chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer (friend of patient) on 31-Jul-2017. Additional information was received on 01-Aug-2017. This case involves a 40-year-old female patient who was vaccinated with fourth dose of RABIES (HDC) VACCINE (IMOVAX) (Batch number, route and site of administration were unknown, dose and expiry date were not reported) on an unknown day in Jun 2017. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown and patient's illness at the time of vaccination was none as per reporter. Patient's other vaccinations within 4 weeks of vaccinations was reported as unknown. Concomitant medications were not reported. On an unknown day in Jun-2017, about one week after the vaccination, patient had diarrhea, nausea, vomiting,aches and pains, dehydration, slightly elevated temp, dizziness, general weakness in body, pain, tingling, numbness in hands and feet. On an unknown date, following the vaccination, the patient had pain in hands and feet and tiredness had persisted and she could not go to work. Patient's friend would be taking her to a neurologist Previous doses indicated that the patient was previously vaccinated with three doses of IMOVAX on an unknown date. On 17 Jul 2017, patient required visit to the emergency room (ER) few weeks after. Laboratory investigations were negative for a "virus" and she had a stool culture done that was also negative. Corrective treatment was not reported. The outcome of the events aches and pains, dehydration, pain in hands and feet, nausea, dizziness, general weakness in body, tiredness, tingling in hands and feet, and numbness in hands and feet were reported as not recovered, and the outcome of slightly elevated temperature, diarrhea and vomiting were reported as recovering. List of documents held by sender: none.
Hot, red, swollen arm at injection site. Pt came into pharmacy on 9/19/2015 @3p with un relieved symptoms even after taking hydrocodone, otc pain relievers and applying an ice pack.
Pt tested positive for COVID-19 on 2/10/2021 and died from illness related to COVID-19 on hospice at home on 2/18/2021, per care facility.
Woke up the following day with  propensity to fall followed by headache ; later accompanied by deep aching arm pains : diagnosis was: cervical radiculopathy;  however due to persistence of severe symptoms I sought  second opinion with general neurologist who considered occipital neuralgia , possible migraines;  later on referred me to the headache clinic
Received flu vaccine 9/17/12. Developed generalized itchiness 9/19/12. Still scratching today. No complaint of respiratory distress. Has had flu vaccine without problems in the past. When questioned, has diarrhea when eating eggs.
Rash/bumps on upper lip and side of mouth. Started around 2 days after vaccination, no past events have occured like I had when I took the other vaccines. Hurts to touch, and some weird sensation on the tip of my tongue as well.
sars-Cov-2 nasal swab on 01Sep2021 with result of positive; sars-Cov-2 nasal swab on 01Sep2021 with result of positive; This is a spontaneous report from a non-contactable consumer (patient). This 46-year-old female patient received dose 1 of BNT162B2 (lot number EP6955) via an unspecified route of administration on 07Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunization and dose 2 of BNT162B2 (lot number EP6955) via an unspecified route of administration on 28Apr2021 (at the age of 46-years-old)  as a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not have any known allergies. On 25Aug2021 the patient experienced muscle aches, fatigue, and headache. The events were reported as non-serious. The patient was not hospitalized for the events. The patient underwent lab tests and procedures which included sars-Cov-2 nasal swab on 01Sep2021 with result of positive. The patient did not receive any treatment for the events. The outcomes of muscle aches, fatigue, headache, and sars-Cov-2 were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pityriasis rosea; cold; viral infection; This spontaneous report was received from a consumer via company representative, referring to her son of unknown age.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   On an unknown date, the patient received 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).          On 14-JAN-2022, the patient was seen by pediatrician since it was noted to have vesicles with suspect chicken pox.  The patient was diagnosed pityriasis rosea (pityriasis rosea). The patient also had a cold/virus (nasopharyngitis) the previous week so rash was said to be post viral infection (viral infection).  The outcome of the events and the causal relationship between the events and therapy with varicella virus vaccine live (oka/merck) (VARIVAX) were not reported.
