chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A marble size lump at the injection site that is still there 7 weeks later; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729) via intramuscular route administration, administered in arm left on 22Apr2021 13:00 (at the age of 63-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient had no Known allergies. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) via intramuscular route administration, administered in arm left on 01Apr2021 (at the age of 63-year-old) at dose 1, single for covid-19 immunisation. Patient did not have other vaccine in four weeks, other medications in two weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. On 22Apr2021 13:00 the patient experienced a marble size lump at the injection site that is still there 7 weeks later. Patient did not receive treatment for the adverse event. Outcome of the event was not resolved.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.
Warm to touch; Red and warm to touch; Injection site started to itch; Felt tender; Area along the muscle were the vaccine was administered has a bump; Very severe arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very severe arm pain), VACCINATION SITE MASS (Area along the muscle were the vaccine was administered has a bump), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site started to itch) and VACCINATION SITE PAIN (Felt tender) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Renal disease (Kidney Disease).  Concomitant products included RAMIPRIL for Renal disease.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Very severe arm pain). On 09-Jan-2021, the patient experienced VACCINATION SITE MASS (Area along the muscle were the vaccine was administered has a bump) and VACCINATION SITE PAIN (Felt tender). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site started to itch). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Red and warm to touch). On 09-Jan-2021, PAIN IN EXTREMITY (Very severe arm pain) had resolved. At the time of the report, VACCINATION SITE MASS (Area along the muscle were the vaccine was administered has a bump) and VACCINATION SITE PAIN (Felt tender) had resolved and VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site started to itch) and VACCINATION SITE ERYTHEMA (Red and warm to touch) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Phone call from patient, states she has "hives all over". Transferred patient to triage nurse.
Information has been received from a company representative concerning a 6 year old male relative who was vaccinated with varicella virus vaccine live (Oka/Merck) and subsequently the patient "broke out with chickenpox after getting varicella virus vaccine live (Oka/Merck)". The number of lesions was unknown. The lot number was not provided. There was no product quality complaint. Additional information has been requested.
PT complaint of left lower rib pain, radiates up into her shoulder and painful breathing with deep inspiration.  associated radiation to her neck as well.  concerned for past history of DVT.
Congestion; She is breastfeeding; Itching; Redness; Red itchy eyes; Numbness; Feeling hot; Rash; Hives all over her body but primarily on forearms, elbows and hairline; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline), NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching) and ERYTHEMA (Redness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hay fever. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 08-Jan-2018 to an unknown date for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Fatigue). On 23-Apr-2021, the patient experienced URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline). On an unknown date, the patient experienced NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Red itchy eyes), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 04-May-2021 to 2021 for Hives, at a dose of 1 dosage form; OATMEAL for Hives, at a dose of 1 UNK and ASCORBIC ACID (VITAMIN C CITRUS) at a dose of 1 dosage form. On 26-Apr-2021, URTICARIA (Hives all over her body but primarily on forearms, elbows and hairline) had resolved. At the time of the report, NASAL CONGESTION (Congestion), MATERNAL EXPOSURE DURING BREAST FEEDING (She is breastfeeding), PRURITUS (Itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Red itchy eyes), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot), RASH (Rash) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.    This case was linked to MOD-2021-271601 (Parent-Child Link).   See case MOD-2021-271601 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: FU received: Added events, outcome updated, con med added, patient demographics.
delayed reaction 9 days later with swelling at injection site - red, elevated, itchy, hot. The size of the palm of my hand
On 10-03-11, I was given a FLUARIX  -36+ month - PF latex - flu shot within a week, I began having discomfort and stiffness in my arm and shoulder. Prior to the flu shot I had no injuries, issues or problems with my left arm. As it got worse, on 11-28-11, I went to the doctor regarding the increased pain in my arm and shoulder. The constant throbbing and the pain limited my abilities to use my arm and was getting only about 2 hours of sleep a night due to this situation. On 12-14-11, I again returned to the doctor as the pain was increasing even more and my range of motion was very limited at that point. It was difficult to dress or do anything that required use of my left arm. On 1-12-12, I again returned to the doctor as the pain had increased to unbearable. He ask that the following tests be done and they were that day. Chest x-ray and shoulder x-ray. They showed no problems. On 1-20-12, a MRI was done with no contrast. All the above tests showed no signs of rotator cuff tear or injury. On 1-25-12, I was seen at orthopedics and given a cortisone injection and arm exercises to try to increase my range of motion. Because I had no prior issues or injury to my left arm before the flu shot, I began and extensive internet research regarding side effects to the flu shot. I was stunned at the information I found and the problems I've encountered are ?not? uncommon. The flu shot is so recommended by doctors, pharmacies, insurance companies and media, but no where were there any warnings about possible side affects! I truly believe all the problems I've had with my left arm - the pain, suffering, loss of motion etc. was ?all caused by the flu shot? I received. Currently my out of pocket expenses total $532.00. This includes doctor visits, x-rays, MRI and medicines, not to include the pain and suffering - and not knowing that the pain will ever truly go away and/or that I'll have full use and range of motion in that arm. At a minimum, I should be reimbursed for ?all of pocket expenses? due to this fiasco. If I or others would have been provided the possible side affects - this could have been avoided as I would have never agreed to have the shot in the first place.
