chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incident Details: Per Drs. email sent out on 9/1/22- "the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand". The patient was seen in office on 9/1/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS. Recommendation: I would recommend holding a meeting to notify Leads/Supervisors/Managers of any changes regarding COVID vaccine administration, rather than sending out an email that may not be read by all staff. If an email is needed to be sent, I recommend making it clear that a process is being changed.
Pt was taken to facility on 5/21.  Report states patient presented with rash on face, trunk and extremities.  6/9/09 Medical, hospital, DC summary received DOS 5/22/09 to 5/23/09. FINAL DIAGNOSIS: Nonspecific rash Post vaccination: Presented with diffuse erythematous, hive-like rash on face, trunk and extremities. Fussy, crying, difficult to console. Dehydrated. Later maculopapular lesions on face, trunk, extremities.  ICD-9 Codes: 782.1 Non Specif Skin Erup 695.10 Unspecified erythema multiforme 276.51 Dehydration.
Patient was given a 3rd dose of Gardasil which was not needed. Patient had previously Received 1st dose at age 12 and 2nd dose at age 13. On Saturday 8/8 patient c/o lower back pain which did not subside til Sunday (8/9) evening
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and demographics. The nurse practitioner reported that the patient was vaccinated with the first dose of GARDASIL in 2010 (exact date unspecified) and a second dose GARDASIL on 20-MAR-2013 (inappropriate schedule of drug administration). Patient route of administration and lot no. information were not provided. No adverse event was reported. Additional information has been requested.
Appetite lost; This is a spontaneous report from a contactable consumer, the patient. A 64-years-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 04Jun2021 at 15:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jun2021, at 04:00 the patient experienced appetite lost. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event appetite lost was unknown at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Stopped breathing, turned blue on extremities, stopped being alert, became jaundice, stopped crying, eyes always glassed over and swollen.
doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR. At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown ages and genders who on an unknown dates were vaccinated with improperly stored dose of GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information is not expected because the physician cannot be contact.
This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The reporter reported that improperly stored VAQTA (Lot# unspecified) (2 doses) were administrated to unspecific number of patients (dose, frequency and route unspecified). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was vaccinated by nurse outside of vaccine recommendation window established by FDA with vaccine not FDA approved for patient's age group.
This is a spontaneous report to Pfizer from Merck Research Laboratories, Service Request Number 1-398461704. A contactable nurse practitioner reported that a 22 month old patient received 3 doses of PREVNAR and 1 dose of PREVNSR13 and had an "abnormally low pneumococcal titer". The outcome of the event was not provided. No further AE information was provided.
Fatigue, vertigo, headaches.  Suspected low blood sugar but blood panel pointed to thyroid imbalance.  I've been diagnosed with Hashimoto's since 1974 and since then only major events such as pregnancy have resulted in being extreme hypo.  The vaccine must have caused this imbalance.
Moderna  COVID-19 Vaccine EUA Covid arm started the day after and was red rash for two days. Eight days after the injection it was itchy red rash that lasted five days.
This is a spontaneous report received from a contactable reporter consumer or other non HCP. The reporter is the patient. A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 12:00 as dose 1, single (Lot number: ER8729), on 05May2021 at 14:00 as dose 2, single (Lot number: EW1072), in left arm and on 08Dec2021 at 11:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Shellfish" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test was positive. Therapeutic measures were taken as a result of Covid-19. Clinical information: Adverse event includes that I am currently day 5 after finishing my Paxlovid course and I feel just as sick as I did when I tested positive before taking it. I started feeling sick yesterday with congestion and a headache, and today I have that plus sore throat, fatigue, and low fever 100.1. Anti-viral details includes that patient undergone COVID 19 Treatment. Brand was Paxlovid. Treatment start date was 03May2022 and treatment stop date was 08May2022. Patient had no other medication in 2 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Painful, itchy lesion around vaccination site roughly 2 inches in diameter lasting 3 or more days.
1hr after vaccine chills started. Within another 1 hr started achey.  Cintinued to worsen   At 1:30 am he was so weak could barely get to bathroom. Had to hug the walls to walk. Sever pain at this point. All his joints had shooting pain. Started getting better by morning but still very achy and very fatigued. Slept most of day. Ate very little. Probably didn?t drink enough water. Still weak on 3-10-2021. By evening of 10 th seemed normal. This man normally walks 5 miles a day, does 150 push-ups daily. Never sick. Very healthy.  Then on  3-17-2021 during the night he got sick again.  Joint pain, temperature at 100.4. Severe weakness.  Wobbly when walking.
