chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic Spontaneous Urticaria- recurrent every 1-3 days. Appear in different areas but most commonly on hands, feet, and neck.
Severe Inflamation. 7 day onset.Hand/Feet swelling; Severe Inflamation. 7 day onset.Hand/Feet swelling; Nerve pain in neck; Stomach cramping; Hiccups; lower than normal blood pressure (99/65 one night same as low temp); lower than normal temperature (95.3F one night); 1-4 Bubbles under skin in back of mouth after eating; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:00 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included horrible seasonal allergies, mild asthma, mild Reynod's. The patient had known allergies to NSAIDs (Thought Corn was the cause of the bubbles in mouth, but since the 1st vaccination everything I ate caused it), Dodecyl Gallate, Gentamicin, Neomycin, Nickel, Polymyxin B, Thimerosal, Indium, Manganese, Stannous Chloride, Bee Venom, Hops, Rye, Chocolate, (Thought Corn was the cause of the bubbles in mouth, but since the 1st vaccination everything she ate caused it). Concomitant medication(s)/other medications the patient received within 2 weeks of vaccination included fluticasone, azelastine, famotidine and montelukast. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at the patient had severe inflamation. 7-day onset. Hand/Feet swelling, Nerve pain in neck, Stomach cramping (no nausea or diarrhea), Hiccups, lower than normal blood pressure (99/65 one night same as low temp), lower than normal temperature (95.3F one night), Diminished by day 17 after 1st injection. 1-4 Bubbles under skin in back of mouth after eating. As a result of event patient required visit to Doctor or other healthcare professional office/clinic visit. No treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are needed. No further information is expected.
a little tiredness and achiness the next day; a little tiredness and achiness the next day; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140, expiry date: 31Mar2021) intramuscular on left arm (left deltoid) single dose for COVID-19 immunization on 21Dec2020, 10:20 am, at 43-year-old. No medical history, drug allergies and family history. Concomitant medication included: multivitamins (unspecified) daily whenever she remembered to take them. The patient had no issues with that vaccination, maybe a little tiredness and achiness the next day (22Dec2020), but no reactions, no asthma, anaphylaxis or anything. Had a CBC, CMP, and 2 chest x-rays and they were all normal. The patient was not deceased. Relevant tests included: CBC, CMP and twice Chest X-ray; all with normal results. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
Pt states no known health issue however after receiving the vaccine he had syncope. Pt states he hadn?t eaten the whole day and this happens when he doesn?t eat. Pt was breathing normal but unconscious briefly.
A hour after vaccination, patient reported rash on left arm and chest, dizziness, itching, tightness of throat, difficulty swallowing. Reported to ER at 9:59 am Received promethazine 25 mg IM and triamcinolone acetonide 40 mg IM and condition improved then discharged to home.
Employee received flu vaccination on 9/12/18. That night the pain at the injection site woke her up out of sleep and she had to take over the counter medication for relief (Motrin). Employee continued to have pain at injection site and the next day developed a red rash along arm, down left breast and chest, and across shoulder. Employee then began to have shooting sharp pain down shoulder and into left breast. Employee went to see her doctor who ordered imaging. About 2 weeks after vaccine employee developed blisters where red rash was that were very painful. Clothing against the rash exacerbated the pain. Employee talked to her doctor through online portal and based on her description the doctor said it sounded like shingles and offered medication to employee. Employee declined as she was already towards the end of the shingles course.
7-10 1/2 cm erythema with increased warmth - circle, sl. edema and tenderness to touch. Was put on Augmentin 875mg BID 10 days. 3/28/08 Cellulitis improved.
A 35 year old male was seen on 11/16/2003.  Clinical information: Vaccine Related Adverse Event, specifically Anthrax.  Date of Onset: 11/13/2003.  Symptoms: Localized erythema and edema involving the SC tissue of left posterior arm. Labs: none.  Local Reaction: Injection site erythema, 1-5cm (dia) or mild tenderness within 24 hours.  Systemic Reaction: Global headache within 24 hours.
Hives- generalized- after rec'd FLUZONE, VARIVAX. Hx: allergies
Within an hour after tetanus shot, the arm became black, blue, red and was very sore and swollen spreading down and around the arm. Went to PCP on 7/24 and she noted the adverse reaction and upon recommendation. I went to DR (allergy specialist) to see if it was an allergic reaction. Dr noted that the reaction was due to tetanus protein and an awakening of antibodies already in my body. An increase of headaches was also noted at this time.
50 hours after receiving vax shortness of breath and found blood clotting in lungs and legs
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 05-MAR-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-SEP-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles and neuropathy. The patient was prescribed gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, neuropathy was considered to be medically significant. Additional information has been requested.
Received call 5/27/2021 @  about  3:00 pm from patient.  He said 2 hours after receiving the Moderna Vaccine on 5/26 he got hives on arms.   Today the hives spread to all over his body including face.   I recommended he call his primary md and could take Benadryl 25mg  - 1 q 6 hours.  If 1 did not help in about an hour I told him he had the option to take another Benadryl 25mg.   I warned of extreme drowsiness and not to drive.  Patient was very calm and seemed to appreciate the advice.
