chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe allergic reaction; Full body hives; Face swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "no reaction to the 1st or 2nd dose of this vaccine"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "no reaction to the 1st or 2nd dose of this vaccine". The following information was reported: HYPERSENSITIVITY (medically significant), outcome "unknown", described as "Severe allergic reaction"; URTICARIA (medically significant), outcome "unknown", described as "Full body hives"; SWELLING FACE (medically significant), outcome "unknown", described as "Face swelling". The events "severe allergic reaction", "full body hives" and "face swelling" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of hypersensitivity, urticaria, swelling face treated with multiple Epinephrine shots.  Clinical course: The patient have no known allergies and have no reaction to the 1st or 2nd dose of this vaccine. This random excessive allergic reaction has happened again requiring ER visits and EPI shots.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received my 1st Pfizer vaccine 1/10/2021. Did great!  Received my  2nd Pfizer vaccine 1/31/2021 1130 am 6 hours later at 6:30 pm ate packaged veggie dumplings and 15 min later my tongue swelled and my face felt swollen and itchy.  Took  Benadryl 25mg, Allegra 180mg and Pepcid 20mg with relief.   6 hours later, awoke  with itchy throat and face  and took Benadryl 25mg with relief.   Next morning, 2/1/2021:  8 am ate  my regular breakfast of peanut butter on toast and 15 minutes later my face started itching. Took Allegra 180mg with relief.  11:30 ate pretzels and face started itching `15 minutes later.   Everything I ate that day caused me to itch 15 min afterwards  just like when I  would have food reactions when first diagnosed with Alpha Gal  and my IGE histamine levels with 3x normal.   I increased my Allegra 180mg to  3x a day for 24 hours and Pepcid 20mg to 2x a day for 24 hours.   48hours after vaccine  I was able to decrease Allegra 180mg  to 2x a day with Pepcid 20mg to 2x a day and was able to eat bland food without itching afterwards.   My allergist felt the 2nd vaccine  may have caused an inflammatory response and flared up my alpha gal symptoms.
under a lot of stress; tired; rapid heartrate; her own arm looks like a monster; Upset; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Sep2021 (Lot number: FC3183) 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: STRESS (non-serious) with onset Sep2021, outcome "unknown", described as "under a lot of stress"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "tired"; HEART RATE INCREASED (non-serious) with onset Sep2021, outcome "unknown", described as "rapid heartrate"; PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "her own arm looks like a monster"; EMOTIONAL DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "Upset". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient states she was upset and her own arm looks like a monster. She was under a lot of stress right now. She feels the same way, tired and a rapid heartrate.   No follow-up attempts are possible. No further information is expected.
pt recv vax; local pain, swelling, redness, hot (10x12cm); tx w/ ice pack & hydrocortisone cream & apap;
Fluzone flu vaccine administered, as vaccine completed patient immediately developed a 6.5 x 5.5 cm flat round erythemic area with pruritis.  No respiratory distress.  O2 sat 100%.  Given Benadryl 50mg po and monitored.  Rash abated in 60 minutes.
This spontaneous case reported by a consumer, describes the occurrence of dyspnea (shortness of breath) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022M21A) for COVID-19 immunization. The patient's past medical history included no historical condition reported. On Feb 26, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 3, 2021, patient experienced dyspnea (shortness of breath). At the time of the report, dyspnea (shortness of breath) outcome: unknown. No concomitant medication or treatment information reported. No adverse event after the second dose. Action taken with mRNA-1273 in response to the events: not applicable.
Information has been received from a physician concerning an infant, a cousin to one of his patients, who may have been vaccinated with MMR II (manufacturer unknown). Concomitant therapy included several "unspecified immunizations". Subsequently the infant developed autism after receiving several unspecified immunizations. The physician was not sure if the patient received "MMR". The physician was contacted for additional details; however the physician stated that the infant was not one of his patient's, therefore had no additional information to provide. Upon internal review, the patient's autism was considered to be an other important medical event. No additional information is expected.
