chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose #1 03/07/2021 Moderna lot # 032M20A  Pt died of cardiac arrest 8/2/2021
Migraine for 2 days controlled with medication, Severe swollen eyes with discharge from eyes, itchy, red watery eyes began the evening of the vaccine and ongoing.  using BENEDRYL and ALLEGRA to decrease symptoms.
Narrative: Patient received three doses of Pfizer COVID 19 Vaccine. The patient tested positive for COVID 19 on 26 April 2022. The patient presented to the ED with chest pain, shortness of breath, and cough. The patient was admitted to the hospital with respiratory failure with hypoxia, and chest pain. The patient was treated with IV antibiotics, steroids, and bronchodilators. The patient was discharged from the hospital on 27 April 2022 and then re-admitted to another hospital on 7 May 2022 with continued respiratory failure and pneumothorax. The patient was still in the hospital as of 17 May 2022. Reported per EUA.
Patient developed hives, swelling to lips/face, rash at site. All symptoms started about 2 hours after receiving TDaP. Received care at local ER, steroids, BENADRYL were given.
A few hours after receiving an IM hepatitis B vaccination (#3), redness, tenderness and induration occurred. The symptoms were at their worst after 36 hours and improved over the next 12 hours. At that time, there was 6 x 8 cm of induration.
1 Day after shot , pt complained of stiff neck  and  neck  pain. 2  Day  after ,  pt  had  vomited. 3 Day after,  Rash  all  over  body. 4 Day after ,  man  took pt to ER to be examined.
Initial unsolicited report received from a nurse on 30 December 2015. This case is a cluster of three cases and linked with 2015SA153209 and 2016SA003167 (same vaccine, different patient). This case involves a 37-year-old female patient who was vaccinated with a dose of Fluzone QIV (batch number: UI445AC, expiry date: 30 June 2016) in right deltoid on an unknown date. The patient medical history reported as allergic to egg or egg products, history of Guillain Barre syndrome, allergic to thiomersal, allergic to latex reported as no. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed aches, chills and fever. It was reported that the patient had not worked the day after but fine within 24 hours of vaccination. Laboratory data and corrective treatment was not reported. The patient was recovering from all the events. It was reported that the patient felt better 14 day later. List of documents held by sender: none. Follow up information received from a nurse on 29 February 2016. Patient had received Fluzone QIV intramuscularly on 30 September 2015. Patient had no other vaccination within four weeks prior to vaccination and illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as all-Biaxin (hives). On 30 September 2015, same day following the vaccination patient had experienced the events. On an unspecified date, patient had recovered.
Pt. described reaction as: itching hands in 10-20 mins. after injection. Next morning woke up with bilateral hand and wrist edema. No other symptoms. Treated with SOLU-MEDROL 125 mg and BENADRYL 25 mg.
staring off into space when leaving clinic cracky, fever during the noc, breathing was shallow then rapid;
Patient broke out in hives around the injection site. It was very painful and red and took up a large area of the deltoid. Patient said they still hadn't gone away two days later.
Broke out in spotty rash 10 days after VARIVAX. Pimple like, itchy-improved on day 11 post vaccination.
Vaccinated for Rotavirus on 1-21-08.  Within hours had explosive diarrhea and vomiting (projectile).  Patient refused to eat, and when she did, it would result in immediate diarrhea afterwards.  She was taken to the ER twice.  She required fluids for dehydration.  It has taken her two weeks to fully recover.  One week after vaccination she also developed a full body rash.
Patient had near syncope episode with slow responses. Upon eval pt was bradycardic, hypotensive and lethargic.
Information has been received from a health professional concerning a 16 year old female who on 10-JAN-2008 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (Lot # 658937/1560U) SQ in the left arm. On 11-Jan-2008, the patient experienced swollen, red 1 1/2 inch size area. Additional information has been requested.
Severe Diarrhea for over 1 month; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe diarrhea for over 1 month.  The patient was considering not receiving 2nd dose. The reporter denied to provide any further information or demographics.
Patient's mother reports that approximately 2 to 3 hours after vaccine administration, child began to break out in hives. Hives started on child's abdomen but spread systemically. Mother administered over the counter Benadryl and reports that the reaction resolved by morning. After administration of Benadryl, child was laid down for bed near mother for further monitoring. Child has recovered and there does not appear to be any lasting adverse side effects.
Patient contacted us 3 days after receiving vaccination. Patient stated that site around the injection was red and warm to touch. Also stated that site was getting bigger and inflamed. She also was feeling achy and felt chills the day prior.
Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) patient is a 90-year-old male with history of coronary artery disease, basal cell carcinoma of the nose presented from facility emergency department.  Presented for decreased energy weakness and confusion.  Workup notable for hypoxia presentation, viral testing COVID positive.  Patient was combative and confused on presentation this improved following high-flow oxygen.  She was started on Decadron for COVID treatment family refused remdesivir.  Family declined further aggressive care or imaging.  Oxygen gross or titrated down to room air prior to discharge home.
