chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a male patient of unknown age regarding himself. The patient's medical history was not reported. In 2010 (Reported as about 10 years ago) the patient was vaccinated with first dose of ZOSTAVAX. No adverse reactions were reported after the first shot of ZOSTAVAX. On an unknown date the patient was vaccine with second shot of ZOSTAVAX as a booster. On an unknown date patient experienced his body as hot, sick to stomach and felt awful. The patient stated that he felt like it was going to kill him. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
It moved bad through her body, and it lasted one week until it was gone.; had an allergic reaction, she had a serious reaction, I'm allergic to it; was really sick; More than 35 days after the first dose without receiving the second dose; her full body had a total rash, had a full body rash from her neck to her ankles.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (her full body had a total rash, had a full body rash from her neck to her ankles.), RASH (It moved bad through her body, and it lasted one week until it was gone.), HYPERSENSITIVITY (had an allergic reaction, she had a serious reaction, I'm allergic to it), ILLNESS (was really sick) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (her full body had a total rash, had a full body rash from her neck to her ankles.). On an unknown date, the patient experienced RASH (It moved bad through her body, and it lasted one week until it was gone.), HYPERSENSITIVITY (had an allergic reaction, she had a serious reaction, I'm allergic to it), ILLNESS (was really sick) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (her full body had a total rash, had a full body rash from her neck to her ankles.), RASH (It moved bad through her body, and it lasted one week until it was gone.) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved and HYPERSENSITIVITY (had an allergic reaction, she had a serious reaction, I'm allergic to it) and ILLNESS (was really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took Over the counter vitamins supplement concomitantly.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016, from health professional regarding a 4 year old female patient. On 17-DEC-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concomitant products included UNITHROID, phendimetrazine, LEXAPRO and TYLENOL. On 16th May 05:00, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018 less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased, stiff neck and skin cyst. On 16th May 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, cramp, headache and nausea. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the cramp, headache and nausea were recovered/resolved and the outcome of the injected limb mobility decreased, stiff neck and skin cyst were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, cramp, headache and nausea to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased, stiff neck and skin cyst to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The redness, swelling and hot to the touch was started in the middle of the night the evening of the vaccination and progressed the next day. The cramping was primarily in the legs and hips and also started that evening. The swelling of the injection site traveled up her neck and it was difficult to move her arm and neck. The events headache, nausea and cramping started to subside on Saturday (19th May 2018). A day before the reporting date, the patient experienced a red circle patch presented further down from the injection site and was moving toward her armpit area, in between shoulder and the armpit. It was also hot to the touch. The patient described it as feeling like there was a ball under her skin and moving down.
Redness began 7/30 with swelling on R deltoid. Ibuprofen has been used - Patient states it seems to have helped with ice. Current 7/31: 5 - 6" vertical redness with heat and hardness - Come to office. X 4" wide on (R) arm
After the first vaccine within one week I had covid like symptoms and then devolped a small rash on my chest the after my 2nd vaccine thr rash exploded to a full body rash from my neck down. It's itchy red and some blisters.
PATIENT REPORTS THAT 3 DAYS AFTER RECEIVING SECOND DOSE OF GARDASIL 9 SHE STARTED HAVING INTERMITTENT HIVES.
nausea/vomiting/ throwing up; body aches; headache; chills; fever; Caller said that her daughter felt warm last night, but took her temperature just now and her temperature said 100.9; Caller said that her daughter felt warm last night, but took her temperature just now and her temperature said 100.9; nausea; her daughter is really sick since last night; This is a spontaneous report from a contactable consumer (patients mother).  A 16-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route of administration at left arm on 08Aug2021 at 13:00 (lot number: FC3180) (age at vaccination 16-year-old) as dose 1, 0.3ml single for COVID-19 immunization. The patient medical history acne from an unknown date and unknown if ongoing. The patient concomitant medication included doxycycline for acne. The patient did not receive any other vaccines within four weeks prior to the vaccination. The family history and relevant test was found to be none. The patient experienced chills, nausea, vomiting/throwing up, bodyache, headache, really sick since last night, fever, felt warm last night, but took her temperature just now and temperature was 100.9 on 10Aug2021. The patient has not visited the emergency room, but stated that she was going to take her to Urgent Care. The laboratory investigation included temperature was 100.9 on 11Aug2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Papulo-vesicular rash over torso / proximal extremities and fever present x 2 days.
feels like the flu symptom; tired; fever; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like the flu symptom), FATIGUE (tired), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body ache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like the flu symptom), FATIGUE (tired), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, INFLUENZA LIKE ILLNESS (feels like the flu symptom), FATIGUE (tired), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body ache) 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. Treatment information, if any, was not provided.
My COVID-19 symptoms started on 12/16/2022 through out the entire day I had head cold along with congestions and cold symptoms. I felt like I had a bad cold. On 12/17/2022 I tested with a home COVID-19 test which was positive. I did a telehealth on the same day with my doctor. I discussed with my doctor if I should take Paxlovid but we decided not to. Instead my doctor suggested over the counter cold medications such as Ibuprofen, Mucinex, Tylenol and other cold medications as per needed. Also advised me to drink plenty of fluids.
