chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Based on additional information received on 3 September 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 4 August 2015. This case linked to 2015SA088110, 2015SA117517, 2015SA117518 and 2015SA117520 (same reported, different patient). A two-month-old female patient, whose concomitant medications were reported as none, had received a 0.5 ml intramuscular dose of PENTACEL (batch number C4917AB, site of administration was not reported) on 10 June 2015 at 12:17 pm. Illness at the time of vaccination and preexisting physician diagnosed allergies, birth defects and medical conditions were reported as none. It was also reported that patient did not receive any other medication. On 10 June 2015 at 1:50 pm, 93 minutes after vaccination, the patient experienced swollen thigh, redness and hot, irritable, very fussy, painful to touch and rash. Laboratory investigations were not performed and corrective treatments were not reported. On an unspecified date, the patient was recovered from the event. Documents held by sender: none. Follow-up information received from a physician on 03 September 2015. This case involves a patient who was vaccinated with first dose of 0.5 ml of PENTACEL via intramuscular route in right thigh. The patient had also received a dose of HEPATITIS B VACCINE, PREVENAR and ROTAVIRUS VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's had not received any vaccine four weeks before vaccination and illness at the time of vaccination reported as none. The patient had no reaction after receiving Hepatitis B, PREVENAR and Rotavirus. The patient had not recovered from rash. Documents held by sender: none.
24 hours after shot red, swelling size of grapefruit blister dime size x 3 days. Tx-ice, BENADRYL, ADVIL.
Patient felt very nauseated. He said every thing looked grey, he said he could not see any colors.  He said his head hurt really bad.   HIs mother said he did eat before coming in. He drank some gatorade and ate some graham crackers. He said he felt better after about 15 minutes.  He and his mother then walked around the store for 10-15 minutes.  I called his mother around 5:00pm and she said he napped for an hour and felt fine.
Severe Pain; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not available), via an unspecified route of administration, administered in left arm on 17Feb2021 at 09:30 AM (age at vaccination was 57 years) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not received other vaccine in four weeks. On 18Feb2021 at 09:45 AM, the patient was experienced severe pain. No treatment received for adverse event. No COVID prior vaccination and patient was not COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab resulted negative on 01Feb2021. Outcome of the events was recovering.
Headache, stomach upset, fever, all over body aches, sever fatigue.  Unable to get out of bed for3 days/
12:30 am: fast heart beat, palpitations, ringing in ears, itching, dry mouth/eyes. Then more symptoms developed as time went on over 96 hrs +: scratchy throat, stuffy nose, headaches, nausea, neck ache, L foot tingle/vibration, eye pain, prickles all over body, muscle/joint pain, chills, dizzy, sweating, teeth/jaw pain, low back pain.
The patient stated they felt the vaccine go into the arm.  Later that day/night the patient said she experienced extreme nausea and abdominal discomfort and needed promethazine and ondansetron.
Initial unsolicited report received from a consumer on 01-Feb-2018. This case involves 61-year-old female patient who was vaccinated 0.5 ml of FLUZONE frequency one (batch number, expiry date, dose in series and site of administration were not reported) on 31-Oct-2017. Patient's medical history includes- Rheumatoid arthritis diagnosed on an unspecified date of July-2017. Concomitant medications were not reported. On an unknown date, one day following the vaccination patient devolved a sharp pain in her fourth finger on right hand and few weeks following the vaccination patient experienced dizzy, dry, mouth, increased heart rate, stiffness and feet were hurting. It was also reported that patient went to a cardiologist and had an x-ray. Other Lab data was not reported. As a corrective treatment patient received PREDNISONE for sharp pain. Outcome of all the events were not recovered at the time of reporting. List of documents held by sender: none.
Felt joint pain alomost immediately. Followed by diffuse joint aches and muscle weakness and extreme fatigue for months.
Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   Company Comment: This case concerns a 84-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 84-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
patient was sitting down after the flu shot  and fell over in front of the chair. we called her name to see if she responded and held her up and set her in the chair with head down between her leg. she wanted water and was dehydrated ( lips dry and pale) so mom get her orange juice and was feeling fine. she has some scrapes so i put on bandages on her shoulder and knee.  she went home walking and was fine per mom. I called mom 2 times after and mom said she is home and resting, doing fine. i asked her to call me if any questions or concern.
