chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (feel sick) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (feel sick). At the time of the report, ILLNESS (feel sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No concomitant medications reported. No treatment reported.
Rash (injection site) and is swollen and itchy; Rash (injection site) and is swollen and itchy; Rash (injection site) and is swollen and itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (Rash (injection site) and is swollen and itchy), VACCINATION SITE RASH (Rash (injection site) and is swollen and itchy) and VACCINATION SITE SWELLING (Rash (injection site) and is swollen and itchy) in a 70-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Rash (injection site) and is swollen and itchy), VACCINATION SITE RASH (Rash (injection site) and is swollen and itchy) and VACCINATION SITE SWELLING (Rash (injection site) and is swollen and itchy). At the time of the report, VACCINATION SITE PRURITUS (Rash (injection site) and is swollen and itchy), VACCINATION SITE RASH (Rash (injection site) and is swollen and itchy) and VACCINATION SITE SWELLING (Rash (injection site) and is swollen and itchy) 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 Treatment medications was not provided    This case was linked to MOD21-042633 (E2B Linked Report).; Sender's Comments:  MOD21-042633:Crosslinked
Patient received Typhoid and Anthrax at group event on Aug 26. Patient states he began with "head cold" symptoms on Aug 26 after began to have 'severe' diarrhea. On Sunday 9-4 come down with severe cough with vomiting, went to ER then on 9-4.
8 days after injections pt developed a fever and then red bump on leg at site of injection and then a rash 3 days later. When pt was seen in office 12 days post injection she had firm area 4cm with splotchy erythema on anterior right thigh, scattered elsewhere, especially trunk. There is a sparse pinpoint erythematous slightly palpable rash.
positive COVID 19 with symptoms; positive COVID 19 with symptoms; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left, at the age of 61-year-old, on 12Mar2021 09:00, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was reported as none. The patient's concomitant medications were not reported.  The patient had a scratchy throat on 23Mar2021; then she got a cough on 24Mar2021 and had not slept very well; she got a low grade fever of 99.9 and 100.2; then on 25Mar2021 she had a teladoc appointment because she thought she had a sinus infection. The doctor ask her to come in for tests. On 26Mar2021, she had the influenza A and B test and both were negative; and the COVID test which was positive for COVID 19 infection. By 26Mar2021, the cough had become a barking cough. Mentions she lost her taste on about the 27Apr2021 (as reported); she remembers because she was trying to eat a grilled cheese sandwich with lots of butter; adds she could just taste bitter on the edge of the tongue. Even sweet tasted bitter on the middle of her tongue. Her friend sent her something to try; she a roasted orange until it was black on the outside, and ate the warm orange mixed with brown sugar and it tasted like sweet grapefruit and then drank some water; after that her taste was there. When she got the COVID 19 test that was positive she couldn't believe it because she had had the vaccine, but her son told her the vaccine is working because you are not dead. Patient wanted to change her second dose appointment because the patient is now in quarantine and has COVID 19 infection. The events required physician office visit. The patient did not receive other vaccines the same date COVID-19 vaccine was administered and 4 weeks prior vaccination. Outcome was unknown.
Patient received an intranasal FLUMIST, Tdap IM and MCV4 IM. He had a brief syncope episode (possible vaccine reaction) after receiving IM vaccines, sent to ER via EMS.
Pt showed me a red rash on her upper right arm starting around the injection site. It ended near her elbow. She stated that it was painful. She also had a small amount of redness on the right side of her neck. She said it started to develop in the evening on the same day she received her immunization. She has not taken anything prescription or OTC. I called her PCP's office, and spoke to nurse to let them know. Nurse said she would inform the PCP and contact the pt.
Left armpit lymph nodes swollen starting day or two Recombinant zoster (shingles) vaccine.  Shoulder and neck soreness starting 3 days after vaccine.
