chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient developed acute hypoxic respiratory failure in the day following the vaccine administration, in the setting of underlying ESRD on HD, with possible ongoing underlying hypervolemia. Evaluation revealed evidence of pericardial effusion along with significantly elevated inflammatory markers of CRP and ESR. The patient did not have any evidence of myocarditis or pericarditis on laboratory or EKG evaluation. Despite aggressive volume removal with HD, the patient's pericardial effusion remained stable in size over several days. The patient's inflammatory markers also remained elevated at the time of discharge several days following admission but improved.
Feeling like heart racing (>100bpm), could feel with hand to chest; accompanied by some shortness of breath. Radial pulse remained normal (70-80bpm) throughout event. Occurred roughly five times over course of three days (4/12-4/14), usually in evenings. Events lasted less than a minute each. Seems to have abated on its own.
RASH; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2620278, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced rash. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash, and headache on APR-2021. This report was non-serious.
pt recv vax 20SEP96 & has heavy case of chickenpox @ present time since 18MAY98-c/o stomach ache-mouth ulcers;mom states feel hot, no therm-exposed to sibling;
mightily, described as being sick / deathly ill since receiving the series; Both arms are described to be essentially useless due to the symptom; shakes; sweats; migraine headache; diarrhea; chills; fever / modest fever of 99.5 degrees; nausea; his right arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats) and MIGRAINE (migraine headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine headache.   On 11-Apr-2021, 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 an unknown date, the patient experienced ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats), MIGRAINE (migraine headache), DIARRHEA (diarrhea), CHILLS (chills), PYREXIA (fever / modest fever of 99.5 degrees), NAUSEA (nausea) and MYALGIA (his right arm started hurting). At the time of the report, ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats), MIGRAINE (migraine headache), DIARRHEA (diarrhea), CHILLS (chills), PYREXIA (fever / modest fever of 99.5 degrees), NAUSEA (nausea) and MYALGIA (his right arm started hurting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (normal) 99.5.         Treatment He applied ice to his hurting arm and took Motrin after the first dose. No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.     This case was linked to US-MODERNATX, INC.-MOD-2021-073635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073635:1st dose case
Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  The caller stated that they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use and the doctor at the office wants to know if what else should be done. The office manager stated that they called ever patient the following day and no adverse events were noted, and they performed an antibody test on all of them and the patients antibody numbers were in the 800-900 range.    This case was linked to (Patient Link).
COVID ARM RED, SWOLEN BUMP FIRM RED ITCHY ABOUT 3" IN DIAMETER
delirious; hypoxic; fever; ataxic; incontinent; confused; Chills; HA; anorexia/had no appetite; myalgias; extreme fatigue; slept all and had no appetite; This is a spontaneous report from a contactable physician. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 16:00 at single dose for COVID-19 immunization. Medical history included diabetes mellitus (DM). The patient has no known allergies. The patient's concomitant medications were not reported. He was an ER doctor and the medical director of his hospital. The patient was asymptomatic when he got the vaccine on 15Dec2020. 3 hours after the vaccine he began to get chills, HA, anorexia, myalgias, and extreme fatigue. This worsened and he slept all and had no appetite. On 19Dec2020 he woke up delirious with a fever and was ataxic, hypoxic, incontinent, and confused. The patient was hospitalized due to the events on 15Dec2020. The events also caused prolonged hospitalization due to the events. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab post vaccination with unknown results. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events as the patient required oxygen, plasma, and remdisivir.  The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of reported serious events might not be excluded, considering the plausible temporal relationship.  Fever, chills, headache, fatigue and muscle pain are the known adverse event profile of the suspect product.  More information such as detailed underlying medical conditions and concomitant medications are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Large area of redness from top of shoulder down to the mid humerus. Site was itchy and slightly raised with well demarcated borders.
uncomfortable, unconsable, crying bagan 12-31-03 2:00 am to 4 AM. Resumed 9:00 AM to 12:00 noon. No local inflammation at injection site - very passive baby - event muck unlike nature of child and course of sibling immunizations.
Tingling and numbing in feet. Body aches which required bed rest for 3 days. Chills, sweats, and a rash developed for about 5 days and still has not cleared.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients pertinent medical history and drug allergies were not reported. On unknown dates, the patients received either one or two doses of GARDASIL (dose, strength and route unknown). On  unspecified dares, the patients were administered either one or two doses GARDASIL 9 (dose, strength and route unknown), to complete their three-dose HPV vaccination series (interchange of vaccine products). No adverse effect reported. This is one of the two cases received from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 9-year-old male with a antibiotic allergy (CEFZIL)) who on 05-FEB-2007 was vaccinated with Varivax (Lot # 655069/1145F). Concomitant therapy on that day included Vaqta. On 06-FEB-2007, the patient experienced 4.5 cm swelling at injection site with redness; it was also warm to the touch. The patient's mother had been applying cool compresses. The patient was seen by a physician, treatment was not specified. The outcome at the time of this report was not recovered. There was no additional information to report. There was no product quality complaint involved. No additional information is expected.
