chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bells palsy; This is a spontaneous report from a Pfizer-sponsored program.  A Consumer reported for herself.   A 75-years-old female patient  received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient previously took mercury and experienced drug hypersensitivity.  The patient experienced Bells palsy  on an unspecified date with outcome of unknown.    The patient is wondering if Bells palsy may be an adverse reaction to the vaccine.  Information on the lot/batch number has been requested.
Less than 24 hours after injection of the vaccines pt develops erythema, warmth, pain, induration (2a 2a) in the injection site with generalized body aches, headaches and dizziness and nausea, erythema and induration and localized pain persist but no fever.
Patient presented with altered mental status within 24 hours after receiving COVID booster. Found to have SIRS vs sepsis and to be in DKA. Found to have obstructing nephrolithiasis on imaging but infectious workup was negative (negative urine, blood cultures, COVID PCR and normal chest X-ray). SIRS on presentation ultimately felt to be due to DKA rather than infection. Trigger for DKA remains unclear; diabetes is not well-controlled on oral meds at baseline (HbA1c 9.3%), and possible the nephrolithiasis contributed to the DKA.
Presented to hospital with 1-2 days of fever, fatigue, confusion, and generalized weakness on 5/9/21. Primary diagnosis is acute encephalopathy.
100.3 fever; body aches; nausea; cold sweats, woke up in middle of night completely soaking wet; Administration date: 19Jul2021/Dose number: 2/Administration date: 05Jul2021/Dose number: 1; Administration date: 19Jul2021/Dose number: 2/Administration date: 05Jul2021/Dose number: 1; This is a spontaneous report from a contactable consumer (patient). This 40-year-old male consumer reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 19Jul2021 at 18:30 (at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 05Jul2021 at 18:30 (at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included covid-19 prior vaccination. No known allergies. There were no concomitant medications. Facility type for vaccine was pharmacy or drug store. No other vaccine administered in four weeks. No other medications in two weeks was provided. Patient was not tested Covid post vaccination. On 20Jul2021 at 14:00, patient experienced 100.3 fever, body aches, nausea, cold sweats, woke up in middle of night completely soaking wet. No treatment received for AE. The outcome of all events were recovering.   Information about batch/lot number has been requested.
Bronchiolitis and pneumonia. She suddenly developed symptoms of a cold that turned into a horrible cough and bronchial tube being inflamed - bronchiolitis. Shortly after that she got pneumonia. She was given breathing treatment neublizers. Took her weeks to overcome this. Recently was hospitalized again due to Bronchiolitis.
This 30 yo male service member received a routine Typhoid #5 booster and 2nd AVA vaccine to left deltoid, with 2nd hepatitis B vaccine to right deltoid on 5/21/2010 (0930 am). He reported immediate pain with administration of "hep B vaccine and AVA vaccine" that quickly resolved (<60 seconds). 2 days later (Sunday morning) he awoke with redness, mild swelling and itching to left deltoid area with bruises to both deltoid at Hep B/Typhoid" vaccine sites. He denied bruising to AVA vaccine site left deltoid. He self treated with Motrin and Claritin x1. Monday morning the redness was progressing up towards his left shoulder and down towards mid-upper arm (above elbow). By Tuesday the redness now encircled most of his left bicep/deltoid region and was warm to touch. The site was pruritic, but not painful. There was no redness to right deltoid. He denied any hives, rashes, fever, paresthesia, weakness, chest pain, neck pain or limitation in ROM to either arm. He did note some tenderness to upper arms only around bruised areas bilaterally. He denied any trauma or injury to either arm. He also denied any history of blood disorders, easy bruising, gum bleeding or any illnesses or travel. Symptoms: Symptoms, inv skin/integumentary tissue NEC(782.9).
Until got the shot, had shingles/Suspected vaccination Failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that his ex girlfriend dad did not had the shingles until he received the Shingles vaccine. The reporter stated that the patient was cussing at the physician that told him that he should receive that vaccine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Third dose administered mistakenly on the same day as the second dose to a mentally challenged patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Third dose administered mistakenly on the same day as the second dose to a mentally challenged patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mental disability NOS.   On 30-Mar-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021 at 3:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Third dose administered mistakenly on the same day as the second dose to a mentally challenged patient). On 30-Mar-2021, ACCIDENTAL OVERDOSE (Third dose administered mistakenly on the same day as the second dose to a mentally challenged patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment not reported.  This report refers to a case of accidental overdose for mRNA-1273 with no associated AEs.; Sender's Comments: This report refers to a case of accidental overdose for mRNA-1273 with no associated AEs.
