chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menactra exposed to 27F for more than 3 hours due to  temperature was manually changed in the refrigerator, no advesre event; Initial information was received on 01-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174911, 2020SA174940, 2020SA174932, 2020SA174906, 2020SA174910, 2020SA173110 and 2020SA174910 (same reporter).  This case involves MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6621BA and expiration date 21-Mar-2022) which was exposed to 27 F for more than 3 hours and a 16 year old male patient received this vaccine via an unknown route at an unknown administration site on 15-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  The patient's concomitant medication was not reported.  It was an actual medication error case due to product storage error temperature too low. This error occurred due to temp was manually changed in the refrigerator (human error).  No adverse event reported at the time of reporting.  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.
pt recv vax 14AUG95 & 8APR96 pt devel chickenpox w/more than 300 lesions;pt recovered;no further details were provided;
No symptoms reported; improperly stored administered PROQUAD; This spontaneous report was received from a nurse and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) underwent a temperature excursion of 0.6 to -10 up to 8 Celsius degrees during 6 hours and 15 minutes.  On 03-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) 0.5 milliliter, lot #W024551, expiration date reported as 31-JAN-2023 but upon internal validation it was established as 31-JAN-2024 (strength, and route of administration were not provided) as prophylaxis. No symptoms were reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2308USA001053: US-009507513-2308USA000844: US-009507513-2308USA001031: US-009507513-2308USA001156:
pt recv vax 22AUG95 & 21APR97 pt devel 30 lesions therefore a more attenuated case of varicella;
are very anguish; got a stroke, they are numb on the right arm and right hand, can not write; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (got a stroke, they are numb on the right arm and right hand, can not write) and ANXIETY (are very anguish) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBROVASCULAR ACCIDENT (got a stroke, they are numb on the right arm and right hand, can not write) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ANXIETY (are very anguish) (seriousness criterion hospitalization). The patient was hospitalized from sometime in May 2022 to 11-May-2022 due to ANXIETY and CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (got a stroke, they are numb on the right arm and right hand, can not write) and ANXIETY (are very anguish) outcome was unknown.            Concomitant medications tyrod medication and blood thinner were provided. Patient stated that they were in great shape until they took the stupid vaccine. And not provided information on lot numbers for all doses. Treatment information was not provided.  COMPANY COMMENT: This spontaneous case concerns a 77 years old female patient with no medical history, who experienced unexpected serious (seriousness criterion hospitalization, medically significant) AESI event of cerebrovascular accident and unexpected serious (seriousness criterion hospitalization) event of anxiety. Event cerebrovascular accident occurred 2 days after fourth dose of mRNA-1273 vaccine. Advancing age could be confounding for the event cerebrovascular accident. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77 years old female patient with no medical history, who experienced unexpected serious (seriousness criterion hospitalization, medically significant) AESI event of cerebrovascular accident and unexpected serious (seriousness criterion hospitalization) event of anxiety. Event cerebrovascular accident occurred 2 days after fourth dose of mRNA-1273 vaccine. Advancing age could be confounding for the event cerebrovascular accident. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report was received from a 75 year old female patient reporting on herself. The patient's medical history included outbreak pain and burning sensation which occurred 3 years ago for an unknown reason and needed medical treatment. There were none drug reactions or allergies. On 15-JAN-2013, the patient was vaccinated with ZOSTAVAX, 19400 plaque forming unit (PFU), (dose and route were not reported). Lot number H014336 was an invalid lot number for ZOSTAVAX. Concomitant therapies included acetaminophen, LORTAB and ibuprofen (manufacturer unspecified). Approximately on 06-AUG-2013, also reported as "about 6 to 8 weeks ago", the patient developed shingles and experienced burning and pain in the back that spread to her breast area and manifested into rashes. The patient reported that treatment was given with an unknown blue pill and LYRICA. On an unknown date, a computerized axial tomography (CAT) and a magnetic resonance image (MRI) were performed (results were not provided). The patient contacted a physician to seek medical attention. The outcome of the events were reported as recovering. Causality was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown demographics. On an unknown date, those patients were vaccinated with the improperly stored doses of (Oka/Merck) VARIVAX injection (strength, dose, route and site of administration were unspecified). No concomitant medications were reported. No adverse event were reported. This is one of several reports from the same source. Additional information is not expected as the reporter refused any further contact.
