chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient experienced subarachnoid hemorrhag; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003933 (Novavax).  A male patient received BNT162b2 (BNT162B2), as dose  2, 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 (Dose 1), for Covid-19 immunization. The following information was reported: SUBARACHNOID HAEMORRHAGE (medically significant), outcome "unknown", described as "the patient experienced subarachnoid hemorrhag". On 20Oct2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at second dose for COVID-19 immunisation. It was reported the patient experienced subarachnoid hemorrhage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal) 0.2 millilitrs, unknown. FLUMIST QUADRIVALENT (Intranasal) started on 27-Sep-2013. The patient experienced vomiting and received FLUMIST QUADRIVALENT last year and a few hours later was sick which started on 26-Sep-2013. The patient recovered from the event of vomiting and received FLUMIST QUADRIVALENT last year and a few hours later was sick on an unspecified date. The report was considered to be non-serious.
MMRV vaccine may have been given IM instead of SQ not a true "IM" injection either with 5/8 inch needle. The correct needle size was used in the injection however the patient was fighting with nurse during the injection and the angle of the needle was more of a direct 90 degree angle than a 45 degree angle. Phone call follow up was made on 06/26/2018 and no problems were noted by the guardian.
When our facility received the COVID - 19 vaccine, I spoke to Dept. of Health and was told that the exp. date for the vaccine was 9 months from the mfg. date on the box. Which made the exp. date 5/31/22. On 5/20/22 at the  Dept. of Health contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus we unknowingly gave exp. vaccine to patient. Patient tolerated vaccine well, no adverse effects have been reported.
No additional AE; Nurse calling to report an AAE regarding the RECOMBIVAX HB vaccine. Nurse reported that a patient was administered an expired dose of the vaccine. Permission to contact HCP was provided. No additional AE/PQC reported.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 12-JUN-2023, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # U019139, expiration date: 11-JUN-2023 (strength, route of administration, anatomical location not provided) as prophylaxis. No additional adverse event was reported.  .
Information has been received, through a pregnancy registry, from a 32 year old Caucasian female, with no history of prior pregnancies, who tested negative for varicella antibodies in 1997. On 12/15/00 the patient was vaccinated with a dose of varicella virus vaccine live. There were no concomitant therapies. The patient reported that she subsequently became pregnant. her last menstrual period (LMP) was 12/10/00. The physician reported the expected date of delivery as 9/17/01. An ultrasound performed on 2/9/01 was reported as normal. Follow up ultrasound on 8/14/01 was normal. Maternal serum alpha-fetoprotein test performed on an unspecifed date was also normal. A varicella antibody test prior to vaccination in September 1997 was negative. Follow up information received from a completed questionnaire, on 9/21/01, from a physician, indicated that the patient did not have a local reaction at the injection site. In addition, she did not have varicella or herpes zoster symptoms post-vaccination. There were no complications, illnesses, infections, or concurrent medical conditions during the pregnancy. On 9/7/01, the patient delivered a normal, healthy female baby. C-section was performed for cephalopelvic disproportion. It was noted that there were no congenital anomalies or features of congenital varicella zoster syndrome. Follow up information information indicated the patient developed an infection after delivery/during labor (incidental finding). She was positive for group b streptococcus and developed a fever during delivery. The patient was treated with antibiotics for 4 days after delivery. Follow up information in the form of the baby's medical records was received. After birth, the baby was treated with IV antibiotics for 7 days to rule out sepsis. The baby was vaccinated with a first dose of hepatitis B vaccine. A second and third dose of hepatitis B vaccine recombinant, respoectively. The baby was vaccinated with a first, second, and third dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, respectively. The baby was vaccinated with a first and second dose of Haemophilus B conjugate vaccine. The baby was vaccinated with a first and second dose of injected poliovirus vaccine inactivated. The baby was vaccinated with a first, second, and third dose of Streptococcus pneumoniae vaccine. On 11/22/01 the baby failed audio. On 6/3/02 it was noted that the baby makes noises dada, mama and the baby was referred to an ENT for evaluation. Additional information has been requested.
Case number PHEH2015US026952, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 26 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
A non-serious spontaneous report of doctor gave my child a full dose of FLUMIST in one nostril and a full dose of H1N1 in the other nostril was received from a registered nurse/father concerning his five-year-old son. On 14-Oct-2009, the patient received a full dose of FLUMIST in one nostril and a full dose of H1N1 in the other nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
pneumonia; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious social media case from the patient.  This case involves an unknown demographic patient who had pneumonia, after the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not reported.   On an unknown date, the patient received the first dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for the prophylactic vaccination.  On an unknown date, the patient developed serious pneumonia, (unknown latency) following the administration of INFLUENZA VACCINE.   This event was assessed as medically significant.  It was reported that, the pneumonia can be a side effect of flu vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was not reported for pneumonia.  Information on the batch number was requested.; Sender's Comments: This poorly document social media case concerns an unknown demographic patient who had pneumonia, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information role of the vaccine cannot be assessed.
