chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(L) upper arm are of redness with induration and warmth 3.5 x 2.5 cm - no pain with palpation, area marked. Treated with Keflex 500mg. Dx: Cellulitis. F/up in 24 hours or sooner if s/s worsen.
Pt developed full body rash X 3 days, post vax, appears like urticaria. Pt Rx'd Pediapred. Rash developed 7 days after 1st dose of amoxicillin and 3 days after last dose.
1 week post vaccination I received a routine allergy immunotherapy injection. Just prior to the immunotherapy vaccination site was noted to have hardened area(less than 1in). 30 minutes post immunotherapy vaccination site was noted to be swollen, hardened area was larger(2inches), hot to the touch. For the rest of the evening I was fatigued and had a headache.
Chest pain, lethargy, myalgias, headache, nausea, erythema around injection site, scratchy throat, swelling and bruising at injection site. R arm 3/4", L arm 3/4".
Patient complained of dizziness, nausea and dry heaves. The symptoms lasted approximately 8 hours.  No treatment
15OCT93 stiffness in joints of legs-elbows; 16OCT sore throat; 17OCT sore throat worsened, swollen glands; 18OCT still not feeling better; 19OCT still no feeling beter;
VACCINE GIVEN TO Patient under the age of 65 and did not meet manfacture recommendation to receive HD vaccine
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of PNEUMOVAX on an unspecified date (lot #659485/1715U). Subsequently the patient experienced severe pain of the whole arm on an unspecified date. No cellulitis reported. The outcome was unknown at the time of reporting. The patient sought unspecified medical attention. This is one of several reports form the same source. Additional information has been requested.
missed the 42 day window for the second moderna covid-19; Tested postive for COVID / Bamlanivab infusion after testing positive for COVID-19; bruise; I had an old scare that stung; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise), PAIN (I had an old scare that stung), COVID-19 (Tested postive for COVID / Bamlanivab infusion after testing positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (missed the 42 day window for the second moderna covid-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced CONTUSION (bruise) and PAIN (I had an old scare that stung). On 22-Feb-2021, the patient experienced COVID-19 (Tested postive for COVID / Bamlanivab infusion after testing positive for COVID-19). On 17-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the 42 day window for the second moderna covid-19). The patient was treated with BAMLANIVIMAB for COVID-19, at an unspecified dose and frequency. On 01-Apr-2021, CONTUSION (bruise) and PAIN (I had an old scare that stung) had resolved. At the time of the report, COVID-19 (Tested postive for COVID / Bamlanivab infusion after testing positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (missed the 42 day window for the second moderna covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Nasopharyngeal PCR- positive.     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.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Lab test added, treatment received date added in I narrative. On 17-May-2021: Concomitant medication, new events were added
03/29/2005- Diagnosed with having Chicken Pox. Had received vaccine on 09/06/2001.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Itching and rash; Itching and rash; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9809), via an unspecified route of administration, administered in arm left on 19Feb2021 12:00 (at the age of 81-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccine was administered at the clinic. The patient had no known medical history. There were no concomitant medications. On 26Feb2021 12:00, the patient experienced itching and rash. No treatment was received for the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Lump at injection site, progressive inflammation around lump inflammation grew to 4x5 patch w/ raised lump in center.
No adverse effects were reported in the patient; a patient received a dose of VARIVAX following a temperature excursion; This spontaneous report has been received from an office manager, referring to a patient of unknown age.  The patient's relevant medical history, concurrent conditions, relevant past drugs reactions or allergies and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of Varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number N034553 has been verified to be valid for Varicella virus vaccine live (Oka/Merck); expiration date 05-DEC-2019, as prophylaxis, following a temperature excursion. The product storage error was first identified on 16-AUG-2019, with a temperature of 15° Fahrenheit to 46° Fahrenheit (-9°Celcius to 8°Celcius (39Fahrenheit). No adverse effects were reported.
