chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One week after vacination ( after initial symptoms of arm soreness, swelling, achiness and flu like symptoms - all expected, if not necesssarily on 1st shot) had a second reaction that seemed unusual  First arm swelled a second time, while becoming painful, red, and itchy Then bullseye rash developed over injection site Then  arthritis flare ( have spondylarthritis) - joints got sore, overall flulike weakness - difficult to stand up from chair, use stairs Then asthma flare - twice in one day. Unusually severe (for me) responded to relief inhaler+ steroid inhaler Then rash spread to face - spots on face. Underarms got sore So now achy, sore, wheezing, spotted face, bullseye rash on swollen arm & itchy- all more than a week after vaccination...
Hospitalized COVID positive with shortness of breath and hypoxia. Pneumonia due to COVID on remdesivir and dexamethasone and O2.
Rash at the injection site; Rash on abdomen and back; This case was reported by a consumer and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site rash and rash. On an unknown date, the outcome of the injection site rash and rash were unknown.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had rash at the injection site and on her abdomen and back. The patient inquired whether she should receive the 2nd injection in 2 to 5 months. The patient asked would my rash be worse for the 2nd dose.
recurrent internal styes (hordeolum) in bilateral eyes. 3 styes in L eye and 1 in R eye following approximately 2 weeks after 2nd vaccination shot. Eventually Doxycycline was required to clear 3rd infection although as of this date 3-21-21 I am 7 days out from ending my antibiotic and another painful spot is appearing in L upper eyelid on lateral surface.
high fever 103 ax, hallucinations, abd cramping;crying nonstop over 3hr;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 11-JUL-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events to be related to ZOSTAVAX. Shingles outbreak was reported to be disabling. Additional information has been requested.
severe itching all over body , eczema flare up on both my hands that has worsened  since that date
Immediately I experienced muscle pain and what felt like burning sensation go down my arm to my fingers.  My arm was painful and having spasms.  On a daily basis since injection, I've had spasms and muscle/shoulder pain.  I have used ice and salon pas to help with pain, and taken Aleve.  The spasms/pain subside but reoccur several times during the say.  The spasms begin and immediately the pain returns with the spasms.  Pain level 1-2.
3rd dose of Bexsero administered; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number X4BK3, expiry date 30-SEP-2026) for prophylaxis.   Previously administered products included Bexsero (1st dose received on unknown date) and Bexsero (2nd dose received on unknown date).   On 29-SEP-2023, the patient received the 3rd dose of Bexsero. On 29-SEP-2023, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: 3rd dose of Bexsero administered).  The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 A physician reported that a female patient already completed the 2 dose series for Bexsero and was given an accidental 3rd dose which led to extra dose administered. No symptoms reported. The reporter consented to follow up via mail.
p/vax pt exp swelling @ the inj site which dec over a week;approx 10 days later pt devel a rash @ inj site that was described as small bumps that gathered to form a welt;devel cold sx;devel ear infect & loss of appetite;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted and hit his head and scratched his right arm
The patient received her vaccine but after few minutes she said that she is feeling dizzy. Blood pressure checked and it was 140 over 110. We kept monitoring the patient for 15 more minutes but she said I am feeling okay after that. At 3:20 PM, we called her and she said she left early from her job to home and she is feeling fine now.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for ckd stage 3, home oxygen, htn, AF, heart failure, metastasis to cervical lymph nodes, htn, hyperlipidemia, chronic obstructive lung disease, coronary atherosclerosis, dementia, diabetes, carcinoma of skin. Also on home hospice care. Moved to another state in early May. No notation available regarding death on 5/19/2021.
Pt reported sore arms, headache and body aches for one day.  She didn't notify a physician.
Pain in right side of face and head started 2 days after vaccination. Right eye lid became droopy and continued to worsen for 2 more days until he was no longer able to open his right eye. He is still experiencing pain and is unable to open his eye. He states that his vision is slightly blurred in right eye but is able to see.
the site of my arm is hot; the site of my arm is red; the site of my arm is swollen; the site of my arm is itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (the site of my arm is hot), VACCINATION SITE ERYTHEMA (the site of my arm is red), VACCINATION SITE SWELLING (the site of my arm is swollen) and VACCINATION SITE PRURITUS (the site of my arm is itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (the site of my arm is hot), VACCINATION SITE ERYTHEMA (the site of my arm is red), VACCINATION SITE SWELLING (the site of my arm is swollen) and VACCINATION SITE PRURITUS (the site of my arm is itchy). At the time of the report, VACCINATION SITE WARMTH (the site of my arm is hot), VACCINATION SITE ERYTHEMA (the site of my arm is red), VACCINATION SITE SWELLING (the site of my arm is swollen) and VACCINATION SITE PRURITUS (the site of my arm is itchy) outcome was unknown.        No concomitant medications provided No treatment medications provided
very dizzy; can't walk to much; Pain and tenderness arm; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (very dizzy), GAIT INABILITY (can't walk to much) and PAIN IN EXTREMITY (Pain and tenderness arm) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (very dizzy), GAIT INABILITY (can't walk to much) and PAIN IN EXTREMITY (Pain and tenderness arm). At the time of the report, DIZZINESS (very dizzy), GAIT INABILITY (can't walk to much) and PAIN IN EXTREMITY (Pain and tenderness arm) outcome was unknown.            This case was linked to MOD-2021-033870, MOD-2021-033870 (Patient Link).
