chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient arm got dark like a bruise around injection site, and red around that. was red and warm on upper arm.
Staff infection; Shingles; Rash; Fever; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Staff infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced STAPHYLOCOCCAL INFECTION (Staff infection) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), RASH (Rash) and PYREXIA (Fever). On 05-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, STAPHYLOCOCCAL INFECTION (Staff infection) had not resolved and HERPES ZOSTER (Shingles) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  On 23 Apr 2021, second dose was scheduled.  Company comment: 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. Further information has been requested.; 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. Further information has been requested.
5AUG94 mom noticed raised blotches red in color; started out light in color ranging in size from 1 cm to 6cm in diameter; appeared on upper body including face & scalp; faded that same day; pt was also irritable;
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 26-MAR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported having minor reaction to vaccines previously, itching and mild swelling of lips, that resolved with Benadryl and no other medical intervention. Patient also reported that she had taken 25mg of Benadryl PO prior to arriving in office. This nurse instructed patient to stay for observation post vaccination to monitor for reaction due to previous reactions. Within 10 minutes of varivax administration patient began to have mild allergic reaction, redness and itching of upper chest, mouth itching. No swelling was noted. Per the physician who was in clinic, gave patient 25mg of liquid Benadryl PO. Itching and redness resolved within 10 minutes of Benadryl administration. Patient observed in office for 15 additional minutes before leaving of her own accord. Instructed patient to call EMS or go to Emergency room if symptoms return. Patient agreeable.
Not getting 2nd dose; Left breast is swollen; Shortness of breath; Loss of smell; Loss of taste; Lost a lot of weight; diarrhea; She can't lift arm, can't do all the things she used to be able to do; Left breast is very painful; She is afraid; Swollen lymph of nodes; Muscle fatigue; Lump at injection site; heart beats quickly; Headache every night; Feels like she is wasting away; This spontaneous case was reported by a consumer and describes the occurrence of CACHEXIA (Feels like she is wasting away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced CACHEXIA (Feels like she is wasting away) (seriousness criterion medically significant), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful),  FEAR (She is afraid), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), INJECTION SITE MASS (Lump at injection site), HEART RATE INCREASED (heart beats quickly), and HEADACHE (Headache every night). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK. At the time of the report, CACHEXIA (Feels like she is wasting away), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), HEART RATE INCREASED (heart beats quickly), INJECTION SITE MASS (Lump at injection site) and HEADACHE (Headache every night) had not resolved and FEAR (She is afraid) and PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Heart rate: increased (Inconclusive) heart beats quickly.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.        Concomitant product use was not provided by the reporter.; 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. Further information has been requested
Patient was inadvertently administered an HPV9 vaccine instead of a flu vaccine. Patient was monitored for 60 minutes without exhibiting any adverse effects. Medical personnel contacted medical assistance, poison control, and infectious disease at who advised that there is no risk of short or long term complications. Literature was obtained to this effect and was sent to family.
Information has been received from a physician concerning a 21 year old female patient with anxiety who on 24-MAY-2010 was vaccinated with the first dose of GARDASIL (lot number not reported). The patient past out shortly after the vaccination. The patient's condition improved on therapy. No medical attention was sought. On 24-MAY-2010, the patient recovered.
sore arm (unable to lift without aching/hurting) for 2-3 days (improved each day, worst the day after vaccination) chills, low grade temp of 100.4F (went down with Tylenol), malaise, myalgia for one day starting the day after vaccination (Sunday evening and resolved by Monday morning)
2 days after the shot I developed left  arm pain from the elbow to the armpit as well as stiffness and sore left knee (this was a knee replacement done in May of 2020). On sept 21 I had increased arm pain and chest pain.  I was treated for elevated Triponin levels and was told I had an NSTEMI and myocarditis as well as multi inflammatory disease.
Rash on face, neck, upper trunk started 7 p.m. 3/7/12. Itching and facial flushing, blotches a.m. 3/8/12. By 3/9/12 itching, rash and blotchiness lessened.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil", notes: Known allergies: Cefzil; Percoset, reaction(s): "Known allergies: percoset". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Unusual, severe, high pitched crying for more than 1 day on & off w/fever of 101 now resolved;
Saturday around 1PM after child received both meningitis immunizations, her sugar dropped to 54 and she was difficult to arouse, dilated pupils, severe confusion, and paleness. After giving her 10oz of milk and 4 Reese cups, her sugar came up to 84 and she was able to answer basic questions and respond to basic commands. I did have her eat a meal afterwards and continued to monitor her sugar throughout the rest of the day, and had her eat every 4-6 hours, which her sugar stayed above 85.
