chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on 27Oct2019 a 4 month old patient was given ActHIB that expired on 17Sep2019, no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months (reported as 4 months, 3 weeks, and 5 days) old male patient who received a 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UI896AAA (Expiry date 17-Sep-2019), vial- U6018AA (Expiry date 17Sep2019) via intramuscular route in the right thigh on 27-Oct-2019 which was already expired.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included POLIO VACCINE INACT (IPV); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13). All these given in left thigh.  It was an actual medication error case due to expired vaccine used.  At a time of reporting, no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
contracted strept throat; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGITIS STREPTOCOCCAL (non-serious) with onset Apr2021, outcome "recovered" (23Apr2021), described as "contracted strept throat"; ILLNESS (non-serious) with onset Apr2021, outcome "recovered" (23Apr2021), described as "sick". Therapeutic measures were taken as a result of pharyngitis streptococcal, illness.  Additional information: The patient was seeking information on any drug interactions with the Pfizer Covid 19 vaccine and antibiotic, penicillin v potassium 500mg BID. She was due for her second dose and wondering if it would be safe for her to get it while on this antibiotic.The patient stated she had strep throat and was taking penicillin. She wanted to know if she can get her second dose. She wanted to know if there was a reaction with drug combined. Patient reported that she got her first dose of Pfizer Covid 19 vaccine on 02Apr2021 and scheduled for her second dose this afternoon. The patient was contracted strept throat this weekend, either Saturday or Sunday (17Apr2021 or 18Apr2021) and symptoms came on super quickly. She was pretty sick Monday and Tuesday and started treatment with antibiotics (penicillin v potassium 500mg BID) yesterday (22Apr2021) and she feel perfectly fine on that day. The symptoms were gone, she didn't have a sore throat and didn't feel sick. She feel totally fine right then. The patient was very frustrating as her doctor referred to the pharmacist and her pharmacist again referred her to the doctor. She was just trying to make the best decision for her health and  didn't want to make a decision that might kill her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A serious report of congenital anomaly has been received from a study investigator concerning a 37-month-old male (subject number 29395693) participating in post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 02-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for congenital anomaly on 23-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
My menstrual periods have been very frequent since my first vaccine. I have had my cycle 3 times between the 2 vaccinations. My normal cycle is 25-28 days and the past few were 17-18 day cycles which is not normal for me
This study case was received from the investigator on 27 September 2012. A 29 year-old male subject with no significant medical history was found to have unspecified disease of pericardium 20 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 22 May 2012. Relevant laboratory data included: a normal Troponin I, a normal ECG, and a normal Echocardiogram. An MRI (brain, spinal cord, heart) and Lumbar puncture were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 48 year old female patient. On 25-SEP-2017 the patient was vaccinated with unspecified dose of PNEUMOVAX 23, administered subcutaneously for prevention of pneumococcal disease. Concomitant therapies were not reported. In approximately September 2017, the patient experienced bad headaches, dizziness, fever, chills, swelling in arm, redness in arm, and weakness in arm. The pharmacist advised patient to take TYLENOL and put ice pack on arm. The reporter also stated that there was no doctor nor hospital visit. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Causality assessment was not reported. Additional information is not expected, as the reporter did not wish to be contacted.
elevated temp (Tmax 99); fussiness, varicella rash; flare of eczema;
This spontaneous report was received from a registered nurse refers to a 16 year old male patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. On 05-OCT-2016, the patient was vaccinated with a first dose of VARIVAX subcutaneously (lot # M006726; dose and expiration date were not reported). On the same day, the patient was vaccinated with a dose of PROQUAD (dose, lot# and expiration date were not provided). No adverse event was reported. Additional information has been requested.
CERVARIX was given to a male patient while the vaccine should be given to female patients only.