3 days after 2nd dose Ic started having pain in left side of chest which got stronger
Almost exactly 24 hours after shot, nausea & dizzy for 2 hours, followed by loose stool for next 3 days. This came back 6 days later to a lesser degree. 16-18 days after shot, a 3? x 4? area around injection site became red, warm & itchy.  Benadryl for 4 days cleared it up.
Allergic Reaction; received possibly the whole undiluted vial of the vaccine / was possibly 90 - 120 mcg of vaccine given to the patient; Please provide the stage of medication error (e.g., prescribing, dispensing, preparation, and administration): preparpation and administration; received possibly the whole undiluted vial of the vaccine / was possibly 90 - 120 mcg of vaccine given to the patient; mild fever; chills; sore arm; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A 58 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: FH8030) as dose 2, single for covid-19 immunisation. Relevant medical history included hypertension (ongoing); osteoarthritis (ongoing); prediabetes (ongoing); Allergic reactions (ongoing); hypercholesterolemia (ongoing); High cholesterol (unspecified if ongoing); Allergy symptoms (unspecified if ongoing). Concomitant medication(s) included ATORVASTATIN taken for blood cholesterol increased (ongoing); ALLEGRA taken for hypersensitivity (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing). Vaccination history included Bnt162b2 (Dose:01, Batch/Lot# 301558A, Time: 13:00, Site and Route of injection, Anatomical Site of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: 301558A / PAA173398), administration date 19Oct2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s) mild fever, chills. The following information was reported OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 16Nov2021, outcome unknown; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 16Nov2021, outcome unknown; PYREXIA (non-serious) with onset 16Nov2021, outcome recovered (2021); CHILLS (non-serious) with onset 16Nov2021, outcome recovered (2021); PAIN IN EXTREMITY (non-serious) with onset 16Nov2021, outcome recovered (2021); HYPERSENSITIVITY (non-serious) with onset 16Nov2021 21:00, outcome recovered (2021). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypersensitivity.  Phone out 3:40 pm  Reporter provided an update that the patient is still OK and doing fine.
Hot; Pain at injection site (right); Swelling; Redness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    A spontaneous report was received from a consumer concerning a 57-years-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site (right)/ vaccination site pain, swelling/ vaccination site swelling, redness/ vaccination site erythema, hot/ vaccination site warmth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, approximately one day prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the events pain at injection site (right), swelling, redness, hot.  Treatment details included Motrin one dose, ice, heat.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, pain at injection site (right), swelling, redness, hot was unknown.
postnasal drip; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UPPER-AIRWAY COUGH SYNDROME (non-serious), outcome "unknown", described as "postnasal drip".  Additional information: Medical Information: There were no unaddressed medical questions referred or forwarded to Medical Information. It was reported that Caller received 1st dose of Covid Vaccine. She wants to take a decongestant for postnasal drip. Also wanted to Know does Pfizer vaccine make you sleepy  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via cell center representative and described the occurrence of throat swelling in a adult female patient who received FLUARIX QUADRIVALENT. Previously administered products included flu vaccine (patient has a history of reactions to flu vaccines (unknown manufacturer) from the last three years). Concurrent medical conditions included multiple allergies (Patient does have allergies and takes CLARITIN for it). On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced throat swelling and hives. The patient was treated with BENADRYL (nos). On an unknown date, the outcome of the throat swelling and hives were recovered/resolved. It was unknown if the reporter considered the throat swelling and hives to be related to FLUARIX QUADRIVALENT. Additional information received: Within an hour of injection, patient experienced: throat, arm and chest hives. Patient had no other issues with any other vaccines.
VACCINE ERROR, ADMNISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEVIED 9.12.23 LATER AFTERNOON.
Acute respiratory failure with hypoxia (HCC) (Primary Dx);  Shortness of breath;  Tachypnea;  Pneumonia due to COVID-19 virus Office Visit 3/4/2021 Internal Medicine   Internal Medicine Cough +2 more Dx Shortness of Breath ? Cough Reason for Visit Progress Notes (Physician) ? ? Internal Medicine ? ? Encounter Date: 3/4/2021 ? ? Signed Expand AllCollapse All      Assessment/Plan      Diagnoses and all orders for this visit:   Cough -     X-ray chest 2 views; Future -     B-type natriuretic peptide; Future -     CBC and differential; Future   Iron deficiency anemia, unspecified iron deficiency anemia type -     CBC and differential; Future -     Iron + Transferrin + % Saturation; Future   Shortness of breath -     B-type natriuretic peptide; Future
Hep A 10:45 am on 6/13/15, Tm 102 at 8 pm on 6/13/15 with green stool, fever x3 days, +swollen glands to neck, complains of joint pain.