Listlessness and lethargy progressing to uncontrollable seizures requiring hospitalization within 5 days of administration. Baby healthy and responsive during pediatric examination on 9/18/2006. Seizures, difficulty breathing, lack of responsiveness indicated. Potentially life threatening. Potential for neurological damage indicated.  10/5/06 Received provider clinic notes dated 9/18/06 which noted patient sleepy & decreased feeding.  Neuro tone was decreased compared to when seen 3 days prior.  Suck reflex was weak to absent & patient was mildly tachypneic.  Dx: consider infection.  Newborn metabolic screening was WNL.  Admitted patient to hospital NICU for septic w/u. 11/27/06 Received medical records from hospital which reveal patient experienced neonatal seizures with sepsis suspected but unproven.  Admitted 9/21/06 & d/c home on 10/02/06.  Patient was 7 days old upon admission with fussiness, poor feeding & increasing listlessness over the prior 24 hour period.  Just prior to LP, seizure activity was noted & continued to have intermittent seizures during admission.  Treated with meds & Vit B 6. Remained on Pb & off B6 on d/c to home.  Concerns remained re possible developmental delays.  Final DX: Neonatal seizures & suspected but unproven sepsis.
Diagnosed with Herpes Zoster (shingles); This is a spontaneous report from a contactable consumer. This 65-year-old female consumer (patient) reported that: A 65-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 16:30 (at the age of 65-year-old) as single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included High BP, High cholesterol, from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included lovastatin (LOVASTATIN); lisinopril (LISINOPRIL) and loratadine (LORATADINE) taken for an unspecified indication, start and stop date were not reported. Patient previously took penicillin and experienced allergies. Patients heroical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3246), via an unspecified route of administration, administered in Right arm on 19Jan2021 at 16:30 (at the age of 65-year-old) as single dose for covid-19 immunisation. Patient was not received any other vaccine four weeks prior vaccination. The patient experienced diagnosed with herpes zoster on 21Mar2021 at 10:00. Since vaccination patient not tested for covid-19. Event resulted to visit Doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events with Antiviral. The outcome of the event was reported as recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Extreme fatigue, headache, body aches, fever 102°, chills, pain at injection site.
Severe shortness of breath with exertion, presyncope events requiring sitting/lying flat to resolve, and fatigue increased despite no change in lifestyle or diet
wife says flu like sx & SOB hospitalized for pneumonia 22NOV94 x 8 days; readmitted 04DEC94-expired 05DEC94; says had been on meds for kidney failure, HTN-autopsy revealed lung cancer;
Diagnosed with type 1 diabetes at the age of 23 requiring the use of insulin for treatment
Adverse Event - High temperature, too weak to stand and walk, confused Treatment - Taken to hospital by ambulance - hospital treatment unsure ( 1 over night stay) Outcomes - continued pain in his neck, ?fuzzy? head, and dizzy 11 days after vaccine
Pt left office with father, he took her home, as getting out of car states she went ridged & fainted. Mother called office to ask if this is normal- states father says she is red all over, pt then started vomiting & c/o headache- instructed family to have her checked.
Patient received vaccine on 8/25/09 and 2 days later she presented to the ED with emesis and currant jelly stools. She was found to have an intussusception which was not reducible by air enema. She went to the OR where the surgeons were unable to free the intussusception so she underwent a right hemicolectomy. She was hospitalized from 8/27-9/1. Four days were in the intensive care unit and the remainder were on the floor.  10/15/09 Hospital records, DC summary received service dates 8/27/09 to 09/1/09. Assessment: Intussusception s/p bowel resection. Parent states baby refuses to eat. Episodes of yellow emesis. Bright red blood per rectum w/o stool or urine. Decreased activity. Dehydration. Abdominal tenderness. Current jelly stool. Enema administration, reduction unsuccessful. Laparoscopic reduction of intussuseption converted to open right hemicolectomy. Ileocolic intussusception had intussuscepted into sigmoid colon, gangrene of cecum, serosal tears of proximal transverse colon with patchy necrosis. Patient stable upon discharge. 12/14/09 Received PCP medical records of  8/25/09 well child visit.
No additional adverse effects reported; The patient was administered the wrong vaccine; 4 month old patient was administered PROQUAD; This spontaneous report was received from a medical assistant who refers to a 4-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 22-MAY-2020, the patient was mistakenly administered the wrong vaccine which was measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), recombinant human albumin (rHA), lot # S031706, expiration date upon internal validation has been established as 06-APR-2021 (same as reported) (dose, strength, anatomical location were not provided), for prophylaxis (wrong product administered and product administered to patient of inappropriate age). No additional adverse effects were reported.
Information has been received from a pharmacist concerning a 60 year old male who in approximately 1995 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  In approximately 1995 the patient developed an injection site reaction with redness, swelling and pain.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Since the day I got vaccinated I started my period 2 days later it?s been over 4 months now and my periods hasn?t gone away I have a period every single day now and now I?m also getting random cramps I?m bleeding so much that now it?s making me feel sick and tired. This has never happened to me I would always get my period on time and in a normal way . I would like to know  what can help my situation?
