chrisvoncsefalvay/vaers-outcomes huggingface dataset:
V safe was checking in with me for the first 7 days.  I initially on the first day after having the shot had a headache and Very sore arm.  The soreness lasted only one day and then no other symptoms until day 8.  On day 8, the injection site was red, itchy and raised.  Then yesterday, day 9 my are was tender to touch, VERY RED and HOT and expanding all over my arm, now in the back of my arm.  All the time remaining afebrile.  V-safe will only check in with me once a week from day 7, for 5 weeks, I am told so I wanted to report this.  I am waiting for a call from my PCP.  She is considering cellulitis, that is how red and hot it is but it is only tender, not hurting or requiring any pain medication.  I have good range of motion, too.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age. The patients missed as unspecified number of doses of GARDASIL (Lot # not reported) and received an unspecified number of doses of GARDASIL (Lot # not reported) outside of the recommended 0-2-6 month schedule. No adverse symptoms were reported. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
P/receiving flu vax pt c/o tingling & numbness in lt arm & leg; reluctant to seek medical care; denies h/a, dyspnea, or visual disturbances; recommended primary care MD visit which finally complied with; supervisor drove to primary care MD;
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
This spontaneous report was received from a registered pharmacist concerning an approximately 69 year old female patient. Approximately on 01-MAR-2013 (about 1 week ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose unspecified), subcutaneously in the pharmacy. No concomitant medications were reported. Approximately on an unknown date in March 2013, the patient experienced redness and swelling at the injection site. There were no lesions. The patient sought medical attention (called pharmacy). No treatment was given. No lab tests were performed. The patient was recovering from redness and swelling at the injection site. The relatedness for redness and swelling at the injection site was unknown for ZOSTAVAX. Additional information was not expected.
Hives started Fri 11/21 after vaccination, lips swelling. Took her own Prednisone. Came to ED. IV initiated. Benadryl, Solumedrol and Pepcid IV given, Vistaril PO. Discharged stable condition.
ear ringing, heADACHE, SORE ARM, dizziness and fatigue, legs felt heavy, dizziness, fast pulse, low blood pressure, chills
Dose 1 - Fatigue and headaches that lasted around 3 days.  Dose 2 - I had brain fog, dizziness and fatigue. Over the weekend, I was still more tired than usual. By Monday, I was wiped out. I had severe brain fog and had to leave work because I couldn't focus on my patients. I also experienced a sore throat and swollen lymph nodes. I was in bed all day Monday and Tuesday due to severe fatigue. It gradually increased, but didn't completely resolved until about 3 weeks later.
2/23 felt manic ?wired but tired?. new feeling for me. 3/3 sudden onset harm ocd. intrusive harm thoughts. ego dystonic but overwhelming and intense. not in context of any new  life stressors. no substance use. resolved slowly over the course of the year.
sore arm; Her uric acid level was 7.8 on 01Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 11:30 (Lot number: EL9269, Expiration Date: May2021) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing), notes: She had her first episode of gout 3 or 4 years ago and this is not a normal occurrence for her.; "High Blood pressure" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Chronic venous insufficiency" (unspecified if ongoing); "stage 1 chronic kidney disease" (unspecified if ongoing). Concomitant medication(s) included: REBIF taken for multiple sclerosis; LISINOPRIL taken for hypertension; LISINOPRIL HCTZ taken for hypertension; HCTZ taken for hypertension; METOPROLOL SUCCINATE taken for hypertension; HYDRALAZINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose: 1, On 04Feb2021 she developed gout in her "left foot in her middle toe she reports it as swollen, red, painful to touch, it has improved but it is still painful."), administration date: 03Feb2021, when the patient was 70 years old, for Covid-19 immunisation, reaction(s): "Gout", "Sore arm", "tired". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; BLOOD URIC ACID INCREASED (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Her uric acid level was 7.8 on 01Mar2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood uric acid increased.  Additional information: Patient has arthritis but she is not taking anything for it. She has chronic venous insufficiency for which she wears compression socks for, she wore wraps initially and in the summers its hots. She used to have stage 1 chronic kidney disease but doesn't have it anymore, her kidneys are fine. It was reported that patient arm was a little sore after the second dose too. She is on colchicine because she cant be on any type of steroid after the shot. She did 2 weeks colchicine and that did nothing, her uric acid went down 1/10th of a point, she was almost vegan on a low purine diet, now having a little meat and poultry. She is now on allopurinol for 45 days which may be helping and they will do more blood work to see her uric acid levels. She wants to know if Nsaids are okay after the shot, she knows with the steroid it depends. She clarifies her outcome saying that when it comes to the uric acid levels she's not really better.  No follow-up attempts are possible. No further information is expected.
