chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Marked redness/swelling onto top of shoulder and all the way to elbow at 48 hours post vaccine. No fever. Some pain. Tylenol/cool compresses.
Information has been received from the physician concerning a 6 year old male patient who on 05-OCT-1999 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported respectively). On 02-FEB-2005, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 15-JAN-2010 the patient experienced mumps. The patient was diagnosed with mumps on 17-JAN-2010. Lab results for 17-JAN-2010: IgM was<1:10, IgG was 7.02 and Serum Amylase was 239. The patient has left parotitis. It was reported that the patient was exposed to others with mumps. The final outcome for mumps was not reported. This is one of several reports from the same source. No further information is available.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-AUG-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 (reported as shortly after receiving ZOSTAVAX vaccine), the patient was admitted to a hospital with a sudden decrease in mental status, disoriented and confused. On or about 01-NOV-2016, the patient was diagnosed with viral encephalitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, viral encephalitis was determined to be a medically significant event. Additional information has been requested.
Information has been received from a Registered Nurse for the Pregnancy registry for GARDASIL concerning a female with a history of obesity who in September 2007, was vaccinated with the first dose of GARDASIL (lot 658556/1060U).  The patient became pregnant at the end of November 2007.  The patient's estimated date of confinement was 03-SEP-2008, and the patient delivered on 20-AUG-2008.  At some unspecified point in the pregnancy, the patient experienced premature contractions and was treated with bed rest. Unspecified blood tests and fetal ultrasounds were performed.  No other information was available at this time.  Upon internal review, premature contractions which required bedrest was considered disabling.  Additional information has been requested.
Heart beating fast, feeling like having heart flutters of some sort. Never experienced this prior. Mentioned to doctor. Only noted, no treatment given. Brought baby aspirin to help because I know it can help with heart
Shortly after vaccination, pt developed dizziness, tremulousness, nausea and anxiety. Symptoms were persistent and EMS was summoned and the pt was transported to the hospital.  There were not symptoms to suggest anaphylaxis. SP02: 97%, HR 92, BP 141/82.
Cried uncontrollably for three hours. Could not move leg four hours after the shot, extreme pain, limped the next day.
Immediately following the vaccination pt. was VERY tired.  He slept much more than unusual.  He was very cranky and, in the evening, began to run a fever which lasted 3 days. He continued to have what appeared to be illness until his death. Death occurred 03/03/2023
tongue was swollen; swollen lips; hives; palm of her hands were itching; red circle on both of her armpit; Case reference number MOD-2021-019368 is a spontaneous case report sent by a Other Health Professional on 31-JAN-2021 , which refers to a Female aged 77 Years .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19. Some    later,  the patient developed tongue was swollen. Over a period of the next  days, the patient also developed swollen lips,hives,palm of her hands were itching,red circle on both of her armpit. Relevant laboratory results included   and relevant physical signs  The patient experienced the following serious criteria:. The eventual diagnosis made on was Swollen tongue . .  The patient was treated for the event. An autopsy was performed on  . In their opinion, other possible etiological factors included   and the patients age/ history or other factors .    The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.   Based on comment, causality assessment is missing, Possibly Related to all events
TC from pt states rash started 11/02/04 and progressively spread and now covers her arms, legs, ears, face, and into her eyes. Rash fine red rash with a few blisters. Rash is itchy, no fever, bilateral swelling of neck, below ears.
Patient had arm pain after vaccine. MD believes injection could have been in bursa sac. Arm function limited. Improving but still not fully normal.
Nausea and feeling of wanting to vomit.  Been resting, took Zofran and thought she was hungry, but still having the same symptoms.
Allergic skin reaction/break out at the site of the injection on outside of the arm and continuing under the arm down the arm. Bumpy itchy and redness.
