chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed out; Felt dizzy; Nasty taste in mouth; was feeling tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced TASTE DISORDER (Nasty taste in mouth) and FATIGUE (was feeling tired). On 26-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and DIZZINESS (Felt dizzy). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Felt dizzy), TASTE DISORDER (Nasty taste in mouth) and FATIGUE (was feeling tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had acetaminophen for the events. Action taken with mRNA-1273 in response to the drug was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested Dose 1 case
Beginning of May, started feeling chestpain especially when exercising. Discussed with cardiologist who ordered nuclear stress test. Started feeling heart fluttering like symptoms. On 6/28 went to dentist in afternoon where felt nausea, dizziness, then chestpain and left arm going numb. Went to urgent care to rule out heart attack. On Thursday evening had to call ambulance as had same symptoms of 6/28. They admitted me and did angiogram. Upon release, i asked what other things can cause heart fluttering, dr suggested esophageal spasms, asthma, or thyroid.
Red, warm, swollen, hard to touch 6cm x 4cm. Hydroxyzine or Benadryl q 6 hrs, warm moist packs-to f/u if no improvement.
Information has been received from a physician concerning an approximately 11 year old female who was vaccinated IM with a dose of GARDASIL. Concomitant therapy included tetanus toxoid (manufacturer unknown) received within the same visit. Unspecified medical attention was sought. Patient recovered on an unspecified date, swelling healed on its own with ice. Additional information has been requested.
severe allergic reaction within 10 minutes of the shot being administered.  severe itchiness, some shortness of breath.  Was able to be calmed down by Benadryl
Pain under the right breast; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAST PAIN (Pain under the right breast) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Pain under the right breast). At the time of the report, BREAST PAIN (Pain under the right breast) had not resolved.        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.   No concomitant medication was reported. No treatment medication was reported.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of vial placed in refrigerator was on 17-NOV-2021 and vaccine did not undergone any temperature excursion. Patient did not experience any adverse event. No concomitant were reported. No treatment were reported.
pt recvd vax 12APR93 & 4AM on 15APR93 awoke w/fever (no value) later in morning temp was 102; pt was restless, fussy, did not sleep more than 10 mins @ a time, had runny nose; 16APR93 went to ER due to t104.6 & screaming;
redness & hot to touch @ site of DTP lt deltoid inject; redness from elbow to upper arm just below the lt shoulder; fever of 102.7 off & on 18AUG92 PM until 21AUG92; pt seen by MD allergy MD no tx x/cold compresses;
Have a rapid heart beat which she did not have before and a bladder condition also which she did not have prior to getting the vaccine.
A literature report was received on 24Mar03 concerning a 51 year old female vaccinee who experienced blurred vision, pain and redness associated with a recurrence of iritis in her left eye approx two weeks after vaccination with virus influenza in later Nov94. She had a history of scleritis and recurrent iritis in both eyes for 25 years. No underlying etiology was established for the inflammation and the last recurrence had been documented in 1990. The vaccinee was part of a retrospective study to investigate the possibility that influenza vaccination is a cause of recurrent uveitis in pt's with a history of pre-existing ocular inflammatory disease. In Dec 1994, the vaccinee presented with blurred vision, pain and redness associated with a recurrence of iritis in the left eye. Visual acuity was reduced to 6/7.5 (20/25). There was a mild ciliary flush in the left eye, fine keratic precipitates were scattered on the corneal endothelium and the anterior chamber showed 2+cells and a trace flare. There was no sign of recurrent scleritis.  Intraocular pressure was 15mm Hg by applanation. Fundus examination was unremarkable. The vaccinee was treated with topical dexamethasone 0.1% drops four times daily, topical atropine sulfate 1% twice daily, and systemic corticosteroids for seven days. The vaccinee fully recovered after 14 days. The authors concluded that influenza vaccination may act as a nonspecific stimulus of the immune system and thereby, reactivate uveitis. The exposure to influenza vaccine triggered a recurrence of ocular inflammation. Update 1, 06May03: A follow up report was received from a health care professional indicating that the vaccinee had recovered without sequelae. Cross ref with: PJP200300141, PJP200300142, PJP200300143.
Patient received 1st Pfizer Covid-19 Vaccine on 03/06/2021 - since receiving the vaccine patient has generalized weakness - muscles spasms and Myalgia that has not subsided since vaccine
Patient had friend call stating patient had muscle pain. Described pain at injection site and lower extremities.
no additional AE reported; HCP reported that patient was accidently administered the wrong vaccine; This spontaneous report was received from a medical assistant and refers to a 13-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 21-MAR-2022, the patient was accidentally vaccinated with the wrong vaccine (wrong product administered), the patient received haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot number U014992 with expiration date 29-OCT-2023 (dose, route and anatomical location were not reported), but it was supposed to received meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA). No additional adverse events were reported.
