chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of headache in a 73-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced headache, nausea and tiredness. On an unknown date, the outcome of the headache, nausea and tiredness were recovered/resolved. It was unknown if the reporter considered the headache, nausea and tiredness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm. The patient experienced a slight headache, nausea and was tired for 3 days. This case has been linked to the US2018GSK180391, reported by the same reporter.
Patient reports an oral temperature of 99.5 degrees F for 2 days following the vaccine with tenderness/soreness of the arm at and around the injection site. This was accompanied by small patches of red spots around the injection site for about a week.
Client's father alerted staff that the client was not feeling well around 2:52 PM.  Client reported having a headache after completing the 15 minute observation period. Assisted client to anti-gravity chair. Vitals obtained at 2:55 PM were as follow: BP 118/76, O2 99%, HR 72. Client was alert and oriented to person, place, time, and situation (AOx4). Client is sitting upright in anti-gravity chair, denied shortness of breath. Client reports headache pain is rated a 5/10 on a 10 point scale 0 being no pain and 10 being extreme pain. HA is located on right side of head on temple area. Pain comes and goes. Client denies aggravating factors. The client stated that her pain became more tolerable after she sat down. Client denies significant past medical history and denies use of medications. Offered the client water, the client denied. The client states she has consumed water and eaten today. Offered the client a juice and the client denied. Vitals obtained at 3:00 PM were as follows: BP 117/72, O2 98%, HR 70, AOx4. The client reports 3/10 pain. Denies any other symptoms. Vitals obtained at 3:10 PM were as follows: BP 118/72, O2 98%, HR 64, AOx4 Client reports 4/10 pain. Denies any other symptoms. Educated client and her father on ED precautions, when to seek EMS, signs of respiratory distress, and s/s of anaphylaxis. Vitals obtained 3:25 PM were as follows: BP112/73, O2 98%, HR 70, AOx4. Client reports 0/10 pain. Denies any symptoms. Client left the observation area with her father. Client left facility under no apparent distress unassisted with a steady gait.
Both patient and guardian came in to get vaccine. Asked age, guardian said 30 years instead of 13 years. Didn't show card and patient was given moderna vaccine. Upon preparing passport card, we realized patiend has Pfizer as first shot and age not applicable to the Moderna vaccine.  On questioning guardian, he said that "my English not good"
Client received the 2nd dose of Moderna COVID vaccine lot # 016C21A and expiration date 5/22/21 at 9:27am.  Client reports to EMT blurred vision and dizziness.  Nurse  provided client with a water bottle and took vitals. At 9:36am vitals: blood pressure:167/95 , pulse:80 , and oxygen:97%. Client is sitting up in chair alert and oriented x 4. Client reports her medical history includes diabetes. Client cannot recall oral medication taken for diabetes. Client reports skipping meal this morning.  Client denies having any chest pain or headache. At 9:41am vitals: blood pressure:152/82, pulse:75 , and oxygen:97%.  Client reports blurriness and dizziness are slightly improved and no other symptoms. Nurse has client place feet up on another chair.  At 9:46 am vitals: blood pressure:151/91 , pulse:83, and oxygen: 97%. Client reports dizziness and blurred vision are improving.  At 9:51am vitals: blood pressure: 151/85, pulse:78, and oxygen:98%. Client reports feeling 70% better.  Provide client with ER precautions and to follow up with her provider in TJ.  At 9:56am vitals: blood pressure:157/80, pulse:74, and oxygen:97%. Client reports slight blurriness and dizziness improved. At 10:01am vitals: blood pressure:150/90, pulse:79 , and oxygen:97%.  Client alert and oriented and reports symptoms are improving. At 10:06am vitals: blood pressure:160/96 remove chair from feet and retake blood pressure: 150/96, pulse:76, and oxygen:99%. Client reports all symptoms have resolved. Call Supervisor to case consult. Supervisor told Nurse to remind client about ER precautions and to review symptoms of concern such as chest pain, shortness of breath, etc. Nurse review ER precautions again. At 10:13am client went to restroom with EMT. Client walked out with a steady gait at 10:17AM.
