chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Strong myalgias in buttocks and hamstrings bilaterally at 2 days migrating to calfs at 3 days. Dull ache pain. gone in buttock on day 3, gone in hamstrings day 4, still slight in calves.; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received bnt162b2, lot number and expiration date unknown, at the Hospital, via an unspecified route of administration on 23Dec2020 at 11:45, at a single dose for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included psoriatic arthritis from an unknown date, for which patient took Enbrel 50 3 weeks prior to injection (in 2020). The patient had no known allergies. Concomitant medications included propranolol hydrochloride (INDERAL LA, 60 mg) and olmesartan medoxomil (BENICAR, 40 mg). In 26Dec2020 at 04:00, the patient experienced strong myalgias in buttocks and hamstrings bilaterally at 2 days migrating to calfs at 3 days. Dull ache pain. Gone in buttock on day 3, gone in hamstrings day 4, still slight in calves. The event was reported as non-serious. No treatment was received for the adverse event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
This summer I started getting a lot of vaginal itching. It didn't go away for a long time. September 2021, I seen a doctor, and they said I have an infection. I had to get emergency care. They diagnosed me with lichen sclerosis. They prescribed a steroid cream that is supposed to be applied locally.
received the covid vaccine on Tuesday and experienced a sensitive allergic reaction consisting of facial swelling; received the covid vaccine on Tuesday and experienced a sensitive allergic reaction consisting of facial swelling; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old female patient received bnt162b2 (BNT162B2 solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an unspecified indication. The patient medical history and concomitant was not reported. On unknown date, the patient received the covid vaccine on Tuesday and experienced a sensitive allergic reaction consisting of facial swelling with outcome of unknown. Clinical measures were taken, She has taken Benadryl for this but it has not gone down, and they are thinking whether she should get the second dose of the vaccine. Therapeutic measures were taken as a result of received the covid vaccine on Tuesday and experienced a sensitive allergic reaction consisting of facial swelling. Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.  \
Perspiring, cool, clammy to touch and O2 sat from 45% -> 100% 15 mins after vaccines administered. O2 per mask at 1.7 L until EMS arrived. O2 started by RN. Client transported to hospital ER.
I currently have a patient in my store who is past due for her 2nd shot. Shot 1 was given on 4/30/21; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I currently have a patient in my store who is past due for her 2nd shot. Shot 1 was given on 4/30/21) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-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 PRODUCT DOSE OMISSION ISSUE (I currently have a patient in my store who is past due for her 2nd shot. Shot 1 was given on 4/30/21). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I currently have a patient in my store who is past due for her 2nd shot. Shot 1 was given on 4/30/21) 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.   No concomitant medication reported.  No treatment information reported.   This case was linked to MOD-2021-227837 (Patient Link).
flu like symptoms; joint pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 09:50 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 02Nov2022, outcome "unknown", described as "flu like symptoms"; HEADACHE (non-serious) with onset 02Nov2022, outcome "unknown"; ARTHRALGIA (non-serious) with onset 02Nov2022, outcome "unknown", described as "joint pain".  Additional information: Started with flu like symptoms, joint pain and headache at approximately 1AM 02Nov2022. Symptoms continue through 6:30 AM. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Doctor ordered Zoster and PPV23 for patient. They were both given but patient had previous Zoster 9-24-15. No adverse reactions 20 minutes following. Patient notified and left appt.
Patient felt dizzy 30 minutes post injection, required extra observation and rest time to dissipate. She was slightly hypertensive 145/88 mm/Hg and 147/91 mm/Hg. Heart rate was consistently in the 80 BPM range.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: felt weird and dizzy, RN gave her water and juice, HR 89, O2 99%, BP 120/92. Advised to have ride home vs driving. Pt called for ride home, lives with roommate.
shiver like freezing cold was under 3 blankets and could not warm up.; pains at the lymph glands at underarms and necks.; Severe Migraine; heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E46162) via an unspecified route of administration in the left arm on 15Apr2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included azithromycin (AZITHROMYCIN PACK); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) taken for unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6455) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. 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. On 15Apr2021, the patient did shiver from 22:00 like freezing cold and was under 3 blankets and could not warm up. The patient had pains at the lymph glands at underarms and necks and severe migraine and heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pains at the lymph glands at underarms and necks, severe migraine and heart palpitations were not recovered at the time of this report while the event shiver like freezing cold was under 3 blankets and could not warm up was recovered on 16Apr2021 at 04:00.  No follow-up attempts are needed. No further information is expected.