That first few minutes after nausea and headache. Got home and I started having warm, flushing feeling. Like you feel hot inside. I took my temperature. It was 99 and then 100. I started feeling like somebody beat me up. My body was over fatigued and feeling weak - sore everywhere. I went to bed as I was dizzy, too. I didn't want to eat anyways because I was nauseated. It was up to 102. I had fever, nausea, and that night my temperature was even higher and I couldn't get out of bed. I had headaches. I took 2 500 mg (1000 mg) of Tylenol. I took Pepcid. I tried to eat something. That headache was so severe and I took Benadryl. That continued on for the next week. I didn't want to keep taking Tylenol all the time. I took 1000 mg and then maybe Ibuprofen or 500 mg of Tylenol later that day and Benadryl that night. Going to the next week, I still had fever, headache, I had gurgling stomach. It felt like someone was working on something inside of my tummy. It wasn't gas. It felt like someone was touching different organs and it was making feel nauseated. I had dizziness if I didn't take Benadryl. Once I woke up, I'd have the headache, dizziness would be better and I'd try to eat but the nausea would still be there - I vomited once or two times. Body sore, really really tired. Chills lasted for more than a week - especially at night. Face was flushed from the first day of injection and it was flushed for about a week because I had a fever. I was so weak - couldn't do anything - like I had the flu but more severe symptoms. Would walk down our stairs and I would already be exhausted. Severe for first two weeks and then the nausea symptoms lessened but it's still on and off when I went back to work. The headache was just there and not going away - my head feels so heavy. Like something is puncturing me - sharp pain. I do have a very high tolerance of pain and so if I say it's hurting, it's really bad. I can tolerate more than other people. Severity of headache has been better since end of April - I was working and it was so hard. I'm a nurse and that's why I can't take off that long from work. The moment I didn't have the fever anymore, I went back to work even though I was suffering from the other symptoms still. . I missed two weeks of work. Because I'm part-time, it wasn't covered to have the time off.  The Tylenol  or alternating with Motrin would help lessen the pain a little but it was not getting rid of the pain so I just stopped taking it because I didn't want to damage my Kidneys. Headache, nausea and dizziness  is at this time  is about 80% gone. It's not as severe as those first month now by the first week of May.
shaking; felt drunk; scared; vestibular issues; dizzy; spinning; stumble; slur words; brain fog; confused; forget what I'm talking about; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizzy), VERTIGO (spinning), GAIT DISTURBANCE (stumble) and DYSARTHRIA (slur words) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Post concussion syndrome, Ear ringing, Immunocompromised and Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriatic arthritis.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizzy), VERTIGO (spinning), GAIT DISTURBANCE (stumble), DYSARTHRIA (slur words), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confused), MEMORY IMPAIRMENT (forget what I'm talking about), FEELING DRUNK (felt drunk) and FEAR (scared). On 17-Mar-2021, the patient experienced TREMOR (shaking). At the time of the report, VESTIBULAR DISORDER (vestibular issues), VERTIGO (spinning), DYSARTHRIA (slur words), MEMORY IMPAIRMENT (forget what I'm talking about) and TREMOR (shaking) outcome was unknown and DIZZINESS (dizzy), GAIT DISTURBANCE (stumble), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confused), FEELING DRUNK (felt drunk) and FEAR (scared) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported doctor was called. Doctor wanted the patient to wait an extra 4 weeks to receive the second dose. Treatment information not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received on 18-MAR-2021, Additional events reported include, stumble, brain fog.
The patient was supposed to receive a 0.5mL dose of Moderna Bivalent Covid Vaccine for a booster dose. However, only 0.25mL were drawn up and administered. Therefore, the patient only received half of the recommended dose.
06/17/08 Got PNEUMOVAX. 6/18/08 Developed hives on and off. 06/19/08 Went to ER.
26 hours after 2nd dose,  80° outside and I'm shivering uncontrollably and feel cold despite wearing 2 layers clothing and being under blankets, yet skin is hot to the touch, numb arms and hands/fingers, extreme exhaustion, upper back pain, injection arm is super painful from elbow all the way up and into that side of my head, muscle sore everywhere to point of being hard to move, some joint pain where I'm arthritic, dizzy and generally feeling completely out of it.  28 hours after, switch from being freezing to very hot, face flushing bright red (which is an allergic reaction for me), hot flashes for next 3 hours.  Wake up day 2 after vax and still dizzy, slightly nauseaus
There was no actual " Adverse Event," per se.  However patient called later concerned about the fact that some blood ran down the arm at the time of needle removal immediately following injection of the vaccine, and the patient was concerned that this was vaccine and that she did not get a full dose.  Following discussion with the vaccinator it was felt that all of the vaccine had been injected and there was no need for follow up with the patient.    This report is to adhere to "adverse event reporting standard in that the patient voiced a complaint about the procedure and this is part of the permanent record.  We were unsuccessful after numerous attempts to reach the patient, so were unable to communicate directly with her.
Fever, Chills,Body Aches, Migraine.   Fever and chills are gone, but still have body aches.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 007m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug).   On 15-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021 at 1:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient had taken unspecified Pfizer medication for treatment of COVID-19 on 11-May-2022 to 17-May-2022. (Batch number not provided). The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. It was reported that after 6 days and when patient finished the medication, got sick all over again and even tested positive after a negative test 6 days earlier.Device Date : 28May2022.  Company comment: This spontaneous case concerns a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Phizer from 11-may-2022 to 17-may-2022. It is reported that after 6 days when patient finished medication got sick again test positive for Covid-19 after negative test 6 days earlier. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Phizer from 11-may-2022 to 17-may-2022. It is reported that after 6 days when patient finished medication got sick again test positive for Covid-19 after negative test 6 days earlier. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This case was reported by a nurse and described the occurrence of ache(s) in a 30-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  Concurrent medications included ADVIL.  On 13 April 2009 at 10:44 the subject received 1st dose of BOOSTRIX (0.5 ml, unknown route, right arm).  Later that night, within hours of vaccination with BOOSTRIX, the subject experienced feeling achy and had neck ache.  The next morning on 14 April 2009, the subject felt groggy and felt like he was getting the flu.  He went to work.  That night, the subject was feverish with temperature of 100.8 degrees Fahrenheit.  The subject also experienced stiffness down arm.  On 15 April 2009, the subject was feeling better.  The subject also experienced a 3-4 centimeter irregularly rounded erythema without swelling, which was observed by the reporter on 15 April 2009.  At the time of reporting the outcome of the events were was unspecified.  Follow-up received from the reporting healthcare professional on 12 May 2009:  BOOSTRIX was administered intramuscularly.  The first signs and symptoms occurred on 13 April 2009.  The events were resolved on 24 April 2009.
