chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rare skin lymphoma recurred/The tumorous ulcer appeared in the armpit of the same arm in which the man had received the injection, and then regressed spontaneously; rare skin lymphoma recurred/The tumorous ulcer appeared in the armpit of the same arm in which the man had received the injection, and then regressed spontaneously; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CUTANEOUS LYMPHOMA (medically significant), NEOPLASM RECURRENCE (medically significant), outcome "unknown" and all described as "rare skin lymphoma recurred/The tumorous ulcer appeared in the armpit of the same arm in which the man had received the injection, and then regressed spontaneously". Clinical course: The (Name Withheld) paper follows earlier isolated reports suggesting a possible link between COVID-19 vaccination and lymphoma. (Name Withheld), who heads the division of clinical dermatology at the (Clinic name withheld) in (State name withheld), co-authored a paper published in May2021 about a patient whose rare skin lymphoma recurred after his initial Pfizer shot. The tumorous ulcer appeared in the armpit of the same arm in which the man had received the injection, and then regressed spontaneously. A second shot of the vaccine, delivered three weeks later, produced no further lesions,   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left leg 5"X5 " Redness and hot. Patient was given benedryl and Bactrim
Patient received DTAP #5, VARICELLA #2 on 6/5/07.  Mom discovered red rash on left leg that is warm to touch on 6/7/08.  Patient not complaining of pain/itching.  No fever or activity change.  No vomiting/diarrhea.  Patient received MMR #2, and IPV #4 in right thigh on 6/5/07 also.
1/28/21 very itchy right hand. Duration approx. 10 min 1/29/21 5am itch started right hand and progressed up to shoulder with intensity increasing over 15 min time. Extreme tingling and itch! Red rash remained.  1/29/21 7PM itch began on left hand similar to in AM.  Continued up arm across chest reaching right shoulder. Applied OTC itch cream and started Benadryl. Continued Benadryl for 3 days.
The pt experienced a high fever of 102, chills, muscle aches, joint pain, left arm pain, headache, watery eyes, nausea. The pt was referred to the ER.
Patient received vaccine on 9/7/10 called 9/10/10 stating she had 2 seizures while sleeping. One on 9/9/10 and 9/8/10.
We spoke with patient's parents, there were no symptoms nor adverse reactions. VAERS created because Vaccines was expired on 3/5/2023 but administered on 3/7/2023.
Had really bad vertigo on 01/16 on 01/17 right leg was very week hah dysiaclokinesia
Flu-like symptoms for two days/which she also had with her second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms for two days/which she also had with her second dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 029L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms for two days/which she also had with her second dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms for two days/which she also had with her second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-398629 (Patient Link).
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unkonwn 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 VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date; 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, 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 1407USA01304 (same reporter link).
expired ACT-HIB was administered with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA264881(CLUSTER).  This case involves female patient of an unknown age who administered expired Hib (PRP/T) Vaccine [Act-Hib] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Prophylactic vaccination.  On 21-Aug-2023, the patient received a expired dose of 0.5 ml of suspect Hib (PRP/T) Vaccine Powder and solvent for solution for injection (frequency: once, strength: standard, expiry date: 10-Aug-2023 and lot UJ739ABA) via intramuscular route in unknown administration site for immunization (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Overnight after the vaccine I had body aches and was sweating pain in neck glands. Pain on the back of the neck dizziness and fatigue with zero appetite. Fever of 101.8 and lasted for two and a half days. Headaches with other symptoms. I went to the doctor after three days. Tylenol helped relieve the body aches and reduced the fever. The symptoms improved and were less severe but lasted five days. Dose two received no similar symptoms with just a sore arm.
BEFORE THE VACCINE, PATIENT STATED THAT SHE WAS VERY ANXIOUS ABOUT GETTING THE VACCINE. PATIENT STATED THAT THE REASON SHE WAS GETTING THE VACCINE WAS BECAUSE HER HUSBAND WANTED HER TO AND SHE WAS VERY SKEPTICAL ABOUT IT. AFTER THE VACCINE WAS ADMINISTERED, PATIENT'S INJECTION SITE BEGAN TO SWELL. PATIENT BECAME VERY ANXIOUS ABOUT THE INJECTION SITE SWELLING AND EXPRESSED THAT SHE WAS FEELING DIZZY. AN ICE PACK WAS PLACED ON THE INJECTION SITE AND A COLD BOTTLE OF WATER WAS PLACE ON THE BACK OF THE PATIENT NECK. SHE DENIED WANTING TO TAKE BENADRYL. 911 WAS CALLED IN THE MEANTIME. WHEN FIRE AND EMS ARRIVED, PATIENT EXPRESSED TO BE FEELING MUCH BETTER AS THE INJECTION SITE SWELLING WENT DOWN. AFTER CHECKING BP, PATIENT STARTED TO FEEL DIZZY AGAIN WHICH RESULTED IN FIRE AND EMS RECOMMENDING PATIENT TO GO TO THE HOSPITAL FOR FURTHER TESTING. PATIENT ACCEPTED AND WAS TAKEN TO HOSPITAL.
