chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like choking; coughing every day; Runny Nose; felt like wheezing; cold chills; A spontaneous report was received from a 70-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt like choking, coughing every day, runny nose, cold chills and felt like wheezing.  The patient's medical history included blood pressure abnormal and thyroid disorder nos. Concomitant medications included thyroid medication, blood pressure medication, fish oil, levocetirizine dihydrochloride and vitamin d.  On 18-FEB-2021, the patient received their one of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly on left arm for prophylaxis of COVID-19 infection. On the same day, patient experienced coughing and she felt sick. The patient had runny nose, cold chills and felt like she was wheezing and chocking from unspecified date in FEB-2021. The patient started using an inhaler which she got from her daughter. The doctor gave her prescription for cough medication. The patient's daughter gave her Tessalon (benzonatate) 200mg. Physician was aware of patient's symptoms. The patient was scheduled for second dose on 18-MAR-2021.  Action taken with mRNA-1273 was unknown.  The outcome of the events, felt like choking, coughing every day, runny nose, cold chills and felt like wheezing was unknown.; Reporter'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.
pt recvd vax; pt exp lightheadness, nausea, vomiting, abdominal cramping, diarrhea, fever, chills; after 2nd dose of vax; pt exp tingling in right foot;
Moderna vaccine was given to a patient under the age of 18 years old. No current side effects or symptoms have been reported by mother
A non-serious spontaneous report of hives has been received from a nurse concerning an eight-year-old female, subsequent of FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST in Feb-2009. The patient received a total of two doses before onset of the event. One week after the second dose of FLUMIST, the patient experienced hives. The event of hives was reported as resolved. Causality was not reported.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. Since 01-FEB-2016, the patients were vaccinated with ROTATEQ (dose, route and site not reported) with lot numbers: lot # L000433 and expiration date 09-JUL-2016 or lot# L013202 and expiration date 27-JAN-2017 or lot# L013206 and expiration date 29-JAN-2017 that was exposed to 31.2 F temperature, outside of the recommended range during one hour. There were no adverse events reported. It was reported that the ROTATEQ vaccine did not experienced previous temperature excursion. Additional information has been requested.
hearing loss Narrative:  Pt reported temporary hearing loss in both ears starting 2/6/2021 lasting approximately 4 days. Both ears have improved in hearing since then.
None.  Patient reported no adverse events from vaccines given via intramuscular route rather than subcutaneous route. ** Please note:  this report is due to administration error; to clarify item 5 -- no adverse events.**
Medical assistant drew partial of the MCV vaccine, did not constitute it properly and administered diluent only. Re-drew the vaccine and second proper dose was administered. Age of patient at time of event: 16 years.
Information has been received from a registered nurse concerning a 25 year old female who on 08-MAR-2007 was vaccinated with Gardasil. On 09-MAR-2007 the patient experienced redness, pain, swelling and rash at the injection site. The patient called the physicians office and was asked if she had trouble breathing. The patient reported no trouble breathing and was instructed to take BENADRYL. Then patient then called the physician's office back to report she had developed tightness in her chest. The tightness in her chest resolved with BENADRYL. Additional information has been requested.
I get cluster headaches; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient himself) reported that a male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, lot/batch number were not reported), via an unspecified route of administration from an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced cluster headaches on an unspecified date and was taking a medicine (Triptans). The outcome of event was unknown.    Information on the lot/batch number has been requested.
I am the epidemiologist reporting on behalf of patient. The patient received two doses of the Pfizer vaccine on 2/17 and 3/10. On 8/10/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/10 and the cause of death is listed as ?Respiratory Arrest.? I do not have any further detail regarding pre-existing conditions or provider information.
Information has been received from a physician concerning a 26 year old female patient who on 27-AUG-2009 was vaccinated with a third dose of GARDASIL (lot # not reported). On 27-AUG-2009 after third dose the patient fainted and vomited. No adverse events were reported after first and second dose of GARDASIL. The patient did not seek medical attention. At the time on the report on 27-AUG-2009 the patient had recovered. Additional information has been requested.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. The pharmacy student reported that on 06-MAY-2013 the patient was administered an expired dose of PNEUMOVAX23 (dose, indication route and lot number were not provided). No adverse effect reported. Additional information has been requested.
