chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the 1st Pfizer COVID vaccine (lot # FK5127, expiration date 11/29/21) at 1258 in her left deltoid by RN.  At 1300 patient lost consciousness while sitting in dad's lap, posterior occipital region bumped on table in process of positioning patient on floor in supine position.  PHN performs sternal rub patient aroused immediately.  Parents deny food or medication allergies, deny significant medical history, current medications or therapies.  1301: PHN calls 911, EMT arrived, patient alert and oriented to person, place, time and situation.  Ice pack applied to posterior occipital area, negative for abrasion, laceration, or discoloration.  Mom, reports throat pain then confirms neck versus throat pain.  Perioral area free of inflammation and cyanosis.  1308:  heart rate 63, blood pressure 105/80, 98% SaO2 on room air.  1310:  Emergency services on site.  1317:  Emergency services transports patient to hospital, patient remained alert and oriented to person, place, time and situation.
Arthritic pain in hand and feet; This is a spontaneous report from a contactable Other HCP (Patient). This A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscularadministered in left arm (left shoulder) on 15Feb2021 at 08:30 am at age of 79-years-old (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included hypercholesterolaemia from 2004 and ongoing (pertinent details: Lowering cholesterol- zetia (cannot tolerate statins)), atrial fibrillation (AFib) from 2002 and ongoing (pertinent details: controlled by sotalol and atenolol), arrhythmia, high cholesterol, herpes prevention. Concomitant medications included sotalol taken for arrhythmia from 2002 and ongoing; atenolol  taken for arrhythmia from 2002 and ongoing; ezetimibe (ZETIA) taken for high cholesterol from 2004 and ongoing; valaciclovir hcl taken for herpes prevention from 2011 and ongoing. The patient experienced arthritic pain in hand and feet on 16Feb2021. Seriousness criteria was persistent/ significant disability/ incapacity. AE required visit to physician office. Treatment included pain medication, tylenol, lidocaine topical cream. The outcome of the event was recovering.; Sender's Comments: Based on the reported information ,a causal relationship between the event Arthralgia and suspected drug 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
SYNCOPE APPROXIMATELY 1-2 MINUTES AFTER INJECTION. NO TREATMENT NECESSARY
Patient specifies that a few days after the shot upon where the injection was given, her left shoulder became very stiff and then the stiffness went to her neck where she could barely move. Patient went to MD office the following week and received a steroid shot and taking muscle relaxant/NSAID/NORCO to help relieve pain and now after about 3 weeks is starting to feel a little bit better.
Pt was under the age of 18 when she received this dose of Moderna. Pt presented with mother and sister to clinic asking specifically for Moderna vaccine. Pt was assumed to be over the age of 18. Pt correct age discovered after administration of second dose 10/14/2021. Mother of pt was informed of this VAERS 10/16/2021. Mother stated pt had typically side effects following second dose such as malaise but had recovered to normal as of the time of the phone call 10/16/2021.  Mother and father both very concerned.
Local reaction consisting of redness, swelling, tenderness, warmth to the touch, and slight itching.  Patient stated that the reaction started on the morning after the vaccine was administered. She notified me (RPh) two days later (Sunday, 3/25/2018). I told her to apply a cold compress to the area for 15 minutes, take an analgesic/anti-inflammatory if needed, and an antihistamine as needed. I advised her to contact her doctor tomorrow morning (Monday).
