chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had reaction to the pneumovax; Numbness in hand; Confused state; This spontaneous report has been received from a consumer via Pfizer, referring to herself, a female patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was not provided.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date not provided).  On an unknown date, the patient reported experiencing a reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccination complication) (did not know what kind of reaction), numbness in the right hand and finger (hypoaesthesia), and was in a confused state (confusional state). She was calling from a nursing home.  At the time of reporting, the outcome of the aforementioned events was not provided.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and vaccination complication was related. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) hypoaesthesia and confusional state was not provided.
Injection given @ ~12:30pm and symptoms were reported as beginning ~2:30p of "scratchy throat" followed by lips puffing and mouth swelling by 5:00p along with swollen lymph nodes in cervical neck area, and in axillary area bilaterally.  He took Benadryl by mouth X 2 before sleeping, and reports that his symptoms were subsided by this a.m. when he arose.
Pt was given second Hep A dose 5 months too early. Pt recommended to complete series 6 months after last dose given. Pt did not have adverse reaction to vaccine.
Pulmonary embolism; Two massive bilateral clots; This is a spontaneous report received from a contactable physician (patient). A 75 years old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 74 years old, administered in arm left on 23Feb2021 (Lot Number: EL9204) as single dose for covid-19 immunization. Medical history included, chronic obstructive pulmonary disease (COPD), history of cancers. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 74 years old, administered in arm left on 02Feb2021 (Lot Number: EN6200) as single dose for covid-19 immunisation. The patient experienced pulmonary embolism on 19Apr2021, two massive bilateral clots on 19Apr2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for all events for 6 days. The patient underwent lab tests and procedures which included Nasal swab: negative on 03Feb2021. Therapeutic measures were taken as a result of pulmonary embolism, two massive bilateral clots and included Heparin and Xarelta. The outcome of the events was recovered with Seroquel in 2021.; Sender's Comments: Based on the temporal relation, the association between pulmonary embolism, thrombosis and vaccination with BNT162B2 cannot be completely ruled out. The contribution of patient's age cannot be completely ruled out in the occurrence of the events. 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.
Fatigue, 100*F,  felt hot, Headache, Muscle aches lasting from 11am and continues today at 2:26pm.
Increasing SOB and low O2 sats. Treatment includes oxygen, IV steroids and an antibiotic.
On 01/20/2023 09:30PM approximately, she started feeling bad and said her arm hurt.  The injection site was red and puffy. She complained of aches and pains for a few days. Within a few months, we noticed bumps on her arm, stomach and back and under her arms. The started to get red and inflamed.  We thought it was her eczema flaring up.  We saw the doctor on 02/03/2023 and she referred us to the dermatologist on 02/23/2023.  The dermatologist confirmed it to be Molluscum Contagiosum. She used Beetle Juice.  She gave her a cream. It is still spreading.
Client given SQ injection of ZOSTAVAX on 6-19-15. Client reports to provider on 6-26-15 that injection site was extremely swollen, red, and had to touch for 4 days after injection. Denies rash or blister. On 6-26-15 client presents with slight yellow-tan bruise noted on Lt SQ site.
Small vesicles like lesions at the site of vaccine for 4 days 1-24-06 to 1-27-06.
