chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right shoulder felt numb/ the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face.; I feel intense tingling sensations throughout the day; lose of control of my right arm and leg; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). This 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 08Apr2021 07:00 AM (Lot Number: EP7533) at the age of 28-year-old as single dose for covid-19 immunisation. The patient medical history was none. No known allergies or other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the evening of the first day after getting the vaccine, on 08Apr2021 at 04:00 PM, patient right shoulder felt numb. Over the course of the next few days, the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face. At this point, he went to the ER and then they admitted him to hospital for 3 days, gave him steroids, did an MRI of his neck and a CT of head. After discharged, in Apr2021, patient felt intense tingling sensations throughout the day making him dizzy, nauseous, and loss of control of his right arm and leg.  Patient has had regular visits with the recommended neurologist where they did an EKG test, and patient is now waiting on a lumbar puncture test. Event numbness resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for three days. Since the vaccination, the patient had not been tested for COVID-19. Treatment received for the adverse event numbness as steroids. Outcome of the events was not recovered.
Patient called office on 5/24/18 and stated she received a vaccine at her visit on 5/22/18 and that her arm was swollen. Patient states swelling starts at injection site and goes down into her forearm. Sore at injection site. Patient stated she took a BENADRYL and the swelling seemed to be getting better. I spoke to patient on 5/29/18 and the swelling has resolved.
It is reported that a 2 mo old female would not respond to her mother following receipt of diptheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). this report was rec'd from the infant's mother and has not been verified by a physician or other healthcare professional.  On 12/10/01, the infant rec'd her 1st injection of Infanrix. on that date, she also rec'd injections of Haemophilus influenza type b conjugate vaccine (brand name unknown), inactivated poliomyelitis virus vaccine (IPOL) Aventis Pasteur), and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle labs). It was not known if she had rec'd previous injections of these vaccines. The parent reported that 1 hr post immunization the infant developed diarrhea., later that evening, an unspecified time post immunization she reportedly developed a fever of 104.7F and would not respond to her mother. The infant was hospitalized from 12/10 to 12/13/01. The parent reported that it was not determined what was wrong with her as of 12/13 the fever and diarrhea had resolved, but the infant still is not acting normal. The mother reported that the infant rec'd Infanrix lot DTPA522284A, however this is not a valid lot number.
Pt received flu vaccine 11/8/12. Pt states he did not notice any symptoms until 2 days later 11/10/12, and at that time his left arm was itching and red. Pt denies any fever, swelling, shortness of breath, or any other symptoms at this time except redness to his left upper arm. Seen by physician today for follow up.
Tinnitus in right ear lasted 10 days.  Patient unable to ear through right ear.  Resolved on its own.   No adverse event reported following first dose.
Headache, sore throat, fever, body aches and chills, diarrhea
Myalgia & NauseaVomiting Narrative: missed work following 1st dose
On 07/04/2022 I began to have a cough and fever. My fever lasted for 3 days but I was treating it with TYLENOL which I believe kept it within a reasonable range. I also felt tired and had the urge to throw up, runny nose, and occasional mild chest pain with shortness of breath. I also experienced a little bit of dizziness. I took an at home COVID-19 test which was positive on 07/08/2022. Before I tested positive, I reached out to my HCF to explain my symptoms. They advised that I stay hydrated, and to gargle with salt water, and to monitor my temperature. I treated my throat with CEPACOL over the counter medication. I am still experiencing a slight cough, phlegm, sneeziness, and fatigue.
12-24 hours after injection, patient developed red, inflamed, warm to the touch, 2" radius reaction at injection site. 48 hours after injection site not as painful.
This spontaneous prospective pregnancy report as received from a registered nurse refers to an 18 year old female patient. The patient's pertinent medical history was reported as none. She had no drug allergies. On 26-FEB-2013 the patient was inadvertently vaccinated with GARDASIL lot # H019088,0 .5 ml (administered via intramuscular injection). She did not take any concomitant medications. At the time of the administration of the vaccine, the patient was 2 weeks pregnant. The LMP (date of last menstrual period) was calculated to be 12-FEB-2013 and EDD (estimated date of delivery) 19-NOV-2013. On an unknown date, after the administration of GARDASIL, the patient presented with diarrhea, nausea and headache. She came to the nurse for treatment on 29-MAR-2013 and was prescribed ZOFRAN on the same date. No lab diagnostics studies were performed. The reporting nurse was not sure if the patient had recovered from the diarrhea, nausea and headache and stated that she was still pregnant at this time. The reporter did not provide a causality assessment for diarrhea, nausea and headache and vaccinated with GARDASIL. Additional information has been requested.
