chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. In or around 16-APR-2015, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, and lot # were not reported) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered from acute bronchial asthma exacerbation and numerous, reoccurring instances of pneumonia requiring several hospitalizations. As a direct and proximate result of the vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. The outcome of the numerous, reoccurring instances of pneumonia requiring several hospitalizations was unknown. Causality assessment was considered to be related. Upon internal review, the event of numerous, reoccurring instances of pneumonia requiring several hospitalizations was determined to be medically significant. Additional information has been requested.
Very soon after the shot I got a fever. Then the muscle cramps started with body aches. I got nauseated and a headache and couldn't focus my brain on anything productive.
After approximately about 15 minutes my left arm where the injection sight was my arm was in intense pain,felt like my injection sight was tearing my muscle apart the pain was intense I then took Tylenol when I got back to work it was still painful. About three days later the pain subsided slightly. I then noticed I couldn?t move my arm behind my back to scratch it without extreme pain, when I would sleep and try to stretch my arm  out I would get a sharp pain. I can?t reach in my refrigerator without pain, I can?t sleep without pain, I can?t exercise without pain. I?m now in physical therapy due to this and their diagnosis is that my arm is froze.
Mild injection site reaction- red, firm, swollen, tender; Mild injection site reaction- red, firm, swollen, tender; Mild injection site reaction- red, firm, swollen, tender; Mild injection site reaction- red, firm, swollen, tender. Most noticeable day 3 after injection. Note that I had COVID dx 21Apr; This is a spontaneous report from a contactable consumer reporting for herself. This 33-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1685) on 17Dec2020 at 07:45, in left arm, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included immune thrombocytopenia 2/2, COVID from 21Apr2020, chronic B12 deficiency, ADHD, depression, anxiety and migraine. Allergies to medications, food, or other products: none. Concomitant medications included sertraline HCl (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), lorazepam (ATIVAN), ondansetron (ZOFRAN) and sumatriptan succinate (IMITREX). On 17Dec2020 the patient experienced mild injection site reaction- red, firm, swollen, tender. It was most noticeable on day 3 after injection. No treatment was given. COVID was not tested after vaccination. The events were resolving.
had a COVID test done which came back positive for COVID/She had mild symptoms of COVID including runny nose and congestion; had a COVID test done which came back positive for COVID/She had mild symptoms of COVID including runny nose and congestion; This is a spontaneous report from a contactable Other healthcare professional, Dentist (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on 06Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, this Dentist is the patient. She got her first dose of Pfizer COVID-19 Vaccine on 06Jan2021. On 22Jan2021, more than 2 weeks after that first dose, she contracted COVID. She had a COVID test done which came back positive for COVID. She had mild symptoms of COVID including runny nose and congestion. The second dose of Pfizer COVID-19 Vaccine was scheduled for 27Jan2021 but she heard when you have COVID symptoms you cannot take that second dose so she cancelled that appointment. She has not gotten the second dose of Pfizer COVID-19 vaccine. She called to ask if she can get the second dose of Pfizer COVID-19 Vaccine, and if so how long does she need to wait to get it or schedule it. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and can be affected by different factors; however, a contributory role to the reported drug ineffective cannot be ruled out.