I had severe pain, swelling and bruises on both legs, groin and torso. I blacked out constantly and was unable to walk or work.
redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around the injection site) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Temp of 101.8 after imms decreased to 100.4 with APAP. Fussy.
golf ball-sized swelling at the posterior base of her right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (COMIRNATY), on 02Feb2021 as dose 2, single (Lot number: EL9264) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE), administration date: 12Jan2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Behind my ear I feel like it's like the gland is swollen/golf ball size swelling behind her ear", "saw the swelling and it's painful, pain a little bit, painful", "golf ball-sized swelling at the posterior base of her right ear". The following information was reported: EAR SWELLING (non-serious) with onset 2021, outcome "unknown", described as "golf ball-sized swelling at the posterior base of her right ear".  Additional information: Caller was a 63 year old consumer who had 3 doses of Comirnaty. The first was on 12Jan2021, the second on 02Feb2021, and the third on 12Nov2021. After each dose, she went to bed feeling fine, but woke up with golf ball-sized swelling at the posterior base of her right ear. Throughout the day, it would resolve. She was asking if it is safe to get another dose. The patient want to get another dose but was afraid it will swell. The patient knows it was probably the gland and was active.
Increased heart rate, dry throat, anxious, itchy skin. Pt was given 2 tabs Benadryl PO, monitored for an extra 30 minutes and cleared.
Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history significant for hypertension, hyperlipidemia, hypothyroidism, and breast cancer.  She presented to the emergency department with reports of possible allergic reaction to Pfizer vaccine.  Patient received her first dose of: Vaccine earlier today and approximately 5 minutes later developed a cough, diaphoresis, and lightheadedness.  She was given 50 mg oral Benadryl in the ED.  Patient then complained of tingling sensation throughout her body and was continuously coughing.  She was brought to the emergency department for evaluation.  Patient noted she felt jittery and "disconnected".  In the ED her cough and dizziness significantly improved.  Upon examination, patient was noted to have right lower extremity weakness.  She denied any weakness.  CT of the head was performed to rule out stroke.  Neurology was consulted.   CT head brain was negative however patient was still having right-sided weakness.  Emergency department physician confirmed the patient was able to get up without difficulty after receiving her vaccine at 1415 immediately following her vaccine.  It was determined she was within the window for TPA.  Patient was transferred to the ICU for further management.
This spontaneous report as received from a health care professional, referring to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-FEB-2018 the patient was vaccinated with M-M-R II per subcutaneous route, lot # N025889, expiration date 18-APR-2018 (dose was not reported). The vaccine was reconstituted with a sterile saline, instead the supplied sterile diluent. There was no adverse effect reported. No product quality complaint was involved.
This spontaneous report has been received from other health care professional, regarding to a 5-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 26-JAN-2023, the patient was vaccinated with improperly stored doses of VARIVAX injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) QUADRACEL (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis. Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion. No additional adverse events were reported in the patient. This is one of several reports received from the same reporter.
Not even two weeks after my second shot, I suffered from an inflamed gall bladder and had to have it removed.  I have never suffered from any time of plain from my gall bladder in my life, and have no family history of it.
This spontaneous report was received from a retired nurse refers to a male patient in his 70's. The patient's drug reaction/allergies include eggs, chicken, unspecified food and airborne allergies. His pertinent medical history and concomitant medications were not reported. Approximately in 2014 (reported as 15 to 16 months ago) the patient was vaccinated with ZOSTAVAX to prevent shingles. On an unspecified date in 2014 (reported as approximately 2 weeks) after receiving ZOSTAVAX, he developed 10 mm to 14 mm size blisters on his legs and feet. He sought medical attention by visiting the office and recovered from the event on an unspecified date. The reporter did not provide the relatedness of the event with ZOSTAVAX. No further information was provided. Additional information is not expected as the reporter did not want any further involvement pertaining to this case and refused tot provide the physician's name and contact information.
Achiness and pain in muscles, shoulder blades, described as severe also legs and arms with general weakness and factique. T 101  called Physician on Tuesday 1/26 who prescribed Tamiflu, took 2 tabs and went to ER on 1/27.  ER physician did test for H1N1 influenze which was neg. also chest xray negative.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient passed out within 3 minutes of vaccine at 01:02 PM on 01/22/2022. Patients brother helped patient lay down on floor. RN removed patients mask to ensure airway. Patient was responsive. Pharmacist rushed to get blood pressure machine to assess patients blood pressure. Patients blood pressure was 99/57. RN stayed with patient and advised patient to continue to lay on floor until 1:20 PM. Patient is sitting in chair and patient was asked to call 911 if condition worsens.
Six days after first Pfizer Covid shot, severe migraines off & on lasting 3 to 5 days. 6 to 7 days after second Pfizer Covid shot, severe nausea Off and on lasting 7 to 14 days
Flu shot given 9/9/14 around 11AM. At 1300 sent to ED for possible allergic reaction. S/S: Knot in throat, progressively getting tighter since shot. Stable at time of triage to ED w/ symptom staying the same. Dc'd home w/ follow-up. Stable condition.
