chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large rash on left arm starting approximately 5 days after vaccine. Arm was very red and tender to the touch. I have photos of this rash.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9266), in right arm, on 12Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 06Dec2021 as dose 3 (booster), single (Lot number: FG3524), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN, start date: Apr2021; ATORVASTIN, start date: 02Dec2021; PAPAYA ENZYMES, start date: Apr2021; ALEVE, start date: Apr2020; FISH OIL NATURE MADE, start date: Apr2021; HEAL N SOOTHE, start date: Apr2022; BRAIN BOOSTER, start date: May2022; VITAMIN D3, start date: Apr2020; ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE], start date: Apr2021. Past drug history included: Known allergies: magnesium, reaction(s): "Known allergies: Magnesium". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19 - start date: 19Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Headache, Myalgia, Arthralgia, PAIN AT INJECTION SITE, FATIGUE Narrative:
Nurse discovered that Pfizer vaccine was not properly removed from the regular freezer on 10/13/2021. The Pfizer vaccine was moved from ultra cold freezer to regular freezer on 09/28/2021 and should have been removed from the regular freezer the end of the day on 10/13/2021 and placed in the refrigerator for 31 days. The vaccine was not removed on this day from freezer. The vaccine is still in the freezer today 10/25/2021. It was investigated and found that the vaccine was used in clinic Monday 10/18 through 10/23. NP called Pfizer med and spoke with an attendant. Walked her through the scenario and she made NP aware that vaccine could not be used past day 17 after being in the regular freezer, voiced that vaccine stability could not be determined and that vaccine should not have been used past the 3 day grace or day 17 and should have been moved to the refrigerator on day 14 after removal from regular freezer. Patient was notified of the incident.
Stomach cramps, gastrointestinal issues, diarrhea, loss of appetite, lethargy, fatigue, occasional dizziness, brain fog, shakiness
Localized rash to right upper arm. "Throat complaints"- no reports of shortness of breath, asthma, and wheezing. Did not use epi pen. Rash increased prior to going to bed on 9/10/217.
Body aches, swelling of lymph node (under armpit on side where injection was), extreme body chills, very high fever (103.2F), extreme fatigue; Took Tylenol, fever reduced somewhat.
Numbness in left arm and hand and diagnosed with Pleurisy  almost 2 months after vaccine. Chest pain started 2 weeks after second Moderna dose and increased in time until I was admitted into  Hospital
Shortly after receiving the Moderna Booster on 12/20/2021 my arm hurt, within an hour I started to get a headache and my joints began to ache. By 8pm that night (12/20/2021) I have a fever, chills, rapid heartbeat, the worst aching I have ever felt in my joints, a headache - which was not a normal headache or migraine - it felt like my brain had swelled and there were random pain points all over my skull. The symptoms persisted into the next day (12/21/2021). However, the fever and chills were replaced by exhaustion, brain fog, and jaw twitching. Over the following week the symptoms gradually lessened. As of 1/5/2022 I am still experiencing some exhaustion, trouble concentrating / brain fog, and intermittent heart racing.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 01/05/2021, 01/29/2021, and 10/04/2021. They tested positive on 11/02/2021. They presented to emergency dept on 11/01/2021 and 11/04/2021. After this second emergency dept visit, they were admitted to hospital. They remained hospitalized until their death on 11/07/2021.
After he got the vaccines within 2-3 hours he was crying inconsolably - even when he was BF, then he listless and would not make eye contact (which is weird because he is a very interactive baby per mom) - he had a low grade fever 100. The screaming last 3 hrs. Fever and listlessness lasted 6 hrs.
