chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the vaccine that have shellfish allergies) 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 Shellfish allergy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the vaccine that have shellfish allergies). At the time of the report, VACCINATION COMPLICATION (reaction to the vaccine that have shellfish allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
She had a burning rash on her back; This morning she has a slight hint of discomfort.; hive reaction; She has a significant rash; she isn't sleeping well; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BURNING SENSATION (She had a burning rash on her back), DISCOMFORT (This morning she has a slight hint of discomfort.), INSOMNIA (she isn't sleeping well), URTICARIA (hive reaction) and RASH (She has a significant rash) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (She had a burning rash on her back), DISCOMFORT (This morning she has a slight hint of discomfort.), INSOMNIA (she isn't sleeping well), URTICARIA (hive reaction) and RASH (She has a significant rash). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL DM) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; FAMOTIDINE (PEPCIDIN) at an unspecified dose and frequency; HYDROXYZINE at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (She had a burning rash on her back), DISCOMFORT (This morning she has a slight hint of discomfort.), INSOMNIA (she isn't sleeping well), URTICARIA (hive reaction) and RASH (She has a significant rash) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. Patient has been treated with (antihistamine), oatmeal baths, topical creams.   Reporter did not allow further contact
Patient was administered the first vaccine 0.5mL dose at 6:03pm in left deltoid and sent to observation area for 30min of monitoring.   Allergies:  - morphine (hives, throat tightness) - toradol (hives, throat tightness) - hydrocodone (hives, throat tightness) - unknown food allergy (hives, throat tightness) Denies history of reaction to injectable therapy.   Approximately how long after the administration the reaction started? 22min   Major signs and symptoms:Throat tightness, lips tingling, itching/hives/erythema across neck/chest/trunk/right ear   Medication(s) given: 25mg PO Benadryl (6:31pm), additional 25mg PO Benadryl (6:41pm), 0.3mg EpiPen (IM right thigh 6:53pm)   Vitals: At 6:25pm the patient reported itching, hives, tingling lips, throat tightness, and erythema on her chest. Taken to treatment area.    Vitals: BP 133/76, R 78, RR18, O2 sat 99%. Diffuse erythema noted across upper chest and right ear. Vesicular breath sounds, no stridor, no wheezing.   6:31pm 25mg PO Benadryl administered.    Patient reported sensation of worsening hives and itching. Diffuse erythema had spread to trunk.   6:41pm Additional 25mg PO Benadryl administered. BP 133/82, HR 79, RR18, O2 sat 99%.    Diffuse erythema / hives had spread to trunk and neck.    6:51pm BP 134/93, HR 111, RR20, 99% O2 sat.   Patient reported worsening throat tightening. Began appearing in acute distress.    6:53pm 0.3mg EpiPen administered to right thigh. Called EMS.   6:54pm BP 222/205, RR 71, 95% O2 sat   Patient reported improved throat "looser than before", but still remaining tightness. Reports feeling "shaky from adrenaline". No longer appears in acute distress; still has hives/erythema across right ear, neck, chest, trunk.   7:01pm BP140/81, HR 89, RR16, 97% O2 sat.    Patient reported a headache.    Approximately 7:05pm EMS arrived. Tag# 3663 Unit 8X. Patient will be transferred to hospital.
101 degree fever - 2 hrs after shots given- no longer running one  Rt. leg- swollen & red
PATIENT REPORTED SHORTNESS OF BREATH, CHEST PRESSURE, DIZZINESS.  PATIENT REPORTED AS THOUGH "SHE WAS GOING TO PASS OUT".  REPORTS FULLNESS IN THE THROAT AND A THICK TONGUE.  EPI ADMINISTERED RIGHT THIGH, BENEDRYL 50 MG ADMINISTERED IM RIGHT DELTOID.  911 CALLED, PATIENT "JITTERY", BREATHING IRREGULAR AND GASPY..  EMS TRANSPORTED PATIENT TO HOSPITAL.
