chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; PROQUAD that underwent a temperature excursion was administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender, identified as NS.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 17-AUG-2021, the patient was vaccinated with an incorrect measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) storage, lot # T010288 with expiration date on 20-SEP-2021, for prophylaxis (dose and route of administration were not provided). The vaccine underwent a temperature excursion of 14°F to 46°F (15.2F) for 4 hours 40 minutes and 0 seconds. There was not previous temperature excursion. No additional adverse effect reported.; Sender's Comments:  US-009507513-2108USA006345:
Syncope with leg twitching 5 minutes after injection.  Also c/o nausea and headache remainder of day.
3/26/21 - awoke during night not feeling well - aches, fever, chills, foggy.  As the day progressed, higher fever, chills, nauseated, itching on top of scalp, no energy; could hardly hold head up.  For a week, low energy, foggy effect, and itchy scalp.
Itchiness on the throat, core of the body, and scalp; Hives on the throat; Itchiness on the throat, core of the body, and scalp; This is a spontaneous report from a contactable other hcp (patient). A 37-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 04Mar2021 12:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunisation. Medical history included Subclinical hypothyroidism. Known allergies of various foods but not top 8. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM); ashwagandha (ASHWAGANDHA); ergocalciferol (VIT D); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient had no Covid prior vaccination. Since 05Mar2021 02:30 AM, the patient experienced Itchiness on the throat, core of the body, and scalp. Hives on the throat. AE resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment. The patient had not tested Covid post vaccination. Outcome of the events was recovering.  No follow-up attempts are Possible. No further information is expected.
no additional signs of adverse reaction to receiving the expired vaccine; expired Vaqta administered to a patient; This spontaneous report was received from a pharmacy student, who received the information from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.   On 09-NOV-2020, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) lot # S032660, expiration date 22-OCT-2020, as prophylaxis (expired product administered) (strength, dose, frequency, and route of administration were not provided). No additional signs of adverse reaction to receiving the expired vaccine were reported.   The outcome of the event, and the causal relationship to the suspect vaccine were unknown.
Information has been received from a medical assistant referring to a 6 week old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 29-AUG-2016, the patient was vaccinated with the pediatric formulation of VAQTA (Inappropriate schedule of vaccine administered) (0.5 ml, lot # M003011, expiration date: unknown) intramuscularly. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician assistant concerning a 14 year old female who was vaccinated, intramuscularly with the first dose of Gardasil vaccine (yeast) (dose and date not provided). It was reported that the patient received the Gardasil vaccine (yeast) from the state and 2 days post vaccination experienced swelling 6.5 to 7 centimeters in diameter that was cellulitis-like swelling around the injection site. The patient sought unspecified medical attention. The physician assistant reported that the patient was seen in the office on 26-MAR-2007 and treated with BENADRYL for the symptoms. No lot number was provided. At the time of the report, it was unknown, if the patient recovered. It was also reported that the patient's 11 year old sister had the same experience after receiving the Gardasil vaccine (yeast) from the state. (WAES0703USA05406). Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Information has been received from a nurse practitioner and a healthcare worker (also reported as an office manager) referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 22-JUL-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K005957, expiration date: 08-MAR-2015, dose, frequency and route were unknown). Concomitant therapies were not reported. On the same day after the vaccination, it was reported that the patient was experiencing nausea and vomiting. The outcome of nausea and vomiting was unknown. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Treatment of COVID-19 with Paxlovid. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reported that he developed diarrhea/nausea within 24 hours of receiving vaccine. No record in Agency of where the vaccine was given, what manufacturer, lot number, etc that it was, other than it was given on 09/12/18.
fatigue on the day of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue on the day of vaccination) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (fatigue on the day of vaccination). At the time of the report, FATIGUE (fatigue on the day of vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported No treatment drugs were reported.   This case was linked to MOD-2022-445612, MOD-2022-445629 (Patient Link).
Injection site pain and knot starting 3 hours after admin. Starting approximately 12 hours after admin, severe headache and muscle pain of neck. Progressed to chills and fatigue. 11/17 felt fine in the morning, then by 12pm fever, chills, muscle aches, and fatigue. Resolved by 6am 1/18/21
Severe pain in injection site.  Limping for two days. SEVERE swelling - 6 by 6.5 inch area on leg.  Red, hot to the touch, extremely hard/swollen and sore area on leg where injection was given.