Early morning the day after receiving the shot, the patient awakened with extreme flu-like symptoms of aches, nausea, and malaise. Patient reported no fever but extreme feeling of fatigue and nausea that lasted greater than 24 hours. No emesis occurred.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2016 (also reported with conflicting information as 06-MAR-2016), the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for the prevention of shingles. Shortly after receiving ZOSTAVAX, the patient developed severe nerve pain, hearing loss and vision loss. As a direct and proximate result of these malfunctions, the plaintiff suffered long-term injuries and damages, and required extensive medical care and treatment. As a further result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a result of ZOSTAVAX, the plaintiff suffered severe and permanent personal injuries. As a further consequence, the plaintiff suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered. The events of severe nerve pain, hearing loss and vision loss were considered medically significant. The events of severe nerve pain, hearing loss and vision loss were considered disabling. Additional information has been requested.
Painful Right arm. 10/10 unable to sleep at night. Significant stiffness.
Patients heart rate went to 91 and she felt palpitations. They lasted for a few seconds and resolved on their own. Heart rate went down to 71.
Patient was given vaccine that had been in refrigerated temperature for 7 days (outside length of time advised in EUA). No adverse events have been reported at this time. We are speaking with company regarding re-immunization.
after vaccine pt had injection site reaction with flushing of face.  Pt complained of lightheadedness pt was given 25 mg of Benadryl and assessed for further treatment over next 2 hrs.
The office had a power outage that required us to move the vaccines to another location. Unfortunately it was determined by the Department of Health and the vaccine manufacturer that the vaccine was believed to be non-viable after this move. No adverse event has been reported.
Swollen area at injection site about the size of an avocado.  No redness or itching at this time.
pt recvd vax & began crying unconsolably for 3 days; gave apap every 4 hrs; saw MD; rxn to pertussis; pt had ear infection & would not take bottle during3 days of cry;
This is a spontaneous report from a contactable consumer (physician assistant) received from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced crohn's disease on an unspecified date. It was reported that patient with Crohn's disease had pneumococcal 13-val conj vac (dipht crm197 protein) shot as a child and at time of report patient was adult and wanted to know the protocol, asking if patient should get shot again since the patient is an adult. The outcome of event crohn's disease was unknown.
3days p/vax pt devel fever of 104f, vomiting & diarrhea; pt taken to ER, personnel noted smell in stool suggestive of rotavirus
Hives to neck, arms, legs, back.  Onset over 48 hours after injection.  she denies oral or throat swelling, shortness of breath.  She declines evaluation and potential steroid therapy.  Tried diphenhydramine with paradoxical wakefulness.  Loratadine offered brief improvement in symptoms, discussed symptomatic treatment, to be seen if symptoms worsen or fail to improve.
Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as time passed, started hot flashes , cold flashes and shakes around 11am, right kidney (?) area on back started to hurt around 11:30am pain increasing as well.  All persistent until about 5:30pm where the kidney (?) pain subdued followed by the hot and cold flashes around 7pm. Nausea and shakes passed by 1/30/21 am after I woke up. Full Left arm pain continued all day 1/30/21.
I had my 2nd vaccine on April 13.  On April 14 I had scheduled annual labs.  My labs came back the next day and were ALL over the place.  My glucose was high , cholesterol Numbers were ALL high, liver enzymes etc.  My labs have always been normal.   My doc said "we will just recheck them in a month" not thinking what my body must be doing to have registered those kind of numbers!  I started feeling ill that day.  Extreme abdominal pain, Extreme bloating, and as the days went on, weight gain of 15-20 lbs of fluid.  I went to my doctor twice, I went to ER and got 2 rounds of antibiotics as they thought it was a bacterial infection in my gut.  I was still in pain, they ordered a colonoscopy.  I never got to do the colonoscopy as I died the night before.  DIED.  For 20 minutes - my boyfriend gave me CPR for 12 then the ambulance team took over.  I was flown that night for 12 days.  It has been a road getting back to anywhere near normal.  I had a 100cc CLOT  in my heart  and 2 mini strokes in my brain because of the clotting.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 31-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unknown date after receiving ZOSTAVAX, the patient was seen by a physician and was prescribed an unspecified steroid for an unspecified reason. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
My mother took 2 doses of the covid 19 pfizer vaccine. After her 2nd dose she was fatigued but she knew that was a side effect. Her 2nd shot was in May 2021. Shortly after that she stayed fatigued. Over the past 3 months she has been in the hospital or Doctors officer. She has tremors, her taste if off, muscle pain, her joints ache, she has a rash, she has lost 20 pounds and she CAN NOT WALK! She has no muscle left on her body. She had none of this before this vaccine. They are saying maybe autoimmune.
