chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states about 2 hours after his immunizations he developed a pruritic rash on his penis. Next day, rash on face with itching and penis seemed swollen. Treated with BENADRYL at home. Seen today at our office. Sent home on prednisone. No S.O.B., no tongue swelling, no swallowing problem.
Localized erythema and swelling at injection site on right leg. Seen at ER on 7/15/01.
Patient presented for COVID-19 vaccine (Pfizer-Sars-COV2-vac), pt received the vaccine and then 15 minutes later started feeling some lumpiness in her throat, watery eyes, and ear fullness. Pt denied feeling any itchiness, difficulty breathing, lip swelling, or throat swelling. Pt received two doses of oral diphenhydramine 25 mg each without improvement in symptoms. Patient was observed for 1 hour and 20 minutes. After consulting with Dr., it was recommended to have the patient go to the emergency room for more observation. The patient was then escorted to the ER by one of the volunteering staff. In ED, reported throat tightness without SOB or difficulty swallowing. Also reports feeling sense of ingestion/gas bubble in chest. Had COVID, dx'd 12/1/20, recovered fully. States that sensation in chest was also felt during her COVID illness and seemed to be brought back by vaccine this afternoon approximately 90min pta, Observation for additional 90min in ED. with possible mild improvement, no progression/worsening. Discharged home
Lost vision in both eyes; Eyes started hurting; Sensitive to light; She was a little tired; Has a headache; This serious, initial spontaneous safety report was received by Novavax on 07-NOV-2022 from a consumer via contact center.   A 16 year-old female of an unspecified race was vaccinated with intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 04-NOV-2022.  No medical history was reported.  No concomitant medications were reported.  On 04-NOV-2022, the same day after vaccination, the individual experienced feeling a little tired (PT: Fatigue). On 07-NOV-2022, reported as about 30 minutes ago, the individual experienced headache (PT: Headache), sensitive to light (PT: Photophobia), eyes started hurting (PT: Eye pain) and lost vision in both eyes (PT: Blindness) (Serious: Medically Significant). Additionally, the reporter asked if they should take their daughter to the Emergency Room.  At the time of reporting, the event outcome of Fatigue was Unknown and event outcomes of Eye pain, Blindness, Photophobia and Headache were Not Recovered/Not Resolved.  Lot number was not provided in the report.  No additional information was provided.; Sender's Comments: This 16 year-old female experienced: Blindness, Fatigue, Eye pain, Headache and Photophobia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Blindness was assessed as serious. The events Fatigue, Eye pain, Headache and Photophobia were reported as non-serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Patient given Janssen Vaccine 1 day before age of 18. Pt is 17 years 364 days old. No adverse reactions.
Patient called on 1/13/2021 with reports of tactile fever/headache/nausea/body aches/right arm pain with limited range of motion/weakness limited by pain developing approximately 2-3 hours after vaccine administration. Findings on exam(1/13/2021):  Right upper extremity with mild swelling at deltoid injection site without erythema but notable tenderness to touch.    With displacement of right upper extremity at shoulder, pain 6/10 present with movement 30 degrees from vertical torso in anterior/posterior and right lateral abduction.  Equivocal tenderness to palpation of soft <1cm x 3/4 cm shotty right axillary nodes that are mobile and non-erythematous.   Screening labs - CBC w/diff, CMP, CRP
This spontaneous report as received from a physician refers to a 6 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This one of several reports received from the same reporter.
I was diagnosed with Shingles 5 days before the 2nd covid 19 shot (Pfizer). It started out with immense stomach pain, then proceeded with a rash on the lower left hip.
On right anterior thigh, pt developed a 12 cm diameter area of increased redness and warmth with minimal swelling. Pt is currently on Zithromax suspension.
Unknown if pt had s/s at time of vaccination  on 1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later, readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette, sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin, rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA r/t either a fib hx or hypercoagulability r/t covid. Pt died.
About 3 days later started getting not headaches but a sharp pain in and around left temple region.  Pain is sharp, like a stab, but first 2-3 days of the pain, it last a few seconds to a few minutes and nothing for the day, occasionally I might have the incident 2-3 times in a day.  But today 01/21/2021, the pain around 4pm, lasted longer, about 2 hours but on and off, not constant. At midnight, the pain seems to have stopped.
Baby went stiff. Eyes fixed.  Mom thought baby was choking.  Tympanic Temp 99.0 at home. Called ambulance. In ER rectal temp 102. Documented febrile seizure.
SM noted pustular rash that started around her inoculation site and has since spread to other arm, legs and back.
Patient stated her arm was red where she received the flu shot. It was about the size of a baseball and she stated it was hard in the center. She also said it was warm to the touch. Patient informed to monitor if it got any larger. Recommended BENADRYL and TYLENOL.