Weak lower extremities. Unable to stand up or walk independently. Acute for about 24 hours and has since receded, but still extremely weak muscles in legs.
Ringing in ears 1 hour post injection - Return of Bells palsy, also " set off arthritis & joint pain".  Has had flu shot every year with 0 reaction did not see a physician
Information has been received from a consumer refers to her 12 year old daughter. In the morning of 29-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 at a pediatric (dose, frequency and route were not reported). After being given the vaccine, the patient felt faint and her mother needed to carry her to lie down for about 10 minutes. It was unclear whether the event was due to GARDASIL 9 or the event of getting a vaccination and associated anxiety. Historically she had not felt faint with other vaccinations. The patient also felt pain in the injection site. At the time of the report, the outcome of the events was unknown. Additional information has been requested.
Arm sore, numb, swollen fingers numb and swollen  ( Rx - pain medication)
Pt fainted, hit head. (+) contusion. Pt observed in office - sent home.
Progressive worsening of pain to left arm, neck, shoulder and back after the flu shot was administered followed by numbness to left arm.
lightheaded; broke out in a rash; This is a spontaneous report from a contactable consumer. An 80-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the arm on 03Mar2021 (Lot Number: EN6205; Expiration Date: 30Jun2021) (at the age of 80 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included heart failure, blood pressure abnormal (reported as blood pressure), and diabetes. The patient was currently taking unspecified medications (reported as "like 50 different medicine"). On unspecified dates in Mar2021, the patient felt lightheaded and broke out in a rash. The patient has been put on antibiotics. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
A report was received from a healthcare professional on 10/20/2003 concerning a 52 year old female vaccinee who experienced swelling and redness 2 days after receiving Fluvirin on 10/14/2003. On 10/16/2003, the vaccinee experienced swelling and redness after receiving Fluvirin on 10/14/2003.  At the time of the report the outcome of the event was unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Headache Employee reports that she had pain/discomfort at injections site, headache and fatigue or tiredness Narrative:
No adverse effects reported.; patient born 04/02/2019 received GARDASIL 9 on 06/06/2019.; This spontaneous report was received from a licensed practical nurse and refers to a 9 week old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 06-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1586751 with expiration date of 16-FEB-2021, for prophylaxis (dose were route were not reported). No adverse effects reported. No additional information provided.
she has a terrible infection in her eyes and nose; she has a terrible infection in her eyes and nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 93-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 93 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunization; BNT162B2 (DOSE 2, SINGLE), for COVID-19 immunization; BNT162B2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: EYE INFECTION (non-serious), RHINITIS (non-serious) all with onset 01Oct2022, outcome "unknown" and all described as "she has a terrible infection in her eyes and nose".  Additional information: The events started a couple of days after the shot. She had the other ones and haven't had a reaction from them.  The information on the batch/lot number for BNT162b2, BNT162b2 OMI BA.4-5 has been requested and will be submitted if and when received.
Patients boyfriend came into the pharmacy on 09/18/21 asking when she received her 2nd dose of the vaccine. I asked if it was because she lost her card and he said "No, she died a few days after and I'm trying to figure out if it was from the vaccine". Date of death/causes/symptoms of death unknown.
Vaccine given 0800 & experienced symptoms of palpitations, abdominal cramping, diarrhea. Treated in ER with BENADRYL IV for HR 150's. Also c/o "numbness" in back of throat. No further symptoms after ER visit.
Sore arm; I have had terrible insomnia; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 29Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, patient got the COVID Vaccine on Sunday evening (29Aug2021) and had a sore arm which was normal. Patient had terrible insomnia from Sunday night (29Aug2021), Monday night and had insomnia, on the date of this report and patient was hoping that patient could sleep. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Two weeks following the booster (above), had left foot drop.  The symptoms became worse over the next 10- 14 days and were similar to guillain-barre.  This resulted in several physician appointments, and emergency room visit with ambulance transfer to tertiary care center.  Inpatient hospitalization for 3 days.
Information rec'd from physicians office. Post vaccine pt developed multiple symptoms including insomnia, fever, malaise, nightmares, myalgia, sore throat, shaking, fatigue, and panic attacks.