. female who presented after a syncopal episode at home.  The patient states she has not been feeling well over the last 3-4 days.  She has a history of hypertension dyslipidemia.  She is COVID-19 positive however is asymptomatic with no respiratory distress or hypoxemia.  Upon admission she was found to be hyponatremic with a sodium of 125. She is on spironolactone/carvedilol/chlorthalidone as outpatient treatment for hypertension though chlorthalidone is only once weekly.  She was admitted to the medical service.  She was given IV fluids with 0.9% normal saline.  She felt significantly better the following day.  Sodium did remain low at 125. Chlorthalidone was discontinued upon discharge.  The patient felt well and will follow-up with her primary care physician.
Arm was severely swollen, red and hot to the touch around vaccine site. Swelling continued to increase. Emergency room visit was made 9/3/2015 due to increase swelling. Diagnosis: Cellulitis and abscess of upper arm and forearm. Cephalexin was prescribed to be administered twice a day for seven days. Child must be monitored if swelling continues to spread or fever develops he must go back to ER.
Flu & Pneumonia vaccine given Friday afternoon. Pt states Right arm was aching that evening (pneumonia vaccination arm).  Next morning complained of swelling and redness. Sunday morning arm was swollen, red and had a pocket of bloody fluid? below elbow.  Went to ER, was given IV antibiotics and sent home on oral medication.  Saw PCP on Monday, who reported that pt is being treated for cellulitis.  Phone call to pt 10/25, states he is improving.
This spontaneous report was received from a physician referring to a 4-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with PROQUAD recombinant human albumin (rHA) (lot # M040141) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis, which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007311: US-009507513-1705USA010146: US-009507513-1705USA010145: US-009507513-1705USA010144: US-009507513-1705USA010143: US-009507513-1705USA010142.
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
PATIENT STATES 4-5 DAYS AFTER VACCINATION HE EXPERIENCED AN ACHEY/BURNING SENSATION OVER OR NEAR HIS HEART. LASTED 4-6 DAYS AND THEN IT RESOLVED.
Triggered off the worst hemiplegic migraine that I have ever had; also, nosebleeds have started - about a week and a half ago.
At the injection site, it was swollen a lot more than usual. Probably like the size of an orange. it lasted 10 days. My doctor gave me a topical steroid or anti inflammatory. The top of my toes also became blistered and discolored-the entire toe.
JAW PAIN; REDNESS ON THE EARS; CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included temporomandibular joint disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included diazepam for temporomandibular joint disorder. On 08-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced jaw pain. On 09-MAR-2021, the subject experienced redness on the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested. The patient recovered from chills on 09-MAR-2021, had not recovered from jaw pain, and the outcome of redness on the ears was not reported. This report was non-serious.
Pt had dry throat, mouth, redness and flushing, tachycardia.
Pt. had pain in L shoulder starting 11/7/17 between 6-7PM. Went to Emergency Room 11/7/17 and was prescribed tramadol. Went to Primary Care MD 11/13/17 was prescribed Ibuprofen and a sling.
Headache, Arthralgia, Fever, NauseaVomiting, injection site pain, fatigue Narrative:
Immediately post vaccination pt c/o dizziness Vitals: 126/86, 79, 16, 97% -- > 119/83, 80, 16, 97% Pt given water and orange juice for hydration.  Pt stable and released from the vaccination site @11:15
This case was reported by a physician, via a GSK representative, and described the occurrence of abdominal pain in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date in the 2nd week of May (year unknown) the subject received 1st dose of CERVARIX (unknown route, unknown arm). A few hours after vaccination with CERVARIX, the subject experienced "severe" abdominal pain. At the time of reporting the event was resolved. The physician called the CDC and was told to restart the series with GARDASIL.
Arm was sore after the shot and I was a little light-headed, but went away--on the 12th I noticed the area of the arm was slightly red and felt slightly stiff. Talked to my Drugist and he said to let you know. Today, 15th, not as red nor as stiff.
on 5/20/21, I felt itchy on my back and started seeing rash near mid, left side of my back. The rash area grew larger over the time and I started feeling the pain the following day. I went to the urgent care on Monday morning and the doctor confirmed that I got shingles. I started antiviral (Valacyclovir) medicine now.
Mild pain in left arm; This is a spontaneous report from a non-contactable consumer or other non hcp. This consumer (patient) reported for herself that 51-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 07Jun2021 as unknown, single dose for covid-19 immunisation. Medical history included pain in lower abdomen and diarrhoea during the time of infection. The patient's concomitant medications were not reported. The patient previously took xeljanz XR (11MG). The patient reported mild pain in left arm after receiving COVID vaccine yesterday (07Jun2021). The patient underwent lab tests and procedures which included colonoscopy: bcteria in her colon on Mar2021 (she was on antibiotics for bacteria in her colon found after a colonoscopy). The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt's parent stated pt went to bed w/o fever or problems; given APAP 26AUG92 830PM; checked pt @ 11PM & fine; 1AM 27AUG parent said pt woke up & stared into space, would not respond to parent; this went on for 20minutes; t104;
Patient had a fever of 106 degrees (F) with erythematous maculopapular rash to the face, legs arms and back. The rash lasted 5 days. The patient was given Amoxil.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: pain and pressure on chest and back-Medium