chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; muscle pain; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case from a patient.  This case is linked to case 2020SA304070 (same reporter).  This case involves a patient of unknown demographics who experienced fever (pyrexia) and muscle pain (myalgia), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date in October 2020, the patient received a dose of suspect influenza vaccine (lot number and expiration date not reported) via unknown route in unknown administration site for prophylaxis vaccination.  On an unknown date in October 2020, same day after initiation of suspect vaccine therapy, the patient experienced fever (pyrexia) and muscle pain (myalgia). Patient got the one for 65 and above.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.    There will be no information available on the batch number for this case.
chills - fever (103) - cough - migraine - aches - 24 hours
Nausea; Dizziness; Very fatigued; Rash on her arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received bnt162b2, Solution for injection, via an unspecified route of administration (dose 2) on 20Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Apr2021, Thursday patient developed a rash on her arm. On 23Apr2021, Friday she began to experience nausea, dizziness and was very fatigued. The nausea and dizziness have gone away but the fatigue is continuing. She wanted to know if this side effect presentation was to be expected with the Pfizer covid vaccine or if this might be atypical. The outcome of the events was recovered in Apr2021 for nausea, dizziness; was not recovered for fatigue and was unknown for other event.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderate to several localized arm pain, hot swollen injection site within 2 hrs Moderate to several muscle and joint pain, primarily hips, knees, thighs and back in 5 hours. Mild to moderate frontal headache in 8 hours. Exhaustion in 8 hours. All lasted about 36 hours
Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles.  By Thursday/Friday I noticed that it seemed as though the glands in my neck were swollen (slightly affecting my salivary glands especially on left side). My left armpit is very swollen and remains swollen to today. By Friday and into Saturday and currently I developed tinnitus in both ears. My ears feel stuffy, like I went up in an airplane and they need to pop.  The tinnitus is really loud, especially at night and has triggered my anxiety. I?m so upset and scared I?ll have tinnitus for life now. I?m an avid bird watcher and I?ve also prided myself on excellent hearing, so I?m taking this hard.  Very, VERY, scared.
pt had tingling in mouth and rash on chest. pt said rash is not bc of allergic rxn. rash it bc of panic , worry feeling. pt requested water which was given. bp was 128/83. she drank water felt better. when offered to call 911, pt refused. pt was ok with previous moderna doses obvserved pt for 1 hour she felt better and left. told pt call 911 if needed
Got Covid; Got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), Suspected COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid".  Additional information: the reporter/ caller is the daughter of the patient. During report caller states that her dad got the Pfizer Covid 19 vaccine and the booster and got Covid. Also had a mild form or reactive arthritis and that went away.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225214 same patient/ reporter, different event/ dose;
pt recvd DTP vax 6OCT92 pt had fever of 104.7 ax (w/digital therm) was treated w/APAP w/good results; pt cried all noc; On 7OCT92 fever remained around 100.0-101.0 ax but lt arm very swollen & lower part of arm was very cold to the touch;
Started with heavy left arm / inability to lift, today progressed to left side pain, tension, and back pressure with leg weakness and difficulty standing
My arm is stiff and has pain in the joint when I reach for something. I also want to report my right hip joint bone crackle and felt like it pop out of place. My heart feels like it is cooking on simmer at times. I feel something so different than I felt before.
After shot, patient begun to experience dizziness, blurred vision, headache, and nausea. Pt was taken to private area and assessed. After assessment all of pt's vital signs were normal. After a few minutes pt stated his symptoms started to go away and he was feeling normal. FD was contacted and pt was assessed and pt's mother refused transport by FD and pt was taken home by his mother.
