chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was given shot and felt fine. Then suddenly became dizzy and started blacking out and sweating profusely. Staff told me my skin was white. I was laid down and my legs were held up while they took vitals. My clothes became drenched in sweat. One nurse told me this was from anxiety. I was not remotely anxious at the time of the shot and do not have a fear of needles - I have tattoos and piercings, have had IVs and had blood drawn numerous times and have never ever had anything like this before. After an hour I could stand but barely walk for a couple hours more.
Rash in the area of injection extended to an area of 5 by 5 centimeters , hot to the touch and itchy.  Headache and malaise.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 26-JUN-2014 the patient was vaccinated with second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J011385, expiry date: 10-MAR-2016, also reported as 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
Hives started 9:00 PM. Next Morning, a Swollen Lip and hives, headache, upset stomach.  Hives continued until 3/9.2021
3-4 hrs p/vax pt devel rash on both lt & rt thighs-more scaling on lt thigh-rash radiated up thighs to back area by 10APR93; 13APR93 pt alert & temp of ? felt warm on 8APR-10APR93;
Chest pressure onset at approx 1525 described as "pulsing"  denies dizziness, SOB, diaphoresis, pain scale initially 7/10  then 3/10 then 6/10 at 1540 Pt states she had  these sx after anesthesia in 2000 Pt states pressure is 2/10 at 1551 Blood sugar at 1535-118.  Pt was advised to proceed to the ED for further workup, states understanding.  She agrees to drive herself.  She is stable to drive Vitals: 1535 HR 84, BP 149/81, O2 99, 1541 HR 85, BP 154/88, O2 100, 1546 HR 80, BP 159/85 O2 100 1551 HR 78, BP 150/85, O2 100, 1558 sitting HR 82, BP 163/87, O2 98 1604 standing HR 89, BP 152/90, O2 1000  Pt discharged at 1604
At 2 month and 4 month vaccines pt was crying uncontrollably began about 1 1/2 hrs after vaccines. After 4 month vaccines pt got a 102 fever.
Pt received flu shot on 10/10/2015 and developed a diffuse, pruritic rash w/ red papules.  Pt took Benadryl for 5 days without relieve.  Seen by primary care doctor on 10/15, and was given hydroxyzine, Allegra, and triamcinolone cream.
Narrative: Pt. developed Guillain Barre attributed to influenza vaccine he received from private Md (outside clinic) in November 2019. Pt sees outside clinic private MD. This is a historical report from clinic primary care provider. No info known of date and place and brand of influenza vaccine given in 11/2019.
pt recv vax; immediate itching & body rash; progressed to sinus tachycardia & dysonea; hosp 6sep95; further rxn to demerol; discharged on 8sep95;
Joint swelling in both hands and digits. feels almost arthritic.  lasting over 3 weeks now. Made an appointment to see doctor.  fingers having a hard time straightening.   Constant, pain and swelling.
Patient called morning of 3/22/21 reporting pain/soreness in right leg and joints starting day of vaccination (3/19/21). Patient routinely wears support hose on legs but indicates his wife finding bruising on back of his right knee. Also, beginning of today (3/22/21) patient states having right-side face tenderness and soreness starting at top of head, down the face, neck, shoulder, and into chest area, making it difficult to chew. Pharmacist on duty told patient to go to the ER as soon as possible. Going to call patient to check in this afternoon.
"Covid Arm":  Oval red slightly itchy rash about 3 inches long surrounding injection.  Had this reaction to Dose #1, but that time it was slightly lower on the arm.  Dose #1 rash resolved in about 6 days.  Currently still have Dose #2 rash.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/11/2021 and 03/11/2021. They tested positive for COVID-19 on 10/02/2021 at the senior living facility at which they were a resident. Repeat testing at the hospital x2 on 10/02/2021 was also positive. They were brought to emergency department on 10/02/2021 for shortness of breath and weakness plus low oxygen. They were admitted and then discharged 10/07/2021. A few days later, they were brought to emergency department again on 10/18/2021 with primary complaints of falls and general weakness. They were admitted again and then remained hospitalized until their death on 10/20/2021. (Some clinical documents have a typo in the date of birth and state it was 12/20/2021. The death certificate, however, has 10/20/2021 for date of death) The individual had experienced complications of COVID-19 pneumonia.