Developed maculopapular rash on day 11 post-vaccination. Visit to Pediatrician the same morning. No definitive diagnosis or treatment given. Benadryl given with no improvement of rash. No fever or other obvious signs of illness at the time. Rash still persists day 2.
significant swelling between collarbone and neck on the side of injection; pain in collarbone; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205), via an unspecified route of administration in left arm on 17Mar2021 at 13:00 (at the age of 53-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included allergy to bixin, asthma, antiphospholipid syndrome and raynauds. Concomitant medications included acetylsalicylic acid (ASPRIN), gabapentin, pantoprazole, cetirizine hydrochloride (CETRIZINE), unspecified medication. The patient previously received rofecoxib (VIOXX) and experienced allergy to Vioxx. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 16:15, the patient experienced significant swelling between collarbone and neck on the side of injection, pain in collarbone area. Also moderate swelling in the same area on the other side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test and procedure which included PCR (other): Unknown results on 22Mar2021. No treatment medications were taken for the events. The clinical outcome for the swelling neck and bone pain was not resolved.  No follow-up attempts needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: VAERS Primary Reporter Addl Qualification updated to patient, age at vaccination updated to 53 years old, narrative relevant sentence updated, past drug event #5 reaction added and coded as drug allergy, allergies to bixin added as relevant med history, vaccine start date/time updated to 17Mar2021 at 13:00, vaccine facility information added, concomitant drug vita removed, then concomitant therapy checked, final sentence in analysis tab updated to no follow-up attempts needed. No further information expected.
pain during the administration; the needle "probably" wento into the deltoid muscle; the needle "probably" wento into the deltoid muscle; This spontaneous report was received from a 32 year old non-pregnant female patient referring to herself. The patient's concurrent conditions included allergy to ondansetron (ZOFRAN). The patient had no pertinent medical history.  On 28-MAY-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (lot #, expiration date, dose were not reported) for prophylaxis (reported as rubella). The patient stated that the needle probably went into the deltoid muscle. Concomitant therapies included ethinylestradiol (+) etonogestrel (NUVARING) and minerals nos (+) vitamins nos (PRENATAL). On the same day, during the administration, the patient experienced pain at the injection site.  The patient did not seek medical attention. No laboratory diagnostics were performed.  The outcome of vaccination site pain was reported as recovered/resolved on 28-MAY-2021. Causality assessment was not provided.
I received my shot on 04/12/2021 in the afternoon and started to feel the effects immediately, It started with sharp shooting head pain and through my neck.  I stayed at the clinic for like 30 minutes and on the drive home extreme fatigue started to set in.  By the time I got home the fatigue was the main symptom that  lasted about 24 hours.  The next morning I noticed edema in my right fore arm where I had a prior injury from 2012.  The extreme fatigue lasted for about 2 weeks before I was able to do my job again.  The edema kept getting worse until the day I went to the emergency room.  I also had sharp shooting head pain, it felt like electricity going through my head and that continued for about 7 weeks.  At the emergency room they just gave me fluids and that was it.  The hospital did bloodwork and did an EKG.  Nothing abnormal was found.  I was told if things got worse that I should come back.  The fluids helped and it took about 3 weeks for the edema to go away.  At some point in the process of my events, I had eye palsy that also lasted about 7 weeks.  It has been about 8-12 weeks, I think I am better, but still feel fatigue, but I am not certain that is from the above mention events, it could be from the sleep apnea.
Patient presented at pharmacy to receive the adult bivalent COVID19 Moderna booster. The pharmacist who prepared the vaccine for the patient drew up the pediatric monovalent COVID19 Moderna vaccine for ages 6-11 years, which was then administered to the patient. The error was discovered when the pharmacy manager returned from their weekend off on 12/05/22 and discovered the wrong vial was used. The patient was contacted, he stated the only adverse side effect that he was experiencing was a sore shoulder (left) that had persisted since the vaccine was administered on 12/03/22.   The patient's primary care provider  was contacted to discuss the incident. The provider assessed CDC guidelines and discussion with pharmacy manager; made clinical decision to have patient wait 2 months following the administration of the incorrect monovalent formulation, and then receive the correct bivalent formulation then.
