chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigue, severe weakness( in bed for 2 days)  dizziness,  disoriented,  nausea, severe headache. injection site swollen(egg size) hot for 4 days(applied ice, and  took Tylenol )  Adverse reaction has lasted 3  days, still feeling disoriented day 4 .
This case was reported by a other health professional via call center representative and described the occurrence of lymph node pain in a 60-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 2nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 3rd August 2018, 1 days after receiving SHINGRIX, the patient experienced enlargement of lymph nodes and chickenpox. On 4th August 2018, the patient experienced lymph node pain. On 8th August 2018, the patient experienced blister. In August 2018, the patient experienced fatigue and red blotches. In August 2018, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the lymph node pain and enlargement of lymph nodes were recovering/resolving and the outcome of the red blotches was unknown and the outcome of the chickenpox and blister were recovered/resolved. It was unknown if the reporter considered the lymph node pain, enlargement of lymph nodes, fatigue, red blotches, chickenpox and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the medical assistant. The patient received SHINGRIX on left deltoid. The day after receiving SHINGRIX in evening the patient experienced swelling in the lymph nodes. She had swollen lymph nodes on her left collarbone (same side as the injection site) and axilla at the same time. It was also painful. At the time of this report, the swelling (swollen lymph nodes) was present but the size of a pea, it was the size of a blueberry. The patient also experienced fatigue, unsure when it started but it had since resolved. The patient applied heat to the swollen lymph nodes on her left collarbone and then developed red blotch area over the lymph nodes. The patient also developed a pox spot with blisters on the right thigh but it cleared after 2 to 3 days.
Child awake this morning at 4AM w/a fever & a rash over body worse on back very itchy.
Left elbow redness and swelling, pain- 5 days duration. Rx Dicloxacillin
1/4/21 Developed redness, swelling, raised, rash, itchy, size of quarter area.  1/5/21 Redness increased to 2 inches by 2.5 inches with same symptoms. Reported to Employee Health refer to Urgent Care.
Migraine, cold sweats about 20 minutes after injection, body aches and pains entire body, chest pain, sore throat, nasal passage restrictions- still able to breath just more difficult, left arm/armpit numbing sensation  all started later Sunday night and has been progressively getting worse. Woke up with abdominal cramping as if I was going to start my period and when I went to the bathroom and wiped I was spotting blood. I had a hysterectomy 4 months ago and have been completely healed for a while. Throat soreness as well started the evening of the 5th.
Patient's mother updated PPA by phone on 2/1/19 that patient had had a headache since about an hour after receiving the Men B #2 vaccine. She had also gone to the ER for this, who had sent her home with supportive care. We directed her to follow up with her neurologist, who apparently felt the headache is related to the MenB. She is apparently not taking the ibuprofen/acetaminophen as per neuro because she is concerned for stomach upset.
(i) Sudden sensorineural hearing loss (left ear), (ii) Vertigo, and (iii) Tinnitus - treatments including oral corticosteroid prescription (3 weeks), intratympanic steroid injections (3 injections to date), and hyperbaric oxygen therapy (13 sessions to date)
Rash in the area of the vaccine that got bigger as days went by, it lasted for about  a week. It felt a little itchy.
SWELLING AT INJECTION SITE AND REDNESS ON ARM PROGRESSIVELY WORSENED AFTER FIRST 24-48 HOURS.  NO TREATMENT UP TO NOW. WILL RECOMMEND ICING AND ANTI-INFLAMMATORY MEDICATION.
arm in throbbing pain. Out of no where I couldn't breathe and felt like someone was crushing my chest.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 09-JUL-2010, the patient received improperly stored VARIVAX dose 2, from lot # 666851/0280Z, expiry date 12-FEB-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse refers to unknown number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On unknown dates, these patients were inadvertently vaccinated with improperly stored VARIVAX (Merck) (lot # L037560, expiry date: 29-SEP-2017) (incorrect product storage). The vaccine underwent a temperature excursion to -6 degrees Celsius for a time frame of 8 hours 58 minutes. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient is a 87 y.o. female, never smoker, no significant prior pulmonary history, other more comorbidities including anemia of chronic disease, chronic kidney disease on dialysis, diabetes mellitus, heart failure with preserved ejection fraction, presented from her nursing facility confusion, dyspnea and weakness.presented to the ED on 05/16/2022 after dialysis due to weakness and not feeling well, diagnosed with COVID.  She had normal vital signs and she was prescribed antibiotics and sent back to the facility.  She had worsening symptoms last night.  She presented to the ED again today.  She was found to be hypercapnic.  She was placed on BiPAP.
