chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness within 15 minutes of receiving vaccine; headache; high blood pressure; This is a spontaneous report from a contactable other health care professional. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), intramuscular on 24Dec2020 08:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included allergic to nuts and peaches.  There were no concomitant medications. On 24Dec2020 08:15, the patient experienced Dizziness within 15 minutes of receiving vaccine; couple of hours after patient reported headache and high blood pressure x2 days. After 2 days both headache and high blood pressure subsided. The patient received treatment for the event headache (Tylenol). It was reported that the patient had a physician office visit. The outcome of the event dizziness was recovered on an unspecified date, while the events headache and hypertension was recovered on 26Dec2020.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Severe, Systemic: Hypertension-Medium, Additional Details: Patient described 104 degree fever the day after vaccination and pain/swelling radiating down arm from injection site and armpit. Never had reaction to previous 2 Pfizer vaccines. She went to ER when fever did not subside. Bloodwork was performed and patient was diagnosed with an infection where she was treated with Zpak and has since recovered. May be due to poor technique/cleanliness from immunizer and site.
soreness on the arm; coughing; They both got allergies and it's like a sinus infection; we had sinus infection; They both got allergies and it's like a sinus infection; we had sinus infection; This is a spontaneous report from a Pfizer-sponsored program Support reported by a contactable consumer (patient) reported similar events for two patients. This is 1st of 2 report. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 30Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness on the arm and got allergies and it was like a sinus infection; we had sinus infection and coughing and anything like that. The patient started with antibiotics on 10May2021, as treatment for the events. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.Sender's Comments: Linked Report(s) : -PFIZER INC-2021540400 Same reporter/diff patient
Several minutes after injection pain in arm and hand. 8 hours after injection swelling and hives at sight of injection, high fever (103*), headache, body aches. Hives at sight if injection worsened over several days and became severe on entire upper arm. Fever and body aches lasted 5 days. Hives took 7 or 8 days to completely clear. Began taking antihistamine and using topical "cortizone" cream on arm at the onset of hives. Saw doctor on 9/24 and was prescribed antibiotics.
The pt developed fine macular/papular rash on the 3rd day after MMR/Varivax vaccinations. Pt also had fever on 2nd day which resolved the next day.
Difficulty breathing; patient experienced extreme dizziness; Chest discomfort; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), DIZZINESS (patient experienced extreme dizziness), CHEST DISCOMFORT (Chest discomfort) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004921A) for COVID-19 vaccination.     The patient's past medical history included Hives and Hay fever. Concurrent medical conditions included Asthma. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced CHEST DISCOMFORT (Chest discomfort) and FATIGUE (Tired). On 16-Jul-2021 at 10:30 AM, the patient experienced DIZZINESS (patient experienced extreme dizziness). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). The patient was treated with PREDNISONE from 16-Jul-2021 to 14-Aug-2021 for Adverse event, at a dose of 5 milligram. On 16-Jul-2021, CHEST DISCOMFORT (Chest discomfort) and FATIGUE (Tired) had resolved. On 16-Jul-2021 at 11:00 AM, DIZZINESS (patient experienced extreme dizziness) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient 's allergic reactions included  Anaphylaxis.  The patient took an antihistamine before receiving the vaccine and drank a lot of water once at home after the vaccination.  Patient received the second dose of Moderna Vaccine on 14-AUG-2021 on the left arm.  Treatment medication included Prednisone in which the patient was continuing still on a dose of 5 milligram.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated the primary reporter's phone number, added the patient details (height, weight, ethnicity and race), medical history, concomitant medication, treatment medication, event (dyspnea), updated the events date and outcome and added information in I-narrative supplement.
Patient's school brought the student down to obtain what they believed to be their second dose. Once the patient was vaccinated, their brother was next to be vaccinated. It was discovered then that both had already received both doses of their series.  This was confirmed by the parents of the children. The brother was not vaccinated but the patient on this report was.
R arm: site of injection - red, warm to touch. Pt states swollen underarm area (lymph nodes)
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 02/12/2021, 03/12/2021, and 11/11/2021. It is not known if this individual had a specific symptom onset, as they had severe dementia and weren't able to report.  They presented to emergency dept via EMS on 01/06/2022 due to generalized weakness and overall health decline including worsening confusion. They tested positive for COVID-19 via PCR test on 01/06/2022. They were discharged to hospice care without hospital admission and died on 01/08/2022.
I am already in a sustained allergic state, according to lab tests, so the "robust immune response" of the vaccine just compounded it.  I had a delayed hyperimmune response in that I became severely allergic to an OTC for acne called Salacylic Acid after vaccination that I never had after numerous applications before vaccination.  It was extremely dry, very red & excessively scaly. It wrapped around the left side of my neck, lower left side of my face, & across to both shoulders.