This case was reported by a consumer (also the subject) and described the occurrence of strange feeling in throat in a currently 42-year-old female subject who was vaccinated with Flu vaccine (Unknown Manufacturer). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to fish and allergy to molds. In 2010, "approximately one year ago", the subject received a dose of Flu vaccine (unknown route). Less than one year after vaccination with Flu vaccine, the subject experienced strange ("weird") feeling in throat. The subject was treated with BENADRYL. At the time of reporting the outcome of the event was unspecified. The subject reported events with flu shot on 03 November 2011. See A0952703A for details regarding the first report case.
Swollen Lymph nodes under left armpit and left supraclavicular. It started from 3 days later after the injection, for the first 3-5 days, the armpit nodes were hurt, but then the pain ended. However, till today, there are still one mode under left supraclavicular and two nodes under left armpit that are not completely back to normal.
7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not had patient details at the time of reporting.  The reporter did not know dates of administration. The reporter consent to follow up. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This case is 1 of 7 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR136362:Same reporter. US-GSK-US2022AMR136361:Same reporter. US-GSK-US2022AMR136348:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136363:Same reporter US-GSK-US2022AMR136360:Same reporter.
PATIENT RECEIVED 0.3 ML OF UNDILUTED PEDIATRIC PFIZER BIVALENT BOOSTER, EQUIVALENT TO 42.85 MCG INSTEAD OF 30 MCG. Patient reports no notable adverse effects .
Swelling, redness, warmth in left upper arm - area of injection local reaction. DTaP and IPV in left arm, MMR in right arm.
On day 5 after vaccination my lymph node in the shot arm became very tender and inflamed. On day 7 my arm at injection site became hot, itchy, swollen and tender.
Arm pain; Fever; Cough; Headache; Sneezing; Fatigue; Congestion; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever), COUGH (Cough), HEADACHE (Headache) and SNEEZING (Sneezing) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011J12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever), COUGH (Cough), HEADACHE (Headache), SNEEZING (Sneezing), FATIGUE (Fatigue) and NASAL CONGESTION (Congestion). At the time of the report, PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever), COUGH (Cough), HEADACHE (Headache), SNEEZING (Sneezing), FATIGUE (Fatigue) and NASAL CONGESTION (Congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
swelling/tingly on her right facial cheek; swelling/tingly on her right facial cheek; This is a spontaneous report from a contactable Other HCP (patient). This 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 21Jan2021 for COVID-19 immunisation. Medical history included rosacea. Concomitant medication was not reported. Patient received vaccine on Thursday and had been experiencing swelling/tingly on her right facial cheek.  She saw both her PCP and dermatologist and has a history of rosacea.  Her dermatologist told her to take cetirizine hydrochloride (ZYRTEC) for a week. Patient asked if this was a reported side effect, the efficacy after one dose; if could get second dose after having a reaction to the first vaccine; efficacy against other variants of the virus; information on rosacea/ autoimmune patients. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Muscle spasms that started in legs and have moved to the rest of the body. Spasms are severe and have not gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (Lot number: EW0164) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Walnuts" (unspecified if ongoing), notes: Known allergies: Walnuts; "Known allergies: Cyprus trees" (unspecified if ongoing), notes: Known allergies: Cyprus trees. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin.  The following information was reported: MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "not recovered", described as "Muscle spasms that started in legs and have moved to the rest of the body. Spasms are severe and have not gone away". The events "muscle spasms that started in legs and have moved to the rest of the body. spasms are severe and have not gone away" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms.  Additional information: The patient did not receive any other vaccine in four weeks. He received supplements. He did not have covid prior to vaccination and was tested for covid post vaccination. The patient was not hospitalized. The device date was 23Jul2022.
