chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In approximately 2004 ("approximately 5 to 10 years ago") the patient was vaccinated with PNEUMOVAX 23, (dose, route and lot# not reported). Because of the pharmacist's limited time availability, it was limited access to the patient's medical history. The patient had an adrenalectomy on an unspecified date "in the past year" (in 2013) related to a cancerous condition. The woman, since her adrenalectomy and being placed on high-dose corticosteroid therapy, has been hospitalized for pneumonia more than once, an unspecified number of times. The reporter did not have much time to go into much detail about which hospital the woman was admitted for treatment, or other medical conditions. The pharmacist did not known whether or not the cancerous condition was related to the patient's receiving PNEUMOVAX 23. The pharmacist was seeking information about which pneumococcal vaccine to administer to the woman, and at the time of this report, the woman was standing at the pharmacist's counter awaiting the response. The outcome of the events was unknown. Upon internal review, the event cancerous condition was considered to be medically significant. The pharmacist is agreeable to follow-up though he cannot determine whether or not the physician would be agreeable to follow-up about this patient. Additional information has been requested.
lifts her arm it is very achy; warm to the touch; injection arm sore/hurt; swollen; achy; sore arm for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a day or two), VACCINATION SITE MOVEMENT IMPAIRMENT (lifts her arm it is very achy), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection arm sore/hurt) and VACCINATION SITE SWELLING (swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a day or two). On 02-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (lifts her arm it is very achy), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection arm sore/hurt), VACCINATION SITE SWELLING (swollen) and MYALGIA (achy). At the time of the report, PAIN IN EXTREMITY (sore arm for a day or two), VACCINATION SITE MOVEMENT IMPAIRMENT (lifts her arm it is very achy), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection arm sore/hurt), VACCINATION SITE SWELLING (swollen) and MYALGIA (achy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Early AM 05/27, had 3 minute episode of stiffening, turned blue. Came around without intervention. Was taken to ER; had CBC and blood culture. Had low grade fever; seemed to feel well when seen in the office 5/28/05.
This spontaneous report was received from a pharmacist via other company Pfizer, refers to a 64 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date a year ago, the patient was vaccinated with PNEUMOVAX23 (Lot # and dose were not reported). The patient had a knot at the injection site which lasted 3 months. The outcome was unknown. The reporter did not provide the relatedness of the event with PNEUMOVAX23. Additional information has been requested.
Nausea, lightheadedness, ringing in ears, body aches, tiredness, and headache leading to legs collapsing. Taken to ER, labs drawn, fluids given with zofran and sent home.  Arm still red and swollen at vaccine site 5 days later and still having nausea, tiredness, body aches, and headache.
In the first week of April, patient developed bruise-like markings on her left upper arm where she received the vaccine.  The following week she noticed swelling and discoloration of her left arm.  She went to Urgent care on April 14th where bloodwork and an ultrasound came back normal.  Over the weekend of April 17-18, the swelling got worse and she called her PCP on April 19th, who advised her to go to the Emergency Dept.  At the ED, bloodwork, an ultrasound and CT of the chest was ordered and she was diagnosed with a blood clot.  Acute deep vein thrombosis of axillary vein of left upper extremity.  She was given a prescription for rivaroxaban.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Pt strart itching chest and extremeties.  We gave her 2 benadryl and kept her for 30 minutes
Progression of symptoms:  back pain for 5 days starting  17 days after 1st vaccination, which resolved and moved to head pain (for 30 days, back of neck everywhere, but right side worse, could take pulse from throbbing) . Controlled with Gabapentin 1 x daily and frequent advil.  Other symptoms included chills, fatigue and night sweats without fever.  As these symptoms resolved, it moved to partial facial paralysis (eyes, nose, lips) for 7 days so far. Hospitalized  at day 2 overnight and given IV Immune Globulin and IV Solvmedrol in hospital.  Released and prescribed Prednizone 40MG tabs for 7 days (3 days left).  No relief so far of these Bells Palsy-like facial symptoms.