I started to have fevers, chills, joint pains. The big symptom I had was abdominal pain. This is what I sought treatment for.
Patient seen for well care on 3/27/2013 was given MMR, varicella, PREVNAR 13. Developed fever 102.8 with wheezing, within 24 hrs and swelling of the eyes within 48 hrs.
Patient experienced numbness, tingling and warmth in her face and arm immediately after the first COVID vaccine. She also experienced swelling under her eyes hours after vaccine. She took Benadryl for her symptoms. One week after the vaccine she experienced the same symptoms.
Within a half hour my face went numb. More so from the top of my to my forehead. Neck felt like I was in a car accident. Medical Director at the site said extreme rare, but should go away in 24 hours that was Wednesday night. Friday morning still numb.
Palpitations,  shortness of breath, dizziness, tachycardia.
pt recvd vax 5JUN95 & 14JUN95 pt devel open lesions & on 19JUN95 pt devel fever; no further details were provided;
This is a spontaneous report obtained from a contactable Health Care Professional (retired physician's  assistant that reported for his mother). A 96 year old female patient received, on 25Oct2016, PREVNAR 13 single dose, for immunization. Relevant medical history included coronary artery disease (3-5 years before this report), open heart surgery (10-15 years before this report, coronary bypass for 4-5 arteries), pacemaker (3-5 years before this report), colon cancer that resolved after surgery, total knee replacement, carpal tunnel repair and dementia. Concomitant medications were unknown. The patient previously received, on an unspecified date, flu vaccine and streptococcus pneumonia vaccine, both for immunization.  On 26Oct2016, the patient's urine output decreased: put out less than 500cc of urine and on 27Oct2016, renal failure was diagnosed. In response to renal failure, she was hospitalized on 27Oct2016. Treatment was received. The patient did not recover from the events at time of this report. Sender's Comments: The reported events are considered most likely as coincidental events, unrelated to PREVNAR 13. 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.
Passed out, brain fog , headache, fever, body aches, pains all over body, numbness, soreness, tachycardia, high blood pressure, lightheaded, dizzy, nauseous, weakness, and  fatigue.
I just wanted to report that I've been experiencing a clogged feeling in my ears, more the right ear. some ringing in my ears from time to time, and feel a little under water still today.  4/29 I did have the fevers and the body aches.
Sometimes it's fine but like last night it woke the patient up 5-6 times; Between the shoulder blade and elbow, it itches and burns/injection area itches and burns; Injection area seems swollen at times; Between the shoulder blade and elbow, it itches and burns/injection area itches and burns; When the patient puts the hand on the arm, it feels very hot/injection area very hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (When the patient puts the hand on the arm, it feels very hot/injection area very hot), INSOMNIA (Sometimes it's fine but like last night it woke the patient up 5-6 times), VACCINATION SITE PAIN (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns), VACCINATION SITE SWELLING (Injection area seems swollen at times) and VACCINATION SITE PRURITUS (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns) in a 71-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced VACCINATION SITE WARMTH (When the patient puts the hand on the arm, it feels very hot/injection area very hot), VACCINATION SITE PAIN (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns), VACCINATION SITE SWELLING (Injection area seems swollen at times) and VACCINATION SITE PRURITUS (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns). On 15-Sep-2021, the patient experienced INSOMNIA (Sometimes it's fine but like last night it woke the patient up 5-6 times). At the time of the report, VACCINATION SITE WARMTH (When the patient puts the hand on the arm, it feels very hot/injection area very hot), INSOMNIA (Sometimes it's fine but like last night it woke the patient up 5-6 times), VACCINATION SITE PAIN (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns), VACCINATION SITE SWELLING (Injection area seems swollen at times) and VACCINATION SITE PRURITUS (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns) outcome was unknown.            No concomitant medications reported. No treatment information was provided.  The itching was not a rash or red in color but was most prominent at one area and was annoying to the patient.