Dry heaving and vomiting 16 hours after injection, fever and night sweats, muscle aches, headache
Severe pain, heart beating very fast. Shaking, sweating, fever. Unable to raise arm. Rgt arm swollen and very lg. Red band on arm.
p/24hr p/vax pt arm swelled, got red & hot to touch;this lasted for 6-7 days;also had a fever for about 4 days;given DPH & put ice packs on area;
COVID arm; Raised Bump; injection arm ache; Red circle; Injection arm ache; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache), VACCINATION SITE REACTION (COVID arm), INJECTION SITE MASS (Raised Bump), PAIN IN EXTREMITY (Injection arm ache) and INJECTION SITE PAIN (injection arm ache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (neck ache) and PAIN IN EXTREMITY (Injection arm ache). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), INJECTION SITE MASS (Raised Bump), INJECTION SITE PAIN (injection arm ache) and INJECTION SITE ERYTHEMA (Red circle). At the time of the report, NECK PAIN (neck ache) and PAIN IN EXTREMITY (Injection arm ache) had not resolved, VACCINATION SITE REACTION (COVID arm) outcome was unknown and INJECTION SITE MASS (Raised Bump), INJECTION SITE PAIN (injection arm ache) and INJECTION SITE ERYTHEMA (Red circle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment of the events include, Ibuprofen and naproxen.   This case was linked to US-MODERNATX, INC.-MOD-2021-098624 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up information was received on 29 Apr 2021, include, contact details, date of second dose administration and events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098624:Case created for second dose
Patient & parent noticed area where vaccine administered was red, swollen, warm to touch. 6-6-12 area (L) upper back arm 6 cm. Patient given BENADRYL 25 mg caps 1 cap P.O. TID, prednisone 20 mg 2 tabs PO daily. Triamcinolone cream apply to affected area.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
Metallic taste in mouth that dissipated after about an hour, redness/swelling at injection site and itching that persisted for 3-4 days.
Erythematous macular rash 3 cm by 1 cm around injection site
Pt stated that he was fully vaccinated for COVID-19. Manufacturer and dates unknown. Pt now in inpatient hospitalization at Hospital. Admitted with back pain, chest pain, low grade fevers, and cough.
Nurse gave the Janssen COVID-19 vaccine on 07/19/2021 per consent which indicated that the patient had never had a COVID-19 vaccine in the past.  This consent was filled out by the nursing staff at a nursing home where we brought the vaccine to give. When entering the Janssen vaccine, it as noted that the patient had previously received 1st dose of Moderna vaccine on 06/23/2021 Lot # 047C21A from the health center.  I notified the director of nursing.  They state they will, in turn notify patient's son who signed consent and the patient's physician.  Per director, patient has no complaints and is doing well with no adverse events.  Nurse advised them to notify health center that she is not to get 2nd dose of Moderna.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from a health care professional on 02 May 2008.  A 14-year-old male patient with a medical history of allergies to Augmentin and peaches, as well as seasonal allergies, had received an intramuscular injection of Menactra, lot number U2613AA, on 01 May 2008 at 4:00 PM.  60 minutes later, the patient called the physician's office to report symptoms of scratchy throat and an itchy rash on his abdomen.  He also experienced wheezing, but his breathing was not labored.  He was seen in the emergency room and was treated with IV steroids (unspecified).  He was discharged to home with an Epi-Pen and prescriptions for prednisone and Zyrtec.  The physician's office followed up with the patient on 02 May 2008 and reported that he was doing well and had recovered from the events.
22 hours after receiving the vaccine , I presented with a violent headache and violent vomiting, duration 24 hours. At the time I received the AREXVY  vaccination, I was also administered  a FLUAD QUAD 2023-2024 SYR vaccine.