syringe was not completely sealed as the product was leaking; leaking on the side; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 30Sep2023 as dose number unknown, single (Lot number: HF5017, Expiration Date: Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious) with onset 30Sep2023, outcome "unknown", described as "leaking on the side"; DEVICE CONNECTION ISSUE (non-serious) with onset 30Sep2023, outcome "unknown", described as "syringe was not completely sealed as the product was leaking".  The reporter considered "syringe was not completely sealed as the product was leaking" and "leaking on the side" not related to rsv vaccine prot.subunit pref 2v. Causality for "syringe was not completely sealed as the product was leaking" and "leaking on the side" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  Additional information: NDC number of Abrysvo: 00069034405, Abrysvo Antigen Vial: NDC number 00069020701, Abrysvo Diluent Syringe: lot number: GY5692, NDC number 00069-025001. During the time the pharmacist was trying to put the adapter on the vial, although it latched on correctly, it was still leaking on the side. It was also stated that the adapter was placed on the vial, when she decided to mix the product there was a leak on the side, leaked from the diluent. It seemed like the syringe was not completely sealed as the product was leaking. Even though the Adapter went in straight, when they dispensed the diluent into the vial, the adapter still leaked out from the side. They used another Abrysvo vaccine to administer to the patient. The fault product was not administered. The Pharmacist didn't want to use that one, because she was afraid it would not be accurate, so she took used another Abrysvo and mixed it and left this one for her to look at. Packaging was sealed and intact.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
After having the hepatitis A shot my daughter vomited in the evening on 3/01/16 and did not have any appetite for food in the afternoon of 3/01/16 and all the following day. I am submitting this report on 3/02/16 and I will be taking patient to the doctor next morning if she continue to have the symptoms.
Heart palpitations during the night of 1/29/2021. Resolved by the next day.
Several hours following vaccine felt flushed, had stomach ache, fatigue and dizziness. Had not eaten/or drank since 7am. T=99.4. Gave fluids, rested and contacted parent. TC 11/10/09 - spoke to patient - without temp/feels much better, still home from school today.
Extreme Nausea w/ Vomiting, High Fever (102*), Chills, Loss of Appetite, Tired/Weak, Muscle Cramps.
My cardiolipin IgM enzymes were elevated abnormally. I was sent to a hematologist for follow-up.  In June 2021, after seeing the hematologist, my cardiolipin IgM enzymes were trending downwards.
Injection site reaction left thigh where Varicella #2 given 7cm x 8cm area of erythema with a few clear vesicles. Injection site reaction from DTaP 6cm x 5cm area of round erythema. Treated with ibuprofen.
PTSD response with very severe depression, anxiety, startle response, mild paranoia, and war related waking hallucination (flashback) on 1st day after shot. Pain at injection site, systemic joint and muscle ache, weakness, exhaustion.
This spontaneous case reported by a consumer, describes the occurrence of pruritic rash (itchy rash on arm) and rash (itchy rash on back, stomach and waistline) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030L20A) for COVID-19 immunization. No medical history reported. On Jan 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pruritic rash (itchy rash on arm) and rash (itchy rash on back, stomach and waistline). Patient treated with triamcinolone 1% for rash. At the time of the report, pruritic rash (itchy rash on arm) and rash (itchy rash on back, stomach and waistline) outcome: unknown. Concomitant medication list not provided. Action taken with mRNA-1273 in response to events: not applicable. This case linked to MOD-2021-023725 (patient link).
12/17/2020 1st Covid-19 vaccine -Pfizer EH 9899 4pm Left arm 01/07/2021 2nd Covid-19 vaccine-Pfizer EL3246 4pm Left arm 6/15/2021 ill 6/16/2021 Covid PCR test Positive 6/26/2021 Potential to return to work
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number L013429 and expiration date 21-JUL-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 16-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient waited the 15 minutes after injection in the store and was on the wat back to the pharmacy to ask questions since they were not feeling well and the patient fainted. 911 was called and pt was still unconscious when taken to the hospital.
Breakthrough case admission after 4 vaccines Moderna 1/18/21 Lot# 012L20A;  Moderna 2/15/21 Lot# 010M20A;  Moderna 11/12/21 Lot# 022J21A;  Moderna 5/9/22 LOt# 057M21A
I had severe shortness of breath that lasted 2 days. My knees and ankles swelled which lasted a few weeks. I was being treated for an autoimmune condition. I am allergic to Nyacin--my entire face was swollen.
Left arm redness, swelling. Fever 101 degrees. Pt went to clinic 6/24/15. Rx clindamycin 300mg 3x/day x10 d.
Large pink flat non-tender reaction to upper right thigh 12 x 10 cm.