Patient received her 2nd dose of Moderna from a refrigerated vial expired by 11 days.
no energy/Feeling of washed out; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 88-year-old female patient received BNT162b2 (BNT162B2), on 19May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 88 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She has been diagnosed with depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 2, LOT: EL3248, Anatomical Location: Left arm), administration date: 01Feb2021, when the patient was 87-year-old, for COVID-19 immunization, reaction(s): "she has received her first dose of the Pfizer Covid-19 vaccine, a second dose (which she referred to as her first booster per RA agent), and third dose (which she referred to as her second booster per RA agent)."; BNT162b2 (Dose: 3 (1st booster), Lot: 30155BA, Anatomical Location: Left arm), administration date: 12Oct2021, when the patient was 88-year-old, for COVID-19 immunization, reaction(s): "she has received her first dose of the Pfizer Covid-19 vaccine, a second dose (which she referred to as her first booster per RA agent), and third dose (which she referred to as her second booster per RA agent)."; Bnt162b2 (Dose: 1, Pfizer Covid Vaccines, LOT: Pfizer EL3TQ8, Anatomical Location: Left arm), administration date: Jan2021, when the patient was 87 years old, for COVID-19 immunization, reaction(s): "she has received her first dose of the Pfizer Covid-19 vaccine, a second dose (which she referred to as her first booster per RA agent), and third dose (which she referred to as her second booster per RA agent).". The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "no energy/Feeling of washed out"; FATIGUE (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of asthenia, fatigue.
pt  w/ allergy to PCN was found to be pregnant, devel URI treated w/erythromycin for 1 wk. delivered normal female infant 30jan96.
Narrative: 60 year old male admitted on July 17 2022 and was transferred with cold-like symptoms and found to have COVID-19. He was admitted to ICU for isolation. He had received Moderna vaccine x 3 on March 24, 2021, April 21, 2021, July 28, 2022. He was treated with he received remdesivir x 5 days and dexamethasone 6 mg IV daily x 5 days. He clinically improved and treatment discontinued after 5 days.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX 0.5 ml subcutaneous (dose number and lot numbers were not reported). No adverse effects reported. This is one of two reports received from the same reporter. Additional information is not expected.
This spontaneous report as received from a licensed visiting nurse refers to a currently 14 years old female patient with allergic rhinitis and no drug reactions/allergies. The patient was vaccinated intramuscularly with lot # (669285/0691AA exp date 17-AUG-2013) dose 1, 0.5 ml of GARDASIL on 22-JUL-2011. The patient was vaccinated with dose 2 (lot # 670050/1229AA exp date 12-NOV-2013) and dose 3 (lot # 672193/1524AA exp date 23-AUG-2014) of 0.5 ml GARDASIL intramuscularly on 10-OCT-2011 and 06-MAR-2012 respectively. No other co-suspects were reported. Concomitant therapy might have include NASONEX. The nurse reported that 2-3 weeks after receiving the first dose (approximately on 05-AUG-2011) the patient developed a nickel sized welt on her right arm at the site where she received the injection. It was also reported that 3-4 months after receiving her third dose (in January 2012) the patient again developed a nickel sized welt on her right arm at the site where she received the injection and once again 4 months after receiving her third dose (in July 2012) she developed a nickel sized welt on her right arm at the site where she received the injection. The patient's mother did not notify the office these events until 06-AUG-2012, during an office visit. The patient was seen in the office that day because she "passed out" (medically significant upon internal review) after having breakfast that morning. No treatment information was reported and no lab diagnostic tests were performed. The outcome of the events was reported as recovered on an unspecified date. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fever-Medium
04/03/2022, non-stop coughing. ( severe swelling of feet and breast- most likely due to side effects from Chemotherapy).
p/vax pt was crying; gasped; went limp; turned blue; eyes wide open; when came to started crying & was sleepy; examined by paramedics-nl exam
Headache; Body aches; Stomach cramps; Exhaustion; General weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: 3248) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID, 19, brand=Pfizer BioNTech,, lot number=EL3248,, administration date=09Mar2021,, vaccine location=Left arm,, dose number=1), administration date: 09Mar2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Body aches"; ABDOMINAL PAIN UPPER (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Stomach cramps"; FATIGUE (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Exhaustion"; ASTHENIA (non-serious) with onset 01Apr2021, outcome "not recovered", described as "General weakness". Therapeutic measures were not taken as a result of headache, pain, abdominal pain upper, fatigue, asthenia. Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient wasn't diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Ethnicity information is available. Race information is available.  No follow-up attempts are possible. No further information is expected.
On May 20, 1999 the pt experienced a high fever of 101F which persisted for days. On May 21, 1999 the rash was generalized, fine, and papular. The skin very red, and there were red bumps in all her hot spots, on stomach, neck, ears, under her arms, and inside her elbows. On 06/01/1999 the pt was afebile, but the rash was increased. The pt was taken to MD seven times, and was taken to a dermatologist. No dx was made. The pt was treated with cortisone cream and antihistamines. Subsequently, the pt recovered from the fever. Follow up was received from MD. Referred to a allergist.