First pregnancy with fetal abnormalities and complications; no hx of risk factors; genetic screenings normal; estimated date of delivery 15 July 2022; fetal demise detected at 28 weeks 5 days gestation; delivered 27 Apr 2022 at 1 lb 10 oz
no additional AE; HCP called to report that a small amount of  PEDVAXHIB got into her eye as she was drawing the product for a patient.; This spontaneous report has been received from a 42-year-old female licensed practical nurse referring to herself. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not reported. Drug reactions or allergies were unknown at the time of call.  On 10-JUL-2023, a small amount of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) got into the nurse's eye as she was drawing the product for a patient (0.5mL, lot# W028534, expiry date 10-MAY-2025, strength and route were not reported) (occupational exposure to product). The nurse was completely fine after flushing her eyes. The nurse noted no additional adverse event or PQC. The nurse had sought for medical attention. The nurse stated that there was no information in leaflet about topical exposures to the product, and she stated that information should be in there.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a mild case of chickenpox. It started on her back, spread to trunk and legs, 30 ruptures,; sore throat; duration 4-5 days. The pt also experienced a fever of 100.5.
Patient admitted to hospital on 4/5 for neutropenic sepsis, cellulitis shoulder at site of covid vaccine.
About 1 week in started to get numbness and tingling in hands and feet.  On the 2 week mark my forearms and calves were constantly "crawling" with a tingling sensation.  Noticed finger tips could no longer feel extreme heat or cold.  Saw Dr. fearful of clot issues, but he advised it would not be in all four extremities and then asked if I saw the other J&J side effect of GBS.  I did not see the August reports of  "about 100" with this side effect.  I lived the next 2 weeks in fear would this progress. Thankful now I'm 5 weeks out and my forearms and calves are back to normal, but hands and feel remain agitated with less sensation and the tingle sensation coming and going. This never happened to me before the J&J shot.
Woke up with muscle spasms all over body, body would stiffen. Also had a warm sensation come over my body from bottom to top, then severe nausea. I would then vomit and have diarrhea at the same time. This went on for 2-3 hours. I couldn?t keep anything down(sips of Gatorade or water). I got so weak I couldn?t walk or hold my head up. My husband had to put me back in bed. I?m scared to take the 2nd dose.
At the time of the injection I could tell it hurt my son (7) as the shot went into his thigh. I could see the pain on his face. My daughter(4)  had the same flu shot and her face did not show any signs of pain. After a few hours, he was unable to walk or put weight on it. He was in pain. His whole thigh was swollen and  bright red/pink red. It was also hot to the touch. This lasted 3-4 days.
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received First dose bnt162b2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and Concomitant medication were not re-ported. On an unspecified date, patient reported that he tested positive for covid after he got the 1st dose. Outcome for events was unknown.
- Localized injection site reaction (redness, swelling, bruising in arm administered in left arm) at injection site - 5 min after vaccine. - Took a BENADRYL 1st used ice pack, swelling went down.
This case was reported by a pharmacist via call center representative and described the occurrence of benign mucous membrane pemphigoid in a elderly female patient who received SHINGRIX (batch number 992H3, expiry date 31st May 2021) for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced benign mucous membrane pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the benign mucous membrane pemphigoid was unknown. It was unknown if the reporter considered the benign mucous membrane pemphigoid to be related to SHINGRIX. Additional details were provided as follows: The patient on an unknown date was recently diagnosed with pemphigoid of gingival mucosa, an autoimmune disease. The patient did not feel that this was due to SHINGRIX.
Patient awoke from pain from shoulder down to forearm at 9am the morning after her vaccine. She described it as "absolute misery" and she had less than 5% range of motion in her arm. She was transported to a hospital where she was released on 6/26/21 at 4pm. She said she also experienced minor nausea.
Complaint of sore/scratchy throat, runny nose/congestion, lose of taste and smell, myalgia and malaise
Moderna Bivalent vaccine vial had a beyond use date of 5/18/2023. Vaccine was retrieved from the refrigerator and administered on 5/25/2023. Monderna healthcare team determined that the vaccine still maintained enough activity to provide protection against Covid-19.
Went to bed early feeling very tired. Woke up about 2 am with vertigo, nausea, vomiting and feeling very weak. Unable to walk to bathroom. Called 911 and went to ER. Day 2 and 3 still very tired.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 32 hours and the lowest recorded temperature reported as 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.