Postmenopausal bleeding; Pfizer Bivalent, Dose Number: 01; This is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 16:45 as dose 1, single (lot number unknown) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE). The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "menopause" (unspecified if ongoing). Concomitant medications included: FLU VACCINE VII taken for immunisation, on 28Sep2022 as dose number unknown, single; BUPROPION; SERTRALINE; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; CLONAZEPAM; BUSPIRONE; LEVOTHYROXINE. Past drug history included: Ibuprofen, reaction: "known allergies: Ibuprofen"; aspirin, reaction: "known allergies: Aspirin". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Sep2022 at 16:45, outcome "unknown", described as "Pfizer Bivalent, Dose Number: 01"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 03Oct2022 at 14:15, outcome "not recovered", described as "postmenopausal bleeding". It was unknown if therapeutic measures were taken as a result of postmenopausal haemorrhage.  Additional Information: The patient did not have covid prior vaccination. The patient was not tested for covid post-vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
GUILLAIN BARRE SYNDROME; HIGH GRADE FEVER; MYALGIA; This spontaneous report was received from literature report. This report concerned a 66 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total, dose 1, for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 2 days after vaccination the patient experienced high grade fever and myalgia. On an unspecified date 16 days after vaccination patient experienced right facial weakness which later progressed to bilateral facial paresis with difficulty in swallowing. The brain MRI (magnetic resonance imaging) was negative for acute changes and subsequently, the patient developed bilateral lower extremity weakness. The lumbar MRI revealed evidence of diffuse enhancement and mild thickening of all the nerve roots of the cauda equina. A lumbar puncture was performed, and CSF analysis showed albuminocytologic dissociation. He was diagnosed with Guillain barre syndrome (GBS), and responded to IV immunoglobuin infusions. Laboratory data (dates unspecified) included: CSF test albuminocytologic dissociation, Lumbar puncture albuminocytologic dissociation, MRI brain Negative, and Nuclear magnetic resonance imaging spinal evidence of diffuse enhancement and mild thickening of all the nerve roots of the cauda equina. Treatment medications (dates unspecified) included: immunoglobulins nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain barre syndrome, high grade fever and myalgia was not reported. Author concluded that GBS was a rare neurological disorder in which the immune system attacks nerves and can result in progressive muscle weakness, numbness, and pain. Adenovirus vector was listed as a rare side effect of COVID-19 vaccine. Author highlighted the importance of recognizing GBS as a potential side effect of the COVID-19 vaccination. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220740619 -Covid-19 vaccine ad26.cov2.s -Guillain barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 07-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Rt leg had Prevnar and Hib 2 days later large local RX per parent. We saw child on 6/19/07 and only 2x3cm reaction left where Hib had been given.
On 03/22/2000, the patient developed "full blown chickenpox with no fever". Subsequently, the patient recovered.
no side effect; HCP calling to report AE for PROQUAD. Improperly stored vaccine was administered. No side effects reported. No other medical information known. HCP permission to contact obtained. See additional AE cases 02477408, 02477522, 02477532, and 02477561. No; This spontaneous report was received from Other Health Professional and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2023, the patient was vaccinated with improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X005166, expiry date 15-AUG-2024 (conflicting information)) subcutaneous injection (strength, route of administration, and indication were not provided). No side effects reported. No other medical information was known.   The temperature excursion was at 6 degrees C during a time frame of 7 hours. No previous temperature excursion was reported.
lump at injection site; warm; hard; arm was red again; red spot size of quarter; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red spot size of quarter), VACCINATION SITE ERYTHEMA (arm was red again), VACCINATION SITE MASS (lump at injection site), INJECTION SITE WARMTH (warm) and INJECTION SITE INDURATION (hard) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Allergy.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red spot size of quarter). On 14-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was red again). On 15-Feb-2021, the patient experienced VACCINATION SITE MASS (lump at injection site), INJECTION SITE WARMTH (warm) and INJECTION SITE INDURATION (hard). At the time of the report, INJECTION SITE ERYTHEMA (red spot size of quarter), VACCINATION SITE ERYTHEMA (arm was red again), VACCINATION SITE MASS (lump at injection site) and INJECTION SITE WARMTH (warm) had not resolved and INJECTION SITE INDURATION (hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
A solicited report has been received from a Health Professional concerning a 13 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The patient experienced ACCIDENTALLY ADMINISTERED EXPIRED FLUMIST TO A PATIENT which started on 24-Feb-2015. The outcome of the event of ACCIDENTALLY ADMINISTERED EXPIRED FLUMIST TO A PATIENT is unknown. The report was considered to be non-serious.
I had a fair amount of pain at the injection site, by night time I had crackling in my lungs and weezing and a low grade temparture.
Period came early - my last period finished up 2 weeks before my shot (April 1) and my period started up again on April 11 which is much earlier than usual.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On 14-JUN-2016, the patient was inoculated ZOSTAVAX at a pharmacy for routine health maintenance and for the prevention of shingles (lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 (reported as "shortly after receiving" ZOSTAVAX), he was diagnosed with shingles inside his left eye and on his head, which contributed to diminished eyesight in his left eye. The patient presented to an Ophthalmologist with these complaints and was diagnosed with glaucoma secondary to eye inflammation. Thereafter, he presented to an eye institute and was diagnosed with disseminated chorioretinal inflammation of the left eye and retinal edema.  Currently, the patient suffers from 50% loss of vision in his left eye, along with continued left eye pain and discomfort. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were not resolved. Causality assessment was related. Upon internal review, ophthalmic herpes zoster, glaucoma, and retinal edema were considered medically significant. Additional information has been requested.
Red patch 4in x 4in at the site of injection; Fever; Body aches; Fatigue; A spontaneous report  was received from a physician  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, body aches, fever and red patch 4in X 4in at site of injection.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, after receiving the vaccine, the patient experienced fatigue.  On 05 Jan 2021, she experienced body aches and a fever. On 06 Jan 2021, she noticed a red patch, 4in X 4in, at the site of her injection. The patient stated her symptoms have improved but not resolved.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, fatigue, body aches, fever and red patch 4in X 4in at site of injection, were considered recovering/resolving .; Reporter'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.