chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive Covid; positive Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Borderline anemic" (unspecified if ongoing), notes: Borderline anemic; "Dose Number: 2,1; Pfizer / BioNTech/ Dose Number: 3; Moderna" (not ongoing), notes: Dose Number: 2,1; Pfizer / BioNTech/ Dose Number: 3; Moderna. Concomitant medication(s) included: OMEGA 3 SELECT; PROBIOTICS; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; CALCIUM; PRESERVISION AREDS 2. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11May2022, outcome "unknown", COVID-19 (medically significant) with onset 11May2022, outcome "recovered with sequelae" and all described as "positive Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive; (16May2022) Positive, notes: barely testing positive (whisper of a line) and feeling much better; (17May2022) Positive, notes: barely testing positive (whisper of a line) and feeling much better; (18May2022) Positive, notes: 30 seconds dark red line; (24May2022) Negative; (25May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included Anti-viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 11May2022, treatment stop date: 15May2022. Other medication in 2weeks product: Omega-3s. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. 25May- tested negative again, still have some congestion, cough, fatigue, cloudy head.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
painful shingles outbreak; Itching; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (painful shingles outbreak) and PRURITUS (Itching) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced HERPES ZOSTER (painful shingles outbreak) and PRURITUS (Itching). At the time of the report, HERPES ZOSTER (painful shingles outbreak) and PRURITUS (Itching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant  medication use was not provided by the reporter. Treatment information was unknown.11April2021 patient received first vaccine dose of vaccine. Several hours after receiving their dose, the patient was on a bike ride and reports their back suddenly began to itch. Patient initially suspected a bug bite, but it later progressed to a painful shingles outbreak. Doctor confirmed diagnosis for patient on 16Apr2021 and she reports symptoms are still ongoing at the time of the call.
Swollen arm; Intense itching; Really uncomfortable; Rash; A bullseye like red blood area around the site of injection; Muscle aches; Lethargy; Stiffness of the neck; Itchiness on their body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), PRURITUS (Itchiness on their body), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Intense itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included VITAMIN D3 for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LETHARGY (Lethargy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), PRURITUS (Itchiness on their body) and MYALGIA (Muscle aches). On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PRURITUS (Intense itching), FEELING ABNORMAL (Really uncomfortable), RASH (Rash) and INJECTION SITE ERYTHEMA (A bullseye like red blood area around the site of injection). On 16-Jan-2021, LETHARGY (Lethargy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), PRURITUS (Itchiness on their body) and MYALGIA (Muscle aches) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), PRURITUS (Intense itching), FEELING ABNORMAL (Really uncomfortable), RASH (Rash) and INJECTION SITE ERYTHEMA (A bullseye like red blood area around the site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant product used was statins. Treatment for the events included lotion, ice pack, fexofenadine, diphenhydramine, some steroid and hydrocortisone.
Office staff member incorrectly selected the Human Papillomavirus Quadrivalent, rather than the Intrapulmonary percussive ventilators (IPV), and handed it to MA who then administered the vaccine.
Patient received undiluted vaccine in error (received approximately 20 mcg rather than 10mcg). Parents contacted on 7/21/2022 after error discovered. No reported adverse effects other than sore arm.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 06-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
FEVER FOR A NIGHT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fever for a night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for a night. This report was non-serious.
This spontaneous report as received from a physician refers to a 19 year old female patient. A patient received her first dose of GARDASIL (strength, dose, frequency, route, lot # and indication were not provided) on 26-SEP-2009, and she received her second dose of GARDASIL (strength, dose, frequency, route, lot # and indication were not provided) on 05-DEC-2009. The patient was in Doctor's office on 29-OCT-2014, and she would be receive her third dose of GARDASIL (strength, dose, frequency, route, lot # and indication were not provided) on 29-OCT-2014. No adverse experience had been reported or demonstrated by the patient. Additional information has been requested.
