chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Most of the vaccine leaked; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Most of the vaccine leaked) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021 at 2:02 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced UNDERDOSE (Most of the vaccine leaked). On 06-Apr-2021, UNDERDOSE (Most of the vaccine leaked) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was a Nurse was reporting on behalf of a patient who received their second dose of Moderna COVID19 Vaccine on 06-Apr-2021 at their clinic. The patient reported that most of the vaccine leaked down from their arm from the needle and felt like they didn't get the whole dose.  On 18-May-2021, Reportedly, the clinicians could not confirm more than half of the dose was administered and it was also reported that the patient returned for additional 2nd dose on 16-Apr-2021.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up was received on 18-May-2021. Added patient demographics. Added vaccine facility information. Updated anatomical location and description of the event.
Exactly one week after receiving the shot, my arm developed a swelled, red area that was hot to the touch and very itchy.    The injection site was very painful the day following the vaccination, but there was no pain after that until yesterday when the site became red, hot and itchy.
initially had tiredness, dizziness, achy arm, that improved by 2 days, but mom noticed a lump over left clavicle, 2 x 2 cm left supraclavicular node palpated, non -tender, no erythema, movable, no cervical or axillary adenopathy
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 29Mar2023 to 03Apr2023 for treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148547 same reporter/patient, different drug/event;
Resident received COVID vaccinations.  No Lot number indiated.  He has since developed COVID-19.
reports on more redness / swelling of Prevnar 13 on fourth dose of Prevnar 13 administered in arm; reports on more redness / swelling of Prevnar 13 on fourth dose of Prevnar 13 administered in arm; This is a spontaneous report from a contactable nurse via a sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration in arm on an unspecified date (Batch/Lot number was not reported) as dose 4, single and doses 1, 2 and 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) in thigh as single dose for immunization for immunization. The patient medical history and concomitant medications were not reported.. The nurse reports on more redness / swelling of Prevnar 13 on fourth dose of Prevnar 13 administered in arm. As compared to previous 1st 3 doses in thigh. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient falsified DOB when registering for vaccination, stating a different DOB for the minor. Guardian consented to the vaccination. Department of Health verified with statistical records what the patient's actual DOB was which made the vaccine a contraindication.  No known adverse reactions noted.
Information has been received from a physician concerning a 14 year old female patient with no medical history or allergies, who on 03-JAN-2007 and on 06-MAR-2007 was vaccinated with a first and second 0.5 ml dose of GARDASIL, respectively (second dose lot# 653735/0688F given IM). Concomitant therapy given on 03-JAN-2007 included a dose of MENACTRA. There was no illness at the time of vaccination. On approximately 03-JAN-2007, the patient experienced fatigue and subsequently recovered. After the second vaccination on 06-MAR-2007, the patient experienced nausea and extreme fatigue. After one of the vaccination the patient fainted. Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.  Additional information is not expected.
This case was reported by a healthcare professional (office manager) via a GSK representative and described the occurrence of drug use for unapproved indication in a 6-month-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date in 2009, the subject received KINRIX (unknown) as the 3rd dose in DTAP series, and experienced drug use for unapproved indication, and administered drug to incorrect patient.  On an unspecified date in 2009, after vaccination with KINRIX, the subject experienced an unspecified adverse experiences.  At the time of reporting the outcome of the events were unspecified.  The office manager reported that the subject was inadvertently given KINRIX that was meant for his 4 year old brother instead of receiving either PENTACEL or PEDIARIX two months ago.  The office manager reported adverse effects with the subject, which was not specifically reported.  No further information was provided to the GSK representative by the office manager.
herpes zoster; Information has been received from a lawyer refers to a patient of unknown age and gender, concerning a case in litigation. The patient's concurrent conditions, historical conditions and concomitant therapy were not reported. In or around 01-NOV-2016, Patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered blisters on the left side of the suprapubic area that cross the midline with burning type pain and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result of company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a nurse refers to patients (clients) of unknown age. On an unknown date, the patient were vaccinated with improperly stored GARDASIL (strength, dose, route of administration and indication were unknown). No concomitant medications were reported. No adverse effects reported at the time of report. No product quality complaint was involved. The outcome of events was unkonwn. No further details provided. This report is linked to 1405USA010570, 1405USA010571, 1405USA010572 by the same reporter link. Additional information has been requested.
