chrisvoncsefalvay/vaers-outcomes huggingface dataset:
13 days after the vaccine I woke in the middle of the night with swollen lips, then the swelling began to spread across my face, ears and throat. It was slowly spreading, by 5 AM I was having trouble swallowing and couldn't catch my breath. Hard time breathing. My husband took me to emergency room as it was getting scary and my throat was closing. I had done NOTHING different in those 13 days, not even eat a new food, no new topical treatments, nothing. I received my 2nd dose on 5/24- and within 36 hours I had the same swelling, but not as bad and only on the right side of my whole body. I did not go to ER, so I took Benadryl.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L001456, expiry date: 22-OCT-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
It's been 8 days since my injection and I still have a red hard lump about the size of a golf ball and it itches.
Cold chills, lethargy, body aches, and a lump in my right armpit.
Soreness at injection site; edema of deltoid muscle; inflammation with a line of redness on side opposite the injection site. Rubbing injection site, massaging affected muscle, elevation and icing for 8 hours. Icing, massage, and elevation were followed with compression stocking applied to left arm. Ibuprofen 400 mg given at 12 hrs after injection to mitigate pain from edema. Edema continued to progress past the elbow, eventually reaching the wrist joint by day 5. Compression stocking seemed to reduce how quickly the edema progressed towards the wrist, however never halted it completely. Pain was reduced by 72 hrs despite no improvement of the edema. Physician was contacted after 24 hrs and photo of reaction forwarded for her records. Pt was not seen in office after reaction occurred. Full function and reduction in edema was complete by day 7.
Patient experienced severe arm pain beginning  within hours after injection, persisted for 2.5 weeks, when she sought treatment at an urgent care facility. Urgent Care facility referred her to ER due to concern of cardiac issues (as patient has history of MI and cardiovascular disease). Went to ER, labwork done, x-rays taken, all cardiac issues ruled out. Severe pain persisted and patient was referred to ortho a week later to rule out injury. Ortho diagnosed with vaccine related injury.
On the 24th after I showered I had red rashes on my torso and it was really itchy and red. It got really welled up and really itchy. I contacted my doctor and he recommended a medicine which made it a little better and I kept going on with Zyrtec and finally I got days off of Zyrtec and because I stopped it started itching more and then I tested positive on Jan 3. Then I started taking Zyrtec again and the itching has gone away a little. My doctor said I need to take less Zyrtec. It comes and goes and it's really bad.
Severe headache; injection site red and swollen; injection site red and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 13:00 (Lot number: EW0178) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Granulomatosis with polyangiitis" (unspecified if ongoing), notes: other medical history: Granulomatosis with polyangiitis; "Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: LOSARTAN; LEVOTHYROXINE; BUPROPION. Vaccination history included: Bnt162b2 (lot number EW0186,, lot unknown False,, administration date=19May2021,, dose number=1,, vaccine location=Left arm), administration date: 19May2021, when the patient was 55 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 10Jun2021 01:00, outcome "not recovered", described as "Severe headache"; INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious) all with onset 10Jun2021 01:00, outcome "not recovered" and all described as "injection site red and swollen". Therapeutic measures were not taken as a result of headache, injection site erythema, injection site swelling. No follow-up attempts are possible. No further information is expected.
Erythematous, warm, hard, circumferential rash noted on the deltoid region of the LUE. There is one blister noted in this area. Good pulses.
10-15' after injection, arm heavy, tingling, numbness from shoulder to hand, numbness fingers.
Lost taste in mouth (3 days) Fever (1 day) Chills (1 day) Severe Fatigue (3 days) body aches and muscle pain (1 day) Pain in arm where injection happened (3 days) Nausea could not eat for (2 days)
itchy; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP7534) via an unspecified route of administration, administered in Arm Left on 22Mar2021 10:30 (at the age of 36-year-old) as single dose for COVID-19 immunization. Medical history included Asthma, year-round allergies, known allergies to shellfish, fish. No covid prior vaccination. Concomitant medication(s) included levonorgestrel (MIRENA); neomycin; polymyxin b, all taken for an unspecified indication, start and stop date were not reported; Allergy shots. The patient previously took amoxicillin and experienced allergy. It was reported that after first vaccine patient arm was just itchy after. The patient did not receive any treatment for the event. Post vaccination COVID was not tested. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist regarding to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unknown date, the patient was vaccinated with his second dose of GARDASIL 9 (lot # R024264, expiry date: 29-OCT-2019 (reported as 27-OCT-2019) dose 1, 0.5 milliliter for prophylaxis. It was reported that the patient was inadvertently administered his second dose of GARDASIL 9 at a 3 month interval rather than the two month interval in the prescribing information. There were no adverse effects.