Swelling on the eyes; Body pain; Feeling itchy from head to toe; Headache; Fatigue; This spontaneous case was received on 19-Oct-2023 from a other non-healthcare professional (consumer) via Company (reference number: SEQW23-03584) and concerned a 70-year-old, female patient.  The patient's concurrent conditions included asthma, hypertension, osteoarthritis, osteoporosis, migraine, and some problems with allergies. The patient's concomitant medications included metoprolol, Claritin (clarithromycin), unspecified nasal spray and unspecified inhaler, all used for unreported indications.  On 17-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.    On 18-Oct-2023, one day after receiving Flucelvax Quadrivalent, the patient woke up feeling itchy from head to toe, had swelling on the eyes, headache, body pain and fatigue. The patient received treatment with Claritin, Benadryl (diphenhydramine hydrochloride) and acemetacin.  At the time of initial reporting, on 19-Oct-2023, the patient had not recovered from the events. As reported, the patient was still having symptoms.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 70-year-old patient developed eye swelling, general body pain, pruritus, headache, and fatigue one day after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 70-year-old patient developed eye swelling, general body pain, pruritus, headache, and fatigue one day after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Information has been received regarding a case in litigation concerning a male who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast).  Within weeks of a vaccination with hepatitis B virus vaccine rHBsAg (yeast) the patient developed numbness of his right thigh which was reported to be the signaling of the onset of multiple sclerosis (MS), "placing the timing within what was considered accepted for causation of a demyelinating injury".  It was reported that, at an undisclosed time, the patient had undergone human leukocyte antigen (HLA) typing which noted that he was prone to developing MS.  It was reported that the patient had two types of genetic problems making him susceptible to developing MS, Tr at 91.  In addition the patient's mother has had autoimmune diseases, thyroid and psoriasis.  The patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) on 11 MAR 1997, and subsequent doses on 09 APR 1997, and 08 AUG 1997.  On 18 APR 1997 the patient complained of a swollen lymph node (unspecified location).  On 3 NOV 1997 the patient was seen by a physician regarding complaints of diminished vision in his left eye associated with pain when moving the eye.  The patient was diagnosed with mild optic retrobulbar neuritis.  On 4 NOV 1997 the patient underwent an evaluation at the division of neuro ophthalmology, and the MRI of the brain was consistent with a demyelinating process.  On 16 JUN 1998 the patient reported the thigh numbness to a neurologist.  Further information is expected.
Pt's mother reported patient had wheezing for 2 days after receiving Flumist.  Used prn Proventil inhaler several times.  Wheezing did not progress; no MD follow-up required.
Myalgia Leg muscle cramps, abdominal cramps, injection arm pain. Narrative:
FACE, MAINLY FOREHEAD RIGHT SIDE OF EYE, BOTH CHEEKS, LIPS AND CHIN FEEL LIKE A SUNBURN AND TINGLING FOR THE LAST 28 DAYS. WORST SOME TIMES THAN OTHERS. WORST IS AFTER  TAKING EVENING PILLS. ENTIRE FACE FEELS LIKE IT IS ON FIRE.
I developed rashes on both of my arms and lower neck area. I was out in the sun the day before (May 1st) for about 3 hours and did not use sun screen. I normally do not get rashes on my skin even if I got sun burned. This was the first time I got rashes after being in the sun for a couple hours. It did not disappear for 2 weeks until I was prescribed and applied the medicine. It may be coincidental that I got my covid-19 shot a few days earlier when this happened, but I just want to report just in case others reported the same situation.
About five minutes after injection, patient began to lose consciousness. Blood pressure dropped and patient sweated profusely. Pulse was also very low. Patient was difficult to rouse for several minutes. Mother is a medical professional and she was monitoring patient. EMS was called and patient evaluated about 10 minutes after injection. At that time patient was coming around but still very pale with low blood pressure.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment details was not reported by the reporter.
Angioedema; Urticaria; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 25-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant) and URTICARIA (Urticaria). At the time of the report, ANGIOEDEMA (Angioedema) and URTICARIA (Urticaria) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ANGIOEDEMA (Angioedema) and URTICARIA (Urticaria) to be related.    Concomitant and treatment medications were not reported.  Company comment: This literature non study case concerns a 25 years old male with no medical history, who experienced the unexpected serious (medically significant) event of angioedema, which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serous event urticaria is also reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature non study case concerns a 25 years old male with no medical history, who experienced the unexpected serious (medically significant) event of angioedema, which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serous event urticaria is also reported. . The benefit-risk relationship of mRNA-1273 is not affected by this report.
About an hour after receiving the second dose, I became severely lethargic and started having chills.   Symptoms lasted about 20 hours.  Woke up and bed was completely saturated with sweat.
Developed per pt report, low grade fever, body aches and chills, evening of Dec 1 flu shot remained ill for several days. Did see PCP no influenza testing, given no dx per pt. No meds for this. No dehydration. No hospital visit. X 3days.
On the evening of 10/7 had bad headache on right side. Usually don't get headache. Bad cough started days later. Had really bad throat; so bad that it was hard to swallow. On 10/7 saw doctor who prescribed cough medicine with codeine and 5 day antibiotic. After finishing antibiotics did not feel much better. Headache and sore throat were gone but cough remains. When the vax was administered felt pain going down right side in back. Told nurse who was surprised to hear about it. Yesterday pain in the right scapula started. It has been hard to walk with crutches. Today has appt with doctor to follow-up pain in back which still hurts.