Case number PHEH2013US013237 is an initial spontaneous report received from a nurse on 14 Jun 2013 with a follow up information received from a nurse on 09 Jul 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml intramuscularly in the left deltoid on 13 Jun 2013. Reporter stated that the un-reconstituted MENVEO reached minus 1 degree Celsius at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up information received from nurse on 09 Jul 2013. Patient demographics (height and weight), site and date of vaccination updated.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
itchy throat, gave Benadryl 50mg - resolved. Then patient sxs returned + she went to ER (pharmacy staff not notified until after)
tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 10:30 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical location: Left arm), administration date: 12Apr2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 13May2021, outcome "not recovered", described as "tinnitus".  Additional information: Reporter stated that after receiving the Pfizer covid vaccine and patient had been experiencing aggravated tinnitus since yesterday afternoon. Reporter would like to know how long her tinnitus would last. Patient queried for should they go see their doctor if it still persists. In response to the query responded that tinnitus was not listed as a side effect as per document attached below: These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine was still being studied in clinical trials. Patient had not attended emergency room and physician room for event reported. 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-2021547757 same reporter/drug/event, different patient;US-PFIZER INC-2021548332 same reporter/drug/event, different patient
Swollen lymph node on throat; Painful lymph node; Headache; Tired; Swollen arm; Redness; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swollen lymph nodes in a adult female patient who received Herpes zoster (Shingrix) (batch number D734X, expiry date 28-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose on unknown date and did not develop anything).   On 06-MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, 3 days after receiving Shingrix, the patient experienced swollen lymph nodes (Verbatim: Swollen lymph node on throat), lymph node pain (Verbatim: Painful lymph node), headache (Verbatim: Headache), tiredness (Verbatim: Tired), swelling arm (Verbatim: Swollen arm) and erythema (Verbatim: Redness). The outcome of the swollen lymph nodes and lymph node pain were not recovered/not resolved and the outcome of the headache and tiredness were unknown and the outcome of the swelling arm was recovering/resolving and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the swollen lymph nodes, lymph node pain, headache, tiredness, swelling arm and erythema to be related to Shingrix.     It was unknown if the company considered the swollen lymph nodes, lymph node pain, headache, tiredness, swelling arm and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2023  The reporter reported that a patient 50 years and above (not sure exact age) received 2nd dose of Shingrix and developed painful, swollen lymph node on the throat, headache, tired.  The whole arm of the patient was swollen but then looked ok and redness was gone.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Pain within first 2 hours, redness and swelling after that. Systemic feelings of malaise started approx 24 hours after vaccine.
It started with weakness and fatigue. Then I started having anemia issues. I have an enlarged liver and some cardiac issues. I also have a dry cough. My sleep pattern is constantly interrupted. I'll sleep about 2 hours and I'm up.
Red, warm rash at the vaccine site, noticed on day 12 after vaccine, but may have been there a day or two earlier
Parents would like me to report the fact that after child has received each Prevnar, within about 20 days, pt developed an otitis and the parents have attributed the otitis on the Prevnar. Of note; the child has had multiple otitis media episodes-4/3/00; 10/31/00; 11/24/00-12/4/00-12/15/00; 1/25/01-2/5/01-2/9/01-2/15/01 (tubes) 3/21/01; 4/26/01. The dates signify visit and recurrence.
Information has been received from a registered nurse concerning a 16 year old Caucasian male with seasonal allergies only who on 3/24/03 in the PM was vaccinated with a first dose of varicella virus vaccine live (lot # 644089/1064M), SC in the right arm. There was no concomitant medication or illness at the time of vaccination. Subsequently, the patient's younger brother had developed chicken pox after the patient had been vaccinated. Subsequently, the patient developed a very mild case of chicken pox. The patient recovered. Additional information is not expected.
Pt Came back to pharmacy and had some swelling of the arm near the injection site. I offered her oral Benadryl capsules 2 (25mg) caps.
