chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired Menactra was accidentally given to a patient/no AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a non health care professional.  This case involves a 12 years old female patient who was mistakenly vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] which was already expired (batch number U6219BA, dosing details 0.5 ml and expiry date 16-JUN-2020) via intramuscular route in the right deltoid on an unknown date for prophylactic vaccination(Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event 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 and Module VI of the 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.
Case was hospitalized for Covid 8 months after receiving the Covid vaccine. Covid course in hospital: Acute hypoxemic respiratory failure due to COVID-19  Assessment & Plan Pt here w/ covid symptoms x 8 days(10/23) w/ new acute hypoxemic respiratory failure overlapping w/ COPD. We will target O2 goal 88-92% as a result. She was vaxxed x 3. Risk factors include morbid obesity, coronary disease, hypertension, diabetes and COPD. Okay to stop abx w/ negative procal, got 1 dose in ED   Plan:  - dexamethasone 6mg daily - remdesivir   Please use the following non medical therapies for COVID patients:  - encourage self proning as able - up to chair when not sleeping to prevent atelectasis - incentive spirometer every hour  - Ambulation TID as tolerated, in addition to any PT / OT
stomach pain; upset stomach; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (upset stomach) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.            No concomitant medication information were provided. No treatment information were provided.
aching; dizziness; Headache; This is a spontaneous report from a contactable pharmacist. A 86-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 15Jun2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history included vertigo. The patient's concomitant medications were not reported. On an unspecified date, patient experienced aching, dizziness and headache. As per report it was reported that, patient took the second Pfizer shot on yester-day (15Jun2021). Patient did not had a lots of symptoms that bothered her after first dose. But with the second shot, patient had aching and headache for which she took Tylenol as a relief to what she was experiencing. Then she was told that she should not take Tylenol. She said that, she did not know that. She got the fact sheet for the first one, but no fact sheet for the second shot. She was told not to take anything after she took the shot, but was told that after she took the Tylenol. It did not say anything about not taking pain medicine. She reported that, other people told her they took Tylenol. She was aching and a little dizzy. Patient took Tylenol as a treatment for events. The outcome of the events reported as unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Two days after receiving the second vaccine, I experienced, what I'm assuming to be a migraine. I felt light-headed and dizzy I had sensitivity to light and sound. The pain started above and around my left eye and then progressed down my cheek and I also had numbness going from around my eye down my left cheek. The migraine lasted from about Monday until Wednesday.
reported fever, headache, sore throat, and itchy bumps to body. Minor's oral temp. 102.1 F. Visible red lesions to head, neck, abdomen, wrist, and leg.
swollen - left arm - it is like a square; red - left arm - it is like a square; hard - left arm- it is like a square; hot - left arm - it is like a square; raised like a hive - left arm - it is like a square; inflammation - left arm; soreness - left arm, arm hurt for a couple of days then went away - left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen - left arm - it is like a square), ERYTHEMA (red - left arm - it is like a square), INJECTION SITE INFLAMMATION (inflammation - left arm), PAIN IN EXTREMITY (soreness - left arm, arm hurt for a couple of days then went away - left arm) and LIMB DISCOMFORT (hard - left arm- it is like a square) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE INFLAMMATION (inflammation - left arm) and PAIN IN EXTREMITY (soreness - left arm, arm hurt for a couple of days then went away - left arm). On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen - left arm - it is like a square), ERYTHEMA (red - left arm - it is like a square), LIMB DISCOMFORT (hard - left arm- it is like a square), VACCINATION SITE WARMTH (hot - left arm - it is like a square) and URTICARIA (raised like a hive - left arm - it is like a square). At the time of the report, PERIPHERAL SWELLING (swollen - left arm - it is like a square), ERYTHEMA (red - left arm - it is like a square), INJECTION SITE INFLAMMATION (inflammation - left arm), PAIN IN EXTREMITY (soreness - left arm, arm hurt for a couple of days then went away - left arm), LIMB DISCOMFORT (hard - left arm- it is like a square), VACCINATION SITE WARMTH (hot - left arm - it is like a square) and URTICARIA (raised like a hive - left arm - it is like a square) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided.