Two weeks after receiving the intranasal flu vaccine, Flu Mist, I developed a horrible earache. This turned into paralysis of the entire right side of my face - bell's palsy. I have now been experiencing extreme inner ear pain since the onset of the symptoms - debilitating pain. My r. eye does not close, the right side of my tongue doesn't taste, my face is motionless on the r. side. I was treated with prednisone, a steriod, to reduce inflammation. I was given hydrocodone for the pain, which does nothing to alleviate the pain. I have gone to acupuncture treatment twice a day for the past five days in a desperate attempt to alleviate the pain. 1/28/2010 Recurring pain in inner ear and along the jawline.
Fever, pain and swelling to (L) lateral shoulder. Pt. seen in ER for c/o fever and pain, treated with steroid injection and antibiotics.
I95.9 HYPOTENSION 12/1/2022 HYPOGLYCEMIA I95.9 HYPOTENSION 12/1/2022 BILAT PNEUMONIA
36 hours after immunizations were given, pt developed red blotches on the sides of her face. The following morning, the site where DTaP was given appeared red, swollen, blotchy and hot to the touch. Rash was on right deltoid 12 X &.5 cm. 3.75 cc Benadryl given in office. Pt is itchy.
Pt sts that evening after administration she noted a large red area around injection site. She put ice on it, no pain associated with it. Redness went away in couple of days, bruising formed at base of redness area.
Pain at the injection site, Severe Fever, Severe Fatigue, Severe Headache, Severe Chills, Severe Muscle pain, Severe Joint pain, Dry cough, Severely Swollen lymph nodes. All symptoms started at 03:00 a.m. on Saturday, September 18th, 2021 and have not stopped.
Patient had tingling and numbness of the mouth and throat 20 minutes after  receiving the COVID vaccine
Blacked out; saw "stars" before it went black; Ears were ringing; Very light headed; soreness in her leg; patient received meningococcal group b rlp2086 in the leg; This is a spontaneous report from a contactable consumer (patient's parent). An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, administered in the leg on an unspecified date (also reported as 23Jun) (Batch/Lot number was not reported) as a single dose for immunisation; also it was reported: the patient received two vaccine doses, one in each leg. The patient remembered one was TRUMENBA but did not remember the other one and did not remember which vaccine went in which leg.  The patient's medical history and concomitant medications were not reported. On an unspecified date (also reported as 23Jun), the patient experienced: blacked out (medically significant), saw "stars" before it went black (non-serious), ears were ringing (non-serious), very light headed (non-serious), soreness in her leg (non-serious), patient received meningococcal group b rlp2086 in the leg (non-serious). The clinical course was reported as follows: The patient's parent reported an adverse experience during the morning. The dates of vaccination was reported as "23Jun." The 18-year-old patient experienced an adverse event when getting the meningococcal group b rlp2086 vaccine in her leg. The patient blacked out for a moment as her eyes rolled up five minutes after receiving that vaccine along with one other shot in the other leg. The patient received two vaccine doses, one in each leg. The patient remembered one was TRUMENBA but did not remember the other one and did not remember which vaccine went in which leg. The doctor said this was a common experience and gave her a Sprite to drink. The patient recovered quickly. The patient's parent reported that the patient was quite thin which may have had an impact. The patient's immediate symptoms were being very lightheaded, saw "stars" before it went black, ears were ringing. Several hours later she was reporting soreness in her leg. Therapeutic measures were taken as a result of blacked out. The clinical outcome of the event, blacked out, was recovered on an unspecified date. The clinical outcome of the remaining events was unknown.  The batch/lot numbers for the vaccine, meningococcal group b rlp2086, were not provided and will be requested during follow up.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # N035171 exp date 09-JUN-2019) (dose and route not provided). The vaccine was reconstituted with properly stored sterile diluent. Data digital logger was reported. The vaccine was exposed to a temperature of 6 °F to 14 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1806USA006475: US-009507513-1806USA006476: US-009507513-1806USA006477: US-009507513-1806USA006478: US-009507513-1806USA006479: US-009507513-1806USA006387.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 15Jul2021 as dose 1, single (Lot number: FA6780), in left arm and on 05Aug2021 as dose 2, single (Lot number: FA7485) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "HLD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Chest X-ray: (18Feb2023) Normal, notes: CXR normal today; Influenza virus test: (unspecified date) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid Treatment start date: 08Feb2023, Treatment stop date: 13Feb2023. No known allergies.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine,  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
acid reflux, light headiness, dizziness, joint pain, muscle pain all over my body, nausea, upset stomach, the feeling like I am moving through water like there is a resistance against my limbs. rapid heart beat, headache, all lasting over 10 days
The patient received a flu shot in the employee health clinic on November 4, 2015. Within a couple of minutes, she developed a tickling sensation in the throat followed by tongue swelling. She was seen by the Employee Health nurse and referred to the ED because she developed some wheezing. She had generalized itching, dyspnea, and there was some redness in the neck area as well. Review of the ED records report that she was evaluated. She did in fact have urticaria, but the rest of the physical exam was entirely normal. She received SOLU-MEDROL, BENADRYL, PEPCID, and IV fluids. With which, she improved and she was discharged after observation and stable status. The patient recalls that she has had flu shots several times in the past without any adverse reaction.