SEVERE ALLERGIC REACTION - LOW GRADE FEVER, FACIAL & TONGUE SWELLING, BLISTERS IN MOUTH AND REDNESS, METALLIC TASTE, CHEST BURNING, HIGH BLOOD PRESSURE, DROPPED POTASSIUM TO BELOW 3, RBC DROPPED. PATIENT SEEN AT A HEALTHCARE ON 7/1/22, VACCINATION GIVEN ON 6/30/22
Tested positive for COVID-19 after receiving dose 1of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after receiving dose 1of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after receiving dose 1of the Moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after receiving dose 1of the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Lot number: 301135BA) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: bananas, avocado" (unspecified if ongoing); "Known allergies: avocado" (unspecified if ongoing); "Known allergies: birch" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, reaction(s): "Known allergies: prednisone"; Cortisone, reaction(s): "Known allergies: cortisone"; Flucatisone, reaction(s): "Known allergies: flucatisone". No other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID-19, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
78 YEAR OLD MALE COMPLAINED OF CHEST PAINS. ONSITE EMS AND PHYSICIAN RESPONDED. BP WAS 180/68 HR 80. EMS DETERMINED IT WAS NOT RELATED TO HEART. HE REFUSED ADDITIONAL EVALUATION AND CARE.
Stevens-Johnson synd reported in pt receiving Fluogen; Pt recvd vax 18OCT91 & became very tired & achy that night had fever, chills, h/a & loss of equilibrium; Seen in office on 22OCT91 & found to have blisters on ear; eye swollen shut;
Shortly after I received the vaccine I began having pain in my arm! The first phase went from 12.16.21 to around 1/8/22 at which around the pain made it difficult for me to even move my arm! Even I?d sleep on my arm I?d lose function of it for hours! Everyday hence I?d notice sharp pains in my heart! This led to feelings of dull pains and heaviness in my chest! Until this time I feel Like I am threatening a heart attack! On March 1st I collapsed in when I went to visit for the parades there and had to be taken to the emergency room! They did an EKG and saw that I have myocarditis: inflammation and swelling of the heart! I never had this before and my other vital signs are perfect! The hospital confirmed this diagnosis! The hospital to this point has failed to treat me even after me telling them it feels like I?m having a heart attack and I?m severe pain
Vaccine administered (witnessed) to be given above deltoid muscle- Had typical soreness first 1-3 days then developed sharp pains and mobility issues commencing on day 4. Requires rest, time out of work and P.T.
Rash - ~ 10 mins after immunization BENADRYL 25 mg P.O. @ 10:18 AM, 10:30 - Rash on back - pacing.
They have vials in a regular freezer which will be 4 weeks in a couple of days; The case was considered invalid as other info, not qualifying for reporting- CEP. It was not confirmed if patient was administered the vaccination or not.  This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported that:  Is the Reporter a Healthcare Professional (HCP)?: Yes; Occupation/ Specialty: Pharmacist Is the reporter the prescribing HCP?: No; Name: Unknown, Address; Unknown; Occupation/ Specialty: Unknown Is the reporter's contact information available to you or a sub-contracted party?: Unknown  Suspect Product(s): Pfizer Covid-19 Vaccine Start date: Unknown  Stop date: Unknown  Verbatim and Event Description: The Caller, Withheld is a Pharmacist, asking regarding the storage of the Pfizer Covid-19 vaccine. They have vials in a regular freezer which will be 4 weeks in a couple of days. Asked if they can still use the vaccine. Provided PMI contact number and HOO. Warm transferred to PMI (Withheld) and created Manual PC form. Created and submitted CITI form #.  Medical Information: Were any medical questions addressed by this program forwarded/referred to Medical Information: Yes  Information on lot/batch number has been requested.  Amendment: This follow up is being submitted to amend previously reported information: event recoded to no adverse effect.
Patient received monovalent Moderna booster after 08/31/2022. Per our program, I needed to submit a report. Patient was traveling with fiancée and requires a booster per patient.  He stated they could not wait for bivalent booster due to their travel plans. Patient had no side effects from booster and is doing fine. He currently does not have a primary care physician.
pain from her arm to her neck; bad headache; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (pain from her arm to her neck) and HEADACHE (bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN (pain from her arm to her neck) and HEADACHE (bad headache). At the time of the report, PAIN (pain from her arm to her neck) and HEADACHE (bad headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were provided.
Parent describes irritability and tactile temperature (fever) on evening of 6/7/2010, hours after receiving vaccines. Became stiff-legged and refused to roll over same evening. Through the night 6/7-morning 6/8/2010, irritable. Pt seen again in our office 10am 6/8/10. Infant irritable, able to move neck, but did not want to change from lying to sit position - stiff back. Fever 102.9 Rectal. Given 72mg ibuprofen. Two hours later, pt. less irritable and moving legs. 6/9/2010 - pt afebrile. Still "slight" stiff back, but improved according to mother.
Vaccine was administered on 5/26/09.  Client had reaction to vaccines  on 6/01/09.  Came in clinic today 6/02/09, left deltoit sligtly redness and swelling  at injection site.  Redness spread out about 2 x 2.5 inches. C/O itching at the site.
