chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:50 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.06.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 9-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976.
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 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Feb2023 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Jan2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 19Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 05Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 03Jun2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: mold" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: 15Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 13Oct2023 to 18Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353185 Same patient, different product, different event;
Over sleeping; Congestion; Severe lethargy; Night sweats; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Aug2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine/dexamfetamine (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Aug2021 at 07:00, the patient experienced severe lethargy, over sleeping, night sweats, and congestion. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe lethargy, over sleeping, night sweats, congestion was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
PATIENT STATES HE DEVEOLPED A RED RASH AROUND THE AREA THAT BECAME LARGE ENOUGH TO CAUSE CONCERN TO GO THE EMERGENCY ROOM TO HAVE IT LOOKED AT.  PATIENT STATES THE PHYSICIANS DIAGNOSED HIM WITH CELLULUITIS AND PUT HIM ON AN ANTIBIOTIC.
Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 02-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Pt age 19, male, four days after his second dose of Pfizer vaccine had chest pain, shortness of breath,. He was admitted for two days to the hospital and had a work up. He improved with no official diagnosis and was released.
Information has been received on 10-JAN-2017 from a nurse regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, an unspecified number of unspecified patients were vaccinated with doses of VARIVAX (Lot number M033214 expiration 13-JUL-2018, lot number M034584 expiration 27-JUL2018, lot number M028552 expiration 07-JUN-2018, and lot number M009766 expiration 23-FEB-2018) for prophylaxis which were improperly stored. The vaccine doses were exposed to -12.7 C for 2 hours 3 minutes, -13.1 C for 1 hour 43 minutes and -12 C for 2 hours 17 minutes. No adverse effected were reported. No additional information was provided. Additional information has been requested.
4/9/21 5:00 PM- back of head headache started, Took Tylenol.  6:00 PM worse headache ever had started vomiting. 7:00 PM headache and vomiting continued layed on bathroom floor could not get up cold and sweating. 11:00 PM made it to my bed and was freezing, shivering and sweating until approx. 8:00AM 4/10/21.
Little discomfort on muscle; Felt very sleepy; Eye lids feel tired, they feel heavy; Dizziness/Lightheaded when she gets up; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little discomfort on muscle), SOMNOLENCE (Felt very sleepy), ASTHENOPIA (Eye lids feel tired, they feel heavy), DIZZINESS (Dizziness/Lightheaded when she gets up) and FATIGUE (Felt very tired) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Dizziness/Lightheaded when she gets up) and FATIGUE (Felt very tired). On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little discomfort on muscle), SOMNOLENCE (Felt very sleepy) and ASTHENOPIA (Eye lids feel tired, they feel heavy). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Little discomfort on muscle), SOMNOLENCE (Felt very sleepy), ASTHENOPIA (Eye lids feel tired, they feel heavy), DIZZINESS (Dizziness/Lightheaded when she gets up) and FATIGUE (Felt very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, chills, loss of appetite, injection site soreness. Narrative:  Three hours after receiving her second dose of the Moderna COVID-19 vaccine, the patient experienced the following symptoms: injection site pain and swelling, a fever (temperature unknown), chills headache, nausea and vomiting, and loss of appetite. She reports taking acetaminophen 650mg every four hours following her reaction. Four days later, she followed up with her primary care physician.
Face began to swell; Developed a rash; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 08:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and asthma. The patient previously took  Augmentin and Pediazol and experienced drug allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 08:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 09:00, within an hour of receiving the second dose, the patient face began to swell and developed a rash. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event face began to swell was resolved (within 48 hours) on 11Apr2021 and developed a rash was resolved (within 120 hours) on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Baby developed rash almost immediately after receiving immunizations. Parents also reported baby acting tired and sleepy. Child's pediatrician notified 12/08/2005 rash gone, baby has low grade fever 100.
Itching arm; Place around the injection is red; Diameter of 3-4 inches around - swollen; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE PRURITUS (Itching arm), VACCINATION SITE ERYTHEMA (Place around the injection is red) and VACCINATION SITE SWELLING (Diameter of 3-4 inches around - swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching arm), VACCINATION SITE ERYTHEMA (Place around the injection is red) and VACCINATION SITE SWELLING (Diameter of 3-4 inches around - swollen). At the time of the report, PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE PRURITUS (Itching arm), VACCINATION SITE ERYTHEMA (Place around the injection is red) and VACCINATION SITE SWELLING (Diameter of 3-4 inches around - swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Moderna Covid-19 Vaccine EUA. Habe swelling , pain, redness, blisters in rash from shot site down to elbow on left arm. Spreading all around the upper limb and in to underarm area. Also spreading to 5 different areas on fingers and hands.
