chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on the verge of fainting; blood pressure was was 82/48/blood pressure remained low; felt faint/extremely light-headed; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 19Jan2021 06:45 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included hypertension, diabetes (well controlled), and fatty liver disease. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; olmesartan medoxomil (BENICAR); and omeprazole (PRILOSEC); and vitamin B complex. The patient previously took the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Dec2020 06:30 (Batch/Lot Number: EL1284) at the age of 62 years old as single dose for COVID-19 immunisation. On 20Jan2021 09:15, the patient experienced felt faint and extremely light-headed and on the verge of fainting. The patient laid down and then took her blood pressure. It was 82/48. Her blood pressure remained low throughout the day and did not return completely to normal until 3 days later. No treatment was received for the events. Outcome of the blood pressure was 82/48/blood pressure remained low was recovered on 23Jan2021 while of the remaining events was recovered on 2021.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of an association of the suspect drug administration with the reported events, due to a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
24 hours after receiving PCV-13 on lower thigh (L) and H1N1 in upper (L) thigh on 7-1-10, started with redness of thigh. Seen in office morning of 7-3-10. Area on (L) thigh red and swollen, no adenitis, positive mild tenderness. Treated with cool compresses.
I have difficulty breathing, shortness of breath, severe coughing, I did two home COVID -19 test that came back negative. I went to an Urgent Care. Once I got into see the doctor, he performed an exam. Listening to my chest and lungs closely. I was diagnosed with bronchitis and an asthma flare. I was given a Medrol dose pack and Prednisone to help with the inflammation, advised to use my nebulizer three times a day and my emergency inhaler as soon as a coughing spell occurs. I am still not well but am getting there. It will take time. I am currently taking Levofloxacin as the congestion in my lungs has started to turn green.
tested positive; had all three Pfizer COVID vaccines; tested positive; had all three Pfizer COVID vaccines; third shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from  group.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: EW0187) at the age of 58 years as dose 3 (booster), single, administration date 19Feb2021 (Lot number: EN6201) as dose 2, single and administration date 29Jan2021 (Lot number: EL9261) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Sleep apnoea" (unspecified if ongoing), notes: Verbatim: Sleep apnea. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "third shot"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "tested positive; had all three Pfizer COVID vaccines". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.
Dose of Tdap given after patient had received a previous dose of Tdap 8-11-06 (provider thought that a Td was given on that date).  Patient complained of site tenderness.
2 days after vaccine arm became red, hot & swollen about 1/2 inch below where injection was given; at times it was itchy. Pain into my armpit.  Day 1 & 2 after vaccine I had body aches, fever, headache, loss of appetite, & fatigue.
TTP flare, child with history of acquired TTP that had been on remission and off treatment for 5 years
Pt is 38 y.o. year-old female status post receipt of second dose of Pfizer Covid vaccine. Patient with hx of allergies to nuts, citrus derivatives, previous reaction to Flu vaccine. Patient had c/o face swelling after the first dose of vaccine which was resolved with oral benadryl and no further symptoms. Patient is brought to triage room after the vaccination due to her allergy hx. Patient stated she had discussion with her primary care provider and allergy specialist regarding getting vaccination in the setting of her allergy hx. Patient says she was counseled on taking the risk of allergy as the benefits of vaccine outweighs the risk of getting covid illness. Patient was advised to take the vaccine in a setting where monitoring is available and to keep Epipen available and current all the time. While in triage room within 10 minutes of getting vaccine patient became apprehensive and reported feeling swelling in throat. Nothing visualized. RN is called to assist. Patient is given 25 mg benadryl oral(10:48 AM) and she was able to swallow this without difficulty. Patient sated she is feeling tight and swollen below the throat and was very anxious. She also reported difficulty in swallowing.  Denies dizziness, itching, hives, SOB, cough, wheezing, chest pain, palpitations or abdominal pain/nausea. Radial pulse palpable and 2+. She is given 0.3 mg Epinephrine IM on left mid anterolateral thigh at 10:53 am. Within 2 minutes she felt better. Within 5 minutes symptoms resolved completely. 14 minutes later( 11:07) she stated feeling slight swelling at throat, but able to swallow and no c/o SOB, continued to converse without difficulty. At 11:10 she stated she feels slight swelling at the back of the throat and some discomfort in stomach, but no nausea. At 11:12 am patient stated her stomach and throat feeling better, but feels mild itching in mouth. Patient stated she has hx of waxing and waning of sx with allergic reactions in the past. Patient remained alert and oriented without acute respiratory distress during the entire time. AT 11:25 am EMS arrived and patient is transported to acute care hospital for further monitoring and evaluation.
STUFFY NOSE NEXT DAY OF VACCINATION; ARM HURTING; NAUSEA; TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced stuffy nose next day of vaccination, arm hurting, nausea, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stuffy nose next day of vaccination, arm hurting, nausea, and tired. This report was non-serious. This case, from the same reporter is linked to 20210801898.