2 weeks after I received injection, I started experiencing a weakness in the left arm. This began Jan 26, 2021. The same evening I experienced an uncontrollable shake in the left thumb. The feeling of weakness/tiredness in my left arm has persisted and has gotten progressively worse. I am currently experiencing feelings of muscle abnormality, reduced strength, and diminished coordination of the left fingers. I have a doctor appointment for this issue scheduled for Feb8, 2021.
pneumonia; with no energy; felt really tired; A spontaneous report was received from a consumer, concerning a male patient of 71-year- old who received Moderna Covid-19 vaccine and experienced tiredness, COVID-19 pneumonia, and no energy.  Medical history included heart operation eight months ago, and since then he has pulmonary problems and respiratory insufficiency. It was reported that he uses Ventolin.  Concomitant  products used are reported as cortisone, salbutamol sulfate and anti histaminic drugs.  On 14-JAN-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   On 15-JAN-2021, the patient experienced tiredness, with no energy and thought it was due to the vaccine.  On 18-JAN-2021, the patient was tested positive for COVID-19 in a rapid test and PCR test. He was feeling well but consulted a HCP while abroad, who detected pneumonia. The HCP prescribed cortisone, anti histaminic and isolation.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, was considered to be resolving at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age along with underlying conditions and recent travel history may have been contributory for the occurrence of the events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-005846:
Received flu shot 11/16/04 at 11:00 Tuesday. Did not feel good Wednesday. On Thursday had hot post nasal drip. Friday, cough , sore throat and feeling weak. Saturday's Sunday, no change. Monday cold or flu leaving.
Rash on left upper thigh with swelling, warm to touch and itchy. Site consistent with varicella vaccine administration.
Triggered systemic inflammation, horrific pain behind my eyes and temple. Heart racing, head spinning and nausea. It's been going on for 5 months now and I am still suffering.
Patient is a 39 y.o. male who was seen at COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination.    He was given the Pfizer vaccination in the left deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience numbness and tingling in the left arm and aching in left hand.  He denied rash, hives, difficulty breathing, wheezing and lightheadedness. He takes no daily prescription medications.    This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes.     ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches    +numbness and tingling of left arm/hand:     Previous Reactions: Denies reactions to prior vaccines.     Objective    Vitals Vitals:   03/22/21 1025 03/22/21 1042 03/22/21 1054 BP: (!) 165/93 (!) 153/95 (!) 138/92 Pulse: 79 70 72 SpO2: 97%   98%      Blood Sugar 286 collected at 10:29am.      Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Musculoskeletal:     Comments: Equal grip strength in bilateral hands. No weakness noted in upper extremities.   Skin:    General: Skin is warm and dry.     Findings: No erythema or rash.  Neurological:     General: No focal deficit present.     Mental Status: He is alert and oriented to person, place, and time.      Assessment/Plan  Treatment included: no therapy Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Encouraged patient to follow up with PCP for annual labs and physical. BP improved prior to discharge.
Redness around vaccination site along with a lump at injection site started 4-23, but had gone away by 4-25, but redness and lump reappeared 4-29 along with slight itching and heat in the area of the injection site
Myalgia, LEFT ARM, SHOULDER, NECK, EAR PAIN, TINNITUS. LEFT AXILLA LYMPH NODES SWOLLEN, PAINFUL Narrative:
30APR91 DTP/OPV booster, morning of 1MAY91 inc temp ax 103 per mom; 2MAY91 mom stated on 1MAY91 fever normal p/6PM no more S/S noted;
T100.4 next day-responded to APAP;devel knot, size of thumb nail @ inj site, hard, dark white drainage; saw MD;
pt woke in AM the day after getting the PPV23 and her arm was red, inflamed and in pain.  She was afebrile.  4/22, the pt was evaluated at which time the area of redness was noted to be 11cmx15cm and was warm to the touch (pt reported that it had improved somewhat from the previous day).  Dx was "probable cellulitis" and she was prescribed Bactrim DS  1 by mouth q 12 hrs x 10 days.
