chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ED with altered mental status, shortness of breath and urine incontinence.  Patient was given fluids, antibiotics and started on Bipap.  Patient tested covid positive.  Chest xray revealed advanced chronic interstitial disease with hyperinflation with opacities.  Patient was transferred to the ICU.  Patient was started on Remdesivir, Decadron and lovenox.  Patient was made a hospice patient and expired due to acute respiratory failure on 02/23/2022.
Initial unsolicited report received from other non-healthcare professional on 28 October 2016. This case involves 84-year-old (also reported as 85-year-old) female who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route and site of administration was not reported) on 29 September 2016. Illness at time of vaccination includes possible bladder Infection and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported mild dementia and hypertension. Concomitant medication reported as none. On 01 October 2016, two days following the vaccination, patient became very groggy. On an unspecified date, (a week later) following vaccination patient become more lethargic. On an unspecified date, following vaccination patient was diagnosed with inflammation and bleeding of the right side of her brain and herpes simplex encephalitis. Patient required emergency visit. On an unspecified date patient was hospitalized. Lab data reported as magnetic resonance imaging (MRI), computerized axial tomography (CAT) Scan, Spinal tap Corrective treatment reported as acyclovir. Outcome of events reported as unknown. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with FLUZONE HD, 2 days after patient was groggy, become lethargic, unable to walk, and left side weakness. Patient was then had undergone CAT scan and spinal tap which she was diagnosed with Herpes Simplex Encephalitis and inflammation and bleeding of the Right side of her brain. Time to onset is compatible, but additional information regarding patient medical history like hypertension, past history of stroke or any other nervous system disorder, infectious history of any herpes infection, any recent history of trauma is needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
None.  Pt. didn't need Hep A 3.  Already has received Hep A 1 7-26-00, Hep A 2 6-9-03.
Pt had fever of 101 Turned purple and flaccid for few seconds 911 was called it took few minutes for pt to be completely back  to normal
Injection of D. T. given on 12/10/02, Sx started 12/11/02 - Sore arm, Swollen arm, Hot to touch, Aching of joints, Flu-Like feeling, Nausea, Pt seen on 12/12/02 - same local sx, Swelling about baseball size & very firm-Systemic sx subsided
Information has been received from a nurse practitioner concerning a female who was vaccinated with a 0.5 ml dose of Gardasil (yeast). Subsequently the patient developed an "allergic reaction". Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a nurse practitioner and a licensed practical nurse concerning a 17 year old female student with asthma and drug hypersensitivity to BEXTRA (gastrointestinal distress) who on 16-JAN-2007, at 16:05, was vaccinated, intramuscularly, into the left deltoid, with a first dose of GARDASIL (lot #655619/1427F).  On 17-JAN-2007 the patient called the physician's office with complaint of "lungs burning" and felt like she had heartburn.  She reported that she felt her heart was racing and had developed blurry vision.  The patient went to urgent care and told by the physician that the events were a possible reaction to GARDASIL.  The patient was advised to take BENADRYL and TYLENOL PM.  It was reported that the patient was resting comfortably after she was seen in urgent care.  On 18-JAN-2007, she had some residual chest tightness.  The patient did not experience shortness of breath or difficulty breathing.  Subsequently, the patient recovered.  No further information is available.
Difficulty breathing - asthma attack was induced 45 minutes later after injection and had to use rescue inhaler 2X; Tingling sensation of tongue w/i 10 min of injection; Lips felt puffy w/i 10 min of injection; Increased heartbeat - RN measured it at 95 BPM after injection w/i 10 min of injection - normally it is at 66 BPM resting; Bad rash on left arm around injection site after returned home 1 hour later - took orally one Benadryl tablet 25mg  Dizziness w/i 15 min of injection - had to lay down at hospital; Felt sick to stomach w/i 15 min of injection - had to lay down at hospital
Next day, Right arm hurts from shoulder (in back) through elbow down arm through thumb, and is hot to the touch, sight of infection red and puffy. By Sunday, (4 days after shot) all symptoms are gone. No pain or swelling left.
one day after injection pt c/o itching and rash.  rash is on chest , rt. upper arm and upper back.  experienced low grade fever x 1 day after injection.   using over the counter Hydrocortisone 1% cream on sites with minimal relief.  No other complaints voiced.  Pt is in no distress.