This is a 85y.o. female with PMH significant for dementia, alzheimers, depression, hypothyroidism who presents to hospital for fall and head injury. History gathered for paramedics and family. Patient from SKLD, baseline A&Ox1-2. Had unwitnessed fall with bleeding in the back of head. She was placed on C collar. During ED eval, COVID positive, placed in isolation. UA + WBC, negative for bacteria. Was started on IV rocephin in EC. Cervical CT showed no acute fracture. Chest xray showed left sided patchy opacity. Head CT showed no acute hemorrhage. Patient was RRT due to lethargy. And her night time risperidone dose was reduced with good improvement. Met with hospice and will follow up with community hospice needs. Patient also tested positive for COVID, was seen by ID, and no txt needed since respiratory status is stable. Discharged in a stable condition.
Administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medications was reported.
Woke up around 11:00 same day I received vaccine with 104.5 fever and extreme headache. Had a fever that went from 104.5 to 103 to 102 over a period of 3 or 4 days and then a low grade fever and sever headache for two and a half weeks.
Initial misuse report received from a healthcare professional on 02 August 2013. A 4-month-old patient was administered PENTACEL and ACT-HIB on the same day. No adverse event was reported. List of documents held by sender: none.
This spontaneous case, initially received on 14-Nov-2018, reported by physician via Merck, concerning a 29-year-old, adult male patient. On an unspecified date, the patient was administered influenza vaccine, [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported]. On an unspecified date, after vaccination, the patient experienced symptoms of transverse myelitis, however on an unspecified date, the patient was diagnosed with multiple sclerosis. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Reddened indurated area of the left upper thigh. Patient advised to use ice on area for 20 twice a day. Given Atarax for itching, to follow up in 2 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2022 as dose 2, single (Lot number: FM0698) at the age of 25 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 18Jul2022, stop date: 20Jul2022; MUCINEX, start date: 19Jul2022, stop date: 20Jul2022. Past drug history included: Ceclor, reaction(s): "Drug allergy: Ceclor", notes: Known allergies: Ceclor; Zithromax, reaction(s): "Drug allergy: Zithromax", notes: Known allergies: Zithromax.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Child was given vaccine, two hours later complained of chills, child complained of numbness to both feet and hands, child dizzy and lightheaded, took next day to Ped Ped felt reaction to vaccine child also with 4 bouts of diarrhea. Numbness to leg/feet 2 days then gone.
and three days later broke out with a nasty case of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: and three days later broke out with a nasty case of shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 2-Jul-2023 The case was received from the patient via interactive digital media. The patient got his or her first shot and three days later broke out with a nasty case of shingles. The patient was told that it was a fluke as shot would not had taken effect for 2 weeks. The patient stated that sure wish he or she had been vaccinated sooner. The shingles were horrible.
developed a rash on her chin on her face and this spread to her cheeks, arms, fingers, and legs - taking Triamcinolone Acetonide 0.1% and Gold Bond over the counter cream.  Not really any improvement with the prescription and rash spread over time.  Started on her face shortly after vaccines
12 hours after the booster - chills, fainting resulting in head injury and headache 4 days after booster - nausea, vomiting, headache followed by bedrest for 3 days
Runny nose since immun but on 16APR91 had severe convuls out 1-5min went directly to PMD; temp there 100.6 given APAP; Also feb convuls, t102R, rash on face, language delay;
On 18 September 2007 the subject received a birth dose of ENGERIX B (10 mcg, unknown). On September 2007, same day as the vaccination with ENGERIX B the subject tested positive for hepatitis B surface antigen. The subject was born to a hepatitis B surface antigen negative mother. Two vaccination dates were provided for ENGERIX B administration dates, 18 September 2007 and 19 September 2007. The laboratory report stated the hepatitis B surface antigen detection was performed on 18 September. No other information was provided. At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. (GlaxoSmithKline).
Severe headache, fatigue, body ache, muscle pain, soreness at injection site - lasting 24 hour.
Bad headache about 45 minutes after shot.  Had headaches for a few days after.  Then after 3 weeks, had a migraine - felt like the one I had the same day of the vaccine, but way more intense.  I now wake up with headaches almost every morning.
Shortly after the vaccination, the patient commented she felt dizzy and light headed.  As a result, a cold compress was administered followed by 3 sets of vitals.  1. Temp, 97.5, HR 71, O2, 99, BP, 140/92  2. Temp 97.5, HR 66, O2, 99, BP 132/90  3.  Temp 97.1, HR 65, O2, 99, BP 124/88   patient cleared and release by, Nurse. Sade.
Got ZOSTAVAX on Sunday, right eye felt discomfort on Monday 5/16. It felt blurry, pain, discomfort. Did not get better from Mon through Tues. She has history of blepharitis and thinks it may be due to that also. I told her to follow up with her MD.
Slight headache Large red splotch below injection site. Covered entire top of arm area?gradually disappearing Sweating during night Very hot?did not take temp EXCESSIVE urination during night?like UTI?several times?was gone by morning.  Was concerned  bladder or kidneys affected
Pt received PNEUMOVAX ON 8/2/12, reports back to pharmacy on 8/4/12 at 11:00am, His arm was red on his upper arm moving towards chest and lower arm. Pt was advised to take BENADRYL and go to the Dr if rash worsens and see PCP on Monday.
pt w/erythema, induration, warmth in area 15 x 8cm 3 days s/p administration of tetanus vax;+ fever, shaking chills, + pruritus;negative bronchioconstriction, negative rash;had similar rxn s/p tetanus vax 1mo prev;
Vomiting lasting for several days after vaccination received, starting about 6 h after shot.
