chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling to left axillary lymph node; This is a spontaneous report from a contactable nurse (patient) reported for herself that a 60-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) via an unspecified route of administration at left arm, on 17Dec2020 16:30 at single dose for COVID-19 immunization. Medical history included cherries and peach allergies. Patient was not pregnant at the time of this report. Concomitant medications were not reported. The nurse received the vaccine at Hospital. She reported swelling to left axillary lymph node since 17Dec2020, no treatment received, event was not recovered at the time of this report (09Jan2021). Nurse denied having COVID prior vaccination.  She had tested COVID through nasal swab post vaccination which revealed negative on an unspecified date. She did not receive other vaccine in four weeks, she had the second dose of BNT162B2 (Lot number EK9231) via intramuscular at left arm on 06Jan2021 01:45 PM at single dose for COVID-19 immunization. Outcome of the event was not recovered.
The vaccine caused me to go into DKA (Diabetic Ketoacidosis). I had to go into ICU. The doctors said that I was less than 24 hours away from DYING!!
Symptoms: Red ichy rashes all over my body Doctor has given Prednisone 20 mg, Montelukast 10 mg, Cetrizine 10 mg Result of above med in 2 days: Early periods. Rashes are still coming all over the body, dont see permanent fix. Increase in weight 1.5 kg. Feeling agitated, uneasy all the time
Covid arm - rash, hot and itchy and thickened skin about 4 inches in diameter just under vaccination site
Information has been received from a consumer concerning a 74 year old male who on 18-SEP-2007 was vaccinated with a 0.65 ml dose of Zostavax. On 24-SEP-2007 the patient experienced extreme pain all over body. At the time of report the patient had not recovered. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
C/o arm being sore for 3hrs after injection and then c/o pain and aching all over with arthralgia for several hrs in the evening of the same day.
pt was given vaccine that expired on 4/12/2022 and it was administered 4/15/2022
PATIENT IS POSITIVE FOR COVID-19, AFTER BEING FULLY VACCINATED, AND AFTER 14 DAYS FROM 2ND SHOT.
Pt. received 1st HBV (Engerix) on 12-13-2004, and experienced dizziness later that day and into the next, with resolution on the 14th.  Dizziness resolved spontaneously without intervention.
Several weeks after vaccine starting "feeling tired" run down and became sick with "flu like" symptoms.  Lasted for almost 2 months and then woke up and could hardly walk in January 2011.  Both knees swollen and legs heavy and extremely painful. Primary MD worked me up for Lupus, RA, and other arthritis and was placed on steroids.  Went to Rheumatologist and had numerous treatments with knee aspirations and work up for numerous possible viruses and all came back negative.. calling it "reactive arthritis" to a triggering agent?  I feel it has to do with the vaccine and possibly the preservatives.  I have had numerous vaccines and I am a Registered nurse and never had anything like this.  Still undergoing treatments and 3 arthritis meds and in pain.  Had knees injected with steroids.
Information has been received from a health professional concerning an 18 year old female who on 11/02/83 and 09/14/94 was vaccinated with the first and second dose of MMR II, respectively (lot not available) A Rubella IgM test, done on 06/06/01 was 0.22. This was considered to be a negative titer. The pt sought unspecified medical attention. Upon follow-up, it was reported that the pt was "not exposed to disease." The physical exam for nursing school required a rubella titer. Because the titer "came back non-immune," despite having had two doses of MMR II, it was reported that the physician advised "another rubella vaccine, which was given on 07/12/01." No further info is expected.
