chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Patient received COVID 19 Treatment with Paxlovid from 03Jul2022 to 07Jul2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. After testing negative from 9-11Jul, (finishing Paxlovid on 07Jul) testing positive again on 15Jul, and cough/runny nose is the symptom. New symptoms started on 13Jul (cough/runny nose). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Negative; (10Jul2022) Negative; (11Jul2022) Negative; (15Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Total bilirubin was 1.7 in June, after receiving first dose; This case was reported by a consumer via call center representative and described the occurrence of bilirubin total increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than a month after receiving Shingrix, the patient experienced bilirubin total increased. On an unknown date, the outcome of the bilirubin total increased was recovering/resolving.   It was unknown if the reporter considered the bilirubin total increased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself. The age at vaccination was not reported. The patient reported that, he received 1st dose of Shingrix vaccine and total bilirubin was 1.7 in june. The reporter did not consent to follow-up. The limited demographics and details obtained, due to reporter disconnecting call abruptly after being told that they would not receive a copy of the adverse event report and definitive confirmation of whether Shingrix caused the increased total bilirubin. For tolerance of 2nd dose refer case US2021AMR172235.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172235:Same reporter.
Patient developed diffuse red raised rash Monday 26APR  beginning on trunk, spreading to back, chest, neck and arms.  No breathing difficulty, dizziness. lightheadedness or wheezing.  Completed 10 day course of Bactrim 26APR.  Received COVID vaccine # 2  at day 7 of  antibiotic.
arm where the vaccine was administered wa warm; area felt hard; the area was red oval-shaped; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm where the vaccine was administered wa warm), VACCINATION SITE INDURATION (area felt hard) and VACCINATION SITE ERYTHEMA (the area was red oval-shaped) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm where the vaccine was administered wa warm), VACCINATION SITE INDURATION (area felt hard) and VACCINATION SITE ERYTHEMA (the area was red oval-shaped). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm where the vaccine was administered wa warm), VACCINATION SITE INDURATION (area felt hard) and VACCINATION SITE ERYTHEMA (the area was red oval-shaped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Plaque psoriasis started on my face in Jan 2023 and progressed to cover ~80 of my body.  Currently on Skyrizi therapy in addition to Betamethasone, Zorvye, hydroxyzine, and doxepin.  Some of the plaques have started to fade since starting Skyrizi, but I've developed a burning, itching rash over my back, shoulders, chest, and belly that seems to be getting worse - very uncomfortable.  I'm due for my 2nd Skyrizi shot on 5/22/23.
I started to feel run down and not well a couple of days after the booster. It was progressively getting worse, on 11/15 is when I felt sick. I took my blood pressure, and it was 180/117.I took some extra mediation and went to bed. The next day I started to decline as the day went on. On 11/17 my doctor told me to titrate up the dosage of my metoprolol until I got my blood pressure under control. I did that and went from 250mg to 400mg. I still haven't been able to get my blood pressure back down. My doctor wants my bottom number below 90 and I haven't been able to, even with medication. My doctor is aware and is looking into it.
From the initial report received on 01/09/2001, it was reported that an 11 year old male was given TD Adult vaccine in the left arm on 01/05/2001. On 0107/2001 at 8am, pt reportedly experienced "skin rash-exanthemas papules with some confluence over trunk and upper extremities. Mild facial swelling Rx-Prednisone taper with good results." The pt reportedly recovered. From follow up information received on 4/10/01, it was reported, "No further care required, no sequellae. Reveiwed, no additional information at this time. From mailed correspondence on 6/25/01 it was stated, "Reviewed, no additional information at this time." This case is closed.