Initially had a lot of sleepiness starting about 8 hours after the vaccine.  This was followed by a moderate to severe headache starting 24 hours after the vaccine which then progressed to a migraine (unclear exactly when) which lasted at least 4-5 days.  Was unable to perform any usual activities for at least 3 days after the vaccine.  Of note, I had similar symptoms after each of the covid vaccines - all Moderna - this was my second Moderna dose.  Symptoms got progressively worse with each shot.  (lasted only 24 hours with the first shot, with only a HA, no migraine).  Recently had the Pfizer covalent booster with minimal adverse effects - felt like a normal vaccine.  Also filed a VAERS report for 3rd Moderna shot.  Only realized that my response was abnormal in retrospect after taking to lots of people about the vaccine.  Of note, as a physician myself and strong proponent of vaccination,  I had significant vaccine hesitancy for the first time given the degree of side effects and hence never got the second booster dose last year.  Pfizer was a "breeze" in comparison......the solution for me.
Developed an all body rash, it's mostly located on neck, trunk, and arms. There are a few spots on the left leg.
Patient reports felling sick and his throat starting to close off less than 2 minutes after vaccination on 8/9/2021.  He reports feeling faint and his nose closing.  On 8/10 a patient representative came to the pharmacy and reported that he was having sign of an allergic reaction still.  This was the first time that the pharmacy was made known of the adverse event.  Pt went to the ER on 8/10/2021.  On 8/15/2021 I called patient to obtain more information to submit this form.  At that time he said he was still feeling week, having a hard time sleeping, and feeling like his throat was not open all the way.
8/17/13 (R) lateral thigh cellulitis, approximately 4 inches of erythema and induration. Taking BENADRYL. Tx BENADRYL 125 mg PO Q6 hours x 2 days, warm compresses. 8/23/13 - Per mom still a small knot, < 1 inch, no heat, no sensibility.
RAPID Ag test at home on 27Dec positive; RAPID Ag test at home on 27Dec positive; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 27 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via unspecified route of administration, administration date 07Dec2021 (Lot number: FF2589) at the age of 27 years as dose 3 (booster), single, then administration date 18Mar2021 (Lot number: EL3247) as dose 2, single and then administration date 25Feb2021 (Lot number: EL3247) as dose 1 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "RAPID Ag test at home on 27Dec positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was further reported that patient had symptoms of head cold and sore throat (ST) on 26Dec2021-27Dec2021 and rapid test Ag test at home on 27Dec2021 was positive. It was unknown if patient was diagnosed with covid-19 prior to vaccination and it was unknown if patient received any other vaccines within 4 weeks prior to the covid vaccine. The patient received the most recent covid-19 vaccine in workplace clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure  and COVID-19 cannot be excluded.  The case will be reassessed if additional information becomes available. Given the nature of the event of immunisation role of suspect product BNT162B2 cannot be assessed for it.
Very hyper and shakey. Felt like I consumed 2+ energy drinks.  Could not fall asleep the night after injection. Very restless Sore Arm Headache
This spontaneous report was received from a licensed vocational nurse concerning a patient of unknown age and gender. Approximately on an unknown date in August 2012 (reported as approximately one year ago), the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and the patient would now like to receive a second dose of GARDASIL. No concomitant therapy was reported. No adverse symptoms were reported. Additional information has been requested.
Vaccine may have been expired at the time of administration. Patient did not experience any adverse effects from the vaccine
Product administered after a temperature excursion; This spontaneous safety report, with reference number was received by the partner on 18-AUG-2023 and forwarded to agency on 22-AUG-2023, from a health professional.  Due to the nature of the event, the causality between the event "Product administered after a temperature excursion." and Vaxelis was not applicable.   Companion Case: MCM-005192.  Further information is expected.
on day 1, 2, 4, and 5 pt reported dehydration. on day 3 pt reported difficulty sleeping Narrative:
Increased crying with high pitched squeak 2 1/4 hours after vaccines were given and continued til Tyl was given five hours after vaccines were given. Local reaction left thigh pin, sl. swollen at both injection sites. Tender if touched area. Cried with right leg movement but no local reaction on rigth site. Required five doses of Tyl. throughout night.
