chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DROWSINESS; FEELING PAIN IN ARM; TIREDNESS; FEVER; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of known drug allergies and no drug abuse or drug illicit use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 18-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the subject experienced feeling pain in arm. On 18-APR-2021, the subject experienced tiredness. On 18-APR-2021, the subject experienced fever. On 01-MAY-2021, the subject experienced drowsiness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling pain in arm, and tiredness, and had not recovered from fever, and drowsiness. This report was non-serious.
dropped dead on the soccer field; Another child has Myocarditis after getting it and dropped dead on the soccer field.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "dropped dead on the soccer field"; MYOCARDITIS (medically significant), outcome "unknown", described as "Another child has Myocarditis after getting it and dropped dead on the soccer field.". The patient date of death was unknown. Reported cause of death: "dropped dead on the soccer field". It was not reported if an autopsy was performed.  Clinical Course: It was reported that, reporter had a caller on the line to complain about the Pfizer COVID 19 vaccine. She did not specify the complaint. Caller stated she had a product complaint. Pfizer was using social media and trying to get parents to get 5 year old vaccinated. She had several children in the (name-withheld) die after getting the doses. There was not news coverage and she goes to local town meetings. One child's father said his child dropped dead after getting 2nd dose. Another child had Myocarditis after getting it and dropped dead on the soccer field. These were young healthy children. She did not had any specific information to provide on any of these children to complete a report for. She was genuinely disgusted for people to gave their children something like sacrificial lambs. She does not know how call handler sleeps at night working for this company. She had a friend who works at (name-withheld) and said that people were sick in ICU after getting vaccine with complications from it. She did not had any specific information to provide on any of these patients to complete a report for. She did not wish to provide an address or email. If someone calls with an adverse event, she said do not censor it and make it count. She does not trust Pfizer. She just does not understand why Pfizer was pushing to vaccinate these young children when the virus does not even affect them.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: dropped dead on the soccer field
A staff member at this assisted living facility. After receiving the vaccinations, she complained of feeling very tired/weak and like she was going to pass out.
Extensive bilateral pulmonary emboli: intrapulmonary catherter TPA, oxygen, chronic oral antithrombotic. Severe exertional SOB. Onset 11/28.  ER/ICU 11/30. Malaise, chills, throat phlem onset 11/25.
No adverse effect; administered a dose or improperly stored VARIVAX; This spontaneous report was received from a medical assistant regarding a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-NOV-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number: S021925, expiration date: 15-JUL-2021 (exact dose, strength, route of administration and anatomical location were unknown) for prophylaxis (product storage error). A properly stored sterile diluent was used to reconstitute the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX). The vaccine underwent temperature excursion from 6 degree Fahrenheit to 14 degree Fahrenheit (14 F) for a duration of 5 hours and from 15 degree Fahrenheit to 46 degree Fahrenheit (15.3 F) for a duration of 1 hour and 15 minutes. There was no previous temperature excursion. A data logger was involved. No product quality complaints were involved.   This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004359:
After the first shot I got all of the side effects mentioned. 103 temp for 5 days, nausea, dizziness, aches and pains and so on. For the next month following the first shot I was very fatigued even when the primary symptoms subsided.  I then get the second shot on July 15th 2021. This is where things got very bad for me. A few days after the second shot I had a 100 degree temp. Then, about 4 days after the second shot the right side of my face started loosing mobility. I contact the doctor after a few days of it getting worse and was given prednisone since I had gotten Bells Palsy in the right side of my face. I took a 5 day dose of prednisone. The bells palsy started to get a little better with the steroid then I began getting extreme pain throughout my body. It felt like my nerves were on fire or had boils all over them. I couldn't describe the pain. I was unable to sleep because of it. The pain started at my feet and I could barely walk. It worked up through my legs, back into my neck then head. It was extreme and lasted for about a week. I thought this was a side effect and rode it out. Then about a week after the pain started I woke up and the pain was mostly gone. I felt pretty well other than dull aches in my neck.   