The patient was anxious, diaphoretic, nauseous, pale, and cold. Complained of palpitations and was laid flat of the floor, with feet elevated. Patient "not feeling well". Poor tolerated sitting up - recurrence of ill appearance and nausea. Blood glucose 91, BP readings - 133/71, 174/91, 149/76. HR 97, Sats 100%.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 29-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 376 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
High heart rate at rest. 125-130bpm. Watch kept giving me alerts that my resting heart rate was high. I felt very anxious and was feeling hot most of the day. Symptoms went away within 24hrs.
It was reported that a female patient received a Typhim VI, a YF-VAX, TD, an IPOL, and a Hepatitis A vaccination on 06/23/00. Reportedly the patient passed bright red blood in her stool approximately 60 hours after vaccinations. Further info is requested.
This spontaneous report was received from a nurse practitioner, referring to an approximately 65 year old female patient with hypercholesterolaemia, hypertension, hyperthyroidism and other unspecified concurrent condition. The patient had a drug reaction/allergy to pain medication (unspecified). On 27-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot # L012039, expiration 07-JUL-2016), 0.65 ml, subcutaneous in the left arm. The patient was reported to be under unspecified concomitant medications. On an unspecified date in 2015, the patient experienced herpes zoster (reported as shingles without the rash). Symptoms included pruritus, pain and burning sensation. On an unknown date the patient sought medical attention by contacting the HCP office. The outcome of herpes zoster was reported as not recovered. The primary reporter did not provide the causality between ZOSTAVAX and herpes zoster. Additional information has been requested.
feverish and achy for 1-2days; feverish and achy for 1-2days; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FK9896) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation; oxymetazoline hydrochloride (CLARITIN ALLERGIC), from 28Jan2022 (Batch/Lot number: unknown) to 28Jan2022 at 10 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left), administration date: 26Apr2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "rash"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "rash". The following information was reported: PYREXIA (non-serious), PAIN (non-serious) all with onset 2022, outcome "recovered" (2022) and all described as "feverish and achy for 1-2days". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for oxymetazoline hydrochloride was unknown. Therapeutic measures were not taken as a result of pyrexia, pain.  Additional information: patient states he developed a rash on his torso 24hrs after his 1st and 2nd pfizer covid vaccines states symptoms/rash cleared on its own after couple days or so. Patient was given Claritin 10mg tab prior to his Pfizer covid 'booster' and watched for 30min, no problems, I called patient today 31Jan2022 to see if any rash developed over the weekend and he said NO. no rash developed this time however states he did feel feverish and achy for 1-2days (feels fine now).  No follow-up attempts are possible. No further information is expected.
On 10/25/17 patient noticed red/warm area to arm where vaccine was given.
Arm is hurting; This is a spontaneous report from a contactable consumer reported that: A 71-years-old female patient received bnt162b2 (BNT162B2; solution for injection), dose 1 via an unspecified route of administration on 02Jan2021 (Batch/Lot Number: EL5318) as single dose for covid-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were unknwon. The patient experienced arm is hurting on 02Jan2021. It was reported that, I took the vaccine yesterday and you know my arm is hurting. I was calling if I could take a Tylenol capsule.  I got it on the 7th /21 Jul2021 (Lot#EN5318). I had it from the, you know they had it, place we go to vaccinate. No, I did not get it from the hospital, I got it from a company is that a, I got it from the emeregency. There they asked us all people had to go get vaccinate. I did not buy. They applied to and gave it to lot of people coming to the place to get there vaccine. Outcome of the event was unknown.