This initial spontaneous report was received from a physician referring to a 9 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 04-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Patient had red arm about 4 inches and some itching and swelling,  I referred her to primary care prescriber or urgent care.
tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; Shingles; hypochondriac; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "deaf" (ongoing), notes: The caller is deaf too. Concomitant medication(s) included: LISINOPRIL; VIT D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (Dose 1), administration date: 30Apr2021, when the patient was 79 years old, for COVID-19 immunization, reaction(s): "tingling in her face, hands and feet, primarily on the left side."; Shingles vaccine (The caller got the shingles vaccine 10-12 years ago), for Immunization. The following information was reported: PARAESTHESIA (non-serious), DISEASE PROGRESSION (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "tingling in her face, hands and feet, primarily on the left side./these symptoms became worse"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles"; ILLNESS ANXIETY DISORDER (non-serious) with onset May2021, outcome "unknown", described as "hypochondriac". The event "tingling in her face, hands and feet, primarily on the left side./these symptoms became worse" was evaluated at the physician office visit. Therapeutic measures were taken as a result of paraesthesia, disease progression.  Additional information: Reporter states patient had been prescribed Gabapentin by her doctor for the tingling, but it is not helping. The caller doesn't take anything and has become a hypochondriac since May2021. The caller had the two Pfizer shots, and she has talked to her doctor multiple times and decided not to get the booster. Caller states she has spoken to and seen her doctor and neurologist about these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt recvd 6 doses of Engrix-B vax is a non-responder;
p/vax pt devel dizziness & vertigo;evaluate for acoustic neuroma;MRI of brain performed using gadolinium;no evidence of acoustic neuroma or CP angle mass;
Covid19 breakthrough.  1st vaccine received on 11/12/2021.  86 y/o with PMHx of DM, Epilepsy, DVT presented to ED with 1 day history of vaginal bleeding, pelvic pain and cough.  Room air sat 96%.  CXR with no focal consolidation, afebrile.  Pt on IV abx.
Pt experienced one episode of general body tingling and itchiness which lasted for 5 minutes then disappeared. Pt developed local left arm pain which persisted but now has diminished. Also experienced joint "cracking" sensations without pain. All symptoms began 2 days post vax.
Diagnosed with Pericarditis as an adverse affect of the COVID-19 Vaccine. Was in the E.R for 2 nights and my troponin levels were high reaching 2.71 %. Was put on colchicine, prilosec, and ibuprofen. Still in pain after 2 weeks of pain starting. Was told pain should subside by 3 weeks.
Bacterial cellulitis, warm spreading erythema + axillary LAD + circumferintial edema, no streaking. Dicloxilia 250mg PO QID x 10 days
her injection arm is a little sore.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of malaise (injection arm was red and itchy but resolved') and pneumovax with an associated reaction of pruritus.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was talking about the past The patient stated that that after getting her yearly flu shot her injection arm was a little sore.  The reporter did not want to answer any further questions and did not provide the name of the flu shot.  The reporter did not consent to follow up.
- Pt had taken benadryl 50mg at 4:35pm prior to vaccination due to facial swelling with 1st vaccine reportedly (administrator was aware). 2nd pfizer vaccine was administered at 4:50pm. Pt left clinic at 5:05pm but shortly returned due to some new R cheek swelling. Checked on pt at 5:20pm - no throat swelling, no significant facial swelling - slight erythema to R cheek, RRR, non-labored breathing. Pt was provided water. She remained stable at 2nd check (CN V, CN VII, CN XII tests wnl, non-labored breathing, no throat/neck/eye swelling but R cheek swelling still persisted -did not worsen). Pt opted to leave clinic and monitor symptoms closely at home. Strict ER precautions provided. Advised pt that she can repeat benadryl dose in 2-4 hrs as needed. Pt left with husband at 5:39pm from clinic.
