chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An investigator reported that a 6 month old male received a 2nd dose of Prevnar vaccine on 11/23/01, as "Post marketing Evaluation of Prevnar Pneumococcal 7-Valent conjugate vaccine (CRM197 protein conjugate); Safety of Prevnar Administered Concurrently with Routine Infant Vaccinations  at 2,4 ,6, and 12 to 15 Months of Age."  Concomitant medication included Infanrix, Polio vaccine and Hib-Titer. The coroner's office reported that the infant "hadn't been feeling good" for 2-3 days, was not eating and fussy while at "sitter's" house. Sitter said he ate very little. The infant was put down to sleep and 1/2 hours later, was fine. In another 1/2 hour, a blanket was found around the infant's face and he was found not breathing but with a heartbeat. "911" was called, resuscitation was attempted and the infant was pronounced dead. The pathologist that handled the case, determined the cause of death as SIDS. The investigator noted that a MD at the hospital said he sent the final report to the coroner's office; however, the coroner's office said that the hospital would have the workup. The investigator is still attempting to track down the documentation. The investigator and the medical monitor agree that sudden infant death syndrome (expected per local package insert) as "not related" to study vaccine. Additional information received 03/29/02 from investigator. The infant was described as previously healthy, except for recent fussiness related to teething. He was dropped off at the babysitter's residence at approximately 0700 on 01/24/02. He was not eating well.At 09:00 he took four ounces of Enfamil in the car seat. he was then put to bed in a portable crib and asleep at approximately 09:15. Two months ago he took antibiotics for an ear infection which has now cleared. At approximately 1000 he was checked and seemed to be fine, supine position.At 10:30-1100, he was found with the quilt over his face and unresponsive. 911 was called, He was in full cardiac arrest upon arrival of the paramedics. Coroners' autopsy report confirmed cause of death as SIDS.
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Product removed from freezer 8 AM,15-OCT-2021 No Treatment information was provided. No concomitant medication was provided
This case was reported by a physician and described the occurrence of an injection site reaction in a 4 year old female pt who received Infanrix. On 8/4/04, the pt received the 5th dose of Infanrix, in the left thigh. On 8/4/04, the pt also received an injection of IPOL, in the right thigh. At an unspecified time following the injection of Infanrix, on 8/4/04, the pt experienced an injection site reaction on the left thigh that was characterized as inflammation, redness and was "warm to touch". The pt was seen at a physician's office and was treated with unspecified anti-inflammatories and antihistamines. The event resolved on an unspecified date in 8/04. The reporting physician considered the injection site reaction to probably be related to the lot of Infanrix administered.
Janssen vaccine was administed to patient after being punctured and out at room temperatre for approximately 4 hours, which was 2 hours passed the recommended storage of 2 hours at room temperature. Thus, the vaccine was considered "expired" at this point in time, which was noticed the following day of administration. The patient did not have an actual adverse reaction and currently does not have any adervse reactions either.
LMP 2/18/2022. Patient had positive pregnancy test 3/23/2022. Heavy vaginal bleeding and pelvic cramping starting 4/4/2022.
Information has been received from a consumer concerning her 12 year old daughter with no known medical history and allergies, who on 10-JUN-2008 was vaccinated with a first dose of GARDASIL.  On 10-JUN-2008 the patient experienced fever of 102 for three to four days.  She also started getting depressed, and she begun having mood swings, memory loss, achy back and muscle pain.  After she received the second dose of GARDASIL, she came down with a fever of 103 and the symptoms continued and had not improved.  There were no laboratory diagnostics performed.  The patient did not seek medical attention.  At the time of this report the patient had not recovered.  Follow up information received on 19-JAN-2009 stated that a phone call was received from the reporter, she mentioned that a physician did not administered the GARDASIL vaccine, a nurse did.  Additional information has been requested. 3/2/09 Per reporter/parent pt has not sought tx for fear of being prescribed psychiatric meds.  7/1/09 MR received for ER visit 5/8/09 with dx: Tachycardia, paroxysmal. Pt presented with c/o onset of palpitations, chest pressure/pain, mild SOB and H/A-frontal.   7/27/09 Medical records received, including cardiology consult, DOS 5/11/09 to 6/29/09. Assessment: Tachycardia. Patient complains of elevated heart rate and chest pain. Fever, body aches, did not feel right. Depression, mood swings, memory loss, muscle pain, back pain, aggessive behavior, isolating herself, abdominal cramps. Fatigue, anxiety. Depression. Sweats. Sometimes does not recognize people. Indigestion and heart burn. Knee and arthritis pain. Sleeping more.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/25/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 4/11/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/25/2023 CKD STAGE 4 (GFR 15-29) HYPOXIA 4/11/2023 CKD STAGE 4 (GFR 15-29) ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/25/2023 LOWER GI HEMORRHAGE HYPOXIA 4/11/2023 LOWER GI HEMORRHAGE
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF THE COVID-19 VACCINE. THE FIRST VACCINE ADMINISTERED WAS JANSSEN ON 3/23/2021, THEN PFIZER WAS ADMINISTERED ON 8/5/2021. UNKNOWN WHETHER PATIENT EXPERIENCED ANY NEGATIVE SIDE EFFECTS. NO TREATMENT PURSUED. OUTCOME UNKNOWN.
