chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was confused and tired; was confused and tired; it feels weird in her abdomen; lot of pain; would go to urinate and she had light blood; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:00 pm (age of vaccination was 62 years) as dose 2, single for COVID-19 immunization. The patient's medical history included asthma that was fine, inflammation and cysts (it was reported that they had took out her uterine, it was removed for cysts and it was so many years ago, 5 years and now she didn't bleed). Concomitant medications included vitamin C [ascorbic acid], vitamin D NOS and zinc all taken for an unspecified indication. The patient took an inhaler for asthma sometimes if she had one, she took 5 mg for inflammation and asked what was inside the tube of the inhaler. She didn't have anything else. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8730, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 25Mar2021 at 14:00 pm (age of vaccination was 62 years) as dose 1, single for COVID-19 immunization and experienced lot of pain, hot flashes and it was so like burning. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient provided that with the 2nd one it was the same thing continued but more intense. She stated that she did not have a fever. On 15Apr2021, Thursday, the patient would go to urinate and she had light blood and it freaked her out, that was the 2nd day after and she thought ok 2nd day. The patient clarified that by the night after the 2nd dose she started having light blood and it was the same color and she thought it was going to go away and it didn't worry her and she didn't know what to think. On an unspecified date, the patient was very tired and very confused, airy head like go out of herself at work and just didn't want to move and she was still very tired and was feeling a lot of pain. The patient was confused and tired and woke up fine in the afternoon and had very light blood and she thought it was from taking a lot of vitamins, she always took Vitamin C, Vitamin D, and Zinc and it was not a big deal. She stated that it then continued and it felt weird in her abdomen. The patient was scared and she didn't know what to do. She wanted to know if that was a side effect.The adverse did not require a visit to Emergency Room or Physician Office. No relevant tests were done. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash- Pt was given 40 mg Solumedrol I/M in office
At the end of the week of the same week as the shot, after other symptoms had subsided, began to have symptoms that seem to be consistent with Irritable Bowel Disease. Initially, had constipation that lasted 3-4 days and then had diarrhea for a day. Experienced weight gain that may have been due to waste retention, which was lost back to starting weight once symptoms subsided. Symptoms subsided after the 5th day, but returned 4-5 days later. Symptoms have continued in this pattern until the present day, slowly reducing in frequency. Saw specialist in July at the direction of my regular care provider. Specialist  prescribed stool softener, laxative, and probiotics, as well as some dietary changes. Have no prior history of IBD symptoms.
On May 15, 2000 mother noted a raised tiny pin head like rash on child's left leg, the next week it had spread to right thigh 5/22/2000, and today 5/23/2000 she noticed a few of them on child's forearm and face. Rash is not red in color and does not seem to itch, child does not scratch at it. No fever noted.
Rash erupted on chest, back and upper arms in 'Christmas tree' pattern.  Diagnosed as pityriasis rosea.  Temporally associated to receipt of the smallpox, anthrax #1 and typhoid vaccines on 29 Jan 08.  There are 27 cases of pityriasis rosea reported to the Vaccine Adverse Events Reporting System associated to all vaccines and their combinations; 10 of 27 reported after live vaccines and their combinations, 2 reported after the smallpox vaccine.  We cannot prove or disprove causality to the vaccines received on 29 Jan 08.  No treatment is necessary.
Pt has symptoms of a flu (flu like symptoms). She had fever & could not get out of bed for 1-2 days. After 2 days, patient started to feel better.
Warm to touch at the injection site; Itching at the injection site; Redness at the injection site; Muscle soreness at the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Muscle soreness at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Muscle soreness at the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form (used for first two days). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Muscle soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient took Advil for the first two days.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Rash. Swelling. Redness. Itchy. Looks like cellulitis. Current spread is 4" x 10". Started at injection site
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 16 years old male patient who felt light headed, dizzy and his tongue felt funny, while he received vaccine MENACTRA. The patient's past vaccination(s) included MENACTRA on 06-AUG-2013 with no other information available regarding his first injection. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medication was not reported. It was also reported that No other vaccines were given this same day. On 11-Sep-2018, the patient received a second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5841AA via intramuscular route in the right deltoid. On 11-Sep-2018, the patient developed a non-serious he felt light headed (dizziness) 15 minute following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 11-Sep-2018, the patient developed a non-serious dizzy (dizziness) 15 minute following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 11-Sep-2018, the patient developed a non-serious his tongue felt funny (paresthesia oral) 15 minute following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was also reported that Patient reports eating a small sandwich 6.5 hours prior to this 2nd injection. (Other relevant tests included No lab data.) Final diagnosis was his tongue felt funny, dizzy and he felt light headed. An unknown corrective treatment was received. It was also reported that Patient was then given orange juice, took vitals, observed for one hour by physician. The patient outcome is reported as Unknown for he felt light headed, as Unknown for dizzy and as Unknown for his tongue felt funny. List of documents held by sender: none.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: 30May2022 she tested positive for Covid.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Diarrhea for one day with no fever.  Patient then developed cramps in both legs and unable to walk.