Severe weakness; shortness of breath; Blood pressure increased; a little fever; severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Severe weakness), DYSPNOEA (shortness of breath), BLOOD PRESSURE INCREASED (Blood pressure increased), PYREXIA (a little fever) and NAUSEA (severe nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Asthma. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT) for Asthma, CENTRUM VITAMINTS for an unknown indication.    On 15-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ASTHENIA (Severe weakness), DYSPNOEA (shortness of breath), BLOOD PRESSURE INCREASED (Blood pressure increased), PYREXIA (a little fever) and NAUSEA (severe nausea). On 25-Apr-2021, ASTHENIA (Severe weakness) had not resolved and DYSPNOEA (shortness of breath), BLOOD PRESSURE INCREASED (Blood pressure increased), PYREXIA (a little fever) and NAUSEA (severe nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, SARS-CoV-2 test: (Positive) Patient was tested positive for COVID-19.. On 14-Apr-2021, Antibody test: (High) Patient's antibody test showed increase in antibodies..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication provided by the patient was blood pressure medication. No treatment medications were reported   This case was linked to MOD-2021-054697 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Patient demographics added, Lab data added, medical history and concomitant medications added, new events added, outcome of event(pyrexia) changed from unknown to recovered
Chills; Has a temperature; Nauseated; Getting paranoid like someone (shadow) was standing behind her; Can not think clearly; Mind fogginess; Headache; Arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 10:00 (Lot number: 801358A, Expiration Date: Nov2021) at the age of 67 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing). Family history included: "Alzheimer's" (unspecified if ongoing), notes: Mother passed away from Alzheimer's. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 29Sep2021, outcome "unknown", described as "Mind fogginess"; HEADACHE (non-serious) with onset 29Sep2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021, outcome "unknown", described as "Arm is sore"; CHILLS (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Chills"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Has a temperature"; NAUSEA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Nauseated"; PARANOIA (non-serious) with onset 29Sep2021, outcome "recovered" (29Sep2021), described as "Getting paranoid like someone (shadow) was standing behind her"; THINKING ABNORMAL (non-serious) with onset 29Sep2021, outcome "unknown", described as "Can not think clearly". Therapeutic measures were not taken as a result of feeling abnormal, headache, pain in extremity, chills, body temperature abnormal, nausea, paranoia.  Additional information: The patient was on the phone 45 minutes ago and the mind fogginess happened again. Has a severe headache, but states it's not that bad. Mind fogginess As soon as the injection happened. she is on blood pressure medications. she has not taken any new medications two weeks before the events occurred. Never had a flu shot. Can't get the Flu shot because she is allergic to the eggs associated with it. COVID-19 vaccine is the first vaccine she has had since her childhood vaccinations. when she got the vaccine that it was like she was having foggy brain and cannot think clearly. Stated that she cannot remember what else she talked about. Stated that today she is having chills and a temperature. Stated that she has not had a temperature in 20 years. Wanted to know if these are common side effects. Wanted to know if she had so many side effects with first shot should she take second shot. Stated that she is nauseated. Stated that yesterday she was getting paranoid like someone (shadow) was standing behind her. Stated that this happened last night. Stated that someone told her that the shot that she got yesterday does not protect her from the delta variant and she wanted to know if this was true. felt paranoid after the sun went down yesterday.    No follow-up attempts are possible. No further information is expected.
9/30/21 Reported feeling nauseous the evening after vaccination. 10/1/21: shortness of breath, Fatigue, felt like heart was racing. Went to the ED on 10/1/21. Found to be in atrial fib, shortness of breath continued until respiratory distress increased to him being intubated on a ventilator. Possible sepsis. Cardiac rhythm converted to Atrial Flutter. Extubated by 10/4/21. 10/7/21 Walking in hallway.
Failure of vaccine. Dx'd with Chickenpox on 8/20/02.
15 minutes after injection severe pins and needles tingling on right, previously injured finger, radiating through hand/palm. Subsided after several minutes to dull tingling.   Approximately 2-3 hours after vaccine I began having severe sciatic pain (pain originating in back, shooting down the back of my right thigh and tingling toes on right side). Bruising on right shin without injury. Lasted approximately. 36-48 hours after shot.   5 days after shot I started sneezing profusely. Developed signifying head/chest congestion and cough. Currently have cold symptoms 8 days post vaccination. 2 Covid tests have come back negative.
