chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stopped by the pharmacy the day after she got her flushot to say she had an allergic reaction to the flushot. Patient said her arm starting hurting about an hour after the vaccine so she took some otc pain med, and about 2 hours after her face started to swell and she felt like her throat was closing. Patient states she took some Benadryl then and now most of the swelling has subsided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2008, a healthcare provider administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 27-AUG-2015, the patient was treated by a Dermatologist for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
NEUROPATHY  3/29/2022,  6/1/2022,  7/30/2022  -- RECURRENCE OF SAME SYMPTOMS
Patient had chest pain starting a few days after receiving second dose of COVID-19 vaccine, patient was hospitalized, initially had elevated tropamine levels, but then after EKG and angiogram all came back normal, hospital reported cause of chest pain to be myocarditis. After seeing reports of correlation with vaccine, patient believes to be associated with vaccine. Patient symptoms have since resolved.
she passed away on 19Feb as she had a HGB of 5; O2 sats were in 70s; she had a HGB of 5; on the same side the patient hand started swelling; lymphedema from L breast; swelling all over; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. An 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at 13:45, at single dose, in left arm, for COVID-19 immunization. No other vaccine was given in four weeks. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Known allergies: none. The patient had no COVID prior vaccination and was not tested after vaccination. Concomitant medications were not reported, however, the patient received other medications in two weeks. On 05Feb2021 at 09:00, on the same side the patient hand started swelling and doctor gave her some furosemide (LASIX). One week from vaccination she started having lymphedema from L breast and started noticeably swelling all over. On 18Feb2021 she was taken to the hospital as O2 sats were in 70s. She passed away on 19Feb2021 as she had a HGB of 5. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 1 day. No treatment was received. No autopsy was performed. Low oxygen saturation, hand swelling, lymphedema from L breast and swelling all over final outcome was unknown. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: she passed away on 19Feb as she had a HGB of 5; she had a HGB of 5
LEFT ARM - SWOLLEN, HOT, READ AND PAINFUL, PT WAS GIVEN PCV 23 AND TDAP IN THE SAME ARM. PAIN WAS SO SEVERE SHE HAD TO MIS WORK FOR 2 DAYS.
Patient seen in ER for fever 103.5, swelling, redness and pain at vaccine sites. She was treated with antipyretics and antibiotics. She was doing well when seen at our clinic for follow up. Plan to space vaccines in the future.
Red blotchy area around shot origin. Area extended to shoulder and around arm. Arm hurt but this is 2nd shot and it hurt with the 1st shot to. No fever and it did not itch.
Day after dose: Fever, dizziness, headache, chills, muscle aches, nausea
BAD HEADACHE (PULSATION IN HEAD AND FEELS LIKE ITS GOING TO EXPLODE); This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, non smoker, and potentially has gilbert syndrome, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced bad headache (pulsation in head and feels like its going to explode). Laboratory data included: Body temperature (NR: not provided) 97.5, 98. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache (pulsation in head and feels like its going to explode). This report was non-serious.
Scheduled for vaccine and is nervous; Has allergies and is scheduled for vaccine; This is a spontaneous report from a contactable consumer (patient) received from Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH-COVID 19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was nervous and had allergies. The patient schedule for vaccine next morning and she was nervous. She had allergies and wanted to know thoughts on getting the COVID-19 Vaccine with her allergies. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected. Information on the Lot/Batch number has been requested.
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses(3 doses) of VAQTA (2 doses of batch# M001815 with an expiry date 20-SEP-2017 and 1 dose of batch# M030598 with an expiry date 13-OCT-2017) (dosing details not known). The administered doses experienced a temperature excursion of 0.5 degree Celsius for 1 hour and 32 minutes. The vaccine underwent previous temperature excursions of 1 degree Celsius for 7 hours and 34 minutes. The call was because of a "data logger". No adverse effects were reported. This is one of two reported received from the same reporter. Additional information has been requested.
