chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in at 1400hrs to get second Pfizer vaccination.  She had her 1st vaccine on 04/28/2021 without any complication. She reported history of Seizure and had follow-up with PCP yesterday, as outpatient.  She reported taking Keppra and confirmed taking her daily dosage today.  She reported having a snack approximately 45 minutes prior to this visit, including fluid.   Patient drove here on her own with no problems. Her 2nd dosage was administered at 1405hrs.  She was directed to sit across the main floor in direct view of the providers to facilitate monitoring.  A full bottle of water was also given to patient. A few minutes later, Client developed a seizure.  This was witness by pharmacists, R/N (volunteer nurse today) and myself. Patient fell on the floor from the sitting position.  Immediate assistance was provided to keep her from any sharp objects or walls.  Her head and body was stabilized to prevent further injuries.  Patient had a good pulse throughout her seizure that lasted for about 8 minutes. Her breathing was also monitored and she vomited scant amount of sputum on carpet floor.  Good chest rise was observed and her color was normal.  Her skin felt very warm and so her sweater was removed to assist with body temperature.  No cyanosis was observed during the event.   ED was already alerted and they arrived at vaccination center at approximately 1415hrs.  After a few minutes, patient regained consciousness and was taken by EMS personnel to ER.  She was stable at the time of her transfer to EMS.
Muscular pains  Rash covering injection site, left arm, body trunk, front and back, from collar bone down, right arm , slight rash inner thighs slight swelling at injection site
Nausea/ Stomach cramps High fever (over 100)        Both started night of injection and resolved over night with some help of Ibuprofen  Patient had COVID-19 2 months prior to receiving vaccine.
Chills, fatigue, sore injection site, redness and swelling at injection site, sweating, & muscle aches.
Crying non stop, curling up in a ball in pain, could not sleep for hours up at night, could not sit still.  Restless and hitting.
Patient reported nausea, fatigue on day 1 Redness, swelling, warmth, tenderness on day 2 to the underside of the right arm
A non-serious spontaneous report of seizure has been received form a non health professional concerning a seven-year-old male, subsequent to FLUMIST. Neither the patient's medical history nor the concomitant medications were reported. The patient received FLUMIST on 28-Nov-2011. On 30-Nov-2011, two days after receiving FLUMIST, the patient experienced seizures and then two weeks later he got it again. The outcome of the event seizures was unknown.
I received the shot about 9:30 AM on Oct 6, 2010. The bigger dose FLUZONE HIGH-DOSE - 2010-11 SYR. About 4 o'clock PM, my left eye felt like I had something in it, I rubbed it a little. I checked it in bathroom mirror and seen it was bloodshot both eyes. I also felt sort of feverish about 6 o'clock PM. I called my Dr. they felt it was just a reaction to the shot to take some ADVIL and see in morning. It was a lot better in morning. My eyes were almost clear.
Developed fever, chills and lightheadedness for 12 hours. Acetaminophen
Fatigue, muscle fatigue since the second day, to the present does not resolve. More on the lower extremities ( bilateral)gluteus and lower back , feel weak .
DEVELOPED 2 INCH AREA OF ERYTHEMA, WARM TO TOUCH WITH DIFFUCLTY MOVING LEFT ARM. C/O NUMBNESS IN LEFT FINGERS
On 02/24/05, aching in wrist, knees, right shoulder and neck. On 03/03/05, went to emergency room, Medrol dose pack ordered. After 1st does felt a little relief, gets better each day. Day after medication was finished, swelling in hands and joint pain returned. Joint pain much better but swelling is still there.
Administered Pneumonia shot in left arm at about 2:30PM 10/22/04. Pt noticed around Friday evening left arm from shoulder down turned red and some swelling. Pneumococcal vaccine polyvalent Pneumovax 23 Lot 0513P ex 03/09/06.