Soreness in arm near injection site. Went to bed immediately after shot (felt weak and a little disoriented shortly after injection). Slept (unconscious from 0900 to noon); had a full nite sleep 1200-0900 the nite before) and awoke a little groggy. Called in sick to work at noon. Went back to bed and slept for 4 more hrs. Awoke feeling a little better but rested the rest of the day and got a good nites sleep. Low blood sugar (Diabetic) may account for some symptoms. Fealt Ok the following day and went to work.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks: Yes. The patient was received Paxlovid (Treatment start date: 10Feb2023, Treatment stop date: 15Feb2023). Known allergies: No, Other medical history: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective , Covid-19 and the use of suspect product BNT162b2 cannot be fully excluded.
Narrative:  Patient received the first dose of the Moderna vaccine 0.5 ml IM (MOD; 012L20A; 07/06/2021) on the morning of 1/19/21. It appears he called reporting symptoms on 1/21/21 of itchy rash diarrhea, nausea, vomiting, dyspnea, swelling armpit/groin, 'bone' aches x 3 days. Ge also reports that he had not eaten for 4 days and had aches, pains, and diarrhea (at the time of this writing, it is unclear whether the aches, pains, diarrhea were present prior to vaccination). Rash resolved with antihistamine and steroid administration in ED and patient was ultimately admitted with a diagnosis of AKI. 2/2 dehydration. Fluids administered in ED and are to be continued upon admission. Symptoms:  Myalgia, SkinRash, Rash, UrticariaPruritus, Diarrhea, NauseaVomiting & Dyspnea, Swelling
About 10 days later I had severe joint pain to a point where it was incapacitating. I called my doctor who advised anti-inflammatory which we followed. For the first 2 weeks I could not walk, it was so painful. It improved after that but took 6 weeks to completely resolve. We took Tylenol to help.
diabetes; This case was reported by a nurse via call center representative and described the occurrence of diabetes in a 7-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   In October 2018, the patient received RabAvert. On 27th November 2019, less than 2 years after receiving RabAvert, the patient experienced diabetes (serious criteria GSK medically significant). On an unknown date, the outcome of the diabetes was unknown.   It was unknown if the reporter considered the diabetes to be related to RabAvert.  Additional details were provided as follows: It was unknown if the patient received Rabavert vaccine for pre or post exposure prophylaxis.  The patient was diagnosed with diabetes on 27th November 2019. The reporter was questioning whether the company had seen any correlation between diabetes and Rabavert. The case has been linked to the case US2019234432, reported by same reporter.
Pt arrived to observation area after pfizer dose # 2 and 5 minutes later stated feeling dizzy and assisted to cot and laid down and vitals taken 1:15 pm 110/60, 67 bpm and 97% O2sat Pt given po fluids water and juice and states feeling better and assumed sitting position 1:30pm 100/60, 73 bpm, 98% O2 sat Pt reported feeling well and wanted to depart and iz side effects and ER precautions reviewed and pt and husband verbalized understanding and pt left iz area
admitted for weakness, afib w/ RVR, COVID PNA, SPo2 93, Remdesivir/dexamethasone given
Hard time breathing, heavy chest first 2 hours; rested uneasy for another 2 then severe not being able to breathe, felt like heart attack; chest tight and heavy; hyperventilated; almost passed out; all body weakness. Blood pressure when arrival at ER was 142/89.