Patient was admitted on 7/3 for PLTCS 2/2 Prelabor rupture of membranes with baby in breech presentation. She was taken to the OR. One minute apgar of 3 and five minute apgar of 9. She was found to have uterine fibroids during the case. The procedure was complicated by postpartum hemorrhage with blood loss of 1334mL. Patient's hgb nadir down to 7.2; she was asymptomatic. Patient as given IV Venofer x2 doses. She was discharged on post operative day #2 in stable condition. She was prescribed iron sulfate 325mg TID for her anemia.
PT REPORTED NUMBMESS/TINGLING ON LEFT SIDE 1 WEEK POST VACCINATION. ALSO HAD BLURRED VISION
blurred vision; shortness of breath; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision), DYSPNOEA (shortness of breath) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (blurred vision), DYSPNOEA (shortness of breath) and FATIGUE (fatigue). At the time of the report, VISION BLURRED (blurred vision), DYSPNOEA (shortness of breath) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
JANSSEN COVID-19 VACCINE ADMINISTERED AFTER BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS; JANSSEN COVID-19 VACCINE BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced janssen covid-19 vaccine administered after being at room temperature for over 2 hours. On 18-MAY-2021, the subject experienced janssen covid-19 vaccine being at room temperature for over 2 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the janssen covid-19 vaccine administered after being at room temperature for over 2 hours and janssen covid-19 vaccine being at room temperature for over 2 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545147.
Fever, chills, nausea, vomiting, redness and inflammation at the vaccine site
I began developing hives all over my body and swelling on my lips and eyes. When it was especially bad I would feel it internally in my chest, like I had swallowed a pill that got stuck at the base of my throat. The hives and swelling were always worst in the morning and would migrate by the next day. It got worse when I did not sleep enough or drank alcohol, but still occurred even without these triggers. My reactions peaked May into June where my hives got so bad at points that I couldn't move my hands - as if my hands were just two giant hives. When I had bloodwork done my inflammation numbers were off the charts, but nothing else was abnormal. I began on a regimen of steroids (only 4 days) and antihistamines (consistently) that moderated but did not stop my reactions. By late July it was mostly under control, with hives showing up roughly once every 1-2 weeks. Since then the longest period I've gone without a flare up is 1 month. It seems to get worse around my menstrual cycle. I am now only taking the antihistamines as needed when I wake up with hives or swelling.
Had covid; Pneumonia; having pain it feel like a razor blade sticking through his back; Feels like he has the flu; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (Had covid) in a male 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.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Had covid) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced INFLUENZA (Feels like he has the flu). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and BACK PAIN (having pain it feel like a razor blade sticking through his back). The patient was hospitalized on 12-Mar-2021 due to COVID-19, and then on 12-Apr-2021 due to PNEUMONIA. The patient was treated with IBUPROFEN for Flu, at a dose of 1600 mg once a day. At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (Had covid), INFLUENZA (Feels like he has the flu) and BACK PAIN (having pain it feel like a razor blade sticking through his back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Oxygen saturation: 75 % (Low) 75%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. Patient stated that he was treated with oxygen support during hospitalization.  On 12-Mar2021, patient had covid and was in hospital on oxygen. Patient was released and went back in the hospital for 4 days with covid an pneumonia. Patient went back to hospital on 12-Apr-2021 and was put on oxygen and was told his oxygen level was 75 percent. Patient stated since 12-Apr-2021.  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.
15 year old received SHINGRIX; received SHINGRIX instead of Meningitis vaccination.; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 15-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were reported as follows: The Glaxosmithkline account manager called to report that  patient received SHINGRIX instead of Meningitis vaccination, which led to inappropriate age at vaccine administration and wrong vaccine administered. No further details were provided at the time of the call. The reporter consented follow-up. This case was linked with USUS2021214417, Reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021214417:same reporter
No adverse event; Patient received the vaccine past the beyond used date; Accidental underdose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine past the beyond used date) and ACCIDENTAL UNDERDOSE (Accidental underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine past the beyond used date) and ACCIDENTAL UNDERDOSE (Accidental underdose).    Case included information of 5th patient out of 6 reported patients.  No concomitant product reported by reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-705086 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705086:Master
Hives all over body. Pt states they were itchy, initially thought he  had gotten into Poison Ivy. Pt proceeded to take hot shower and then cold shower and used Calamine Lotion. Pt states total reaction lasted approximately 1.5 days.