chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: unknown) 1 total, administered on 20-AUG-2021 to right arm for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  On 05-JAN-2022, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The patient was experiencing symptoms cough, sneezing, nasal congestion, body aches (symptoms started on 05-JAN-2021). Laboratory data included: COVID-19 rapid POC test (NR: not provided) and result found to be positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210326.; Sender's Comments: V0: 20220108048-covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
12/22 - HEADACHE. TOOK TYLENOL 12/23 - MILD HEADACHE IN THE MORNING
"Employee reports fever, chills muscle aches " felt like full blown flu" This is the first of 2 such identical reports from this source.  No other information provided
Shortness of breath, wheezing started on sunday the 20th.  Patient used the ventolin inhaler and it did not improve symptoms.   On Tuesday  the 23rd the patient went to urgent care and was given a steroid injection and prescription for prednisone.
Information has been received from a health care coordinator and a nurse concerning a 7 month old female with no pertinent medical history and no known allergies who on 15-NOV-2007 was vaccinated intramuscularly in the right thigh with pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot # 655591/0886F). Concomitant vaccination on 15-NOV-2007 included the third dose of hepatitis B vaccine, recomb (manufacturer unknown), the third dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), the third dose of poliovirus vaccine live oral (manufacturer unknown), and the third dose of Hib conj vaccine (unspecified carrier) (manufacturer unknown). The nurse reported that the patient was supposed to receive pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) when pneumococcal 23v polysaccharide vaccine was given by mistake. The nurse stated that the mistake occurred because the physician may have ordered the wrong vaccine and mentioned it can be confusing as far as which vaccine needs to be given to which age group. No adverse reaction was reported post vaccination. Medical attention was sought in the physician's office. Upon follow-up received from the healthcare worker, it was reported that the error was "strictly human error" on the medical assistant's part, two different ones unfortunately". The reporter stated that " it was not a matter of product confusion, the vaccines were in different containers on different shelves, the medical assistant just made a mistake". This is one of two reports from the same source. Additional information has been requested.
Patient came in to get his second dose forgetting that he had already received it. He has suffered no ill effects from the extra vaccine. Also his doctor was notified.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (unknown route and dose) lot # K005110 with expiry date of 04-APR-2016. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
This initial spontaneous case, was received from other non-healthcare professional on 09-Nov-2017, concerning a 38-year-old, adult, male patient. On 19-Oct-2016, patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm (unspecified), batch number: 185888, expiry date: May-2017). On 22-Oct-2016, after 4 days of vaccination, the patient started to experience hives on arms, hands and feet. The patient took anti-histamines and topical cortisone cream. The patient was completely recovered from the event after 4 days. The reporter assessed the event as non-serious and considered the causality of the event as related to the suspect vaccine. Follow up report received on 27-Nov-2017: The dose, route of administration, anatomical location, indication of the vaccine and onset date of the event were updated. The narrative was amended accordingly.
Red itchy rash on left arm below injection site. Oblong about 4? x3? lasting 2-3 days.
Flushed; Heaviness of arms and legs; Injection site itching; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed), LIMB DISCOMFORT (Heaviness of arms and legs), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FLUSHING (Flushed), LIMB DISCOMFORT (Heaviness of arms and legs), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, FLUSHING (Flushed), LIMB DISCOMFORT (Heaviness of arms and legs), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was mentioned. No laboratory details was given. No treatment information was mentioned.