Expired vaccine were given to patient. At the moment that they were give we were unaware that they were expired. When I went to get vaccine they were drawn in a basket that we always place them and  I also witness another co-worker drawing up the vaccine.
Patient received the Covid 19 vaccine on 12/24/2020. On 12/27/2020 she c/o new onset fatigue, cough associated with slight itching of the throat and chills. Denies fever. Hx of allergic cough.  Covid test scheduled on 12/28/2020 at Employee Health.
General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat
Metallic taste in mouth, headache, fatigue, nausea, stomach cramps, explosive diarrhea, fever, injection site pain, injection site swelling,Red circular itchy welts/ rash.
very hard to see and she needs a magnifying glass; patient had been given an expired vaccine; Initial information received on 19-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 17 years old female patient who had been given an expired vaccine and very hard to see and she needs a magnifying glass and patient  while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]).  On 29-Dec-2021, the patient received a  0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  once (strength, formulation was unknown, lot E563088 and expiry date: 21-Nov-2021 via intramuscular route in the right arm for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "very hard to see and she needs a magnifying glass" (visual impairment) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "patient had been given an expired vaccine" (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported"Physician states that Adacel was given to a teenager and it was one month expired. " Is it necessary to redo the shot and any issues to be concerned about?" Additional Description of event Adverse events :PTC(product technical complaint) : Physician states that the NDC  (unspecified abbreviation) is very hard to see and she needs a magnifying glass."  PTC assessment medical/Physical : Physical  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (patient had been given an expired vaccine, very hard to see and she needs a magnifying glass).  At time of reporting, the outcome was Unknown for the event patient had been given an expired vaccine and was Unknown for the event very hard to see and she needs a magnifying glass.  Reporter causality: Related
This spontaneous report as received from a pharmacist via field employee refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 injection (lot #, expiry date, dose, route and indication unknown). The pharmacist mentioned on an unknown date the patient developed an unspecified reaction to PNEUMOVAX 23. The pharmacist mentioned this adverse event might have been previously reported. The outcome of unspecified reaction was unknown. Additional information has been requested.
pain and soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain and soreness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain and soreness). At the time of the report, PAIN (pain and soreness) had 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.   Treatment details included None. Concomitant medications reported were Vitamins, Insulin, diabetic medication  The reporters comments in follo-up were that "she is doing fine and declined further follow-up". There was no other additional information provided in follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: event outcome updated and declined for a follow-up.
By mistake patient was administered with Covid- 19 Vaccine (Booster Dose Only, Lot: AR6965B, Exp: 11/25/22) instead of Covid- Updated Booster (Bivalent). Patient was contacted and notified about incident. She indicated that she has NOT suffered from any type of side effect.
Patient had miscarriage prior to vaccine, blood levels of patients post vaccine still indicate that she may be pregnant. Patient did not inform pharmacist of miscarriage/possible pregnancy, checked off "no" on questionnaire for pregnancy.
Pt developed severe diarrhea, vomiting, light-headedness, & chills hours after receiving H1N1 vaccine on 12/09/09. On 12/20/09 this pt experienced body ache and fever of 100.3.
Fever of 100.8, redness and burning pain at injection site 10/09/21 @11:00AM Red splotchy rash/hives on face, neck and chest developed 11/10/21 in the morning. Some improvement but still visible when she came in person to report on 10/11/21 at 04:00PM.  Patient was advised to continue taking benadryl, to apply ice to pain at injection site and to seek immediate medical attention if signs of more severe allergy develop.
Patient found dead in crib on 3/30/04. Other correspondence on 05/05/04 states: file complete. Autopsy Report received on 6/17/2004 states COD was SIDS.
On 9/22/10, patient was given TDAP 0.5 ml IM at 12:50pm. At 14:05 patient c/o SOB, nausea, and abdominal pain and feeling "sleepy". MD order to observe patient closely & hold discharge order. Patient was given respiratory treatment.