Neurological tics; This spontaneous report has been received from a pharmacist via Pfizer and refers to a 16-year-old male patient. The patient's current conditions included an autoimmune disease (unspecified). His medical history included coronavirus disease-2019 (COVID-19). Concomitant medications were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (manufacturer unknown) as prophylaxis (dose, route of administration, anatomical location of vaccination, lot number and expiration date were not provided); and with COVID-19 vaccine (dose, route of administration, anatomical location of vaccination, indication, lot number and expiration date were not provided).  On an unknown date, the patient experienced neurological tics (tic).  The outcome of the event was not provided.  The reporter considered tic to be not related to measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (manufacturer unknown), but to be related to an autoimmune disease. The causality assessment between the event and COVID-19 vaccine was not provided.
First day had hives and welts forming on back and chest, then the next day covered her entire body from head to toe. Was not allowed into daycare until I received a doctor's note.
Severe chills; Body aches; Fever; severe headache; Extremely tired; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 01May2021 at 07:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer survivor and known allergies to penicillin, bee stings and adhesive. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and collagen (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 10Apr2021 at 08:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 13:00, the patient experienced severe chills, body aches, severe headache, fever of 101 and was extremely tired. On 02May2021, the patient underwent lab test and procedure which included body temperature and the result was 101(unspecified units). No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe chills, body aches, severe headache, fever of 101 and extremely tired was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
About an hour after the patient had flu shot she began itching but she said she didn't think anything about it because she itches alot due to the PSC. Then her lips began to swell and her eyes. She also had whelps all over her body. She went to urgent care and they put her on steroids and Atarax and told her to take OTC Zyrtec and Zantac (double dose twice a day). The whelps lingered for about 3-4 days.
Patient received the PREVNAR 13 vaccine and 24 hours later developed severe musculoskeletal pain throughout his lower chest/rib area as well as abdominal pain. Various lab and radiographic testing done during the past 5 months, have turned up no cause for his pain. We wonder if the PREVNAR 13 vaccine might have something to do with causing our patient's symptoms.
This spontaneous report as received from a certified medical assistant (CMA) refers to a 6 month old patient of unknown gender. The patient's pertinent medical history and drug reactions were not reported. On an unknown date, the patient was vaccinated with a first dose of ROTATEQ vial (lot # reported as K024700, expiration date 30-JUL-2016, route of administration default to oral, dose was not provided). The patient's concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
I did not have an adverse reaction to the vaccine. I was diagnosed with a gallbladder infection in 02/2023. I had my gallbladder removed as an outpatient surgery on 03/31/2023. I am feeling better.
Fever; pregnant at the time of vaccination; pregnant at the time of vaccination/Other vaccine same date; pregnant at the time of vaccination; Other vaccine same date; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (pregnant: yes) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date unknown) via unspecified route of administration on 06Jan2021 10:30 AM (Right arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included Diabetes mellitus. No covid prior vaccination, no covid tested post vaccination and no Known allergies. The concomitant drug was reported as atorvastatin (LIPITOR), Metformin, clonazepam. After getting the vaccine (on 07Jan2021 15:00) patient was experiencing fever as a side effect. Patient had other vaccine same date. Patient was pregnant at the time of vaccination. No treatment was received. The outcome of event fever was not recovered.  Information on Lot/batch number has been requested.
Pt recvd vax & 2 days p/inject in the AM, had a cold, runny nose, stuffiness;
Patient administered FLUMIST vaccine 11/14/2008 via nasal route. Only vaccine given. Developed Urticaria about 3 hours later.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-OCT-2013, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-APR-2016, the patient was treated by a certified physician's assistant (PA-C) at a healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 outcome of the events was unknown. The reporter considered the events as related to ZOSTAVAX. Additional information has been requested.
migraine aura/migraine that was strong enough that she could not see; flashing lights; blocked vision/migraine was strong enough that she could not see; This is a spontaneous report from a contactable consumer reported for herself. A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on left arm on 18Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication reported as unspecified (Caller states that she does take a few medications but nothing has changed with those in years, so she does not think anything else is relevant). Historical vaccine include flu shot and does have reactions. Caller stated she received Pfizer COVID shot first dose and within an hour she had migraine without the headache but did have the vision blocked out. It resolved after some time. she wanted to know the ingredient of the vaccine to see if she should take the second dose. Caller states that she had her first Pfizer COVID Shot on 18Jan2021. Caller states that she didn't have any of the ordinary reactions, both the caller and her husband had the shot and neither of them got a sore arm or swelling at the site. Caller states that after they stayed for a half an hour, and when they were driving back to, the caller started to get a migraine aura. Caller states that she has had them before, but not often, and she has not had one for about 10 years. So caller states that her aura started while they were driving, and then the caller's husband dropped the caller off at the grocery store. After being dropped off, caller states that her migraine came on strong. Caller states that her migraine was strong enough that she could not see, she was experiencing flashing lights, and blocked vision. Caller finally turned to another customer to ask if he could see the cucumbers in front of them. Caller states that she waited outside for her husband to get her. Caller states that migraine probably lasted for about 45 minutes. Caller is wondering if this could have been from the shot or not. Caller states that she does have reactions to flu shots sometimes, but not like this. Outcome of the events was recovered on 18Jan2021.
