chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles/pain in her lower back and burning rash in the lower right side and was diagnosed with shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. The patient was prescribed the zoster vaccine live(ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-FEB-2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) by a pharmacist. She suffered the following injuries and was diagnosed on the following dates as a result of the zoster vaccine live(ZOSTAVAX) vaccine: pain in her lower back and burning rash in the lower right side and was diagnosed with shingles on 06-DEC-2014. She claimed compensatory damages to her for past, present, and future damages, including, but not limited to, pain and suffering for severe and permanent personal injuries sustained by patient, health and medical care costs, together with interest and costs as provided by law. At the reporting time, the outcome of shingles was unknown. The causality between the event and zoster vaccine live(ZOSTAVAX) was considered as related by lawyer and patient.   The event shingles was determined to be disabled by lawyer and patient.
Body rash began on day 4 after vaccine. Rash spread to entire body over the next few days. Diagnosed as full-body Erythema multifome with mucosal involvment. Prednisone 40 mg x 1 week, followed by Prednisone 2- mg. x 2 weeks. Topical steroid for lesions on the face, scrotum, penis, anus, and scalp.
Swollen and painful armpit on the side of infection. Started about 11 hours after infection.  Also that the night after injection had shivers and body aches. Next day no shivers but still had body aches.  Treating with ibuprofen.
Discomfort; tingling; Numbness facial; burning; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd October 2019, 1 days after receiving Shingrix, the patient experienced tingling, numbness facial and burning sensation in face. On an unknown date, the patient experienced discomfort. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the tingling, numbness facial, burning sensation in face and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the tingling, numbness facial, burning sensation in face and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and next day, experienced tingling, numbness and burning on the right side of his face going from his temple down to his jawbone. The patient went to emergency room (ER) and had a computerised tomogram (CT) scan that did not show any blockages in his head. The patient saw his primary care provider and she could not tell him anything other than that it might be nerve related. The patient was still experiencing the symptoms and they have not changed. It was not painful. The reporter consented to follow up.
Made her really sick; Arm really sore; Itchy spots on face; Red spots on face; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2023, the patient received the 1st dose of Shingrix. On 2nd February 2023, 13 days after receiving Shingrix, the patient experienced itchy rash and red spotty rash. On an unknown date, the patient experienced sickness and pain in arm. The patient was treated with alendronate sodium (Fosamax), prednisone and antibiotics nos (Antibiotic (Unknown Type)). On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the pain in arm was unknown and the outcome of the itchy rash and red spotty rash were not recovered/not resolved.   It was unknown if the reporter considered the sickness, pain in arm, itchy rash and red spotty rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: The reporter was the owner of the medical spa where the patient came for regular facials. The reporter reported that the patient came in for facial on 1st February 2023 and then started with red itchy spots on face. The patient failed to mention at the time of her facial that she received first dose of Shingrix which made her really sick and her arm really sore. The reporter did not have any further information regarding these side effects, but rather just what the patient stated. The patient also did not mentioned until after the spots appeared that she just started taking Fosamax, Prednisone and an Antibiotic. The patient still had the red spots. The patient sent a picture to the reporter on day of reporting and it was hard to determine if the spots were all over the face or only on one side. The reporter consented to follow up.
Client given High dose intended for 65 years and over.  Client 36 years old.  Client denies any adverse effect.  Stated she had a slight fever and some pain when raising arm above head for 1 to 2 days.
Date 2-3 from vaccine developed fever, rigors and nausea that lasted about 24 hours. On 3/26 noted pain in right posterior chest then on 3/28 noted visible rash.  Weight of a shirt causes discomfort to the T5-T6 dermatome area.  Primary care provider treated with Valayclovir.  Evaluated in Employee health on 3/29 temp 96.8, HR: 68, RR: 18, BP: 110/76. Rash consistent with Shingles. Interesting in that recombinant vaccine should not be capable of causing disease (? stress reaction???)