MUSCLE SPASMS; SEVERE BODY ACHES; SEVERE PAIN; CAN BARELY EAT ANYTHING; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021, the subject experienced muscle spasms. On 05-APR-2021, the subject experienced severe body aches. On 05-APR-2021, the subject experienced severe pain. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced can barely eat anything. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle spasms, severe pain, severe body aches, and can barely eat anything. This report was non-serious.
12 days p/receiving vax, developed rash (Fine) all over body; Temp of 102R given APAP for 36hrs;
She had a inflammation at the injection site she said it was more swollen the day after -- taking BENADRYL and ibuprofen.
Severe rash throughout body, very itchy, brown spots throughout the body still exist after three (3) months.  Possibly Lichen Planus.
Pt recvd Td vax & devel a bruised mass @ the site of inject;
Shortness of breath; back pain; Chest pain; Diahhrea; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number were not provided, Expiration date were not provided), via an unspecified route of administration, administered in Arm Left on 26Jul2021 13:00 (at the age of 34-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. No Prior to vaccination, was the patient diagnosed with COVID-19. On 28Jul2021, the patient experienced shortness of breath, back pain and chest pain, diarrhoea. The patient not received treatment. The outcome of the events was recovering.   No Follow-up attempts are possible. No information is expected further.
Information was received from a physician concerning a 15 month old male with no medical history who on 24 NOV was vaccinated into the thigh with a first dose of MMR.  Concomitant vaccine therapy included a dose of varicella vaccine.  There was no illnesses at the time of vaccination.  There was no other concomitant medication.  On the morning of 26 NOV 2004 the patient experienced right parotid gland swelling.  He was afebrile.  Unspecified medical attention was sought.  No treatment was required. One week later the patient recovered.  No product quality complain was involved.  Additional information was not requested.
Client's mother phoned on 2-6-08 to report child had headache and fever-p.m. of 2-5-08, by 2-6-08 fever 104.2 degrees.  Took client to Emergency Room - there she had IV rxs to reduce the fever and was given Tylenol & treated with ibuprofen and sent home.  Within 30 min.-at ER-fever down to 103.1 then 101.8.  Phoned mother on 2-7-08 she reported child's temp 98.8 today.  Child will see her MD next week.
Moderna's vaccine viles for a 11 year old are meant to be 0.25mL, the vile is at least 5mL and the entire vile was drawn up for this patient. Patient received 5mL instead of 0.25mL . This was not discovered until after vaccine administration due to an email being sent clinic wide that the Moderna Vaccine viles are overfilled.
Pt states she got home and had swelling at the injection site and she went to the ER and they told her it was cellulitis. Pt is under 50 years old but had a prescription from her MD and was immunocompromised which is how she qualified to get the vaccine here
Mom states, the pt had a 105F fever (rectally) at about 04:00 on 1/11/02. He had a "seizure" with "stiffened muscles" "eyes rolled back in head" and then became "limp".
Varicella vaccine given in right deltoid.  On the day after the vaccine was given, the patient developed swelling and erythema circumferentially on her right upper arm.  She also had fever and 3 episodes of diarrhea.
After within a week of the vaccination I had a lymph node on left armpit wore really swollen. After a week that went away. Then in December I started feeling shortness of breath very simple task will leave me out of breath and that had prompted me to see a doctor on January 10th and we had an ultrasound and the ultrasound didn't show anything. On January 13th I went and got a CT scan of chest and abdomen and it show some lymph and show I had small amount of fluid around my heart and lung. The 14th I went in and had blood work done and in the afternoon I had an Echocardiogram and it showed I was having heart failure atrial fibrillation. I had to go to ER and they shocked my heart to its normal rhythm. I stayed in the hospital for 3 days. Before I went home, I had an MRI on my heart, and I didn't have any inflammation on my heart it looked normal but it was really weak. They put me on medication to help support my heart so it can build itself back up to normal strength. I went to an appointment it my heart is building his way up to his strength.