Patient notified clinic on 11/9/21 at 4:32pm with concerns of Left arm swelling, redness, and pain. Provider discussed with patient and advised to take Benadryl, and Tylenol and cool compress. ROM every 12 hours while awake, elevate extremity and if worsens to to ER, not improved TO next day.
fall; bruised rib; bruised hip; This is a spontaneous report from a contactable consumer (reporting for his father). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration into the left arm on 12Jan2021 at a single dose for COVID-19 immunisation (COVID prevention). The patient's medical history included Alzheimer's disease and stroke. There were no concomitant medications. The reporter was calling regarding his father who was an 87-year-old combat veteran. The reporter stated that the patient received the first dose of the Pfizer COVID Vaccine on 12Jan2021. The patient was scheduled for his second dose on 02Feb2021, but they had to cancel that appointment because the patient was in the hospital from a fall he had on 29Jan2021 where he bruised his hip and bruised his rib. The patient was hospitalized from 30Jan2021 and was released from the hospital on 05Feb2021. The reporter stated that the clinic said they are not able to make any more appointments right now. The reporter was wondering if there were consequences of, or a danger in, getting the second dose outside of the recommended timeframe. The patient is now on a waiting list to get the second dose and he would like to know how far past the recommended 21 days can he go and still have the vaccine be effective. The patient received no other vaccines on the same day as the COVID vaccine. The patient has had an MRI before where it was indicated that there were some spots from a past stroke. The reporter stated that no paralysis has been identified. The outcome of the events was unknown.
old sore clear up on my lip;  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  , Manufacturer- Unknown, Dose no- 1 and 2), for COVID-19 Immunization; Herpes viruses (I have historically been vulnerable to herpes viruses), for Immunization, reaction(s): "historically been vulnerable to herpes viruses". The following information was reported: ORAL HERPES (non-serious), outcome "unknown", described as "old sore clear up on my lip".  Additional information: Verbatim: Is there any info you can provide as to whether I should take the second Pfizer booster approximately 5 days after having a cold sore clear up on my lip. I have historically been vulnerable to herpes viruses and am concerned about the potential side effects of getting the booster after having had a cold sore.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.   Follow-up (18Apr2022): New information received from a contactable consumer reported that included verbatim and additional information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2021 I experienced a sudden onset of large muscle pain on awakening. Mostly in the deltoid muscles, then next day also glutes (butt), most severe, and to a lesser extent hamstrings, quads and biceps. To be clear this is muscle not joint pain.  I rate the pain as 3 to 4 on a scale of 10. It is enough to wake from sleep several times a week and always present on rising from bed in the morning.  The pain decreased with activity over the course of the day. But the glute pain is there to a greater or lesser extent on rising from sitting position.  It?s now been 4 months, and while not as severe, it is still there every morning.
I experienced hallucinations around 0500, lasting only a few minutes. Very dark, disturbing imagery. I have never experienced any hallucinations before, even bad dreams are very rare for me and are never close to this severity. No drugs or alcohol used, no stressful events or scary movies prior to the event. No history of mental illness. This was very out of the ordinary.  Reporting simply to inform as a person with mental health concerns may have a more severe reaction.
Swollen, red, sore arm from shoulder to the elbow beginning Friday 1/15/21. Physician recommended Benadryl 25 mg every 6 hours.
Platelets at my physical in February of 2020 were 187.   I had the first two Pfizer covid vaccinations in February 2021.  At my physical in 3/2021, the platelets went to 135.   Had my first Pfizer booster dose December 2021.  Physical in March 2022, platelets went to 57.  Repeat of platelets with citrated tube showed Platelets on 03/25/2022 were at 54.  My  primary care physician referred me to Dr. of hematologist/oncologist for treatment.  I am currently being treated with prednisone (varying doses) to try to bring up platelets
did not get 2nd dose; bad headache stopped after Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (bad headache stopped after Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (did not get 2nd dose   ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020 and Headache (After experiencing covid-19, patient continued having headaches.).    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (bad headache stopped after Moderna vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get 2nd dose   ). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (bad headache stopped after Moderna vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get 2nd dose   ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  Patient had COVID-19, after it patient continued having headaches. But a week following vaccination headaches subsided. Patient did not get second dose.
Significant swelling in the left arm that was hot to the touch and itching.  Appeared to be an allergic reaction and was more than just the injection site.  The swelling and itching continued for approximately 7 days. Ibuprofen, tylenol, and benadryl were taken to counteract the allergic reaction.
Fever over 101, nausea, chills, heart pounding, body aches, rash on upper arm where injection was.  Extreme fatigue and headache.  lack of appetite.  Today is day 3 and I am still tired and have no appetite.