This spontaneous report as received from a registered nurse refers to one patient of an unknown age and an unknown gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L003227, expiry date: 13-OCT-2016; dose and route of administration were not reported). The vaccine was stored at 46.4 degrees Fahrenheit for a time frame of 36 minutes and was administered to the patient. There was no previous temperature excursion. The call was a result of "data logger". No adverse symptoms were reported. Product quality complaint was not filed. Additional information has been requested.
25 patients were administered an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 patients were administered an expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 patients were administered an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 patients were administered an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not  provided.  HCP consented permission to document details of the call.  HCP (Pharmacist) reported 25 patients were administered an expired vaccine one day after the vial's manufacturer expiration date (Moderna).  Individual patient demographic information not provided. HCP would like to know if the doses administered to the patients were valid or do they need to revaccinate?  Details of Vaccine  Lot number:  026A21A (all 6 vials). Manufacturer Vial Expiration Date: 26Aug2021.   Number of doses/vials.  25 doses/6 vials. On 26Aug2021 Date the vial was initially stored in the refrigerator and moved from freezer to fridge. Date placed in Freezer is Unknown, but HCP can find out if needed.  Date of administration of vaccine is 27Aug2021 (all 25 patients administered dose on this date). The Vial undergone no temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77° F) is unknown but HCP can find out if needed. Min and Max Temps: C or F? Unknown buy HCP can find out.  Thawed Vials observed/inspected
Nausea, upset stomach, queasiness, headache, body ache, very dry throat, lightheadedness -- second night got very bad chills, but no fever.
lt leg groin pain -acute 18hrs p/vax in lt arm-lasted approx 48hrs; marked tenderness lt adductor tender;
Patient called today our clinic saying he has been having ongoing left arm pain since the vaccine in May.  He saw his PCP Dr. and it was suggested the patient call us. We are not the PCP.  Patient states the arm slightly hurt at first and would come and go. In the recent weeks his arm has hurt more.
Patient called on 6/10/12 and to alert me she got little bit hives around the injection site. No trouble breathing nor other symptoms. She said she already told her MD on 6/9/12 as well as Rx dose in the evening. She is ok; just hives.
pt recv vax 21FEB97 & on 28FEB97 pt exp severe joint pain, stiffness & rash;
presented to ED with fever, elevated glucose cough, nausea, shortness of breath, chills, weakness and fatigue, loss of taste and smell. Patient had been out of state when he got sick. He was hypoxic with a po2 of 54 and o2 sat of 85%.
Pt received 2 vaccinations of covid19 on 4/7/21 & 5/7/21. Patient was placed in 30 min observation after receiving 2nd dose of moderna.approximately 23 min after immunization, pt's husband alereted this nurse that his wife was experiencing right leg cramps. Pt denies having leg cramps prior to injection. Pt states " I am only getting cramps on and off in the right leg for the past 15 min. Itr started about 10 min after injection. cramps don't last that long." Pt also states that she is now not having the cramping." Patient was taken to ER for observation and given an RX for TIZANIDINE HCL 4MG TAB five day supply.
5/15/23 I had a sore throat, coughing and sneezing. I thought it was allergies. By the next day, I was getting suspicious. I took an at home COVID test and it was positive. I texted my PCP on 5/19/23 and he recommended antihistamines, acetaminophen and a decongestant. Because of my medications, he did not want me to take PAXLOVID. He told me to check back with him if I did not feel better or got worse. I still have a stuffy nose and a bit of a sore throat. I never had fever.
20MM X 20MM REACTION SPOT ON RIGHT ARM, RIGHT WRIST SWELLING & RT/LT GREAT TOE/FEET SWELLING.
Difficuly Breathing; Dizziness; Neck was hurting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficuly Breathing), DIZZINESS (Dizziness) and NECK PAIN (Neck was hurting) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, CYANOCOBALAMIN (VITAMIN B-12) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DYSPNOEA (Difficuly Breathing), DIZZINESS (Dizziness) and NECK PAIN (Neck was hurting). On 26-Mar-2021, DYSPNOEA (Difficuly Breathing), DIZZINESS (Dizziness) and NECK PAIN (Neck was hurting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Heart rate: fast (High) fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included IV Fluids.
After receiving the first dose I just became very tired and fatigued. It was a gradual increase. The next day it wasn't that bad, but by the second day I wasn't feeling very well so I stayed home that day. I had fatigue, chills, a low grade fever, and body aches.
Happened in (R) thigh the evening following administration pt had significant swelling (R) thigh was described the swell to twice its size and was very red and hard. Stayed this way for 16 hours, then deceased.
Patient had headache, diaphoresis, low blood pressure and seizure.  Patient got Tylenol for her headache and was observed for a few minutes. She was offered Benadryl but patient was allergic to Benadryl. She exhibited grand mal seizure twice. The ambulance was called after the second grand mal seizure.