Immunocompromised patient received a 3rd dose of the Moderna vaccine from a vial that had been first punctured more than 12 hours ago; Immunocompromised patient received a 3rd dose of the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Immunocompromised patient received a 3rd dose of the Moderna vaccine from a vial that had been first punctured more than 12 hours ago) and EXTRA DOSE ADMINISTERED (Immunocompromised patient received a 3rd dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Immunocompromised patient.).    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Immunocompromised patient received a 3rd dose of the Moderna vaccine from a vial that had been first punctured more than 12 hours ago) and EXTRA DOSE ADMINISTERED (Immunocompromised patient received a 3rd dose of the Moderna vaccine). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Immunocompromised patient received a 3rd dose of the Moderna vaccine from a vial that had been first punctured more than 12 hours ago) and EXTRA DOSE ADMINISTERED (Immunocompromised patient received a 3rd dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Information has been received from a pharmacist concerning a patient who on 14-FEB-2011 was vaccinated with PNEUMOVAX 23, 0.5ml, intramuscular, lot no. 667695/1028Z. It is unknown if the patient received PNEUMOVAX 23 in the past. On approximately 15-FEB-2011 the patient experienced slightly raised reddish pink colored welts covering the shoulder around the injection site. The patient sought medical attention via office visit, and was given BENADRYL and MOTRIN to treat the symptom. At the time of report, the patient's symptoms persisted. The pharmacist was requesting a lot check. This is one of two reports received from the same source. Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released.
Patient came to pharmacy around 2:30pm 10/20/20 to speak with pharmacist. Stated that she received 3 vaccines on 10/15/2020 and is experiencing redness, irritation, and warm to the touch feeling in her right arm at the site of injection. Instructed patient to seek medical treatment at her Dr. office - may just be an irritation but would feel  better if she had it looked at.
04/26/2021 I developed blisters and at first that it was poison oak but it was worse than usual. I only got a physical and was offered topical lotion(calamine) and followed by returning and getting a steroid shot and being on steroid pills for about a month.
Headache and next, shoulders, and upper back pain started on 11/1. Injection pain and itchiness started 11/2.
she denied further AE; VAQTA was administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 03-OCT-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date on 03-DEC-2021 (conflicting information also reported as 13-DEC-2021) 0.5 milliliter, for prophylaxis (strength, route of administration and anatomical location were not reported); after experiencing a temperature excursion (product storage error).  Vaccine was improperly stored at 50°F during a time frame of 0 hours and 30 minutes. No previous temperature excursion were reported and medical assistant denied further Adverse Event (AE) (no adverse event). ; Sender's Comments:  US-009507513-2110USA007288: US-009507513-2110USA007310: US-009507513-2110USA007316: US-009507513-2110USA007379: US-009507513-2110USA007269: US-009507513-2110USA007272: US-009507513-2110USA006972:
a 13 year child female was given J&J in error.  She was to be administered phizer.  Nurse errored in administering the correct vaccine despite proper labeling on the bottle and the syringe properly labeled as phizer.  We stayed with child and parent for more than 30 mins.  Per the parent request to leave.  Management contacted :  for advisement and how to manage the situation. J and J lot number 043a21a
itchy skin on belly.  Approximate 10 red  dots which are similar to the reaction of Mystique bite.  It appears after fever at 37.9C.
Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: A 12 y/o female got 2nd dose pfizer vaccine, verbally informed to sit for  15 mins which she complied to. Few minutes after the administration while seated, patient fainted, fell on the ground as stated by her mother. Another caregiver called me stating someone had fainted. I rushed to the seating area, found patient on the ground slightly conscious with her eyes open but weak. I offered water , to call 911 but declined. She was monitored for 15 more mins and left the pharmacy. I will follow up
left ear pain, chest pain as described by patient - 15 minutes post vaccine, sent to ED for evaluation.
INTENSE DIARRHEA; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 638H8, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced intense diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense diarrhea. This report was non-serious.
knocked me out for two days, meaning I had to sleep for 2 days; injection site was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 3 (booster), 0.3 ml single (Lot number: GJW665) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing); "Knee replacement" (unspecified if ongoing). Concomitant medication(s) included: DILAUDID taken for knee arthroplasty; MAXZIDE taken for hypertension. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot number: ER2613), administration date: 17Mar2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "I did have COVID"; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 immunization, reaction(s): "I did have COVID".   The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "injection site was sore"; HYPERSOMNIA (non-serious) with onset Nov2022, outcome "unknown", described as "knocked me out for two days, meaning I had to sleep for 2 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypersomnia, vaccination site pain.  Additional information: Patient had no prior vaccinations (within 4 weeks), but had COVID and waited 3 months before getting the booster. Treatment in response to adverse event was reported by the patient as 'no' and the patient just wanted to report it for keeping the data up to date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282627 same patient different dose/drug/event;
Severe pain in left arm and left breast; Severe pain in left arm and left breast; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198, expiration date: 30Jun2021), administered in left arm, on 26Feb2021 at 11:00 AM (at the age of 68-years-old) at 1st dose, single for COVID-19 immunisation. The patient was not pregnant. Medical history included celiac disease and known allergies: gluten. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications were not reported. No other vaccine received in four weeks and no other medications in two weeks. The patient experienced severe pain in left arm and left breast, lasting a few minutes on 27Feb2021 at 03:00 AM. The events were reported as non-serious. No treatment was received for the events. The patient had recovered from the events on 27Feb2021.   No follow-up attempts are possible. No further information is expected.