Pfizer cap administered past the BUD of 04/20/2022. Pfizer contacted and extended BUD to 04/22/2022. Revaccination recommended.
Received vaccination and within approximately and hour began to feel ill, went home, took Benadryl, shortness of breath, rash, itching, worsened overnight.
R LEG SWOLLEN AND RED (4X3CM) TENDER TO TOUCH.  PT TREATED WITH KEFLEX 125/5 QID, COMING BK TO OFFICE ON 04-23-2010 FOR A RE CK.  SPOKE TO G-MA, SHE STATES ITS DOING BETTER--CMA
Itchy throat, itchy ears, itching from head to toe starting at 1800 (three hours after the vaccination), dizziness, blurred vision 6 hours after the injection.  Redness and swelling with a large ring around injection site.
coughing; did not get second dose yet (more than 36 days have passed since first dose); Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PRODUCT DOSE OMISSION ISSUE (did not get second dose yet (more than 36 days have passed since first dose)) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced COUGH (coughing) and PRODUCT DOSE OMISSION ISSUE (did not get second dose yet (more than 36 days have passed since first dose)). At the time of the report, COUGH (coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PRODUCT DOSE OMISSION ISSUE (did not get second dose yet (more than 36 days have passed since first dose)) outcome was unknown. Not Provided      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.   Reporter did not allow further contact
Adverse events: extreme headache, extreme dizziness, vomiting,  hot/cold flashes, numbness in face & hands, feeling faint at times, high blood pressure. Vaccine administered at 9:45am, approximately 10:15am 2-3 seconds of dizziness and left hand numbing.  7:45pm left arm at injection site started huring and pain alongside of left neck and into the back of the head uknown time (approx. 2 or 3am) - woke up with severe headache approximately 6am - woke up to severe headache, took 500mg of tylenol and started vomiting around 7:00am Headache became progressively worse, whenever I opened my eyes the room was spinning increasing the dizziness, which in turn made me vomit. Vomited approximately 10 times (only water came up, and some yellow looking vile after dry-heaving a few times).  Body started aching all over so went into ER at approx. 11:30am.  ER diagnosis: Adverse effect of vaccine, initial encounter; acute nonintractable headache, unspecified headache type; dizziness Lab tests completed: Basic Metabolic panel (BMP); CBC + differential; Glucose by meter; ISTAT HCG Quantitative Pregnancy POCT; Troponin I Imaging Tests: EKG 12 lead Medications given: Sodium chloride 0.9% dexamethasone PF (Decadron) diphenhydrAMINE (Benadryl) Ketorolac (TORADOL) Magnesium sulfate in D5W prochlorperazine (Compazine)
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 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:37 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 67.05.  Concomitant products were not provided.  On 20-Mar-2021, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  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 Fisherbrand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Lateral epicondylitis and arthritis, inflammation of the elbows for 4 months
tested positive for COVID 19; tested positive for COVID 19/ sore throat, cough and tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 21-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Batch/Lot number: unknown), on 04May2021 as dose 2, single (Batch/Lot number: unknown) and on 30Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 01Jul2022, outcome "unknown", described as "tested positive for COVID 19"; COVID-19 (medically significant) with onset 01Jul2022, outcome "unknown", described as "tested positive for COVID 19/ sore throat, cough and tiredness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) positive.  Clinical course: This 21-year-old female received the Pfizer COVID 19 vaccine on 13Apr2021, 04May2021 and a booster on 30Dec2021. On 01Jul2022 she developed a sore throat, cough and tiredness. On 04Jul2022 she tested positive for COVID 19. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
6cm area of redness, induration and swelling at 48 hours after shot; right deltoid.
