chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got Abrysvo on 9/19/2023 five days later reported labored and difficulty breathing lasting or about 4 days.
Fever,  chills, body aches, blotchy skin, fatigue, nausea, headache, arm pain
This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown age and gender. On unspecified dates, the patient were vaccinated with RECOMBIVAX HB (lot number, concentration and dose were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Large, itchy red patch around swollen painful injection site. Fingers on both hands painful, brittle-feeling.  Bear in mind that the onset of symptoms was nine days after the (symptom-free) injection.
Pallor, hypotonia hyporesponsiveness; occurred 2-3 hrs p/vax given; lasted 4-5min;
Guillian barre Syndrome ~2 weeks following second shot of Pfizer vaccine ; ultimately resulting in intubation and invasive ventilation
Administered with no reports of concern or symptoms at 0945 on 10/5/2023. Sent back to class. Per school nurse, child became sweaty, pale, felt hot, dizzy and vomited at approximately 1030 on 10/5/2023 and she sent him home. She did not obtain vital signs prior to sending home.
Approximately 4 days after adminstration of the vaccine, the patient developed an area of erythema measuring 5cm. Clear fluid was observed draining from the site close to the adminstration site. There was no focal abcess formation. The patient, an employee of this hospital, was seen by our emergency department staff. The fluid was drained, antibiotic ointment applied and covered with a dry dressing.  No further treatment is anticipated.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS PRESSURE HEADACHE; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included none reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown  expiry UNKNOWN) frequency 1 total dose was not reported, administered at right arm on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 05-JUL-2021, at night the patient started experiencing symptoms until next morning on 06-Jul-2021 the patient had sinus pressure headache, mild sore throat, some body aches, cough, chills, fever. On 07-JUL-2021, the patient experienced more severe sore throat, increased body aches, loss of taste. It was reported that he did not actually take his temperature but felt that he had fever. On 08-JUL-2021, Laboratory data included: COVID-19 PCR test and patient experienced confirmed covid-19 infection and confirmed clinical vaccination failure. On 09-JUL-2021 he received his positive results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pressure headache, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210722832-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 4 patients. This is the 3rd of 4 reports. An adult patient (over 60) of unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration, in the days before report (Dec2016), at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced localized allergic reactions in Dec2016 with outcome of unknown. The patient was treated in an urgent care center. Sender's Comments: Linked Report(s): US-PFIZER INC-2016595831 Same reporter/drug/event, different patient; US-PFIZER INC-2016595836 Same reporter/drug/event, different patient; US-PFIZER INC-2016595837 Same reporter/drug/event, different patient.
I had a 100.7 fever, mild headache and mild nausea on 4/8.  On 4/9, I woke up in the morning with red swollen, itchy eyes, which resolved with steroid eye drops and tinitus (loud high pitched ringing in my ears) which I still have more than a month later.
Vaccine administered on Oct. 7, 2008.  On October 16th, Parent brought child to clinic with compliants of a body rash that began one week prior to visit.
Arms are little sore you have to think about it to think it was sore; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events for 2 patients. This is 1st of 2 reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported (BNT162B2), via an unspecified route of administration on 15Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On an unspecified date, the patient experienced arms are little sore you have to think about it to think it was sore. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021202608 same reporter/drug/event, different patient
Short visual effect of a kaleidoscope half-ring for about 30 minutes. Extreme cold feeling/shivers during night for around 3 hours followed by feeling of being extremely hot for about 2 more hours. Bad migraine lasted one day. Feeling of unbalanced and needing assistance to walk for about 2 hours after waking up next morning. Head felt stuffed up similar to sinus pressure, but no other sinus symptoms.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On an unspecified date, the patients were vaccinated with GARDASIL (dose, route of administration, lot# and expiration date were not reported). No concomitant therapies were reported. On an unknown date, the patients were off-schedule receiving second and/or third doses of GARDASIL or GARDASIL 9. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Parent notified school nurse 11/18 and stated child had chickenpox, not Dr confirmed.
This spontaneous report was received from a pharmacy technician concerning an unspecified patient of unknown age. The patient was vaccinated with a dose of expired ZOSTAVAX (lot number was unknown, dose, injection site and route were not reported) which was 3 to 4 months expired when given on an unspecified date. Additional information has been requested.
SEVERE PAIN IN THE ARM. THE DAY AFTER, REDNESS AND PAIN.