skin rash, itching, redness and swelling, red indurated area 1"x2" area, excoriation, local reaction from varicella to L thigh
Site: Pain at Injection Site-Severe, Systemic: Fainting / Unresponsive-Medium
Around 2am, I began getting very intense heart palpitations, headaches, body aches and nausea. This continued for 48 hours.  It has been 15 days since my shot -- I was perfectly healthy before -- and now I am completely a mess.  I have whole body inflammation and joint pain, frequent headaches, and my digestion is not functioning properly.
This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with a dose of ROTATEQ, "2ml, 10 unit dose tube", lot # K020183, expiry date: 25-JUN-2016, orally, which was improperly stored at 1.11 Celsius Degrees (34 Fahrenheit) for 24 hours, 11.66 Celsius Degrees (53 Fahrenheit) for 120 hours and 8.88 Celsius Degrees (48 Fahrenheit) for 32 hours. The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe chest pain. Worse than the usual chest pain I have every once in awhile. Made a doctor's appointment. They couldn't figure out what was causing it.  It finally subsided after 4 days.
sore, hard,  red rash like area approx. 1.50x1.50 inches, hard, warm to touch Symptoms appeared seven days post injection No treatment to date
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unkonwn date, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) injection, (lot # K007798, expiration date 29-NOV-2015) (strength, dose and route not reported). No adverse effects reported for the patient. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I had chills at 3:30 a.m which woke me up but temp was only at 98.8 a degree higher than normal for me. My left arm ached at the injection which I know is normal. But my upper legs felt achey and upper arms felt achey on both sides near the shoulder. My temp slowly went up to 99.9/99.8 to 100.1. I took a shower trying to get ready for work at 5:45 am when I took it again and it was normal. around 6:20 I took it again and it was 100.1 and I called work. to call off.  I had a headache so i took some over-the-counter headache medicine and the headache subsided. I put on fleece blankets over my legs and my upper body and my temp went up to 101.2. I use a digital thermometer behind my ear to take the temprature.  It has been holding at 101.2 since 6:40 or so. It did go up to 101.9 but I wrapped tight one of the blankets around my upper body closed, so I loosened it and it went back to 101.2 Probabaly a lot of info you don't need , sorry.
Egg shaped knot, hot and itchy next day and is still swollen  and itchy 4 days later. Applied ice.
Patient experienced a painful rash on the left corner eye lid about 3 days after receiving the vaccine
For two days following vaccination, blood was present in stool. No prior history of bloody stools. In addition, moderate to severe chest pain was experienced intermittently in the weeks following the vaccination. This was accompanied by shortness of breath.