on 3/13/2021 developed fever and cough.   Tested positive for COVID.
pt recv vax & devel a large area of cellulitis (area of rxn spread 3x the initial size) tx w/Keflex po;;rxn resolved p/approx 1 wk;this is 1 of 8 patients from this site who exp above rxn
Achy, shakes/shivering, nausea, muscle aches, joint aches, stiff neck, follwed the next day by severe cold type symptoms.
not feeling good; throwing up/ vomiting; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY), administration date 10Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 10Nov2021, outcome "unknown", described as "not feeling good"; VOMITING (non-serious) with onset 10Nov2021, outcome "unknown", described as "throwing up/ vomiting"; HEADACHE (non-serious) with onset 10Nov2021, outcome "unknown", described as "headache". Additional information: Patient was reporter's wife. Wife received the Pfizer COVID-19 vaccine couple hours ago on 10Nov2021. She was throwing up and not feeling good on 10Nov2021. She had a headache on 10Nov2021. She kept on vomiting. Husband also asked how long these symptoms can be last. It was informed to him headaches and vomiting have been reported with Pfizer COVID-19 vaccine. This is a normal immune response. However, if you notice these symptoms are progressively getting worse please consult your health care provider. Informed him these symptoms may vary from one person to another. The symptoms can last for a few days. Should he notice these symptoms are not getting any better please contact your health care provider for treatment recommendations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/Batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Arm hurt; got bad chills; slightly nausea; low grade headache; This is a spontaneous report received from a contactable consumer, the patient.  A 72-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in right arm on 04Mar2021 at 09:45 hours (at the age of 72-year-old) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included unspecified medication.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL926), via an unspecified route of administration in left arm on 11Feb2021 at 09:00 hours, as a single dose for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19.  On 04Mar2021 at 16:00 hours, the patients arm was hurt, that night she got bad chills, felt slightly nausea and low-grade headache.  The patients arm hurt for about 3 days, got bad chills for about 4 hours, felt slightly nausea for 2 days and low-grade headache for 2 days. The patient did not receive any treatment for events.  The clinical outcome of the event chills was resolved on 04Mar2021 at 21:00 hours, for events nausea and headache were resolved on 06Mar2021 and whereas for event arm hurt was resolved on 07Mar2021.  No follow-up attempts are needed. No further information is expected.
This patient was scheduled to receive her flu vaccination on 10/6 and as the result of a clinician error received a Pfizer COVID-19 vaccination.  Prior to this vaccination the patient had already received her "third dose"  from another provider on 9.2.21.  As a result this ended up being her 4th dose"
After administering IPV SC, a 2 1/2 cm sized area appeared on clients right arm above areas of insertion. The pt experienced redness in the area also. An ice pack was applied. Tylenol was given by mom.
Within 10 minutes of receiving the shot, I felt dizzy, light-headed, weak, tongue swollen and numb - those side effects went away 4-5 hours later, but were replaced by severe body aches, fatigue, chills, freezing/shaking/fever, severe headache; in addition to the side effects previously listed 8 hours after the shot I developed congestion, lots of sneezing for 4 hours; The body aches, fatigue, chills, freezing/shaking/fever, severe headache has continued and is continuing, on and off - mostly on, for the past 48 hours.