Experienced swollen lymph nodes on the left side where he received the injection; Booster; Swollen left arm (he received the shot on his left arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 15:30 (Lot number: FG3527, Expiration Date: 28Feb2022) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: He has mild Asthma diagnosed as a child., Mild Asthma like seasonal. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot EW0158), administration date: 15Apr2021, when the patient was 18 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, LOT EEW0172), administration date: 07May2021, when the patient was 18 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 29Nov2021, outcome "not recovered", described as "Experienced swollen lymph nodes on the left side where he received the injection"; VACCINATION SITE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "Swollen left arm (he received the shot on his left arm)".  Additional information: The patient's mother enquired for her son who was away at college  for swelling,which did not happen before with the primary series to him. The patient received the booster 6 months after 2nd shot. This did not happen before. He just had shot on Sunday before going back to school. His primary care provider just retired and has another appointment at Christmas with a new primary care. She did not wish to provide any contact details for the new one. She confirmed all 3 were the Pfizer COVID vaccines. He received, unknown expiration.  Injected in unknown arm. unknown expiration.  Injected in unknown arm. They were the worst state in the country.  They were having to bring in the National Guard because so many people did not get the vaccine.The swollen lymph nodes took about 24 hours and did not happen initially. The patient did not go to Emergency Room or Physician Office, did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no adverse events following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
fatigue, sore joints, headache, swollen around eyes, blurred vision (2-22)
Information has been received from a health professional concerning a 63 year old female who on 9/22/00 was vaccinated with pneumococcal vaccine 23 polyvalent in the deltoid. On 9/24/00, the pt's arm was swollen, tender and very red from elbow to back. The pt was seen and treated at urgent care. The pt's experience was considered an "Other Medical Event" by the reporter. On 9/28/00, still not feeling well with a low-grade fever, no temperature elevation or swelling was noted. The physician notes stated "multiple constitutional symptoms, most likely secondary to pneumococcal vaccine 23 polyvalent (MSD)". Additional information has been requested.
upset feeling digestive tract/jumping and feel gurgling; not eating right/eating little; headaches; loose phlegm in back of throat; nausea; sneezing; she has had a runny nose so she has been getting very little sleep; she has had a runny nose so she has been getting very little sleep; very unsteady the whole week; noise and mucous in the back of throat; gas and bubbling; she has all the gas and bubbling and swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH EUA COVID-19 VACCINE, solution for injection, Lot number: EN5318, expiration date: May2021) via unknown route of administration on 19Feb2021 at 14:00, dose 1, single (age at vaccination: 87 years) in her arm for COVID-19 immunisation. Medical history included small intestinal bacterial overgrowth (SIBO) (she has been taking supplements to keep it under control and having fermented foods), endometrial cancer, right lung lobectomy, total hysterectomy, high potassium, edema, Mohs surgery (surgery done to her forehead recently) and blood pressure. The concomitant medication included losartan for blood pressure. Patient reported that she got the first injection a week ago today, on 19Feb at 02:00PM. She said she had no problems until Sunday and through the rest of the week. She says today is the first day she almost feels as good as she felt before getting the vaccine. She reported she has had issues in Feb2021 with upset feeling digestive tract, and not eating right (eating little), she has had nausea slightly though she never did upchuck. Patient also reported she has had headaches, sneezing, and loose phlegm in back of her throat. She said she has been gargling for that at night. She reported that she has had a runny nose so she has been getting very little sleep, she has had noise and mucous in the back of throat and noise in her digestive tract. She says she has problems with her small intestine bacteria overgrowth, also called SIBO, for which she has been taking supplements to keep it under control and having fermented foods, she puts her hand on her stomach and can feel it jumping and feel gurgling, she has been very unsteady the whole week. She says she is sorry that she took the vaccine since her immune system is totally compromised, over the years she has had 4-5 bouts of cancer, and her intestines has more bad bacteria than good bacteria, she has all the gas and bubbling and swelling because of that. The outcome of the events upset feeling digestive tract, not eating right/eating little, headache, loose phlegm in back of throat was resolving and outcome for rest of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Headache, fever/chills, unable to sleep, stiffness shoulders and neck that has not resolved.
PT CALLED REPORTING ADVERSE RXN TO FLU SHOT THAT HE RECEIVED AT ANOTHER KROGER PHARMACY.  COMPLAINTS OF IMMEDIATE PAIN ARM BETWEEN ELBOW AND SHOULDER SHARP PAIN WHEN LIFTING NO SWELLING OR REDNESS RECOMMENDED PT TO CALL MD AND LET MD LOOK AT ARM FOR TREATMENT.
reaction after Tdap but also not sure if it was Adacel or Boostrix.; Initial information received on 18-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (non health care professional).  This case involves patient with unknown demographics who had reaction after tdap but also not sure if it was adacel or boostrix. 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with unknown dose lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient had reaction after tdap but also not sure if it was adacel or boostrix. (nonspecific reaction) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (reaction after Tdap but also not sure if it was Adacel or Boostrix.).  At time of reporting, the outcome was Unknown for the event reaction after tdap but also not sure if it was adacel or boostrix.