On evening of 10/21/09 pt developed a fever up to but > 101 degrees, generalized body aches and fatigue. Self treated with TYLENOL and by 10/23/09 symptoms had resolved. (Pt requests VAERS be filed)  10/28/09 Medical records received service dates 9/30/09 to 10/17/09. Assessment: Fever and body aches. Patient reports fever and body aches the evening after receiving the H1N1 vaccine. Much improved today.
mom states was throwing up & wouldn't take bottle & was crying a lot;went to ER & temp was 101 & was given med & kept overnight;
Diarrhea; Itching; Couldn't control legs, like they were rubber; Feeling sick; Fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), PRURITUS (Itching), LIMB DISCOMFORT (Couldn't control legs, like they were rubber), MALAISE (Feeling sick) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2019 and COVID-19 (she had COVID-19 the first week of December, and she also had it back on March) in March 2020. Concurrent medical conditions included Blood pressure abnormal, Depression and Cholesterol total abnormal NOS. Concomitant products included POTASSIUM and VITAMINS NOS for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (Itching), LIMB DISCOMFORT (Couldn't control legs, like they were rubber), MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PRURITUS (Itching), LIMB DISCOMFORT (Couldn't control legs, like they were rubber), MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 105 °F (High) (105°F).     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.   Concomitantly, patient was taking medications for blood pressure, depression and cholesterol.
This case was reported by a consumer via call center representative and described the occurrence of tinea in a 82-year-old female patient who received Shingrix for prophylaxis. On 13th August 2018, the patient received the 1st dose of Shingrix. In September 2018, between 2 and 3 weeks after receiving Shingrix, the patient experienced tinea. On an unknown date, the outcome of the tinea was unknown. It was unknown if the reporter considered the tinea to be related to Shingrix. Additional details were received as follows: This case was previously reported to the physician. The age at vaccination was not reported. The reporter was a patient. The patient experienced ringworm infection on her body that developed a week ago and was seen by her physician.
Fast heartbeat, sharp pain in head, dizziness, slight difficulty breathing for about 5 minutes that passed slowly.
10 mins after receiving 4 mos immz client developed localized rash below the knee bilaterally to anterior legs. FOC stated client received 2 mos immz. and no Rxn developed. Client observed in clinic: Temp 97.1, no difficulty breathing, no swelling to face or extremities. Within 10 mins of observation rash began to clear on Rt. leg. No Tx needed informed parents on s/sx of allergic Rxn; instructed parents to continue to observe client and if s/sx develop to take client to ER. Parents acknowledged understanding and agreed.
I95.9 HYPOTENSION 4/12/2023 ACUTE CHOLECYSTITIS
First shot muscle body ackes woke me up, lsdted a couple of days, second shot had a high resting heart beat for a few days and still a month later i have severe body muscle aches feels like the shot woke up my inflammatory system and hurts like arthritis
Patient came to emergency room with shortness of breathe, low grade fever, light cough Lipitor, Tylenol, Aprefoline, patient is still in emergency room
given in error a KINRIX vaccine; error a KINRIX vaccine she was a 41 year old female; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 41-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5R3KX, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-AUG-2022. Reporter's Comments: The reporter stated that the patient in their care was given in error a Kinrix vaccine. She was a 41-year-old and was to get a TDAP. The reporter gave consent to follow up. Additional supportive Information: The 41-year-old patient received in error a Kinrix vaccine instead of TDAP, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about May 2016, the patient was treated and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Breakthrough case of COVID, I felt really tired and aching, then I got the worse sore throat of my life, headache, body aches and dry couch. The dr. prescribed Paxlovid, and it is helping with the sore throat, but I still have dry cough and really tired and get lightheaded when I am standing up.
Headache; Right arm, itchy / in the right arm, site of the vaccination, it's itchy.; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in right arm on 05Apr2021 (at the age of 61 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Vaccination facility type was military base. Prior vaccination (within 4 weeks) and adverse event following prior vaccination was none. No other vaccines were received within four weeks prior to the administration of bnt162b2. On 05Apr2021, the patient experienced fever and weakness, on 06Apr2021, the patient experienced headache and right arm, itchy / in the right arm, site of the vaccination, it's itchy. Additional context received as, the patient states she had the vaccine on 05Apr2021 afternoon, the patient doesn't see an expiry date also states she can't read NDC or LOT because of it being so small. The patient does verify information is handwritten on card. The patient does locate LOT and provides it. Overnight she has had fever, still has a headache and she woke up today with headache, her headache is not serious because she has Tylenol and her headache was persisting, even with taking Tylenol. The patient states she can't read the LOT of Tylenol. Patient states LAD16, FLA, she doesn't know if its a 0 or 15. Caller states expiry date is JUL 2022. UPC: The patient states they are really small, she can't read it, she can't see them because it is too small. Caller states bottle has 400 tablets. Dosage on each tablet is 500mg. The patient took one, 500mg tablet, and she takes it every four hours. Tylenol strength and count size dispensed: 400 tablets, 500mg tablets, she takes one, 500mg, every four hours. The patient was weak after the vaccine and weakness was started after three hours of the vaccine. The patient also states in the right arm, site of the vaccination, it's itchy, this started this morning when she woke up. No relevant tests. The report was non serious. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Around 7:00 pm I started having severe chills, with my fingers being so cold they were throbbing and numb. I then started shaking. After putting on warm coverings (sweats, hat, gloves, robe and blanket), I turned the heat on. The shaking persisted for about an hour, with shortness of breath. The pain in my fingers lasted about three days (minus the numbness and throbbing). I took Tylenol for the fever and pain. About 3:00 am Tuesday morning I woke up sweaty. I was also extremely weak until Tuesday late afternoon. My knees were also hurting during this time. I started feeling better Thursday.