Headache, achy and dizzy on evening of March 26 (about 6 hours after).  This continued morning of March 27.  Then suddenly mid-day (about 24 hours after the vaccine) fever (over 100), chills, shaking, dizzy, nausea set in  (could not function) and lasted for 14 hours.  March 28, still achy, dizzy and feeling of light headedness and exhaustion.
From provider's note on 3/9/20: Prolonged muscle pain after Shingrix injection. Patient reports that her harm was sore right after getting the vaccination and it has never completely gone away. She denies ever having a hot, red, or swollen area at the injection site. She was a little achy but it only lasted about 24 hours. Since that time the left upper arm has been tender, not really tender to touch but tender with mobility. If she raises her arm such as when driving, she will get an aching sensation in that muscle that makes her have to lower her arm. She reports when it is really bothering her it can be a 4/10 on a pain scale. She has not been able to palpate any lumps and palpating the area occasionally creates some mild discomfort but not all the time. It truly is with movement and using that arm where she gets most of her symptoms. She has never had any arm or shoulder pain before. She has no pain radiating to her forearm. She has full mobility to her shoulder, elbow, and wrist.
After receiving H1N1 nasal mist - had nausea and headache. Mom picked from school @ 11:15 am. Received imm appx 10:am. Mom states has low grade temp at this time (2:48 pm)
This case was reported by a pharmacist and described the occurrence of fainting in a 34 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. There were no concurrent medications. The subject has no food or drug allergies. On Nov 2 2005 the subject received 1st dose of Engerix B in the left arm (lot AHBVB135AA). During the injection, the subject reported to the pharmacist that the injection was extremely painful. It felt like the administering nurse hit the bone. The arm is sore where the Engerix B was administered. On Nov 2 2005, less than one day after vaccination, the subject experienced fainting, hypotension, tinnitus, and nausea. The fainting, hypotension, and tinnitus resolved on Nov 20 2005 and the nausea resolved on Nov 3 2005. The outcome of the injection site pain and soreness was not reported. Fainting was assessed as medically serious by manufacturer. (OMIC)
NauseaVomiting, HYPERtension & HYPERglycemia
Itchy bump at injection site; Small, round bump atinjection site; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 18Mar2021 at 13:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported. Concomitant medications included fluconazole (MANUFACTURER UNKNOWN), ibuprofen sodium (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE) and cyclobenzaprine hydrochloride (FLEXERIL) taken for unknown indications from unspecified dates. The patient did not have any allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient experienced slight headache on the seventh- and eighth-day post vaccine. On 26Mar2021 at 22:00, the patient experienced a small, round bump at injection site (vaccination site lump) and itchy bump at injection site (vaccination site pruritus) approximately half an inch in diameter which appeared on the eighth day post vaccine. The patient did not receive any therapeutic measures for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event slight headache and small, round, itchy bump at injection site was not resolved.   No follow-up attempts are needed. No further information is expected.
COVID symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COVID-19 (COVID symptoms). At the time of the report, COVID-19 (COVID symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Treatment medication was not provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable
VACCINE ONLY SHOWN 3 DOSE OF VACCINE AND I WS THINKING GIVEN HER HER 4TH DOSE BUT NOT 7TH DOSE.  I ALREADY REPORT HER 5TH DOSE UNDER VAERS (CASE # 874028)
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe, Additional Details: after vaccination 11:45am patient reported being thristy within 2-3 mins, upon giving water asked if he was ok he said he is feeling dizzy, he was seating , so measured BP 11:50am ;41/34 -75pulse rate, 11:53 97/73 70 pulse rate , 11:55 94/79 74 pulse rate , 12:05pm 100/71 69pulse rate , patient was feeling absolutely fine by this time, patient left after 12:30pm . he was fine while leacing but followed up at 4pm and he was doing perfectly fine.
There is a red rash about 2.5 inches in diameter around the injection site. Pt. says it feels warm to the touch.