Pt given DTaP and IPV in left upper arm. Twenty-four hours later complained of itching and discomfort. Forty-eight hours later noted to have redness, firm swelling, itching in area of immunizations. There is no fever or tenderness. No axillary node swelling.
PT WAS ADMINISTERED VACCINE AFTER REVIEWING PRESCREEN QUESTIONARE.  PT DENIES ANY PRIOR VACCINATION COMPLICATIONS OR ADVERSE REACTIONS.  ROUTINE MONITORING OCCURED  AND APPROX 15 MIN AFTER STAFFF WERE NOTIFIED BY PT THAT SHE HAD A FEELING "LIKE SOMEONE PUNCHED HER IN THE THROAT."  MEDICAL PERSONNEL CHECKED ON THE PT.  STAFF AND STAFF QUESTIONED THE PT.  PT DENIED ANY DIFFICULTY BREATHING, AND PT WAS ABLE TO SPEAK IN CLEAR FULL SENTENCES.  VITALS WERE TAKEN AT THAT TIME: 15:48 1ST VITALS BP: 142/98 HR: 64 RR: 30-36 ASKED PT TO REMAIN ON SITE A LITTLE TIME LONGER FOR OBSERVATION PIRPOSES, AND TOLD WILL DO A SET OF VITALS EVERY FIVE MINUTE   PT WAS ASKED TO NOTIFY IF ANY CHANGES ARISE BY HONKING OR TURNING ON HER FLASHERS.  PT WAS MONITORED BY PERSONNEL.  PT STATED THAT THEY NOW STARTED TO FEEL LIGHTHEADED, AND WAS EXPERIENCING SOME BLURRED VISION.  PT'S COLOR WAS NOW PALE IN TONE.  STAFFE, DECIDED TO CALL 9-1-1.  STAFF, SPOKE WITH 9-1-1 TILL AMBULANCE CREW MADE CONTACT WITH PT.   SECOND SET OF VITALS:  15:54 BP: 170/115 HR: 82 RR: 36  FOLLOW UP QUESTIONING FOUND THAT PT HAD RECENTLY BEEN TESTED FOR REACCURING LIGHT HEADEDNESS TIMES TWO MONTHS.  LAST ORAL INTAKE AN HOUR PRIOR  (CHIPS & SALSA). ALLERGIES: TRAMADOLE MEDICATIONS: RUSPIRONE 10MG DAILY / CITALOPRAM 20MG DAILY  UPON ARRIVAL OF AMBULANCE THEIR CREW WAS BRIEFED BY STAFF, AND ONCE AMBULANCE CREW MADE CONTACT WITH PT CARE WAS TRANSFERED.  AMBULANCE CLEARED SCENE APPROX 10 MINUTES AFTER ARRIVAL.
Pt is complaining that the injection site is "oozing" and then forming a scab and that her arm is hurting from the shoulder down towards her hand. She has a lump at the injection site
Extreme headache specifically at the top of my head is where it starts. It's sharp and dull pain. Some mornings I wake up with a headache like this morning , other times over the last couple of weeks it takes a few hours to start and has become a migraine 3 times. At that point when I take the migraine medication it migrates to my ears and eyes get super sensitive - I try to take my meds as quick as possible to avoid how far it spreads. But i'm limited to how much I can take because the meds are hard on your body and I am limited to how much I'm given per month. So I always try to take Excedrin first but. One of those 3 times with the migraine I've taken the medication that you take 1 and then a second dose later. The headaches are getting lighter and shorter in duration the further out from the dose of the vaccination. I previously filed a report from the 2nd dose.  Fibromyalgia has intensive and same as the headache, the further away from the vaccination the closer it gets to my norm. With the asterixis that my norm has seemed to permanently changed since my initial covid shot. Like everything is more sensitive. The pain that comes for a short period time varies and comes from deeper within rather than the surface---but now after the shot the pain comes from deeper within and is more intensified as well as sometimes it's really sharp, which is different from what I have ever experience. The fibromyalgia and the way it works has been changed from the initial shot in a negative way. It has also made the restless leg pain more often and harsher and longer duration.  Chronic fatigue has exacerbated since first shot and has not changed like the other symptoms. I can't do anything. And there has also been a lot of dizziness to the point that I wouldn't drive. Because of the fatigue and pain, I've not been able to start my post surgical physical therapy.
beginning 22FEB93, pt had fever of 102; pt had a cough & began trembling & eyes were twitching; pt never lost consciousness, but seemed incoherent; taken to ER & was told by MD pt had febrile sz & didn't feel it was related to DTP; sore arm
Itchy red rash developed to right arm about 2-3 days after she received the shot. Rash lasted several days. Did not go to MD for this.