I originally received J&J vaccine on April 12, 2021, on November 18, 2021 I was given a bossier shot of Moderna. Within the first 24 hour period I had a mild headache and arm soreness as expected. After 24hrs I felt normal. Today on November 22, 2021 I woke up with a dime sized lump on my collar bone or Cervical lympadenopathy. It is a bit swollen and tender only to the touch.  I called my GP who suggested drinking water, continued monitoring for changes and not to manipulate the area. I did not go to the doctor in person.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient stated she has an itchy rash spreading from elbow to injection site area
Pocket, which became swollen and raised; Pocket, which became swollen and raised; Given slightly below the deltoid; Injected more into the subcutaneous region; Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. Additional event(s) included intramuscular formulation administered by other route on 29th May 2020, hand swelling and skin nodule. The outcome of vaccine administered at inappropriate site was unknown. The outcome(s) of the additional event(s) included hand swelling (unknown), skin nodule (unknown) and intramuscular formulation administered by other route (unknown).     Other possible cause(s) of the hand swelling included Diphtheria toxoid 2 IU, Tetanus toxoid 20 IU, Pertussis toxoid 8 ug, Filamentous Haemagglutinin 8 ug, Pertactin 2.5 ug. Other possible cause(s) of the skin nodule included Diphtheria toxoid 2 IU, Tetanus toxoid 20 IU, Pertussis toxoid 8 ug, Filamentous Haemagglutinin 8 ug, Pertactin 2.5 ug.   Pharmacist states that Boostrix was administered to a patient who had a very large arm, and it was given slightly below the deltoid region. He also states that it was injected more into the subcutaneous region rather than intramuscular due to this and developed a pocket, which became swollen and raised. He is inquiring if the needs to be repeated? Did not consent to follow-up. Call Notes:HCP declined to leave patient demographics and does not wish to be contacted about this case.  Additional details were provided as follows:  The age at vaccination was not reported. The Boostrix vaccine was administered to the patient who had a very large arm, and it was given slightly below the deltoid region, which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. The reporter also stated that it was injected more into the subcutaneous region rather than intramuscular due to this and developed a pocket, which became swollen and raised.  The pharmacist asked if the needs to be repeated. The reporter did consent to follow up.
Parent reports patient stuttering after adminisration of vaccines, feels strongly it is because of MMR and wants "report filed".
vesicular rash;erythematous lesions;imp varicella?;+ strep cult @ time of office visit;
Received Rotateq 11/27. 11/29 developed severe green watery diarrhea. No fever, no vomiting. No contact. Breast fed infant. 12/29/06 Received medical records from PCP which reveal patient was well on day of vax with only umbilical hernia & left hydrocele noted.  Next visit is 12/4/06 when had diarrhea x 4 days.  Dx: Rotavirus.
6X7cm redness + induration to injection site, to give Ibuprofen.
Pt woke up with c/o arm pain. Mother noticed on (L) arm at injection site - softball size swelling, redness, and warmth. Pt c/o pruritus to lower arm. Mother took pt to local physician. Physician stated allergic reaction and prescribed antihistamines.
This spontaneous report as received from a nurse refers to unspecified patients. The patients medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
high blood pressure/ after the first shot it went up to 159/85; heart palpitations; PVCs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "low blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERTENSION (medically significant), outcome "recovering", described as "high blood pressure/ after the first shot it went up to 159/85"; PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations"; VENTRICULAR EXTRASYSTOLES (non-serious), outcome "unknown", described as "PVCs". The events "high blood pressure/ after the first shot it went up to 159/85", "heart palpitations" and "pvcs" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 159/85 mmHg, notes: High: after the first shot it went up to 159/85; 100/60 mmHg, notes: usually 100/60.  Clinical course: Caller, female, almost 72 years of age, has had 5 previous shots of the Pfizer COVID vaccines. She is calling about the new one that was just released but no where has it yet. She had a different reaction to each vaccine but would like to stick with Pfizer because that is what her body is used to. She does have a lot of allergies. The first shot she had a very severe reaction to. She developed high blood pressure, and she had always had low pressure. Her blood pressure was usually 100/60 and after the first shot it went up to 159/85 she thinks. It was like that for quite a while, until right before she had to get the second shot and it got better. She called the Pfizer reaction line and they told her that its happening to people but its temporary and if you already deal with that issue the shot could make it worse, but she never had that issue before. So she went to the heart hospital to go get checked out. She was having heart palpitations and PVCs bad. She could feel them. She always gets them but doesn't feel them. But she didn't have that strong of reaction again like she did to the first dose of the Pfizer COVID vaccine. When she went to see the doctor and told her about it, the doctor, who is thin like her, said she got the Moderna COVID vaccine and she also was having heart palpitations.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300611 same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300300610 same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300300609 same patient/vaccine, different dose/event;US-PFIZER INC-202300300612 Same reporter, patient, product, different dose and event;
PT COMPLAINED OF MILD SOB AND FEELING WOBBLY. SHE WAS ADVICED IN THE PAST OF POTENTIAL REACTIONS TO VACCINE AND AGREED TO TAKE ONE TODAY. SHE WAS ON  HER 28TH MINUTE OF OBSERVATION WHEN SHE HAD ONSET OF SYMPTOMS. NO TREATMENT WAS PERFORMED BUT VITALS WERE TAKEN ALL WITHIN NORMAL LIMITS, WITH EXCEPTION OF BP ON THE SECOND TIME TAKING IT, SHE WAS HYPERTENSIVE. PT WAS ASSESSED AND ADVISED TO SEEK MEDICAL ATTENTION AND GIVEN SYPTOMS TO BE CAUTIOUS OF.