Patient received Moderna Dose #1-01/08/2021 and Dose #2-02/05/2021.  He was admitted to Medical Center on 03/08/2021 with confusion and decreased O2 sats; date of death was 03/12/2021.
Client mistakenly given a Pfizer 5-11 yo dose instead of an adult dose. Error immediately identified. Client was given an adult dose, which is correct. Client was very understanding.
I got sick in the middle of December with a respiratory virus. I was hospitalized in January of this year. In the middle of December, I got an upper respiratory infection with a lot of pain in my face. It was my ear, jaw, sinus cavity, neck and then it moved around to the other side of my side. Then it was a lot of nose-blowing and ultimately coughing. I tested myself 3 times and did not have COVID-19. I did a telehealth visit with my doctor and he said it was an upper respiratory virus. He prescribed a pill for the cough called Benzonatate. It helped with the cough, but the other symptoms would only slightly be relieved by Tylenol. After 10 days it went away. A month later, my blood pressure spiked. I monitor it daily so when I woke up and took it, it was very high and kept getting higher. I went to the emergency room and was admitted on January 12, 2023. My blood pressure was 208/110. They started me on a blood thinner Heparin because when they did blood work, I had components in my blood stream that showed heart attack or symptoms of heart damage. They also gave medication to reduce the blood pressure. I was also taking Lisinopril also which they took me off of and started Entresto and Lopressor.  My blood pressure went down to the normal reading after 24 hours. They diagnosed me with Non-Ischemic Cardiomyopathy. They completed an Echocardiogram and a CTA. They also did a chest x-ray and an MRI. They were still monitoring me, but the diagnosis changed to viral induced myocarditis. Due my heart being damaged, this put me into to heart failure. They advised me to follow up with my cardiologist and my primary care physician and a cardiologist. They took me off of Lisinopril due to drug interactions. They changed the Metoprolol to a Tartrate and added Jardiance as well Entresto. It seems like I have recovered based on my most recent echocardiogram I am also doing cardiac rehabilitation.
Patient received her influenza vaccine at approximately 5 pm on 9/21.  Mom noticed redness at the site of the injection around 11 am on 9/22.  It did not seem to bother her, but looked red and a little swollen.  It got a little worse-spreading and a little more swollen throughout the day on 9/21.   She does not seem to be in a lot of pain. She does itch at it.  She is walking per normal. Acting fine.  She has 1 pinpoint spot that developed near the injection site. Mom saw a little drainage come from it this morning.  She has not had any fever, URI sx, cough, vomiting. She slept fine last night.  She is eating per normal. No evidence of pain anywhere.  Energy per normal. Mom was not terribly concerned, but sister developed similar reaction around the exact same time and hers seems much worse.
On January 21st he started to get an headache, brain fog, and dizziness. Went to see his doctor the next morning his doctor didnt know what to do so he set him up for an MRI but the results didn't show anything. Seen a Neurologist on January 23rd but all he did was prescribe him with a stronger Effexor.
Woke up on 2nd day after shot with a red swollen  line running from arm pit on injection arm down to elbow on underside of arm,  the line is about 9 inches in length and 1/2 inch wide.  It hurt to lift arm, getting better as the day goes on.  Not other issues.
Chills, fever, muscle aches, dizziness, nausea. I thought I was going to die.
Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 28-year-old female patient received bnt162b2 (lot number: EL0140), intramuscularly at arm right, first dose on 27Dec2020 10:15, at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS) and hypertension from an unknown date. The patient was not pregnant. No known drug allergies. Concomitant medication included losartan, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, redness and pain in injection site, headache on 27Dec2020 12:00. Therapeutic measures were taken as a result of body aches, chills, redness and pain in injection site, headache, treatment included Tylenol. The events were reported as non-serious. The outcome of the events was not recovered.