This is a spontaneous report from a contactable pharmacist. A 60-year-old female patient of unspecified ethnicity received PREVNAR 13 (Lot# M60993, Expiration Date Jul2017), subcutaneous, on an unspecified date, at 0.5ml single, for immunisation. The patient medical history was not reported. Concomitant medication included ZOSTAVAX, subcutaneous. The patient was administered a dose of pneumococcal 13-val conj vac (dipht crm197 protein) subcutaneously so was administered a repeat injection intramuscularly in the upper arm on the same day. The patient experienced redness and soreness in arm. She also received Zostavax in that arm. Follow-up (27Sep2016): New information received from a contactable pharmacist includes: patient's details, concomitant's route of administration, vaccination site for second dose of Prevnar 13, events added. Follow-up attempts completed. No further information expected.
I had the shingles vaccine at pharmacy on 11/5-11/6 started with a reaction at the injection site, ended up at Urgent Care by Thursday eve because it was spreading was put on 500mg of Cephalexin 3 times a day they drew a circle around the inflamed area. Went to my PC on Friday because it was spreading quick was given an injection of ROCEPHIN new inflamed area marked, appt made for Urgent Care on Saturday (Urgent Care Dr. stated vaccine given too low, her nurse agreed. PC Dr. also states in wrong place, her nurse agrees) went to appt at Urgent Care was told to go right to Hospital ER. Comment at new Urgent Care "why was the vaccine given there?". Went to ER got IV of ROCEPHIN had to return next day (24 hours later) for another IV of ROCEPHIN along with the continuation of Cephalexin antibiotics original visit gave me. Sunday finally some relief from this raging infection. Now just continuing on oral antibiotics. Again in ER was told by numerous hospital staff that vaccine was not given where it should be???
Breakthrough  case admission after 2nd dose  /2// Pfizer Lot# EM/ Pfizer Lot# EN
This spontaneous report was received from a healthcare worker and refers to a 18 year old patient of unspecified gender. On 04-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 (lot number: L001312 and expiry date: 24-FEB-2017) and on 06-AUG-2015, the patient was vaccinated with second dose of GARDASIL 9 in error (lot number: L001312 and expiry date: 24-FEB-2017). The patient did not report any adverse effects. The outcome of inappropriate schedule of drug administration was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Patient received a Shingrix Vaccine 2-27-2020 Shortly afterwards she contracted reactive ShiNgles iN her eye. 500mg Valacyclovir oNce daily presribed
immune system to weaken; herpes reaction; Urinary tract infection; history included multiple sclerosis and immune system weakened; history included multiple sclerosis and immune system weakened; This is a spontaneous report from a contactable consumer reported for self. This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not known) via an unspecified route of administration on 18Jan2021 at single dose in arm for COVID-19 immunization; and unspecified steroids via an unspecified route of administration from an unspecified date at unspecified dosage for unspecified indication. The patient medical history included multiple sclerosis and immune system weakened. The patient concomitant medications were not provided. The patient reported that she had multiple sclerosis, every time she went on steroids, her immune system was weakened, which is reported "unrelated". The patient received vaccination on 18Jan2021. When she was on steroids about 2-3 days later, she got a herpes reaction and urinary tract infection afterwards from 20Jan2021. The doctor told her it was because her immune system is weakened because of steroids. The patient was wondering if it is a normal reaction for her immune system to weaken due to the vaccine, if it is safe for her to get the second vaccine. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of light headedness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 20 min after receiving SHINGRIX, the patient experienced light headedness, labored respiration and chest tightness. On an unknown date, the outcome of the light headedness, labored respiration and chest tightness were unknown. It was unknown if the reporter considered the light headedness, labored respiration and chest tightness to be related to SHINGRIX. Additional details were reported as follows: This case was reported via chat. The age at vaccination was not reported. The patient experienced heavy breathing. The HCP did not have patient or vaccine information because the patient received SHINGRIX dose at different location.
Extreme body pain (ached all over) late in day and next two days.  By the third day an itchy rash came on my back and eventually spread all over my back.  It gradually went away after about a week.  The first couple of days my tummy did not feel like eating, but managed to get a little food down.  I had had shingles some years ago and my primary care doctor felt I should get the shingles vaccine to prevent getting them again.
Patient received Moderna booster dose (0.25 mL) instead of Pfizer dose 2 in error on Friday 10/29/21. As per CDC recommendations, contacted patient to request that he return back to clinic for full dose of Pfizer dose 2 at his earliest convenience. Patient is not interested in returning for another vaccine and is asking if he is considered fully vaccinated. This writer is unable to provide that interpretation and reinforced recommendation for 2nd dose of Pfizer vaccine. Patient is interested in checking vaccine antibody levels before making a decision about receiving additional vaccine. Patient verbalized fevers within first 24 hours post vaccine but has since recovered.