Onset of anxiety, depression, loss of appetite started approximately on 11/2/2022.  Weight loss began approximately on 11/16/2022 and accelerated throughout the next four months for a total of 25 pounds.  Shoulder pain and weakness (both) started early January and became worse to the point that patient cannot raise his right arm above his waist.  Left shoulder remains painful.  Right shoulder has considerable muscle atrophy.  Has had four weeks of physical therapy resulting in no improvement.  MRI on right shoulder at Medical Center on 2/14/2023. Has appointment with orthopedic surgeon on 2/23/2023.
Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB vaccine, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #13 of 32, a 44 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 44 year old female on an unspecified date was vaccinated with the first dose of RECOMBIVAX HB vaccine (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At  the time of the report, the patient's outcome was not reported. The authors stated the RECOMBIVAX HB vaccine may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB vaccine (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 104USA02337, WAES # 1004USA02339 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Chills Fever  Severe diarrhea for 6 weeks Dehydration  Pleurisy  Esophagus inflammation  Lethargy
Headache with suboccipital pressure, fatigue, symptoms similar to increased intracranial pressure that had been experienced in the past
Chron's disease; This spontaneous report was received from a physician referring to a 16 years old male patient. The patient's pertinent medical history, concomitant drugs and drug allergies were reported as unknown.  On 29-JUN-2018, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, route, lot number and expiration date were not reported) for prophylaxis. And on 31-JAN-2019, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).    On 30-JUN-2019, the patient was admitted to the hospital and on an unknown in 2019, he was diagnosed with Chron's disease. The outcome of Chron's disease was unknown. It was unknown if he received any treatment. It was unknown if the patient had sought medical attention or if any lab diagnostics/studies were performed. The outcome of crohn's disease was unknown.  The causality between Chron's disease and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, Chron's disease was determined to be medically significant.
woke up 3NOV93 in AM w/eye itching swelling around eyes w/mild reddness, SOB, mild rash;
Eleven months after the first vaccine I was diagnosed with MIBC, muscle invasive bladder cancer.  Treatment was about 15 days of chemo, Cisplatin and etoposide. About 35 days of bladder radiation and 6 treatments of BCG.  Six or eight surgeries to remove/scrape bladder in city and/or city and take biopsies. Currently cancer free but in surveillance treatment every three months which involves cystoscope and CT scans.
COVID-19 BREAKTHROUGH CASE THAT EXPIRED APPROXIMATELY THREE MONTHS AFTER COMPLETING VACCINATION SERIES.
pt recvd vax;few mins later turned pale & passed out; legs & head began shaking; eyes rolled up; md stated looked like grand mal sz;  lasted about 2 mins;to hosp; CT scan & EEG ordered
He started with a fever.  Had the fever until the middle of the night Saturday morning.  Started with the fever again Saturday afternoon and had it until early Sunday morning.  Had the fever again Sunday night until Monday morning complained that his feet hurt and his hands hurt and he really did not want to walk.  He did not have a fever Monday night but he got up Tuesday morning with a Rash all over his torso, arms face, and legs.  It is very itchy.
3 inch x 3 inch red, firm, hot swollen area on deltoid surrounded by 1 inch pink area (total area 4 inch x 4 inch). Tx cold compress, BENADRYL.
This  60 year old female received the Covid shot on  2/26/21    and went to the ED on 3/3/21     and was admitted  on 3/3/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC)
Patient received vaccine 8/7/06. Per patient report, itching and pain at vaccination site 8/8. Worsening pain, redness, edema, and induration on 8/11. Fever and headache developed 8/12. To clinic for evaluation 8/14. Afebrile but 7x7cm region of tenderness, erythema, and induration over injection site noted. To follow-up with patient later this week.
PCR test performed on 7/17/21 at 17:15. Test came back positive. Case investigation interview with patient has not been performed at the time of this written note.
Soreness in right knee started after 2 days, had continued since. Non-existent during days at night starts to ache and throb.
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 15-JUL-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route af administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 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, 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, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
missed the second vaccination shot; A spontaneous report was received from a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) but missed the second vaccination dose.   The patient's medical history was not provided. Concomitant product use was not reported.   On 14 -an-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.    On 11-Feb-2021, she was scheduled for second dose but missed the vaccination dose due to being in quarantine. No adverse event were reported, and no treatment medications were reported.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event missed the second vaccination dose was considered resolved on 11 Feb 2021.; Reporter's Comments: This report refers to a case of  Missed dose for mRNA-1273, lot # unknown with no associated AEs.