Rash on face, neck and in ear; started on Wednesday after vaccine administered on Tuesday per patient. No previous problems with flu shot per patient 10-17-11.
pain redness at injection site. pt reports "fist-sized" rash and it is still red and hot to the touch today 7/30 (3 days later). currently taking Tylenol for pain, I recommended ibuprofen. Pt also put in a call to her md
Blurred vision. I received my covid-19 Pfizer booster vaccine on 1/11/22 at about 5:15 PM, this was roughly eight months post second dose (4/23/21). I felt fine after injection, went home and did my evening routine. At roughly 10 PM I am laying in bed trying to read a TV show description on the TV and noticed that my vision became blurred in both eyes. I started to see rainbow halos and my perphial vision was all black. I noticed it was worse in my left eye than right.I got up and drank some juice and then cried out of fear. After about 30/60 minutes my vision seemed to reset but not completely. I went to sleep hoping that would help. Today, 1/12/2022, my left eye is still not fully back to normal, the vision is semi blurred and the eye feels dry and hurts. Preventative for covid 19
PATIENT PASSED OUT FOR FEW SECONDS FOLLOWING THE ADMINISTRATION OF VACCINE. PATIENT'S BP AND HEART RATE WERE NORMAL. PATIENT HAS HAD HEADACHE FOR FEW HOURS FOLLOWING THE INCIDENT.
Large hard lump appeared at site of injection. Extremely itchy. With in 2 hours, lump grew to be 3 inches in diameter with a 5 inch diameter  redness around from site of injection. Extremely hot to the touch. Lasted 3 days. No fever, vomiting, or diarrhea. Took Benadryl, advil, and used benadryl and cortizone  cream.
Pain at the injection site Flush face Headache Body ache Mild pain on all skin Energy level at zero
Patient received VARIVAX via intramuscular route instead of subcutaneous route.; No additional AEs were reported; This spontaneous report has been received from a nurse referring a patient of unknown age and gender. Concomitant medications included sterile diluent. The patient's pertinent medical history, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number w017551 with expiration date 01-JUN-2024, administered intramuscularly for prophylaxis (specific dosage, vaccination scheme and anatomical site of application were not provided) (incorrect route of product administration). No additional adverse events were reported.
Woke up at 2:30 am the morning after the shot. My hands and arms were tingling and my legs were numb. It resolved but recurred at 3:30 am today 4/11/21.   I awoke with stomach pain., leg numbness and tingling in my arms and hands.
Two weeks to the day after my second shot I developed atrial fibrillation and was hospitalized. This was an incapicating  event I have never had ever, even though I?ve had rare events of SVT - never ever a fib! Coincidence? If so it?s a huge coincidence!!! Now I have to deal with this forever. Only received vaccine due to employer mandate as I already had a mild case of covid.
Severe onset 12/30/2021 severe pain and swelling in the left knee, have been previously diagnosed with  CPPD but have not had any issues with CPPD flare in 6 years. Saw orthopedic and received cortizone shot and predispose pills which helped temporarily. But as soon as the pills wore off the pain came back. Also tried Euflexxa injections.  Shots didn't help and pain expanded to right shoulder then left shoulder. Orthopedic doctor felt something else is going & referred to Rhuematologist. I saw Rheumatologist doctor in February 2021 he ran extensive tests & xrays and diagnosed with inflamatory Arthritis. Started treatments with prednisone and methotraxate. Now taking 25mg of Methotraxate Injection and Prednisone 5mg- and still in daily pain.  To add to reaction from booster-I felt flu like symptoms about 24 hours after shot.
Initial unsolicited report received from consumer on 24 February 2016. This case involves a 79-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number and route of administration not reported) in the left deltoid on 26 October 2015. The patient was unsure about previous vaccination with FLUZONE HD vaccine, illness at time of vaccination was reported as none, pre-existing physician diagnosed allergies was reported as seasonal allergy. Birth defects, medical conditions was not reported. The patient's concomitant medications were not provided. On 24 January 2016, two months following the vaccination, the patient had experienced cough, runny nose. The patient was diagnosed with sinusitis and diarrhea. On 25 January 2016, she was tested positive for Influenza B. It was a case of suspected vaccination failure. The patient required ER/doctor visit. Laboratory test included flu swab (unspecified). The patient's received treatment (unspecified). On an unspecified date, the patient recovered from events. Upon internal review the case was considered as serious because of important medical events: suspected vaccination failure and influenza B virus test positive. List of documents held by sender: none. Sender's Comments: This is a case of possible vaccination failure (tested positive for Influenza B) in a 79-year-old female patient after INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. As with any vaccine, INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE may not protect a 100% of susceptible individuals. The patient was also diagnosed with Sinusitis and Diarrhea. Laboratory test (Flu swab) was unspecified. Additional information on the tests performed to confirm H1N1 infection would be helpful to further assess this case.