Immediate arm numbing, tingling, pain followed by a skin rash on the arm that received the shot, and on the neck and face, hives, nausea, stomach upset
Chest Pain Pt has been having flu like sxs the past few days and tonight was woken out of her sleep by chest pain. (3/13/2021) pericarditis, atrial fibrillation, and CHF
My heart started fluttering even after almost a month after the vaccine but it did start to happen less over time but still happens. After the vaccine for about for days I had intense headaches and body aches throughout my body.
Vaccine given at approximately 3:15 pm on 10-1-08.  About 15-20 minutes after injection patient developed mild dizziness, restlessness, sensation that she had to move, and "giggling" (strong urge to laugh).
Atrial fibrillation resulting in emergency room visit and hospital stay.  Lost consciousness for brief period due to onset of AFib.  Treated with beta blockers which has normalized heart rhythm.
5th August @3pm until 7th August 8am sore swollen red painful to touch or lift arm/injection site  nausea  5th August (few hours After the shot) early hours 3am: abdominal cramps nausea weak feeling lots of gas and pain 6th August weak fatigued no more abdominal cramps but nauseous low energy levels through til 7th August 8th August : light sensitivity headaches muscle pains can?t put chin to chest area between scapulas extremely sore esp when moving neck.  9th symptoms have eased but still experiencing bouts of nausea and slight neck stiffness and fatigue and tiredness
Myalgia, Arthralgia, Chills, Narrative:   Other Relevant History:
Leukocytoclastic vasculitis; This is a literature report.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (ongoing); "hypertension" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Metformin for diabetes; Lisinopril for hypertension. Vaccination history included: Bnt162b2 (Dose 1, single, 4 months prior to receiving his booster injection), for COVID-19 immunisation; Bnt162b2 (Dose 2, single, 4 months prior to receiving his booster injection), for COVID-19 immunisation. The following information was reported: CUTANEOUS VASCULITIS (medically significant), outcome "unknown", described as "Leukocytoclastic vasculitis". The patient underwent the following laboratory tests and procedures: biopsy: showed neutrophilic inflammation with fibrinoid, notes: necrosis and fragmented neutrophilic nuclei (leukocytoclasis), consistent with leukocytoclastic vasculitis (LCV). Therapeutic measures were taken as a result of cutaneous vasculitis.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Cutaneous vasculitis and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available.  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.
p/vax pt exp, on two separate occasions & in two separate dermatomes, a herpes zoster type rash;
localized itching x 12hrs followed by erythema & urticaria & edema x 36hrs; Reported @ 36 hrs; Given Hydrocortisone Cream & DPH;
body aches, sore arm at injection site, increased arthritis pain, light headache and weakness Narrative:
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting fatigue, swollen glands
Abrupt onset of widespread joint pain, stiffness, significantly limited range of motion within a few days of receiving his covid vaccine -- > PMR like symptoms -- > elevated CRP
Loss of appetite; tiredness; sore arm; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Sep2021 04:45 (Batch/Lot number: unknown) at the age of 21 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, administration date 02Sep2021. Past drug history included: Ibuprofen, reaction(s): "allergies". The following information was reported: DECREASED APPETITE (non-serious) with onset 14Sep2021 05:00, outcome "recovering", described as "Loss of appetite"; FATIGUE (non-serious) with onset 14Sep2021 05:00, outcome "recovering", described as "tiredness"; PAIN IN EXTREMITY (non-serious) with onset 14Sep2021 05:00, outcome "recovering", described as "sore arm"; HEADACHE (non-serious) with onset 14Sep2021 05:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of decreased appetite, fatigue, pain in extremity, headache.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching).  Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues.  Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives.  EMS called and patient sent to ED.  During initial presentation to ED, BP 180/80, HR 85, and 97% on RA.  Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055.  1L LR bolus given at 2059.  BP lowered during ED observation (BP 160/80 on 2/20 at 0442).  Acetaminophen 650mg PO given at 0442 prior to discharge.  Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider.  EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time.  Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable).  Patient has no history of diabetes, but noted that has similar "episodes" with low BG.  EMS checked BG (POC = 144).
Body ache; Flu-like symptoms; Low energy; This is a spontaneous report from a non-contactable consumer. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Apr2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced body ache, flu-like symptoms and low energy on day received shot. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of the events body ache, flu-like symptoms and low energy were recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt got no sleep from stomach aches, aching & itching; vision was blurred & sensitive to movement driving the next day; ached all over w/sharp joint pains @ the hips; swollen glands; ears ringing, abdo pain, fever, slept all day;
Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 as a single dose for COVID-19 immunisation. Medical history included hypertension and asthma. The patient did not have any known allergies to food, medications, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D3), acetylsalicylic acid (ASA) and fish oil (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 08:00, the patient experienced diarrhea after 3 days of receiving vaccine which was still ongoing at the time of this report. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event diarrhea was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.