Initial unsolicited report received from a physician in on 31-Jan-2018. This case involves a nine months old male patient, who was vaccinated with a 0.5 ml dose of FLUZONE (batch number, expiry date, dose in series and route of administration was not reported) in thighs down on an unknown date. Patient's medication history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced vomiting and redness in lower extremities. Lab data and corrective treatment were not reported. Event outcomes were not reported. List of documents held by sender: none.
patient fainted and hit the head after receiving GARDASIL 9; patient fainted and hit the head after receiving GARDASIL 9; This spontaneous report was received from medical assistant and refers to a adolescent male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2023, reported as in the last few weeks, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for HPV prevention (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient fainted and hit the head, it was stated that the patient received unspecify treatment for the events, he was checked by the physician's assistant who did a neurological check and referred the patient to the emergency room for further evaluation, then the patient went to the hospital for a neurological exam and hospital visit exam (no hospital admission was performed). The outcome of the event was not reported.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the event syncope was determined to be medically significant.  This is one of 2 cases from the same reporter.; Sender's Comments:  US-009507513-2310USA003339:
Bipolar I disorder, single manic episode, severe, with psychosis. ED visit and hospital admission. This visit was within 6 weeks of receiving COVID vaccine.
Pt reported red, itchy, hot and swollen area about a 4 inch in diameter area around the injection site starting about 24 hours after receiving the moderna vaccination.
Redness tenderness noted @ site of DTP inject rt deltoid w/in 48 hrs of vax by 5th day post vax there was a mass & redness about 1in in diameter; the arm was very tender; exp linear macular streaking from the infect site; dx abscess;
Within 45 minutes after the shot. I had a lump in my throat/closing and felt ill. I took Benadryl and  within an hour I felt better
Ongoing arm pain in the area of the shot (deltoid muscle) continuous for 6 months since the shot
8cmx9cm redness and swelling to left deltoid with 3cmx3cm inner firm area to center - area warm and tender to touch
monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster).    No concomitant medication was reported.  It was reported that the caller was the office manager, who had a situation and found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters.  She called public health, who said there's no harm in it. She was also told to call VAERS. She was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  No treatment medication was reported.
Patient received their first dose. Patient is afraid on needles and started to feel dizzy while waiting his 15 minutes. He stood up to get the attention of my technician and started to get lightheaded. He slumped into the chair and lost consciousness for 5-10 seconds. He did not have a rapid heart rate of increased breathing rate. He came to and began speaking and started drinking water until the paramedics arrived.
No reaction to first vaccine dose. Gum tingling starting 10 minutes after second vaccine shot. Progressed to intermittent numbness and tingling in tongue, gums and right side of face over five days. Still ongoing.  No prior history of Bell's Palsy.
pt approx 3-4 minutes p/shot became acutely dizzy, pale, diaphoretic
Raise in blood pressure to 220/110. I took another dose of my medication with no results. . I proceeded to the hospital  and spent the evening at the ER.  I was advised it was a reaction to the vaccine and was sent home around 2AM, after my blood pressure was under control. they let me rest and I was monitored.
Intussusception reduced  5/04/09 Received vaccine & PCP medical records of 4/13-4/27 as well as hospital d/c summary  of 4/27-4/28/2009. FINAL DX: Intussusception, enema reduced Records reveal patient experienced projectile vomiting, irritability, decreased appetite, sleep disturbance, sunken eyes x 2 days.  Tx w/air enema & admitted overnight for observation.  Progressed well & d/c home.  6/8/09 Hospital records DC summary received DOS 4/27/09 to 4/28/09. FINAL DIAGNOSIS: Intussusception, reduced with air enema.  Post vaccination: Fussiness, not sleeping well. Projectile emesis, knees flexed. Admitted to hospital with abdominal pain and intermittant vomiting. Reduction by air enema. ICD-9 Codes: 5600 Intussusception.
pt had gen tonic clonic sz activity @ 140PM on 27MAY96 sz lasted 15min;pt had recv vax 11:45AM same day;no fever (t100.9 R); no other known illness referred via EMS to hosp ER;
This spontaneous report was received from a clinical supervisor, concerning a 12 months old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with PROQUAD lot # N012489 with expiration date on 17-OCT-2018; and VARIVAX lot # reported as N005796 with expiration date on 26-MAY-2018; both administered for prophylaxis (strength, dose, route of administration or anatomical location for neither of them was reported) and reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. Lot number N005796 is an invalid lot number for varicella virus vaccine live (Oka/Merck).