Joint pain was excruciating and at same level as traumatic fracture; fever of 102 with tylenol 500 mg x 2, extremely disturbing nightmares and flashback to military combat.
a little tired and achy in the arm; a little tired and achy in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little tired and achy in the arm) and FATIGUE (a little tired and achy in the arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (a little tired and achy in the arm) and FATIGUE (a little tired and achy in the arm). On 20-Feb-2021, PAIN IN EXTREMITY (a little tired and achy in the arm) and FATIGUE (a little tired and achy in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Headache, muscle and joint soreness, chills, fever, fatigue, diahria, dizziness for 3 days. Experienced constipation, headache, muscle and joint aches, chills, fever, dizziness, and worse fatigue symptoms on the 9th day. I feel that the relapse was because I did too much on the previous day. Fatigue still persists.
Expired MMRII was given to that patient by a medical assistant around 5:00pm on 2/24/21
Approximately 10 hours after the injection, my left arm started feeling sore. I went to bed and woke up around 3:45AM with a headache, muscle aches, and my arm was at a level 7/10 for pain. I took Tylenol which helped some.
About 6-7 hours after the vaccine, right eyelid began to swell. The following morning it was more swollen and edge of eyelid red. Some eyelid pain.
severe injury; stomachache; wheelchair; having only to be able to take food through the feeding tube; This is a spontaneous report received from a non-contactable reporter(s) (Nurse), Program ID: (004756).  A female 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: INJURY (medically significant), outcome "unknown", described as "severe injury"; ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "stomachache"; WHEELCHAIR USER (medically significant), outcome "unknown", described as "wheelchair"; FEEDING TUBE USER (medically significant), outcome "unknown", described as "having only to be able to take food through the feeding tube".  Clinical course: Caller is a former nurse who is asking our exact location in the withheld and the last name initial and said call is being tape. She is asking personally if I have taken the Pfizer COVID 19 kill shot that is killing, destroying, meaning disabling millions across the world. She wants to specifically report and talk about a very specific case. That is withheld who is in the United States, she was a participant in the Pfizer COVID 19 trial and her severe injury results in her being in a wheelchair, having only to be able to take food through the feeding tube. She's been recorded as having a stomachache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt c/o redness swelling, pain to  lt arm;also states arm is hard to touch & hot
I received the COVID vaccine at the same time as my flu vaccine.  Both were in my left arm.  No issues at the time, but about 24 hours after I had trouble moving my left arm and shoulder without extreme pain.  I also have tingling down to my fingertips.  It's possible there was an injury to the muscle at time of the vaccination.
dizzy; sweaty; lethargic; difficulty standing; brain fog; aches and pains; weak leg muscles; jittery; stomach ache; sore arm; chills; fatigue; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing) and FEELING ABNORMAL (brain fog) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), FEELING ABNORMAL (brain fog), PAIN (aches and pains), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (low grade fever). At the time of the report, DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), FEELING ABNORMAL (brain fog), PAIN (aches and pains), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (low grade fever) had not resolved.            No concomitant medications were provided. Treatment medications included paracetamol, ibuprofen. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079068 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079068:1st dose vaccine
Patient reports that received COVID-19 (Moderna) Vaccine 1st dose on 01/28/2021 in left deltoid. Had no pain; swelling; bruising or other complaints following immunization. Reports that 6 days later (02/03/2021) when getting ready for bed; he noticed bruising to the area. Discussed changes in medications/illness prior to vaccination. Reports that 2 weeks prior to receiving COVID-19 Vaccination (approx. 1/14/2021) on his own he had increased Chewable ASA; 81 mg daily to Chewable ASA 81 mg twice a day. Did recently consult primary provider regarding bruising noted 6 days post vaccination.  Has had no pain; swelling; warmth or other concerns other than healing; resolving; persistent bruising to left deltoid.
