chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I'm just sitting here trying to check on my own vitals; This spontaneous case was reported by a consumer and describes the occurrence of VITAL SIGNS MEASUREMENT (I'm just sitting here trying to check on my own vitals) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VITAL SIGNS MEASUREMENT (I'm just sitting here trying to check on my own vitals). At the time of the report, VITAL SIGNS MEASUREMENT (I'm just sitting here trying to check on my own vitals) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: normal (normal) Result : patient tried to check on its vitals.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided. Patient went to a hospital a lot.
Patient had increased weakness and ended up in the emergency room department. It took one clinical observer and one volunteer to get her moved. Son reported he could not get her into the house alone , and she was definitely weaker than normal.
Patient received vaccine more than 6 hours after vial had been punctured, have not received return call from patient
Drug ineffective; I was fully vaccinated (Pfizer) + boosted twice (Pfizer). Latest booster (Pfizer) 09Feb2022/Tested positive for Covid on 27May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), 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 on 09Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "I was fully vaccinated (Pfizer) + boosted twice (Pfizer). Latest booster (Pfizer) 09Feb2022/Tested positive for Covid on 27May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: I tested positive for COVID-19; (07Jun2022) Positive, notes: wake up with symptoms. Test showed & was positive again for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional adverse event; That patient received improperly stored vaccine; This spontaneous report was received from a nurse referring to patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-FEB-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot # S009759 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 27-SEP-2020). Other suspect therapies included sterile diluent (lot # N029157 has been verified to be a valid lot number , expiration date reported and establish as 17-APR-2020).  The temperature of storage and time frame of the excursion were 6° Fahrenheit (F) to 14°F and 5 minutes respectively.  A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
SHIVERS, CHILLS, FEVER FOR 3 DAYS, SWEATING, FATIGUE, MUSCLE ACHES AND A HEADACHE FROM HELL!   NAUSEA AND DIARRHEA!  THIS IS CRAP.  STOP POISONING US!
ELEVATED D DIMER; ITCHY AND UNCOMFORTABLE RASH ( BOTH LEGS AND RIGHT FLANK); This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no other pertinent medical history shared. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number:1805018 and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced elevated d dimer, and itchy and uncomfortable rash (both legs and right flank). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets, white blood cells and red blood cells are normal, and Fibrin D dimer (NR: not provided) weakly positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchy and uncomfortable rash (both legs and right flank), and the outcome of elevated d dimer was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
pt recvd vax & mom noticed sm circular hardened area  on 14jul94 & noticed skin dk over area on 17jul94; pt taken to clinic; not warm; no temp
gave an Engerix B Pediatric dose to a 59 year old female; gave an Engerix B Pediatric dose to a 59 year old female; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 59-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On 08-NOV-2023, the patient received Engerix B pediatric (intramuscular). On 08-NOV-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: gave an Engerix B Pediatric dose to a 59 year old female). On an unknown date, the patient experienced underdose (Verbatim: gave an Engerix B Pediatric dose to a 59 year old female). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 09-NOV-2023 The medical assistant reported that one of their staff gave Engerix B Pediatric dose to a 59 year old patient which led to underdose and adult use of a child product. The reporter consented to follow-up.
Patient vaccinated with Pfizer on 3/9/21 and 3/30/21. Presented to ED with complaints of worsening shortness of breath. Previous medical history of type 2 diabetes, urinary incontinence, spinal stenosis, emphysema, and RLS. Chest x-ray showed pulmonary edema. Patient admitted for further workup. Admitted 12/26/21, discharged 12/28/21.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Mar-2021 at 11:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:34 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 29.22.  No concomitant medications were reported.  On 20-Mar -2021, 19 vials were moved to clinic.   The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021.   On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 37 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 20-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.  This case was linked to MOD-2022-566976 (Patient Link).