Not adverse  effect of vaccine.  on 12/26/2021 I started getting sick and tested positive for Covid on 12/27/21. I had headaches, chills , fever , muscle pain, weakness, nausea, cough, chest pain, asthma symptoms, brain fog and trouble focusing. I?m on steroid inhaler and still feel that my breathing is not back to normal.
Rash and facial swelling that started the evening of 11/7, worse the next morning. Discontinued amoxicillin when rash started. Rash improved by late morning 11/8
Redness 45mm across by 60mm up and down, swelling, warm to the touch
allergy; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; my Tongue started swelling; both hands started swelling; Foot swelling including the ankle; Foot swelling including the ankle; This is a spontaneous report from a contactable other hcp reported for himself. A 56-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: bh9899), intramuscular on 31Dec2020 13:30 in left arm at single dose (first dose) for COVID-19 immunization. There were no concomitant medications and medical history. After a day of the vaccine which was giving on Thursday 31Dec2020, patient started experiencing sided effects of his foot swelling including the ankle. On Sunday (03Jan2021), both hands started swelling, Monday (04Jan2021) morning his tongue started swelling and went to his doctor. He administered a steroid and prescribed an Epinephrine pen just in case it got worse and was also prescribed additional medicines for his allergy. Since he had had additional swelling around his upper body including his right eye and right upper quadrant, right ribs. AE treatment including steroid injection, hydroxyzine HCL 25 mg, Methylprednisolone 4 mg. AE resulted in doctor or other healthcare professional office/clinic visit. No other vaccine in four weeks and no other medications in two weeks. There was no COVID tested post vaccination and COVID prior vaccination. The outcomes of events were resolved with sequel.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. 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.
pain and aches all over his body; sick; patient stayed off from work for two days following the dose; fever which went up to 102.1 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain and aches all over his body), ILLNESS (sick), IMPAIRED WORK ABILITY (patient stayed off from work for two days following the dose) and PYREXIA (fever which went up to 102.1 degrees) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 on 19-Mar-2021. Concomitant products included PRAVASTATIN and VITAMINS NOS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain and aches all over his body), ILLNESS (sick), IMPAIRED WORK ABILITY (patient stayed off from work for two days following the dose) and PYREXIA (fever which went up to 102.1 degrees). At the time of the report, PAIN (pain and aches all over his body), ILLNESS (sick), IMPAIRED WORK ABILITY (patient stayed off from work for two days following the dose) and PYREXIA (fever which went up to 102.1 degrees) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.1 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: The patient took Tylenol for the adverse events.   This case was linked to MOD-2021-098409 (Patient Link).
axillary lymph node swelling (L side underarm); pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (axillary lymph node swelling (L side underarm)) and VACCINATION SITE PAIN (pain at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST SODIUM (SINGULAIR) for Allergy.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced LYMPHADENOPATHY (axillary lymph node swelling (L side underarm)) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, LYMPHADENOPATHY (axillary lymph node swelling (L side underarm)) and VACCINATION SITE PAIN (pain at injection site) had resolved.      Concomitant product use was not provided by the reporter.  No treatment information provided.  It was reported that Patient was taking Birth Control Pills for birth control on an unspecified date of 1995 daily by oral route which was still ongoing.   This case was linked to MOD-2021-407016 (Patient Link).
