chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse via other company Pfizer refers to over 100 patients of unknown age (both pediatric and adult) and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In MAY 2016 and JUNE 2016, the patients were vaccinated intramuscularly with unknown doses of PNEUMOVAX23 (lot # L022262, expiry date 05-NOV-2016) after temperature excursion included 192  hours total of refrigeration for a maximum temperature of 49.8 degrees Fahrenheit. The reporter confirmed that 7 doses of PNEUMOVAX23 were given in MAY 2016 and was unable to confirm how many doses were given in JUNE 2016. No patients received doses after 29-JUN-2016. The reporter's institution did not receive any report regarding any adverse events involving these patients. Additional information has been requested.
rash; Allergies; burns; swelling; Acne; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2023 at 02:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: TOPAMAX. The following information was reported: ACNE (non-serious) with onset 13Jan2023, outcome "not recovered"; HYPERSENSITIVITY (non-serious) with onset 13Jan2023, outcome "not recovered", described as "Allergies"; THERMAL BURN (non-serious) with onset 13Jan2023, outcome "not recovered", described as "burns"; RASH (non-serious) with onset 13Jan2023, outcome "not recovered"; SWELLING (non-serious) with onset 13Jan2023, outcome "not recovered". The events "rash", "allergies", "burns", "swelling" and "acne" required physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of rash, hypersensitivity, thermal burn, swelling, acne.  Additional information: Reported as Serious: Yes. Seriousness criteria-Disabling/Incapacitating: Yes. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Topamax within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, the patient been tested for COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills  started an hour and a half later, fever , , the next 2days afterthat vomiting began, then diarrhea for another 2 days.
Swollen arm; red arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and PAIN IN EXTREMITY (Sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As a corrective treatment, patient put ice on the area and has been taking Multim and Benadryl.   No concomitant medications were reported.
He still doesn't feel great like 100%; He feels like nervous anxiety in his body; His feet were burning; He felt nauseated; His body was warm; something came out of blue on a flash, and he had a weird reaction; His heart rate became elevated; Patient had very bad reaction for 24 to 48 hours after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Patient had very bad reaction for 24 to 48 hours after receiving 1st dose), FEELING ABNORMAL (something came out of blue on a flash, and he had a weird reaction), HEART RATE INCREASED (His heart rate became elevated), FEELING ABNORMAL (He still doesn't feel great like 100%) and SKIN WARM (His body was warm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION COMPLICATION (Patient had very bad reaction for 24 to 48 hours after receiving 1st dose). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (something came out of blue on a flash, and he had a weird reaction), HEART RATE INCREASED (His heart rate became elevated), SKIN WARM (His body was warm), BURNING SENSATION (His feet were burning) and NAUSEA (He felt nauseated). On 25-Mar-2021, the patient experienced FEELING ABNORMAL (He still doesn't feel great like 100%) and ANXIETY (He feels like nervous anxiety in his body). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Patient had very bad reaction for 24 to 48 hours after receiving 1st dose), FEELING ABNORMAL (something came out of blue on a flash, and he had a weird reaction), HEART RATE INCREASED (His heart rate became elevated), FEELING ABNORMAL (He still doesn't feel great like 100%), SKIN WARM (His body was warm), ANXIETY (He feels like nervous anxiety in his body), BURNING SENSATION (His feet were burning) and NAUSEA (He felt nauseated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: increase (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
At first, arm was sore and a little red at injection site. Over the course of 6 days, arm pain was gone and redness became less and less. However on day 7 after vaccination, injection site became extremely itchy, red, has fever in it, and is swollen and hard at injection site. Oral antihistamines have not helped.
Patient received primary COVID Pfizer dose on 9/30/22. Returned for dose #2 and was inadvertently given COVID BIVALENT booster on 10/21/22.
immediately got sick; Initial information was received on 10-Dec-2020 regarding an unsolicited valid non-serious case received via social media from a consumer (patient).  This case involved an unknown age patient who got sick (Illness), while he/she received INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient immediately got sick (Illness) following the administration of INFLUENZA VACCINE .  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.   There would be no information available on batch number for this case.