This study case was received from the investigator on 30 November 2011. A 25-year-old male subject received the following vaccinations: On 14 October 2011 an injection of ACAM2000 (lot number not reported) and INFLUENZA, INTRANASAL (manufacturer and lot number not reported); On 05 October 2011 an injection of anthrax (manufacturer and lot number not reported), an injection of hepatitis A and hepatitis B vaccines (manufacturer and lot number not reported) and TYPHIM Vi, sanofi pasteur SA lot number not reported. The subject has no significant medical history. On 25 October 2011, the subject had an abnormal Troponin I of 14.04 and abnormal electrocardiogram (ECG). On 26 October 2011, the subject had a normal echocardiogram. On 31 October 2011, the subject was diagnosed acute pericarditis, unspecified. The outcome was not reported. Note: There is not reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Pneumonia; cough; fever; headache; bodyache and muscle aches; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), COUGH (cough), PYREXIA (fever), HEADACHE (headache) and MYALGIA (bodyache and muscle aches). At the time of the report, PNEUMONIA (Pneumonia), COUGH (cough), PYREXIA (fever), HEADACHE (headache) and MYALGIA (bodyache and muscle aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Forty-eight hours after receiving the second dose of the vaccine, the patient experienced fever, cough, headache, bodyache and muscle aches.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  This case concerns an adult male with a serious unexpected event of pneumonia. Latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-025099 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns an adult male with a serious unexpected event of pneumonia. Latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
She got her vaccine, within 10 minutes her heart felt like it was racing.  She noticed over the next 2 days that she was unable to move with nausea and body aches from head to toe and had to lie in bed those days.  She had been exercising regularly and now she had fatigue and had to stop exercising as her heart was acting strange and not able to do so.  On 5/21/21 her heart was beating so fast and went to UC and they tested her blood work.  She said that she had left chest pain, pain down her beds, and pain down her arms.  They did blood work stated that she had very high troponin levels, and her BP was dropping to low levels and they called 9-1-1 and she was taken to another hospital and they did the same tests and found that her troponin levels were even higher, and that her heart was experiencing some kind of arrest.  Her BP was dropping and she was admitted to the ICU where she was there 4 days.  While she was there they did angiograms, echocardiograms, and every one came back stating that her heart was good.  They told her that she may have had a mild heart attack and they did not know why and she said that she felt it was due to thev accine.  on 5/24/21 she was discharged and on 5/25/21 she called 9-1-1 again and her BP was high and her heart rate was high, and she was taken to the ER again.  She was tested again and they did not see anything, and they felt that she had myocarditis or pericarditis and that she needed an MRI of the heart and to contact her cardiologist and her PCP.  She came home that night and went to the ER again the next day and felt that she was heaving a heart attack, arm pain, heart racing, and did the same things again and told them what tests she was supposed to have, and they have not done an MRI of her heart yet.  She is waiting to get a referral from her PCP for the cardiac MRI and she is experiencing the same reactions that she has been having.   They have put her on a baby aspirin to take daily, Lopressor 25 mg twice a day,  Lipitor 40 mg to take once a day,   She continues to have the bouts of the chest pain, erratic heart beat, weakness and not able to take a shower due to the weakness and the heart racing and the shortness of breath.    They were telling her during this time that parts of her heart were dying, and all kinds of other things, and that's when they put her in the ICU.  She went to UC, and was transferred to ER and admitted to the ICU and stayed 4 days.  She was discharged from there on 5/24/21.  Then back to the ER on 5/25/21, and discharged from the ER.  Then she went back again last night 5/27/21 to ER and they treated her partially, they did an EKG and tried to explain her situation and they told her that she was fine, and she told them that her troponin levels were high and he more or less dismissed her and said that his troponin levels would be high if he exercises excessively.  She left the ER as they were not going to do anything for her.    She has a phone appointment scheduled for Tuesday as they have nothing until later in June.
anxiety, tachycardia, palpitations.  all symptoms resolved during observation period of 30 minutes.
Information has been received from the mother of a 4 year old male with allergies to wheat, cow's milk, yeast, fungus, corn, carrots and mangos and no other medical history who on 3/29/01 was vaccinated with the 2nd dose of MMRII. Prior to vaccination, included Hep-B on 9/19/96, 10/28/96 and 5/30/97. On approx. 4/1/01, the mother reported that her son had strange episodes of where his eyes would roll back in his head. The mother reported that she was having problems with her son now. No further information is available.