Neuropathy in hands, feet, lips, constant muscle cramping, especially at night, exhaustion which all began around 4 weeks post Pfizer vaccine.
After 45 minutes of administering Hep-B vaccine, pt experienced redness and itching at right arm, with generalized itching followed after 5 more minutes.
The day I got the vaccine (9 days ago), I got a skin reaction at the injection was. Red, inflamed, hot to the touch. This lasted for about 4-5 days and went away.  I also had arm pain, swollen lymph nodes in my armpits and groin. The lymph node pain lasted for only a day.  The arm pain lasted for 2 days. 8 days post vaccine, I developed the rash again on my right arm at the injection site. Same symptoms, red, inflamed, raised and itchy. No pain but it is itchy.
Redness worsened, circling the arm; Red and itching increased shoulder to elbow; Swollen/injection site swelling; Shoulder to bend of elbow very itchy/itching; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness worsened, circling the arm), PRURITUS (Shoulder to bend of elbow very itchy/itching), PAIN IN EXTREMITY (Arm sore), ERYTHEMA (Red and itching increased shoulder to elbow) and VACCINATION SITE SWELLING (Swollen/injection site swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019b21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN, LISINOPRIL, ATENOLOL and ATORVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm sore). On 26-Mar-2021, the patient experienced PRURITUS (Shoulder to bend of elbow very itchy/itching) and VACCINATION SITE SWELLING (Swollen/injection site swelling). On 29-Mar-2021, the patient experienced ERYTHEMA (Red and itching increased shoulder to elbow). On an unknown date, the patient experienced ERYTHEMA (Redness worsened, circling the arm). The patient was treated with CLOBETASOL for Adverse reaction, at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Redness worsened, circling the arm), PRURITUS (Shoulder to bend of elbow very itchy/itching), PAIN IN EXTREMITY (Arm sore), ERYTHEMA (Red and itching increased shoulder to elbow) and VACCINATION SITE SWELLING (Swollen/injection site swelling) had resolved.            This case was linked to MOD-2021-039323 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up report included updates on event outcome and treatment medicine.  Treatment included Clobetasol.
pt well until 0400 16MAY fever 102.6, vomited x 1, had large stool, shaking all over by hx (mom's account), seemed out of it for 5min, eyes rolled, 911 called;16MAY seen 950AM by MD;t102.8, no source on exam for fever
Muscles near vaccine site swollen and itchy. When touched feels like touching a bruise. Hurts.
The day after receiving the vaccine, I was extremely fatigued, had fever as high as 102, had a headache, body aches, chills.  2 days after receiving the arm I got the vaccine in  became red and swollen.  That lasted 4 days.  5 days after receiving the vaccine I had a low grade fever. Called my Dr about the redness and swelling.  She gave antibiotics, but said not to take them unless it grew.
Pt. experienced pain, at site, body aches, chills, red hot raised area 4" x 4" below injection site within 24-48 hours.
Patient suffered Celulitis with the second dose; This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 04Aug2021 at 13:30 (Batch/Lot Number: FA7484) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been been tested for COVID-19. The patient suffered celulitis with the second dose on 04Aug2021 at 13:30. Therapeutic measures were taken as a result of patient suffered celulitis with the second dose. Outcome of the event was recovered. The patient received first dose of BNT162B2 on an unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "Cellulitis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Change to menstrual cycle: Mild cramping began the evening of receiving the shot. Heavy vaginal bleeding (period) began day after receiving the shot, initiating bleeding about 2 weeks earlier than regular menstrual cycle.
