chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. No information regarding patient's concurrent conditions, medical history and concomitant therapies was reported. On 04-APR-2017, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, lot# and expiration date were not provided). On 05-APR-2017, the patient experienced a large swollen area appeared around injection site that was warm to the touch and itchy. The pharmacist instructed the patient to put a cool compress on the area as a treatment. The outcome of the adverse events was unknown. The causality between the events and ZOSTAVAX was not provided. Additional information has been requested.
Painful injection site with redness and warmth distal to the injection site with swelling. No red streaking. Local reaction to pneumonia vaccine. Treatment with PREDNISONE 20mg QDx3 days and rest right arm.
red 1" painful circular area developed / Near but not including actual injection site; red 1" painful circular area developed / Near but not including actual injection site; red 1" painful circular area developed / Near but not including actual injection site; initial red area turned purple and lighter red area; Painful and itchy; Painful and itchy; Lymphadenopathy in armpit; shaking; chills; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 11:15 (Lot number: FJ1620) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Past drug history included: Amoxycillin for Known allergies: Amoxycillin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 31Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 10Mar2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 11:15, outcome "unknown", described as "booster dose"; ERYTHEMA (non-serious), PAIN (non-serious), VACCINATION SITE REACTION (non-serious) all with onset 01Dec2021, outcome "not recovered" and all described as "red 1" painful circular area developed / Near but not including actual injection site"; SKIN DISCOLOURATION (non-serious) with onset 01Dec2021, outcome "not recovered", described as "initial red area turned purple and lighter red area"; PAIN (non-serious), PRURITUS (non-serious) all with onset 01Dec2021, outcome "not recovered" and all described as "Painful and itchy"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Lymphadenopathy in armpit"; TREMOR (non-serious) with onset 01Dec2021, outcome "not recovered", described as "shaking"; CHILLS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "chills". The events "red 1" painful circular area developed / near but not including actual injection site", "red 1" painful circular area developed / near but not including actual injection site", "red 1" painful circular area developed / near but not including actual injection site", "initial red area turned purple and lighter red area", "painful and itchy", "painful and itchy", "lymphadenopathy in armpit", "shaking" and "chills" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of erythema, pain, vaccination site reaction, skin discolouration, pain, pruritus, lymphadenopathy, tremor, chills.  Additional information: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Pain where shot was given. Fever from 99.4 to 101.2 for 24 hours. Headache. Tiredness. Achy.
Received vaccine on Wednesday, January 13, 2021, at 11:40 AM.  Had severe, shaking chills at 2:30 AM Thursday   Had elevated temperature all day Thursday (ranging from 100.4 to 99.8).  Woke up Friday morning with normal temperature and feeling well.  Have had no further events or ill feeling.
a lot of pain; numbness on her whole left side of her body; numbness in her leg; having trouble walking; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (a lot of pain), HYPOAESTHESIA (numbness on her whole left side of her body), HYPOAESTHESIA (numbness in her leg) and GAIT DISTURBANCE (having trouble walking) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (a lot of pain), HYPOAESTHESIA (numbness on her whole left side of her body), HYPOAESTHESIA (numbness in her leg) and GAIT DISTURBANCE (having trouble walking). At the time of the report, PAIN (a lot of pain), HYPOAESTHESIA (numbness on her whole left side of her body), HYPOAESTHESIA (numbness in her leg) and GAIT DISTURBANCE (having trouble walking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported  No Treatment medications were reported
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 30-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 with expiry date: unspecified for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012656 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014705:
A consumer report has been received. The report concerns a patient, female consumer, who had been receiving FLUMIST Quadrivalent (intranasal) 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. Reporter stated that the pregnant patient, 1 month to full-term, was administered FLUMIST. The outcome of he event of pregnant patient, 1 month to full-term, was administered FLUMIST is unknown. The report was considered to be non-serious.
Case received second Moderna booster at 0815 on morning of 04-11-22; She states she had a very busy day afterwards and that she was "pushing herself" around the time she was in her basement cleaning when she suddenly felt very dizzy and felt like she was going to pass out.She also felt hot and she had sweat on her forehead.She is unable to state exactly how long this lasted. She did not pass out and the faint feeling began to ease as she lowered herself to the floor.She  got herself up the stairs by taking one step at a time  in a sitting position.She checked her pulse which was 102 (slightly elevated for her).As she was continuing to feel better she decided she did not need medical help. Case upset about this  as she is very active in her daily life and has never had any side effects to any vaccine.
I began having heart palpitations on 4/7/2022, which was 4 days after I received my second Moderna booster. I saw my PCP on 4/19/2022. The PCP confirmed that she had detected premature ventricular contractions (PVCs), and she ordered bloodwork and an echocardiogram. She also instructed me to wear a heart monitor for three days. I did not receive the heart monitor until 4/27/2022, and I mailed it back on 4/30/2022. I never got the echocardiogram, because it wouldn't be possible to get an appointment until June. Regarding the bloodwork, my sodium was low, so my PCP had me restrict my fluid intake. The PVCs continued, and on the weekend of May 13-15, I felt like I was having angina pains. On 5/16/2022, I went to the emergency room. I was evaluated, and all the test results were either normal or stable. Even though I was still having PVCs, the doctor thought that my condition was stable and referred me to a cardiologist for further evaluation. My appointment with the cardiologist is on 5/25/2022. At the time of this writing, I continue to have PVCs intermittently on a daily basis.