Itching, Wheezing, Facial Flushing.   Patient had pre-medicated with 50 mg oral benadryl one hour prior and albuterol/atrovent neb 15 minutes prior. After reaction, patient was medicated with Famotidine IM
A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 19-Dec-2013. Office Manager reported that they inadvertently administered expired FLUMIST QUADRIVALENT to a patient on 19-Dec-2013. Not reported symptoms. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine administered to patient past its 30 day expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 10:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:01 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's ethnicity was reported as white.  No concomitant medication was reported.  On 02-Apr-2022, the patient received the second booster dose of the vaccine.  No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
"Coldness in arm" pain around injection site injection site radiates neck and shoulder - "tingling"in left hand". Date given 10/19/09.
Patient tolerated flu injection well, she was talkative with mom and was able to out of the room unassisted. Mom had to stop at our front desk for future scheduling, a that time patient was found to be sitting in the waiting room chair, slumped back and pale. Nursing staff was readily available to assist patient and mother (patient was still in chair and did not fall nor slip off), a doctor was called out to the waiting room help to assess the patient as well. Pt was instructed to lean forward, take deep breaths, and a cool compress was applied to the nape of her neck. Her BP was checked. Orange juice was provided to the patient as well. Patient felt well enough to walk back to the office room where she was monitored and re-assessed by her doctor. Her BP and pulse was continuously monitored, OJ was provided to drink, and a cool compress was also applied to her forehead. Patient stayed with mother in office room for several minutes. Prior to discharge, pt's doctor re-assessed patient and discharged her. The office placed a follow up call with mother the net day, she was very appreciative of the call. Patient was doing well the following day with no adverse symptoms reported. Mom explained that she forgot too mention to staff that patient had fainted when she was 11 years old after receiving the flu vaccine. This has been noted in the chart for future reference of staff and provider.
THIS PATIENT IS 15 YEARS OLD AND RECEIVED A THE FLUBLOK VACCINE FOR 18 YEARS AGE AND OVER.  THE PATIENT HAS NOT REPORTED ANY ADVERSE EVENTS.  FILLING OUT THIS FORM DUE TO THE FACT THE FLUBLOK WAS GIVEN FOR SOMEONE  UNDER 18. WE DID NOTIFY HER PRIMARY CARE PHYSICIAN BUT HE HAS NOT RETURNED THE CALL
10 minutes after receiving vaccine, patient was having tachycardia and chest tightness. IV Benadryl was administered in the emergency department with improvement
Unfortunately the rumor is true. I started feeling winded and tired 3 days after my booster. It got to a point where a simplest physical activity such  as walking out my dog and putting garbage out became extremely challenging. I was short of breath and had to stop every few seconds due feeling dizzy. On the top of that, I was sweating profusely. On day 4, I started feeling a slight discomfort in my upper chest area. Overnight that discomfort changed into a rigid pain. I got scarred and decided to go and get help. I ended up being admitted for observation due to the symptoms and high blood pressure ... 160/115 (I do not have problems with  high blood pressure). They were suspecting a blood clot forming and wanted to rule it out. All tests came back negative including blood work, couple of EKGs, stress tests and other diagnostic tests they ran on me. I was told I was dehydrated but that's about it. They suggested staying in the hospital for additional 24hrs but I refused. I was discharged without a diagnosis. I spoke with a cardiologist who informed me he is not supposed to officially say it but considering my good overall health, lack of any risk factors and no medical history he suspects the booster shot  had something to do with it. I requested to receive a written statement/diagnosis but my request was denied.   It took me about a week to get back to feeling 100%.  Per email
Pt received vaccine on 09/20/2018. On 9/21 pt woke up with a fever of 101. She had very bad chills, with dizziness, (flu like symptoms).
Patient's wife came to one of the nurses to tell her that her husband felt like he was about to pass out. RN came to check on the patient, asked his name and then he passed out. He was assisted to the floor and transferred to a cot. EMS came and assess him. Patient felt better after the assessment and drank Gatorade. Patient denied transportation to hospital.
Vaccines administered to patient.  Pt. left office well and happy.  Twenty minutes later mom carried pt. in. She reports pt. started c/o chest hurting and stomachache in the car.  Pt. appears very pale, eyes glassy and several large hives on trunk of body.  Dr reexamined pt.  ZYRTEC given in office pt. monitored X 20 minutes and sent home "feeling better" color returned in face.
Right eye throbbing pain by the day after vaccine sclera became red. Placed on opth antibiotics, did not clear. Dx by opthamologist with uveitis and placed on steroid gtts. Vision in right eye is impaired.
Muscle pain ongoing, joint pain and stiffness ongoing. Treated with ibuprofen, cyclobenzaprine and gabapentin; with zero response to treatment.
At night I started feeling chills, headache and pain on my left arm returned.  Not only at the injection site, but the whole arm hurts. It lasted for about 3 days. Now I just have a little bit of the swollen lymph node on my left underarm from the 1st dose.
tiredness; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for a male patient (husband) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and had muscle pain (my husband reported muscle pain after the first shot). The re-porter reported adverse event for husband after receiving Covid-19 vaccine. She stated he had tiredness after the 2nd one on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.