Vaccine was given at another clinic - Clinic on 7/31/19  in the right deltoid per patient report and immediately felt a tingle in the right jaw and a metallic taste in her mouth.  Over the last 3 days has had numbness in the right jaw, tongue, and mouth, but today (8/3/19) start having numbness sensation moving up the right side of the face and having difficulty closing the right eyelids tightly.  No obvious facial asymmetry to the patient, but on exam there is right eyelid weakness and right corner of the mouth is asymmetric with smiling.  Treatment started prednisone 60 mg once daily x 7 days with planned follow-up with PCP 8/5/2019.
headache; chills; muscle pain; tiredness; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3302), via an unspecified route of administration at the left arm from 30Jan2021 3:00 PM at SINGLE DOSE for covid-19 immunization. The patient is not pregnant at the time. The patient was vaccinated at a Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included cancer cured. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that there are other medications the patient received within 2 weeks of vaccination, however it was unspecified.  The patient previously took demerol and experienced allergy. It was reported that the patient experienced headache, chills, muscle pain, tiredness, feeling unwell on 30Jan2021 09:00 PM. The outcome of the events was recovered. No treatment was received for the adverse events. The case/ events were reported to be non-serious.
Diarrhea, gastritis. I already had colitis, it aggravated it and I had to see the gastroenterologist. I was given ZANTAC and LIALDA.
Muscle aches, fever of 100.5°F, injection point pain (extending to the elbow), general malaise, and difficulty concentrating lasting over 24 hours.
Patient states he was seen by physician for symptoms after the immunization and physician stated he had a non-traditional case of Guillain-Barre syndrome.
Approx 6:15pm began feeling what I first thought was heartburn. Approx 8-8:15pm severe congestion and swelling in both eyes. Right eye swelled almost closed. BENADRYL relieved the congestion, but eye swelling wasn't entirely gone until the second morning.
pt recvd vax; swelling, redness, soreness & tenderness in lt upper arm down to mid forearm;
no adverse event; 5 patients received the vaccine on 12-Jun-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received the vaccine on 12-Jun-2023) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received the vaccine on 12-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received the vaccine on 12-Jun-2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 patients received the vaccine on 12-Jun-2023).    Concomitant product use was not provided by the reporter.  Expiry date of the suspect vaccine was reported as 07-Jun-2023.  Treatment information was not provided.  This case contains information about patient 3rd out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-728837 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728837:Master Case
Female patient reported respiratory difficulty and that her trachea was blocked, tremor and tachycardia. Vitals taken, O2 administered.
16 years old and received vaccine; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received vaccine) and FATIGUE (Fatigue) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis since 06-Sep-2017, Syncope vasovagal since 30-Oct-2019, Asthma since 07-Apr-2021, Heartburn since 06-Sep-2017, Insomnia since 30-Oct-2019, Food allergy (Cabbage) and Drug allergy (Famotidine). Concomitant products included LORATADINE (LORA [LORATADINE]) from 07-Apr-2021 to an unknown date and FLUTICASONE PROPIONATE (FLUTICASONE [FLUTICASONE PROPIONATE]) from 07-Apr-2021 to an unknown date for Allergy, ALBUTEROL SULFATE from 07-Apr-2021 to an unknown date for Asthma, DICYCLOVERINE HYDROCHLORIDE (BENTYL) from 04-Mar-2020 to an unknown date for Gastritis, LANSOPRAZOLE (PREVACID) from 03-Apr-2021 to an unknown date for Heartburn, MELATONIN from 30-Oct-2019 to an unknown date for Insomnia, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), DICYCLOVERINE HYDROCHLORIDE (BENTO) and ALBUTEROL [SALBUTAMOL] from 07-Apr-2021 to an unknown date for an unknown indication.   On 23-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021 at 7:00 PM, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received vaccine). On 27-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received vaccine) outcome was unknown.            Other vaccine -CRR is reported. Concomitant medication-ORTHO TRI-CYCLEN is reported. No treatment medications were reported.   This case was linked to MOD-2021-222970 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Patient medical history,Concomitant products,Event details are added . Patient information,Patient details and second dose details are updated.
Found deceased at home, less than two weeks after second Pfizer  vaccine.  Had no complaints of illness, chest pain, dizziness, dyspnea or SOB on exertion,  ME exam tox negative,  enlarged left ventricle , likely dysrhythmia .   Very active man,  without significant PMH ED, borderline HTN when at MD office once, (140/84), normal EKG at age 50.  No family history of sudden cardiac death.