Accidentally administered the M-M-R II and PROQUAD vaccines to pediatric patient at our facility; This spontaneous report was received from a medical assistance referring to a pediatric patient of unreported age and gender. The patient's medical history, current condition, and concomitant medications were not provided.    On 03-JAN-2022, the patient accidentally administered measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) and measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (accidental overdose) for prophylaxis (dose, vaccination scheme frequency, route of administration, lot number, and expiration date were not reported).
Left sided parentheses and numbness sensation which then spread to right side. Strong headache initially then resolved,  rapid heart rate, confusion, dizziness, high blood pressure,
Initial and follow-up information has been received from a certified medical assistant concerning a 22 year old female who had one previous pregnancy and one full term delivery, who on 31-JAN-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (Lot# 654540/0800F).  On 29-MAR-2008 the patient was vaccinated with a second dose of GARDASIL (Lot# 654885/1424F).  In July 2007 the patient was determined to be pregnant.  Her third dose of GARDASIL will be delayed until after completion of the pregnancy.  No problems were reported.  The patient sought unspecified medical attention.  On 28-AUG-2007 an ultrasound was performed for dating and the results were placenta previa.  On 28-NOV-2007 a repeat ultrasound revealed small gestational age and on 24-JAN-2008 an ultrasound revealed placenta previa resolved.  At the time of the report, the patient's outcome was unknown. No product quality complaint was involved.  Follow-up information indicated that 40.5 weeks from her last menstrual period on 13-MAR-2008 the patient gave birth to a male infant.  The infant weighed 7 pounds and had an Apgar score of 9/9.  The infant was normal with no congenital anomalies and no abnormalities.  The complication of marginal placenta previa took place during the pregnancy.  Other medication taken during the pregnancy starting on 23-JUL-2007 included prenatal vitamins once daily.  Additional information is not expected.
Missed dose; A 16 year old patient received the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   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.   This case was linked to MOD-2021-268440 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up contains non significant information. On 25-Jul-2021: Added patient ethnicity, race and second dose information .
no adverse event; Pharmacist inadvertently administered a dose of the monovalent vaccine to a patient which was beyond the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered a dose of the monovalent vaccine to a patient which was beyond the 30 day use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered a dose of the monovalent vaccine to a patient which was beyond the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered a dose of the monovalent vaccine to a patient which was beyond the 30 day use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered a dose of the monovalent vaccine to a patient which was beyond the 30 day use by date).    Concomitant medications were not reported.  Use by date was 14Jan2023 and date of administration was 16Jan2023. Treatment medications were not reported.
Strain and pain in left arm, limiting motion for over 10 days now. Acute pain during the night.
PATIENT DEVELOPED A LARGE RED CIRCLE AROUND INJECTION SITE. THIS WAS STILL PRESENT ON 1/16/20
Felt like she's experiencing COVID-19 again.; Felt weak; still felt freezing; could not stop shaking despite wrapping herself wit a lot of blankets; chills; bad Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (bad Headache), ASTHENIA (Felt weak), COVID-19 (Felt like she's experiencing COVID-19 again.) and TREMOR (could not stop shaking despite wrapping herself wit a lot of blankets) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills), HEADACHE (bad Headache) and TREMOR (could not stop shaking despite wrapping herself wit a lot of blankets). On 15-Apr-2021, the patient experienced ASTHENIA (Felt weak) and FEELING COLD (still felt freezing). On an unknown date, the patient experienced COVID-19 (Felt like she's experiencing COVID-19 again.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (chills), HEADACHE (bad Headache), ASTHENIA (Felt weak), COVID-19 (Felt like she's experiencing COVID-19 again.), TREMOR (could not stop shaking despite wrapping herself wit a lot of blankets) and FEELING COLD (still felt freezing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Localized rash approximately  2 inches by 4 inches ,  increased over the course of 24 hours ,told to apply cold compress
30 minute episode w/10 min stiffened limbs w/postictal state, 2nd sz after apparent roseola.