had shots in left shoulder and almost immediately had issues with left shoulder; had shots in left shoulder and almost immediately had issues with left shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 Immunization, reaction(s): "has issues with my left shoulder".  The following information was reported: VACCINATION SITE DISCOMFORT (medically significant), MUSCULOSKELETAL DISCOMFORT (medically significant), outcome "recovered" and all described as "had shots in left shoulder and almost immediately had issues with left shoulder". Therapeutic measures were taken as a result of musculoskeletal discomfort.  Patient had shots in left shoulder and almost immediately had issues with left shoulder. Patient has PT and 2 cortisone shots and after 6 months shoulder is good.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My mouth and tongue became itchy about two minutes after the injection.  My throat felt strange.  My arms were itchy as well.  The pharmacist gave me two  children's chewable Benadryl.  My symptoms remained, so the pharmacist injected me with an EpiPen and called an ambulance.  I was taken to the ER at the hospital.  By 5:00 pm, the ER staff gave me IV fluids, Benadryl, and steroids.  I was experiencing nausea, and so Pepcid was also given via IV.  I also had a rash on my arms and legs.
My brother has ckd and had 2 doses and 2 boosters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown", described as "My brother has ckd and had 2 doses and 2 boosters".  Clinical course: Reporter's brother had ckd and had 2 doses and 2 boosters. His gfr has gotten worse since last year. Reporter wanted to know if this is due to the vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pediatric dose of Hepatitis B vaccine was administered to patient, instead of Adult dose. This was the second Hep. B in series.
Patient described a bursitis like feeling beginning the morning following vaccination. Shoulder and upper arm of the left side were stiff and achy. Symptoms were intense for a few days but became progressively milder over time. Patient stated that her partner is a physician and expressed the opinion that the vaccine administration site may have been too high on the shoulder and caused irritation to the tendon or bursa.
temp up to 103.6, crying for 2.5 hrs unable to console; given DTP/HIB & hep B;
On 9/10/20 at approximately 3:52pm, patient was given a flu shot (Fluad 2020-2021).  I advised him to remain at the pharmacy in case of an adverse event.  Approximately 5 minutes later, patient complained that his legs were hurting and that he was having difficulty standing.  In addition, he claimed to having chest pains.  I then helped him sit down while a nearby patient called 911.  I also gave the patient 4 baby aspirin.  The patient was conscious and aware.  Minutes later, EMTs arrived and measured the patient's vitals.  The patient did stand and seemed to feel better soon after the vitals were taken.  As a precaution, the patient left with the EMTs in an ambulance.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-JUN-2012, a healthcare provider administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Injection site pain; headache; Left side earache; sinus pressure; This is a spontaneous report from a contactable consumer (reported for his father). A 94-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 (at the age of 94-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced injection site pain, headache, left side earache and sinus pressure. The clinical course was as follows: the reporter stated that the patient experienced a little soreness at the injection site which was normal and a little bit of a headache. Now, his father has a lot a of sinus pressure. reporter started out with an earache of his left side which is the side his injection was given in his arm. However, it has now moved to his right ear. The caller is asking if this is something his father should be concerned about. Have there been any reports of any earaches. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Received a Pfizer bivalent vaccine on 11/30/22. On 12/2/22 his son called to report the symptoms his dad had experienced after the vaccine. 12 hours after the vaccine, the client awoke with a 103 fever, extreme lethargy, and body aches. I assured him that these were expected immune responses to the vaccine. He said the severity of them got so bad that he had to be taken to the hospital because he was unable to get to the bathroom on his own due to extreme fatigue. The client spent 1 night in the hospital and was discharge on 12/2/22. He is feeling better now that the immune response is over. His son wanted to report the symptoms to VAERS due to the severity and cause of hospitalization.
Mom said patient is "scared" of needles. She was a little nervous. I gave the shot and she sat down on the bench. She said she was dizzy so I went to get a cool paper towel for her face. When I came back she fainted. She was out for about 1 to 2 minutes. We gave her some Sprite to drink. Mom said she has low blood sugar often. We think the low blood sugar may have contributed to her fainting. I also gave her a glucose tablet to bring her blood glucose up. After about 5 minutes she felt fine.
This spontaneous case reported by a consumer, describes the occurrence of constant dizziness and occasional nausea in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's medical history included asthma since an unknown date. Concomitant products included Albuterol (salbutamol sulfate) for asthma. On Apr 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 12, 2021, patient experienced constant dizziness and occasional nausea. At the time of the report, constant dizziness and occasional nausea outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or treatment information.