Stroke; Neck aches; Itching at the injection site; Soreness at the injection site; Random headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced NECK PAIN (Neck aches), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Random headaches). On 18-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), NECK PAIN (Neck aches), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Random headaches) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.   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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received on 19-JUL-2021 updated new event-Stroke and outcome of the event.; 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.
Chronic insomnia; Nerve damage; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Chronic insomnia) and NERVE INJURY (Nerve damage) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (2 weeks after 2nd dose) and Pfizer (1st dose). Past adverse reactions to the above products included DVT with Pfizer; and Fibrin D dimer increased with Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Chronic insomnia) and NERVE INJURY (Nerve damage). At the time of the report, INSOMNIA (Chronic insomnia) and NERVE INJURY (Nerve damage) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
fingers got tighter; tired; 30-40 minutes after the injection her arm kept getting bigger,getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (fingers got tighter), FATIGUE (tired) and VACCINATION SITE SWELLING (30-40 minutes after the injection her arm kept getting bigger,getting bigger) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058M21A and 039F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (fingers got tighter), FATIGUE (tired) and VACCINATION SITE SWELLING (30-40 minutes after the injection her arm kept getting bigger,getting bigger). On 05-Dec-2021, MUSCULOSKELETAL STIFFNESS (fingers got tighter), FATIGUE (tired) and VACCINATION SITE SWELLING (30-40 minutes after the injection her arm kept getting bigger,getting bigger) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that She called the pharmacist who recommended certain things and was told to call moderna or go to the ER if things got worse  No concomitant medications were used  For treatment patient used ice on her arm to help with the swelling
Overall not feeling well or like herself. Heart racing, cough and congestion, nausea, sore throat, diarrhea - was seen in the office on 10/16/13 and dx with viral illness.
No adverse effects; improperly stored vaccine, VARN AX, was administered to one patient; Assistant confirmed route of administration was "intramuscular"; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 12-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, once, via intramuscular route (confirmed by medical assistant) (lot # S002877 has been verified to be a valid lot number, expiration date 29-JAN-2021) for prophylaxis (anatomical location was not reported). The vaccine was reconstituted with a properly stored sterile diluent (lot # S000130, expiration date 23-AUG-2021).  The vaccine underwent a temperature excursion of 8.1 degrees Fahrenheit for 20 minutes. Previous temperature excursions were reported of 8.1 degrees Fahrenheit for 17 minutes and 9.5 degrees Fahrenheit for 21 minutes.  Digital Data Logger was involved in recording of the excursion. No adverse effects were reported.
This case was reported by a nurse and described the occurrence of shingles in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter was seeking information on occurrence of shingles after 1st dose of SHINGRIX. The reporter did not see shingles listed as a possible side effect or adverse reaction to SHINGRIX, but she had a reason to believe that it might had occurred in the patient (possible SHINGRIX reaction). The reporter was aware SHINGRIX was a attenuated vaccine.
VACCINE SITE REACTION DESCRIBED BY ERYTHEMA, SWELLING, HEAT AND ITCHING THAT DID NOT BEGIN TILL 8 DAYS AFTER ADMINISTRATION.
This spontaneous report as received from a medical assistant and refers to a 12 month old male patient. No information regarding medical history, concurrent conditions and concomitant therapies was provided. On 18-OCT-2017, the patient was inadvertently vaccinated with VARIVAX lot # N012487 with expiration date on 20-APR-2019 (dose and route were unspecified) for prophylaxis and PROQUAD lot # N013268 with expiration date on 25-OCT-2018 (dose and route were not provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). No adverse effects were reported. No Product Quality Complaint (PQC) was involved.