Not to feel well and he had to sit down in shower, usually stands; Ongoing shortness of breath with exertion; continues to shortness of breath with exertion; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): UNT-2022-022833.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; treprostinil sodium (TYVASO), since 26Sep2022 (Lot number: 000276P, Expiration Date: 30Sep2023) at 16 ug 4x/day for pulmonary arterial hypertension; treprostinil (TREPROSTINIL), since 26Sep2022 (Batch/Lot number: unknown) at 16 ug 4x/day, nasal for pulmonary arterial hypertension. The patient's relevant medical history included: "Primary pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: TADALAFIL; ELIQUIS; OPSUMIT. Vaccination history included: Bnt162b2 (Dose 1, Ongoing shortness of breath with exertion; continues to shortness of breath with exertion), for COVID-19 immunization, reaction(s): "Ongoing shortness of breath with exertion; continues to shortness of breath with exertion"; Bnt162b2 (Dose 2, Ongoing shortness of breath with exertion; continues to shortness of breath with exertion), for COVID-19 immunization, reaction(s): "Ongoing shortness of breath with exertion; continues to shortness of breath with exertion". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not to feel well and he had to sit down in shower, usually stands"; DYSPNOEA EXERTIONAL (non-serious), outcome "not recovered", described as "Ongoing shortness of breath with exertion; continues to shortness of breath with exertion". The action taken for treprostinil sodium and treprostinil was unknown.  Additional information: On an unreported date in Sep2022, the patient had ongoing shortness of breath with exertion (dyspnoea exertional). On 04Oct2022 he received his 3rd COVID booster. On 05Oct2022, 10 days after initiating Tyvaso, he was not feeling well and he had to sit down in shower, usually stands (malaise). The reporter did not provide the causality for the event of dyspnoea exertional. The reporter did not provide causality for the event of malaise. The reporter's causality for the event of malaise with COVID-19 vaccine was considered to be possibly related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Td booster dose.  Patient was ill with a presumed mild viral respiratory infection at the time of the injection.  Several minutes after the vaccination, family informed the clinic staff that he had 'slumped over and fell to the ground'.  He awoke very shortly thereafter, and remained slightly groggy for several minutes.  After 5-10 minutes, he reported he felt normal and wanted to leave.  Vital signs including blood pressure were all normal prior to vaccination, except for temp=99.7.  Patient and father both stated they felt he was 'queasy' from seeing the needle inject him.  Telephone follow-up later that day confirmed patient was in his usual state of health (healthy adolescent boy).  No abnormalities seen on physical exam at any point during visit, other then temp=99.7.
balance was weird; left side of head, above my ear felt like something inside my head popped and liquid drained; felt really terrible; she thought that maybe she was hallucinating; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (she thought that maybe she was hallucinating) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dyslexia and Thyroid associated orbitopathy (Unspecified Allergies).   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible). On an unknown date, the patient experienced HALLUCINATION (she thought that maybe she was hallucinating) (seriousness criterion medically significant). On 12-Feb-2021, HALLUCINATION (she thought that maybe she was hallucinating), BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible) had resolved.            No treatment medications were provided.  Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.
hearing loss; herpes zoster; Bell's palsy/facial paralysis; 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 medical history, concurrent conditions, or concomitant medications. On or around 12-APR-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose and route of administration were not reported) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as after receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster, Bell's palsy, hearing loss and facial paralysis. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his 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 Company's wrongful conduct, 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 Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, Bell's palsy, hearing loss and facial paralysis was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   The events of herpes zoster, Bell's palsy, hearing loss and facial paralysis were considered to be disabling. Upon internal review, the events of Bell's palsy/facial paralysis and hearing loss were considered to be medically significant.
Having muscle soreness, some tightness like pressure in upper arm. Arm pain was so bad the day of the injection she had to sleep on the couch
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 17:00 (Lot number: 33030BD) at the age of 70 years as dose 3 (booster), single for covid-19 immunization. Patients' medical history included rheumatoid arthritis, fibromyalgia, shrogen's syndrome, hypertension, heart murmur, ulcer, known allergies: Penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included: lisinopril; multivitamins, Nyquil, Tylenol, magnesium. past drug history included: morphine, reaction(s) include known allergies: morphine, Demerol, reaction(s): known allergies: Demerol, tramadol, reaction(s): known allergies: tramadol, stadol, reaction(s): known allergies: stadol. Patient previously received Bnt162b2 (COVID 19, Pfizer, lot number=EW0167, location=Left arm), on 21Mar2021, at 12:00 am, when the patient was 74 years old, as DOSE 1 SINGLE, for COVID-19 immunization and Bnt162b2 (COVID 19 immunization, Pfizer, lot number=EW0167, location=Left arm) as DOSE 2, SINGLE, on 29Apr2021 at 12:00 am, when the patient was 70 years old, for Covid-19 immunization. On 20Nov2021patient experienced dose number: 3, On 20Nov2021 12:00 Persistent hypertension even with Lisinopril. Was taking 15mg OD (had weaned down over past year from 30mg BID) Had to go back to 30mg BID. Still ranging from 180/110 to 140/90, PVC's chest pain, left arm numbness with tinnitus, left arm numbness with tinnitus, headache, Aggravated ulcer with abdominal pain, vomiting, Multiple joints and muscles painful, Aggravated ulcer with abdominal pain. Patient underwent lab tests and procedures which include blood pressure measurement 180/110 to 140/90 on an unspecified date. Therapeutic measures were not taken as a result of hypertension, chest pain, hypoesthesia, tinnitus, headache, abdominal pain, vomiting, pain. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
No adverse event; Patient received a vaccine 12 hour beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine 12 hour beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult 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. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine 12 hour beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine 12 hour beyond use date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine 12 hour beyond use date).    Concomitant medication was not reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment drug was not reported.