Severe back pain on 7/14/2021 as I woke up and severe sciatica attack on left leg (not able to walk or sit) that required emergency hospital visit.  Treated with cortisone injection and ibuprofen.  Pain lasted for 2 weeks and it resulted in numbness of the left lower leg and foot (foot drop) which has impaired walking.  An MRI on 8/29/2021 revealed inflammation in lumbar spine with an L5/S1 disc causing sciatica.   Other long -term side effect - very pronounced alopecia areata (circular spots) on left side of scalp.
General body pain; Chills; Coldness; Tiredness; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), CHILLS (Chills), FEELING COLD (Coldness), FATIGUE (Tiredness) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included NAPROXEN SODIUM (ALEVE), BIMATOPROST (LUMIGAN), LEVOTHYROXINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (General body pain), CHILLS (Chills), FEELING COLD (Coldness), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN (General body pain), CHILLS (Chills), FEELING COLD (Coldness), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Aleve.   Reporter did not allow further contact
3:30am Chills with shaking and teeth chattering,  Fever 4 points above normal, Body aches, Left arm swollen and sore, slight dizziness Took Tylenol every four hours 4pm - Fever needs to drop one more degree, still have body aches, left arm swelling   No more chills or dizziness
Arm was tender and patient said the shot hurt more than remembered from previous years. Patient stated bruising began the day after and came to the pharmacy about 5 days post-vaccine to report. Bruising on arm appeared green-yellow in color with other areas of dark discoloring. Patient stated arm was never red or inflammed. Patient also stated has never had bruising before but did have a reaction at the doctors office when she got the shingles vaccine in the other arm.
post vaccination, pt fainted at the front of the store.  her husband caught her before she fell.  she was provided with a seat to sit. offered her water but husband purchased some gatorade for her which she sipped on.   was feeling better although felt a little hot. she decided to leave after waiting around the 15 minutes post vaccination to head home.   pt reported after she  fainted that this reaction had occurred before after giving blood but it was a long time ago.
9:15am 8/25/21-dizziness, lightheaded, hard to focus, loss of balance.10pm 8/25/21 woke up with chills, midnight awoke again with chills & uncontrollable shaking. 8/26/2021 fever of 102.4, aching, sore muscles, large rash on injection site of arm, lump in left lymph node near collarbone, arm is feverish, swollen bright red rash & painful. 9/1/2021. Arm is still somewhat red but lessened quite a bit, lump in lymph node still there but arm is intensely itching.
Euphoria began ~2hours after vaccine lasting ~2.5 hours.  Unable to process information, irritability, anxiousness, generalized not feeling well around 5pm day of; went to bed. Woke up at 10:30pm with headache, took Tylenol.  Wednesday didn't feel well in general, left work at noon, went home to bed. Thursday felt better but not baseline self. Friday generalized not feeling well. Saturday went to ER due to feeling much worse generally, SOB. Tests Urine, blood. Everything within normal limits.
Tension Migraines and Tinnitus. This started the day of the vaccine and has occurred every single day since receiving the 2nd dose on 4/27/21.
Soreness in shoulder and upper left quadrant still feels lump in arm feels "hot" inside but not to touch.
Second dose not given in allowed time; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not given in allowed time) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not given in allowed time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not given in allowed time) had resolved.        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 not provided by the reporter.  No treatment information was provided.
p/vax pt feeling pain in shoulder then later extreme pain;could not raise upper arm;took alleve & applied cold pack;did not sleep much that noc d/t pain;it persisted next day;diff dressing;MD felt probably inflam bursa;
Patient received the vaccine at 0816 and then did some errands/shopping.  Patient returned home around 11 am and noticed she had a funny feeling in her throat.  Patient took Benadryl 50 mg and slept for at least 3 hours or longer.  When patient woke up she noticed that feeling in her throat had returned but had spread from back of her tongue to down her throat.  Patient described that it felt like her throat was swelling and she had swelling in her nose as well.  Patient went to ED for further evaluation and treatment on 12/21.  ED provider note described patient felt like her throat and nose were swollen and her chest was tight.  Patient was given solumedrol 125mg IM at 1825 and a written prescription for prednisone 20 mg bid for 5 days.  Symptoms improved after solumedrol was given.  ED provider had neck imagine done.  Impression from imaging "the superficial soft tissues appear grossly normal. No prevertebral soft tissue swelling.  The airways appear widely patent.  No evidence for epiglottitis"
Infantile spasms onset 5/12/07. Vaccine given 4/10/07. Mom recorded video 1 day after shots and on review saw facial movements that were part of infantile spasms when fully expressed 1 mo later. Was Rx'd with IM ACTHAR and recovered fully. 12/13/08 MR received for DOS 5/22-24/07 with DX:  Infantile spasms.  Pt presented with abnormal movements of increasing frequency x % days. Mainly upper extremity myoclonic movements. Neuro exam WNL. Tx with Pyridoxine and d/c for out pt f/u.