Uncontrolled chills x 3 hrs even after acetaminophen. Body joint pain, eye pain and general malaise x 18 hrs.
Breakthrough COVID-19 case with symptom onset 7/20/2021:  Muscle or body aches,  Fatigue or tiredness,  Nausea or vomiting. Living in a nursing home at time of positive COVID test. Death 08/12/2021
Seizure (convulsive) 1 minute following vaccination of approx 30 seconds.
Patient says she's experience fever-like symptoms, feeling warm and flushed. Arm is sore and is swelling that is a little bigger than a quarter-size. This happen about 12 hours after getting the PNEUMOVAX-23 vaccine.
Swelling on face started and has not subsided. Face swelling on lower lip, under both eyes, on left side of chin and stye on right eye.
I had the shot at 8 am and about 6 pm I had a terrible headache until I went to bed about 8:30 and too some Tylenol.  It was gone in the morning.
Patient Received an Expired Dose of Heplisav-B; Initial report received on 30-Oct-2023.  A nurse in the reported that a 63-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 30-Oct-2023, the patient received the second dose of HEPLISAV-B (Lot #937234, expiration date 12-Sep-2023, and NDC #43528-003-05) from a nurse (route and site not specified).  The dose was expired.  No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Developed hypertension and pounding heart beat/palpitations starting Jan 15, 2021.   Symptoms worsened over several weeks; necessitating 2 Emergency room visits on Feb 1 and Feb 20.  BP upon arrival ED ~ 200/110.  Pt has no history of hypertension.  Over the next several months, hypertension slowly resolved.  Several antihypertensive medications used to obtain blood pressure control. By May 8, 2021, pt reliably normotensive.  The pounding, hyperdynamic heart beat has persisted.  Pt can feel a regular, hyperdynamic heart beat, as much as 24 hours/day.  It is reliably worse while supine at night.  Pounding heart beat's severity has improved, slowly, over time, but has not resolved.  Pt being treated with beta blocker for symptoms.  There has not been any arrhythmia.  There is very intermittent chest pain best described as feeling "inflammatory";  at times there is chest discomfort with palpation over the sternum.  No dyspnea.
Large itchy red rash on arm around injection site. Hot to the touch. Appeared out of no where on day 8.
pain in her shoulder; dizziness; vomiting; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on Mar2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if pain in her shoulder, dizziness and vomiting are 'normal' symptoms associated to the vaccine. The patient reported that the day she received her vaccine on Mar2021, she experienced shoulder pain and dizziness. The day after, she felt better. Then she vomited on Mar2021, Wednesday night and Thursday morning. The patient wanted to know how long these symptoms are going to last. The outcome of the events pain in her shoulder and dizziness was recovering while the outcome of the event vomiting was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid arm; expanded rash to underside of arm and up to elbow; rash at injection site; feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), PYREXIA (feverish), VACCINATION SITE RASH (rash at injection site) and RASH (expanded rash to underside of arm and up to elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (feverish). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE RASH (rash at injection site) and RASH (expanded rash to underside of arm and up to elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE RASH (rash at injection site) and RASH (expanded rash to underside of arm and up to elbow) outcome was unknown and PYREXIA (feverish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication, triglyceride medication and potassium. The patient felt feverish eight days after the first dose and that lasted for 2-2.5 days. It was reported that the rash had begun to lighten up.