Student administered the influenza vaccine to the patient under the supervision of nursing instructor.  The injection was given into the deltoid muscle approximately 2 inches below the acromian process in the left deltoid muscle.  The patient states that after the injection she had immediate pain to her neck and head.  The next day she had a fever, chills & body aches.  She went to the ER on 11/2/2015 with a terrible headache.
Information has been received from a pharmacist referring to an 84 year old female patient with high blood pressure. The patient had no drug allergies. The patient received a dose of PREVNAR on 07-AUG-2015. On 07-DEC-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009876 with expired date 19-MAR-2016, 0.5 ml, intramuscular) in the arm. Concomitant therapies included some unspecified high blood pressure medications. On the same day (overnight), the patient developed "excruciating pain" (from injection site to elbow), redness and swelling. The patient applied ice to arm and took ADVIL. No lab tests were performed. The patient visited the pharmacy for medical attention. The reporter stated that she planned to contact the patient's primary care physician about experience and treatment options. The events were considered as significant disability by the patient as she could not move her arm at all. Additional information has been requested.
Received the high dose instead of the regular dose.  Mom reported was more tired than usual the day after.
Urticaria on trunk of body (front and back). Timestamped images documented and sent to doctor via text message for provider's office.
the first, second and third doses were administered to the patient on 08-FEB-2012, 09-APR-2012 and 13-NOV-2012, respectively; the first, second and third doses were administered to the patient on 08-FEB-2012, 09-APR-2012 and 13-NOV-2012, respectively; This spontaneous report was received from a nurse and refers to an 8-week-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant vaccinations included rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ) (manufacturer unknown), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).   On 08-FEB-2012, the patient was vaccinated with dose 1 of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, then, second and third doses were administered to the patient on  09-APR-2012 (Inappropriate schedule of vaccine administered) and 13-NOV-2012 (Inappropriate schedule of vaccine administered) administered as prophylaxis (strengths, lot #s, expiry dates, and routes of administration were not provided).  Other vaccination included: diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP); influenza vaccine; hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9); hepatitis a vaccine inact (manufacturer unknown),  polio vaccine; measles vaccine, mumps vaccine, rubella vaccine (manufacturer unknown); meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA); and varicella vaccine (manufacturer unknown).   This is one of several cases of the same patient.; Sender's Comments:  US-009507513-2307USA010360:
she tested positive with the Covid-19 virus; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient had her first dose of the vaccine on 19Mar2021 and she tested positive with the Covid-19 virus today 25Mar2021. Her husband was waiting for his result for today but had been exposed and currently had a sore throat and cough. Her husband was scheduled to get his 2nd dose on 01Apr2021. The patient asked if her husband, would be tested positive with the Covid-19 virus, can he still get the 2nd dose on the scheduled date or does he need to reschedule it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Arm became very painful a few hours after vaccine was given, could not move the arm at all the next day.
Patient developed erythema, swelling and pain around site of injection. Erythema was originally circumferential, but decreased. Arm was 1.5 cm > than other (injection was in right arm). Also unable to lift arm above head.
Red, inflammation and pain on left arm. Patient sure it was radiating from pneumonia shot. Lasted for 2 weeks. Had fever of around 101 degrees F. for 4 days.
Swelling and redness at site of injection. Soreness in arm when moving or lifting arm.
Patient states that after receiving immunization her arm was painful and difficult to lift. States it is still painful 2 days after injection.
Short explanation: DEVELOPED ALL HORRIBLE SYMPTOMS OF SKOGREN'S SYNDROME, AN AUTOIMMUNE DISEASE-  FLUMIST MADE ME HAVE AN AUTOIMMUNE RESPONSE/REACTION.  ALSO DEVELOPED FIBROMYALGIA
R09.02 HYPOXIA 7/7/2022 JAUNDICE
abn eye movements began w/in 24hr of vax;subsequent developmental delay but now better;