48hr p/vax pt devel an allergic rxn characterized by gen rash, swelling of the hands & diff breathing;pt was taken to ER for tx;
After the vaccine: 10 minutes - small headache started 30 minutes - swollen throat, pale color 40 minutes - shaky legs was administred two pills of benadryl  following day, 9h30am - area around right eye swollen and rugged (consistent with previous allergy case - 10 years ago) tooke 1 pill of Cetirizine Hydrochloride 10mg
Received third shot of COMIRNATY on 05Nov2021; Soreness in arm where vaccine was administered; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the third dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) on 05Nov2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On the date of Nov2021 patient experienced soreness in arm where vaccine was administered and on 05Nov2021 the patient received third shot of COMIRNATY. The patient underwent lab tests and procedures which included body height: 6 feet and weight: 157. The outcome of the events was not reported.   The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Severe soreness at injection site. Turned into a big welt. Pt had very little movement from shoulder to elbow. Site was hot to the touch. Symptoms lasted about two weeks. Swelling and hives were also a symptom.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included pulmonary thrombosis. On 11th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced muscle pain, fatigue, shoulder pain and back pain. On 21st October 2018, the patient experienced chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the muscle pain, fatigue, shoulder pain and back pain were not recovered/not resolved and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the muscle pain, fatigue, chills, shoulder pain and back pain to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the second dose of SHINGRIX, the patient experienced the same muscle pain as after the first dose, also in additional to pain in the left side of her shoulder and back along with fatigue. The patient experienced chills one day before the date of reporting but on the date of reporting the chills were not present. This case was linked to case US2018192646 (1st dose), reported by the same reporter for the same patient.
Pt recv vax on 11/17/97; on 11/20/97 pt exp myalgia &arthralgia; pt recovered in 3-4 days w/o tx.
I started to have mild symptoms (malaise, flush feeling and then numb, tingling, weak hands followed by joint pain) in the afternoon of 1/7. The symptoms progressively worsened into what my husband (an immunologist) called an intense hyperimmune response. I had severe COVID symptoms (intensified from my experience having the virus in Sept): fever 100-102, flushed face, intense muscular and some neurologic symptoms--joint arthralgia and myalgia, headache, shivers/rigors, extreme weakness (especially my hands) and later I could barely stand or walk, glandular pain with minor swelling (axillary and neck), nausea, and my hearing was temporarily diminished--nearly lost for a few minutes; tylenol 500 mg taken the night of 1/7. The intense symptoms have subsided. Currently I am tired, weak, achy, and afebrile (last ibuprofen 200 mg taken last night). My hands remain weak.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection was received from a physician regarding a 3 year old female patient who developed redness, swelling, and a red streak going up the side of her thigh. At 3 years of age, the patient received the fourth dose on 11/03/2004. Medical History: The reporter indicated that the patient is a "well baby, no birth defects, no allergies". Product details: Indication for Prevnar was immunization. Product was administered on 11/03/2004. Dose regimen was 1 dose intramuscularly. Concomitant Therapy: Concomitant medications were not reported. Event Details: On 11/05/2004, a 3 year old female patient developed swelling, redness, and red streak going up the side of her thigh ( erythema) after receiveing an injection of Prevnar. The child's parent contacted the physician: treatment was not administered. No additional information was available at the time of this report. Manufacturers Comment: This is one of 2 patients from this facility who experienced this event following receipt of Prevnar lot No. A083578E/ See related case HQWYE334710NOV04.
Patient described severe flu-like symptoms x 2 days that resolved w/OTC IBU use.
4OCT90 vaccinee experienced generalized itching all over body (no fever, no rash) approx 8 hrs p/1st inject of series. Itching resolved w/in a few hrs
This spontaneous report was received from Registered Nurse regarding unspecified number of patients of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not reported. On an unspecified dates the patients were vaccinated with improperly stored of PROQUAD (Merck) (therapy type digital data logger) (lot # L051100, expiry date 17-JUN-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to temperature excursion of -6.1 degree C for a time frame of 30 minutes. The vaccines were not subjected to previous temperature excursions. The outcome of temperature excursion was reported to be supported until expiry date. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two reports received from the same reporter. Additional information is not expected as reported did not wish to be contacted further.
Cellulitis with fever and injection site pain. Prescribed Cephalexin 500 mg BID for 5 days.
Full body hives and dyspnea. Received an IM dose of Solumedrol at PCP office on Monday 3/30/20.
lower back problems on waist and breathing. pain in my chest, pain and sweating. Went to ER on 3Oct2021 and 6 September2021.
I felt like I had a stiff neck one morning when I woke up. 2 days later I had swelling and a lump on the left side of my neck. I called my doctor, and they did an examination. I am going to see an oncologist on 7/19/2022 and an ENT doctor on 7/20/2022. The lump is pretty visual from my ear down to my throat.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild
Weakness, slid out of W/C which is unusual for him.  Vomiting at approx 1pm