chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The patient died on 14-Mar-2021. The reported cause of death was Heart attack. An autopsy was not performed.            Treatment information was not provided.  Company comment Very limited information regarding this event/s has been provided at this time.  Further information has been requested   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up received and contains reporter contact information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: Heart attack
Like somebody punched them in the arm/felt the same thing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Like somebody punched them in the arm/felt the same thing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOMFORT (Like somebody punched them in the arm/felt the same thing). In 2021, VACCINATION SITE DISCOMFORT (Like somebody punched them in the arm/felt the same thing) had resolved.            No Concomitant information was reported. No Treatment information was reported. Patient has complained about hers for a day was like somebody punched her in the arm for 2,3,4 days.   This case was linked to MOD-2022-522811, MOD-2022-522804, MOD-2022-522968, MOD-2022-523034 (Patient Link).
Three hours after having the shot he had a fever of 101.5, sweats, headache
Rash all over with swelling of face six hours after vaccinations which lasted for about 12 hours.
Fever, aches, headache, chills, sweating, nausdia, body ache, sore arm
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 17-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
CVA/thrombotic event.  R sided weakness and sensory deficit.   No preexisting risk factors.  Hypercoaguable work up negative.  Managed conservatively.  Improvement without resolution of symptoms to date.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #L044525 with expiration date 09-NOV-2017, dose and route were not reported). The vaccine was improperly stored at 40.1 degree Fahrenheit for 50.5 hours. Data logger was involved. There was no prior excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Rash-red round, 3-4mm raised, scattered down through diaper region, crossing midline at umbilicus, right thigh.
Feverish x 24 hrs; lump on lt side of neck; rash all over upper torso-face-neck arms etc x 3d; c/o head hurting x 2d w/excessive sleeping;
Began to develop chicken pox on back of neck and then continued developing Chicken Pox until approximately 1/2/2015 on the truck of his body, head, arms, leg and feet.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Pneumonia Vaccine for prophylaxis. On 28th September 2018 11:31, the patient received SHINGRIX. On 28th September 2018, the patient received PNEUMONIA VACCINE. On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced fever. In October 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site erythema, injection site rash and injection site itching. The patient was treated with Valacyclovir. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, injection site erythema, injection site rash and injection site itching were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, fever, injection site erythema, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX in the left arm and pneumonia vaccine in right arm. That night she had a fever of 103 degree F. The fever lasted for 2 days. Four weeks following the vaccination, the patient reported a red, itchy rash at the injection site. This case was considered as suspected vaccination failure, since the details regarding the details regarding the completion of the primary immunization for influenza and laboratory confirmation for shingles were not provided. On 4th November 2018, it was diagnosed as shingles. She was started on valacyclovir that day to treat the shingles and was on a maintenance dose of 500 mg per day currently. It was unknown if the reporter considered the fever to be related to Pneumonia Vaccine. Consent to follow up was given.
Initial unsolicited report received from a consumer on 09-Oct-2017. This case involves a female patient of unknown age who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route and site of administration were not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed systemic symptoms. The patient's laboratory data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Swelling; Redness / Swelling was red; Swelling was warm to the touch; This case was reported by a consumer and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling, erythema and skin warm. On an unknown date, the outcome of the swelling, erythema and skin warm were recovered/resolved.   It was unknown if the reporter considered the swelling, erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided, but selected as an adult as per vaccine indication. After vaccination, experienced swelling and redness for 3 weeks and the swelling was red, with a 2 inch diameter, and warm to the touch. The patient asked was this a serious reaction and could receive 2nd dose of Shingrix.
Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram.  COVID- 19 tests were negative 4 times in the last 1 week.  Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative.  Rheum consulted for hx of lupus.  They did not feel this was lupus pneumonitis.  Negative anti-dsDNA/SSA/SSB and RF.  Pts resp status continued to decline.  She was intubated on 4/3 and transferred to the ICU.  Bronch washings were also neg for COVID.  Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime,  without benefit.  IV steroids added for possible reactive pneumonitis.  Pt with shock, likely multifactorial including septic and cardiogenic.  Multiple pressors maximized and BP remained low.  Nephro following for worsening renal function.  CRRT initiated to attempt to correct electrolyte and acidosis.  Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal.  Hgb dropped and CRRT held.  Pt went into cardiac arrest at 1329 on 4/8/21.  After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved.  Family notified of death at 1344 on 4/8/21
tested positive for Covid/not much symptoms of Covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for Covid/not much symptoms of Covid) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE, METOPROLOL and IRBESARTAN (AVAPRO) for Hypertension.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (tested positive for Covid/not much symptoms of Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at a dose of for 5 days. At the time of the report, COVID-19 (tested positive for Covid/not much symptoms of Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No allergies (medications, food and other products) were reported. The patient did not experience a similar event in the past.   This case was linked to MOD-2022-667741 (Patient Link).
8/27 5:30 pm, slight restricted airway, mild cough. Symptoms remain the same for 24 hrs.  8/28 6:00 pm, breathing is shallow when horizontal but not when sitting up.             9:30 pm, tingling and itch in left arm, hand, and fingers. No noticeable hives or rash.            10:00 pm, take one oral Benadryl  8/29 5:30 am, restricted breathing wakes me up while sleeping on left side. Switch to right side and breathing becomes easier             7:00 am, both hands (palms and fingers) become inflamed, red, and itchy (no hives). Condition receded 10-20 minutes later             8:30 am, hives on left arm             8:45 am, hives cover both thighs           12:30 pm, hives recede             6:27 pm, itchy inflamed hands, shallow breathing. Take one oral Benadryl  8/30 7:00 am, lower legs begin to itch, hives begin at the ankles. Over the course of 30 minutes, hives completely cover legs, hips              8:42 am, hives appear on torso            12:30 pm, disorientation, "foggy brain". Take two inhaled doses of Albuterol              12:45 pm, steroid injection at medical clinic            7:00 pm, hives begin receding   Prescribed (14) Cetrizine 1x nightly, and the week-long Medrol pack.   9/10 (two weeks from injection) 7:00 am, itchy and inflamed hands. Hives cover entire legs, torso, then receded two hours later
Developing shingles on the same side as shot, but on top shoulder/neck area six days after first dose. Previously had covid April 2020
Faintness; Fatigue; Minor chest pain; dizziness; nausea; This a spontaneous report from a contactable consumer (patient).  This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number 301308A), via an unknown route administered in the left arm, on 18Oct2021 at 17:15 (at the age of 39-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. No relevant medical history and concomitant medications were provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 before the vaccination. On 20Oct2021, the patient developed faintness, fatigue, minor chest pain, dizziness, and nausea. No seriousness criteria were provided.  The patient was not treated for the events. Post-vaccination COVID-19 test was not done. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Fast heartbeat; This is a spontaneous report from a contactable consumer (Patient herself). A 72-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6265), via an unspecified route of administration, administered in Arm Left on 24Feb2021 12:45 (at the age of 72-years-old) as dose number unknown, single for covid-19 immunization at Pharmacy or Drug Store. The patient's medical history included hypertension. Concomitant medication included losartan and acetylsalicylic acid (ASPIRIN) (low dose aspirin) both for unknown indication and start stop date not reported. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not tested for covid post vaccination. The patient previously took amoxicillin;clavulanic acid (AUGMENTINE) and alendronate and experienced known allergies. On 28Feb2021, the patient experienced fast heartbeat. The patient did not received treatment for event. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
pt received initial dose 06/29/2022 at pharmacy, Second dose 11/01/2022 at pharmacy.  In error patient received additional dose 01/07/2023 at pharmacy. No adverse events have been reported. Error was discovered by utilizing database to search for recommended vaccinations.