pain and swelling in foot; pain and swelling in foot; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 29Mar2021 (at the age of 65-years-old) as dose 1, single for covid-19 immunization. The patient medical history included gout (She has gout), chronic pain in her shoulder, chronic pain in her shoulder and back. Concomitant medications included hydrocodone bitartrate, paracetamol (NORCO), hydrocodone bitartrate, paracetamol (LORTAB [HYDROCODONE BITARTRATE; PARACETAMOL]), hydrocodone (HYDROCODONE) all taken for pain in her foot from an unknown date. It was reported that, patient reporting on herself. She had her 1st Pfizer shot for Covid today. She has gout. Her doctor gave her Norco, that is generic for Lortab and it's also known as Hydrocodone. She takes it for the pain in her foot. She see's a doctor at the pain center and the medicine is given to her from there. She goes to the pain center because she also has chronic pain in her shoulder and back. After the shot today on 29Mar2021, her foot is swollen and painful and she is asking if it would be ok to take one of her pain pills. The doctor information is not the same doctor that is for the pain pills. That's her pain doctor. Patient declined to provide pain doctor information and she just wants her question answered if she can take the pills. She has so much pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approximately one week after second dose became extremely itchy. Primarily on the arms legs back. This has continued and still to this day. I scratch uncontrollably. I then have similar to hives all over in the areas I have scratched.
Severe dizziness (24 hours) headache.  Lightheaded for a few days.
Client received 1st COVID vaccine Pfizer (Lot#EW0185 expiration 05/22/21). At 4:28PM Client reports headache, no dizziness, no lightheaded, no blurred vision, no chest pain, no shortness of breath. Client has already completed 20 minutes of observation. EMT obtained vital signs blood pressure 116/71, heart rate 87, oxygen saturation 98%. At 4:33PM, RN responded to the event. Client and father reports history of asthma and no known allergies. Offered supplemental nutrition and fluids. Client accepted. Client reports to RN about no chest pain, lightheaded was improving, headache is going down. At 4:39PM vital signs are blood pressure 130/84, heart rate 96, oxygen saturation 99%. Client reports lightheaded, blurred vision, no shortness of breath. RN educated Client and father in regards to ED precautions and common adverse effects of COVID vaccine. 4:44PM vital signs are blood pressure 121/79, heart rate 92, oxygen saturation 98%. Client reports no chest pain, no shortness of breath, lightheaded is improving, headache is going down, no blurred vision, no dizziness. Client remains sitting in a chair and eating/drinking supplemental nutrition and fluids. At 4:49PM vital signs blood pressure 118/78, heart rate 89, oxygen saturation 99%. Client reports all symptoms has resolved. Client has a steady gate and is waiting for other siblings to complete observation.
Started Levocetirizine 5mg q24hrs 2 days prior to vaccine. Approximately 20-25min after receiving the vaccine developed an acute headache (top of head) and tingling/ fuzzy feel to tongue. Tongue appeared visibly more pale than normal and possibly slightly swollen. Symptoms lasted 2-4hrs (gradually improved over that time frame). Breathing/ heart rate normal during the entire time. Burnt tongue feeling lasted for 5-7 days (only noted intermittently over last 2 days). Soreness to arm noted next day (mild) and resolved after 48hrs. Started taper Prednisone dose after reaction x 10 days. No further reactions noted.
FAINTED OUTSIDE GROCERY STORE AND THIS IS 3RD TIME SINCE SHE FAINTS EVERY TIME. SHE HIT HER HEAD BUT WAS OK.
feels like her back got hit by a truck; Patient also has Stomachache, headache, nausea, low blood pressure and covid arm; Patient also has Stomachache, headache, nausea, low blood pressure and covid arm; Patient also has Stomachache, headache, nausea, low blood pressure and covid arm; Patient also has Stomachache, headache, nausea, low blood pressure and covid arm; Patient also has Stomachache, headache, nausea, low blood pressure and covid arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels like her back got hit by a truck), ABDOMINAL PAIN UPPER (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm), HYPOTENSION (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm), LIMB DISCOMFORT (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm) and NAUSEA (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm) in a 73-year-old female 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 information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (feels like her back got hit by a truck), ABDOMINAL PAIN UPPER (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm), HYPOTENSION (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm), LIMB DISCOMFORT (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm), NAUSEA (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm) and HEADACHE (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm). At the time of the report, FEELING ABNORMAL (feels like her back got hit by a truck), ABDOMINAL PAIN UPPER (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm), HYPOTENSION (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm), LIMB DISCOMFORT (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm), NAUSEA (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm) and HEADACHE (Patient also has Stomachache, headache, nausea, low blood pressure and covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
High fever 102, swollen arm. Dizziness,  extreme tiredness. migraine clusters
Patient had shot in Morning and by that Night she had Headache, Muscle aches, fever and shivering. Was in bed till 3 pm the next day when she started feeling better.
Patient reported lightheadedness and a 10 second period where he blacked out while driving his car.  Patient also reported mild sweating after regaining consciousness.