PAIN RADIATING UP LEFT SIDE OF NECK AND DOWN ARM. LEFT FINGERS TINGLING.
Paxlovid COVID 19 Treatment; Paxlovid COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: 6201), in right arm, on 25Mar2021 as dose 2, single (Lot number: en6200), in right arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: O49L21A), in right arm and on 10Oct2022 as dose 5 (booster), single (Lot number: A57163B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancers that have been removed" (unspecified if ongoing); "Skin cancers that have been removed" (unspecified if ongoing); "Known allergies: anaphylactic allergy to peanuts" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03May2022, outcome "not recovered", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Suspected cellulitis; swelling; Arm erythema; discomfort; fever; This spontaneous report was received from pharmacist, referring to a 50-years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-AUG-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)  injection 0.5 milliliter at arm (lot #U027357 has been verified to be a valid lot, expiration date: 25-MAR-2023) for prophylaxis (strength, and exact anatomical location were not provided); and  meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) in the same arm (strength, dose regimen, lot #, expiration date, route of administration, and indication were not provided).  On 23-AUG-2022 (also reported as "the next day, 24-AUG-2022", conflicting information), the patient experienced arm erythema, swelling, discomfort, fever and a suspected cellulitis. The physician prescribed amoxicillin (+)  clavulanate potassium (AUGMENTIN) as treatment. At the time of the report, the patient had not recovered from the events.  Causal relationship between the events with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) was not reported.
A non-serious spontaneous report of received half dose was received from a consumer/non health professional concerning a 10-year-old patient. The patient's medical history was not reported. On 13-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
L arm swelling - Pt reported fever to 101 x 2 days after 2 days on 4/3/09 redness- swelling inner L arm 5"X3" - No fever - Tx BENADRYL and KEFLEX.
Narrative:  Pt reported that his arm pain started about 6 weeks prior to his  PCP follow-up on 11/19/21 (estimated 10/8/21). Vaccine was administered on  8/12/21. Patient thought arm pain might be related to vaccine.
pt recv vax 11JUN96 & later that day mom reported fever to MD;pt was seen by MD 12JUN96 & was noted to have t99;that noc the pt was taken to ER w/a fever (degree unspecified);pt was seen by MD 13JUN96 & was noted to have a temp 104.5;
EDD 4/23/18 at 14 weeks gestation at time of vaccination. Miscarried 11/17/17.
c/o extreme vertigo, then collapsed. Eyes open but unresponsive to stimuli. Fugue-like state for 15minutes, then c/o severe left arm pain (lower arm). Gradually got more oriented & responsive, then fell asleep for the nite. Awoke this AM without any recollection of previous night's events/collapse.  Also awoke with raised rash on upper back, chest, upper arms, & forehead.  Given Atarax 25mg, also, given prednisone 20mg; applied topical rx cortisone cream to rashes. Left upper arm swollen, red, warm & painful to touch. Pediatrician notified by phone, also left voicemail with Rheumatologist notifing her of rash, just in case rash could be from auto immune disease. I strongly feel the rash is from the vaccine.
bilateral lower facial numbness after their first dose that lasted for 4 days; This is a spontaneous report from a contactable pharmacist reported for a patient. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: was not reported), via an unspecified route of administration, administered anatomical location not reported on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After first dose, on unspecified date, the patient has experienced for 4 days, bilateral lower facial numbness. Patient sought emergency medical attention at the time but is unsure of the treatment received. Reporter instructed the patient to report. Reporter wanted to check with Pfizer Medical Information to see if this adverse event was likely to be caused by the vaccine and if the patient could safely receive the second dose of COMIRNATY vaccine. Advised reporter that no information is available to suggest a causal relationship between the PFIZER-BIONTECH COVID-19 vaccine and facial numbness. Advised reporter that Pfizer cannot make the determination on whether or not the patient receives the second dose of the vaccine. Deferred to clinical judgment and patient decision. The outcome of the event was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.