chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BROKE HIP; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (BROKE HIP) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In February 2021, the patient experienced HIP FRACTURE (BROKE HIP) (seriousness criterion medically significant). In 2021, the patient experienced FATIGUE (TIRED). In 2021, HIP FRACTURE (BROKE HIP) had resolved. At the time of the report, FATIGUE (TIRED) had not resolved.            Concomitant Drugs Not Reported. treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns an elderly female patient aged 69 years with relevant medical history of RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (medically significant) event of Hip fracture that occurred on an unknown date (in Feb.2021) after first dose of mRNA-1273 vaccination. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. Patients elderly age and relevant medical history could be  risk factors to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns an elderly female patient aged 69 years with relevant medical history of RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (medically significant) event of Hip fracture that occurred on an unknown date (in Feb.2021) after first dose of mRNA-1273 vaccination. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. Patients elderly age and relevant medical history could be  risk factors to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
had sz like activity 2 hrs p/#1 DTP; stiffening & tremors of extremities; no fever;
Allergic reaction; Redness; Itchiness; This case was reported by a consumer and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and an unknown time after starting Zyrtec, the patient experienced allergic reaction, erythema of extremities and itchy upper limbs. The patient was treated with cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the allergic reaction, erythema of extremities and itchy upper limbs were unknown.   It was unknown if the reporter considered the allergic reaction, erythema of extremities and itchy upper limbs to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had an allergic reaction on both of my arms with redness and itchiness ever since.  The patient recommended zyrtec 10 mg. at bedtime to help with the rash and itch.  The reporter reported if not better in two weeks she would recommend a dermatologist. The reporter asked was this unusual or have others had this reaction.
The client returned to clinic on this date showed her (R) arm which was very red warm to touch and measured 3 in and 2.5 inches in diameter.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not reported. On 08-MAR-2016, the patient was vaccinated with a dose of GARDASIL which had a lot # of K016966, an expiration date of 10-MAY-2017 (concentration, dose, dose number, route and anatomical place of vaccination were not provided), for prophylaxis. Subsequently on 11-NOV-2016, the patient was vaccinated with a dose of GARDASIL 9 which had a lot # of M023169, an expiration date of 13-JUN-2018 (concentration, dose, dose number, route and anatomical place of vaccination were not provided), for prophylaxis. No adverse effects were reported. Additional information has been requested.
body aches; fatigue; slight cough; bloody nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 07:15 as dose 1, single (Lot number: HF9275) at the age of 29 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 19Sep2023 as dose 1, single (Lot number: 944457), in right arm for influenza immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing), notes: Sulfa based medication - Steven-Johnsons Syndrome as a result of allergy; "COVID-19", start date: 2022, stop date: 2022, notes: Treatment of COVID-19 with Paxlovid from 21Jun2022 to 26Jun2022. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: EPISTAXIS (non-serious) with onset Sep2023, 30 hrs after the suspect product(s) administration, outcome "recovered" (Sep2023), described as "bloody nose"; PAIN (non-serious) with onset 19Sep2023 at 21:00, outcome "recovered" (Sep2023), described as "body aches"; FATIGUE (non-serious) with onset 19Sep2023 at 21:00, outcome "recovered" (Sep2023); COUGH (non-serious) with onset 19Sep2023 at 21:00, outcome "recovered" (Sep2023), described as "slight cough". Therapeutic measures were not taken as a result of pain, fatigue, cough, epistaxis.  Additional information: Approximately 14 hours after receiving both the Flu and Covid Vaccines, patient experienced body aches and fatigue and a slight cough that lasted roughly 24 hours. Then 30 hours after vaccination, patient experienced a bloody nose. No treatment was received. The patient did not COVID tested post vaccination.
Fever of 101, redness, swelling and pain at injection site. Dr. prescribed antibiotics.
I got the vaccine on 4/14, the next day I had arm soreness and heaviness. That lasted about 2 days. Not long after, I started getting a rash on my jaw neck throat shoulder s and chest are. I had a bump near the injections site. I was diagnosed by 2 dermatologists with acneiform rupture. Within a week of the 2nd dose, I saw a dermatologist who diagnosed me with that. I saw another doctor on 4/22 who agreed with the initial diagnosis. It eventually got better. I was prescribed a topical foam which did not completely help.