This spontaneous report was received from nurse practitioner  refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. Since 01-APR-2014 the patients were vaccinated with M-M-R II (lot number, expiration date, route and dosage were not reported). That was improperly stored. No adverse events were reported. Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Right arm erythema and pain with onset 7 days after the injection. Erythema spreading from injection site about 4 inches distal. Treating with ibuprofen and Tylenol for pain and inflammation and keflex for possible cellulitis.   I did have initial right arm tenderness for first day after injection but it resolved by the next day. Returned with erythema (redness, swelling and warmth) one week after injection
Severe body aches, uncontrolled shaking & chills, unclear thinking within 10 hours of vaccine that lasted for 24 hours.  Tylenol every 4 to 6 hours did provide some relief.
On 01/26/2021 in the morning I got a rash on my face. My face felt itchy I had bumps on my face & it was very red. I had to take Benadryl & it resolved the same day.
COULD NOT MOVE ON; FELT TERRIBLE; SWEATING; COUGH; FEELING SICK; FEVER; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JNJ041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced headache. On 07-APR-2021 21:30, the subject experienced chills. On 08-APR-2021, the subject experienced could not move on. On 08-APR-2021, the subject experienced felt terrible. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced cough. On 08-APR-2021, the subject experienced feeling sick. On 08-APR-2021, the subject experienced fever.  Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough on APR-2021, was recovering from feeling sick, and the outcome of headache, chills, fever, sweating, felt terrible and could not move on was not reported. This report was non-serious.
Patient states w/in a week (can't remember number of days ) after receiving vaccine, she broke out in a rash around neck and felt like she had fluid in her lungs.
UPPER RESPATORY, SORE THROAT, SWELLING IN THE BACK OF NECK, THRASH ANTIBIOTICS STEROIDS (PREDNAZONR), AUGMENTEN
Child under 12 months of age was given Havrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received HAV (Havrix pediatric) (batch number 95ej7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received the 1st dose of Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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: 15th Apr 2022 Reporter's Comments: The practice manager stating that a child under the age of 12 months was given Havrix.  She had no further demographics for the child.  The child was not having any side effects. The reporter consented to follow up. Additional Supportive Information: The 2 months old patient pediatric dose of havrix which led to inappropriate age at vaccine administration.
red (arm); swollen (arm); It moved up and down the arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (red (arm)), VACCINATION SITE SWELLING (swollen (arm)) and LIMB DISCOMFORT (It moved up and down the arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red (arm)), VACCINATION SITE SWELLING (swollen (arm)) and LIMB DISCOMFORT (It moved up and down the arm). At the time of the report, VACCINATION SITE ERYTHEMA (red (arm)), VACCINATION SITE SWELLING (swollen (arm)) and LIMB DISCOMFORT (It moved up and down the arm) outcome was unknown.        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.   This case was linked to MOD21-041738, MOD21-041784 (E2B Linked Report).; Sender's Comments:  MOD21-041738: MOD21-041784:
No other adverse events reported; VAQTA was administered to a patient and the vaccine was expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.     On 19-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T014590, expiration date 15-APR-2021; strength, dose/frequency and route were not reported) for prophylaxis (expired product administered). The reporter would like to know if they need to administer another dose of the product. No other adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
arm soreness/Arm hurt; headache; swollen glands; head "felt stuffy"; very weak muscles (had to be helped to the bathroom); very weak; not feeling well; very sick; This is a spontaneous report from a contactable consumer (patient).  This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 12Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 70-year-old. Medical history included Sars-Cov-2 infection (Mar2020), sick for 5 or 6 days, who knowingly has antibodies, and has donated plasma on multiple occasions, asthma but does not report respiratory symptoms, mild hypertension, migraines, vascular problems, and chronic portal vein thrombosis (PVT). Concomitant medications included linaclotide (LINZESS), hydrochlorothiazide, rosuvastatin, montelukast, levothyroxine, clopidogrel.   On 13Jan2021 at night, she reports arm soreness/arm hurt, and that when she woke up the next day she 'felt like she had Covid all over again' with: headache, swollen glands, head 'felt stuffy', very weak muscles (had to be helped to the bathroom), no fever but caller did state that she took a Tylenol. From Wednesday to Saturday she didn't feeling well, but every day she felt a little better. She has asthma - drug out my peak flow meter (as reported). No asthma sx during this whole thing. She reported adverse events and thinks some might have been stunted by the Tylenol she took after the first dose. She reported she was very sick, she still had like waves of not feeling well. She had most of the symptoms that she had was when she had Covid. She was sick, she was in bed and could not move. The most severe symptoms were on 13th and slowly each day felt better and it was until Saturday was when she really started to feel a 100 percent herself. Events were reported as non-serious. She had recently lab test within the last month or so. She had two or one and blood and everything was negative, everything was normal. Outcome of very sick and not feeling well is not recovered, while the outcome of the other events is recovering. She should receive the second dose on 02Feb2021. Information about lot/batch number has been requested.