This spontaneous report was received from a registered nurse refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with VARIVAX lot # M027886, 03-JUN-2018 and M-M-R II M008588 16-FEB-2018. No adverse effects were reported. Additional information has been requested.
Injection area just a small tender bump; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a 74 year old female patient who experienced at injection area just a small tender bump (vaccination site pain), after she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included flu vaccine (received once in life) for prophylactic vaccination. The patient's medical history, past medical treatment(s), family history and concomitant medication were not reported.  On an unknown date, the patient received a high dose senior vaccine of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient experienced at injection area just a small tender bump (vaccination site pain), (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Client reported dizziness to EMT. The client ambulated and sat down in the anti-gravity chair. The anti-gravity chair was reclined to a semi-fowler's position. Lead RNs responded. The client reported blurry vision, dizziness, and chest pressure. The client reported that he has been experiencing chest pressure and body aches for the last few days. The client also stated he felt he was, "not able to fully fill my lungs." Vitals obtained at 11:56AM were as follows: BP 122/70, HR 88, O2 99%. The client stated his chest pressure was currently at a 7 on a 10 point scale. The client started drinking water. The client stated the chest pressure has been at a 6/7 out of 10 the last few days. The client stated the chest pressure has been intermittent over the last few days and that sitting makes it worse. The client denies any current medications, chronic conditions, or known allergies. The client stated his symptoms were "getting a little better." The client stated he did eat about one hour before coming to the vaccination site but has not consumed any water today. The client reported "trouble focusing" his vision. The client also stated that his dizziness was a little better. Repeat vitals obtained at 12:02PM were as follows: BP 118/66, HR 93, O2 99% The client reported that his chest pressure was "a little better" and rated it at a 3/10. The client stated his breathing was "better." The client stated his dizziness was going away. The client denied any other signs or symptoms of anaphylaxis.  Repeat vitals obtained at 12:07PM were as follows: BP 122/60, HR 88, O298%. The client was sitting in a high fowler's position. The client stated the dizziness was at a 2/10 and "still there a little bit." The client declined any snacks. RN provided education regarding possible adverse reactions, when to seek care, and V-Safe. RN also recommended the client follow up with a primary care physician regarding his ongoing chest pressure. The client voiced understanding of this education. RN provided the client a list of community clinics. The client reported a history of anxiety and stated he "sort of had the same chest pressure before." Vitals obtained at 12:17PM were as follows: BP 124/62, HR 68, O299%. The client stated the dizziness was at a 1/10 and that he was able to focus his eyes. The client also stated he has been experiencing palpitations over the last few days and is experiencing some now. RN noted lungs clear to auscultation and no gallups, rubs, or murmurs noted. The client stood up unassisted and denied any current dizziness. The client stated he "felt normal." The client stated his mother was driving him home. The client ambulated unassisted with a steady gait out of the vaccination site at 12:26PM.
About 24 hrs p/receiving vax, pt awoke from nap & cried for about 105 min; cry was high pitched & pt was inconsolable during this time; no apparent source of discomfort;
Received vaccine on 10/13/04 at 0815.  States had soreness at injection site immediately.  On 10/14/04 in the evening noted swelling and heat on dorsal aspect of L upper arm from area of injection site to elbow.  Area is errythematous and warm to touch currently.   Denies new medications, new skin care products, laundry soap, or new foods.  States has been afebrile.  Has never had a vaccine reaction to previous vaccines.
No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine).    This case was created for 11th patient of the 20 patients involved. Concomitant medication was not provided. Pharmacist called to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine, located in the freezer thawed.  They were all in intact carton. Vial size was 2.5 ml and had not underwent any temperature excursions. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:Patient 3 out of 20
Some fatigue and weakness since getting Pfizer vaccine for COVID-19 (not present before getting vaccinated).
Novocaine like numbness. Started at injection site up to ear, jaw then within hours whole body numb.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the right arm on 24Mar2021 at 16:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (ASPIRIN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 17:00, the patient experienced novocaine like numbness started at injection site up to ear, jaw then within hours whole body numb and by next day it was better. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event body numbness was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
temp to 104 noc of inject; intermitent vomiting since then; PE nl 11 days p/vax;
This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, less than an hour after receiving Meningococcal B vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Meningococcal B vaccine. Additional details were reported as follows: The case was reported by the patient's father. The age at vaccination was not reported. Less than 5 minutes after vaccination, the patient experienced a terrible reaction. The patient would not be getting the 2nd dose. The patient never had a problem with any other vaccinations ever, but this one scared the patient's father.