Pt devel fever 103, vomited x 2, 1hr later high pitched scream x 20min, fussy & crying all night;
CO SORENESS AT SITE ,REDENESS,STATES UNABLE TO LIFT LEFT ARM TO ABOVE HEAD.
25-year-old female RN was received a flu shot on 09/28/2020. She denies any abnormal placement or sensation during the administration. She tells me that last Wed (10/21/2020) she developed redness and swelling around the injection site on the left arm. She reports that this started with a reduced AROM. She tells me that she had not felt that type of reaction previously. She reports the pain worsened and has since been stable. She denies any fevers but reports a 99+ temp as the highest in the last week.  She denies numbness or tingling. She has been using Tylenol for pain as she is allergic to NSAIDs. On presentation she reports that she had constant pain rated 4/10 while sitting which is described as a dull ache. The pain is worsened with over the head reaching and forward reaching as well as direct pressure. She denies other medical problem and possibility of being pregnant. She Denies any recent illness.
Breakthrough case admission; event occurred after 3rd dose 2/17/21 Moderna Lot# 015M20A 3/17/21 Moderna Lot#002M20A 11/9/21 Moderna Lot# 039F21A
Office practice was to draw up all doses from vial in the morning. They did not routinely do a double check and discarded vial. They used bivalent NDC, lot and expiration that was on a sticky note to enter all data into EMR. At some point they realized that some days they had pulled monovalent and administered instead of the intended bivalent booster. It is impossible to know which vaccine the patient received.
This case meets criteria for vaccine breakthrough review. Symptoms include cough, body aches, fatigue, fever, sore throat and SOB.
Vaccinated 10/1/12 Lot # 1204201 FLUVIRIN Lt. deltoid. 10/3/12 Reports to nurses station c/o redness, tender to touch, edematous arm with lymph node enlargement. Sent to EF. Rx pain med and antibiotic given. Dx "reaction to flu vaccine".
ONset 3 AM post vaccination: rigors, fever up tp 102F, severe HA, body aches, fatigue injection site pain, edema and erythema. Ongoing for the next 24 hours without improvement, then  improved on day 2 post vaccination. Afebrile on day 3 post vaccination,  with resolution of all symptoms but fatigue, mild injection site pain and erythema, and intermittent HA (mild-moderate).
Patient received 0.25mL Moderna booster dose on 11/03/21, even though she had already received a 0.5mL Moderna 3rd dose on 10/20/21. Patient lives in congregate care setting. Patient had no adverse outcomes.
Pt said that in the past she has fainted in the past with other vaccines. Pt was also currently fasting which probably contributed to the episode. Patient was given vaccine and felt fine immediately afterwards, she sat in our immunization room for a few minutes before standing. She then walked to our "waiting area" and sat down. About 5 minutes after, she said she felt dizzy and asked for water. We asked her to sit and would bring her water. Pharmacist (reporter for VAERS) brought water out to her and she fainted in her presence. Pharmacist kept patient upright to prevent her from sliding to the floor. Patient said she has lost vision (was just a bright light). By this point the paramedics have already been called. Patient was feeling much better by the time paramedics came, but they still wanted to check her out to make sure everything was ok. Patient had a long drive back home so not sure what the outcome was.
About 24 hours after the vaccination I experienced swelling at the injection site as well as swelling in my left armpit. About 36 hours after the vaccination I experienced uncontrollable chills and shaking. My menstrual bleeding cycle had just ended before taking the vaccination.  I started experiencing returned, heavy menstrual bleeding within 24 hours of vaccination. And I've now been experiencing 21 straight days of menstrual bleeding, which is highly irregular.
have a cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (have a cold) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (have a cold). At the time of the report, NASOPHARYNGITIS (have a cold) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient was scheduled to get a booster of Moderna Bivalent the day after in afternoon but had a cold.  Treatment medications were not provided.   Reporter did not allow further contact
no adverse event details were provided; expired vaccine administered; This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. Her medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 30-NOV-2021, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024367, expiration date was provided as 08-AUG-2021 however upon internal validation it was established as 06-AUG-2021, at the dose of 0.5 milliliter (strength, route of administration, and anatomical location were not reported) for prophylaxis (expired product administered).  It was stated, that the patient did not have any other reactions or events since the suspect vaccine administration (no adverse event). No other details were provided.