Extreme muscle pain in both legs and arms; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via unspecified route of administration in the left arm on 16Mar2021 at 11:00 as a single dose (at the age of 72-years-old) for COVID-19 immunisation. The patient was not allergic to medications, food or other products. The medical history of the patient included type 1 diabetes. Concomitant medication was reported as insulin (MANUFACTURER UNKNOWN) for unknown indication. The patient received this medication within 2 weeks of vaccination and the exact therapy dates were not provided. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 00:00, the patient experienced extreme muscle pain in both legs and arms. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent nasal swab test on 28Feb2021 and the result was negative. The clinical outcome of muscle pain in both legs and arms was not recovered.   No follow-up attempts are needed. No further information is expected.
I did not have an adverse event after receiving the vaccine. I tested positive for COVID-19 in 01/2023. I contacted a provider and got a prescription remdesivir. I tolerated the medication without any complications. As of today, I am feeling better with no lingering COVID-19 symptoms.
Both time i got very sick; Headache; My arm is still swollen and very painful; My arm is still swollen and very painful; The pain extends from my arm to my shoulder and neck; The pain extends from my arm to my shoulder and neck; Cannot sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "Headache", "Very sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Both time i got very sick"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "My arm is still swollen and very painful"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "The pain extends from my arm to my shoulder and neck"; INSOMNIA (non-serious), outcome "unknown", described as "Cannot sleep". Therapeutic measures were taken as a result of headache, pain in extremity, arthralgia, neck pain.  Additional information: The patient got the second COVID-19 vaccine dose. Both time the patient got very sick. 5 days of headache and now with the second dose, 7 days later my arm was still swollen and very painful. The pain extended from my arm to my shoulder and neck. The patient already massaged it but it was useless. The patient have two babies under two and taking 6 pain killer every 5 hours to deal with the pain. The patient couldn't sleep.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
VACCINE ADMINISTERED ON 6/26/20. ADVERSE EVENT REPORTED AND SYMPTOMS DEVELOPED ON 6/28/20. SYMPTOMS REPORTED: SPLOTCHY RED RASH WITH SMALL RAISED BUMPS LOCATED ON THE STOMACH, CHEST AND BACK, NO ITCHING, NO RAISED WHEALS, NO PAIN, NO BREATHING COMPLICATIONS, NO SITE REACTION (OTHER THAN MUSCLE PAIN AT INJECTION SITE ON DAY OF INJECTION), NO LYMPH PAIN IN INJECTED ARM.  PT STATES THIS REACTION IS SIMILIAR TO HER LAST FLU SHOT THAT CONTAINED THIMERASOL. REPORTED SYMPTOMS WERE NOT PRESENT DAY OF INJECTION AND PT THINKS SHE MAY HAVE HAD MILD RASH DAY AFTER INJECTION BUT IS UNSURE.
Patient had large red swollen areas at each injection site (approximately 1.5-2.5 inches in diameter).  Area was raised and warm to touch. Also sore to palpation. Complaint of soreness extending down into axillary region upon all ranges of movement. Patient was advised to apply cold compresses to the area, take diphenhydramine by mouth every 6 hours for the reaction and otc analgesics for the pain. Also, advised patient to follow up with her medical doctor immediately if anything became worse.  Patient stopped by pharmacy 2 days after administration and stated it was looking and feeling a small amount better. Advised patient to continue to monitor and to follow the aforementioned advice.
About a minute after receiving the vaccine, my teeth started to hurt. As I waited the required 10 mins before leaving the pharmacy, the pain progressed to my cheeks and sinus cavities. I took 2 advil. The pain went away quickly and no problems thereafter.
I was unable to find an alternate source within the 42 day timeframe.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I was unable to find an alternate source within the 42 day timeframe.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 PRODUCT DOSE OMISSION ISSUE (I was unable to find an alternate source within the 42 day timeframe.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I was unable to find an alternate source within the 42 day timeframe.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Large localized hive like reaction.  Seen by MD on 11/6, it was 5x5 inches.
Client awoke with chest pain and visited local ER for suspect M.I.  Transferred to Hospital for angioplasty, related to thrombosis in R) coronary artery. Treated for 3 days and released to home with 3 months of follow-up cardiac rehab. Scheduled to return back to work as an auto mechanic on 4/26/2021.