numbness, a weird taste on her mouth and her throat got really dry; tickle on her nose and headaches; nausea, headaches, chills and extreme weakness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness, a weird taste on her mouth and her throat got really dry), NAUSEA (nausea, headaches, chills and extreme weakness) and HEADACHE (tickle on her nose and headaches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027a21a and 019b21a) for COVID-19 vaccination.     Concomitant products included BUPROPION, SPIRONOLACTONE and VITAMINS NOS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Mar-2021, the patient experienced NAUSEA (nausea, headaches, chills and extreme weakness). On 13-Mar-2021, the patient experienced HEADACHE (tickle on her nose and headaches). On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness, a weird taste on her mouth and her throat got really dry). At the time of the report, HYPOAESTHESIA (numbness, a weird taste on her mouth and her throat got really dry), NAUSEA (nausea, headaches, chills and extreme weakness) and HEADACHE (tickle on her nose and headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
he was not feeling to well; This is a spontaneous report received from a non-contactable consumer via the Pfizer sponsored program. A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said he took the first shot on 25Mar2021. Stated he went in and took a Covid-19 test, and is still waiting for the results. Said today he was not feeling to well (on an unspecified date) and did not elaborate. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a 19 year old female who on 26-JUL-2007 was vaccinated with Gardasil (lot # 0469U). Concomitant therapy included LOESTRIN 21). The nurse reported that a patient experienced generalized achiness for 5 days after administration of her first dose of Gardasil  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 19 year old female who on 26-JUL-2007 was vaccinated with a first (lot # 0469U) IM in the left deltoid. Concomitant therapy included LOESTRIN 21. On 08-AUG-2007, approximately 2 weeks later (also reported as 26-JUL-2007), the nurse reported that a patient experienced generalized achiness (bones/joints) for 5 days after administration of her first dose of GARDASIL. The patient treated herself with ADVIL. On 13-AUG-2007 (also reported as 01-AUG-2007), the patient recovered from generalized achiness. The patient did visit the office regarding the adverse experience. Additional information is not expected.
Patient was given a 3rd dose. Pt did not have any adverse reactions to dose given.
12/22/22 presents to ED for "shortness of breath". PMHx of "COPD, SLE, chronic anemia, CKD"
Diagnosed with COVID-19 after receiving primary series of Moderna COVID-19 Vaccine and a Pfizer booster; Received primary series of Moderna Covid19 vaccine and a Pfizer booster; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Diagnosed with COVID-19 after receiving primary series of Moderna COVID-19 Vaccine and a Pfizer booster) and INTERCHANGE OF VACCINE PRODUCTS (Received primary series of Moderna Covid19 vaccine and a Pfizer booster) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Diagnosed with COVID-19 after receiving primary series of Moderna COVID-19 Vaccine and a Pfizer booster) and INTERCHANGE OF VACCINE PRODUCTS (Received primary series of Moderna Covid19 vaccine and a Pfizer booster). At the time of the report, COVID-19 (Diagnosed with COVID-19 after receiving primary series of Moderna COVID-19 Vaccine and a Pfizer booster) and INTERCHANGE OF VACCINE PRODUCTS (Received primary series of Moderna Covid19 vaccine and a Pfizer booster) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient received Pfizer booster vaccine.  Treatment information was not provided by the reporter.  Company Comment: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving mRNA-1273.  It was reported that the patient was diagnosed with Covid19 after receiving mRNA-1273 as primary series and Pfizer as booster (interchange of vaccine products).  Clinical course, labs, concomitant medications, and treatment details not reported.  The outcome was unknown.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving mRNA-1273.  It was reported that the patient was diagnosed with Covid19 after receiving mRNA-1273 as primary series and Pfizer as booster (interchange of vaccine products).  Clinical course, labs, concomitant medications, and treatment details not reported.  The outcome was unknown.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Localized reaction 6cm area induration, 2.5cm area erythema surrounding injection site. Mild tenderness.
Blood pressure of 185/125; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure of 185/125) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure of 185/125). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure of 185/125) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 185/125 185/125 no unit availble.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included nurse at the facility gave the patient Benadryl 15 milligram to help.   Reporter did not allow further contact
COVID-19 (Moderna) vaccine given to a 17 year old patient.  Patient had both vaccines without any adverse reactions that we know of at this time.