Immediate redness (measuring approx. 3x2) noted at injection site; no redness or respiratory distress noted.
Pain at injection site, heat observed for at least 3 hours, fading away through the night. Chills and lethargy the following morning.
1 of 6 pts who was immunized from the same vial & devel a fever which lasted a couple of days & an inject site reaction which included intense itching, extreme erythema w/silver-dollar size nodule, swelling, warm & tender to touch;
Pt recv vax on 1/9/99; on 1/10/99 pt exp nasal drainage, headache, sneezing, fever; tx=2 day rest
Inability to walk, talking and cognitive abilities declined - Same day as the shot by 7:00 pm unable to really walk. We had to wheel her on her walker.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently, on an unknown date the patient experienced an enlarged lymph node and became very sick.  It was stated that a doctor said it was an allergic reaction to PNEUMOVAX 23. The patient sought medical attention via office visit. At the time of the report, the patient's status was unknown. Additional information has been requested.
This spontaneous report as received from a nurse (LPN) referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 17-MAY-2016, the patient was vaccinated with their first dose of RECOMBIVAX HB (dose, route, lot # and expiration date was not provided) for prophylaxis. On 17-JUN-2016, the patient was vaccinated with their second dose of RECOMBIVAX HB (dose, route, lot # and expiration date was not provided) for prophylaxis. On 27-APR-2017, the patient was seen in the office to receive their third dose of RECOMBIVAX HB (inappropriate schedule of drug administration as the third dose was due in DEC-2016). At the time of this report, the third dose of RECOMBIVAX HB has not yet been given. No adverse effect reported. No product quality compliant (PQC) involved. Additional information has been requested.
Pale, lethargic, eyes dysconjugate, fever in the first 6 hours and very quiet over the next 24 - 36 hours.
severe nausea and vomiting lasting 4 hours; moderate headache lasting 12 hours; mild left arm pain at site of injection
Sore arm; Fever; Chill; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chill) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chill). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Np treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on 16-07-2021 contain non significant information
Information has been received from a registered nurse concerning a 79 year old white male pt with cardiomyopathy, anemia and a penicillin allergy, and a history of congestive heart failure, skin cancer, and mylaogenous leukemia who on 10/29/02 at 13:30pm was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (643784/0676M) SC in the left arm. Concomitant vaccine therapy included an eighth dose of influenza virus vaccine (Fluzone lot U0883AA in the right arm). There were o adverse events following prior vaccinations. Other concomitant therapy included synthroid, Coreg, temazepan, allopurinol, hydralazine, ferrous sulfate and epostin alfa 60,000 untis every two weeks. On 10/31/02 at 9am, the pt developed redness, edema and heat over the left deltoid and pain at the injection site. The discolored area was reported to be 12cm x 29cm. A diagnosis of cellulitis was made. The pt was treated with Levaquin 500mg daily for seven days. The pt was to have been seen for follow up two days after the antibiotics were started. It was reported that on 11/2/02, the pt recovered. The pt's cellulitis was considered to be an other important medical event (OMIC). Additional info is not expected.
pt had a positive COVID test on 11/16/21 at Rehabilitation Hospital; 12/19/21 pt brought to Medical Center with SOB; requiring increased amounts of O2 at SNF; CXR showed multifocal pneumonia; had been treated with ABX for pneumonia at the end of November 2021; pt still requiring increased amounts of O2 at 15 L via mid-flow and O2 saturation of 83%; begin to experience bright red bleeding from rectum, painless, subsided the next day; pt less responsive and weak; over the next couple of days pt made slight progress, more responsive; DNAR, comfort care; inpatient hospice where pt expired
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 01-AUG-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
ACHY; FEVER; This spontaneous report received from a parent concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included brain tumor, and allergy to tree nuts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-JUL-2021, the subject experienced achy. On 14-JUL-2021, the subject experienced fever.  Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and achy. This report was non-serious. This case, from the same reporter is linked to 20210738675.