Injection site aching, chills, body aches, fatigue, tiredness, nasal congestion. 12/23/2020 in AM  All symptoms starting to resolve - feeling better;  Nasal congestion, Fever 102.1, Tylenol and Ibuprofen some relief; fever at time of reporting 100.5.
Information has been received from a nurse concerning a 25 year old female who on 02-FEB-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL vaccine (yeast) (lot #655503/012U). Concomitant therapy included DEPO-PROVERA. Illness at the time of vaccination included flu-like symptoms. Immediately after vaccination, the patient had syncope and passed out for approximately one minute. It was also noted that her eating was sporatic. The patient has not passed out with previous injections in the past. The physician did not believe the injection cause the syncope. Unspecified medical attention was sought. On 02-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007 Information has been received from a nurse concerning a 25 year old female  child care provider with no known drug allergies who on 02-FEB-2007 was vaccinated IM with a fiest dose 0.5 ml dose of GARDASIL vaccine (yeast) (lot # 655503/0012U). Concomitant therapy included  DEPO-PROVERA . Illness at the time of vaccination included common cold-type symptoms. Immediately after vaccination , the patient had syncope and passed out for approximately one minute. It was also noted that her eating was sporatic. The patient had not passed out with previous injections u=in the past. The physician did not believe the injection cause the syncope. Unspecified medical attention was sought. On 02-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Body Tremors, dizziness, headaches, balance issue, tremors get worse when I feel cold, I blurt out words,
Patient received first dose of Moderna on 3/10/21 then received this second dose too early on 3/31/21. Patient is feeling fine, just received Moderna 7 days before due date.
No adverse events/no signs or symtoms reported; temperature excursion on VARlVAX / Improperly Stored Administer Vaccine; This spontaneous report as received from a consumer (reported as administrator) referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies and drug reactions and allergies were not reported  On 25-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, route of administration, site of administration) (lot # T025946, expiration date 30-JUL-2020) 0.5 milliliter for prophylaxis.         On 25-MAR-2021, the vaccine underwent a temperature excursion of 11.5-degree Fahrenheit (F) for a period of 1 hour and 10 minutes. The excursion was not called by a digital data logger and there was no history of previous temperature excursion. The patient did not experience any adverse event.; Sender's Comments:  US-009507513-2104USA000712: US-009507513-2104USA000712:
Initial information was received on 12 May 2014 from an investigator participating in a trial. A 20-year-old male subject, with no relevant medical history, received the following vaccines on 22 April 2014: ACAM2000 (lot number, route and site of administration not reported); typhoid vaccine (manufacturer, lot number, route and site of administration not reported); and anthrax vaccine (other manufacturer, lot number, route and site of administration not reported). One day post-vaccination, on 23 April 2014, he developed chest pain and shortness of breath, headache, and fever. He was seen in the emergency room and diagnosed with bronchitis. On 01 May 2014, ECG and troponin I levels were normal (troponin <0.10 ng/mL). Treatment included MUCINEX, beginning 26 April 2014. The event was considered to be possible myopericarditis, was moderate, and was still ongoing at the time of the report. The investigator considered the event to be possibly related to study vaccine. Documents held by sender: None.
Smallpox vaccination (health care response team member) 3/11/03.   Course of response "normal," nothing unusual.  Take response read as "major."  Patient was a revaccinee, previous vaccination 1962.   On Sunday June 1st 2:30am aoke to burning and tingling sensation in chest, left arm and jaw.  Drove self to ER. Given 3 nitro and morphine; cardiac enzymes and EKG normal at that time.  Admitted.  2nd set of cardiac enzymes tropinin elevated (28), CKMB elevated (400); diagnosis: MI. Transferred to Medical Center at noon. June 2nd: EKG showed inferior wall MI.  Q wave appeared 2 weeks later.  Cardiac cath: no damage/no occlusion - ? vessel spasm or clot. June 3rd: discharge in PM. Returned to work June 9th. Treadmill early July, normal. Q waves remain. Current meds: Cardizem, Plavix, Prozac, Pamelor. Family history: father died of MI @ 54 years.  Brother hx of cardiac problems since age 40.  States no previous cardiac events. Previous treatment: hypertension and depression.  Meds before event: Prozac, Pamelor, Plendil.
