chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ear inflammation; 2nd- After 3-4 weeks had little rash; 2nd-tiredness; 2nd-little fever; 2nd-big headaches; 2nd-sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (2nd-sleepiness), EAR INFLAMMATION (Ear inflammation), RASH (2nd- After 3-4 weeks had little rash), FATIGUE (2nd-tiredness) and PYREXIA (2nd-little fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (2nd-sleepiness), FATIGUE (2nd-tiredness), PYREXIA (2nd-little fever) and HEADACHE (2nd-big headaches). In April 2021, the patient experienced RASH (2nd- After 3-4 weeks had little rash). In September 2021, the patient experienced EAR INFLAMMATION (Ear inflammation). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Ear inflammation, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (2nd-sleepiness), EAR INFLAMMATION (Ear inflammation), RASH (2nd- After 3-4 weeks had little rash), FATIGUE (2nd-tiredness), PYREXIA (2nd-little fever) and HEADACHE (2nd-big headaches) outcome was unknown.            It was reported that  3-4 weeks after Dose 2 she had little rash, but does not recall where on body. states Patient stated that she does not take any medications and so no concomitant medications were mentioned.   This case was linked to MOD-2021-403064, MOD-2021-403034 (Patient Link).
bradycardia; hypotension; This is a spontaneous report from a contactable nurse (Registered nurse with title of Infection Preventionist). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269; expiration date: 01May2021) via an unspecified route of administration on 26Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was with bradycardia, hypotension (seriousness criteria: hospitalization, death) and she passed away in the emergency room (ER), critical labs, she didn't even make it one day, the reporter send her out and she passed away in the ER. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Sender's Comments: A causal relationship between BNT162B2  and the events hypotension,bradycardia cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .; Reported Cause(s) of Death: bradycardia; hypotension
Localized varicella reaction around injection site redness and swelling around injection site, small blisters around site.  3 small pox like lesions with redness 9 days after shot.
Aside from  expected soreness at injection site, no adverse reactions  through rest of Feb  10 and all of Feb 11 and 12 Starting February 13 and continuing through today (Feb 22), I have had the following symptoms: Vestibular migraine - very severe at the beginning, receding with time, but still concerning Nausea - on and off for full period, no relation to food intake Fatigue - tired most all of the time, could fall asleep at any time Balance - variable for this period, no falls, but do not feel safe to drive
Redness of >10cm just below the injection site initiating 1day after injection and persisting. Now 3 days after injection. Redness area is warm to the touch; Redness of >10cm just below the injection site initiating 1day after injection and persisting. Now 3 days after injection. Redness area is warm to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: ATORVASTATIN; ASPIRIN 81. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 16Jan2023, outcome "not recovered", VACCINATION SITE WARMTH (non-serious) with onset 18Jan2023, outcome "not recovered" and all described as "Redness of >10cm just below the injection site initiating 1day after injection and persisting. Now 3 days after injection. Redness area is warm to the touch". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth.  Additional Information: Facility type vaccine was reported as Pharmacy or Drug Store. If other vaccine in four weeks was reported as No. Adverse event was reported as redness of >10cm just below the injection site initiating 1day after injection and persisting. Now 3 days after injection. Redness area is warm to the touch. patient had no known allergies.Since the vaccination, the patient had not been tested for COVID-19.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
started crying 2 hrs p/shot; temp went to 103; started shaking @ MN; cold, pale, toenails blue; took to hosp following day; adm to hosp stayed 3 days dx allergic reaction to pertussis; pt cried for approx 8 hrs w/1st inject;
Suspected Vaccination failure / have had them 11 times since the vaccine; have had them 11 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles 11 times since the Shingles vaccine. The patient would never have let the doctor talk him/ her into it if the patient would have known. The patient stated that the stupid pneumonia shot the doctor had talked him/ her into last year almost killed the patient.  The patient would not take any more vaccine of any kind. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
0.2ML OF PURPLE CAP PFIZER ADMINISTERED INSTEAD OF ORANGE CAP. NO REPORTABLE ADVERSE EFFECT BY THE EVENING BY MOTHER
got the flu shot for years always got the flu anyway; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported got the flu shot for years always got the flu anyway while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination .  On an unknown date the patient developed a non-serious event "got the flu shot for years always got the flu anyway" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "got the flu shot for years always got the flu anyway It is unknown if the patient experienced any additional symptoms/events".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot for years always got the flu anyway).  At time of reporting, the outcome was Unknown for the event got the flu shot for years always got the flu anyway.