That same day, and into the next the left side of my face started loosing mobility. I then developed Bells Palsy in the left side of my face. I reached out to a doctor again, and he said 'this must be neurological and we need cat scans'. He did not want to entertain this could have been from the vaccine. He asked that I get blood work so I did. After a few days, my face got far worse. I contacted the doctors again and requested a different doctor who prescribed another round of prednisone. I was also sent to get more blood taken for mono and shingles.   I'm almost complete with the second round of prednisone. The Bells Palsy is mostly cleared up now. I'd say it's about 90% recovered. I received my blood work and tested positive for shingles since it must have reactivated chicken pox from when I was a kid. I was also tested positive for lyme antibodies even though I have not been bit by any ticks and I was 100% indoors for work at home during the time. Lyme antibodies is likely a false positive in my blood work with all of the other issues I was experiencing due to the vaccine. My cholesterol is also elevated now because of the prednisone that I've had to take twice. I had no cognitive disorders with all of these issues.  Prior to getting the vaccine I've been in perfect health with no medical issues.  Symptoms: Bells Palsy twice - Left / Right side of face Shingles activated from having chicken pox as a kid Up to 103 temp for an extended period of time Nausea Dizziness Falling over Weakness Extreme Pain Headaches
She complained of fever of 101 deg, swelling and pain of administration site, headache and neck pain. Pain in arm lasted 5 days and she felt sick enough to miss work on Monday after getting shot on Saturday.
Sometime following vaccination, the pt developed a large local reaction of redness and swelling. The pt was treated with antibiotics. Further information requested.
Severe pain developed locally at injection site about 6 hours after injection lasting about 72 hours.
PATIENT HAD A HOT, RED TOPICAL REACTION 12 BY 19 CM ON DAY 3 POST VACCINATION AND DESCRIBES FEELING SEVERE FLU LIKE ILLNESS BODY ACHES, FEVER, AND HOT RED TOPICAL REACTION.
Information has been received from a female consumer concerning her daughter of unknown age. The patient did not pregnant. The patient's concurrent condition, medical history and concomitant therapy information was not provided. In 2016 (reported as one year ago), the patient was vaccinated with the first dose of GARDASIL (1 dose, route: intramuscular) (lot#, expiration date and strength were not reported) for human papillomavirus (HPV) by an anonymous physician. On an unknown date, the patient experienced dizziness but it laid down and recovered on an unknown date. The patient did not return for the second or third dose. Causality between the event and GARDASIL was unknown.
lingering side effects of pain in her arm; pain in her breast; pain in armpit of the opposite arm; bone aching but it's not terrible, but still hurts; developed a scab/blister that appeared on her elbow a day later; not feeling so great; swelling of the lymph nodes which started after week 1; dizzy /lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (lingering side effects of pain in her arm), BREAST PAIN (pain in her breast), AXILLARY PAIN (pain in armpit of the opposite arm), BONE PAIN (bone aching but it's not terrible, but still hurts) and BLISTER (developed a scab/blister that appeared on her elbow a day later) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (dizzy /lightheaded). On an unknown date, the patient experienced PAIN IN EXTREMITY (lingering side effects of pain in her arm), BREAST PAIN (pain in her breast), AXILLARY PAIN (pain in armpit of the opposite arm), BONE PAIN (bone aching but it's not terrible, but still hurts), BLISTER (developed a scab/blister that appeared on her elbow a day later), MALAISE (not feeling so great) and LYMPHADENOPATHY (swelling of the lymph nodes which started after week 1). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (lingering side effects of pain in her arm), BREAST PAIN (pain in her breast), AXILLARY PAIN (pain in armpit of the opposite arm), BONE PAIN (bone aching but it's not terrible, but still hurts), BLISTER (developed a scab/blister that appeared on her elbow a day later), MALAISE (not feeling so great), DIZZINESS (dizzy /lightheaded) and LYMPHADENOPATHY (swelling of the lymph nodes which started after week 1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment details included, acetaminophen.