An expired vial was used in the administration of this vaccine. The vial was approximately 20 hours past the initial puncture date. I personally called patient today who reported NO adverse effects whatsoever, aside from arm soreness.
Day 2 after injection. LA with itch, redness, and warmth. These Sx went away gradually but returned today 12/27, 9 days after injection.
Pale/lethargic.  Eval children's ER.  Dx - seizure D/o.
Patient ordered to receive vaccinations prior to discharge.  This consisted of Vaxelis (DTaP, IPV, Hib, Hep B), PCV 13, and Rotavirus.  Immediately following the administration of the medications, the RN came to notify me that she had unintentionally gave the Rotavirus IM instead of PO.  She stated that she drew up two 1ml syringes and administered those in her right thigh.  The RN went and notified the mother and grandmother.  The mother was distraught, yelling in the hallway that the RN should be fired.  Dr.  and I asked if we could speak to her in their private room.  Grandma was holding the patient.  Patient assessed. Patient well-perfused and stable.  Right thigh slightly edematous but soft with 2+ pedal pulses.  Patient hooked up back to monitor and vital signs stable.  Discussed with family the plan to involve pharmacy to look at any known risk factors.  Pharmacy found a CDC MMR from 2014 detailing similar experience.  The side effects reported included redness at insertion site and irritability.  We also notified and included our charge nurse, nursing manager and director.  The mom asked to speak with social work who quickly arrived at bedside.  I spoke with staff who had not seen a previous incident but asked us to follow for the following concerns symptoms; fever, erythema at the site, decreased perfusion including prolonged capillary refill, decreased palpable pulses and firmness at the site.  Pharmacy contacted Merck, the manufacturer of the product Rotateq, who did not have documentation of any similar cases but would email us with any further information.  Upon discharge from the unit, the VS remained stable with her right thigh much less edematous and good perfusion.  Grandmother is a family nurse practitioner and verbalized understanding of concerning symptoms to notify provider regarding patient.  Plan to contact family tonight and tomorrow to follow up on patient status.
expired vaccine administered; no adverse effect reported; This spontaneous report as received from a Nurse refers to a  patient of an unknown age and unknown gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On 09-MAY-2019, the first patient received a dose with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Lot number N030364 and expiry date 06-MAR-2019), route via oral for an unknown indication. The nurse reported that, the patient received expired rotavirus vaccine, live, oral, pentavalent(ROTATEQ)(expired product administered). No adverse effect was reported(No adverse event).
PMS; My usual (like clockwork) menstrual cycle hasn't been the same / start date gets later and later every month; cramps and flow has been almost unbearable; cramps and flow has been almost unbearable; 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), administered in arm left, administration date Jan2022 at 10:30 am (Lot number: 33025b1) at the age of 41 years as dose 3 (booster), single, administered in arm left, administration date May2021 (Lot number: ew0182) as dose 2, single and administered in arm left, administration date Apr2021 (Lot number: ew0158) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PAXIL [PIROXICAM]. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered with sequelae", described as "My usual (like clockwork) menstrual cycle hasn't been the same / start date gets later and later every month"; DYSMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 2021, outcome "recovered with sequelae" and all described as "cramps and flow has been almost unbearable"; PREMENSTRUAL SYNDROME (non-serious), outcome "recovered with sequelae", described as "PMS". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, menstrual disorder, premenstrual syndrome.  Additional information: Patient stated her usual (like clockwork) menstrual cycle had not been the same since she got her first shot. Sometimes it was long (up to 9 days) and sometimes short (as little as 4 days). The cramps and flow were almost unbearable. And her start date gets later and later every month. It was about 11 days late this time. Lastly, she felt like she was experiencing PMS all the days as it was late late. Prior to the vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Patient had no known allergies and no other medical history. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
local reaction w/swelling, redness, pain forming a hard knot 1 inch diameter;
Bright red itchy and painful rash at injection site, started about 12 after injection and remained for 1 week. Size from shoulder to below elbow.