Patient returned to clinic to receive second dose of the COVID vaccine. 1st dose was administered on 5/20/2021, Pfizer. On 6/10/2021 patient received a second dose of Moderna. No adverse reactions were noted. Patient was kept in observation, vitals were taken and recorded.
66 year old patient who was inadvertently vaccinated with GARDASIL 9; No additional AE reported; This spontaneous report was received from a reporter of unspecified qualifications and refers to a 66-year-old male patient. His pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T008152, expiration date 21-JUN-2022 (formulation, strength, exact dose, anatomical location and route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). The outcome was not reported. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
A skin rash appeared about 7 or 8 days later.  Red welts appeared on both wrists and forearms and on left leg on outer thigh.
On 08/18/2003 child had rash to extremities, rash spread and covered entire body, bright red, irregular shaped areas, swollen fingers, joints, lymph gland and lips. Temp up to 100 degrees. Did see PCP and mom states PCP stated pt was allergic to "a component in vaccine".
Large R axillary lymph nodes noted, tenderness at injection site, erythema at injection site, palpated enlarged lymph nodes.
Two weeks after second shot had SVT episode with heart rate of 210. Went to ER. since then have been 5 more times with out of control heart rate, neurological issues like inability to move hands and fingers, to walk correctly, developed a stutter for 3 days after one of these episodes. Has been happening all the time since second vaccine. Have now been diagnosed with orthostatic intolerance and dysautonomia.
Fever; Chills; Joint pains; Headaches; Injection site pain; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pains), HEADACHE (Headaches) and VACCINATION SITE PAIN (Injection site pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pains), HEADACHE (Headaches), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pains), HEADACHE (Headaches), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient reported using ice for treating the events.
01/16/2021-palpitations for 5 minutes. 01/20/2021-SVT(heart rate at 200?s) with palpitations for 17-18 minutes.
The 5th day of 2nd dose started with numb hands and tongue, high blood pressure 150/100 numb feet. My dr said it was a panic attack but I never experienced something similar to this. Same event happened 3 days after the first one
What do I put on the injection site to reduce the swelling and; What do I put on the injection site to reduce the swelling and pain; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain, fever and chills. On an unknown date, the outcome of the injection site swelling, injection site pain, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient got an injection yesterday (date of reporting 10th March 2020) from his doctor and he was experiencing pain and swelling at the site and had a low grade fever and chills. The patient had a concern that what do he put on the injection site to reduce the swelling and pain.
On the morning of 1/10/21, approximately 2 weeks after receiving the injection, and 2 days after testing positive on COVID-19, I developed a splotchy rash on my left arm at and around the injection site.  Initially the rash did not itch, but as the day progressed, the rash became itchy.  It is raised, red, and warm to the touch.  I took liquid benadryl before going to bed that evening, but when I woke up this morning (1/11/21), the rash is still there and it does still itch on ocasion.
Sever headache ( occipital neuralgia ) lasted about 12 hours, then about 12 hours later severe pain of rhemotide arthritis of left ankle which lasted about 12 hours,
About 8 days following the first dose, my arm became sore and heated to the touch, by the next morning I had an itchy, red rash on my arm in a circle shape at the injection site.  Within 48 hours, the rash spread down the interior portion of my arm.  Today is day  12.  My arm is not as sore, however, still itchy, warm, and red.
Approximately 16 hours after injection, experienced body aches, chills, severe headache and fatigue. Symptoms resolved after approximately 14 hours later.
4/10- shot, left arm 4/14- slight rash left cheek, I ignored it 4/21 -left check twitching, didn't think about it, ignored it 4/28- Food tasted off 4/29- in the morning, left eye blurry and teary, smile looked off, left ear hurt, headache - later afternoon self-diagnosed with Bell's palsy- confirmed at Urgent Care 4/30 Blood test negative for Lyme's Disease 5/1 Talked to my Acupuncture therapist- (I am her 4th Bell's Palsy case post Pfizer shot #2). I thought this definitely should be reported.