Felt ill on 6DEC91 h/a, nausea, weakness, generalized aching; 10DEC early AM devel rt shoulder & chest pain; to hosp;
Chills; Temperature max of 100.4; Swollen axillary lymph nodes in same side of injection; Fatigue; This is a spontaneous report from a contactable Nurse reporting for herself. A 36-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 07Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history included COVID-19 prior vaccination. Concomitant medications included dextromethorphan hydrobromide, paracetamol, phenylephrine hydrochloride (TYLENOL COLD AND FLU DAYTIME), naproxen sodium (ALEVE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. The patient historic vaccine included the first dose BNT162B2, via an unspecified route of administration at Left arm received on 22Dec2020 16:30 for covid-19 immunization and Covid test was Positive on 28Dec2020. The patient experienced Chills, Temperature max of 100.4, Swollen axillary lymph nodes in same side of injection, Fatigue on 08Jan2021 11:30. No treatment received for the events. The outcome of the events was recovered on an unknown date in Jan2020.  Information on Lot/Batch number has been requested.
11-17-09-Fever during night. 11-18-09-Fever. 11-19-09-Fever 100.6, herpangina. Rx: MOTRIN 1 tsp Q 6-8 h, Rains solution 1 mL swish/swallow Q 4 h.
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9264), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6203), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 13Apr2022 at 15:45 as dose 4 (booster), single (Lot number: FJ5682) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic peripheral neuropathy" (unspecified if ongoing); "Bee venom" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (12May2022) Positive, notes: Tested positive with home Binax test. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. Treatment start date was May2022 and treatment stop date was May2022. The patient finished Paxlovid with morning dose on 07May2022. Symptoms started returning 11May2022. Tested 12May2022 as symptoms seemed to get worse (sore throat, runny nose, slight cough). Tested positive with home Binax test. Other medication in 2 weeks was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a 34 year old female patient. The patient had no pertinent medical history or drug reactions or allergies. On an unknown date (reported as "as a child"), the patient was vaccinated with M-M-R II injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On an unknown date (reported as "recently"), the patient had titers drawn for school which came back negative (date was not specified). It was reported that the school required her to receive the revaccination with M-M-R II. The patient sought medical attention (unspecified how). No treatment was given due to the event. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and M-M-R II. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 26-year-old male patient. No information regarding the patient's pertinent medical history, concurrent conditions or concomitant therapies was provided. On 19-JUL-2016, 19-AUG-2016 and 21-OCT-2016, the patient was vaccinated respectively with the first, second and third dose of GARDASIL 9 intramuscularly, lot # L014198, expiration date 05-SEP-2017 (dose was not reported). There were no adverse effects reported. Additional information has been requested.
Dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to the company on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.            Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: No specific follow-up information recorded.
This spontaneous report as received from a healthcare worker and nurse refers to an unspecified number of patients of unknown demographics. Healthcare worker reports the patient may have received doses of PROQUAD that were exposed to an unspecified temperature excursion. Healthcare worker could not provide details for the temperature excursion. Nurse reported that PROQUAD and VARIVAX (Merck) went through a supported temperature excursion. No adverse effect reported. It was not reported if the patients had received the doses or not. Outcome was unknown. No PQC was involved. Additional information has been requested.
sudden appearance on the 8th day after first dose of Moderna    nothing until day 8  ... very itchy, red swollen area, small area, at the vaccination site... not a big deal  but was told to report any reaction.
MMR, Varicella, Hep. A & PREVNAR given on 1-8-10. Also given ACCUHIST & AMOXIL for otitis. On 1-16-10, began with hives on head which progressed to feet/entire body. Not pruritis, seen in ER @ Hosp on 1-17-10! Also with fever 1-18-10 still still with rash.
About 90 minutes after injection, developed headache worsening over the course of the day - body aches and low grade fever. Took ibuprofen 800 and felt some relief but went home and went to bed. Better the next day but took another dose of NSAID. Of course, arm is sore, but no site reaction.
Patient developed blurry vision and headaches 16 days after her vaccine. went to the ER a week later and was diagnosed with Optic Neuritis via CT imaging