No additional AE.; she went to a pharmacy to report vaccine on 28-MAR-2023; A HCP called and reported an expired dose of MMR II was given to a patient on 3/27/2023. No adverse effects were reported. No additional information was provided to further clarify any other details. No additional AE. No PQC.; This spontaneous report was received from a nurse and referred to a 28-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent and varicella virus vaccine live (oka/merck) (VARIVAX).   On 27-MAR-2023, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA) injection (0.5 milliliter/once, lot #U007686, expiration date: 09-MAR-2023 (upon internal validation), anatomical location: right arm, strength and route of administration were not provided) for prophylaxis, which was purchased by private funds (Expired product administered).  Provider notified manager and patient and patient understand this event. Provider recommended patient to repeat vaccine in 28 days.  On 28-MAR-2023, the patient went to pharmacy to repeat measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose, lot, expiration date, anatomical location, strength and route of administration were not provided) for prophylaxis (Inappropriate schedule of product administration).  No additional adverse event (AE) (no adverse event). .
Systemic: Dizziness / Lightheadness-Mild, Systemic: left hand felt numb-Mild, Additional Details: light headed right after vaccine. offered and accepted water. observed her for 20minutes. left arm numb. mother was here. offered to call emergency services. pt said no. mother took her home for further observation. checked on her at 8pm. she was back to normal
Pain and swelling at injection site even after 5 days. Headaches, body aches, tinnitus, general malaise, difficult concentration for 5 days
Patient reports nausea, vomiting and diarrhea 2-3 hours after receiving pneumonia vaccine. There was also weakness and diaphoresis. Patient was advised to go to ER but chose to remain home. Gradually improved over 3 days.
Fatigue, Dizziness, Arm Pain, Redness, Swelling, Light sensitivity, Headache, Muscle Pain in arms and legs, Painful to touch the arms and legs, felt like she worked out extremely long, right knee/leg swollen. Dr. Prescribed cephalexin and Naproxen 500, helped swelling, started taking on 12/25. There was a break in between the pain, from 17th to 20th there were the first symptoms, and then a break, but muscle fatigue started on 12/23.
inflammation with scab; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: cl9261, Expiration date was not provided), via an unspecified route of administration in right arm on 21Jan2021 11:45 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced inflammation with scab in center on 23Jan2021. No pain no itching no oozing. Patient did not receive vaccine in four weeks. Patient did not have covid prior vaccination. Patient was tested covid-19 post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Jan2021. The outcome of the event was unknown.
66 y/o male with PMHx of DM, gout, Hyperlipidemia, HTN, and kidney stone admitted for SOB due to Covid-19 on 8/7/21 Symptoms also include nonproductive cough, HA, and myalgias. Chest x-ray demonstrates multifocal patchy ground glass and airspace nodular opacities. Treated with supportive care. Pt discharged home on 8/9/21.
This spontaneous report was received from a doctor of pharmacy refers to a 84 years old male patient who on 17-MAY-2012, was vaccinated with a dose of ZOSTAVAX (lot number 672606/1655AA, Exp. Date: 21-JAN-2013)(dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that from the time of vaccination on 17-MAY-2012, the patient had a sore on his arm that would not heal. It was stated that the patient presented to her pharmacy the evening of 20-AUG-2012, and presented his arm for examination: The pharmacist reported that the back side of his deltoid had a scabbed area that looked like it had been picked at. She indicated that the wound appeared to be irritated from being picked at. The pharmacist stated that the patient had not reported this wound to his physician. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient did not seek medical attention. The relatedness for sore on his arm that will not heal and the wound appeared to be irritated from being picked at was unknown for ZOSTAVAX. Additional information has been requested.