This spontaneous report was received from a physician concerning a male infant patient of unknown age with immunodeficiency condition (unspecified). On an unknown date, the patient was vaccinated with BCG live (manufacturer unknown) (lot number, expiry date, dose and route unspecified). Other suspect therapies included poliovirus vaccine inactivated (unspecified) (manufacturer unknown) (lot number, expiry date, dose and route, date of administration unspecified). The patient was vaccinated in another country. Since an unknown date, the patient was experiencing ascending flaccid paralysis (disability) and the healthcare team who was attending the infant was suspecting that there was an immunodeficiency condition that was progressing, as the child was unable to mount an immune response to a live-virus vaccine that he received. The physician also indicated that the BCG live (manufacturer unknown) vaccine injection site of the patient was oozing approximately on an unknown date in 2013. The physician was short on time, and she did not specify if the infant was an inpatient at the hospital, but the health status of the infant was progressive and serious. Health Department was notified. The physician was contacting the company to inquire if she could enroll the infant in the compassionate use program for PLECONARIL. No product quality complaint (PQC) was identified. The events were not resolved at the time of report. The relatedness for the events was unknown for BCG live (manufacturer unknown). Additional information has been requested.
Headache, NauseaVomiting, bad headache, bilateral ear pain and nausea. Injection site was red, warm and slight swelling. Narrative: 1st vaccine on 1/15/21 woke up on Sat and Sun with a sore arm and 1/19/21 morning with bad headache, bilateral ear pain and nausea. Injection site was red, warm and slight swelling. Self care with otc acetaminiphen Missed work on 1/19/21 has returned to work on 1/20/21. Reports feeling better
Notice leg swollen 3 times normal size between knee cap and hip. Some redness on inner thigh probably due to friction between swollen leg and pants. No redness observed around injection area. Contacted doctor on 6/17 (continued) who recommended Benadryl which decreased swelling; leg back to normal by Sunday morning. No pain at any point; no bug bites or nothing.
Pt reported swelling in same side upper body to include neck shoulder with enlarged glands within 24 hrs after IZ, worse at 48 hours after IZ. Seen 72 hours after IZ with soft tissue (R) neck swelling and (+) supra clavicular, (+) ant cervical nodes, (-) erythema, (-) Fever, Pt has F/U appt for repeat clinical exam.
Case number PHEH2015US021592, is an initial spontaneous report received from a other health professional on 22 Oct 2015. This report refers to a 16 year old female patient. Past medical history and concomitant medications were not reported. This 16 year old female patient was vaccinated with FLUCELVAX (batch number: 173253) on an unknown date. No adverse event was reported following this administration error (Inappropriate age at vaccine administration). Follow up information was received from a other health professional on 23 Dec 2015 and 24 Dec 2015: Patient's initials, age, date of birth and gender were updated.
Five days after the vaccine I woke up and could feel a lump on my collar bone that was very painful and could move when touched.  The pain eventually subsided but the swollen lymph node is still there to date.  A week after I noticed another swollen lymph node appeared in my neck  and once it became inflammed my face and scalp became very to the touch and my whole mouth got inflammed also.  I went to the PCP who prescribed an antibiotic which did reduce some of the inflammation and pain in my face but the enlarge lymph node on my shoulder is still there.
Patient presented to ED with complaint of right sided facial droop accompanied by numbness and tingling. The patient went to bed at 0700 after working third shift with no symptoms and awoke at 1400 with these complaints. Patient was hypertensive at ED presentation. Patient was diagnosed with stroke and admitted to the hospital. Patient received clopidogrel (loaded with aspirin per self at home PTA).
The patient experienced no symptoms; a patient who had completed a series of GARDASIL was administered a dose of GARDASIL 9; a patient who had completed a series of GARDASIL was administered a dose ofG ARDASIL 9; This spontaneous report has been received from a physician concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were not reported.      On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine) (GARDASIL) as prophylaxis (concentration, dose, frequency of vaccination scheme, route and anatomical location of vaccination, lot number and expiry date were not reported).   On an unknown date in 2020 (reported as within the past few weeks), after completing a series of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine) (GARDASIL), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), one dosage form as prophylaxis (circumstance or information capable of leading to medication error, inappropriate schedule of product administration) (concentration, route and anatomical location of vaccination were not reported; frequency of vaccination scheme, lot number and expiry date were unknown to the reporter).  The patient experienced no symptoms.