Vasovagal reaction with some associated nausea and retching following intranasal influenza vaccine. Per parent's report, patient "passed out" while at the grocery store. No confirmed loss of consciousness. Symptoms resolved after a bowel movement.
Second Shingrix vaccine administered was expired on date of administration. Administered 2/17/2023, expired 11/7/2022. Discovered thru internal audit. Primary care physician has been notified, incident has been submitted, and patient has been notified and will stop in this week to receive re-administration of 2nd dose (as per CDC guidelines)
About 1 week after receiving vaccine, noticed persistent redness and swelling below injection site. It was also itchy. Called nurse advice line the following day who recommended being seen by primary care doctor for possible cellulitis. Had appointment with the doctor on 19 Jan and the doctor also diagnosed with cellulitis and prescribed antibiotics. Shortly after, articles began coming out about COVID arm and I realized that's exactly what I had. within 3-4 days after the doctor's appointment, my symptoms were completely cleared.
Intussusception 1 day after second dose of DTaP, IPV, HIB and Prevnar. Surgical reduction done.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 29-JUL-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX with lot No. L034724 Expiration date: 09-DEC-2016 (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature was -14 C for 4 days. No data logger and no previous excursions involved. No adverse effects were reported. No Product Quality Complaint (PQC) was involved). This is one of three reports received from the same source. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of pain in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain, malaise and injection site pain. On an unknown date, the outcome of the pain, malaise and injection site pain were unknown. It was unknown if the reporter considered the pain, malaise and injection site pain to be related to Shingrix. Additional details were provided as follows: The patient had reported experiencing malaise, feeling  achy and that the vaccine was painful. Five out of 3 patients experienced the same events.
Shingles in the ear; Passed out; Couldn't mover her arm, head, legs, chest, felt paralyzed; Felt weak; A spontaneous report was received from a consumer concerning a female patient of 75 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced loss of consciousness, paralysis, weakness and shingles in the ear.  The patients medical history, as provided by the reporter, included myasthenia gravis. Concomitant medications reported included lidocaine patch and prednisone.  On 10 feb 2021,prior to the onset of events, the patient received their first of two planned dose of mRNA-1273(Lot number:010M20A  ) intramuscularly on an unknown arm for prophylaxis of COVID-19 infection.   On 11 feb 2021, one day after vaccination,patient experienced loss of consciousness,paralysis and weakness. The  event loss of consciousness and paralysis was also considered to be medically significant. On 16 feb 2021, patient experienced shingles in the ear. Treatment for the events included acyclovir and ice.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the events loss of consciousness, paralysis, weakness and shingles in the ear were considered as unknown.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded.
within about 5 min after getting shot my mouth , lips and tongue began to feel weird,   Tongue swelled
Right after vaccine pt. failed. O2 99% BP: 94/52, light headed for 20 min. Pt given popsicle and water. Rest in room until feeling better with mother.
I did not have any reaction at all to the vaccine until I woke up on 2/6/21 with my arm really hot Touch in the deltoid area and lots of cramping in my arm. I did a telephone visit and sent pictures to an online doctor who said it looked like cellulitis but it was 9 days after the injection so that was unlikely. It went away in about a week. Well I was diagnosed with COVID on  12/8/21 and decided to get the antibodies IM injections at my pharmacy on 12/8/21. I did really well with the injections then about 4 days later I started having pain in my left upper arm. Like sharp pain around the Deltoid. I reposted to pharmacist who gave the injection and he made a report. Over time the pain has gotten worse and yesterday in the exact same area as before with the 1/28 dose of vaccine I had a red hot area appear. I can?t even use my arm for long  because of the cramping pain in the upper arm.