Pt recvd 3 doses of Hep B vax on 3OCT84, 2NOV84, & 3NOV85 & on 13SEP91 lab eval was neg for Hep B surface antibodies & post for Hep B surface antigen;
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-OCT-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Approximately December 2015 (reported as two months after receiving ZOSTAVAX), the patient developed a severe, persistent pain in her face. The patient presented to the emergency room and was diagnosed with trigeminal neuralgia, a condition of chronic, sharp, shock-like pain which affects the trigeminal nerve secondary to a shingles infection. The patient continues to suffer sharp shooting pain, hearing loss, difficulty opening her eyes and walking. As a direct and proximate result of these malfunctions, she has 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, pain and suffering, and other damages. Upon internal review, hearing loss was considered medically significant event. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 70 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Primary Lateral Sclerosis" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Gadolinium agents allergy" (unspecified if ongoing). Concomitant medication(s) included: BACLOFEN, start date: 01Dec2019, stop date: 19Sep2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Anti-viral details: Paxlovid (full 5 days) was received in Sep2023 for COVID 19 Treatment.
Patient started feeling ill same night and developed a fever of 100.7F he then developed symptoms of nausea and vomiting over night around 12am 10/21/2020. There was two episodes of vomiting but arm did not develop localized reaction. He is the first patient to present with these symptoms in our office after receiving Flu Vaccine Lot#: UJ533AA
Information has been received from a physician and an employee in a physician's office concerning a 50 year old male who within the last two weeks in October 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 640981/1050L). Subsequently in October 2002, the patient developed erythema, warm, silver dollar swelling of the vaccinated arm. The physician requested that a lot check be initiated. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The patient sought unspecified medical attention. The physician also provided information concerning another patient's experience. Additional information has been requested.
Since receiving my covid shot I have had a severe flare of psoriasis and a cold sore that is rare for me
I woke up this morning around 7:45am with severe stomach cramping and pain and had to go to the bathroom. I noticed my intestinal lining shedding when I went to the bathroom. I feel like I am having a flare up of my ulcerative colitis.
acute myocardial injury; herpes zoster of the left upper face, eye; herpes zoster of the left upper face, eye; rash on the legs and arms; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 03-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered acute chest pain located over the left chest and neck. The patient also had a rash on the legs and arms. The patient was diagnosed with having an acute myocardial injury. A few months later the patient suffered from a rash over the left side of his face. The patient was diagnosed with herpes zoster of the left upper face, eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events rash on the legs and arms, acute myocardial injury and herpes zoster of the left upper face, eye was not recovered and causal relationship was assessed as related.   The lawyer considered the events rash on the legs and arms, acute myocardial injury and herpes zoster of the left upper face, eye to be disability.   Upon internal review the events acute myocardial injury and herpes zoster of the eye were determined to be medically significant.
Information has been received from a pharmacist concerning a female patient who on 10-SEP-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot number not reported).  On 10-SEP-2009 the patient experienced pain at the injection site, fever and had difficulty raising her arm.  It is unknown if the patient recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Pt vaccinated with DTP/OPV 2 hrs after vaccine started vomiting, diarrhea, cold extremines, fretfulness, drowsiness.
Having COVID19 following vaccination; Congestion in her chest; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Having COVID19 following vaccination) and NASAL CONGESTION (Congestion in her chest) 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. On an unknown date, the patient experienced COVID-19 (Having COVID19 following vaccination) and NASAL CONGESTION (Congestion in her chest). At the time of the report, COVID-19 (Having COVID19 following vaccination) and NASAL CONGESTION (Congestion in her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a female patient of unknown age, with no medical history disclosed, who experienced the unexpected non-serious adverse event of special interest of COVID-19 with other non-serious unexpected event. The event of COVID-19 occurred on unknown date, after the most recent dose of Spikevax (Moderna COVID-19 vaccine). No information is provided regarding dates of events and vaccination, so assessment is very limited. The rechallenge was not applicable as dose number is not informed in the source document. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Pain in the left leg which increased in intensity.  Leg felt heavy, muscle wouldn't work, swelling, color change to purple and blue, pain.  Diagnosed the end of April with 7 occlusive blood clots in the left leg.  First initial symptoms noticed the first part of April.  After Ultrasound completed, started on Lovenox injections twice a day for 10 days, Xaralto 15 mg twice a day, then to Xaralto 20 mg once a day.  This is the first of September, and I still have 2 totally occlusive veins, 2  veins have cleared, 3veind have blood flow but clots still present 5 months later.