1 7/8 x 1.5 cm area redness/warmth.  No purulence.
"Vomited twice, very weak, temp 102.0 this AM" (9/29) tried TYLENOL but temp went up again. Better this afternoon. TYLENOL was repeated, no complaints of arm hurting this after noon. Fever4 "began last night" (9/28) resting/sleeping @ 5:30 pm 9/29/10. Called 9/30 - "much better" No more vomiting, drinking well.
anembryonic pregnancy diagnosed on 1-19-2022 at 9 weeks gestation
Medical resident injected approximately 9CMs below acromion process. Did not check for landmark. Stated when offered by NP in clinic to give the injection said she had given before and before I could say anything  she gave the injection. No pain but approximately three days later noticed a hematoma at site and itching. Over time have developed pain with various movements of arm and with extension developed moderate to severe cramping at site. Negative impact on quality of life at this point.
Patient completed a monovalent Pfizer primary series 10/22. Pt was in office for covid booster bivalent. Pt given Moderna bivalent in error as our office does not supply Pfizer under 5 yrs.
Difficulty walking 3 X 4 cm area of warmth, erythema tender to touch.  Advised MOTRIN, cool compresses call PRN.
It was reported that a 47 year old female patient received a Fluzone vaccination on 11/28/2000 at 8:00 am. Reportedly on 11-29-2000 at 10:00, the patient developed a localized area of cellulitis 6cm. Reportedly the patient recovered from this experience. From additional correspondence received on 02/21/2001, it was reported, "reviewed, no additional information at this time - CD 02/14/2001". This case is closed.
Chills, body aches, extreme exhaustion, headache, soreness at injection site, swollen lymph glands in armpit of injection arm
Patient was administered Moderna as second dose in series instead of Pfizer. Discussed current CDC recommendations regarding mixed dose series and that repeating dose not needed however mixed series are not recommended
LOW TEMPERATURE 96.5  - 95.6 TO 95.9  FOR  5DAYS AND THEN FROM 95.8 TO 97.00. OXYGEN WAS 93-95. FEEL WEAKNESS , HIGH BLOOD PRESURE
Within 45 minutes of receiving the vaccine I started having dizziness and nausea. By 2 hours later symptoms of sinus infection started along with fever and chills. By following morning symptoms had worsened to scratchy throat and cough. Symptoms continued to worsen to those of strep throat/tonsillitis/sinusitis/bacterial infection/laryngitis over next several days and continued through the following week, 14 days total, and also included coughing up yellow/green mucous and chest burning during mucous expulsion, additionally experienced fever, chills, nausea, headache, irritation/itching deep down in ears and throat, lack of appetite, tiredness/lethargy.  I have been through 2 rounds of antibiotics- Cefdinir 300 MG twice a day, after 4 days with no improvement a Z-pack was added to the Cefdinir and finally relief began about a day ago. Currently I still have a sore throat, feels like I have rocks instead of tonsils, coughing, sinus drainage.
A non-serious spontaneous report of administered expired FLUMIST was received from a nurse concerning a six-year-old female.  FLUMIST that expired on 08-Jan-2009 was administered on 05-Feb-2009.  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.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 09-Apr-2009 that included the results of an investigation for a medication error.
generally didn´t feel good; dizziness; sore throat; body ache; temperature; chills; headache; nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (generally didn´t feel good), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), PAIN (body ache) and PYREXIA (temperature) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (generally didn´t feel good), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), PAIN (body ache), PYREXIA (temperature), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (generally didn´t feel good), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), PAIN (body ache), PYREXIA (temperature), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
patient received a third Menactra vaccine, one month from his second Menactra vaccine in error, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old male patient who received 0.5 ml third dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6521AA, Exp. Date 26-Jan-2021) via intramuscular route in the right deltoid on 26-Sep-2019 and patient was previously vaccinated with the second dose of the same vaccine on an unknown date (one month ago).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLULAVAL) for Immunisation.  It was a case of actual medication error due to extra dose administered.  It was reported that a patient received a third Menactra vaccine, one month from his second Menactra vaccine in error.   At the time of reporting, no adverse reactions were 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.