Joint pains on Left shoulder - unable to lift arm for 2 weeks, joint pains on both wrist, fingers, toes and knees. Unable to do any work involving my hands and have difficulty walking. Swelling around all my toes. I started most of my symptoms post my 2nd dose but did not know about reporting this until today. Getting worse with my 3rd booster dose. My doctor has referred me to arthritis doctor and I got appointment for December 5th 2022. Its still very far away.
Tested Positive for COVID-19/ Mild flu-like symptoms; Tested Positive for COVID-19/ Mild flu-like symptoms; Booster; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 28Oct2021 (lot number: EW0217) at the age of 42-years as dose 3 (booster), single, administered in arm right, administration date 25Jan2021 (lot number: EL3247) at the age of 41-years as dose 1, single and administered in arm right, administration date 15Feb2021 (lot number: EL3247) at the age of 42-years as dose 2, single for COVID-19 immunisation; and influenza vaccine (FLU), administered in arm right, administration date 28Oct2021 (Batch/Lot number: unknown) at the age of 42-years as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 28Oct2021, described as "Booster"; VACCINATION FAILURE (medically significant) and COVID-19 (medically significant) all with onset 29Dec2021, outcome "recovering" and all described as "Tested Positive for COVID-19/ Mild flu-like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure and COVID-19. Clinical course: The patient tested positive for COVID-19 on 31Dec2021. Symptoms started on 29Dec2021. Mild flu-like symptoms persisted until at least 04Jan2022 (as reported). The patient has no known allergies and was not diagnosed with COVID prior to vaccination. It was unknown if there were other vaccines in four weeks.
Within minutes felt hot, profuse sweating, increased heart rate and BP, nausea and dizziness, blurred vision, then diarrhea followed by chills and shaking. Stayed at clinic for an our hydrated and waited for dizziness to pass. Drove home with severe chills. 2hrs post vaccination elevated temp 102, continued to experience chills sore joints and moderate nausea. By evening site of injection and right arm pain. Sx improved after taking Tylenol. Day 2 moderate joint pain and nausea low grade fever 101- controlled by Tylenol.
The day after the injection, 4-14-18, a rash and swelling started to develop on the arm, about 1 inch BELOW the injection site. The patient's husband reported the reaction at the pharmacy on 4-17-18. He said she does not get out much. The rash and swelling spread around the arm, but did not travel up or down. On 4-19-18 the patient described to pharmacist the current rash/reaction in phone call. She stated the reaction on her arm as "hot, raised, and red". She said it is "itchy and hurts."  She also said she suspects it's "systemic."
Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On or about 04-NOV-2011, the patient was vaccinated with ZOSTAVAX, (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries. No other suspect or concomitant therapies were reported. On an unknown date, the patient was diagnosed with shingles (herpes zoster), and on an unknown date the patient was diagnosed with other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. On or about 10-JAN-2012, the patient was treated for shingles. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter determined adverse events as medically significant, disabling and life-threatening events.
Patient vomited in waiting room. He was brought back into the exam room and assessed. VS stable and exam unremarkable. His father thought the patient threw up due to crying while getting the vaccine. Patient reported that he no longer felt like he needed to through up and that he felt "good".
9 Hours after 1st covid vaccine, pt developed multiple hives at injection site, then developed hives of the back. He took cetirizine and hives resolved and it not come back. Mom brought This up at an acute visit for an unrelated issue
Chest pain, heart racing, shortness of breath intermittently for 2 weeks post vaccine
hives, itching, redness to head, face, and neck, requiring admit to hospital, discharged
Patient stated that she sometimes gets a little lightheaded after a vaccine and would like to wait her 15 minutes after the vaccine in the room instead of the waiting area.  After the administration of the vaccine she stated she was going to pass out and lost consciousness.  She had a normal pulse and was breathing normally.  Her mother stated that she has passed out after injections in the past.  Once for close to an hour.  Her mother indicated that she did not want an ambulance called.  I watched her closely for about 30 to 40 minutes and made sure she was not disoriented until she felt steady enough to stand up and walk.  Upon leaving the pharmacy the patient felt fine and ready to get on with her day.