my face and hands have gotten progressively worse; my skin is constantly peeling and having red rashes show up; my skin is constantly peeling and having red rashes show up; my face and hands have gotten progressively worse; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2022 12:00 (Lot number: 30130BA) at the age of 21 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; TRESIBA; PHENTERMINE. Vaccination history included: Bnt162b2 (Dose 1, Prev dose lot number= 30130BA, Prev dose administration date=08Sep2021, Prev dose administration time=01:00 PM, Prev dose vaccine location=Right arm), administration date: 08Sep2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "My skin on my face and hands dried out ", "peeling and burning". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Jan2022 12:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; DRY SKIN (non-serious), outcome "not recovered", SKIN EXFOLIATION (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "not recovered" and all described as "my skin is constantly peeling and having red rashes show up"; CONDITION AGGRAVATED (non-serious) with onset 15Feb2022, outcome "not recovered", described as "my face and hands have gotten progressively worse". The events "my face and hands have gotten progressively worse", "my skin is constantly peeling and having red rashes show up", "my skin is constantly peeling and having red rashes show up" and "my face and hands have gotten progressively worse" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inappropriate schedule of product administration, dry skin, skin exfoliation, rash erythematous, condition aggravated.  Additional information: Patient reported it did not occur until 4 days after initial dose. My skin on my face and hands dried out so bad that it started peeling and burning. Nothing made it better. Still to this day on 15Feb2022 my face and hands have gotten progressively worse. I can not wear any makeup at all because my skin was constantly peeling and having red rashes show up.Patient ad not received any other vaccine in four days. Patient did not had Covid prior vaccination. Patient tested covid  post vaccination. Patient had no known allergies. The event not resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
Retaining water weight/wont come off; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (Retaining water weight/wont come off) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLUID RETENTION (Retaining water weight/wont come off). At the time of the report, FLUID RETENTION (Retaining water weight/wont come off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Arm pain in the beginning. At midnight I got up to go to the bathroom and fainted in the bathroom. When I woke up I started having uncontrollable dry heaves. Everytime I tried to stand up I felt like I was going to faint again. I took some TYLENOL and tried to get to sleep. I have had severe body aches all day today and needed to take pain reliever.
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 22 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination (Dose series number : 1). No concomitant medications were reported. On 13-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 13-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219807, 20211219686 and 20211219731.
COVID 19 Treatment; COVID 19 Treatment; Moderna, Dose Number: 1, Dose Number: 2; Pfizer / BioNTech, Dose Number: 3, Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Lot number: 9J6239) at the age of 41 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Mar2021 as dose 1, single (Lot number: 039A21A), in left arm and on 24Apr2021 as dose 2, single (Lot number: 009C21A), in left arm. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Dec2021, outcome "unknown", described as "Moderna, Dose Number: 1, Dose Number: 2; Pfizer / BioNTech, Dose Number: 3, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (07Feb2023) positive, notes: positive COVID test for myself. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 24Jan2023 to 29Jan2023 for COVID-19 treatment. The patient had the following symptoms: congestion, runny nose, lethargic.
29-SEP-93 PC from mom pt recvd vax 16AUG93 & since that time lt ant leg raised size of nickel had become red & drained pus; very small & x 2 dec in size then black & blue; dx infection or hematoma;
Reaction from medication 24 hours after flat warm raised area approx. 3 inches in diameter. (last few years reaction has worsened each year).
Pain, edema and erythema at injection site. Later low-grade fever, myalgia, arthralgia and fatigue for about a week.
A week later I developed ringing in my ears which has persisted till today.; This is a spontaneous report from a contactable consumer (patient) patient of unspecified age and gender received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number, and Expiration date was not reported), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Apr2021, (a week later), patient developed ringing in his/her ears which had persisted till today. It had been terrible. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 02-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Patient reported epistaxis (nose bleed). It was noticed by patient approximately 90 minutes post vaccination, as blood inside her mask.
Allergic reaction to the shot; Shortness of breath; Right leg looked like COVID-19 arm; Both legs started getting more red/real red and blotchy; Both legs swelled up/There are bumps on his legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to the shot), DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Both legs swelled up/There are bumps on his legs), VACCINATION COMPLICATION (Right leg looked like COVID-19 arm) and ERYTHEMA (Both legs started getting more red/real red and blotchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011V20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PERIPHERAL SWELLING (Both legs swelled up/There are bumps on his legs) and ERYTHEMA (Both legs started getting more red/real red and blotchy). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction to the shot), DYSPNOEA (Shortness of breath) and VACCINATION COMPLICATION (Right leg looked like COVID-19 arm). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (SMZ-TMP) at a dose of 800-160mg. At the time of the report, HYPERSENSITIVITY (Allergic reaction to the shot), DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Both legs swelled up/There are bumps on his legs) and VACCINATION COMPLICATION (Right leg looked like COVID-19 arm) outcome was unknown and ERYTHEMA (Both legs started getting more red/real red and blotchy) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: no change (normal) No change from 10 years ago when he had those tests. On an unknown date, Echocardiogram: no change (normal) No change from 10 years ago when he had those tests. On an unknown date, Ultrasound Doppler: negative (Negative) Negative.         No concomitant medications were provided. Treatment medications included steroid, 20mg of water pill, inhaler. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-049470 (Patient Link).