CHEST PAIN; INJECTION SITE PAIN; INCORRECT ADMINISTRATION (VACCINE ADMINISTERED TOO LOW IN HER ARM); This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced incorrect administration (vaccine administered too low in her arm). On an unspecified date, the patient experienced chest pain, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and injection site pain, and the outcome of incorrect administration (vaccine administered too low in her arm) was not reported. This report was non-serious.
Vaccine out of BUD date (2/16/23) was administered on 2/20/23 to patient. Vaccine was in the refrigerator which was not taken out of the fridge on 2/16/23. According to Pfizer, we should reach out to patient for readministration of the vaccine for full protection, and have patients report any side effects
Neighbor had side effects from his last Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Neighbor had side effects from his last Moderna shot) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced IMMUNISATION REACTION (Neighbor had side effects from his last Moderna shot). At the time of the report, IMMUNISATION REACTION (Neighbor had side effects from his last Moderna shot) outcome was unknown.            No concomitant information provided. It was reported that reporters neighbor had side effects from his last Moderna shot. No treatment information provided
Redness, tenderness, itchyness at injection site. Appeared 8 days after injection.
2cm granuloma, still persistent at day 8. Prescribed NSAID, topical steroid, warm compress. Child in significant pain and limited use of arm
Within 24 hours the upper lateral left arm was swollen, painful and erythematous. The pain increased to where she could not move her arm.
Pt is 14 weeks pregnant. She had a sore arm immediately. about 12 hours after the injection she started with a fever, shaking chills, rigors, severe muscle and bone pain, treated with Tylenol. Headache started the next day.
Was diagnosed with a one of the best neurosurgeons/know of two people (person 1) that that have recently got it that have been diagnosed with it after they received the COVID shot/Myasthenia gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYASTHENIA GRAVIS (medically significant) with onset 2023, outcome "unknown", described as "Was diagnosed with a one of the best neurosurgeons/know of two people (person 1) that that have recently got it that have been diagnosed with it after they received the COVID shot/Myasthenia gravis". The event "was diagnosed with a one of the best neurosurgeons/know of two people (person 1) that that have recently got it that have been diagnosed with it after they received the covid shot/myasthenia gravis" required physician office visit. Clinical course: reporter mentioned that she knew her twin brother knew the patient that that had recently got it that had been diagnosed with it after receiving the COVID shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201185389 same reporter/product, different patient/event;US-PFIZER INC-PV202300186639 same reporter/product, different patient/event;US-PFIZER INC-PV202300186627 same reporter/product, different patient/event;
This spontaneous report as received from Physician Assistant refers to a 79 year old male patient. Information on medical history was not reported. Approximately in August 2010, reported as approximately 3 years ago, the patient was vaccinated with ZOSTAVAX (lot # not reported) 65ml, subcutaneously, (exact date, frequency not reported). On 23-AUG-2013 the patient come into the physician assistant's office presenting with severe case of shingles on his hands and face. The onset of the shingles was not reported. No treatment was given for the event. The patient sought medical attention by coming to physician's assistant's office. The outcome of severe case of shingles on his hands and face was reported as not recovered/not resolved. The reporter did not access the relationship between the shingles and ZOSTAVAX. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Pt. broke out in hives immediately after receiving  Moderna vaccine. No SOB, face or tongue swelling and no other complaints. Pt. was observed  in the vaccine  clinic and evaluated by the  clinic physician. Hives persisted and started to itch. Pt. was taken to UTC accompanied by an RN. Pt. did not want to take Benadryl because she stated it would make here sleepy.