I have some flat mole on underneath my breast a flat mole and they have always been there for years but all of sudden one or two of them start to range you know get bigger; I have a rash underline breast more underline left breast then the right; I start feeling this itching under my breast and it's progressive till like it is now; it left the big scars I don't now it's a red that's all I know. It's all red on under there now; it left the big scars I don't now it's a red that's all I know; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 28Jul2021, this case contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient).   A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 14May2021 (Batch/Lot Number: EW0185) (at age of 84-years old) as dose 1, single and on 04Jun2021 (Batch/Lot Number: EW0187) (at age of 84-years old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included warfarin sodium (COUMADIN) and clopidogrel bisulfate (PLAVIX).  The patient had a rash underline breast more underline left breast then the right and she stated she never had any situation in her life like this and the only thing that she could pick it up to do with the shot the vaccine that she took, the vaccine could cause her any problem howsoever neither shot. The patient started sometime after she got a shot she started feeling this itching under her breast and it was progressive till like it was till the time of reporting and she used all kind of thing where she could fix it, that would make it go away but it did not go away. The only thing the patient thought of it could be because it was not from any kind of soap or any kind of detergent soap. The patient mentioned that it had not gone away and in fact it seemed to get little bit worse. It was stopped and left big scars, it was all red on under there till the time of reporting. The patient had some flat mole on underneath her breast, a flat mole and they have always been there for years but all sudden one or two of them had started to range and get bigger. The patient have not taken any treatment and just decided to call as she was reading the papers that she had to see if that could probably be one of the condition that she got after having a shot but since she did not have any pain or anything after she took the shot she did not think she could be able and would never have such a thing at all. The outcome of the events pruritus, erythema and scar was not recovered, while the outcome of other events was unknown.
Rash, UrticariaPruritus, Site pain Narrative:  Went to ER for tx of steroids and H2 antihistamines for pruritic relief  Other Relevant History:
Vaccine Moderna 1/7 /21 That evening myalgias, arthralgias - following day same with temp 99.7 by the evening. AM 1/9 all of the above Sx's had resolved.  PM of 1/9 noted intense itching of fingers and wrists - fingers appeared slightly swollen to her. Similar Sx's feet and ankles a few hours thereafter. Took Benadryl  Hs and slept comfortably.   1/10 - awoke with urticaria back of legs - from knees to buttocks bilaterally.    Hives resolved after 2 hours after Claritin. Another episode finger itching and swelling lasting 30 minutes.  Resumption low grade temp last PM 99.7 - 100.4 max last night in evening transiently. Back down to  99.9 1-2 hours thereafter.   + fatigue since immunization.   Took Claritin this AM. No further hives.
jaundice, T bilirubin 8.0, GGT 250-3 days post vax, nausea, vomit 24hr post vax;
pt recvd vax & had joint swelling & aching; pt was told by MD nl rxn; pt taken to MD due to swelling & jt pain in L wrist; dx w/ arthritis due to vax;
Patient was inadvertently given a dose of Moderna 22 days after a dose of Pfizer. Patient presented to clinic to receive second dose of Pfizer but Moderna was administered through fault of human error.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild
SEVERE MIGRAINE; SWELLING ON SITE OF INJECTION; SORENESS ON SITE OF INJECTION; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced severe migraine. On 08-APR-2021, the subject experienced swelling on site of injection. On 08-APR-2021, the subject experienced soreness on site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe migraine, and had not recovered from swelling on site of injection, and soreness on site of injection. This report was non-serious.
Child began stuttering while speaking. Notified MD office on 10/3, they stated to watch him and it should go away in a couple weeks and not to call attention to it.
Patient's mother states that he awoke in the early am of 10/31 complaining of abdominal pain.  He went to school on 10/31 but called mom because of a severe headache and neck pain.  Mom says that shortly after he arrived home that he had an episode of syncope.    Patient's mom was advised by PNP to take patient to either Urgent Care or ED for further evaluation.
Pt recv vax on 11/2/98; on 11/4/98 pt exp flu sx of myalgia, arthralgia, malaise, nausea & slight twitch
pt recvd 3 doses of vax & 2 days p/dose 3 exp back & neck pain which lasted 3-4 dasy;
Patient reported that approximately 3-4 days after receiving vaccine, she developed itching and redness around the shot area, with symptoms worsening each day.  Reported that she self-treated with steroid cream (name not given), anti-itch cream, and diphenhydramine oral at bedtime.  Symptoms lasted approx 10 days and were completely subsided when presented today for Dose 2.
Post vaccine- Hour 28- lethargic, zero energy Hour 36- migraine, sensitive to light Hour 48- continued with migraine and zero energy Hour 55- developed tinnitus and vertigo. Moderate headache Hour 61- tinnitus subsided. Mild vertigo Hour 72- all symptoms subsided except low energy.  Hour 96- back to normal