Mom reports approx 3 hrs post vax, temp to 105 AX, given APAP; Exp crying & sleepiness; Have DT only today;
Information has been received from a medical assistant referring to a 11 year old male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 06-AUG-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details unknown, lot# N022583, expiry date: 20-JUN-2020) in the right arm for prophylaxis in a public health clinic/hospital using public funds (Incorrect product storage). Other suspect therapies administered on the same day included MENACTRA (lot # U5948AB) and ADACEL (lot #U5770AA). No other doses of the vaccines were administered previously. No prescription drug treatment was required for the experience. The patient did not receive any reverse reactions to the vaccine. The vaccine was stored at a temperature of 0 Celsius (C) degree to 1 C degree for 41 hours, below 0 C degree (-0.01) for 27 hours and between 9 C degree to 25 C degree (16.4 C) for 12 hours 30 minutes. Previous temperature excursion were 0 C degree to 1 C degree for 27 hours. Data logger was involved. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1808USA003706:
NO ADVERSE REACTION REPORTED. VACCINE WAS GIVEN ON THE DAY MONOVALENT COVID VACCINE NO LONGER APPROVED BY FDA AND REPLACED BY BIVALENT VACCINE. PATIENT AND PCP WAS CONTACTED AND AWARED THAT PATIENT HAS TO WAIT 2 MONTHS BEFORE HE CAN GET  BIVALENT BOOSTER VACCINE.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The concurrent conditions and medical history were not provided. On 01-FEB-2016, the patient was vaccinated with dose of GARDASIL 9 lot #: K026246, expiration date on 28-JAN-2017 (route, dose and anatomical location were not reported); which were incorrectly stored as they underwent a temperature of 30.7F during 20 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
On 2/7/2021, I had a vertigo attack, and the ambulance was called. The paramedics thought I was having a heart attack because my blood pressure was over 200. They took over 6 hrs trying to lower my blood pressure. They did a CT scan of my brain and admitted me to hospital. They eventually told me I had 2 blood clots in my brain. The next day they determined it was 1 blood clot and a vein in my brain that was not emptying properly. There were general doctors, hematologists, internists, neurologist seeing me. I was admitted for a week until 2/13/2021. I was put on blood thinners. I was discharged and ended up back in the ER on 2/18/2021. I was having tremors and was experiencing sounds in my ears, and I also could not deal with sound in my ears. I was admitted for 3 days. I was discharged with instructions to be on complete rest. I was anxious about this, so I was put on painkillers and anxiety medications. My doctor said I needed to get a neurologist involved. The hospital could not determine any diagnosis. I was referred to a facility. They referred me to the school of neurology. Imaging for vascular imaging He saw all my images and said it was not a stroke, but he was no sure what it was. I was told to see an ENT since my main symptoms were my ears and migraine.  In April, the hematologist tested my blood which came back positive for antibodies of Lupus. The hematologist said he was not going to diagnose me with lupus since that would entail being on blood thinners my whole life. Because my whole immune system was affected, I was retested in AUG and lupus was negative My current symptoms are migraines. The ENT said my ears are not the problem. The neurologist and ENT have assumed a diagnosis of vestibular disequilibrium. I am now in physical therapy. The tests ran show that my vestibular system is functioning at 30%. My blood pressure is still erratic. They are still trying to target the anxiety. The sounds in the ears are still present as well.  Currently, there is still no certain diagnosis.   My social life is nonexistent right now because I am not able to deal with more than one person talking at the same time. I also noticed I am extremely hypersensitive to light. 23 physicians have seen me thus far.
Extremely swollen lips and hives on much of my body. After talking to my doctor, I began taking Benadryl  36 hours after the vaccine shot. Lips and hives reduced somewhat but swelling and itching persists.
On the second day after the administration of the second dose of the vaccine I began to feel tired (day 1 and 2) fever (day 2) pain in the bones (day 2) chills (day 2) intense heat in the sole of the right foot that even today (day 2 and 3) and low back pain (day 2 and 3).
Fever, eye redness, body pain starting 1 day after vaccine cough, nausea, abdominal pain 3 days after vaccine 1 episode of emesis 5 days after vaccine  - Admitted to hospital with suspicion of MIS-C - As per ID and Hem/Onc, Started on IVIG and aspirin (5/23/21) - currently still admitted for management of MIS-C
mom stated pt broke out w/rash starting on back of neck @ hair line;pt was taken to MD & was told to wait it out had the measles;rash persisted for 6 days; no tx was given;
Lymph nodes Swelled; Arm Hurt; Couldn't swallow; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Lymph nodes Swelled), MYALGIA (Arm Hurt) and DYSPHAGIA (Couldn't swallow) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic, Drug allergy, Latex allergy, Gluten intolerance, Food allergy, Milk allergy, Allergy to antibiotic and Wheelchair user. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced LYMPHADENOPATHY (Lymph nodes Swelled), MYALGIA (Arm Hurt) and DYSPHAGIA (Couldn't swallow). At the time of the report, LYMPHADENOPATHY (Lymph nodes Swelled) had resolved and MYALGIA (Arm Hurt) and DYSPHAGIA (Couldn't swallow) had not resolved.        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 treatment information was provided by the reporter.
Swelling in both hands and feet with generalized itching and joint aches. No Shortness of Breath or Cardiac Problems
Self-limiting, delayed, hypersensitivity response to the Tdap vaccination; onset approx 27 hours post administration, resolve approx 96 hours post administration.; without need for medical treatment-urticaria of the anterior right upper arm.
Initial misuse report received from a healthcare professional on 24 October 2013. The cases were received on 21 March 2014. This case is link with case: 2014SA044587 with same product and same reporter. A 04 years old patient, received 0.25 ml dose of FLUZONE (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Left eye to side of mouth switching a couple times a day lasting an hour.  Eye twitches as well as lid. Under nose to side of mouth.
Very sore arm for 1st week.  Arm still sore after 2nd week. Flu like symptoms for 3 days.  Observed "gray" stools (affecting my liver) after 3 days; diarrhea; Low grade flu continued for 4 weeks.  Fatigue, mild body aches