7/26/21: Patient presented to the ER with shortness of breath over the past several days associated with malaise. Patient tested positive for COVID on 7/24/21, currently on 6L O2. COVID antibodies not detected on 7/26 test.  Diagnosed with: respiratory failure with hypoxia, pneumonia, COVID-19 positive Note: patient was previously vaccinated with the Pfizer COVID-19 vaccine; 2nd dose administered in Feb 2021. 8/9/2021: the patient is still admitted at the time of this form submission. Please note: Patient received First dose of Pfizer COVID-19 vaccine on 1/28/2021, followed by the second dose on 2/18/2021 (confirmed through database)
78 y/o female who was a resident of a long-term-care facility for 3+ years, rec'd influenza vaccine on 11/4/06.  On aprox 11/17/06 patient's husband stated that the patient became lethargic, refusing food. 11/19/06 patient expired. Patient's huband stated "she died of dehydration and kidney failure".
VACCINE REMAINED IN FREEZER BEYOND MANUFACTURER RECOMMENDATION. AFTER CONSULTATION WITH PFIZER AND CDC, REVACCINATION WAS RECOMMENDED TO ENSURE PROPER EFFECTIVENESS.
Parasthesia to right foot and left hand.  Also sharp Intermittent pain in right side of temple.
1/23/2021: Seven days after receiving Moderna vaccine, arm was bright red, hot to the touch and swollen in area approx 6" in diameter.  Went to ER and was prescribed 5-day Keflex regimen for Cellulitis.  Area cleared up after four days of antibiotics. 1/28/2021: Itchy red rash appears from injection site down to elbow.  Doctor visit.  Was prescribed Aristocort cream and Claritin.  Rash cleared up after several days of treatment. 2/13/2021: Received second vaccine and developed same symptoms one day later.  Used Aristocort cream and Claritin.  Rash cleared up five days later.
pt recv vax & six months later pt devel elevated liver enzymes, which the c/o felt was not due to the vax;
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 15-FEB-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Fever, chills, muscle aches, runny nose, sore throat, headache, fatigue, coughing and wheezing.
COVID-19 infection on 13Jan; COVID-19 infection on 13Jan; flu-like symptoms; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jan2022, outcome "unknown" and all described as "COVID-19 infection on 13Jan"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms".  clinical course: Symptoms include flu-like symptoms for 3 days, but patient states overall mild due to vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine ( diphtheria crml97 protein) injection) was received from a consumer regarding a 6 month old female pt who received a dose of Prevnar on 07/06/04. On the same day, she also received a dose of  haemophilus B conjugate vaccine (manufacturer unknown) and Pediarix (GSK) and developed  a fever, crying and body shakes post immunization. Event Details:  A 6 month old female pt received a dose of Prevnar, Haemophilus B conjugate vaccine and Pediarix on 07/06/2004. At an unspecified time on the same day, the pt developed a fever of 105 degrees F, crying, and body shakes. The pt was treated with Motrin. The events resolved in 24 hours. This report was received from GSK (report # A0517527A) The reporter declined to provide additional info in order to perform follow up.
This spontaneous report as received from a certified medical assistant to a 16 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Had some fatigue, fatigue did not go away after a month when it was noticeable. Went to doctor, then sent to ER from there. At ER they found the platelets were extremely low, antibodies were attacking the platelets. Stayed in hospital for four days, given steroids trying to prevent bleeding. Platelets still fluctuating, RBC, WBC, etc. are low. Now going to get an iron infusion for previous issues. Trying to get blood balanced to where normal antibodies kick in, and now anemic.
Restless sleep and crying occurred PM after AM immunization.  Itchy eye, runny nose, watery eye, red/inflamed eye, low fever, occurred AM after immunization previous AM.  No treatment has been completed.