1st dose 11/15/2020, wondering if needed to repeat; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wondered if he needed to repeat Shingrix. The patient refused to provide any additional demographic details. The patient consented to follow up.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: none-Mild, Additional Details: Pt. went to see MD and was confirmed its Staph infection
Had terrible flare of lupus; This is a spontaneous report from a contactable pharmacist via medical information team. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at the end of May2019 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had terrible flare of lupus on an unspecified date in 2019 with outcome of unknown.  Information on the batch number has been requested.; Sender's Comments: Event flare of lupus is likely due to the intercurrent condition and unrelated to PREVNAR 13.  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.
About 24 hours after vaccine, I had arm pain, heightened Fibromyalgia pain, fatigue, and 5 days later bruises appeared both legs: upper parts. Lasted about 7 to 10 days and went away but they are coming back now as of 07/13/2021.
Initial unsolicited report received from non-healthcare professional on 17-Oct-2017. This case involves a patient of unknown demographics who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 08-Sep-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, four hours later following the vaccination, the patient experienced chills in muscles. On unknown date, following the vaccination pain in wrists, upper arms, shoulders, knees and hips and also reported difficult to sleep. It was reported that It's been 7 weeks now.  Lab data and corrective treatment were not reported. The patient's had not recovered from any of the events, at the time of reporting. List of documents held by sender: none.
06/18/208 Zostavax received on 06/13/2008 11am, right arm subcutaneously.  On 06/14/2008 am pt. noticed injection site felt "hot to touch,reddened raised area size of golf ball, hardened area around there size of softball", c/o itching also. Office visit today, 06/18/2008, for evaluation.  Red raised area size of golf ball still present, no hardened area around the red area noted.  Pt. states still feels "itchy".  States did apply ice  3x with some relief, swelling did go down, itching did subside for a while.
4/16/2021 had Pfizer Covid vaccine #1 4/17 Employee has hx of MS, was not able to get out of bed, unable to walk, had low grade fever.  MS was exacerbated, was started on 8 days of Prednisone
This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is the 1st of 2 reports. A child of an unspecified age and gender started to receive TRUMENBA, NDC: 0005010001, Lot number: W95359, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the child had a severe headache and was taken to the emergency room. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2019059790 Same reporter/drugs/events, different patients.
Pt c/o itching on the back of her Left arm  over the site of her MMR vaccine. Pt received 3 vaccines that day. Only reacted to one. Had a red circle, ~1.5 inch diameter, over site of injection. Back of arm was also reddened where pt had been itching. Pt was going to put anti-itch cream on arm to help with itching. Said she would call if reaction worsened at all.
Continued to have wheezing; Could not sleep at night/unable to sleep; Having a hard time working; Felt fatigued/ chronic fatigue and slept constantly; Heart rate elevated; Blood pressure elevated; That night he had another psychotic episode; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (That night he had another psychotic episode), WHEEZING (Continued to have wheezing), INSOMNIA (Could not sleep at night/unable to sleep), IMPAIRED WORK ABILITY (Having a hard time working) and HEART RATE INCREASED (Heart rate elevated) in a 44-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.     Concurrent medical conditions included Asthma (had asthma as a child).    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced PSYCHOTIC DISORDER (That night he had another psychotic episode). On 31-Jul-2021, the patient experienced HEART RATE INCREASED (Heart rate elevated). 31-Jul-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure elevated). On an unknown date, the patient experienced WHEEZING (Continued to have wheezing), INSOMNIA (Could not sleep at night/unable to sleep), IMPAIRED WORK ABILITY (Having a hard time working) and FATIGUE (Felt fatigued/ chronic fatigue and slept constantly). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PSYCHOTIC DISORDER (That night he had another psychotic episode), INSOMNIA (Could not sleep at night/unable to sleep), IMPAIRED WORK ABILITY (Having a hard time working), HEART RATE INCREASED (Heart rate elevated), BLOOD PRESSURE INCREASED (Blood pressure elevated) and FATIGUE (Felt fatigued/ chronic fatigue and slept constantly) outcome was unknown and WHEEZING (Continued to have wheezing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Blood pressure measurement: high (High) High. On 31-Jul-2021, Heart rate: high (High) High.         Concomitant medications were not reported.  Patient went to emergency room on 31-july-2021 and had more X-rays and breathing treatments. They suggested he had either asthma or pulmonary hypertension but not yet confirmed. On 02-Aug-2021 patient went to a pulmonologist who said it look like asthma and started breathing treatments but not the albuterol. Patient had still albuterol inhaler during night which caused him to be unable to sleep. He had blood work done on 19-Aug-2021   This case was linked to MOD-2021-293168 (Patient Link).