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date in 2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
My daughter felt right at the time of administration that something was wrong.  She said she felt the medication going down her arm.  Immediate soreness in left arm where as for a week she could barley lift her left arm.  Pain did not go away with Tylenol or Ibuprofen.  After about a week the pain lessened but was still there.  Pain not constant but more positional and worse at night.  She had decreased range of motion and still does two weeks later, whereas she has trouble washing her hair and putting on deodorant.  If she tries to pull herself up onto something the arm just gives out.  The left arm also has a lot of cracking and popping noises when she moves her arm.  Pain will shoot down the arm at times.   She was examined at Hospital on 7/8/2020 .  Ultrasound scheduled for 7/9/2020.  We were told she may orthopedic consult and physical therapy.
PATIENT STATED THAT SHE HAD A LOCAL REACTION AT THE INJECTION SITE ALMOST IMMEDIATELY. THE RASH AND ITCHING HAS SINCE SPREAD (AS OF 5/20/17 AT 5:50PM). PATIENT HAS ALSO HAD A HEADACHE SINCE THE TIME OF INJECTION.  SHE HAS BEEN APPLYING HYDROCORTISONE CREAM AND WAS ADVISED TO TAKE BENADRYL.
On 01/27/2021, she began to feel pressure in her right ear and stated it felt like she was underwater.  She also complained of a headache.  On 01/28/2021, she has body aches, chills, fever 100.2, shaking.
pt recvd vax 16NOV92 & exp cutaneous atrophy (dimpling), redness, swelling & poss abscess;
Itchy palms starting Friday 7/27 in the morning, developing hives throughout the day. Severe itching and hives Friday 7/27 at night. Itching and hives continued through the weekend and included red joints that were warm (knees and elbows) on Sunday. Itching and respiratory symptoms continued through week ending 8/4. BENADRYL, Prednisone and CLARITIN taken through 8/7. Itching has subsided by 8/7 but dermatographia and hives continue if skin is scratched. Continue to get red marks and hives, including from showering. Entire body is affected but most itching was concentrated to hands and arms, while face is most sensitive to touch (redness appears easier).
Narrative: COVID infection following COVID vaccine series 01/01 Pfizer, dose#1 02/01, Pfizer, dose#2 10/03 COVID swab, result: detected 10/03 pt cc: exposure: unknown 10/04 clinically resolved
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four-years old male patient who was vaccinated with a 0.5 ml once dose of vaccine FLUBLOK QIV (Batch number: QFAA1814 and expiry date: 30-Jun-2019) via intramuscular route in the left arm on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccine was administered. It was a case of actual medication error due to inappropriate age at vaccine administration because the vaccine was inadvertently administered to a 4 year old male. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patient experienced syncope with alterations in consciousness for approx. 6 minutes. Fruit juice and animal crackers administered. Vital signs remained stable.
called to report to her supervisor/employer that while she was at the gym working out she started to not feel well, she felt she was hyperventilating and then her left arm went numb and although she was awake, she not able to respond. The paramedics was contacted and came. She reported that once she was in the emergency department all her tests were clear, including her CT scan. The MD felt it was most likely a "mini TIA". She has fully recovered and denies any other symptoms at this time, but was instructed by her MD to contact the facility that administered her MODERNA covid vaccine.
Pt vax 3rd dose and was a non responder; 1st 2 doses w/Recombivax;
At 7:30 am, back muscles were aching. About 20 mins later, upper abdomin and lower chest region severe pain in muscles. Hurt and ached really bad. pt rates pain level 7. Pt was sweating which lasted 1-1 1/2 hrs. Went to ER but left when pain subsided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.99 . Concomitant products were not reported.  On 15-Apr-2021, Excursion time was 9 AM, temperature was 34 respectively, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
At an unknown time following vaccine injections pt reportedly experienced hives on abdomen and chest, with some symptoms of throat swelling. Urticaria was diagnosed. Medrol Dose pack, Zyrtec 10 mg daily, OTC Pepcid, BID, was prescribed. Advised to return if dyspnea occurred.