Patient was inadvertently given 2 Spikevax shots (one in each arm). Multiple patients' paperwork and prepared vaccines were in the same area of the vaccination room, so a second Spikevax was accidentally grabbed and administered into his other arm rather than the intended RSV shot. Patient still opted to receive RSV vaccine after being informed of the error. Patient has not reported any adverse reactions as of now, but will call if he does.
This spontaneous report as received from a nurse refers to an unknown number of patients. On an unknown date the patients received doses of improperly stored VARIVAX (Merck) (strength, dose, route and lot# not provided). Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 at 09:45 as dose 1, single (Lot number: EM9809), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: 33036BD), in left arm for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:15 as dose 5 (booster), single (Lot number: GH9702) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid from 23Feb2023 to 27Feb2023 for COVID 19 Treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107485 Same reporter/patient, different drug/event.;
Got flu A; Initial information received on 06-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient with unknown age and demographics who got flu A after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, lot number and expiry: not reported) via unknown route in unknown administration site for Flu B (influenza immunization). Information on the batch number was requested.  On an unknown date, the patient got flu A (influenza) (unknown latency) following the administration of Influenza vaccine.  Reportedly, got flu shot for flu B! Got flu A!! Couple years ago sick as crap.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got flu A).  At time of reporting, the outcome was Unknown.
Injection area on upper R/arm-red almost to shoulder, below including elbow. Very painful to movement & touch. Took about 1 wk to get better.
menorrhagia for 1 week following vaccine accompanied by 'blues' or mild depression and significant cramping; recurred with second shot as well and menstrual bleeding has been irregular  swollen lymph nodes on left side painful breasts
Sore muscles around left shoulder starting 7hrs after vaccination and persisting for 4-5 days.   Pain in left armpit starting 24hrs after vaccine and persisting for 6-7 days.  Migraine 1 day after vaccine. Incapacitated.  Migraine 2 days after vaccine. Incapacitated.
Approximately 9 hours following injection, a localized reaction appeared. Redness, swelling, and pain around site. The site was warm to the touch.  the day after the vaccine, I ran a fever of 100.3 x 6 hours and had severe fatigue, moderate body aches for approximately 12 hours.  Four days following injection, site became reddened, warm, a hard knot the size of an egg formed, site pain worsened. Swelling and redness resolved after 6 days (day 10 after injection).
headache; This is a spontaneous report from a contactable consumer (patient). A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization, and paracetamol (TYLENOL) on 18Mar2021 for unknown indication. Medical history and concomitant drug were not reported. The patient reported that she received the second dose of the vaccine last Thursday 18Mar2021. She had a headache today (23Mar2021). She went for emergency dental work right the next morning of her vaccine appointment. She took paracetamol 2 hours before receiving the vaccine and the nurse told her shouldn't have. It also stated in the fact sheet not to take paracetamol before getting the vaccine. The patient asked that did she need to restart the vaccination series again? Caller states that it made her suspicious because she had no symptoms at all after receiving the vaccine." The outcome of the event was unknown.   Information on the lot number and batch number has been requested.
patient was 17 weeks pregnant at the time, patient experienced an episode of fainting roughly 5-7 minutes following vaccination
no reaction has been reported but this nurse gave 2 doses of diluent and forgot to mix with powder
Varivax vaccine administered to Right arm 7/16/2009. Parent noted red swollen area on right arm 07/26/2009. To clinic 7/29/2009 - area red and warm to touch and the size of silver dollar. ARNP in to see pt and advised OTC ibuprofen for discomfort; Benadryl cream to site PRN itch; and warm moist heat to area. RTC in 2-3 days if not better.
Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-355973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-355973:Original cluster case-MOD-2021-355973
Sore left shoulder/arm and chills--lasting 1-2 days, started about 8-10 hours after vaccine.
16 yr old   pregnancy  13 week gestation  LMP 5/1/2021   EDC 2/5/22  WT 135   MODERNA VACCINE GIVEN TO 16 YR OLD GIVEN OUT OF AGE RANGE   NO ADVERSE REACTON