Loss of vision in left eye. Blood clot in left eye. Received on 10-6-09- noted loss of sight in left eye approx. 10-9-09. I'm now being treated by eye care specialists. 12/02/09 Medical records received for DOS 10/28/09 and 11/01/09. Pt. felt pressure in left eye starting 10/06/09  and suddenly lost vision in left eye. Referred for intravitreal Avastin injection. DX: Dull foveal reflex; significant ischemia involving the macula
Day after: Sore arm Following day: fever, chills Following day: headache, cold/flu-like symptoms Following day: Underarm pain and swelling, cold/flu-like symptoms (stuffy nose, fatigue, mucus from nose-green/yellow)  Today is Tuesday, almost a week since vaccine: cough, a lot of mucus from nose, temp is 99.1, underarm pain is diminishing.
Patient was given vaccine under 18 years of age (off-label use) . Patient and mother denied any adverse reactions/symptoms.
10/17/14 Pt reports 5:30 - 6P - couldn't clear her throat, drank water, sx did not change. Eyes became "bright red", itchy, "felt like sand in them." "Pus-like" D/C running from eyes." 7P hives on face and arms. 10 mins later, inside of mouth swelled lip "Curved" (swollen), 8P - called pharmacist and PVT MD-PT was told to go to ER. Went ER. Pt was given IV BENADRYL and prednisone (states felt better) kept for observation until 1:30 A. Pt states she's "achy" today.
Information has been received from a licensed vocational nurse concerning a 39 month old female who on 25-FEB-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot #659351/1775U) 0.5 ml via subcutaneous administration. The patient was experiencing ear infection when vaccine was given. On 11-MAR-2008 the patient experienced an injection site reaction, had a red indurated area. The patient sought medical attention by speaking with the nurse. Subsequently, the patient recovered. Additional information has been requested.
Patient was inadvertently given the vaccine at the time, there was no adverse reaction after receiving the first dose had patient wait 30 minutes due to age as she was accompanied by her mother who signed the consent to give daughter. Followed up with patient next day 04/08/21 with no side effects.
Patient is a(n) 10 y.o. female who presents to clinic after fainting this morning. She was here for WCC yesterday afternoon, received TDAP, MENACTRA and HPV. We observed her for 15 min after vaccines, she felt great, went home. Her evening was uneventful. This morning, after waking, went to take a bath. While waiting for the tub to fill, she was standing in the tub and suddenly "felt weird." She then noticed she "couldn't see or hear," so went to get out of the tub and find her mom. The next thing she knew, she found herself on the floor. She heard water running, got up and turned off the tub, went to her mom and told her she was having trouble seeing and hearing, fainted again. Her mom said she was unresponsive for a brief period (seconds) and then awoke. After lying on the floor for a few minutes, she was acting normally, reported feeling only tired. Mom brought her in. She feels tired now and on and off has had a mild headache. She isn't sure whether she hit her head, denies any point tenderness to head or other part of body. She's never before fainted. She has several severe food allergies, has had multiple episodes of hives and angioedema.
Information has been received from a certified medical assistant and a physician concerning a 25 year old female with a history of hives due to orange juice who in approximately Oct 2006, a couple of weeks ago, was vaccainted with a 0.5ml first dose of HPV vaccine (lot 653736/0689F). There was no concomitant medication. Approximately 30 minutes after the vaccination, the pt experienced severe itching all over her body. It was reported that there was no rash. Unspecified medical attention was sought. Subsequently, the pt recovered after approximately 2 days. Additional information has been requested.
Patient called on 5/12/11, complained of left arm being swollen, red & painful, stated at appnt on 5/13/11 ran a fever as high as 104 degrees, nausea & H/A. Temperature in office was 99 degrees. Patient was given MEDROL Dose pk & KEFLEX.
pt recvd vax 18OCT93 & w/in 48 hrs exp an inject site rash; rash consisted of a perfect round circle w/outer edges dark red; the inner circle was white;