Information has been received from a health professional concerning his 18 year old daughter who was vaccinated with first dose of Gardasil. Subsequently the patient experienced injection site pain. The patient's outcome was not reported. No product quality complaint was involved.
miscarriage; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 16:00 (Batch/Lot Number: EW1058) as 2nd dose, single or covid-19 immunisation. The first dose was received on 15Mar2021 17:00 (lot number: ENLe208). The patient's medical history was not reported. Concomitant medications were none. No other vaccine was administered in 4 weeks. Six days after receiving the 2nd shot of the Covid vaccine from Pfizer, patient conceived on 21Apr2021. After 4 weeks and 4 days of pregnancy, patient had a miscarriage on 08May2021 14:30. While a miscarriage can happen at the early stages of pregnancy, this stage was exactly when the placenta was forming and patient was wondering that the rumors about the COVID vaccine rejecting the protein of the placenta were correct. No treatment was given. Outcome of the event was not recovered. Patient did not have covid prior to vaccination and had not been tested post-vaccination.
Anaphylaxis, developed papitations, flushed face, abdominal cramping, sob,itchy rash on chest and ears, swollen lower lip and eyes. Administered 25 mg of Benadryl by mouth, rash increased so epinephine 1:1000 0.2ml given subcutaneously. Within 15 min rash was gone, within 30 min all signs and symptoms gone, vital signs stable. No hx of asthma or anaphylaxis.  8/21/07 Received pcp medical records which reveal patient experienced  good health on day of vax.  Parent had requested 2nd varivax.  Minutes after vax developed palpitations, flushed face, abdominal cramps, itchy rash, swollen lip.  Tx w/oral Benadryl, SQ epi.  Symptoms completely resolved.  No past history of vaccine side effects, asthma or anaphylaxis.  Referred for allergy testing. FINAL DX: Anaphylaxis to 2nd Varivax.
Palpitations, Nausea, Headache, Tired, weak, cold sweat, stomach ache, thirsty.
13NOV91 came down w/viral pneumonia seen by MD x 2, antibiotics x 10 days; As of today 11DEC91 still running fevers & productive cough;
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of GARDASIL vaccine (yeast). Subsequently, the patient developed a rash on her face and on her arm at the injection site. The rash lasted 2 to 3 days. The patient told the physician about her rash at the next office visit. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Pt admitted to hospital 8/18/21 due to acute hypoxic respiratory failure.  Per H&P, tested positive at drive-up testing site on 8/14/21
Localized red /hot area at vaccination site saw Dr. 2/8/2012 treated with topical steroid cream.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses in GARDASIL 9, lot number M005714, expiration date: 03-OCT-2017 and lot number M004116, expiration date: 22-OCT-2017, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
The pt developed severe generalized itching, mild wheezing and HA within 30 min of receiving FLUZONE 0.5 ml IM on 10/2/09. The pt presented to ED and was given Albuterol hhn, ATROVENT hhn and BENADRYL 50 mg IV. Symptoms resolved.
patient received their second dose today. during the 15 minute wait period, the patient started to begin sweating a lot. we gave him a couple of water bottles and sat him in front of a mini fan. patient then began to feel chills so we gave him 2 tylenol tablets.
pt recv vax; red raised lump at site of vax w/in 1 hr; high pitched cry cont for 1/2 hr followed by extreme irritability x 1 day;
Diffuse puritis and rash associated with dizziness.  Swollen eyelids and arms, itchy feet, diaphoretic, hypotensive with B/P 55/35.  Sudden onset 4 hours after injection. 11/6/09 DC summary and medical records received for date 11/4/09 to 11/5/09. DX: anaphylaxis from H1N1 vax.  Dizziness, hypotension. Presenting SX to ER: diffused purities and rash dizziness after having H1N1 vax. Assessment: swelling arm, face, eyelids. Pt given IV tx and sx resolved dc home.
Pain at injection site, nausea, diarrhea, dry mouth, running nose  and itchy eyes.
pt brought to ED with increasing SOB, confusion, on O2 via NC; found to have a DVT left upper extremity and PE right lower lung; positive for COVID; coughing; placed on Airvo 55L/91% FiO2; given remdesivir, solu-medrol, baricitinib; pt's condition worsened and she was placed on comfort measures without aggressive treatments; pt died in the hospital
1. Right side of face tingling numbness began the afternoon after receiving 2nd dose.  After 1 week sought neurologist consultation. Had MRI of Brain w/wo contrast.  Nothing found.  2.  On June 21, 2021, left eye vision became impaired.  Sought eye specialist consult who advised that the left eye's optic nerve was swollen and the right eye was beginning to swell.  He stated it was neurological and consulted with my Neurologist.  Had additional MRI, blood tests performed. No clots, tumors, diseases or illnesses found.  Had a spinal tap to relieve any spinal fluid pressure.  Pressure was normal at time of the spinal tap.  3. As of this date, the left side vision of left eye is still impaired.