Information has been received from a registered nurse concerning a  12 month old Caucasian female patient who was was vaccinated with the MMRII in the right leg and the first dose of Varivax in the left leg concomitantly. On10/31/01, the patient developed a rash all over and fever of 99.2 to 102 degrees F. The nurse reported that the outcome was unknown. No further information is available.
Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old female patient who was received vaccine MENACTRA lot U6143AA via intramuscular route in the right deltoid on 10-Dec-2018, while she was pregnant. The date of last menstrual period was reported as 10-Oct-2018. The estimated due date is 17-Jul-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (Flu shot) for Immunisation. It was case of vaccine exposure during pregnancy. The patient was pregnant (first trimester) when she received vaccine. It was unknown whether patient experienced any adverse reaction after the injection. Pregnancy outcome was unknown at the time of report. List of documents held by sender- none.
headache, face tingling,arm extra sore. upset stomach (probably my nerves because I was scared to get shot due to losing alot of family to covid19),dizzy- next day
Varivax given in left arm, has large red, hot area below where the needle mark from shot was.  Seen in ED 101208, put on Clindamycin po.  Mom only gave one dose.
Got 2 shots and shingles too / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got 2 shots and shingles too / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient received two doses of Shingles vaccine last year from reporting. The patient stated that the vaccine did nothing to him/her. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Child back for PPD reading--has hot, red area on right upper thigh 110x55mm. temp 98.3, active child, gait ok, area measured. Mom advised Tylenol, cold compresses, Benadryl to return if symptoms worsen.
has not received her 2nd dose; blur vision; heart was racing; her chest hurt; fluttering heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering heart) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer. Concomitant products included OMEPRAZOLE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), METOPROLOL, VALSARTAN, GABAPENTIN (NEURONTIN), LEVOTHYROXINE SODIUM (SYNTHROID), ALPRAZOLAM (XANAX) and VITAMINS NOS for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced CARDIAC FLUTTER (fluttering heart) (seriousness criterion medically significant), VISION BLURRED (blur vision), PALPITATIONS (heart was racing) and CHEST PAIN (her chest hurt). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose). On 13-May-2021, CARDIAC FLUTTER (fluttering heart), VISION BLURRED (blur vision), PALPITATIONS (heart was racing) and CHEST PAIN (her chest hurt) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of cancer and use of concomitant medication are contributory factors to the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of cancer and use of concomitant medication are contributory factors to the events.
Information has been received from a health care worker concerning an 18 year old female patient, with no pertinent medical history and penicillin and erythromycin allergies reported, who on unspecified dates was vaccinated with "the 3 series" of RECOMBIVAX HB (manufacturer unknown) (lot # not reported). Concomitant therapy included birth control pills. On 20-DEC-2010 the patient had tested positive for hepatitis B. There was no treatment given for the adverse event. An enzyme immunoassay HIV antibody screen test (EIA) was performed (results not provided), and a nucleic acid testing (NAT) was performed. Nucleic acid testing (NAT) test was negative. The patient sought unspecified medical attention. At the time of the report the patient's outcome was not recovered. No further information is available because we can't contact the physician.
Symptoms began on 12/24/2021 with body aches, no temperature, dry coughing and lots of chest congestion and phlegm. The body aches went away with in about 4 -5 days. I had a hell of a week. The bad chest congestion stayed for like a month, it got better, and has still continued but not as bad for the next 3 months, my doctor gave me Flonase, Loratadine. This has helped with the symptoms as long as I take it. My doctor did a physical - nothing was done at that point, I just had a little cholesterol. I am functioning well, I feel like it has been in the long hall, I do okay, but not over the congestion so that is not gone.
Left arm swollen, red and warm to touch and a fever. Seen in ER and given Keflex, Tylenol and cool compresses.
After the patient's first Shingrix vaccine on 1/7/19, the patient reported having cold sores around her mouth that developed and resolved within a week after receiving the vaccine. Now, about 12 days after receiving the second vaccine in the series, the patient developed about 15 canker sores inside her mouth. These canker sores were located in all parts of the mouth, but were primarily located where the patient had previous dental work/extractions. These canker sores lasted for about 4-5 days and were very painful, forcing the patient to avoid solid foods during that time. Additionally, the patient also reported to have sharp ear pain and jaw pain during the same time the canker sores were present. The ear and jaw pain also resolved about 4-5 days later.