No additional AE reported; temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  The blow vaccines (stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ)) experienced a temperature excursion on 29-DEC-2021. On 06-JAN-2022, the patient was vaccinated with improper stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot# T032918, expiration date 12-NOV-2022, once, dose, route and strength were not provided) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot# 1742430, expiration date 16-SEP-2022, once, orally, dose and strength were not provided) for prophylaxis. The vaccine administered experienced temperature excursions of 35.9 Degree Fahrenheit for 20 minutes (product storage error). There was no previous temperature excursion. No additional adverse event reported.; Sender's Comments:  US-009507513-2202USA007167:
swollen injection site with redness; swollen injection site with redness; swollen lymph nodes in armpit and neck; earache; fever of 102; joint pain; fatigue; nausea; diarrhea; headache; loss of smell and taste; loss of smell and taste; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533), via an unspecified route of administration in left arm on 30Mar2021 (at the age of 48-years-old) as dose 2, single for COVID-19 immunization. Medical history included Obesity and Penicillin allergy. Concomitant medication included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS) and calcium. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration on 09Mar2021 09:30 (at the age of 48-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced swollen injection site with redness, swollen lymph nodes in armpit and neck, earache, fever of 102, joint pain, fatigue, nausea, diarrhea, headache and loss of smell and taste on 30Mar2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Patient had temp./fever starting about 66 hours after vaccination (T=100.9). Then was treated w/TYLENOL. Fever went up to 104 degrees (around 80 hours after vaccine) along w/nasal congestion/drainage. Fever resolved after 4th day post vacc.
Narrative: Patient received Moderna vaccine~10 days prior to presenting to the ZVAMC with suspected COVID. The patient was treated with steroids. Reporting hospitalization per EUA documentation.
My husband and I went to vaccine our baby boy 2 months old, after vaccination he start to sleep and start crying for his milk very slow, when we try to wake up him, he can't. We make different things and he wake up. Then he start to present episodes of stare and loss of muscle strength, for 7 times. His visiting a neurologist, gastroenterologist and now it's going to a geneticist.
Headache, nausea, episode of vomiting, fatigue, and chills. Symptoms began at 10pm on 4/26 (got 2nd dose at 1:00pm that same day) and resolved at 10am with sleep and ibuprofen. Also I have a strange rash under my right eye that appeared on 4/27. The rash is not painful or itchy. It?s just reddish purple with some minor swelling. With the first dose I had a skin reaction on my back similar to pityriasis rosea, which leads me to believe the rash under my eye is related to the vaccine as well.
Body aches and chills began 1/5/21 at around 2:30 pm.  Left arm below injection site became red, swollen and hot around 7:00pm of that day.  All symptoms continued through following day with extreme stiffness and soreness in arm.  Area of redness on left arm enlarged over the day and evening. PCP started me on antibiotics and by evening of following day most symptoms were improved. Arm was still red, slightly swollen and itchy. Arm is still red and itchy but has improved today .
Patient received second  dose  5 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second  dose  5 days after first dose) 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 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second  dose  5 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second  dose  5 days after first dose) had resolved.        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 reported.  No treatment information was provided.
Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 15:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma but rarely symptomatic." (unspecified if ongoing); "Known allergies: Almonds" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 18Dec2022 to 22Dec2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201402555 Same patient, different product and event;
Flu symptoms (1 day), left side weakness/numbness/pins and needles (comes and goes), headache (comes and goes)
the evening of day in which vax was given pt had temp of 40C R & had febrile sz; pt was evaluated in ER;
Improperly stored administered vaccines; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 05-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S020160, expiration date 30-JUN-2021 for prophylaxis.  Other suspect therapies included varicella virus vaccine live (oka/merck)(VARIVAX) s038175, expiration date 30-JUN-2021 for prophylaxis (dose, frequency and route of administration were not reported for any of the vaccines involved) (Product storage error).  The improperly stored suspect vaccines experienced all a temperature of - 6 fahrenheit degrees (°F) to 14°F (average 10°F) for 1 hour and 15 minutes; 15°F to 46°F ( average 44.8 °F )  for 1 hour and 30 minutes; 47°F to 77°F (average 50°F ) for 2 hours and 30 minutes.  The call was made due to a digital data logger. No previous temperature excursion was reported.
fatigue after the second dose; fever after the second dose; chills after the second dose; nausea after the second dose; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (fatigue after the second dose), PYREXIA (fever after the second dose), CHILLS (chills after the second dose) and NAUSEA (nausea after the second dose) in a 33-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue after the second dose), PYREXIA (fever after the second dose), CHILLS (chills after the second dose) and NAUSEA (nausea after the second dose). At the time of the report, FATIGUE (fatigue after the second dose), PYREXIA (fever after the second dose), CHILLS (chills after the second dose) and NAUSEA (nausea after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-511202, MOD-2022-511195 (Patient Link).
CoughWheeze, ErthemaMultiform, L arm pain, swelling, runny nose Narrative:
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 33 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
mom called clinic approx 1 hr p/inject stating that pt was itching all over & had red spots; called MD & gave DPH sx subsided;