CLIENT NOTICED A FLUID FILLED LUMP ABOUT 3INCHES IN DIAMETER ON HER LEFT ARM WERE SHE HAD RECEIVED THE VACCINE, IT WAS RED TO TOUCH AND NOT HARD OR WARM TO TOUCH.  NUMBNESS, TINGLING AND PAIN IN THE LEFT ARM, SHOULDER, AND CERVICAL REGION APPEARED 24 HOURS AFTER THE LUMP.  CLIENT SAW A CHIROPRACTER 5/31. THEN ON 6/1 WENT TO ER DUE TO PAIN. ER GAVE PAIN SHOTS TO EASE THE PAIN.  CONTINUED TO SEE THE CHIROPRACTOR. 6/15 SEEING AN ORTHOPEDIST FOR PAIN AND NUMBNESS IN LEFT ARM AND SHOULDER.  DID SPEAK WITH PRIVATE PHYSCIAN WHO FELT IT WAS A REACTION TO THE VACCINE. CURRENTLY TAKING ALEVE 200MG 2TIMES A DAY AND FLEXERAL MUSCLE RELAXER 2TIMES A DAY.
Large painful red welt at injection site. Size of a baseball. Painful to touch, spreading. Headache, fatigue, joint pain, mild sore throat.
One day after vaccination, patient returned to the injection clinic and reported noticed shoulder and arm swelling with a patchy rash to her R shoulder.  Symptoms resolved. She was advised to call the call center and f/u with PCP.
After receiving vaccine and bicillin, Pt c/o of chest tightness, shortness' OF BREATH, AND THROAT TIGHTNESS, PT WAS HYPOTENSIVE. PT WAS GIVEN Epi-pen, Sol-u-Medrol 125 mg, Benadryl 25 mg.
ACUTE NON ST ELEVATION MI 4/13/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Patient was here with mother.  Due to history of chronic immunosuppressants, our computer system flagged this patient stating she was due for a pneumonia vaccine.  Myself and Dr. researched this and per  Immunization schedule, decided to proceed with the vaccine.  We discussed this with mother, and she was agreeable.  Our hospital system had removed Pneumococcal 23 from our clinic, and in multiple staff  meetings, our clinic medical director, Dr. and our lead nurse, LPN, had advised us to use Prevnar 20 instead of Pneumococcal 23.  I administered the vaccine as discussed.  We then found out that Prevnar 20 is not licensed for people under age 18.  Dr. called and relayed this information to the mother, she was not concerned, and patient is not exhibiting any adverse effects.
Approximately 2 hours post vax pt began shaking and having difficulty breathing. Pt was seen in the ER and sent home Pt was seen by RN, PHP who diagnosed a seizure.
product supply issue; mildly sick; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced product supply issue and sickness. On an unknown date, the outcome of the product supply issue was unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had been trying to find any place from past two weeks, that could give their 2nd dose, but due to the problems making and delivering sufficient supply. The patient asked to the GSK, most definitely need to change how to deliver and how to manage such a limited supply. In particular, the GSK need to allocate it in such a way that ensure that those who receive the 1st dose were guaranteed the 2nd dose. Otherwise, people like me have wasted considerable money, received little benefit from the trauma of getting the shot and pretty much abandoned. The patient wanted to know, what supposed to do.
Code green called:  Patient stated that her face was starting to feel hot and red.  Pt. also said her heart is pounding.  Pt. c/o throat swelling but able to talk in full sentences without any distress.  Paramedic and Dr. responded.  Assessed pt. and took VS.  VS as follows:  BP 178/86, HR 68, RR 18, O2SAT 100% on RA.  Pt. observed for 30 mins. total.  Pt. refused to go to ED at this time.  Advised by paramedic and Dr. to take benadryl 2 tabs when she gets home and to continue to monitor for worsening symptoms and to go to the nearest ED if needed.