This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N017700, expiration date: 09-JUN-2019, dose, strength, frequency and route of administration were not provided ) for prophylaxis. The vaccine was diluted with properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes prior to administration. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The call was because of digital data logger. No adverse events were reported. Product quality complaint was not involved. This is one of several reports form the same reporter.; Sender's Comments: US-009507513-1711USA002012:
At 11:20, patient requested for her BP to be taken. Patient was asymptomatic. Asked several times and denied any symptoms. Patient is done with her observation period and she wanted to see her BP because she had transfusion yesterday. Her initial BP was 192/89 (115) 60 97% RA. After she saw her BP, she got nervous and complained about epigastric pain. I gave her an option of going to the ED. Patient waited for 10 more mins. VS 210/90 80HR. Pain was worse during this time. Patient was transferred to the ED. Made doctor aware of patient's situation and disposition.
Patient did not receive full dose of the Moderna COVID-19 vaccine; very little got into his muscle due to the needle retracting during admission; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and did not receive a full dose.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On an unspecified date, the patient received the first of their two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient received the second of their two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient was not administered the full second dose of the vaccine, and very little got into his muscle due to the needle retracting during admission. No treatment information was provided.   Action taken with the mRNA-1273 in response to the event was not reported.  The event, did not receive a full dose, was considered resolved.; Reporter's Comments: This case concerns a male patient of unknown age who received their second of two planned doses of mRNA-1273 (Lot: unknown), reporting Wrong technique in product usage process and Incorrect dose administered.
This spontaneous report as received from a nurse practitioner refers to an adult patient of unspecified age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the adult patient was vaccinated with a dose of PROQUAD injection (dose, route of administration, lot# and expiration date were not provided). Additional information has been requested.
Shortness of breath, dizziness, tingling hands and feet, headache, wheezing
Pt recv'd Pneumovax,meningococcal, & ACTHIB vax. Subsequently, pt exp stroke-like symptoms. Pt sought unspecified medical attention. (OMIC)
Severe chills, high fever, shooting pain in arms, urinary output decreased severely, headache.
Bodyaches numbness in legs and arm of injection site for 2 weeks runny nose snd headaches still to this date
Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was unknown, it this lot number undergone a previous temperature excursion; storage condition at the time of the excursion was frozen storage/refrigerated storage/ambient room temperature frozen storage/refrigerated storage; state of the vaccine at the time of the excursion was partially thawed/liquid, interim disposition of vials (returned to the freezer/refrigerator, or maintained at room temperature): frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; inspection noting any vaccine state change (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all): re-frozen and pertinent detail related to the impacted vial(s) (punctured/unpunctured or temperature fluctuations, etc.): temperature fluctuations, Frozen - refrigerated - re-frozen. Move to fridge date for the vaccine was 06-Oct-2021.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-496015 (Patient Link).
Swelling and redness over injection site where DTaP-IPV given. Patient was started on oral antibiotics for possible cellulitis.
Allergic reaction: swollen bumps similar to mosquito bites on face, neck, and chest . Itchiness . Only on the left side (side where vaccine was given) No known allergies to food, medication or product ingredients. Reaction happens after applying makeup, all products applied have been used in the last week without incident . The day prior to this reaction, I had a fever of up to 103.1 degrees, headache and fatigue which I  treated  with acetaminophen.  No other symptoms on the day of the allergic reaction
Muscle pain near injection site. Lasted for about 2-3 days, worst was about 36 hours after injection.
Post vax, the pt developed swollen area 2 x 3 1/2 inches, redness, soreness, and warm to the touch.
Mom reported t102 x 2 days w/APAP; site very red & swollen from shoulder to elbow; Had red bull's eye, listless, guarding of arm; Seen by MD given ATB;