30 hours of fever, headache, left arm pain, inability to sleep, Muscle aches, mild mental confusion- improved with time and Motrin
Severe red and purple raised rash, extremely itchy, behind bilateral elbows, behind bilateral knees, on bilateral calves, bilateral axilla, left wrist. Rash more severe on left side.
had received her first 2 doses in a 3 dose series of GARDASIL9 in 2015 and has not yet received a third dose; no additional AE; This spontaneous report was received from a registered nurse and refers to a 22-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates in 2015, the patient received 2 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that she had not yet received a third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of vaccine administered). There was no additional adverse event reported.
Shot given 1/31. Redness began after 24 hrs. 210mm erythema & edema at inject site.
Pain/swelling in the injection site the evening  of 2/26 and for a day or two after. Lightheadedness/fatigue the evening of 2/26 and part of the day after. Some tenderness/soreness in underarm area of the same arm injected.  This didn't start for probably a week or so and lasted for maybe a week.  I am not 100% sure on the timelines for that, but I know it didn't start right away and I know it was gone by 2.5 weeks after the injection.
Information has been received from a physician concerning a female patient who was vaccinated with a second dose of Gardasil. On 26-JUN-2007, the patient was very pale and became a little woozy but she did not faint. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse stated that the patient received unspecified doses of ROTATEQ (lot # M031802, expiration date 09-NOV-2017) that were improperly stored (dosages and routes of administration not provided). The doses were administered between 06-APR-2017 and 29-JUN-2017. No adverse effects reported. Excursion information: Temperature 35°F for 30 minutes. No prior excursions. Data logger involved. No further information provided. This is one of four cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004307: US-009507513-1707USA004306.
Patient experienced acute leg weakness progressing to include arm weakness and overall body weakness within a two-week period. Saw family physician on 12/8/08. Extensive lab testing was completed with normal results. Had follow-up visit with family physician who then referred patient to neurologist. Diagnosed by neurologist on 1/5/09 with Guillain-Barre. Patient still experiencing weakness and fatigue.  1/23/2009 MR received from Neurologist for DOS 1/5/2009 with DX: Acute Demyelinating Immune Polyneuropathy (Guillain-Barre syndrome). Appears to be a mild case already improving.  Possibly r/t Flu shot although not certain.  Pt presented for eval of weakness which developed in mid November 2008. Pt's legs felt rubbery and gait was abnormal. No muscle pain or sensory loss. Remained stable x 1 month, now improving x 2 weeks. More easily fatigued.  PE (+) for slight waddling type gait, decreased strength (3/5) of the interossei upper and 4/5 lower extremities, absent tendon reflexes. No tx since pt was improving w/o tx.
She tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced she tested positive for covid on an unspecified date. Reporter stated his wife got (first) shot on 07Apr2021 that was like 3 weeks ago and she was supposed to get second shot on 28Apr2021 which is Wednesday. She tested positive for covid. Now she has Covid. Reported asked if she should go and get the shot or not go and get the shot. The event outcome for events was unknown
Rash/redness at injection site. Itching. Feels like a lump under the skin that wasn't there before. Just started this evening. Will put ice on it and perhaps take an anti histamine tomorrow if it still itches.
Hives on face appearing appropriately three hours after injection. New hives continued appearing over the next few hours up to the size of a half-dollar coin.
Low grade fever, severe chills, headache, no energy Took acetaminophen for fever symptoms lasted about 16 hours
when I was undressing  to take a shower, my left breast intense  itch on the outside to the nipple. After scratching  it, I took a shower, applied hydrocortisone, red lines where left for 2 days. not hives, it did not look like it was caused from the scratching. It was more like red streaks.  The next day I was fatigued, upset stomach, and body aches. My injection site got sore the next day and felt worse the day after. Took Tylenol and  after 3 days I was fine.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and current conditions were not provided. On 21-SEP-2016, the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX 23 (dose and route were unknown; lot number K019386 with expiration date 09-JUN-2016). No adverse effect was reported. Additional information has been requested.
headache; chills so cold her teeth were chattering; nausea; diarrhea; a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA. The following information was reported: HEADACHE (non-serious) with onset 08Apr2021, outcome "recovered" (2021), described as "headache"; CHILLS (non-serious) with onset 08Apr2021, outcome "recovered" (2021), described as "chills so cold her teeth were chattering"; NAUSEA (non-serious) with onset 08Apr2021, outcome "recovered" (2021), described as "nausea"; DIARRHOEA (non-serious) with onset 08Apr2021, outcome "recovered" (2021), described as "diarrhea"; PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "recovering", described as "a sore arm".  Additional information: Patient arm is still little tender but otherwise she is recovered. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), patient's medical history (including any illness at time of vaccination), family history and relevant test reported as none at the time of report. No emergency room or physician office reported at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per patient she started to have redness a few inches below the shot the next day. It has decreased, but there is still some redness today 12/17/22. Pt also reports developing a really bad sore throat on Friday 12/16/22 and she has seen a telehealth doc about. Doctor told her it was not related to the shingles shot.