"feel bad"; lethargic; Back pain; Fever; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("feel bad"), LETHARGY (lethargic), BACK PAIN (Back pain), PYREXIA (Fever) and NAUSEA (nauseous) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING ABNORMAL ("feel bad"), LETHARGY (lethargic), BACK PAIN (Back pain), PYREXIA (Fever) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL ("feel bad"), LETHARGY (lethargic), BACK PAIN (Back pain), PYREXIA (Fever) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
Started with chills Thursday evening, then body aches all over.  Friday morning, extreme body aches.  Fever developed that evening, spiked at 101.7 early on Saturday morning before breaking.  Large red, swollen, feverish circle (about the size of a tennis ball) developed Saturday morning just at and below injection site.  Fever and body aches were gone on Saturday, but skin reaction spread further down arm on Sunday and Monday before going away.  Went to Urgent Care on Sunday to have arm checked for infection, but there was none.  No treatment for any side effects other than ibuprofen.  After skin reaction cleared, there was still slight discoloration on arm, looked like bruising under skin.  Seems to be mostly gone now.
extremely sick; severe reaction; sweats; joints were hurting; fatigue; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely sick), ADVERSE REACTION (severe reaction), HYPERHIDROSIS (sweats), ARTHRALGIA (joints were hurting) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (extremely sick), ADVERSE REACTION (severe reaction), HYPERHIDROSIS (sweats), ARTHRALGIA (joints were hurting), FATIGUE (fatigue), PYREXIA (fever) and PAIN (body aches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and HYDROCODONE for Pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (extremely sick), ADVERSE REACTION (severe reaction), HYPERHIDROSIS (sweats), ARTHRALGIA (joints were hurting), FATIGUE (fatigue), PYREXIA (fever) and PAIN (body aches) outcome was unknown.            The patient states she took ibuprofen and hydrocodone. She states they didn't even really help her with pain.  Patient states that symptoms were not half as bad as the one after the booster.   This case was linked to MOD-2021-363473, MOD-2021-363175 (Patient Link).
significant, rapid hair loss; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (medically significant), outcome "unknown", described as "significant, rapid hair loss". Clinical course was reported as, Reporter was asking for any information that is available about alopecia suspected to be caused by Comirnaty as reporter have a colleague (patient) who has significant, rapid hair loss since she received the vaccine, and she has concerns that her hair loss was caused by the vaccine.  Reporter just want to provide her with any information that is available.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported event and the suspect product BNT162B2 cannot be ruled out.  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.
Diagnosed with shingles (no lab done) on 03.09.2021. Currently on Valacyclovir, ibuprofen ever 4 hours for pain, and gapabentin nightly. Patient reports she previously had shingles in 1973 while pregnant.   03.02.2021 patient noticed pain in her ribs below her breast. Pain worsened and spread to her back. 03.08.2021 patient noticed a red line under her breast. 03.09.2021 doctor confirmed shingles dx. Patient developed blisters on her back and a strong headache. 03.11.2021 patient is still symptomatic with blisters and reports pain is controlled provided she takes ibuprofen every 4 hours.   Patient reports that doctor has advised she get the second dose of vaccine as scheduled, provided she is not acutely ill on day of vaccination.
about 2 hours after the vaccine the patient complained of a burning feeling, itchy and tattoo became discolored. Patient has had the tattoo for 2 years.
Pt recvd 4 doses of Engerix-B & was found to be a non-respnder; exp pain @ inject site w/4th dose; 3rd inject given SEP92 (1991?);
Patient was given a Pediatric Pfizer Biontech covid 19 dose 0.2ml instead of a regular 0.3 ml  Pfizer purple cap. That is patient age is twelve year old.
Little Pain; Flu like Symptoms; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Little Pain) and INFLUENZA LIKE ILLNESS (Flu like Symptoms) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (Little Pain) and INFLUENZA LIKE ILLNESS (Flu like Symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Little Pain) and INFLUENZA LIKE ILLNESS (Flu like Symptoms) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported.
Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swelling throat felt like olive stuck in it I called Kaiser. Talking to them chest began stinging hurting pressure. Told to call 911. I hung up walked two blocks to urgent care.  Chest really hurting feeling dizzy face eyes swelling throat lump getting larger.  My breathing rate normal , blood pressure normal , oxygen normal.  They took me back gave me epinephrine and depo modral  shot in right buttock cheek.  After few minutes felt better chest stopped increasing in pain throat started feeling better, face still swollen. Told me good thing I walked instead of waiting for 911. Very scarey. Told to remain up for 24-48 hours give epi if needed again. Taking 180-360 mg 24 hr Allegra daily. I stayed up  36 hours drank water .  Told can not take second shot. No vaccines until I get tested for what caused allergic reaction. Today March 23 face still off and on swelling and eyes. Seems when I begin to move around swelling starts again.
nausea; Vomit; This is a spontaneous report from a contactable consumer. A 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of administration on 27Feb2021 (Lot number: unknown) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient experienced nausea on 01Mar2021, vomit on 01Mar2021. It was reported that patient mentioned that she was vaccinated on Saturday with the first dose of the COVID vaccine. Everything was fine but yesterday she had been getting nauseated which also brought out some vomit. She would like to know how long is this nausea going to last. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chronic hives (so large many were welts) that covered my entire body for 4-5 months following my booster.  Had to use a 6 day steroid with no results, and see an allergist who recommended 2 Allegra in the morning and 2 zyrtec at night until hives subsided. Discussed possibly needing monthly allergy injection however I declined.