BURNING SENSATION DOWN IN LEFT LEG; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning sensation down in left leg. The action taken with covid-19 vaccine  was not applicable. The outcome of burning sensation down in left leg was not reported. This report was non-serious.
Patient received vaccine at 1pm. In the evening, He was filling feverish and went to bed early. He woke up in the night to use the bathroom. Patient stated that he was unable to walk. His right leg particularly wouldn't moved. He found himself bracing himself in a doorway until his spouse could come to his aid. His spouse suggested going to ER and re refused. By morning, he claims to no longer feel feverish and leg function had returned. As of today, 24h+ later patient is back to normal function and only complains of a very sore arm.
Information has been received from a female licensed practical nurse concerning another female nurse with an unspecified autoimmune disorder who on an unspecified date splashed zoster vaccine live (Oka/Merck) on her lip by accident and developed a cold sore on her lip the next day. At the time of the event the patient's status was unknown. (LANTUS), (AVALIDE), (DIPENTUM), (CRESTOR), (ZYRTEC) and (SYNTHROID). On 07-JUN-2008 (previously reported as 08-JUN-2008) the patient reported that she broke out in a rash. The physician said that it was not chickenpox or the shingles. It was a varicella like rash. The vesicular rash was over the patient's face and neck. Her arm was red and bruised. The patient's eyelids were swollen on her left eye. Subsequently, the patient recovered from the symptoms. The doctor visit was required. Additional information is not expected.
Nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Janssen COVID-19 Vaccine EUA Headache, body ache, difficultly breathing, nausea, tired
Patient states after receiving vaccine, she began getting tendonitis type pain in her arm that she recieved the SHINGRIX shot in. She told her doctor, who told her not to get her second shot because the symptoms continued to last for a month or so and lingered even with treatment for the tendonitis. She reported to us once we called her to get her second shot which would have been end of February.
On 1/5/20 developed swelling and soreness, on 1/6/20 noticed that arm is red, mildly itchy, swollen, sore, and indurated.
A patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-AUG-2021, the patient was vaccinated with one dose improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # U009262 (rHA) and expiration date 19-AUG-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -3.3 degree celsius (°C) for 4 hours 52 minutes; no previous temperature excursions were reported.
Woke up the next morning and could not hear anything out of right ear.  Has not resolved.  Has Dr. appt Thursday Dec. 29, 2022.
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. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 18-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5mL SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On unspecified dates, the vaccine had two temperature excursions; one for 48 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another one for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several received from the same reporter. Additional information has been requested.
8 yr M received Hep-B #4, needed because spacing for Hep B series was given < 3 mths. Given 9-9-14 by PHN. IM/LA. S and S. Local swelling x 2 days, warm to touch. Client rtn to school. No PCP. No fever.
Pt collapsed approximately 5 minutes after receiving dose 1. She did not appear nervous or anything out of the ordinary when I was giving the vaccine. I immediately rushed to her and she was awake but disoriented. I got her to sit on a chair. She said that she had experienced a strong head ache which she said was an 8/10. Before the vaccine, her headache level was 0/10. She said she was feeling better once she sat down.  She was alert and now oriented. I gave her water and asked her repeated if she could breath ok. She said her breathing was fine. I took her blood pressure and it was 129/98. I sat with her and monitored her. After 5 minutes of drinking water and sitting down, her HA level was now 2/0. I retook her blood pressure 10 minutes after her initial reading. It was 109/78. At this point, her HA level was 1/10. I continued to sit with her. She was alert this whole time and said she was ok. I took her third blood pressure reading and it was 102/76. After 30 minutes, her mom said she was ok to leave. Her mom was instructed to monitor her and have her go to the ER  if anything anything serious were to occur once she leaves the pharmacy.  I also told her mom to discuss this with her pediatrician to see if she would like the second dose. Also, if she does get the second dose, she was advised to get it at a hospital setting in case anything serious were to happen. I made sure that the family was completely ok before they left.