This spontaneous report has been received from a registered nurse, concerning two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On 23-JUL-2018, the patients were vaccinated with improperly stored doses of VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. No adverse effect reported. The vaccines were stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The outcome of product storage error and no adverse event was unknown. This is a non-valid case due to lack of patient identifiers. As of 10-DEC-2018, all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 30-JAN-2019 from the registered nurse regarding a 15 years old male patient (previously unknown). The date of VARIVAX storage error was 22-JUL-2018. The vaccine was stored out of range at -6 degree Celsius for an approximate time of 15 minutes. The patient received VARIVAX the week immediately following the product storage error (product start date approximated as July 2018). No adverse events were reported. This case was previously considered as non-valid, but upon receipt of follow-up it was determined to be valid as patient identifiers are provided. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Chief Complaint  Increased SOA x3 days, COVID positive today. Reports low spO2 on clinic monitor. 92% on RA on arrival to the ED.  History of Present Illness  50-year-old female with past medical history significant for asthma, type 2 diabetes, and obesity (BMI 86.6), presented to LMH with 3-day history of shortness of breath and recent Covid positive test.  Patient reports being in her baseline state of health until 6 days prior to admission.  She received Covid vaccination series in February 2021.  On September 4, patient went out with friends to a bar, fell and injured her left leg while climbing up on the stage.  Since that time, she has felt more weak, has had pain in her left leg, and some increase
Approx. 2 hrs after rec. flu shot, face became bright red, neck itching and c/o H/A. Symptoms resolved within 2 hrs on there own - no meds were taken.
Information has been received from a pharmacist concerning a pt who was vaccinated with a dose of varicella virus vaccine live and had " a reaction ".  Unspecified medical attention was sought. No product quality complaint was involved. No additional information was provided. Follow up information from a pharmacist indicated that the event was reported to VAERS.  No additional information is expected.
Patient recieved vaccine on 10/9/20, that next morning at 3am, started breaking out in hives, contacted teladoc and they prescribed benadryl taking 4 days, only getting hives in the evening but not during the day. Started a methylprednison pack today to see if it can help with hives
blood in urine; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (blood in urine) and HEADACHE (headache) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose) in May 2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 27-Dec-2021 at 2:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced HEADACHE (headache). On 28-Dec-2021, the patient experienced BLOOD URINE PRESENT (blood in urine). At the time of the report, BLOOD URINE PRESENT (blood in urine) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Blood urine present: blood in urine (abnormal) blood in urine.         No treatment medication was reported. No Concomitant medication was reported. Patient did not take any medications for symptom relief. Adverse events were still persisting. Patient had blood in urine and it was his first time experiencing this. Patient  still has a trace of it.   Reporter did not allow further contact
This medically confirmed spontaneous report (initial receipt 17-Dec-2012) concerns a 54 year old female patient. Concomitant medications included fluticasone nasal spray. On 04-Dec-2012, the patient received AFLURIA (batch: P50608) via intramuscular route in the deltoid in the left arm at a dose of 0.5 ml. The patient had no previous doses of AFLURIA. On 05-Dec-2012, the patient developed local pain and tenderness with a stiff arm (including loss of range of motion) following vaccination with AFLURIA. The patient had restricted range of motion in the left arm. She was unable to lift her arm for several weeks after. The reporter indicated that the range of motion had improved, but the patient currently still could not fully extend the arm or raise the arm above the shoulder in the arm that was vaccinated with AFLURIA, due to the stiff arm (including pain and tenderness). On 30-Jan-2013 the range of motion in the patients arm was improving. The event outcome was recovering. Reporter's comments: The reporter considered events to be serious as it resulted in persistent or significant disability/incapacity. Follow-up #1 (30-Jan-2013): current status of patient. Follow up #2 (15-Apr-2013): upgraded to serious, reporter assessment, injection site (left arm).