HP came in and received Moderna vaccine. HP already received both shots of Pfizer in February and March of 2021. She falsified our consent questionnaire and lied to staff in order to get vaccine. She has no reported symptoms or  concerns after administration. She did  intend on getting Moderna vaccine in hopes of extra coverage against delta variant.
Admitted to COVID unit on 9/23. Was transferred to ICU and intubated on 10/2. Expired on 10/4
It was reported that an 18 month old male received vaccines on 10/18/99. On the same day, the pt's "left arm (was) red, hard, warm and swollen." This lasted for 2 days. The pt has recovered. Correspondence received stated, on 11/22/99, "Reviewed, no additional info."
Pt states arm is still very sore especially when lifting arm straight out and up.  This has been going on since the day after injection on 10/25/20.
Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a patient of unknown age and gender. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In November 2014, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a physician at a hospital. On an unknown date, the patient was treated by a physician at a hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Sudden vaginal bleeding in March, passing a large clot., only lasted a matter of 5-6 hours. Haven?t had a heavy period in years due to birth control. In May, have had a heavy period for 13 straight days. Again, haven?t had a heavy period in 20 years due to continuous birth control and never one that lasted more than 4-5 days. I?m on say 13 now, with no end in sight.
Vomiting; decrease urine output (adverse event) "flu-like symptoms" Versus viral infection
I woke up with a sore throat in March 2023.  It was painful to swallow.  I was nauseous and sick to my stomach.  I tested positive for COVID-19 on March 3, 2023.  The next day I was so sick I was unable to get out of bed.  For 4 days I was unable to keep any food down.  In the two weeks I was very fatigued.  I had a headache and body aches in my joints.  I am still a little fatigued.
A report was received from a healthcare professional on 10/03/2003 concerning a female vaccinee of approximately 30 years of age who experienced an injection site.  The area was not itchy.  The swelling resolved on 10/02/2003.  The redness covered an area of approximately 3 inches by 2 inches.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
got the virus; got the first shot for the virus then I got the virus; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the first shot for the virus then she got the virus. It was reported that patient was done with all of that, and she already received both doses of the Pfizer-BioNtech Covid-19 vaccine. The outcome of events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Urticarial rash, onset 1 hour post vaccination. Symptoms refractory to p.o. Zyrtec. Responded to epinephrine without incident.
Patient stated that the same day a few hours after she started getting reaction it was hot to the touch, painful at site of injection, painful to move her left arm. Also mentioned it there was a bruise at site of injection. She said she applied ice. It has improved since yesterday 5/19/19. Today it only appears bruised, not warm to the touch, and only painful if touched with some pressure.
Initial onset pain at injection that lasted for over 24 hours. Fever started within 12 hours. Starting approximately 28 hours following neurological symptoms began and left side in the arm and hand. Experienced numbness and tingling from the elbow down. Sunday morning left hand and fifth finger had tremors  that lasted for several hours
Patient states 9 days after vaccination with COVID Booster, she developed head-to-toes hives.  She has received a steroid shot on 12/13/21, and is taking benadryl OTC q4H to continue to treat the hives, without much relief.  She has tried Sarna lotion and Calamine lotion.
Inject site became erythematous almost immediately p/inject; became "angry"; cold compresses to site w/minimum results; meds given; erythema & edema resolved;
This was a vaccine error.  Patient had already been fully vaccinated, receiving the COVID Pfizer vaccines on 2/5/21 and  2/26/21. When questioned, patient denied being vaccinated, so the Janssen vaccine was given. Discovered documentation of prior vaccination after administration.
13 year old received the pediatric COVID 19 vaccine for her 2nd primary dose.
During dinner, approximately 7 PM, experienced loss of appetite, weakness, fatigue, inability to stand up without help.  About 30 minutes later experienced fever and chills, increased weakness.  During night, unable to get out of bed to use bathroom with subsequent urinary incontinence.  Next morning (10/27/23) still having low grade fever, no chills, but continued weakness.