On  8/22/2022 thru 8/24/2022 my left arm was very sore.  On 8/25/2022  I started having sharp bee stinging pain and very painful electrical shocking pain - extremely painful.  I checked with the pharmacy they advised to apply ice pack twice daily.  Pain continued on and off.  Never stopped.  On 9/19/2022 saw primary doctor.   She prescribed Prednisone 20 mg twice daily for 7 days along with Gabapentin 100 mg 3 times daily.  I had some relief but it doesn't go away.  It continues daily off and on.  Mostly the electrical current type of pain from the near shoulder (left) all the way down to hand.  Totally  reduced my quality of life
Leg Pain  Muscle Pain (thighs/legs/knees) Leg Swelling Leg Tenderness Sharp Pains in Calf Area
Received second Shingrix vaccine (7/16/2020). Pain, redness, swelling at injection sight the following day and for about a week afterwards. I was also running a fever, had a headache and chills for a day. Three weeks later, around 8/7/20120, broke out with shingles Currently still have shingles along with being tired and achy.
J&J Dose 4/7/21 (043A21A) Pfizer Dose 12/20/21 (NA) COVID Positive 3/27/22  3/16/22: 64-year-old man who was transferred from Emergency Department for further treatment and evaluation of acute pancreatitis and  uncontrolled diabetic ketonemia.  He reports feeling unwell since December with multiple complaints of abdominal discomfort, diarrhea, generalized weakness and malaise.  Acute episode of illness is reported since approximately 10 days ago with worsening abdominal pain aggravated by alcohol use.  He has a known history of alcohol use disorder, drinks 8-10 beers as well as several shots of whiskey daily.  He is denying any prior history of delirium tremens or withdrawal related seizures.  He denies any prior diagnosis of acute pancreatitis and denies previous diagnosis of alcohol related liver disease.  He reports that his last drink was last week Thursday.  He reports recently been diagnosed with type 2 diabetes mellitus last week and started on oral anti diabetic medications, he is not aware of his hemoglobin A1c at diagnosis.  He has not been compliant with anti diabetic medications.  He presented to the source of referral with worsened abdominal discomfort and on evaluation was found to have markedly elevated lipase levels of 7300.  He was also hyperglycemic in the 400s with elevated  anion gap and serum ketones without accompanying acidosis, pH of 7.39 was reported.  He was transferred for further treatment and evaluation.  4/1/22: 64 male with a history of chronic alcoholism presented to ER complaining of abdominal pain, diarrhea and generalized malaise for several days. Patient diagnosed with DKA, alcohol withdrawal symptoms and acute pancreatitis.  Patient later transferred from the ER to continue with management.  He was moderately hypoxic on arrival to the medical floor.  The chest x-ray showed basal infiltrate/atelectasis.     He was treated with NPO, IV fluid, parenteral opiate analgesics, insulin, IV antibiotics, benzodiazepine protocol  and other supportive care.  Patient was having intermittent fever but blood cultures x4 came back negative.  He has been gradually improving with complete resolution of fever. Curiously the hemoglobin A1c was only 5.4% indicating he may not have diabetes despite the blood glucose was quite elevated on initial presentation to the ER.  On re-evaluation today he is a alert and oriented in all parameters.  Abdominal pain resolved.  The glucose monitor his between 100-130 mg/dL.    He will be discharged on his pre-admission medication only.  I advised him regarding diabetic diet and also counseled him to quit drinking which is the etiology of his problem.  He promised to quit drinking.  He will follow-up with the PCP in 1-2 weeks.  I field out form for him to continue with physical rehabilitation post discharge.
Cellulitis L thigh tx with Augmentin 400/5 T po bic with food x 10d.
HARD TO READ/CONCENTRATE; HEADACHE; DISCOMFORT WITH DIZZINESS; FEVER; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38.5 Degree Celsius, and Body temperature decreased (NR: not provided) 38 and 37.8 Degree Celsius. On 16-MAY-2021, the subject experienced discomfort with dizziness. On 16-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced hard to read/concentrate. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 16-MAY-2021, was recovering from headache, and discomfort with dizziness, and the outcome of hard to read/concentrate was not reported. This report was non-serious.