Fever to 101, headache, significant body aches, fatigue Treated with Advil 400mg
This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. No information about her pertinent medical history was provided. The patient was allergic to penicillin, cephalosporin, adhesive tape, NEXIUM, hydrochlorothiazide (captured in MARRS# 1506USA012939), iodine and oxycodone. She developed a rash and itching to oxycodone in the past (date unspecified). On 22-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L008357, exp. date: 11-JUN-2016 (dose and route of administration not reported). Patient's concomitant medication included PULMICORT inhaler. On 24-JUN-2015, also reported as "today", the patient called the pharmacist and reported that on 23-JUN-2015 she developed an injection site reaction. The patient stated that the injection site was a swollen area approximately 3 inches by 1.5 inches in diameter. The area was red, itchy and warm to the touch with a mild burning sensation. The patient stated that it looked like "one big hive". No treatment was given to the patient. The outcome of the events was reported as not recovered. The relatedness between ZOSTAVAX and the events was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Developed fever on day of vaccine.  1 day later fever continued and erythematous patch to left upper outer breast appeared.    Tender, firm, has progressively spread. Currently rash is 2.5x2.5 in.  Seen in clinic 1/12/2021 as a new patient for wellness exam
Pts left arm became very painful with redness and swelling extending from the elbow to the shoulder. Pt was seen in the ER and treated with antibiotic and Tylenol.
Localized reaction: bruising, swelling, itching, hot to touch. Recommended ice packs, pain reliever of choice (APAP/IBU), hydrocortisone crm.
I had a massive stroke 5days after my 2nd Pfizer vaccine.sure makes me wonder if it caused blood clots.
Rash that is growing; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that is growing) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced RASH (Rash that is growing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash that is growing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Patient reported tenderness to the site for 2 days post injection and got better. Patient reported today that he noticed that he was having increasing tenderness 12 days later and today has profound limited ROM and a lot of pain. Site does not appear swollen in comparison to opposite arm, strength is equal bilaterally but patient unable to perform independent or passive ROM with pain.
I had severe chills body aches and nausea for about a day and a half and I felt really lethargic.  Symptoms started to dissolve on day 2.  Day 3, I started feeling numbness and tingling in both arms and my tongue. I had a little chest discomfort and felt like I was about to have a heart attack. I went to an Express Care for treatment because I felt like I could not make it to the Emergency Room.
On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling.  I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak.  On 3/21/2021 I noticed that I had a rash developing in places.  On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched.  I took Benadryl and that is when I went to the ER.
Developed recurrent spots; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, 5 hrs after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced spot-like rash. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the spot-like rash was recovering/resolving.   It was unknown if the reporter considered the pain in arm and spot-like rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. Approximately 5 to 6 hours after receiving Shingrix, the patient experienced a sore arm that lasted approximately 3 days.  The patient developed recurrent spots on him that came and go within a month or two months after receiving Shingrix. The minor spot outbreaks recurred twice. The reporter consented to follow up. This case has been linked to US2020133250, reprted by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020133250:(same reporter)
Patient found confused and unresponsive and brought to the ED.  Patient was admitted with Covid.
Information has been received from a licensed visiting nurse concerning a male who on 24-MAY-2006 was vaccinated intramuscularly in the right arm with a 0.5 ml of pneumococcal 23v polysaccharide vaccine (lot#653284/0002F).  On 24-MAY-2006, following vaccination, the patient experienced pain in right arm.  Unspecified medical attention was sought.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
I received my 4th Pfizer Bivalent booster on 10/13/2022. My COVID-19 infection started on 12/29/2022 in the morning. I woke up with headaches. When I tested positive on 01/02/2023 with a home test I had sinus congestions, chest congestions, body aches, fatigue, and low grade fever. I called my doctor on the evening of January 2nd and I got a call back on 01/03/2023. I did a telehealth with my doctor on 01/03/2023 at 12:50pm. He prescribed me with PAXLOVID for 5 days. I tested negative on 01/08/2023.
Both vaccines in the same (left) arm. 2 days after vaccines, pt presented with generalized redness from mid-bicep to elbow on left arm. Area was painful, and red. Did not appear to be inflamed.
Around 7:00 pm patient noticed itching around his neck and chest. He got up and went and looked in the mirror and noticed tiny red bumps all over his torso from his neck to just above his pants line. He read the information sheet given to him about delayed reactions and started taking Benadril. The itching has subsided and the rash is decreasing. He will continue with Benadril treatment and if symptoms worsen he will contact us again.
I95.9 HYPOTENSION 3/24/2021 ATRIAL FIBRILLATION, UNSPECIFIED