1st day p/inject upper arm swelled followed by red ring atarting @ 2" diameter to 5" diameter; sx of nausea & itching;
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red Rash; Red spot; feel Warm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash), RASH MACULAR (Red spot) and FEELING HOT (feel Warm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red Rash), RASH MACULAR (Red spot) and FEELING HOT (feel Warm). At the time of the report, RASH ERYTHEMATOUS (Red Rash), RASH MACULAR (Red spot) and FEELING HOT (feel Warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that after the Vaccine, experienced a Red rash, Red spot , feels warm, and it is below the injection site. Concomitant medications and treatment information was not provided.
LARGE WELTS (HIVES) OVER LARGE PORTIONS OF BODY: BACK, ARMS, ANKLES, ACCORDING TO FATHER
tested positive for covid; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032141A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (Patient had received one Johnson&Johnson COVID-19 vaccine dose). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26 (JNJ 78436735).    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 05-Jan-2022, the patient experienced COVID-19 (tested positive for covid). On 31-Dec-2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. At the time of the report, COVID-19 (tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: tested positive for covid (Positive) tested positive for covid.         Concomitant information was not provided. Treatment information was not provided. The patient reported that she feels ok.  State was reported.  Company comment: This is a spontaneous case concerning a 56 year-old, female patient with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. Additionally, interchange of vaccine products was reported in this case since the patient received a dose of Janssen COVID-19 vaccine on an unknown date. The event occurred approximately 5 days after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 56 year-old, female patient with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of COVID-19. Additionally, interchange of vaccine products was reported in this case since the patient received a dose of Janssen COVID-19 vaccine on an unknown date. The event occurred approximately 5 days after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Patient had a history of shingles and she had a very sensitive skin. All pertinent medical history occurred prior to the ZOSTAVAX. Patient did not have drug allergies. About a year ago in 2014, the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous (lot # and expiry date unspecified). Concomitant medications included unspecified blood pressure medications. Within 24 hours of receiving the vaccine, she developed redness, swelling, and blistery looking things broke out around the injection site. On an unspecified date, the patient went to the pharmacy to show the symptoms that she developed. She was informed to take BENADRYL for the events. No lab tests were performed. The reporting pharmacist also stated that on unspecified dates she administered an unspecified amount of doses of ZOSTAVAX to an unspecified amount of patients who had a previous history of shingles. No adverse effects were reported for these unspecified patients. The female patient recovered from the events about 3 or 4 days later after developing the symptoms. Causality assessment was not provided. Additional information has been requested.
Onset around 5am the next day. Severe headache, nausea, vomiting initially. Then around 7am, I had body aches and chills. Then around 1pm I developed a fever (100.0). Took two tylenol and by 2pm had a fever of 101.0
soreness in the arm/pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm/pain in her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (soreness in the arm/pain in her arm). On 11-Feb-2021, PAIN IN EXTREMITY (soreness in the arm/pain in her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment information were provided.   This case was linked to MOD-2021-387051, MOD-2021-387066 (Patient Link).
Gave incorrect age related vaccine. Gave 5-11 y/o and should have been 12+
muscle aches, runny nose, cough, headache, fatigue, loss of taste and smell, congestion
Information has been received from a consumer for the pregnancy registry for GARDASIL concerning his 17 year old girlfriend with anemia, irregular menstrual cycle and no known drug allergies/ drug reactions who on 21-Apr-2009 was vaccinated with the first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication reported. It was reported that about two to three weeks after getting the vaccine (approximately on 06-May-2009), the patient went to a clinic and had a urine pregnancy test done, which showed she was pregnant. It was reported that the last menstrual period was on 27-Mar-2009. It was reported that on 18-May-2009 the patient had her menstrual cycle. It was reported that the patient has not seen a physician since received her menstrual cycle on 18-May-2009. It was reported that the consumer was uncertain if his girlfriend was still pregnant or not as she had not seen a physician since the menstrual cycle on 18-May-2009. The estimated delivery date was on 01-Jan-2010. No further information is available.