Child has not been feeling well since 09/13.  She continues to be achy all over, she is spiking random fevers. She has had diarrhea. After the vaccines almost immediately she spiked a fever and body aches, and GI issues. The fatigue and GI issues have persisted.  She slept from 5pm to 11am the next day.  This is unusual.  Offered an office visit and mother declined, will wait another week to see if things get better.  If not, mother will let office know and she will be scheduled ASAP
12 Mins after vaccination numbness, tingling hands radiated to arms, hot flash in chest, EMT O2 stat monitor heart rate increased to 135, numbness and tingling in tongue, EMT stated pt red in chest and ears as well. Bad feeling, of something going wrong, not right. Pt was told to drive to ambulance with EMT after ae subsized. After pt arrived to ambulance, pt had second ae with same symptoms, loss coconsciousness in car, heart rate  145, O2 85-86. Pt states was informed by EMT pt was asking to be taken to ER while in car during second ae. Pt was then transferred to stretcher in ambulance heart rate and O2 began to stabilize, BP 110/8?. Pt states while being asked questions from EMT in ambulance on route to hospital, pt thoughts couldn't process, trouble with speech and could not talk and  only kept repeating "4" to EMT's however pt understood in "her head" she was speaking and answering questions coherently and in complete sentences. Pt was treated in ER, Epipen not given and received treatment with IV Pepcid and Benadryl and then discharged. At home, same day after discharge, later 6:19PM walking around heart rate 127, sitting 114 O2 stat 97%, laying down heart 88 O2 Stat 96%.  12/30, 12/31, 01/01 severe arm pain, unable to lift, severe fatigue and headache' 01/02 symptoms resolved. 01/03 " large lump" appeared on left clavicle-lymph node, tender to touch; lump has increased in size, severe pain and has not resolved. 01/04 f/u with PCP -- severe pain traveled to neck and base of neck.  lumps appeared on neck and base of neck also this day  US for clavicle collar bone - swollen lymph nodes not infected -- results swollen; blood pressure 142/102. elevated this day. Today, 1/14 swollen lymph on cervical collar bone still present, no pain. Pt having troubled turning neck to left, feels like whiplash.   Med Center ER visit
Sweling of the eyes, throat, hands and feet.  Difficulty breathing, hoarseness, high blood pressure, severe itching all over especially the hands and feet.  Right eye was almost swollen shut and the left eye was severly swollen.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, medical history, drug reactions or allergies was unknown. Concomitant medication therapies included sterile diluent. On 29-OCT-2018, the patient received 2 doses of PROQUAD rHA (recombinant Human albumin) (lot # R015738 with expiration date auto-populated as 12-FEB-2019; strength and dose detail were not provided) subcutaneously for prophylaxis (overdose). No adverse effect was reported.
It was reported that a pt (9 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Concomitant medication was not provided. Treatment information was not provided.
23Jan98 pt recv 1 dose vax. 18Feb98 pt exp 50-100 hemorrhagic lesions, & petechiae around the lesions. "Linear pustules". Pt was in the Caribbean from 10Feb98 to 17Feb98.
no adverse effects were reported; received a fourth dose of GARDASIL-9; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  On 01-OCT-2018, the patient received a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number: N035032; expiration date 24-SEP-2020; strength was not reported), intramuscularly for prophylaxis (extra dose administered). No adverse effects were reported. The outcome of the event was unknown.
Information has been received from a nurse practitioner concerning a patient who was vaccinated with the second dose of GARDASIL (route, site of administration and batch number not reported) early on 02-OCT-2008. Subsequently the patient experienced pain from GARDASIL. The outcome is unknown. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow up information received from a nurse practitioner providing the name and date of birth of a patient who experienced pain after her second dose of GARDASIL vaccine (yeast). Follow up information was received from a nurse practitioner concerning the 11 year old female patient with no pre-existing allergies, birth defects, or medical conditions who was vaccinated intramuscularly in the left arm with the second dose of GARDASIL vaccine (lot#659962/1740U) on 02-OCT-2008. On 02-OCT-2008 the patient experienced pain from GARDASIL vaccine. There was no illness at the time of vaccination. No relevant diagnostic tests or laboratory tests were performed. The patient recovered on 02-OCT-2008. This is one of several reports from the same source. No further information is available.