Received DTaP on 5/11/17 which resulted in extensive limb swelling of his entire right arm - also had fever 103. Pt seen 5/12, 5/13. 5/15 - swelling resolving.
On Saturday I started noticing itching and blisters  and I had shingles. On my upper chest, and one about the size of quarter with four or five blisters, and about ten other smaller ones around my right arm. I went into the urgent care. They gave me hydrocortisone cream for the shingles
patient stated that on 11/8/2023, approximately 20 hours after receiving both vaccinations that she experienced a severe drop in blood pressure along with sweating and nausea. she stated that she was able to lie down a while and after about 2 hours her blood pressure returned to normal and she is feeling much better, she did not have to seek medical attention
Slumped over, pasted out- then laid out and went stiff and began shaking arms and legs and uncontrollable throwing of arms and legs. Eyes were glaring and glassed over - then came out of it.
Chest Pains, weird palpitations, accelerated heart rate- 2 months on and off Completely thrown off cycle, very long, painful and abnormal-   2 Weeks long for 2 months
Patient sent a portal message on 11/26/2022. Stating that 2 weeks after receiving Pfizer covid Bivalent Vaccine patient began to have vaginal bleeding for about 1.5 hours and she was experiencing the bleeding again on 11/26/2022.  Patient had hysterectomy  in 2011. Patient stated that these two were the only accounts of vaginal bleeding since her hysterectomy.
Approximately 1 day post vax, the pt had swelling in left arm with a reddened line below area of injection. Normal ROM, however guarding arm. No fever noted. The pt was seen by an MD.
Cold sores then rash on chest{very itchy] became infected with impetigo for 5 days.  Current scars are visible today
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Pt passed out approximately 2 minutes post-vaccination. EMS came to evaluate/ Pt declined transport. Stated mom would pick him up. Symptoms improved in approximately 15-20 minutes.
Burning sensation in chest; Experienced was heartburn, took antacid (unspecified medication) and that did not help; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: other medical condition: No. There were no concomitant medications. The following information was reported: BURNING SENSATION (non-serious), outcome "recovered" (2021), described as "Burning sensation in chest"; DYSPEPSIA (non-serious), outcome "recovered" (2021), described as "Experienced was heartburn, took antacid (unspecified medication) and that did not help". Therapeutic measures were taken as a result of burning sensation, dyspepsia.  Additional information: Patient thought it was heart burn, so he took antacid (unspecified medication) and that did not help and after several hours patient took Ibuprofen "300 mg" (further not clarified) tablets and that seems to resolve it (Treatment), so patient experience the burning sensation in chest for 24 hours at first patient thought it was heart burn but he did not respond to antacids and when he took ibuprofen it resolved, so he is recovered and it lasted for 24 hours.  Patient did not receive any other vaccines within 4 weeks prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recieved both Covid vaccines, developed atrial fibrillation secondary to pericarditis. Requiring 1L draining of fluid around heart. Discharged home.
9/16/22 I was at the clinic and had lab work. Told them about a bump in my carotid gland. On 9/27/23 I had an ultrasound, and they found a tumor. I had an appointment for a biopsy on 11/4/22. I was diagnosed with a small cell cancerous tumor. I had a full body PET Scan on 11/15/22, confirmed the tumor. I was admitted into the hospital on 12/5/22 and had a Carotid Endarterectomy. After the surgery, they also did radiation therapy. On 4/3/23 I went in for a routine check up and I was admitted to ICU because of heart blockage. The next day, I had a pacemaker put in.