Flu-like symptoms that have lasted over 3 weeks Body aches Swelling on arm Dr thought I had cellulitis in my arm, so I began taking antibiotics.  4 days later, not feeling better. Cellulitis was ruled out.  I feel like poison was injected into my body. I thought I was going to die
FEVER, HEADACHES, BODY ACHES, DIARREAH, SORE LUNGS, SHORTNESS OF BREATH, MORE HEADACHES, MORE FEVER
Felt very dizzy and chest started to hurt. I was very thirsty and my mouth felt like it was full of cotton. My lips swelled. This happened within a few minutes of getting the vaccine. I was already being observed in a 30 minute seat, 20-30 minutes were added and three different professionals addressed the issue including a nurse practitioner. About 20 minutes after leaving the facility, about 1.5-2 hours after getting the vaccine, I noticed I was easier to breathe and I hadn?t realized how much my tongue and inside of mouth had been swollen previously. After these 2 hours, I felt fine. The following day I experienced a headache and was tired. Otherwise was fine.
On the way out of the Dr office, pt c/o nausea, dizziness, being hot and cold, soreness in arm, headache.
R09.02 HYPOXIA 11/26/2021 ABDOMINAL PAIN
VZV given (L) deltoid (10/17/08). Erythema/ +1 - induration swelling noted 10/19/08 (PM) worse AM. 10/20 - seen late in day - resolving/ no sign cellulitis.
The area around the VARIVAX injection site was swollen, red, warm, itchy, and had approximately 3 bumps.
developed thyroid whereby his Tsh levels shot up; developed thyroid whereby his Tsh levels shot up; eczema deteriorated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Pfizer sponsored program. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, eczema deteriorated, and he also developed thyroid whereby his Tsh levels shot up after taking both the Pfizer COVID shots), for COVID-19 immunization, reaction(s): "Tsh levels shot up", "eczema deteriorated", "thyroid". The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), THYROID DISORDER (non-serious), outcome "unknown" and all described as "developed thyroid whereby his Tsh levels shot up"; ECZEMA (non-serious), outcome "unknown", described as "eczema deteriorated". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: My son, 14 years old, eczema deteriorated, and he also developed thyroid whereby his Tsh levels shot up after taking both the Pfizer COVID shots. Have you received similar feedback from other parents whose children's have taken these shots.   The lot number for bnt162b2 was not provided and will be requested during follow up.
1st shot, spent 1 day and 2 nights in bed with fatigue and flu-like-Lyme symptoms, over a year of bed rest and shot and had extreme fatigue followed by sudden severe chest pains, incapacitating for several hours; accompanied by severe Lyme symptoms. Bone pain, head and neck pain, chills, tingling in limbs, muscle pain, vision problems, numbness of face, pain in joints and hands, disorientation treated for 2 years. So far still being treated. 2nd shot, had adverse reaction of extreme chest pain, incapacitated. Should have called an ambulance but could not move my arms. Extreme Lyme symptoms.
This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 02-JUL-2014 the patient was inadvertently administered a dose of PROQUAD (Merck) (dose: 0.5 ml, subcutaneously, lot # H020851) that had expired on 26-MAY-2014. No adverse effects were reported. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042b21a) for COVID-19 vaccination. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). On 05-May-2021, PRODUCT ADMINISTRATION ERROR (Product administration error) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was unknown by the reporter. Treatment information was not provided.
This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown deltoid). At an unspecified time after vaccination with KINRIX, the subject experienced injection site cellulitis, injection site swelling, injection site warmth and injection site redness. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case was associated to a product complaint. This case was one of 8 cases of injection site reaction reported by the same reporter regarding the same lot of vaccine.
This spontaneous report as received from a other health professional and refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB lot # N002202 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002611: US-009507513-1708USA002041:
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient states she states to itch in the injection area and the area is really red. she is worried about getting secon dose
Injection site visible. Redness is 8-9 cm below site and is irregular. Redness extends from outer to inner aspect of arm and ends in a hive approx 3-4 cm in length - Hot to touch at inj site.
48 hours after first covid vaccine, severe burning in mouth, gums, lips, and throat, roof of mouth advised to get 2nd dose. 45 hours after 2nd dose increased much more severe burning mouth, gums lips, throat, roof of mouth, tongue raw, inflamed and with with horrible looking spots and also 24/7 nausea.
itchiness to lower back and groin. Denies SOB or systemic effects. No rashes, redness, or hives noted upon assessment.
Patient was given his #2 shingrix 11/10/2022.  His first shingrix was given 09/29/22.  Full 2 month time frame between dose 1 and 2 was not met.  No adverse reactions.