Patient stated she had an elevated heart rate and suffers from anxiety/panic attacks.  She stated she had not taken her Ativan today. HR was 133 and lowered to 78 after sitting in a chair with legs elevated on another chair.  Pt  was in a talkative mood and showed no outward signs of distress. She was reassured and  after 30 min pt stated she felt well enough to leave.
Two days after injection, experienced muscle pain in localized area of injection and pain up into shoulder blade.  Follow up on 11/16, pain remains, less severe.  Daughter also reacted like this to tetanus.
The patient experienced syncope about 5 minutes after receiving vaccine.  The patient was conscious again in about 30 seconds.  A physician examined the patient and monitored blood pressure for about 30 minutes.  The patient recovered and his father drove him home.
Excessive fatigue, later in the day after the vaccine; 12 hour sleep overnight; still fatigued the next day.
Extreme drainage from nose, then developed into severe cough and flu-like symptoms. Ended up flat in bed without being able to drink or eat for 3 days, missed a week of work. Tested and did not have flu, but determined had flu-like virus..With help from my holistic doctor treating adverse reaction to the shingrix vaccine, I began drinking and eating and am recovering.
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient was diagnosed with cellulitis at the ER
This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (Broke out into hives), VACCINATION COMPLICATION (Covid arm), VACCINATION SITE RASH (rash on right arm) and VACCINATION SITE ERYTHEMA (Big red circle around her arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced URTICARIA (Broke out into hives), VACCINATION COMPLICATION (Covid arm), VACCINATION SITE RASH (rash on right arm) and VACCINATION SITE ERYTHEMA (Big red circle around her arm). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) on 09-Aug-2021 for Adverse reaction, at an unspecified dose and frequency. On 11-Aug-2021, URTICARIA (Broke out into hives), VACCINATION COMPLICATION (Covid arm), VACCINATION SITE RASH (rash on right arm) and VACCINATION SITE ERYTHEMA (Big red circle around her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Moderna COVID-19 Vaccine EUA  Vaccine afternoon of 16th: injection site pain, evening - stomachache, midnight - vomiting, overnight - chills 17th: 5am - vomiting, headache. Rest of day: headache, extreme fatigue, injection site pain 18th: all day - headache, stomachache 19th: All better!
Severe headaches started next day, continued for approximately 9 days - most severe 3-5 days after vaccination. Moderate fatigue. Extra moody (moodiness may not be related). Consumed caffeine and Tylenol for headache. Was told be a coworker not to take NSAID after vaccination.
Pt awoke Kw/swollen arm, fever, emesis and involuntary twitching. Lethargy next day but much improved by 48 hours though arm still red and swollen.
Adm TWINRIN (2BA47) and Hep B (C7EP5), the Hep B was meant to be TDAP. No RXNs, pt informed and unalarmed. Pt. advised to wait 15-20 in waiting room
Patient had syncopal episode while waiting in the post-vaccination area.  Patient recovered and was released to home.
Woke up with cough and headache, thought I had strep, went to urgent care clinic and found I had breakthru CoVid. Received Phenergan with codeine, Albuterol inhaler, Albuterol liquid, and tessalon pearls after being discharged. Symptoms lasted for about 2 days.  All meds were take as needed. Followed up on 9/2 for another test thru the drive thru. Did another rapid and send-out just to be certain. Both came back positive. Continued to quarantine for the required 10 days. Recovered at that time.