Received An Expired Dose of Heplisav-B; Initial Report Received on 15-Dec-2022  A medical assistant reported that a 54-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that expired.  Medical history was reported as unknown.  No relevant concomitant medications were reported.    On 15-Dec-2022, the patient received a dose (unspecified dose number) of HEPLISAV-B (Lot # 935848, expiration date 02-Dec-2022, NDC # 4352800301) intramuscularly in the left deltoid.   The HEPLISAV B dose administered was 13 days past the expiration date.  The patient had no other adverse effects.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
2 1/2 hrs p/vax pt devel limpness, pallor, grunting respirations, diaphoresis; 02 recvd; color improved, pt began crying loudly; transported to ER via ambulance;
Chills, no fever, strength in legs gone, fatigued.   Fell twice day after vaccination.  Arm strength was OK, Day 2 could walk  and do steps.  Took acetaminophen 1000mg twice daily
Swelling in throat, difficulty swallowing. Redness and swellilng at injection site.
Blood pressure dropped; anaphylactic event; passed out; hit her head; This is a spontaneous report received from contactable reporter(s) (Physician).  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BLOOD PRESSURE DECREASED (medically significant), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "Blood pressure dropped"; ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylactic event"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; HEAD INJURY (non-serious), outcome "unknown", described as "hit her head". The events "blood pressure dropped", "anaphylactic event", "passed out" and "hit her head" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Decreased, notes: Patient's blood pressure dropped to 60 ten hours after the second dose was given.  Clinical course: Patients other condition was reported as no. Other products and investigations reported as unknown. Patient's blood pressure dropped to 60 ten hours after the second dose was given, passed out, hit her head, and taken to ER. Given fluids at the ER. Reporter thought it was an anaphylactic event. Reporter assumed that the patient was fine as reporter trying to figure out if patient should get boosted or not. Patient doesn't have any other comorbidities.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Caller reports no additional adverse reactions; Patient was administered 4th dose of GARDASIL 9 on 7/28/2022; This spontaneous report has been received from a prescriber nurse, concerning a female patient of unknown age.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date (reported as 0 months), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. On an unspecified date in 2016 (reported as 2 months) and in August 2016 (also reported as 6 months), the patient was vaccinated with the second and third doses, respectively, of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. The three doses were administered at a dose of 0.5 ml as prophylaxis (lot numbers, expiration dates, routes of administration, and anatomical locations were not provided).   On 28-JUL-2022, the patient was administered with a 4th dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot number, expiration date, route of administration, and anatomical location were not provided) as prophylaxis (Extra dose administered).  No additional adverse reactions were reported.
1st vaccine on 2019, 2nd dose had not been administered; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose administered on 21st March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter reported the patient wished to receive 2nd Shingrix vaccine. The reporter consented to follow up.
Information has been received from an office manager in the physician's office concerning her 1 year old granddaughter who on approximately 28-NOV-2007 was vaccinated with a dose of measles virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (no lot number available). On 09-DEC-2007, the patient experienced fever after being vaccinated "2 weeks ago." On 10-DEC-2007, the patient developed red blotches on her stomach and back. On 12-DEC-2007, in the morning the patient was seen in the physician's office, the patient looked terrible and the blotches started to move up to her face. The patient was brought to the emergency room but was not admitted to the hospital. Lab diagnostic studies performed included " blood work." The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
Information has been received from a physician concerning a 71 year old female with a history of drug allergy/reaction to tetanus vaccine (local redness after tetanus booster 15 years ago) and hydrocodone and no pertinent medical history. The patient had no illness at the time of being vaccinated. On 31-OCt-2007, the patient was vaccinated with a first dose of PNEUMOVAX 23 vaccine (lot # 655765/0061U) 0.5 ml subcutaneously in the right arm. Concomitant therapy also given on 31-OCT-2007 in the left arm included a first dose of ZOSTAVAX vaccine (lot # 658604/1088U), and influenza virus vaccine (Sanofi Pasteur (lot # 112515AA). Other concomitant therapy included LEXAPRO and blood pressure medicine unspecified. On 31-OCT-2007 (also reported as 01-NOV-2007), the patient experienced erythema, swelling, pain, and warmth from her neck to elbow where PNEUMOVAX 23 vaccine was given. The immediate area around the injection site was normal in color. On 02-NOV-2007, the patient was seen by the physician and was started on therapy with KEFLEX. At the time of reporting, the outcome was unknown. Additional information was received from the physician. On 02-NOV-2007, the patient visited the physician's office. The patient had swelling and erythema over her right arm extending from the elbow to deltoid/base of neck. No diagnostic tests were performed. The patient was treated as cellulitis with KEFLEX. On an unspecified date, the patient recovered. No additional information is expected.