Pale, Apnea 15-20 seconds in duration O2 Sat 85-98% at room air x 40 mins. Event resolving. Transferred via EMS to medical center at 1145.  8/26/08 Reviewed hospital medical records of 7/29-7/30/2008. FINAL DX: none provided. Consults state GERD, vasovagal syncopal episode Records reveal patient experienced pallor, staring, decreased O2 sats & unresponsiveness within 5 min of receiving vax.  Tx w/supplemental O2.  Sent to ER & then transferred to higher level of care for PICU.  Neuro consult done.  No further episodes noted while hospitalized.
back twitching/ her fingers and feet twitching at night when lays in bed and also her butt twitching sometimes/ her eyes will twitch on and off too/ arms, legs, hands, calves twitching; arms, legs, hands, calves twitching was reported as worsened; The twitching is interrupting her sleep at night; This is a spontaneous report from a contactable consumer or other non hcp (patient).    A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Aug2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 57-year-old) for covid-19 immunisation. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) taken for blood pressure abnormal from an unspecified start date and ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced back twitching/ her fingers and feet twitching at night when lays in bed and also her butt twitching sometimes/ her eyes will twitch on and off too/ arms, legs, hands, calves twitching on 21Aug2021, arms, legs, hands, calves twitching was reported as worsened (condition aggravated) on an unknown date in 2021 and the twitching is interrupting her sleep at night on an unknown date in 2021. Caller states she had a question, states she got her first dose of the Pfizer Covid vaccine on 21Aug2021, when she got home her leg started twitching, caller states when she lays down at night arms and legs will twitch, states her calves will twitch and her eyes will twitch on and off too, states her eye is not that bad, its mostly her legs and arms and even her butt sometimes. Caller wants to know if this is a side effect or if it has been reported. Caller states she was supposed to get the second dose on Saturday but has not because she is scared to due to this side effect. Also noted caller stated that the twitching doesn't happen while she is up walking, only when she is laying down. The outcome for event The twitching is interrupting her sleep at night was unknown while rest were not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Upper outer arm redness with swelling and warm to touch. Itching noted x 1 week. Complained of voice hoarseness x 5 days. Body aches and stomach cramps x 4 days.
My physician proactively prescribed  Claritin 10mg Pepcid AC, Prednisone 20mg  morning and 10mgz of Zyrtec Pepcid AC and Prednisone 20mgs in the evening five days before receiving the Vaccine as I had an allergic reaction after my first booster. On 9/27 I started to get hives on my face, arms and chest. I contacted my Physician and was prescribed Benadryl in the evening for 3 days along along with my previous prescriptions for hives.
2/13/2023 in the evening fever, headache, chills. Tested with an at home COVID-19 test televisit with doctor who prescribed PAXLOVID. I had bad nausea and vomiting with PAXLOVID resulted in only taking it 2 days. Symptoms remained about he same. With fatigue and loss of taste. Everything cleared up after 2 weeks.
Moderna first shot: no reactions other than a sore arm. Moderna second shot, day 1: Within a few hours developed severe nausea. Day 2: Developed rash near injection site, along with swelling the size of a tennis ball. Day 3: Additional spot developed. Day 4 developed another spot. Day 11-15: Continued to have flu-like symptoms. Concerned about possible contraction of COVID-19 and was tested. Waiting results. As of today's date, April 24, 2021, a dark shadow still appears. The onset of the rash followed severe flu-like symptoms that continue today.
Technician went to give vaccine to shot and when inserted needle she hit the bone and was worried and pulled the needle all the way out. we drew up a new vaccine with a new needle and was given without any problems. patient does not report any issues or discomfort
Caller had symptoms like vertigo and nausea after the 1st dose; Caller had symptoms like vertigo and nausea after the 1st dose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose,  COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced symptoms like vertigo and nausea after the 1st dose. She wanted to know what to take or to do. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Raised, Red, Itchy Circular Rash around injection site.   Rash was firm to touch, very itchy. Bright pinkish red color. Circular extending around injection site Fairly evenly about 1-1.5 inches.   Rash lasted approx 72 hours then itching lessened and color faded and texture returned to normal pretty quickly after this time period. Was 100% gone within a week.   Treatment: at home. Did not report to physician. Used  Gold bond topical anti itch lotion which relieved itch dramatically.   Outcome: signs and symptoms gone within a week.