Information has been received from a physician, via a company representative, concerning a "teenaged" female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included Menactra. Subsequently, after receiving the first dose of Gardasil, the patient developed hives, that "were most severe on the injection site arm." The physician confirmed that the patient had recovered from the hives (duration and date not provided). The patient sought unspecified medical attention. The physician reported that three additional teenaged female patient also developed hives after vaccination with the first dose of Gardasil (lot # not provided (WAES: 0707USA01121, and 0707USA01122). Additional information has been requested.
pt was diagnosed with covid on 3-29-21 , hospitalized for pneumonia and respiratory failure and expired on 4-6-21 at Hospital
A bilateral subdural brain hemorrhage leading to a 6 mm midline shift of the brain. Symptoms started on Thursday, August 5 with a headache and led to an urgent care, emergency room, and hospital admission on Saturday, August 7 (admitted overnight, August 8). The presenting symptom moved from a headache to confusion and the feeling of needing to vomit with no result. When transported between hospitals there was erratic  behavior and loss of consciousness. There was no known drooping of the face, loss of ability in the limbs or other stroke type symptoms. Once admitted the subdural hemorrhage was drained with the result being that the bleed was "old". This was not an active bleed or one that continued. The determination of age of the blood/bleed origination was 3 to 4 months prior to symptom onset. A series of small issues elongated the hospital stay included aspiration pneumonia, a closed loop small intestine blockage, thrombus of the forearm, and pneumothorax.
Headache, Myalgia, NauseaVomiting, c/o being flushed,slight sob Narrative:
1 Tdap area 30mm x 24mm red, warm on day 2 also aches when lays on it.  2 Varicella area 70mm x 60mm red, warm, & hurts to touch on day 2 (8-1-08).
MMR 19Dec, Started having high fever on 24Dec, ran T 104-105 several days according to mom, pt was out of state
I started getting sick Thursday 06/29/2022 I didn't think too much about it because I have sinus issues and long Covid issues. 06/30/2022 Friday I start having coughing and I tested and it was negative. I thought it was just a cough. 07/01/2022 Saturday I started coughing up blood, lightheaded, fever, body aches extreme fatigue, sore throat, ear pressure that was unbearable (felt like they were going to burst), itching all over, and nauseated. Issues breathing have always been present since previous COVID case but it's gotten so much worse. November 17, 2021 was the first time I encounter COVID-19. I have been in a program which gives them access to every reading I take linked with my insurance. Called my doctor and she ordered PAXLOVID and azithromycin. Sunday 07/02/2022, I started having high blood pressure readings. I was able to go pick up the prescription. It reduced most symptoms also helped with fever and with the coughing. Monday 07/03/2022, I took it for 5 days and which helped but didn't resolve everything. It seems like as soon as I completed the PAXLOVID the symptoms came back. The cough has been better than before it's still present but not nearly as bad as before. Tuesday 07/04/2022, If I started to feel lightheaded or dizzy to take my blood pressure again so they can continue to watch all my numbers. 07/07/2022, I completed the PAXLOVID and all symptoms came rushing back. Recently I have noticed the lymph knots under my arms irritated and tender to the touch. On the right side is so painful I thought it was something going on with my kidneys. Its worsen since and in the mid lower back area. 07/09/2022, I noticed that a color change in the mucus which was also thick. The color at this point was yellow. 07/11/2022, They prescribes BACTRIM (5 days) for the ear, headaches and the throat pain along with the yellow mucus. I noticed that a color change in the mucus thick and clear. 07/14/2022, I still have slight headaches, body sore, still have a cough, short of breath and phlegm which isn't as dark now its lighter in color. It seems like it's trying to clear up.