allergic reactions; I have itching, swelling; I have itching, swelling; hives and breakout; had rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Aug2021 11:30 (Lot number: EW0170) at the age of 68 years as dose 1, single and intramuscular, administered in arm left, administration date 30Aug2021 11:00 (Lot number: FC3183) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure; "Pain" (unspecified if ongoing); "heart" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for cardiac disorder; POTASSIUM; TIZANIDINE taken for pain; VITAMIN D NOS; METOPROLOL taken for blood pressure measurement; VENLAFAXINE. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reactions"; PRURITUS (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "I have itching, swelling"; URTICARIA (non-serious), outcome "unknown", described as "hives and breakout"; RASH (non-serious), outcome "unknown", described as "had rash". Therapeutic measures were taken as a result of hypersensitivity, pruritus, swelling, urticaria, rash.  Additional information: The patient reported that got the Pfizer, first Pfizer, Monday and having reaction, allergic reaction to it and had itching, swelling. The patient stated that dont have it anymore, had it yesterday and the patient was retired. Treatment: The patient stated: took some Tylenol and some Benadryl and wiped out with alcohol. No other vaccination 4 weeks prior. Just taking medicine across the counter Tylenol. (Intent: Medical Information). Follow-up attempts are completed. No further information is expected. The patient reported Had rash and hives after taking both vaccines, return to health department on 21Sep2021 for booster vaccine  No follow-up attempts are possible. No further information is expected.
cough; fatigue; She's been having a hard time breathing, walking up hill, up stairs, doctor gave her an inhaler; low fever; couple days of body ache/body aches in her legs; did not feel well; This is a spontaneous report from a Pfizer- sponsored program Support from a contactable consumer (patient's husband). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient received first dose of vaccine on 24Mar2021. 1 day after vaccine she had low fever, and did not feel well, day 2 she was fine, day 3, having covid like symptoms, cough, fatigue, couple days of body ache. She's been having a hard time breathing, walking up hill, up stairs, doctor gave her an inhaler, that's continued, and no fever. Tested day 4, day 6, and day 8 with PCR tests, and were all negative. On day 3 she had body aches in her legs for a couple days but no other body aches, and she no longer has anymore. The patient underwent three Covid tests, 3-4 days later, 5-6 days later, and 7-8 days later.  The reporter added that it was thought she had Covid so they did a full screen, and she had positive antibodies. It has been three weeks since symptoms, and the worst few days. The patient experienced fatigue, hard time breathing, coughing on 26Mar2021 and not recovered, and experienced low fever, did not feel well, bodyaches in legs on unknown date in Mar2021 with outcome unknown. She was scheduled today for 2nd dose, want to know if she should get the vaccine today.  One doctor said to wait one week because of her symptoms. The patient had an EKG and full blood work - all were normal.  She also has the antibodies, but he does not know how they measure that.  Bloodwork was done approximately 10 days after the vaccine.  She had 3 Covid tests total. She was given three covid tests, all negative, and did test positive for Covid19 antibodies. It is unclear if she had Covid before or after getting the vaccine, and that the physician thought maybe she had covid before getting vaccinated which is what caused her reaction to the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient stated she had tingling in her face 10-15 minutes after receiving the vaccine.  She thought maybe it was just her mask, but wasn't sure. She stayed an additional 15 minutes for a total of 30 minutes and at that time said it was better but still existent. She went home with understanding to call 9-1-1 if any symptoms of anaphylaxis.
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (lot # L034727, expiration date 09-DEC-2016, strength, dose, dose# and route unknown) which were previously exposed to temperature outside of the recommended range. Temperature was 8.1F and time frame was 6 hours. No adverse reactions reported. Additional information has been requested.
Feel really sick; Really freezing/ Really cold; Feeling lousy/ Do not feel well; Jittery; Tired; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Feel really sick), FEELING COLD (Really freezing/ Really cold), MALAISE (Feeling lousy/ Do not feel well), FEELING JITTERY (Jittery) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 025A21A and 020E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was sick for almost 8 months; was constantly on low dose Medrol pack and doxycycline) in 2020 and Wheezing (Still experiencing wheezing, after recovering from COVID).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced ILLNESS (Feel really sick), FEELING COLD (Really freezing/ Really cold), MALAISE (Feeling lousy/ Do not feel well), FEELING JITTERY (Jittery), FATIGUE (Tired) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (Feel really sick), FEELING COLD (Really freezing/ Really cold), MALAISE (Feeling lousy/ Do not feel well), FEELING JITTERY (Jittery), FATIGUE (Tired) and MYALGIA (Body aches) had not resolved.            No concomitant medications was provided by reporter.  After getting the booster dose, patient was feeling really sick, really freezing, really cold, jittery, tired, having body aches, feeling lousy, do not feel well and tired. Patient had taken Advil which may have alleviated the symptoms little but not completely.   This case was linked to MOD-2021-390907, MOD-2021-390908 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". 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.