Information has been received from a medical assistant referring to 5 unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On an unknown date, 5 unspecified patients were vaccinated with improperly stored VARIVAX (dose and rout unknown, lot# N021318 with expiration date 07-AUG-2019, lot # R002051 with expiration date 22-JAN-2020) and PROQUAD (dose and route unknown, lot# R003292 with expiration date 31-JUL-2019, lot # R002935 with expiration date 29-JUL-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is a non-valid case due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information was received from Licensed Practical Nurse on 30-JUL-2018 and refers to 4 year old female patient. The patient previously received one dose of measles virus vaccine live (Enders-Edmonston) mumps virus vaccine live (Jeryl Lynn) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 09-JUL-2018 the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the right thigh for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 53NB2 dose 1, intramuscular in the left thigh for prophylaxis. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1808USA000455: US-009507513-1808USA000456: US-009507513-1808USA000457: US-009507513-1808USA000458: US-009507513-1808USA000459: US-009507513-1808USA000460: US-009507513-1808USA000461: US-009507513-1808USA000462: US-009507513-1808USA000463: US-009507513-1808USA000464: US-009507513-1808USA000465:
cellulitis on her arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (cellulitis on her arm). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided  Patient reports getting antibiotics.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a physician, via a field representative, refers to a female patient of unknown age. In 2012 the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent (DILUENT MRK). On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster is unknown.
Sick after vaccination; Breathing issues; Coughing; fever was really high; Shakes; red at the injection site; Sore at injection site; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Shakes), VACCINATION COMPLICATION (Sick after vaccination), DYSPNOEA (Breathing issues), COUGH (Coughing) and PYREXIA (fever was really high) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE PAIN (Sore at injection site). On 01-Apr-2021, the patient experienced TREMOR (Shakes). On an unknown date, the patient experienced VACCINATION COMPLICATION (Sick after vaccination), DYSPNOEA (Breathing issues), COUGH (Coughing) and PYREXIA (fever was really high). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, TREMOR (Shakes), VACCINATION COMPLICATION (Sick after vaccination), DYSPNOEA (Breathing issues), COUGH (Coughing), PYREXIA (fever was really high), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 150/97 (High) 150/97. On an unknown date, Heart rate: 111 (High) 111. On an unknown date, Oxygen saturation: 85-88 (abnormal) could not keep her O2 under wraps it was fluctuating between 85 to 88.         Treatment information include unspecified antibiotics.   This case was linked to US-MODERNATX, INC.-MOD-2021-071397 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071397:Dose 1 case
After getting her COVID booster in the morning, later on 1/22/22 patient stood up and fainted at home. She hit her forehead on a wooden part of the couch. She was evaluated on 1/26/22 and diagnosed with a concussion following that head injury. She had headache, problems concentrating, worsening headache pain with light/sound.
Big red spot at injection site. It is hot and hard and painful. Began within several hours of vaccination. I still have symptoms today (2 days later). I also became unstable on my feet about 20 min after vaccination.
facial numbness to right side of face, crossing midline at chin and across upper lip, spreading from jaw line to periorbital area
Several pains in back of both legs, escalated to burning pain in both legs. Burning is now in the entire body, back of throating also burning, also the right eyelid feeling burning sensation.
During the administration of COVID-19 vaccine, the needle and the syringe (GTIN (01)85907996099210) was loose so the vaccine spilled out and patient received very little of the vaccine, most of it (at least 90%) squirted out. I re-drew the vaccine in another syringe and gave the patient patient another dose. The patient seemed OK and did not have any issue with it.
No adverse event; Medical assistant reports patient was accidently administered an expired dose of MMR II on June 22, 2022. Product expired on Mar 7, 2022. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC; This spontaneous report was received from  a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-JUN-2022, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, once, for prophylaxis (lot number: T030481 expiration date: 07-MAR-2022, route of administration was not reported). The dose expired on 07-MAR-2022. There were no previous temperature excursions or adverse events reported.
Received PPV23 and influenza vaccines in right arm 11/14/07 approx 11 a.m. at our Health Dept  influenza immunization clinic. Client stated that approx 3 p.m., arm pain began, self-described as "excruciating with loss of range of motion." Stated he took 800 mg ibuprofen approx 6:30 p.m. then Vicodin Plus at 10:30 p.m. Stated at 12:30 a.m. "throat felt like it was closing up, I was afraid for my life, I slept sitting up in chair so I could breathe." His spouse notified our flu clinic staff of client condition on 11/15, who advised ER or personal physician follow-up; client contacted his physician who advised trip to ER if breathing problem worsened; client stated arm had "pulsating pain" on 11/15. On 11/16 during follow-up phone call stated arm "still not fully mobile, can't lift it" completely. Stated no fever during episode. We advised further contact with his physician as necessary.
1) Palpitations 2) Abdominal Pain 3) Nausea