Arthralgia Pain at injection site, Sharp pain in back-states feels muscular Narrative:
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Taste loss, Constipation, Hemorrhage and Bladder disorder NOS. Concomitant products included PLANTAGO OVATA (METAMUCIL CITRON) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-015720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information received: Updated second dose details, medical history and concomitant medication.
This spontaneous non-valid report as received from a pharmacist refers to a patient of unknown age and gender. Patients' concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, units and frequency not reported) (lot# and expiration date not reported) intramuscularly. On an unknown date, patients experienced soreness at injection site. The outcome of the event injection site pain was not reported. The reporter did not provide the causal relationship for the event with suspect therapy PNEUMOVAX 23. This is a non-valid spontaneous report due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because of patient identifier. Information has been received from a pharmacist on 16-MAY-2018. Reporter clarified that, this report refers to male patient of an unknown age. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1805USA007662: US-009507513-1805USA007660: US-009507513-1805USA007661.
Janssen Covid-19 Vaccine EUA  Body Aches, headache, fever, chills, sweats, nausea, short of breath
Extreme pain at injection site to half way down arm as well as under arm.  Entire body in extreme pain. Very Sleepy. Fever of 100.9  Took Ibprofen which barely touched the pain, slept.  I'm still having symptoms on 6/17/19, but not as bad as first two days.
One day post administration redness (approx 40mm) and swelling and extreme pain (rated 10 out of 10) at injection site accompanied by flu-like symptoms. Patient returned to doctors office and was given Vicodin.  Day 2 post injection redness and induration had increased to size of grapefruit and pain and flu-like symptoms worsened.  Patient seen in doctors office was given Dilaudid and Celebrex x1 week.  Flu-like symptoms gone by day 3 and redness and induration slowly receeded.  8 days post injection redness and induration at injection site 20 mm. This event seemed like a severe local reaction -- not an allergic reaction but since it required 2 additional doctors visits I thought I would report it.  Also advised by my doctor not to get another PPV23 injection in the future.  I am an RN as well as the patient and I work in an immunization clinic.
Axillary Lymph Node Swelling- size of baseball. Tenderness and pain
Mother is stating that 7days after vaccine was given child has "throat spasms", dizziness for 4days,right side pain in shoulder,eye,foot. Also stating balance is off and at times her mental status is unclear.
I felt fatigue, nausea, sore arm and chills on the day of vaccine, day 1.  On day 2 , fatigue and nausea, and soreness persisted with general body aches.  On day 3 , fatigue, nausea, and persistent headache, with sore arm abating.  On day 4, fatigue, nausea, and persistent headache.  On day 5, fatigue, nausea, persistent headache, chills and pronounced vertigo. Today is day 6 and it's too early to tell if symptoms will return.
On 5/20/07, pt developed vomiting and hemoccult positive, pink, mucoid stools admitted -> Hosp. 5/21/07, Contrast BE -> NL No intussusception found. Abd/Renal US NL.  6/29/07 Received hospital medical records which reveal patient experienced intermittent bilious vomiting & bloody green diarrhea.  Seen in PCP office 5/21 & admitted to hospital 5/21-5/23/07.  GI consult done FINAL DX: acute gaastroenteritis. 7/3/07 Received vax record from pcp which indicated RO only vax given that date & lot & dose correct as reported.  T/C to pcp office to confirm.
No further adverse event (AE) details; Proquad was stored in the refrigerator instead of the freezer since 01-DEC-2020; This spontaneous report has been received from a nurse regarding to a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 28-JAN-2021, the patient was vaccinated with an improperly stored dose (stored in the refrigerator instead of the freezer since 01-DEC-2020) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live  (PROQUAD) injection, at a dose of 0.5 milliliters (mL), lot number reported and validated as T025221, expiration date reported and validated as 19-JAN-2022, (strength, route of administration, anatomical site of vaccination, and vaccination scheme frequency were not reported) (product storage error) and on an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 mL (strength, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported) both as prophylaxis.   It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature of 44 Fahrenheit degree (F) for the time frame of 1506 hours. There was no previous temperature excursion and the call was not due to a data logger.  No adverse effects reported.