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 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 12:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 12:01 PM, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 44.15.  Concomitant product was not provided.  On 13-Feb-2021, excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Feb-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  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 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 medication was not reported.
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 34-year-old male 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 2:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:23 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 34.91.  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 09-May-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 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.
positive Abbott BinaxNOW nasal swab test; positive Abbott BinaxNOW nasal swab test; Cough; Fever; Headache; Chills; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a representative. The reporter is the patient.  A 48 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in arm left, administration date 13Oct2021 (Lot number: EW0180) at the age of 48 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 16Mar2021 (Lot number: EN6199) as dose 2, single and intramuscular, administered in arm left, administration date 23Feb2021 (Lot number: EN5318) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included INFLUENZA taken for immunisation, administration date 29Sep2021. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Dec2021, outcome unknown; IMMUNISATION (medically significant) with onset 13Oct2021, outcome unknown; COUGH (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021); PYREXIA (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021); HEADACHE (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021); CHILLS (non-serious) with onset 22Dec2021 10:00, outcome recovered (Dec2021). The patient underwent the following laboratory tests and procedures sars-cov-2 test (23Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of COVID-19, cough, pyrexia, headache, and chills.
area over lt deltoid red, hot, swollen area 23cm x 14 cm;
autistic patient received Tdap. He experienced muscle weakness shortly after the vaccine was administered. Patient layed down pulse & O2 normal. Had patient wait 10 mins before leaving the clinic.
06/06 woke up with diarrhea, felt shaky, tired, recovered by afternoon, Had similar problems on 06/18. On 06/20 had a doctor visit, stool sample was taken for possible stomach virus, was off milk for 10 days. Pt is a dancer and after recitals on 06/24 and 06/25 complained that legs were really tired, felt weak and shaky. 06/28 embarged on family trip and especially during 06/23 - 06/30 complained that arms were falling sleep, tingly including legs. Malaise continued for rest of trip until 07/02. Mother attributed problems to tiredness due to trip. During early July pt had similar problems off and on (tingling) and then had gone away. Pt had stomach issues again in early September. Information from Follow-up report states: Spoke with pt's mom. She states that pt. is doing fine. Every now and then, she still has tingling in fingers and then it goes away. She is walking with no problem. Also pt. had developed a rash between mid July to mid August on the upper arms to lower arm to fingers and mid thigh to feet. Dr office notified. Not itchy. Started on upper arm. No pain. No previous rashes. Rash cleared without problems. Mom was told by me to follow-up with PCP if she has further problems.
Feeling sickish, dizzy 'said felt funny and then started stuttering and now is worst then the beginning in speech can not understand him.
11/19 began with typical cold symptoms. Headache, cough, congestion, and low grade fever. Tested positive for COVID-19 on 11/20. Reached out to PCP on 11/21 and it was decided that I did not need Paxlovid. Took tylenol for head and body aches and OTC cough syrup. Helped relieve symptoms but didn't resolve. It took approximately 2 weeks to recover from symptoms. Also followed up with Cardiologist 11/22.  Also, began experiencing tachycardia after first two doses of Pfizer.    Always wear masks very strictly
UrticariaPruritus, itchy throat Narrative: Symptoms occurred within 1 hour of the second vaccine dose. Treated in the urgent room.
Hives to entire body, no itching, no fever, mom will give Benadryl.
UPPER L ARM FELT HOT, RASH, ITCHY, DONOR DID NOT CONTACT CTR UNTIL 10/15/16. DONOR DID NOT TAKE ANY STEPS TO CARE FOR REACTION SITE.
Pt received ROTATEQ vaccine - dose #1 at age 8 mos. - No adverse reactions anticipated or occurred.
Fever, chills, tiredness, feeling unwell, flu like symptoms; Fever, chills, tiredness, feeling unwell, flu like symptoms; Fever, chills, tiredness, feeling unwell, flu like symptoms; feeling unwell; Fever, chills, tiredness, feeling unwell, flu like symptoms; dose 1 received on 17Dec2020 while dose 2 received on 05Jan2021; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 05Jan2021 15:30 at single dose in her right arm for covid-19 immunization. Medical history included hypertension. Concomitant medications the patient received within 2 weeks of vaccination included metoprolol and hydrochlorothiazide. The patient had known allergies to lisinopril and had historical vaccine included her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 17Dec2020 15:30 in her right arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, chills, tiredness, feeling unwell, flu like symptoms on 06Jan2021 15:30. The adverse events fever, chills, tiredness, feeling unwell, flu like symptoms result in any of the following included doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events fever, chills, tiredness, feeling unwell, flu like symptoms. The outcome of the events fever, chills, tiredness, feeling unwell, flu like symptoms was recovering.
patient has a rash on her left arm about 36 cm square. patient states that she feels warm around the rash and mild itching some time
Acting as if in pain, would not eat, then when holding her, she arched back as if she had passed out, went into Grand Mal Seizure, 3-4 minutes-Petit Mal lasting a total of 2 1/2 hours, 2 doses of Ativan did nothing, 100 mgs of phenobarbital put her brain to sleep to stop the seizure.
Blood clot at injection site in left arm. Place where I was injected still hurts and feels like there is a bullet lodged under my skin when I touch my arm.  The pain isn't as severe as it was last week but the blood clot is still there under my skin.
She developed symptoms of right lower leg pain 4 days after receiving the vaccine.  It then progressed to right chest pain, tachycardia, and shortness of breath.  She was diagnosed with a DVT and PE.
(unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSPHAGIA (difficulty in swallowing). At the time of the report, DYSPHAGIA (difficulty in swallowing) had not resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient take medicine for allergies as a Concomitant drug  No treatment medication was provided b reporter
I am a nurse practitioner who admitted a male in his late 30s to the hospital about 4 to 6 months ago. Two weeks after receiving the second Modern vaccine he developed chest pain with significantly elevated cardiac markers/troponin. Angiogram at the time was unremarkable. Symptoms were attributed to myocarditis at the time. I don?t have the patients name but could find it if needed. At the time this was not a common adverse reaction seen after Covid vaccine. Now that there?s been an increase in cases of myocarditis following the Covid vaccine I feel I should report it.
Lethargic; Legs began feeling heavy; Couldn't focus/felt like I wasn't sober/felt like she was on medication; Felt hot; Itching; Cotton mouth; Blood pressure became really low; red; Firm; Uncontrollable laughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargic), LIMB DISCOMFORT (Legs began feeling heavy), FEELING ABNORMAL (Couldn't focus/felt like I wasn't sober/felt like she was on medication), FEELING HOT (Felt hot) and PRURITUS (Itching) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Sulfa.).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2020, the patient experienced LETHARGY (Lethargic), LIMB DISCOMFORT (Legs began feeling heavy), FEELING ABNORMAL (Couldn't focus/felt like I wasn't sober/felt like she was on medication), FEELING HOT (Felt hot), PRURITUS (Itching), DRY MOUTH (Cotton mouth), HYPOTENSION (Blood pressure became really low), ERYTHEMA (red), FEELING ABNORMAL (Firm) and INAPPROPRIATE AFFECT (Uncontrollable laughing). On 23-Dec-2020, LETHARGY (Lethargic), LIMB DISCOMFORT (Legs began feeling heavy), FEELING ABNORMAL (Couldn't focus/felt like I wasn't sober/felt like she was on medication), FEELING HOT (Felt hot), PRURITUS (Itching), DRY MOUTH (Cotton mouth), ERYTHEMA (red), FEELING ABNORMAL (Firm) and INAPPROPRIATE AFFECT (Uncontrollable laughing) had resolved. At the time of the report, HYPOTENSION (Blood pressure became really low) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns a 43-year-old female with a nonserious unexpected events of hypotension, pruritus, erythema, dry mouth, lethargy, feeling hot, feeling abnormal, inappropriate affect, and limb discomfort. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient experienced pain for the first two weeks, which she thought was normal, then kept experiencing pain off and on for the next few months including numbness, heaviness, radiating pain down to her arm.  No knots or bumps were noticed.
PERIPHERAL NEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Seizure-Severe
Redness about 5 inches around site of injection, heat, pain in shoulder lasting 6 days after injection treatment: ibuprofen, BENADRYL.
intense shaking; cold; felt tired; reaction after second injection was worse; weird; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction after second injection was worse), FEELING ABNORMAL (weird), INFLUENZA LIKE ILLNESS (flu like symptoms), TREMOR (intense shaking) and NASOPHARYNGITIS (cold) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARISOPRODOL (soma) and HYDROCODONE for an unknown indication.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-Apr-2021, the patient experienced VACCINATION SITE REACTION (reaction after second injection was worse), FEELING ABNORMAL (weird), INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (felt tired). On 11-Apr-2021, the patient experienced TREMOR (intense shaking) and NASOPHARYNGITIS (cold). On 12-Apr-2021, VACCINATION SITE REACTION (reaction after second injection was worse), FEELING ABNORMAL (weird), INFLUENZA LIKE ILLNESS (flu like symptoms), TREMOR (intense shaking), NASOPHARYNGITIS (cold) and FATIGUE (felt tired) had resolved.            No treatment details were provided.
pt recv vax;cried constantly for 2 hrs;golf ball size knot on rt leg;T 102;mom gave apap;lt leg also swollen;
Patient had syncopal episode immediately after being given vaccine. Out for about 20 seconds per mom. Revived quickly with seat reclined and cool air and compress given.  Vss throughout. Observed for 30 min after. Home with parents.
Pain at injection site, fatigue, fever & chills; Pain at injection site, fatigue, fever & chills; Pain at injection site, fatigue, fever & chills; Pain at injection site, fatigue, fever & chills; Other vaccine same date product: Flu; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 18Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 18Oct2022, outcome "unknown", described as "Other vaccine same date product: Flu"; VACCINATION SITE PAIN (non-serious), FATIGUE (non-serious), PYREXIA (non-serious), CHILLS (non-serious) all with onset 19Oct2022, outcome "unknown" and all described as "Pain at injection site, fatigue, fever & chills". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaccination site pain, fatigue, pyrexia, chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a 13 year old female with hypersensitivity ("allergies") who on 27-JUL-2007 was vaccinated with a first dose of GARDASIL (lot# 658490/0802U). Concomitant therapy on 27-JUL-2007 included Menactra. Other concomitant therapy included Rhinocort.
mom reports pt vomited about 12:45 & became very pale;called PHN told to call MD;told by MD to come to ofc-pt blue around lips, t98.8 @ MD ofc;transported to hosp by amb for observation;t102.7 R;1AUG96 pt home MD felt was rxn to pertussis;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction after first dose of SHINGRIX. The reporter did not gave consent to follow up. The reporter was unable to collect any additional information.
This spontaneous report was received from two physicians referring to sever unspecified female patients of unknown age. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Approximately in October 2018, reported as within the last 6 months, the patients had finger sticks at their doctor visits in order to check their cholesterol levels. The same patients then were vaccinated with a dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis at the same office visit. The same patients fainted (syncope) after receiving dose of GARDASIL 9. The patients sought medical attention in the doctor's office. The outcome of the event was unknown. The action taken with the suspect vaccine was not applicable. Upon internal review, the event of  fainted (syncope) was considered as medically significant. The causality between the event and the suspect vaccine was not reported by the reporter. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1904USA013123.