About 45 minutes after the vaccine, I got home and started having bad chills all over my body, headache and feeling really tired. I was very sleep without any strength. The next morning I woke up with my body hurting I couldn't get out of bed and I had a fever, my body was not functioning like it normally does. All I did the next day was sleep, take Tylenol and drink some Gatorade.  I went to an Urgent Care, they told me that the side effects were normal, but just back to them If I couldn't walk or symptom worsen. They were looking for if I didn't have any strength in my legs to walk.  The lasted about 5 days and I have recovered.
A physician reported that a male received an injection of TD Toxoids Adsorbed, Purogenated and subsequently, the pt developed a fever and a rash. He also, developed swelling and redness at the injection site, lasting more than 4 days. The pt was treated by the physician for a dx of cellulitis. This is 1 of 2 pts from this facility who had an adverse experience following this vaccine, lot 470535.
swelling in her leg; pain in the leg she received the vaccine in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 02Aug2023 as dose number unknown, single, in leg for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Aug2023, outcome "not recovered", described as "pain in the leg she received the vaccine in"; PERIPHERAL SWELLING (non-serious) with onset 03Aug2023, outcome "not recovered", described as "swelling in her leg". The events "swelling in her leg" and "pain in the leg she received the vaccine in" required physician office visit. Therapeutic measures were taken as a result of peripheral swelling, vaccination site pain. Additional information: The reporter stated that his daughter received it yesterday (02Aug2023) and now (03Aug2023) she has swelling in her leg and pain in the leg she received the vaccine in. The reporter stated that the product was Prevnar "23" (as reported). The reporter was the one who took the patient back to the pediatrician this morning. The swelling didn't improve, and the patient is in a lot of pain and her leg is crazy swollen like balloon. They took her back to the pediatrician because they said they wanted to make sure it was not an infection in her joints or muscles. The reporter stated they have been alternating Tylenol and Motrin to help her stay out of pain. The reporter stated that he is contacting Pfizer because he figures Pfizer would know a lot more about the vaccine than the pediatrician. The pediatrician was not really as aware as he has hoped.   No follow-up attempts are possible. No further information is expected.
Just wanted to touch basis regarding side effects to the Moderna vaccination.  I received the first vaccine yesterday evening, today I have experienced a low grade fever, tiredness, chills, weakness and a headache.  BP was 129/67 this AM. I understand these are some typical symptoms but thought it would be good to communicate.  Unfortunately the test samples were low in this ethnicity, low in senior citizens, and kidney disease is not listed.  Only a very small percentage had two extenuating conditions; while I have diabetes, CKD, hypertension/previous heart related disease.  I understand that the second vaccination could present even more severe side effects.  Any thoughts?
Dizziness, Vertigo, Nausea started one day after shot. Has lasted for two weeks to date. Occurs daily. No remission.
Bruising and nodule on right thigh developing 1 day after vaccination. Not painful to patient. No other concerns after the vaccine. Has not changed significantly in 2.5 weeks after the vaccination.
3 Days after my 2nd shot on 5/8/21, I was woken up by numbness on both my feet and side of lower legs, more on the left than right. The numbness then work its way further up the side of my legs. It stays with the same degree of numbness for at least 2 hrs, but slowly improved after the 3rd hr, but it didn't go away until 6 hrs after it started. Even after the numbness subsided for the most part, I still have tingling feeling on my legs and feet. The next day (4 days after 2nd shot), I started feeling tingling on my hands and along side of my arms. Currently it's been over 2 wks, tingling has lessen in the last 2 days, but got a little worse again today, especially on left feet. Symptoms of tingling persisted and haven't gone away yet.
It was reported that a 42-year-old male patient received an Imovax Rabies vaccination on 22-Aug-2000, 26-Aug-200 and 2-Sep-2000. Reportedly after 26-Aug-2000 dose, within 1-2 hours the patient developed a stiff neck. After 2-Sep-2000 dose the patient developed pain in neck and upper back, shoulders and right deltoid muscles. These symptoms subsided after 24 hours. From additional information received on 4-Dec-2000, the vaccine administrator and responsible physician information were provided. Also the product lot number and times of administration were provided. No "other medications" were reported. Reportedly the patient recovered from this experience.
Could not move my arm due to the severity of the pain, a few hours later started feeling faint and had to lay on the floor so I would not pass out. A day later and since then I have had tinnitus.