Headache, seizures, fever, dizziness, lupus like syndrome; Started - approximately 4 months after last injection, patient hospitalized several times placed in intensive care unit 11/17/08 records received-for DOS 7/27/08-admitted via ED for C/O abdominal pain for 5 days, no bowel movement in 5 days. Seen by PCP on 7/24/08 with no diagnosis. Seen 2 days prior in ED with negative workup. Signed out AMA. Notes for DOS 8/18/08-DX-Drug-induced lupus, questionable. Possible underlying systemic lupus. Viral syndrome, questionable viral encephalitis. Inflammatory renal disease. Myalgias with possible peripheral neuropathy. Possible reaction to vaccination. Anemia. Elevated erythrocyte sedimentation rate suggesting underlying inflammatory disease. Abdominal pain possibly secondary to renal inflammation. Presented with C/O abdominal pain, intermittent joint and neck pain and headache.Records for 8/30-9/02/08 DC DX: new-onset seizure activity. Possible benign vasculitis to inflammatory vasculitis. Possible cerebral infarct evolving nature with edema involving multiple areas of brain as per MRI. History of lupus positivity possibly drug induced lupus. Questionable viral meningitis with negative CSF. Generalized pain and fatigue. Peripheral neuropathy. Possible meningitis inflammatory nature. Renal failure with reversal. Normal creatinine. Transferred.12/8/08-records received for DOS 9/2-9/12/08-DC DX:PRES. Hypertensive Disorder. Presented with 2 month history of headahces, joint pains, and abdominal pain. Presented to ED 3 days prior with severe headache, vomiting and multiple generalized tonic clonic seizures. Headaches began end of June and diagnosed with sinusitis. Subsequently developed leg aches, wrist aches, joint stiffness and mild rash on legs. Extreme headache, double vision vomiting. Symptoms improved but developed severe stomach pains and constipation.  Improved with Prednisone but symptoms began after Prednisone taper. Rheumatology thinks this is a vasculitis secondary to OCPs. Ophthalmology mild esophoria visible with alternating cover tear. Malignant HTN. Anxiety. Photosensitivity,
Itching 15 minutes after dose given. Possible mild throat itching. Dizziness. Administered 15ml of liquid diphenhydramine HCL. Monitored for 6o minutes with resolution of dizziness. Vital signs remained stable throughout.
Patient admitted to HCF as observation on 11/06/2021 due COVID-19 infection with delirium.  Patient was tested for COVID-19 and was positive on 11/6/2021.
Rapid onset of right arm redness, swelling, warmth, pain, and malaise. Elevated WBC count, treating for cellulitis.
pain in injection site, up shoulder, down elbow on rt arm, small of back pain,  left quad pain up hip, shooting pain up spine, torso pain
AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/22/2021.pfizer Lot#EK9231 2nd dose:01/11/2021.pfizerLot#EL3248 Diagnosed covid positive: 03/08/21 Exposure:Home Exposure Symptoms:GI upset
Pt presented 24 hrs post vaccination administration (R) deltoid Hep A/meningococcal (L) deltoid Tdap. Pt c/o pain to (R) deltoid, (R) shoulder/neck/face. Mild swelling (R) deltoid. Slight swelling (R) face. No cervical adenopathy. No specific lesions, no fever.
pt rcvd vax; pt exp diarrhea, nausea, back pain, & neck pain;
He went to the doctor because he thought he had a UTI. He had been running to the bathroom and it was burning an hurting. When we got to the doctor the blood pressure was really low and his heart rate was in the 150's. The doctor sent him to get checked at the emergency. The urgent care did a COVID-19 Test on September 08, 2022. They plugged him to a monitor and started him on IV medication to slow his heart rate down, The IV medicine got his heart rate down and his blood pressure had improved. They sent him home on Metoprolol and Xarelto. So far he has been good with no other issues with his heart to date.