A patient received an expired vaccine as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received an expired vaccine as a second dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received an expired vaccine as a second dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received an expired vaccine as a second dose) outcome was unknown.        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.
Child became dizzy within 5 minutes and collapsed to the ground. Unconscious for 1 minute. Had some jerking movements in both upper extremities, lasting for a minute.
The day after all vaccines listed above were given patent developed a small rash on both inner arms. The rash continued to spread to other places on body. The rash started as a bright red speckled rash. The rash did not seem to be painful for the first week. Over the next several weeks the rash got worse. It was covering the entire body of the infant. The effected areas became sore and painful to touch.
fever of 100.4,Nauseous,head ache,chills,light headed,body pains
injection site it is red and swollen; injection site it is red and swollen; Lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site it is red and swollen), INJECTION SITE SWELLING (injection site it is red and swollen) and LYMPHADENOPATHY (Lymph nodes swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site it is red and swollen), INJECTION SITE SWELLING (injection site it is red and swollen) and LYMPHADENOPATHY (Lymph nodes swollen). At the time of the report, INJECTION SITE ERYTHEMA (injection site it is red and swollen), INJECTION SITE SWELLING (injection site it is red and swollen) and LYMPHADENOPATHY (Lymph nodes swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided
Patient reports onset of left shoulder pain the night of vaccine administration and presented to clinic 1 month later on 2/7/19 with continued shoulder pain. Currently being treated as with NSAID and home exercises for shoulder bursitis.
Gradually Child Began to have different sort of twiches.  Blinking of the eyes more often with muscle retraction until in a period of a month a whole body retraction with the drop of the head and extremities was reported to the Doctor.
Brain fog, severe headache, blurred vision, constant urination, fatigue , leg cramps, trouble breathing and irregular heart beat. that have lasted since day of vaccine. Still suffering from some symptoms
This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 03-FEB-2016 the patient was vaccinated with improperly stored PNEUMOVAX 23, time of frame was 35.5 hours at a temperature of 27F (strength, dose, and frequency were not provided) lot # L040181 and expiration date 18-AUG-2018 and lot# L040178 and expiration date 18-AUG-2018. Concomitant therapies were not provided. The nurse did not report adverse symptoms. The nurse was not able to provide the lot # and expiration dates for the PNEUMOVAX 23 was administered to the patient. This is one of several reports received from the same source. Additional information has been requested.
1/30/2021- he was found to be confused by family and taken to the ER where he was found to have bilateral pneumonia, symptoms of decompensated heart failure.  he did not improve with interventions and ultimately was placed on comfort care and passed away in the hospital 2/2/2021
Information has been received from a physician concerning a 19 year old female patient who in June 2008, received the first dose of GARDASIL vaccine (yeast) IM. On 23-AUG-2008, the patient received the second dose of GARDASIL vaccine (yeast) IM. There was no concomitant medication. The patient experienced the following symptoms within 2 hours after receiving the second dose of GARDASIL vaccine (yeast): hives, swelling of the hands and redness of the hands, itching, tingling along nail and toe nail beds. Given BENADRYL which helped within 1/2 hour. Then put on CLARITAN for maintenance for 10-15 days. Had been off CLARITIN for 36 hours and all of the symptoms recurred. Symptoms are not severe, but hives and itching, swelling of the hands and redness recurred. Took another CLARITIN and BENADRYL. At time of reporting, the patient's adverse experiences were still being treated. No additional information is expected.
A nurse reported that her 7 month old son post vaccine's developed an injection site reaction described as hot, raised and red.
Initial unsolicited report received from a consumer on 27 October 2015. This case involves a female (age unknown) patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, route and site of administration were not reported)on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced unique reaction. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.