No additional AE reported; a 33 year old consumer was inadvertently administered PROQUAD rather than MMR-II; a 33 year old consumer was inadvertently administered PROQUAD rather than MMR-II; This spontaneous report as received from a nurse refers to a 33-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 24-JAN-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD), lot # T028298, expiry date 16-FEB-2022 (dose, route and site of administration were not reported) for prophylaxis, rather than with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered, product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
The tinnitus on my right ear is louder than usual, and the noise type now has frequent variations--noticed this change after the other symptoms went away; Had arm pain, low grade fever, tiredness, and a headache on April 4th and 5th.; Had arm pain, low grade fever, tiredness, and a headache on April 4th and 5th.; Had arm pain, low grade fever, tiredness, and a headache on April 4th and 5th.; Had arm pain, low grade fever, tiredness, and a headache on April 4th and 5th.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 03Apr2021 at 16:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included rosacea, tinnitus, acne cystic, marginal eye ulcers. The patient previously had peanut and experienced mild peanut allergy. Concomitant medications taken within two weeks of vaccination included tretinoin (MANUFACTURER UNKNOWN), metronidazole (MANUFACTURER UNKNOWN), simeticone (GAS-X) and cetirizine hydrochloride (ZYRTEC), antiacids; all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had arm pain, low grade fever, tiredness, and a headache on 04Apr2021 and 05Apr2021. On 06Apr2021 the patients tinnitus on her right ear was louder than usual, and the noise type had frequent variations-- she noticed this change after the other symptoms went away. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events arm pain, low grade fever, tiredness, and a headache on 04Apr2021 and 05Apr2021 was resolved on 05Apr2021. The clinical outcome of the event tinnitus on right ear was louder than usual, and the noise type had frequent variations-- noticed this change after the other symptoms went away was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Site: Pain at Injection Site-Medium, Additional Details: Husband called to say that she was still having a burning sensation and pain at the injection site a month later. He said the pain is not in the joint, but rather squarely in the mass of her deltoid muscle.  They were encouraged to see a doctor, however, he said they did not plan on seeing one.
Per pt they got the first booster on 1/18/22 and since then they have had fluid retention in arm. pt stated he needed a report because his doctor and lawyer told him he needed surgery due to water in arm and that it was caused by the covid shot.
Delayed soreness and swelling with a rash, at the injection site 8 days after vaccine received.
2/3/21; Approximately 12 hours post vaccine, injection site swelling and stiffness, 18 hours headache and body aches that were not diminished by 500mg ibuprofen. 2/4/21; whole body muscles aches and headaches that went away 6:00pm. 2/5/21; sore throat began pm, large and small white patches seen on tonsils 2/5/21 11:00 pm to 2/8/21 am. Care team took throat culture 2/8/21 to determine strep recurrence, culture returned as negative. White spots on tonsils diminished 2/8/21. 2/9/21 hives on extremities with certainty to no possible allergens or new product exposure.
no adverse event; 5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose) and NO ADVERSE EVENT (no adverse event) in a 5-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. In July 2022, the patient experienced ACCIDENTAL OVERDOSE (5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL OVERDOSE (5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose).    No concomitant drug information was provided.  It was reported that the patient got vaccine 4 weeks ago. The patient was 4-5 months short of being 6 years old.  No treatment drug information was provided.
burning at injection sit, 12 hours later 3am total body aches, trouble walking, breathing, chest pains, tingling in hands and feet
Severe pain in right elbow.  Severe to moderate pain in both hands. I can't work the way  I worked in my computer. Had  to buy many arthritis creams and take Naproxen. I have an appointment with a physiatrist. I fear  I can loose my job because of that problem.  In the last three weeks my pain is not going away and This is worrying me.
Attendee received first dose Pfizer vaccine at 15:48 in the Left arm.  Lot# FK5618. Attendee was directed to observation area.   At 16:15 voiced complaints of itchiness with hives on the front and back of her neck, chest, and back.  Flushed cheeks. Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic. 12.5 mg Benadryl administered. 911 called.  HR:  100   BP:  120/80   RR:   16   O2Sat%:  98   Temp:        16:20 - Attendee stated she felt better and the hives were disappearing.   HR:  90   BP:  118/80   RR:   16   O2Sat%: 98    Temp:    16:25  EMS arrived on scene and took over care of the attendee.    16:30  Father refused transport, hives were gone.  Cheeks remain flushed.  EMS educated on home discharge/adverse reaction instructions and attendee was discharged to home with her father.   Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.  Attendee was retained for a longer observation time to make sure that it was safe for her to leave.