Patient felt dizzy and like she was going to pass out. Patient was sweaty and clammy. Gave patient water, brought a fan over. She did pass out for a second or two so we laid patient on the floor. We called 911. Firemen arrived and took patient blood pressure (around 90/60). Patient reported having low blood pressure and occasionally passing out after giving blood. After about 15 minutes of laying down, firemen helped patient sit down. Patient refused to go to hospital.
patient bled more than usual after administration; 14 year old male patient; not sure if she hit something; This is a spontaneous report from a contactable pharmacist. A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as Unknown single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced bled more than usual after administration in which the circle bandage was immediately filled up. reporter states that patient utilized a 1inch needle. The patient does not take any medications. Reporter queried never seen this before in her three years of administering vaccines. not sure if hit something or what caused him to bleed more than normal. Caller was asking if the patient needs to be revaccinated due to the patient bleeding more than normal after vaccination. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.  Follow up (01Jun2021): This is a follow up spontaneous report from a contactable pharmacist. This Pharmacist reported for 14-years-old male patient, no lot number, no expiry date and no new  adverse event was added.  Information on the lot/ batch number has been requested.  .
From initial information received on 6/1/05 from a physician regarding an adverse event, it was reported that a 21 year old female patient received her second dose of JE-VAX, lot number EJN213A, administered on 5/27/05. The route and site of administration were not reported. Twenty minutes later, the patient developed erythroderma with redness and blotching as well as dizziness and decrease in blood pressure from the 90s to 80s. The patient was treated with epinephrine and IM Benadryl. She did previously receive her first dose of JE-VAX, lot number EJN214A, a dose of IPOL, lot number X0367, a dose of MENOMUNE A/C/Y/W-135, lot number UE289AA, a dose of TYPHIM Vi, lot number X0794, and a dose of HEPATITIS A VACCINE, lot number AHAVB032BA, administered on 5/20/05 with no reactions reported. It is unknown at this time whether the patient recovered from the events. The reporter of this case is the same reporter as case 200501039. (OMIC)
Headache; severe chills; severe shivering/shakes; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), intramuscularly in the left arm, on 21Jan2021 10:30 (at the age of 26-years-old) at a single dose for COVID-19 immunization. Medical history included latex allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included ethinylestradiol, etynodiol diacetate (KELNOR) taken as a contraceptive and fexofenadine hydrochloride (ALLEGRA). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0142), intramuscularly in the left arm, on 31Dec2020 at 17:00 (at the age of 26-years-old) for COVID-19 immunization. The patient experienced headache, severe chills, and severe shivering/shakes on 21Jan2021 at 21:00. The events were reported as non-serious. The clinical course was reported as follows: Less than 12 hours after getting vaccinated, the patient experienced headache, severe chills, severe shivering/shakes that didn't stop. Being under blankets didn't help but using heating pad helped a lot. The shaking stopped the next morning, but patient still had a bit of chills and headache the next day. Therapeutic measures were taken as a result of the severe chills and severe shivering/shakes as aforementioned. The patient did not receive any treatment for headache as reported. The clinical outcome of headache and chill was recovering and of severe shivering/shakes was recovered on 22Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Rash on L arm around site, itchy, spread full body by 11/12/09 - taking ZYRTEC and BENADRYL.
Expired Jynneous vaccine administered beyond use date.; Case reference number US-BN-2022-004177 is a spontaneous case report initially received on 24-Oct-2022 from a health professional via Agency (reference number: USBAV22-1761) and concerns a patient of unknown gender or age.  The patient's medical history and concomitant medication details were not provided.  On a 19-Oct-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and monkeypox vaccine (live modified vaccinia virus Ankara; batch number: FDP00014) at unknown dose, at an unknown route or site of administration, for active immunization against Monkeypox.  On a 19-Oct-2022, as reported, the patient received Jynneos vaccine with beyond use date of 15-Oct-2022 (explicitly coded as 'Expired product administered').   At the time of this report, it was unknown if the patient experienced any adverse event.  No further information is provided.  Non-significant case correction performed for information received on 24-Oct-2022 from Bavarian Nordic included local BN case ID; Reporter's Comments: A patient of unknown gender or age was vaccinated with the first dose of Jynneos vaccine for active immunization against Monkeypox. Reportedly, the patient received vaccine with beyond use date of 15-Oct-22 on a 19-Oct-22, which is considered as expired product administered. The event is listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Expired product administered is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown gender or age was vaccinated with the first dose of Jynneos vaccine for active immunization against Monkeypox. Reportedly, the patient received vaccine with beyond use date of 15-Oct-22 on a 19-Oct-22, which is considered as expired product administered. The event is listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Expired product administered is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 at 10:00 as dose 1, single (Lot number: FG3527) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "colon cancer" (unspecified if ongoing), notes: 10+years ago. The patient took concomitant medications. The following information was reported: VERTIGO (non-serious) with onset Nov2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient was tested for COVID post vaccination. Patient used Birth control medications in two weeks and Vertigo sudden onset 2 days later. Now common and happening more frequently.