DOSE 1: LEFT HAND NUMBNESS (NEVER RESOLVED); DIARRHEA, NAUSEA, BODY SWEATS, HEADACHES, SORE THROAT LASTED 2 WEEKS  DOSE 2: LEFT ARM NUMBNESS FROM ELBOW DOWN TO HAND (NEVER RESOLVED); DIARRHEA, NAUSEA, BODY SWEATS, HEADACHES, SORE THROAT LASTED 2 WEEKS
First symptoms were dry, chapped, swollen, and bleeding lips. They started to blister inside upper lip. Overnight the blisters had broken exposing tissue. Extremely painful. Saw doctor on 2/12/2010, and was given 3 medications. She advised me to keep moisturized with Vaseline only.
Sensitive skin; Delayed reaction; Hives; I got rashes like some of them were little itchy; Eczema; Red bumps; I got rashes like some of them were little itchy; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) for covid-19 immunisation. When probed for the concern, consumer stated, I wanted to report the side effect, I think I got (side effect) from Pfizer (second shot) vaccine (unspecified vaccine) after 3 weeks I got the shot." When paraphrased the concern, consumer stated, "After 3 weeks I got the second shot, my skin goes very sensitive after 3 weeks after I got the shot, it came out as delayed reaction and I got hives, I got rashes like some of them were little itchy and this is going on since I got. I think I am getting better then I get back now its settling down. It was the delayed reaction after 3 weeks, it's like eczema, hives, red bumps. I wanted to know at the peak might possible it feels like going away, I am getting better, I wanted to know people are getting this?" When probed for consumer's Mailing address, consumer stated, "What is this for now? It's going away now, I wanted to report it." In response to file safety report, consumer stated, "Is that a "VAER" (Further not clarified) report? Do you know what, I can't talk any more here now? I have to call back, let me call back." When probed for vaccine LOT#, consumer stated, "No, I don't have with me right now." As consumer was not willing to proceed the call and abruptly hung up. Product details (expiration date, NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided. The outcome of the events was reported as recovering.  Information about lot/batch number has been requested.
Abdominal Pain: hemorrhage - information has been received from a health professional concerning a 15 year old female who on 14 Nov 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  On 16 Nov 2000 the patient experienced abdominal cramps.  she was taken to the emergency room, subsequently the patient was found to be pregnant.  Subsequently the patient experienced intermittent bleeding, LMP was 15 oct 2000.  Expected date of delivery is 27 Jul 2001. No further information is abailable. Per F/U 8/9/02: The pregnancy was confirmed by a pregnancy test. Follow-up information has been received and indicated that the RN could not provide any additional information. No further information is available.
Woke up with asthma attack, nebulizer used with 2 vials albuterol, some response but not clear
PATIENT DEVELOPED A RASH ON THE LEFT ARM 4 HOURS AFTER THE INJECTION. THE INJECTION SITE WAS A LITTLE SWOLLEN AND THE RASH ON THE ARM WAS SLIGHTLY PAINFUL (BURNING SENSATION). THE FOLLOWING DAY THE PATIENT HAD RED BLOTCHES ON THE FACE THAT RESOLVED WITHIN 24 HOURS.
Redness, pain, swelling from shoulder to elbow. Unable to move arm for a day. Pruritus developed as pain improved.
Presented to hospital with chest pain and was diagnosed with STEMI. Treated with 2 drug-eluting stents and did well. Had a prior history of CAD.
PATIENT CALLED ON 09/04/18 STATING THAT HIS ARM WAS STILL HURTING AFTER HE GOT THE FLU SHOT ON 01/17/18. HE SAID THE PAIN NEVER TOTALLY WENT AWAY BUT IT FLARES UP EVERY ONCE IN A WHILE. HE SAID HE DID NOT CHECK HIS DR AS YET ABOUT THIS.