approx 13 days p/ vax pt devel a chickenpox like rash w/10-12 lesions. f/u fr MD described rash as erythematous papules w/vesicle eruption.
Refridgeration excursions identified/undergone several temperature excursions; No adverse event; vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Patient had no known allergies.  It was unknown that the patient ever been diagnosed with or tested positive for COVID-19.     On 21-Sep-2022 at 3:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Sep-2022 at 3:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients).    Concomitant product use was not provided by the reporter.  Dose 4 received on deltoid.   It was reported that refrigeration excursions identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department and made aware of the situation.   Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to patient.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-670292 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670292:same reporter
Information has been received from a medical assistant concerning a female with AUGMENTIN allergy who on 22-JAN-2009 was vaccinated with the third dose of GARDASIL (lot # 661766/0652X).  The patient developed a rash after her third dose of vaccine.  The rash included blisters at injection site, rash from her mid forearm to her neck line on the injection arm and rash on her chest and back.  BENADRYL had been prescribed.  The patient received her first (lot # 660555/0279X) and second (lot # 661530/0575X) dose of GARDASIL on 01-JUL-2008 and 10-SEP-2008 respectively.  At the time of reporting the patient was not recovered.  The patient did not seek medical attention.  Additional information has been requested.
Tinnitus:  This morning I noted a roaring sound (like roaring traffic) in my ears, and my ears feel plugged up.
Information has been received from a physician concerning a pt who was vaccinated with varicella vaccine. Subsequently the pt experienced a mild case of chicken pox. The physician heard the info at medical rounds and has no pt info since the pt was not hers. No further info is available.
11 days after receiving  the 1st vaccine, my upper arm are at sight of shot became bright red, swollen, hard to the touch and very itchy.  The red area became larger and worse each day until I received medical advice on the 5th day after the redness began. The swelling  has abated 2 weeks after treatment, but still has some hardness and soreness on the upper arm.
BREAKTHROUGH COVID: FULLY VACCINATED. 86-year-old female, she was brought to the ED for COVID infection.  Apparently patient tested positive on 07/05/2022.  He has reported weakness, poor p.o. intake and hypoxemia.  He was brought to the hospital. Pt resting on room air.   He has fever, leukocytosis here.  TREATMENT WITH IV antibiotics, Rocephin and Zithromax. ID following. Follow cultures, Foley catheter in place, monitor urine output , Monitor oxygen saturation.  DVT prophylaxis with lovenox subcutaneously. 86-year-old female with dementia, she was brought to the ED for COVID infection.  Apparently patient tested positive on 07/05/2022.  He has reported weakness, poor p.o. intake and hypoxemia.  He was brought to the hospital.  He is currently resting in bed, on room air.  RN states that he is really nonverbal but is comfortable. CTA with 1.  Motion artifact precludes evaluation of the subsegmental pulmonary arteries. No evidence of pulmonary embolism through the segmental pulmonary arterial level. 2.  Bibasilar airway wall thickening and small airway mucous plugging suggestive of bronchiolitis. No consolidation.  He has fever, leukocytosis here.  He has elevated lactate 2.2.  He was given Zosyn and IV fluids.   Additional information for Item 19: 2.  Bibasilar airway wall thickening and small airway mucous plugging suggestive of bronchiolitis. No consolidation. He has elevated lactate 2.2.
Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.