Patient presented on 4/8 to  Hospital for COVID pneumonia, transferred to another hospital on 4/21/2021.  At Hospital, she was treated with convalescent plasma, course of remdesivir, and dexamethasone. She was requiring HFNC during day and BiPap overnight. She began to improve with decreasing O2 requirements on 4/15. On 4/17, she was found to have L-sided deficits and increasing hypoxia, which required emergent intubation. Dexamethasone was increased to 6 mg BID and she was started on Levaquin and Flagyl for aspiration penumonia, consolidated to ertapenem on 4/20. She had been on Eliquis prior to this, but this was discontinued after she developed the stroke sx on 4/17, switched to Lovenox. Initial head CT negative, but repeat head CT on 4/19 showed large R sided MCA territory infarct. She was placed on ASA. 4/21 head CT showed edema and mild midline shift. Neurology was consulted, who recommended hyperventilation, 3% saline, and elevating HOB > 30 degrees. She was then transferred to St. Mary's ICU on 4/21. At  Hospital, patient was treated for aspiration pneumonia (cefepime 2g Q8H on 4/22-4/25, meropenem 2g once on 4/22, tobramycin 400mg daily on 4/22-4/23) and COVID.  However, she had significant difficulty weaning from mechanical ventilation. Given her prolonged course and her right MCA CVA with significant deficits it was predicted that she would need long term ventilatory support therefore PEG and tracheostomy were placed on 4/29. She remained relatively stable until 5/2 AM when she suddenly developed massive subcutaneous emphysema and hypoxia. It was suspected that her tracheostomy had become dislodged. Patient was re-intubated orally with difficulty however there was no color change with EtCO2 and patient was in cardiac arrest. CPR was briefly performed however code status was clarified and patient was DNR. Trauma surgeon and intensivist were in agreement that any other interventions would be futile. Time of death was 0645 on 5/2/21.
Numbness, tingling, swelling of both feet approximately 2-3 weeks after vaccine - started as stiff ankles to tingling balls of feet to waking up to left foot asleep/numb right less symptomatic. Dropped foot - P. therapy.
Swelling of shoulder and glands in left arm. High fever for 3 days. Headache & nausea for over seven days.
Bright red rash over neck and shoulders and inside of both elbows. Not painful or itchy.  Rash has persisted for at least the past 24 hours.  As an aside, I had a shingles vaccination in January of this year (shingrex, I believe) and had an almost identical reaction.  The reaction to the shingles shot was a little less severe and less persistent.
Slight stomach pain that continued toget worse throughout the day.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 14:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included penicillin allergy. The patient was allergic to amoxicillin. The patient did not receive any other medications within 2 weeks of vaccination prior to the COVID-19 vaccination. The patient previously 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 10Feb2021 at 14:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021, next morning after vaccination, the patient woke up with a slight stomach pain that continued to get worse throughout the day at random times with no consistencies. The patient would feel fine then the sharp pain would start again. At some points, the pain had the patient doubling over and whimpering because it hurt so bad. The patient had the runs twice in the morning but that was it. Patient felt it very odd considering she had no history of stomach issues or any issues really. She tried seeing if this was a common side effect on the CDC website and it didn't really confirm stomach pain, just pain in general. The adverse event resulted in calling Teladoc who thought it was gastritis or some kind of stomach virus that might have been a reaction from the vaccine considering the pain was peaking exactly 24 hours from the time of vaccination. Therapeutic treatment taken as a result of stomach pain was tylenol in the morning, which didn't help and tums a few hours later which helped make the pain less intense The clinical outcome of the event stomach ache was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
3-4 in. area of erythema and swelling to (R) upper arm/deltoid. Treatment: Cool compress, TYLENOL/Ibuprofen, BENADRYL.
This spontaneous report has been received from a pharmacist via a company representative referring to a female patient of unknown age. Current or historical conditions were not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneously, lot number and expired date were not provided). Concomitant medication was not provided. The next day after vaccination, the patient experienced "extreme" inflammation at the injection site and pain from shoulder to the elbow in the same arm that ZOSTAVAX was administered. No treatment was given. The outcome of the events was reported as recovered. This is one of 2 reports received from the same reporter. Additional information is not expected as we have no consent to contact the pharmacist.
Large swollen red hot area at injection site; Large swollen red hot area at injection site; Large swollen red hot area at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history was unknown. Allergies to medications, food, or other products was unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously 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 25Mar2021 at 14:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 10:00, the patient had 8cm (centimeter) and growing, large swollen red hot area at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event large swollen red hot area at injection site was not resolved at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
patient with history of right knee replacement several years ago. prosthetic right knee only. one day after vaccination patient reports pain redness and swelling of right knee only. severe by days 3 and 4 post vaccination. evaluated in office 7/30/21. improved with treatment of ceftriaxone 1 gram IM x 1 dose and doxycycline 100mg BID x 10 days. however note follow up agency report -- same reaction after 2nd dose as well.
pt recv vax 23JAN97 & over 2hr of inconsolable crying;
mom states pt ran fever of 105; however when mom initially reported vomiting also this on 21MAY93, stated temp was only 103;
Raised area about 6 cm X 6 cm directly where injection point occurred.  The area was flushed with redness and very itchy. This area was uncomfortable to sleep on, however on Day 8 (today), both swelling, redness and itching have diminished somewhat.