Recipient received the second dose of Moderna early, second dose given at 18 days from first dose.  Spoke with Moderna and there is no further action to take, third dose at another interval not required, advised watch for side effects.
This spontaneous report as received from a reporter through a newspaper article, refers to several unspecified patients of unknown age and gender. Medical history and concurrent conditions of the patients was not reported. On an unknown date the patients were vaccinated with M-M-R II. On an unknown date, the patients experienced an outbreak of measles of which one patient had to be hospitalized (The newspaper article also reported that the vaccination status was known for 39 patients, of which 32 were unvaccinated and seven were fully vaccinated). Five other patients employed with an organization were diagnosed with measles and these were asked to provide vaccination records or do a blood test that showed they had built immunity to the disease. It was reported that measles outbreak has expanded and was infecting people in the broader community. The outcome of measles was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
PERIPHERAL NEUROPATHY 11/22/2021 GI HEMORRHAGE  PERIPHERAL NEUROPATHY 11/22/2021 BILE DUCT STRICTURE  PERIPHERAL NEUROPATHY 11/22/2021 FEVER  PERIPHERAL NEUROPATHY 11/22/2021 ABDOMINAL PAIN  PERIPHERAL NEUROPATHY 11/22/2021 FEVER
Swollen and painful right arm.  Negative echo and MRI. Recommended compression sleeve. Arm still painful and swollen August 2021
Per pt-not seen in person-left side (arm and leg) swelling and in pain. Pt had trouble walking, weakness, dizziness. Pt reported to MD, given ibuprofen. Pt reported to be ok next day when we followed up.
My arm had a rash that went all the way down to my elbow and wrapped all the way around my upper arm. The rash was itchy and hot. I feel like this was an allergic reaction and not normal. I got the second vaccine almost two weeks ago and all of the symptoms are gone except for the redness.
Patient admitted with multiple comorbidities and caregiving needs with positive COVID test.  Discharged from hospital on 12/05/22 to hospice care services for end stage alzheimers with subsequent death on 12/07/22.  Provider d/c note:  "Per HPI, a 87 YO male with h/o Alzheimer's dementia, HTN presenting to the ED for evaluation of AMS   Patient unable to provide any history due to mental status. History obtained from chart review and speaking with sons at bedside. Patient was seen in the ED on 11/26 with similar symptoms, was sent home due to hemodynamical stability however patient was exhibiting generalized weakness and family was unable to support him. Patient is nonverbal at baseline, though able to ambulate without difficulty. He lives with his wife who is also COVID+ and is unable to take care of him.    In the ED, pt febrile to 39.1c, otherwise hemodynamically stable. Lab work significant for Cr 1.3, AST 188, ALT 73.    Hospital Course: 1. Alzheimer's dementia: end stage. Wife POA is agreeable to switch code status to DNR/DNI CC at this time. Family signed for hospice - Home memantine    2. COVID: febrile to 39.1c, maintaining adequate saturation on RA.  - Antipyretics PRN   3. Generalized weakness: suspect due to above - PT/OT   4. Acute renal insufficiency: likely due to dehydration. Received 500ml bolus in the ED   5. LFT elevation: as above. Trend while on remdesivir    6. HTN - D/c 'dantihypertensives "
Immunization (DTaP) given left deltoid 1/8/08.  Mt noticed redness, warmth and swelling of left upper arm 430pm on 1/9/98.  Brought to office 1/10/08 for nurse to assess.  Area of upper deltoid warm, red and 3 3/4" long circumference of left mid upper arm 9" versus 7 1/2" on right arm.
17 year old patient received Moderna vaccine at a mass vaccination event but the minimum age is 18 years old.
Excessive swelling and redness to site and outer arm of injection lasting 2-3 days. This was accompanied with pain. Symptoms began w/in 4-6 hours of administration.