severe tenderness rt hip, temp 105 x24hr then dec 101 x 2 days;
The vial was stored in fridge post puncture; No adverse event; Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours), PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours), PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Moderna COVID-19 Bivalent after the vial had been punctured more than 12 Hours) and PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture).    No concomitant medications were reported.  It was reported that individual vials of Moderna COVID-19 vaccine, Bivalent was initially stored in the refrigerator on 22-Oct-2022. The vial was first punctured on 17-Nov-2022 at 8 AM. The vaccine was administered to 2 patients on 18-Nov-2022 at 11:43 AM and 2:23PM.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682297 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682297:Same reporter
Moderna vaccine was administered - reported by patient  G47.33 OBSTRUCTIVE SLEEP APNEA 9/3/2021 OBSTRUCTIVE SLEEP APNEA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/24/2022 OBSTRUCTIVE SLEEP APNEA J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/3/2021 OBSTRUCTIVE SLEEP APNEA G47.33 OBSTRUCTIVE SLEEP APNEA 9/3/2021 OBSTRUCTIVE SLEEP APNEA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/24/2022 OBSTRUCTIVE SLEEP APNEA J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 9/3/2021 OBSTRUCTIVE SLEEP APNEA
Sudden eyes watering; nausea; vertigo; violent body shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 14:00 (Lot number: Ew0169) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: LACRIMATION INCREASED (non-serious) with onset 05Aug2021 15:00, outcome "recovering", described as "Sudden eyes watering"; NAUSEA (non-serious) with onset 05Aug2021 15:00, outcome "recovering", described as "nausea"; VERTIGO (non-serious) with onset 05Aug2021 15:00, outcome "recovering", described as "vertigo"; TREMOR (non-serious) with onset 05Aug2021 15:00, outcome "recovering", described as "violent body shaking". The events "sudden eyes watering", "nausea", "vertigo" and "violent body shaking" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of lacrimation increased, nausea, vertigo, tremor.   Additional information: The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. The patient had not known allergies.  No follow-up attempts are possible. No further information is expected.
4 months pregnant, dizzness, sweaty shortness of breath, hearing buzzing in ears
large lump on injection site after each vaccine she had a fever for 2 weeks off and on at around 6 months of age used to say momma or DaDa lost all speech each time vaccinated complete regression happened both girls shared similar symptoms. There were meeting all developmental milestones until 6 months of age when we first saw a difference in their behavior. Days of fever, uncontrollable crying, and swelling at the injection site occured with each vaccination they recieved. Following their 3/20/2019 (MMR/DTAP/PCV 13) vaccines, symptoms dramatically worsened. They stopped responding to their names, stopped letting people hold/console them, loss of eye contact, baby babble stopped even basic "ma ma" and dada". Immune problems occured, sick more often, loose bowel movements, crying holding their abdomens, severe diaper rashes, banging their heads on the floor and walls, overwhelmed by noises / sensory issues), flicking of items with fingers These symptoms prompted us to pursue speech and occupational therapy for the girls, at which time they were diagnosed with a developmental delay.
About 30 minutes post vaccine injection started having complaints of headache. One hour later by 13:00, patient was vomiting, continued to generally feel poor (aches, chills) also experienced tingling in the throat for which she took a 50mg dose of Benadryl and required no further treatment. On 10/15/13 followed up with the patient and she was still feeling poor, but improved from the day before. It should be noted that this patient experienced similar symptoms one year prior after recieving an influenza vaccine. The time course was similar.
FLUZONE HIGH-DOSE QUADRIVALENT was given to a 43 years old adult male patient/ no AE; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from other healthcare professional and non-healthcare professional via call center via Information (Reference number- 00759924).  This case involves a 43 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 08-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (frequency: once, strength: standard, lot number: UJ715AA and expiry date: 30-JUN-2023) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event reported.  It was reported "caller would like further information regarding adverse effects on individuals under 65 years of age".  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. 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.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.9 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This is a prospective pregnancy case. This female subject was enrolled in an open label study during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV in January 2015. In January 2015, an unknown time after receiving Flu Seasonal QIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: GSK nurse practitioner administered a Flu vaccine to a pregnant patient today. Lot number/expiration date were unknown. Gestational age/due date are unknown. No other AEs were reported.
Patient felt faint after 10 minutes.  Fainted x 3 in lobby with  Involuntary movements of right upper extremity. EMS called. Patient transferred to ER.