RED SPLOTCHES ON INSIDE OF ARM.  NOT AT NEEDLE POINT BUT A FEW INCHES INSIDE ARM.  REDNESS AND TENDERNESS FOR ABOUT A WK.  NOT A PROBLEM - JUST SO YOU KNOW.  NOT SURE ABOUT WHICH FLU SHOT SO ENTERED 1'ST ON LIST.
At approximately 8:45 am-pt. brought into health center for Tdap shot- No contraindications and consent form signed and Tdap given. Due to pt's age NCIR stated not valid.
Nausea, chills and muscle pain started after 3 days from the 2nd dose (5/18/21) and symptoms persists as of 9/7/21. Symptoms worsens every few weeks to a level where I need to lay down.
45 y/o female c/o CP following Pfizer vaccination. Pt denied any dizziness, SOB, arm, jaw or back pain. 12 lead showed NSR in all leads. Pt provided 325mg ASA by medics. VS: BP=177/89, HR=94, RR=22, 98% RA.  Pt on cardiac monitor for over 30 minutes and remained in NSR. After 10 mins pt stated symptoms resolved. Repeat VS: BP= 147/80, HR=70, RR=20, 100% RA.   Pt medically cleared by medical provider and left A&Ox4 and free of chest pain.
pt recv vax & 4JUL98 devel cellulitis @ the site of vax; pt severely immunocompromised, neutrophils zero;clindamycin started w/o pos cultures, cellulitis resolved; clinicians believe cellulitis due to anaerobic infection;
rash across trunk; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (rash across trunk) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) 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 an unknown date, the patient experienced RASH (rash across trunk). At the time of the report, RASH (rash across trunk) outcome was unknown. Not Provided      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 medicines was not reported by reporter  treatment information was not provided
Blood sugar was elevated; Chills after 2nd dose; Fast heartbeat after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat after 2nd dose), BLOOD GLUCOSE INCREASED (Blood sugar was elevated) and CHILLS (Chills after 2nd dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B218 and 17B218) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes mellitus, INSULIN GLARGINE (LANTUS) for Type 1 diabetes mellitus, GABAPENTIN, LISINOPRIL and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat after 2nd dose) and CHILLS (Chills after 2nd dose). On 29-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar was elevated). On 29-Apr-2021, HEART RATE INCREASED (Fast heartbeat after 2nd dose) and CHILLS (Chills after 2nd dose) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar was elevated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood glucose: elevated (High) Elevated. On 28-Apr-2021, Heart rate: fast heartbeat (High) increased.         Treatment for the events included paracetamol  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-098766 (Patient Link).
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. The nurse stated that, on an unknown date, the patients were vaccinated with a dose of ROTATEQ (lot# and expiration date were not reported), oral, which was stored improperly. Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected.
Pt recvd vax on 21APR92 & 23APR92 devel urticaria on hips & stomach; On the 16th day p/vax pt was treated in an ER romm w/Cyproheptadine & recovered;
diarrhea, fussy 2x1cm erythematous, SQ mass lt thigh for 5 days post inj; no fever noted;
Started feeling extremely nauseous about 6 hours after vaccine (to the point of nearly vomiting; Nausea has continued through the next day (2PM 4/29 as of writing this) and is now accompanied by a pounding headache.
Pt inadvertently received received a second dose of Pfizer instead of a second dose of Moderna. Pt received 1st dose of Moderna at another facility other than this facility. Received Moderna LOT: 037AZIB on 04/09/2021 28 days prior to dose of PFizer.  PT had no reaction during observation period. PT left facility AAOX's 3 and in no present distress and denied any complaints.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 13-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date of 15-SEP-2017, (dosage schedule, route and anatomical location were not reported). On unspecified dates, the RECOMBIVAX HB had two temperature excursions of 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 304 hours and 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for 40 hours (lowest recorded temperatures). The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received 0.5 mL dose of Fluzone HD vaccine on 10/1/2019. Patient reported that after receiving the vaccination, hs had incredible arm/shoulder pain for approximately 3 weeks, in the same arm that received the vaccine (left arm). This was also the same arm he had previously had total shoulder replacement surgery. Reported this adverse reaction to his doctor who performed shoulder surgery on him, who informed the patient this was commonly reported to him by other patients.
Erythematous macular rash similar to rubella & OM bilaterally; rx Amoxicillin;
The family reported an adverse reaction to Dr. at 18 months well visit on 12/15/2021.  The family stated his problems began 12 hours after the vaccinations, Pentacel # 4 and Prevnar 13 # 4, were given 9/15/2021.  He reportedly did not respond to his name for 4 days and seemed dazed. He reportedly was nonverbal until 12/7/2021. They reported between 12/7-12/15/2021 appointment, his speech returned to the previous level and his speech was normal for 18 months age per parents and examiner at the 12/15/2021 appointment.
No adverse affects reported.; an expired dose of VAQTA was inadvertently administered to the patient on 7/20/2020; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 20-JUL-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S018772, expiration date 07-JUL-2020, (exact dose, injection site and route of administration were not reported) for prophylaxis. There was no adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S018772; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient felt light headed and unbalanced after receiving the vaccine. He laid down and drank water and was able to recover within 20 minutes to be able to walk to his vehicle to be driven home.