Less than five minutes after injection, I experienced a tightness in my chest and difficulty breathing, followed by intense pain in my lower back and hip area and minor dizziness.  The severity of the symptoms seemed to lessen after about 10-15 minutes (I did not seek help which my wife is a little pissed off about).  I have never had a reaction like this to a flu shot or any vaccine.
Well I had no other symptoms, no fever no day after problems like people say they have. I started spotting blood vaginally and by night time I was full blown bleeding. And to note, this is my 7th miscarriage in three years, it may not be shot related it may be just me. I had an appointment with my DR due to my history of miscarriages and I went in on Monday. My date was delivery was to be February 22 2022.
few minutes after injection, patient felt heart racing, throat tight, felt dizzy and warm, headache on and off, hr on watch said 115, brought to obs, 1453 bp 191/108 hr 86 rr 18 sats 99% ra. 1457 bp 169/106 hr 100 rr 20 sats 99% on ra, states feeling better after resting. vs repeated and around same every few minutes, discussed ems transporting patient to ed for further eval, patient agreeable.  upon ems transport at 1525, bp 152/96 hr 85 rr 20 sats 99% on ra. report provided to ems and patient taken to hospital.
vomittng, vision blury, numbness in both arms and legs. Patient was refered to urgent care, Doctor, or Emergency Room. Pateint went to see her Doctor, but do not know the out come
Flu like symptoms normal side effects to be expected after vaccine; My urine has a strange smell after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms normal side effects to be expected after vaccine) and URINE ODOUR ABNORMAL (My urine has a strange smell after receiving the vaccine) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023D21A and E53E21A) for COVID-19 vaccination.     No medical history information  was reported.  Concomitant products included INSULIN ASPART (NOVOLOG) and LEVOTHYROXINE SODIUM (TIROSINT) for an unknown indication.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms normal side effects to be expected after vaccine) and URINE ODOUR ABNORMAL (My urine has a strange smell after receiving the vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms normal side effects to be expected after vaccine) and URINE ODOUR ABNORMAL (My urine has a strange smell after receiving the vaccine) had not resolved.            The treatment information was  not provided.  It was reported that patient experienced the events after first dose of vaccine and its still continues
Rashes and spots on both of arms and back; Rash on chest no spots; Headache increased; This is a spontaneous report from a contactable healthcare professional, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 01Apr2021 at 13:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included migraines, iodine allergy and unspecified allergy called deloted. Concomitant medications included naratriptan (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN, tramadol (MANUFACTURER UNKNOWN) and ondansetron (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 15:00 the patient experienced rashes and spots on both arms and back, rash on chest no spots and headache increased. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of rashes and spots on both of arms and back, rash on chest no spots and headache increased included treatment with benadryl and cortizone 10. The clinical outcome of the event rashes and spots on both of arms and back, rash on the chest no spots and headache increased were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Patient c/o "numbness et tingling" to lower extremeties. States she does not feel SOB at this time, states she has own EPI pen but has not given herself a dose. Nurse evaluated said person, noting HR is tachy, lungs clear et person states "I can breathe" Person then states, "My lips feel a little numb." Person asked for a bottle of water. Nurse asked the person is she felt she needed Benadryl or possibly an ambulance. Person  stated, "If you tell me how to get to the ER, I will go there and get checked out." Nurse led person to ER where she states she no longer needed nurse's services.
This spontaneous report was received from a physician, via a company representative, reporting on his 81 year old mother. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The physician reported that on an unknown date, his mother developed shingles "2 weeks" after receiving ZOSTAVAX. The patient developed shingles on the "right side of her head". The first three days of this was "quite painful" for the patient; however, the patient "feels like it is getting better." At the time of the report the outcome of the shingles and the pain was reported as recovering. The patient seeks medical attention and received an unspecified anti-viral medication as treatment. Additional information has been requested.
fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101; left neck and chest swollen lymph nodes; stomach aches; abdominal pain; It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die; heart attack; left flank pain; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on left arm on 19Jan2021 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included post-partum hypothyroidism. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on 29Dec2020 for covid-19 immunisation. The patient stated "The day after second vaccine and that week, I had chills, aches, fever 101, left neck and chest swollen lymph nodes, stomach aches. 28Jan2021, I started having severe left flank pain and abdominal pain. On 04Feb2021, I had a heart attack, was in V-fib arrest, and subsequently found to have fibromuscular dysplasia (FMD), which caused 3 artery dissections and narrowing of other arteries. Did not know I had FMD prior to the heart attack. Most people who have FMD never show signs or symptoms and don't know they have it. Others with FMD have it affect maybe one artery. Something caused my FMD to go into overdrive, affecting 3 arteries. It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die - that was my 28Jan2021 pain. Coincidental my FMD acted up this way a little over a week after receiving the second Pfizer shot?" Events were reported as serious and resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalization for 9 days. Treatment received for all events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on an unknown date (Covid test post vaccination). The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.