Within one hour of vax pt became flushed at face and neck. 1/2 hour later pt became nauseated and vomited.
Patient was given bivalent 12 + years instead of bivalent 5-11 years. No side effects noted at time of dose given.
I have metastatic melanoma, my 3rd melanoma was in my right lymph nodes after they were removed I became part of a vaccine program in Hospital in 1997. Over a time period I received 15 or 16 vaccines on my left arm. At this point because it is now 24 years later they are not visible, after my second vaccine they are all ringed, the skin is pink around all of them and you can see all of them with the pink skin. They are all highlighted now.  This was not an overly large experimental group so this happening to other people it's going to be like 1 in several million but I felt like the agency should be aware that it happened. The arm is sore and a little itchy and a little warm, again nothing that is debilitating and nothing I cant handle. The vaccine has obviously reacted with these old vaccine sites. I do know that the vaccines that I received had cells from the tumor taken from my body, essentially cleaned up and connected to the tuberculosis vaccine and then injected back into me.  The idea of that particular vaccine like any was to get my body to build antibodies to the cancer, at this point I believe they have been successful with that.
I experienced extreme pain to my left arm but not at the injection site. I experienced swelling and redness  to my left arm with a hot sensation upon palpation. My pain got so bad that I had to ice it.
Developed severe myalgia/arthralgia after both doses, resolved in~3-4 days after 1st injection. After 2nd injection, was severe immediately and took several days to resolve. Limping, unable to bear weight for normal length of time, suddenly had to sit down frequently while doing chores. Resolved after several days. By 2/7/21, developed quadriceps weakness over ~24 hours - had been able to easily pull a child up a hill on a sled 2 days prior then was struggling to climb stairs and walk uphill. Had abnormal strength on exam. Only in LE's, not arms. Took 3 weeks to fully resolve. No pain or signs of inflammation.
Injection site soreness, swelling, bruising of entire upper arm and rash. Never had  a reaction to any vaccine before.
Terrible arm pain 9 days after the vaccine.; I could move, it was very painful like arm nerves were squeezing; "I wet to the doctor a diagnostic shingles"; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 14Apr2021 at 09:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks of the COVID-19 vaccination. On 24Apr2021 at 03:00, the patient experienced a terrible arm pain 9 days after the vaccine. The patient "could move, it was very painful and like arm nerves were squeezing". The patient "wet to the doctor a diagnostic shingles". The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events terrible arm pain 9 days after the vaccine, "could move, it was very painful and like arm nerves were squeezing" and "wet to the doctor a diagnostic shingles" was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is excepted.
Heart Attack; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: EP7533) (at age 51-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications and no other vaccine within 4 weeks. The patient experienced heart attack on 07May2021. The event resulted in emergency room/department or urgent care, and hospitalization for 5 days. Treatment included IV blood thinners and blood thinner medications. Outcome of the event was unknown. Patient was not diagnosed with COVID prior to vaccination and had been tested post vaccination: nasal swab: negative on an unspecified date.  Follow-up attempts are completed. No further information is expected.
FLARE UP OF RA; This spontaneous report received from a health care professional via concerned a 38 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency once total, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient experienced flare up of Rheumatoid Arthritis (RA). Patient stated that physician told that flare up of RA caused by COVID vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flare up of RA was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210512871-covid-19 vaccine ad26.cov2.s-Flare up of rheumatoid arthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
A report from a health care professional on 11/08/02, concerning a 29 year old female vaccinee who inadvertently received 0.5 mil Fluvirin with a TB syringe and may have received the vaccinee subcutaneously on 11/11/02. The reporter speculated that the vaccinee may have received Fluvirin via the subcuataneous route. The vaccinee did not experience any adverse events. There was insufficient information to determine the reporter's causality assessment.
Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F; Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) had resolved.        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.   Dose was administered in deltoid muscle.  No concomitant medications were reported.  No treatment information was provided.