Severe body aches and trembles for the first 36 hours. Followed by diarrhea and nausea. Have had a continuous headache the entire duration of time since getting the vaccination. As well as two days with a fever of 102°, that Tylenol nor Motrin could relieve.
Myalgia and myositis unspecified, pain in joint, rash and other nonspecific skin conditions, skin sensation disturbance, burning or prickling sensation, swelling of limb, headache, itching, fever, dizziness, chills, edema, numbness, tingling.  8/14/2007 Lengthy medical record received for multiple OVs beginning 12/10/2003 with c/o high BP, high cholesterol and triglycerides, low back pain, and L foot pain.  Initial psych intake 12/10/03 as well with dx Depressive Disorder.  Multiple visits 12/2003-7/2007 for the following problem list:  Hypertension, Major Depressive Disorder, allergic conjunctivitis, Chronic LBP, foot pain, fascitis, plantar fascial fibromatosis, myalgia and myositis, PTSD, major depression-recurrent, spinal stenosis-cervical region, otitis media, peripheral neuropathy, Tinea versicolor, Impotance-organic, blepharitis, myopia, presbyopia, Fibromyalgia, hyperlipidemia.
CRAZY ITCH WITHOUT ANY RASH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:45 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced crazy itch without any rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of crazy itch without any rash was not reported. This report was non-serious.
Patient reported feeling anxious before vaccination Patient reported after of dizziness, lightheaded ness, anxious and appeared pale Patient provided with water and car AC turned on, patient seen by medical team, refused medical transport and signed AMA form Patient stated feelings have resolved
This is one case of a cumulative total of 234 cases solicited from the database during the surveillance period from 01 January 2010 to 19 September 2014. These 234 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 19 September 2014 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 21 month-old female subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received four doses of DAPTACEL; dose one on 05 November 2012, dose two on 14 January 2013 and dose three on 14 March 2013 and dose four on 03 March 2014 (lot numbers, routes and sites of administration for all doses not reported). The subject developed cough, paroxysmal cough and cold-like symptoms on 24 June 2014, approximately 113 days after the last dose of DAPTACEL. The subject also experienced post-tussive vomiting on an unspecified date. Laboratory testing included a positive PCR on 07 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 July 2014 for an unspecified duration. The subject was not hospitalized. At the time of final contact on 08 July 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This spontaneous report was received from a 53 year-old male patient who was reporting on himself. The patient had no pertinent medical history or concomitant medications. He reported having unspecified allergies. On an unknown date in August 2017, the patient was vaccinated with the first dose of RECOMBIVAX HB (Thimerosal status not provided; exact dose, route of administration. lot # and expiration date were not reported), for the prevention of hepatitis B. The patient reported that, on an unspecified date, he felt tired, like he just ran a marathon. The patient was vaccinated with the second dose of RECOMBIVAX HB on 21-SEP-2017, and still felt tired. He did not contact his physician, no treatment was given for the event. The outcome of the event was reported as not recovered. The causality assessment between the event and RECOMBIVAX HB was not provided.
Patient passed out about 2 minutes after all vaccines given. He came out of it in less than a minute.
DTaP and IPV given left deltoid 2/24/03 at 10:30 a.m. Child went to school and by 6 p.m. left deltoid was swollen 3x larger than normal. It was red, hot, and painful with temp 101 deg. Was taken to urgent care on 2/25 and was started on prednisone bid x 5 days.
Clenched fists, stiff legs, stiff ankles, general weakness and drowsiness.