After receiving vaccines pt was sitting in chair & passed out with 3 min. arms & legs were shaking & she was clammy. Pt came to within a minute. B/P was 120/64 AP 80 & irregular. Pt was given juice & water. Pt states she had not eaten earlier in the day. Pt became sick again - shaking, emesis, diaphoretic. 911 was called. B/P 140/80. Paramedics checked pt & referred to take her to ER. Mom refused. Pt then became well enough to go home with mother.
pt recv vax 4MAY98 & 22MAY98 pt devel little blisters over face w/o itching;seen by dermatologist who according to pt told her had skin tage & prescribed aclovate cream;pt now has 1/8 inch circumscribed area on cheeks surrounded by some red
I had felt fatigued and achy after receiving the vaccine for about a day. In 05/2023, I had a very bad sore throat. I went to a doctor and got diagnosed with strep throat. It was really bad, and I couldn't talk.  I got a prescription for an antibiotic, steroid and cough medicine. As of today, the strep throat has cleared up and I'm dealing with allergies.
Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm tenderness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The patient had blood pressure in the normal range (for the past two years). The patient had two syncope events in 2020 after heart surgery related to low blood pressure medication (as that medication caused her blood pressure to dip too low. Concurrent condition included cholesterol. The patient never been diagnosed with/ tested positive for COVID-19. The patient's past medical history included Pernicious anemia in 1970, Syncope in 2020, Blood pressure low and Cardiac operation. Concurrent medical conditions included Food allergy (poultry), Allergy to antibiotic (biaxin) and Thyroid disorder since 08-Oct-2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 10-Aug-2020 to an unknown date for Cholesterol, FOLIC ACID (FOLVITE [FOLIC ACID]) for RBC count abnormal, DOCUSATE SODIUM for Stools hard, LEVOTHYROXINE from 08-Oct-2020 to an unknown date for Thyroid disorder, CYANOCOBALAMIN, TILACTASE (LACTAID), LORATADINE (CLARITIN [LORATADINE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FISH OIL (OMEGA-3 FISH OIL), VACCINIUM MACROCARPON (CRANBERRY JUICE EXTRACT), CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]), VITAMIN D3 and GLUCOSAMINE & CHONDORITIN for an unknown indication.    On 04-Mar-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 VACCINATION SITE PAIN (Arm tenderness). At the time of the report, VACCINATION SITE PAIN (Arm tenderness) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient blood type was reported as A positive. No treatment medication was provided.   This case was linked to MOD-2022-539717, MOD-2022-536098 (Patient Link).
Information has been received from a physician assistant concerning a 33 year old female with niacin allergy 01-Jan-2009 who on 04-FEB-2009 was vaccinated with her first dose of PNEUMOVAX (lot number 660685/0619X) 0.5ml IM into her left deltoid. On 08-FEB-2009, 4 days after administration of the first dose, the patient was diagnosed with pneumonia. The patient was evaluated at an urgent care facility, prescribed LEVOQUIN and was referred to an unspecified pulmonologist. On 30-MAR-2009 the patient was administered the second dose of PNEUMOVAX (lot number 660685/0619X) 0.25ml IM into her left deltoid. Concomitant therapy included VALTREX, propranolol HC1, YAZ, MSD and transfer factor. On 31-mar-2009 the patient developed swollen, red, hot reaction at the injection site of the left deltoid with golfball-sized area of induration. On 01-APR-2009 the patient was examined in the office and the symptoms were improving with use of BENADRYL and ice compresses. Follow up information was received from a physician. 4 days after injection on 04-FEB-2009 the patient developed pneumonia and was seen in urgent care. The patient was given LEVAQUIN with 10 days. She was not hospitalized. On 31-MAR-2009 the patient developed large local reaction at injection site. The physician indicated that the patient's experience required an emergency room/doctor visit. The patient recovered. There was no illness at time of vaccination. There was no relevant diagnostic tests and laboratory data. This is one of several reports received from the same source. Additional information has been requested.