Patient was seen and examined. She was getting chemotherapy today with taxol and incidentally noted to have O2 desat to lowest of 89% for a brief second then comes back up to ~93. Her Heme/Onc physician was concerned for PE and asked that she be evaluated in ER. She was never symptomatic.  In ER CTPE was negative and no other acute cardiopulmonary issues were identified.  She had COVID19 about 3 weeks ago with mild symptoms and remains with nasal congestion.
Received vaccine at 1130. By afternoon left arm became warm to touch, reddened, and tender to touch. Symptoms worsened by evening. Took codeine 20mg for pain. Called doctor given Prednisone 60mg for 4 days.
Erythema, induration along medial arm, biceps which began within 24.  Some spread noted overtime.  No associated fevers.
Have noticed a lot of sneezing, itching skin all over body (face, neck, arms, legs, stomach, underarms). It feels as though I have bumps all over skin, but not visible. Slight cough which causes itching/burning sensation on inside of throat/ears.
This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown date on or after 05-APR-2016, the patients were vaccinated with improperly stored doses of VAQTA which had lot #L043209, expiry date: 17-SEP-2017 (dose and route not reported). The vaccine was exposed to temperature of 34 degree Fahrenheit for 3 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Patient complained of severe pain at injection site, all down her left side especially around left back blade and around to front left breast. Patient felt fuzzy, she felt she could not think, Patient is starting to feel better today 3/31/18.
One day post-vaccination with JE-VAX, client's arm was swollen, red, and itchy from elbow to shoulder and felt hard to the touch. Topical benadryl during daytime and oral benadryl at night time did not relieve symptoms. Client spoke to pharmacist at her health insurance provider 2 days post-vaccination, who advised her not to receive additional doses of JE-VAX but that she could consider trying new IXIARO vaccine for Japanese Encaphalitis if doses become available before travel. 9 days post-vaccination, client's arm is still tender to touch but redness, itchiness, and swelling have been relieved. A small bruise at the injection site, square in shape, is still visible. Hepatitis A dose #2 vaccine was given IM in same arm on same day, with no soreness or side effects.
The patient was diagnosed with postherpetic neuralgia; Patient developed bronchitis; Suffered a painful and debilitating shingles outbreak across her face, in her ears, and around her eyes; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 17-OCT-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a painful and debilitating shingles outbreak across her face, in her ears, and around her eyes. These injuries persisted for weeks and the pt was diagnosed with postherpetic neuralgia. Additionally, the pt developed bronchitis. It was also specified that the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were caused by zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling due to serious, permanent and incurable injuries.
NECK PAIN; PAIN IN LEGS, PAIN IN ARMS; MUSCLE WEAKNESS; PAIN IN KNEES; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced neck pain, pain in legs, pain in arms, muscle weakness, pain in knees, tiredness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, pain in knees, pain in legs, pain in arms, neck pain, tiredness, and muscle weakness. This report was non-serious.
Upon pt receiving TD injection in left deltoid. Pt left tingling "headrush" feeling. Felt "moderate" pain upon returning to her unit. c/o soreness @ x s 1 week post injection
Vaccine was administered 26 days after the "use by" date. No adverse reactions. Patient was contacted about the error and reports no adverse reactions.
bipolar disorder; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult (reported as mid to late 20s) male patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history was reported as "there may have been signs of bipolar issues well before the disease was recognized, just as a note, not 100% sure." It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccine. The patient's concomitant medications were not reported. The following information was reported: BIPOLAR DISORDER (hospitalization), outcome "unknown", described as "bipolar disorder". Therapeutic measures were taken as a result of bipolar disorder. The patient was diagnosed with bipolar disorder. There were several events that led to this, including hospitalization for some days due to episode. The reporter believed hospitalization event may have been early 2021 but was unsure. The reporter believed the patient was potentially diagnosed post-vaccination. The reporter did not  know dates of vaccination for the patient but believed he was definitely at least fully vaccinated now. The reporter was not exactly sure which vaccine was received and what dose. The reporter believed the patient had more recently been trying different medications or had been in the process of finding a good one with least negative effects.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow-up.