Vaccine administered in left deltoid hurt more than usual upon administration.  I had the anticipated sore/tender feeling that I have had in the past after immunization, but it persisted past the normal 2-3 days.  The discomfort has persisted daily.  Now, 10 weeks later, I am struggling with decreases in strength and range of motion.
Information has been received from a physician concerning an under 65 year old female with diabetes who was vaccinated with PNEUMOVAX vaccine. Subsequently, the patient experienced swelling at the injection site which went up the arm to her neck which the physician called quite remarkable. The area was hard to the touch and the patient experienced malaise. As of 05-NOV-2008 the patient was not recovered. The patient sought medical attention. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 69 year old female patient with osteoporosis, schizoaffective disorder and hyperlipidemia. On 13-OCT-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # K009105 exp 21-JAN-2016) intramuscularly. Concomitant therapies included LEXAPRO; loperamide hydrochloride, lorazepam and ibuprofen. The nurse reported that on 14-OCT-2014, the patient developed swelling, redness, warmth to touch and soreness and pain of her upper arm from the elbow to the shoulder after receiving PNEUMOVAX23. The patient was treated with ibuprofen and applied ice. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
I21.4 - NSTEMI (non-ST elevated myocardial infarction) K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type
Facial swelling with rash on arms and legs 36-48 hrs following injection 9/8/14 - SOLUMEDROL 40 mg IM. Prednisone taper, hydroxyzine.
Head aches, first the on 4/14 went to hospital for severe stomach and back pain which lasted about 6 Plus hours with nausea still had head ache for 2 more days. Had no insurance haven't had any problems before injection.
I received my Covid 19 vaccine on 11/5/2022. On the morning of 01/02/2023 I was feeling achy and had a fever. I went to the doctor and was prescribed LAGEVRIO and benzonatate. Symptoms are still ongoing.
Swollen lips; Hives; Welts on back; A spontaneous report was received from a Healthcare Professional concerning a 41 Years-old male patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events, swollen lips, welts on back and hives .  The patient's medical history is unknown. Concomitant medication levothyroxine were reported.  On 21- Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 032L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 22-Jan-2021, the patient experienced circular hives all the way from his neck down to his lower back. they were spread out all over and he also had swollen lips.   Laboratory details are not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events include swollen lips, welts on back, hives was not reported.   At the time of this report, the outcome of the events swollen lips, welts on back, hives was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
tested positive for COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive tested positive for COVID-19.         Treatment included monoclonal antibody infusion.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
By the evening of 4/14/21, my knees were feeling mildly sore. The weather had been improving so I thought it was just that I had been more active outdoors, but the pain in my knees peaked after my second dose (5/5/21, Lot# EW0182, Pharmacy Store). I've had constant knee pain (both knees) since then to where I cannot squat or lift anything heavy; I wake up at night with my knees aching. I've consistently used NSAID (Naproxen Sodium 440mg x 2/day) every day, iced. elevated, rested, compressed... still no change in my knee pain. Within a few weeks, I went from normal and healthy to limping and in pain.
Information has been received from a physician concerning her daughter who on an unspecified date was vaccinated with a dose of MMR (lot # not reported). The physician reported that her daughter got a really bad rash after vaccination with MMR. The rash was red, had bumps, and was all over the patient's body. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly doses of M-M-R II Lot M022407, expiration date: 02-MAY-2018. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit (53.4F) for 54 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA007194: US-009507513-1707USA009212.
Woke up with COVID-like symptoms similar to when I had contracted COVID 5 months earlier. Headache, mild loss of taste, body pains all over body, extreme back pains not typical of back problem,  fatigue, nausea, vomiting
Patient reported complaints of tiredness and headache with pain and redness at injection site 12/03/2013. Then patient noticed scattered reddish lesions around face and chest. Patient was instructed to stay in apartment until lesions were scabbed. The redness and warmth at the injection site were treated with Keflex 500 mg twice daily for 10 days.
The patient received a COVID-19 booster dose later found to be involved in a temperature excursion of 34 hours at max temp of 8.54 Celsius. The manufacturer was unable to provide additional stability information that applied to this excursion. The patient/parent notified.