Fever (up to 102 F); headache;  mental confusion; lack of responsive speech or delay in responding to questions.   Symptoms began around 11:30 a.m. on Feb. 21.  Administered one Tylenol at 2:30 p.m. on Feb. 21.  By  6 p.m. on Feb. 21, the fever and headache abated.  But confusion and lack of speech continues to Feb. 22 (10:30 a.m.) as I prepare this report.
Rash - Information has been received from a 27 year old female consumer who on 15 mar 2000 vaccinated with one dose of varicella virus vaccine live (site unknown).  there was no concomitant medication. on 24 mar 2000 the patient experienced a rash that is red with some raised spots around the injection site.  the patient sought unspecified medical attention. at the time of the report 27 mar 2000 the patient's rash presisted.
Patient presented with his father for COVID-19 vaccine. Father completed the admin/consent form and listed patient's age in 2 locations as 12 years old. Our clinic administered the adult/adolescent dose of the Pfizer COVID-19 vaccine. Upon entering the patient's shot into our system, we noted  the child is actually 11 years old. The father put the wrong age on the form. Patient should have received the pediatric dose of the vaccine. Spoke to patient's father to inform him of the error. He stated his son is doing fine, and not having any adverse symptoms or reactions.
AFTER 10 MINUTES OF GETTING SHOT, PATIENT FELL ON THE FLOOR.  WAS SHAKIN FROM THE FALL. ALL RED (BODY & FACE), SWEATING WITH MOUTH OPEN HAVING TROUBLE BREATHING. GAVE EPIPEN 0.15 mg. WATCHED FOR PULSE & SLURING WITH WORDS
Massive chills then fainted which resulted in  fractures of pubus bone in pelvis .went to ER
received a dose of Moderna vial after vial had been punctured 20 times already; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already). At the time of the report, ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) to be not related.    There are no treatment or concomitant medications provided.   This case was linked to MOD-2021-392366 (Patient Link).
Fever >101. Urticaria like rash x2 days, brief difficulties of breathing 1 day after vaccines given; cough x2 days.
approximately 20 minutes after vaccination in the clinic (which is inside store), the patient fainted and hit her head in the store at 320pm.  I was summoned by store personnel to assist. BP 90/60, HR 95, patient was awake and alert when I saw her.  Patient was assisted back to clinic after a few minutes to wait on EMS eval. Mom declined emergency transport.  Patient remained alert and oriented.  EMS assisted patient to private vehicle and out of clinic at 335pm.
The day after the second vaccine I got bodyaches and a headache. The next day I had pain in my hands and feet and they felt like they were swollen, but I had no swelling. Over the next week the sensation of swelling continued in my hands and feet and I have severe joint pain and mild swelling in my lower extremities. I have not felt well since.
Cold-like symptoms, positive COVID test (rapid test and PCR test); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient Relevant medical history and concurrent condition reported as none.  Concurrent medical conditions included Allergy (Unspecified drug).    On 09-May-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2022 at 9:00 AM, the patient experienced COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2022, SARS-CoV-2 test: positive (Positive) time: 09:00 Positive and positive (Positive) time: 09:00 Positive.         It was unknown if the patient was taking any other medications or products within two weeks of starting COVID-19 treatment with Paxlovid. Company comment: This spontaneous case concerns a patient of unspecified age and gender,with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)) which occurred 20 days after the fourth dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. SARS-CoV-2 test was positive as on 29-May-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender,with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)) which occurred 20 days after the fourth dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. SARS-CoV-2 test was positive as on 29-May-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Gestational hypertension systolic 150, diastolic 100-109. Was first observed at during labor but did not continue through the course of that hospital stay. Patient was discharged 2/9 and instructed to monitor blood pressure at home once a day. Patient reports feeling slightly short of breath at home and symptoms were worsening. Patient experienced lightheadedness on 2/11. 2/11 was instructed to come to the hospital