breast tender; Right breast nipple very itchy; breast felt a bit full; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 06Feb2021 at 16:15 (at the age of 70-year-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6202) via an unspecified route of administration in the right arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history included menieres disease and the patient was allergic to iodine, sulfa antibiotics, shellfish, fish, mushrooms and animals. Concomitant medications included triamterene/hctz (hydrochlorothiazide) 37.5/25 (unit unspecified) (MANUFACTURER UNKNOWN), travoprost (TRAVATAN), timolol (BETIMOL) and levocabastine hydrochloride (ZYRTEC) for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021 (3-4 days after vaccination), the patient experienced right breast nipple very itchy and then tender. The breast felt a bit full and slightly tender. It was reported that, the patients symptoms were improved, then felt of fullness and tenderness in right breast again after second dose. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events itchy, breast heaviness and breast tenderness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sunday 1/24/21 developed sudden headache on the left occipital area that progressively got worse over the next 24 hours. Developed tingling on the left side of my face and near the left eye. That Monday evening, I felt tender bumps on my scalp and I had swelling on the back and side (left) of my scalp. The headache progressed from the occipital area to the side and front of my head, took Tylenol and Ibuprofen and neither helped. That Tuesday went to the ER. They confirmed I had shingles. I was evaluated by an ophthalmologist in the ER, there was no shingles in the eye. I was placed on a 2 week course of Valtrex and 6 week course of steroid taper, gel pack.  Follow with ophthalmology clinic 2 weeks later and was cleared.
fever, body aches, headache, sore throat, cough, chills, nasal congestion, sinus congestion, post nasal drainage. starting 12/26/21
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/20/21 pfizer,Lot#EK5730 2nd dose 01/08/21 Pfizer,lot#EL3248 Diagnosed covid positive:08/03/21 Symptom onset:08/03/21 Exposure:Travel Symptoms:Fever, cough, fatigue,muscle aches,nausea/vomiting
Pt was not given a full dose of 0.5ml.  administering pharmacist is certain at least 0.25ml (half the dose) was administered
Information has been received from a physician concerning a 12 year old female who was recently IM vaccinated with GARDASIL (lot number 655208/1426F). Subsequently the patient felt woosie. While the patient was in office, she started to have some mild dizziness which she recovered from. However, at home, she complained of increasing dizziness and was unable to get out of bed all evening. The patient recovered on 05-Apr-2007. No other information was available.
Burning on left leg started 3/10. By 3/16 rash developed on torso. Confirmed as shingles on 3/18.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site burning in an unspecified number of patients who received HAVRIX for prophylaxis. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. It was unknown if the reporter considered the injection site burning to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist noted that he had seen some burning at the injection site for HAVRIX in a few patients. The practice area for the pharmacy was in a high Hepatitis A outbreak area, and the pharmacy was giving out more injections of HAVRIX that before. The reporter was from the GlaxoSmithKline outbound vaccines service center. He was notified last night during an outbound sales call to the pharmacist. There was no QA to report. This case has been linked with case US2018143555, reported by same reporter.
This spontaneous report was received from a pharmacist and refers to a 66 year old female patient with no drug reactions or allergies. The patient's pertinent medical history included asplenia. On 09-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L028281, expiration date: 28-OCT-2016, dose 0.65 ml, subcutaneously. There was no concomitant medication. On 10-NOV-2015, the patient was not feeling well and went to see her physician who diagnosed her with internal shingles. The physician informed the patient that she ended up with internal shingles because of her preexisting disease - asplenia. The physician prescribed acyclovir 800 mg as a treatment for the patient. The outcome of the events was reported as recovered on an unknown date in November 2015. The relatedness between the events and ZOSTAVAX was not reported. The event of internal shingles was considered to be life threatening by the reporter because the doctor told the patient that if it was left untreated it could have gone to her brain. Additional information has been requested.
Sore, puffy underarm, same side that was vaccinated.  Swollen lymph node.
Injection site reaction to deltoid, erythema, edema, warmth to site, possible cellulitis
High fever fatigue 48 hrs. Then low fever etc. For 4 days. Then face numb since and continues. Had face numbness after 4/24 shot but wasn't sure if related as slowly got better but back quickly and worse after booster.
Peds Pfizer vaccine given to patient without dilution. Patient monitored 15 min for any signs or symptoms of reaction. None observed. Patient discharged home with parent.
Pt waited 15 minutes after her dose with no issues.  She came back after 30 minutes and said one of her legs was itching.  She said it felt like a skin irritation but had no rash or redness.  She didn't have any other symptoms.  I offered her some diphenhydramine and to wait in the pharmacy, to go home and take DPHM or to present to the ER.  She chose to go home and take DPHM.  I advised to make sure that someone was home with her and to present to the ER if she has any other symptoms.   We followed up with her the following day and she was not having any more issues.  She had taken 2 doses of DPHM.
Pain in right arm to start followed by chills and tiredness. The next day much the same. Now 3 days later still feeling nausea and fever and chills.
Information has been received from a physician who vaccinated another female physician with zoster vaccine live (Oka/Merck). Subsequently the physician developed mild hematoma and swelling at the injection site, high fever and chills. This one of several reports received from the physician. Additional information has been requested.
Pt came into office today due to rash and lab work - noted by PCP to have petechial rash on injected arm from area of injection down to hand.   pt reported this started about 1 day after injection and is present today when reported to PCP.