Patient arrived at office for 11yr well check at 830am accompanied by mother. Patient received scheduled vaccine tdap/left deltoid, menveo + hpv right deltoid) at 9am. Approximately 30 seconds after receiving injections she experienced a syncopal episode. Patient was still in exam room on bed. When Dr. arrived at bedside she remained unresponsive. After Dr. was at bedside for about 1 min she began to posture with tonic contraction of arms and fists, eyes rolled back and was unresponsive. The seizure episode lasted approximately 10 seconds. 911 was called. Dr. remained in exam room until arrival of EMS. Vital signs obtained. B/p 108/55, heart rate 110, Pulse ox 99%. Patient began talking a few minutes after seizure episode but she was still very pale and lethargic. EMS transported patient to ER for further evaluation.
Patient called the pharmacy and reported that she was diagnosed with cellulitis at the injection site after receiving her vaccine. She was prescribed Bactrim DS 1 tablet twice daily for 10 days to treat the infection.
Stated she had a severe headache and still does (11/08/2016). Arm is swollen and red and hot. There is a bruise at injection site.
Case number PHEH2014US025099, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 32 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 20214. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Systemic: SWELLING OF THE HAND-Severe, Additional Details: PT DIAGNOSED WITH RHEUMATOID ARTHRITIS FOLLOWING VACCINE
A non-serious spontaneous report of positive for flu has been received from a pharmacist concerning a five-year-old female, subsequent to FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 26-Sep-2009. On Monday night, 28-Sep-2009, the patient woke up with a high fever, runny nose and sore throat. She was examined by a doctor on Tuesday 29-Sep-2009; a nasal swab was performed and was positive for flu. The outcome of the event is unknown.
No other adverse effects were reported in the patient; Nurse reports that a patient was inadvertently given an adult dose of VAQTA instead of a pediatric dose; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 22-JUN-2020, the patient was inadvertently vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/mL (units per milliliter), 1 mL as prophylaxis instead of pediatric dose (lot # S018419 has been verified to be a valid lot number for hepatitis a vaccine, inactivated; expiration date reported and established as 12-JUL-2020) (incorrect dose administered).  No other adverse effects were reported in the patient.
Throbbing pain in lower back up to cervical spine region.  Low energy.  Swollen lymph nodes in the posterior neck region.
tested for COVID19 and result came out positive,cough; tested for COVID19 and result came out positive; runny nose; This is a spontaneous report from a non-contactable other HCP. A female patient in her 40's received her second dose Pfizer COVID19 vaccine. This is Case No. 12294 as announced by the press release on 10Jun2021. This other HCP reported for a female patient of 40-years-old received second dose of bnt162b2 (Pfizer-Biontech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 30Apr2021 as 2ND dose single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. It was unknown that the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that the list of any other medications the patient received within 2 weeks of vaccination. Previously patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified) on 09Apr2021 as 1st dose, single dose for covid-19 immunization. She travelled on 03Jun2021 with negative COVID19 test result within 3 days prior to her departure. On 07Jun2021 while she was traveling she developed cough and runny nose but she did not seek medical attention. On 09Jun2021, her household members developed fever and were tested positive for COVID 19. This patient was then also tested for COVID19 and result came out positive. The outcome of the events was unknown.  No follow-up attempts possible. information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
On 1/1/2021, in the early morning, I started having severe shoulder pain in my right shoulder (the arm opposite of the injection site arm).  By the afternoon the pain was so bad that I was unable to lift my arm all the way.  I sent a message to my PCP but have not heard back yet, probably because it is a holiday.  I have been applying ice and heat to the area with little relief.
new onset headache (3d post vaccination) no history of similar headaches.  increased word finding difficulty (nondense aphasia), decreased alertness/malaise, chest pain
the patient received a vaccine that was expired. the vial was still located in the fridge with vaccine remaining
This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. Pertinent medical history and concurrent conditions were not reported. On 19-OCT-2015, the patient was vaccinated with a dose of GARDASIL (lot # K010215, expiration date May 2017) 1 shot (strength, dose and route were not provided). Concomitant medication was not reported. The physician reported that the patient experienced a syncope expressed as "passed out" 15 seconds after getting the shot while using GARDASIL. The patient also received influenza virus vaccine (unspecified) reported as "the flu shot" in their other arm at the same time. The patient did not seek medical attention and no treatment was given for syncope. The patient recovered of syncope the same day on 19-OCT-2015. The reporter did not assess the relatedness of GARDASIL to syncope. Additional information is not expected because the physician did not have specific information to provide.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 34 years, in left arm 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 included: "Ulcerative colitis" (unspecified if ongoing); "primary sclerosing cholangitis" (unspecified if ongoing), notes: Other medical history: primary sclerosing cholangitis. Concomitant medication(s) included: PREDNISONE; STELARA, stop date: 22May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Jun2022 at 08:00, outcome "unknown", COVID-19 (medically significant) with onset 25Jun2022 at 08:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound of COVID-19 symptoms 5 days after completion of paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no allergies. Patient received treatment of Paxlovid for covid-19, treatment start date: 16Jun2022, treatment stop date: 20Jun2022.  No follow-up attempts are possible. No further information is expected.