painful area on bottom of second and third toe on left foot has disappeared; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer colleague (patient's daughter). An 80-years-old female patient received BNT162B2 (PFIZER, formulation: solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 80-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Patient previously received first dose of BNT162B2 for COVID-19 immunisation. Medical history included Something on the bottom of her left foot/like something hard that bothered her and it would hurt when she walks. Something that was like itching on second and third toe underneath. There were no concomitant medications. On an unknown date, the patient's painful area on bottom of second and third toe on left foot has disappeared. It was reported that, she just told her she had the two doses of the Pfizer Covid vaccine as well, she said that used to have something on the bottom of her left foot, something that was like itching on second and third toe underneath, like something hard that bothered her and it would hurt when she walks and since her mother had the two doses of the vaccine, states it is gone. Her mother washes feet every day with very warm water and noticed it was gone. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My son received his first DTaP injection on the morning of 1/18/00 at 2 months of age.  He also received his first IPV and Hib on the same visit.  He has a mild upper respiratory infection when he received this vaccination.  I called my doctor that afternoon approximately five to six hours later because my son was sleeping through his feedings and I could not wake him up.  Doctor said the excessive sleepiness was probably due to the tylenol he received and not a cause for alarm.  I told him that I was calling because it was very unusual behavior for my son and that I read that hypersomnolence was a reportable adverse event for DTaP.   At three months of age we noticed he developed some unusual posturing.  He would arch his back severely, especially when he was drifting off to sleep. (My husband named the pose the "torti" pose short for torticollis)    At 9 months of age began to have frequent viral infections and ear infections.  He also had a chronic red facial rash.  His motor development appeared to slow.  He started pulling up a bit but didn't walk until 141/2 months of age.  At 15-18 months his language development plateaued and he regressed socially.    He was diagnosed with autism and a motor coordination disorder at 28 months of age.  He has since been treated with a combination of therapies including floortime, behavioral (ABA), occupational, physical and speech therapies and biomedical interventions.  Most recently he was re-evaluated and diagnosed with static encephalopathy on 1/3/05.
his temperature fluctuates; feels like he has a cold; body aches; he is weak all through the day; lost all his appetite; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number FA6280), dose 1 via an unspecified route of administration on 24Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced his temperature fluctuates, feels like he has a cold, body aches, he is weak all through the day, lost all his appetite. The patient underwent lab tests and procedures which included body temperature: 99.7 his temp goes to 100.9. He said that his temperature fluctuates and this morning his temperature was 100.9. He said that he is driving to work and right now has a temperature of 99.7. He feels like he has a cold, he has body aches, he is weak all through the day, and said that when he goes home his temp goes to 100.9. He also stated that he lost all his appetite and has no appetite. He said that maybe the air conditioner has something to do with it. There is bad handwriting on his vaccination card and he had trouble reading the Lot number. The caller said that he is kind of wondering if these are usual side effects, he said that from people that he works with, he said that they usually say that their symptoms are gone after 2 days and he still has symptoms, and it has been 4 days now. No further details provided. Caller did not have time to complete a safety report at this time as he was at work. The outcome for all events was unknown.  Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.
heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Patient had no past heart conditions. No known allergies.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient was not asked about consent to follow up.
diarrhea 24 hrs p/vax; sx lasted 25 days a/subsiding; stool specimen for culture O&P obtained; all neg; diarrhea eventually subsided; unable to determine if sx definitely from vax;
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 04Mar2021 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was asking can I received my second vaccine dose if I tested positive for COVID after my first. Patient reported that he received his first vaccine dose last week on 04Mar2021 and since then he had developed COVID, was tested 2 days ago and tested positive. He reported he think he was getting better but asked should I continue on in 2 weeks if he was feeling better to get his second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax;same day arm felt heavy & was a little tired;next day extremely tired;
This was given at the same time and in the same arm as the KINRIX vaccine (lot number 5ay2j). Child dev red rash at site of both injections ( MMRV worse than Kinrix) then following day with red lesions and some with dryness but no vesicles on neck/ face and trunk. none on palms or soles but some papules on webs of fingers. no itching; no F/V/D
Flu shot administered 9-15-11 right deltoid IM - used 2 cotton swabs to stop bleeding - RPh told her to wait 15 min - tender to touch - arm felt like lead - took ALEVE qid for 4 days, ice pack - hot - slight fever. 9-27 still very tender & 2 dollar bruise.
Patient stated she could not feel her face and that she was tingling.  Symptoms went away within 10 minutes of vaccine after sitting down and drinking some water. EMS was called by mother's request.  Vitals were checked and patient deemed ok - mother refused hospitalization and took her home.
Muscles were so sore; Body was so sore; Sole was so sore; This is a spontaneous report from a contactable consumer. An 81-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. 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 04Mar2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. On 26Mar2021, one day after the second dose of vaccine, the patient experienced muscles, body and sole so sore to where she stayed in bed. The effects lasted for 24 hours and then she felt fine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events, muscles, body, and sole sore was recovered on 27Mar2021, after the duration of 24 hours.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.