Sore arm; all the flu symptoms; sore neck; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves adult and unknown gender patient who experienced sore arm, all the flu symptoms and sore neck after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient developed sore arm (pain in extremity), all the flu symptoms (influenza) and sore neck (neck pain) (unknown latency) following the administration of influenza vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted 5 minutes after administration during 15 minute post-vaccine observation period.  Per witnesses he slumped over to his left side and fell onto the floor to his left side loosing consciousness briefly.  He was assessed by immunizing pharmacist and nurse practitioner and was found to have normal regular pulse & was pale in color. He regained consciousness shortly after a few seconds, EMS came over and assessed him later and was deemed ok to go home after 30mins.
Eyes became dilated and she said she could not see; off label use; Eyes became dilated and she said she could not see; tired; sweating; drug use in unapproved population; This is a spontaneous report from a contactable consumer (patient reported for herself). A 11-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: Fk5127), via unspecified route of administration, administered in arm right on 13Nov2021 at 11:45 AM (at the age of 11-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included eczema and allergic to strawberries/gluten. The concomitant medications were reported as none. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Nov2021 at 11:45 AM, the patient experienced eyes became dilated, and she said she could not see. Lasted a couple of minutes. No other symptoms other than about 5 min after that resolved, she said she was tired and started sweating, off label use and drug use in unapproved population. Patient did not received treatment for events. At the time of this report, outcome of the events eyes became dilated, and she said she could not see was recovered on 13Nov2021 at 11:50 AM while outcome of other events was unknown. Device date was 13Nov2021.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. In 2015, between 20-MAY-2015 and 14-JUL-2015 the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous, lot number J012818, expiration date 10-OCT-2015 (also0 reported 24-JUL-2015). There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter (case # 1507USA013304). Additional information has been requested.
At the time of the injection my head started tingling, after 20 minutes I was very lightheaded and dizzy.  This continued for most of that day.  The arm pain I experienced was the worst I have ever had from injections and lasted 72 hours.  I had a headache and fatigue, muscle aches.  The second shot was more fatigue, arm pain wasn't as bad but still quite painful.  Headache.  I also got the head tingling again and dizziness.  Very ache and fatigued. Stayed in bed on the second day.
Sinus congestion, poss fever (unknown temp), body aches for x1 day, resolved after 1 day of resting.
6:30 PM Sore throat and tongue swelling.  No wheezing or increased shortness.  No hives, nausea, or vomiting.  Took Benadryl x 2 and symptoms improved.
Red Rash on Bilateral Legs and Forearm; This spontaneous case was reported by a health care professional and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on Bilateral Legs and Forearm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on Bilateral Legs and Forearm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red Rash on Bilateral Legs and Forearm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Stomach pain , back pain, nausea, confusion, headache.. Started around 2pm in 02/20/2021. Ambulance was called,  stated she felt like she was dying and was having severe pain
Around 3 weeks after Moderna- heart began racing. At ER, one chamber was 300bpm. Dx him with A-flutter
The patient's father called the Health Unit on 12/13/2018 at approximately 3:45 p.m. to report that the patient had an approximate 5x3 circular red patch on her left arm. The father stated that the red patch was first noted on the morning of 12/13/2018 prior to the child's departure for school. The father stated that the patch was warm to the touch, very tender, and hard. The father denied any allergies or chronic medical conditions and stated that the child is very healthy. The father denied all other symptoms including nausea, vomiting, shortness of breath, and dizziness. The father stated that an ice pack was placed on the arm upon her arrival home from school but that no other treatments were provided at this time. Dr. medial director was made aware of these symptoms. The patient's father was instructed to inform the patient's pediatrician of these symptoms and to seek care at a local urgent care center. The father stated that he works in the medical field and was comfortable monitoring these symptoms but would seek care at the local urgent care center if the patch worsened. The father was encouraged to provide oral benadryl to the patient per Dr.'s recommendation. The patient's father was called on 12/14/2018 for a status update and the father stated that the patch was much better and that he would continue to provide benadryl as needed.
This spontaneous report has been received from a nurse, via a company representative, referring to a 37 years old female patient. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medications was unknown by the reporter. On 28-SEP-2018, the patient was vaccinated with PROQUAD (recombinant Human albumin [rHA]) injection, 1 dosage form (DF), for prophylaxis (dose number, route and anatomical location of vaccination were unknown by the reporter; lot number R003294, expiration date 31-JUL-2019). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, 1 DF, administered to the patient on the same day at a different injection site (dose number, frequency, route of administration, lot number and expiration date were not provided). On 30-SEP-2018, the patient experienced symptoms of weakness in both arms and legs and stiffness in her neck for which she sought for medical attention. On 02-OCT-2018, the patient went back to the clinic with "the same symptoms". On 03-OCT-2018, the patient went back to the clinic and "the symptoms were starting to spontaneously resolve". It was unknown by the reporter if the patient was given any treatment or performed any laboratory or other diagnostic studies for the adverse events. No product quality complaints were involved. The reporter's causality assessment between the occurrence of the adverse events and vaccination with PROQUAD and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid was not provided.
Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot# K010215, expiration date 05-MAY-2017; K008931, expiration date 04-MAR-2017; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-392935 (Patient Link).
feels numbness in her whole body and her head; Feels head pain; Feeling very funny; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (feels numbness in her whole body and her head), HEADACHE (Feels head pain) and FEELING ABNORMAL (Feeling very funny) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Aneurysm in 2008.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (feels numbness in her whole body and her head), HEADACHE (Feels head pain) and FEELING ABNORMAL (Feeling very funny). At the time of the report, HYPOAESTHESIA (feels numbness in her whole body and her head), HEADACHE (Feels head pain) and FEELING ABNORMAL (Feeling very funny) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant products reported
Information has been received from a registered nurse concerning her 23 year old daughter who "about one month ago" was vaccinated with the first dose of GARDASIL. After receiving the vaccine the patient developed shooting and burning pain in the arm the injection was given down to fingertips. At the time of reporting it is unknown if the patient recovered. Additional information has been requested.
numbing/ pins and needles feeling in hands stated feels change in blood pressure and also fast heartbeat
Presented to clinic on 7/17/06 with c/o Nausea, Vomiting, HA, x 2-3 days. Had smallpox vaccination on 7/8/06. Mildly dehydrated. 0.9% Normal Saline 1000cc IV given, Phenergan 25mg. To f/u on Wednesday 7/9/06.
This initial spontaneous report was received via an online news article. The article described an infant who suffered a severe reaction to the MMR vaccine (manufacturer not specified). The infant was a one year old healthy baby girl who was already walking and climbing. On 13-FEB-2013, she received vaccinations for MMR (manufacturer not specified), hepatitis A (manufacturer not specified), Hib (manufacturer not specified), PREVNAR, and varicella (manufacturer not specified).  That evening, the mother noticed the baby was irritable and feverish. After a call to the doctor, the mother was advised to give the baby TYLENOL and BENADRYL. The fever continued for several days and on the evening before the baby's scheduled pediatrician visit (exact date not specified but considered to be in 2013), the baby began having seizures. She was rushed to the Emergency Room (ER) where she went into cardiac and respiratory arrest and doctors placed her on a ventilator. The seizures and cardiac arrest left the baby with severe brain injury, encephalopathy, cortical vision impairment, truncal hypotonia, and kidney failure. After months of treatment at the hospital, she finally went home but her disabilities require specialized medical care and supervision around the clock for the rest of her life. The settlement would pay for the baby's constant high-level medical care for the rest of her life. The author of the article went on to say that the government and "Big Pharma" consistently tell the public that vaccines are safe and effective.  However, "the fact that vaccines kill and injure people, including young babies and infants, is not a fact that is in dispute". The outcome of cardiac and respiratory arrest was considered resolved. It was unknown whether the irritability, fevers, and seizures continued. The outcome of severe brain injury, encephalopathy, cortical vision impairment, hypotonia, and kidney failure were considered not resolved as the patient required specialized medical care and supervision around the clock for the rest of her life. Causality assessment was considered related to MMR for all events. Causality assessment was not specifically stated for the other vaccines. Brain injury, seizures, cardiac arrest, respiratory arrest, encephalopathy, cortical vision impairment, hypotonia, and kidney failure were considered disabling as the baby now required medical care around the clock for the rest of her life. Upon internal review, brain injury, cardiac arrest, respiratory arrest, seizures, encephalopathy, cortical vision impairment, and renal failure were considered to be medically significant. This is one of two reports from the same reporter (see case # 1509USA014655 discussing autism in boys in the same article). Additional information is not expected as there was no contact information.
1 st  symptoms developed chronic headache. treated with 500mlg ibuprofen. 50-300-40 Butalbacetamin-Caff. 2 nd symptom developed body rash. Both arms, legs, torso, face. Daily dose of  Benadyl. 2 MG/% ML Cyproheptadine Syrup
pt recv vax;devel a reticular body rash macular/papular;fever of 101;99 in clinic;
day after vaccination  -- ausust 8th., 2019:  crawled to kitchen, due to fatigue, to get coffee..  experienced nausea, sweating and almost lost consciousness .  this was before eating or drinking anything that morning. ate little food and slept most of the day.  still tired 3 days later.
All of its sequelae; Shingles; This spontaneous report as received from a lawyer concerning a case in litigation and refers to a 64 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis.         On 03-JAN-2015, the patient suffered shingles (herpes zoster), including any and all of its sequelae (Ill-defined disorder). The patient suffered serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish.   The outcome of herpes zoster was unknown.     The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  The lawyer considered the shingles and Ill-defined disorder as a disabling events due to it were permanent.