VACCINATED ON JULY 25TH WITH 4MO SHOTS DTAP, IPV, HIB, PCV AND ROTATEQ, CAME IN ON MONDAY JULY 28TH WITH RASH BOTH LEGS  RAISED BUMPS STARTING AT INJECTION SITE  DOWN TO KNEE
Tendonitis; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2021 (Lot number: EL3246) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Anatomical Location- Right arm, Lot number- EL1284), administration date: 30Dec2020, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Cellulitis", "Periodic pain in arms at injection site". The following information was reported: TENDONITIS (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Tendonitis". Additional information: Patient age at time of vaccination was reported as 37 years. Vaccine facility type was reported as Hospital. Vaccine was administered at a facility. Patient medical history and concomitant medications were reported as None.  Prior vaccinations were reported as None. On 15Jan2021, patient experienced Cellulitis and received antibiotics as treatment for it and the event Cellulitis resulted in physician office visit. Patient experienced periodic pain in arms at injection site on an unspecified date. On 04Mar2021, patient experienced Tendonitis. The outcome of the event Tendonitis was not resolved.   No follow-up attempts are possible. No further information is expected.  Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
suspected vaccination failure; shingles / got the vaccine a few years ago and got the shingles; Not comfortable at all.; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and discomfort. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the discomfort was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and discomfort 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 got the shingle vaccine a few years ago and got the shingles last winter.  The patient was not comfortable at all. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Tinnitus - low level, began one week after vaccine. Got worse after I had Covid (09/14/2022), now much more noticeable. I can still hear, but it?s quite a buzz; , it comes and goes.
Passed out for 1 minute; Near syncope; Felt dizzy; Epigastric pain x3 days w/N/V; This is a spontaneous report from a non-contactable Pharmacist. A 57 years old  female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) intramuscular at single dose for COVID-19 immunisation on 24Mar2021. Relevant history included Pancreatitis, Abdominal cancer and Colostomy. Prior to vaccination, the patient was diagnosed with COVID-19. Relevant concomitant drug was unknown.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had near syncope in parking lot after COVID vaccine on 24Mar2021. When walked out of hospital entrance, she felt dizzy, sat down, and passed out for 1 minute, she was met by code team and brought to ED. The patient reported epigastric pain  for 3 days w/ N/V. Relevant lab tests included POC BG: 111;  A&Ox1 VS @1409: Temp 98.2F, BP 134/96, HR 67, SpO2 99%, RR 18.  The adverse events resulted in emergency room/department or urgent care. Treatment therapy included ondansetron and morphine injections. The outcome of events was resolved .  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported loss of consciousness  and the use of BNT162B2 cannot be fully excluded.  As there is limited information available to further assess the case, the case will be assessed further upon receipt of new information.  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.
Approximately 10 hours after getting the shot, I awoke with severe chills, a fever of 101.7 degrees Fahrenheit, body aches from head to toe, an intense headache, and a very runny nose. I was also quite dizzy and vomited 3 or 4 times. I could do little more than lay in bed for the next two days.
sleeping 40 hrs; Severe diarrhea; vomiting; Unable to walk without help; This is a spontaneous report received from a contactable consumer (patient himself). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Unknown/ not available at the time of report completion), via an unspecified route of administration on right arm on 23Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included liver disease and "chrons". Patient had no allergies. Concomitant medication included paracetamol (TYLENOL). The patient experienced severe diarrhea, vomiting, unable to walk without help and sleeping 40 hrs on 28Jan2021 01:00. Patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The seriousness of the events was reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; Information about lot/ batch number cannot be obtained.
When I received the shot I felt it in my teeth.  Didn't think anything of it until that evening when my shoulder started hurting much more than any other shot I'd had before.  Sleepless night with so much pain.  Pain the next day and next evening so bad that it was impossible to sleep.  Finally took a Tylenol and that helped a bit.  Better for a few days and then a week after the shot my shoulder is hurting again, with weakness and reduced range of motion.  I'm thinking that the needed went in too deep and caused an injury.  I have had this issue before where I've had a year of pain and therapy to my shoulder and am wondering if it was caused by an incorrect injection during a flu shot.
Tiredness, fatigue,  Body aches, Headache, soreness at injection site
pt recv vax & exp severe pain in the inj arm;the pain readiated to the neck;addtl info recv 26DEC96 indicated that the pain persisted for 12hr then resolved completely;
8 PM - eyes dry, puffy, blurry - soon throat and chest got tight - then uncontrollable vomiting and diarrhea. 9 PM - called 911 - ambulance to ER. Barely able to speak.
Patient noted with respiratory distress on 1/10/2021, transferred to hospital via 911.