Itchiness; Soreness/a little tender; Red rash approximately the size of a tennis ball; Red rash approximately the size of a tennis ball; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Soreness/a little tender), VACCINATION SITE RASH (Red rash approximately the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Red rash approximately the size of a tennis ball) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Soreness/a little tender), VACCINATION SITE RASH (Red rash approximately the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Red rash approximately the size of a tennis ball). At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Soreness/a little tender), VACCINATION SITE RASH (Red rash approximately the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Red rash approximately the size of a tennis ball) 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.   Concomitant medication was not provided.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Outcome of events, reported no events after 2nd dose of vaccination
Horrific joint pain; fever; headache; dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0180) via an unspecified route of in the left arm on 15Jun2021 at 1215 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not included. The patient past drug history included sulfa drugs (MANUFACTURER UNKNOWN) for an unspecified indication. No other medications were received by the patient within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0186) via an unspecified route of in the left arm on 21May2021 at 1715 as a single dose for COVID-19 immunisation. On 15Jun2021, the patient experienced horrific joint pain, including fingers and toes, fever, dizziness and headache. For the events patient took ibuprofen (MANUFACTURER UNKNOWN) and tylenol (MANUFACTURER UNKNOWN) as treatment. The clinical outcome of the events horrific joint pain, fever, dizziness and headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Within a few minutes of the vaccine my child experienced ringing in the left ear and moderate dizziness. Symptoms have persisted for 24 hours.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported. On 08-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX lot# M036296, expiry date 14-NOV-2017 (exact dose and route of administration were not reported) for prophylaxis. The lot and expiry of sterile diluent which was used to reconstitute ZOSTAVAX was unknown. There were no adverse effects reported.
Severe  vomiting for 4 days, headache continues 3 weeks later and rash on body
This spontaneous report as received from a pharmacist refers to a patient at the age of approximately 52 years. The patient's concurrent conditions included unspecified reaction to latex. On 07-NOV-2014, the patient was vaccinated with ZOSTAVAX (lot # K009773, expiration date 09-OCT-2015) in the left posterior arm (dose and route of administration were not provided). In February 2015, the patient experienced a softball size numbness in left arm and complained to the pharmacist. No treatment was given for the adverse event. The outcome of the event was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and the adverse event was not reported. Additional information has been requested.
Moderna COVID-19 vaccine EUA  ?? vertigo, a couple of events the day following injection, lasting around 5 minutes twice. The next day, only slight vertigo lasting a very short time, but knew I wasn?t feeling 100%.
EXPIRED VACCINE ADMINISTERED ON 27-AUG-2021 (VACCINE WAS EXPIRED ON 24-AUG-2021); This spontaneous report received from a health care professional concerned a 24 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced expired vaccine administered on 27-aug-2021 (vaccine was expired on 24-aug-2021). The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered on 27-aug-2021 (vaccine was expired on 24-aug-2021) was not reported. This report was non-serious. This case, involving the same patient is linked to 20210931844, 20210931810, 20210931982, 20210932593, 20210931951, 20210932240, 20210932567, 20210932874, 20210933076 and 20210933129.
Patient came in for a covid booster, I went and drew up the vaccine and gave patient 0.3 ml. After patient left I realized the vial was/had expired. No symptoms at time of immunization was given. Informed/called patient after he left & informed him what happened. Informed PCP as well, & we rescheduled patient to come back in 4 days to provide patient w/ correct dose & up to date.
Patient was given his first Hepatitis A dose on 10/05/17. He was administered his second dose on 1/22/17. No known adverse event.
About an hour after the vaccine, a migraine started that has been unrelieved day and night with max doses of Tylenol. Bilateral eye twitching and freezing mid-twitch has worsened to every few mins with a peak 6 days post-vaccine. 7th day post-vaccine intermittent eye twitching throughout the day with less frequency, however continued migraines without relief.  14 hrs post-vaccine awoke from sleep with excruciating 10/10 pain in my already bothersome hips. Felt like I was in labor, awoke crying in my sleep and screaming out in pain. Hip pain returned to baseline the following day with no return of increased pain.
Crohn's disease flare up; Booster; This is a solicited report based on the information by Pfizer, Manufacturer control number: 21K-163-4137399-00 from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 3 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNK (CF) for crohn's disease; influenza vaccine (INFLUENZA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included Moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced crohn's disease flare up (medically significant). The action taken in response to the event for adalimumab, and for influenza vaccine was unknown. The outcome of the event was unknown.   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the Serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Received dose #2 Shingrix, within 14 hours extreme dizziness, myalgia (could hardly move), fever of 102 degree degrees F. Had shingles in august 2019, intermittent neuralgia starting December. First dose Shingrix 2/24/2020 with no problem.
shaking; joint pain; couldn't catch his breath; cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (couldn't catch his breath), COUGH (cough), TREMOR (shaking) and ARTHRALGIA (joint pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced DYSPNOEA (couldn't catch his breath), COUGH (cough) and ARTHRALGIA (joint pain). On 22-Apr-2021, the patient experienced TREMOR (shaking). At the time of the report, DYSPNOEA (couldn't catch his breath), COUGH (cough), TREMOR (shaking) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included steroids, anti-inflammatory and morphine.  No Concomitant products was reported.