Foggy; right arm has been twitching; Itching at the injection site; Redness at the injection site; swelling at the injection site; Blotchy at injection site; Couldn't stay awake; Confused; Had no energy; feverish; Nauseous; Eperienced a sore arm for 1-2 days which was worse the second night, tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Blotchy at injection site), SOMNOLENCE (Couldn't stay awake), CONFUSIONAL STATE (Confused), ASTHENIA (Had no energy) and FEELING ABNORMAL (Foggy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced VACCINATION SITE PAIN (Eperienced a sore arm for 1-2 days which was worse the second night, tenderness). On 23-May-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Blotchy at injection site), SOMNOLENCE (Couldn't stay awake), CONFUSIONAL STATE (Confused), ASTHENIA (Had no energy), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), PYREXIA (feverish) and NAUSEA (Nauseous). On 27-May-2021, the patient experienced MUSCLE TWITCHING (right arm has been twitching). On an unknown date, the patient experienced FEELING ABNORMAL (Foggy). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. On 26-May-2021, SOMNOLENCE (Couldn't stay awake), CONFUSIONAL STATE (Confused), ASTHENIA (Had no energy), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (Eperienced a sore arm for 1-2 days which was worse the second night, tenderness), PYREXIA (feverish) and NAUSEA (Nauseous) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Blotchy at injection site), MUSCLE TWITCHING (right arm has been twitching) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved and FEELING ABNORMAL (Foggy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient slept, and used cold packs on her head and arm for her symptoms.
Moderna Primary series and Pfizer Booster  8mins post vaccination pt reported rash on the chest. Vitals: 14:20 154/92, 73, 18, 100% -- > 14:30 154/85, 71, 18,100% Pt given Benadryl 25mg PO @14:05. 14:30 Pt asymptomatic 14:33 Pt stable and released from the vaccination site, accompanied by pt's mother
On Thursday 09/15/22 I beginning to have headache, stomach upset and muscle pain. The next couple days I developed a terrible pain in my hips and back (V5 and V4), dizzying and trouble with my eyesight that sometimes I could not focus for few seconds.
Information has been received from a physician concerning a 78 year old male who on 10Aug04 was vaccinated IM in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M). On 12Aug04, two days post vaccination, the pt developed a macular, papular rash on the arm that spread all over his body. The pt was treated with unspecified oral steroids and the rash did not improve. One month after vaccination, the client was seen by two dermatologists and was treated with unspecified creams, unspecified steroids and salve. In Jan 2005, the pt was seen by an allergist and there was no improvement in the rash. The pt presented to his primary care physician on 08Feb05 with shortness of breath and rash. Chest x-ray and computed axial tomography (CT scan) were ordered. Two days later on 11Feb05, the client was enroute to see his physician when he collapsed. He was taken via ambulance to the hospital and admitted with the diagnosis of allergic alveolitis. The pt had diffuse infiltrates of both lungs and kidney failure. A Ct scan was performed (results not reported). He was taken to intensive care and placed on very high doses of steroids for weeks, and a full face mask for breathing. While on the high dose steroids the rash disappeared, but when the steroids were reduced to 2.5mg the rash reappeared. The pt was hospitalized for approx two weeks and released when he was breathing better, kidneys were responding and he was able to urinate. The outcome of the reappearing rash was unk. A concern regarding the lot was reported by the physician. Macular papular rash, allergic alveolitis, kidney failure and collapse were considered to be disabling and immediately life threatening events that required intervention to prevent serious criteria.  Additional information has been requested.
11am: HPV vaccine IM (L arm) - immediately she felt faint; dizzy, got pale and fell sleep. BP = 114/70; PR = 80. ACCUCHECK 90. 12 noon: Pt sitting up still tired; awake and felt better.
Patient has now had sores on vulva after 2 of her COVID vaccines.  Dose number two and dose number 3. The COVID vaccine 2nd dose was given on 6/11/21 and she developed the sores on 6/15/21.  The vaccine was Pfizer lot EW0183 and given IM  in left arm.
Itchy all over his body; Shivering; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), PRURITUS (Itchy all over his body) and CHILLS (Shivering) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (Itchy) and CHILLS (Shivering). On an unknown date, the patient experienced PRURITUS (Itchy all over his body). On 16-Feb-2021, PRURITUS (Itchy) and CHILLS (Shivering) had resolved. At the time of the report, PRURITUS (Itchy all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever 100.4 10 hours after shots. Also eczematoid rash on face. Flexural ? of extremities 24 hours after shots. No treatment done.