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 48-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 10:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:04 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 48.87.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34, 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. Vaccine BUD date was 09-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 (Patient Link).
Skin: Linear vesicles on hands, arms and under breasts + urticarial rash and LMP 3/20/04. Ed: Launder all clothing in hot water. Prescription given.
Forgot to refrigerate the product and took 2 doses of the Vivotif; A spontaneous report was received from a consumer on 27SEP2022. It described a female patient of unknown age who "forgot to refrigerate the product and took 2 doses of the Vivotif" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) for immunisation. It was reported that the patient picked up Vivotif from her pharmacy on the 14SEP2022 and forgot to refrigerate the product. Reportedly, she took 2 doses of the Vivotif that were left unrefrigerated. Further, it was reported that the patient took the second dose of Vivotif on 27SEP2022 (today as per reporting). Additionally, the lot number of the product was provided as 3003687, 3003788 and the patient did not remember which lot number corresponds to her vaccine versus her husband's vaccine. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Based on the information available in the document two individual case safety reports 22000222 (wife) and 22000223 (husband) were created and cross-linked in the database.  Company comment: It was reported that a consumer forgot to refrigerate the product and took 2 doses of the Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.; Sender's Comments: It was reported that a consumer forgot to refrigerate the product and took 2 doses of the Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.
Pain at the site of injection; Fatigue and chills; Fatigue and chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the site of injection), FATIGUE (Fatigue and chills), CHILLS (Fatigue and chills) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Jan-2021 and the estimated date of delivery was 18-Oct-2021. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of injection), FATIGUE (Fatigue and chills), CHILLS (Fatigue and chills) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at the site of injection), FATIGUE (Fatigue and chills) and CHILLS (Fatigue and chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient stated, she does not want to take the second in her first trimester because of the fever aspect of the vaccine may have on her baby. Patient received the vaccine in the right arm. Patient is taking other medication.  Treatment medication not reported.
Rashes that look like streaks, fever and soreness in her shoulder where he received the vaccine.; Caller stated that he is experiencing rashes that look like streaks/caller stated that the rashes have become bigger and "more filled in; Rashes that look like streaks, fever and soreness in her shoulder where he received the vaccine.; Rashes that look like streaks, fever and soreness in her shoulder where he received the vaccine.; 20 Mcg/5 ML; Sinus Issues; This spontaneous report has been received from a consumer referring on himself, a 20-years-old male patient. His concomitant medications included haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (reported as" hameophylis B") (manufacturer unknown) and a tetanus booster (manufacturer unknown). It was reported that he did not had any pertinent medical history, past drug reactions or allergies.  On approximately 01-AUG-2021 (reported as "3 days ago"), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 20 microgram per 0.5 milliliter (reported as "20 Mcg/.5 ML") (product use issue) at a route of administration reported as injection (dose number, vaccination scheme frequency, exact route and anatomical site of administration, lot number and expiration date were not provided) for sinus issues (product use in unapproved indication).  On 03-AUG-2021, the patient experienced rashes that looked like streaks (vaccination site streaking), fever (pyrexia), and soreness in his shoulder where he received the vaccine (vaccination site pain). It was stated that the rashes had become bigger and more filled in (rash vesicular).  It was reported that the patient had a blood work done but no information or details were provided. He sought for medical attention and had been in contact with his physician.  The outcome of the events was reported as not recovered at the time of this report. The causality assessment between the suspect therapy with all the events was not reported.
Headache, Sedation, Myalgia, Fever, Diarrhea NauseaVomiting, Pain/Swelling @ injection site, Chills Narrative:
GENERALLY NOT FEELING WELL, FATIGUE, CHILLS, FEVER, HEADACHE, NAUSEA, SORE THROAT, UNABLE TO HAVE FULL ROM TO LEFT ARM, UNABLE TO SLEEP
vomiting; coughing; sore throat; This is a spontaneous report from a contactable consumer (wife). A 33-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 28Apr2021 (reported as on Wednesday) (at the age of 33-years-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications was not reported. On an unspecified date in 2021, after vaccination, the patient experienced vomiting, coughing and sore throat. It was reported, Today (at the time of report) after vaccination, the patient was having symptoms of vomiting, coughing and a sore throat. Reporter was asking should the patient go get tested for COVID or are these symptoms from the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
She is out of breath when she goes for her regular walk; She has no energy; I just don't feel good; She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),; She has constant headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 2 dosage form. At the time of the report, DYSPNOEA (She is out of breath when she goes for her regular walk), ASTHENIA (She has no energy), MALAISE (I just don't feel good), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.9 F to 99.9 F  normal temperature was 97.8 F.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient stated that after all the other Moderna shots, she had similar side effects but with previous shots the side effects lasted only 4 days.   No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750464 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750464:Case for Shot 3 and Shot 4: First Moderna Booster dose
Patients were administered the Moderna COVID 19 vaccine a day after the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna COVID 19 vaccine a day after the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna COVID 19 vaccine a day after the expiration date). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna COVID 19 vaccine a day after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter  No treatment medications provided by the reporter.   On 06 Oct 2021 , the vial was initially stored in the refrigerator . The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received states that the patient experienced no adverse events.
Fever of 100.6 degree; tiredness; Injection site soreness; headache; This is a spontaneous report received from a contactable consumer, the patient. A 39-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in left arm on 24Mar2021 at 14:00 (at the age of 39 years), as a single dose for COVID-19 immunisation. Medical history included asthma, ADHD (attention deficit hyperactivity disorder) and spinal arthritis. The patient was allergic to penicillin, amoxicillin, ceclor, erythromycin, onions and garlic. The patient received amfetamine aspartate, amfetamine sulfate, dexamfetamine sulfate, dexamfetamine saccharate (ADDERALL) and salbutamol (ALBUTEROL), both for unknown indication since unknown dates within two weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 21:30, the patient experienced fever of 100.6 degree celsius, tiredness, injection site soreness (vaccination site pain) and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events fever, tiredness, vaccination site pain and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Facial swelling and hives all over body, went to ER received epinephrine and reaction resolved.
A few minutes after blood draw and vaccine admin, pallor, diaphoresis, bradycardia, BP and pulse ox - normal.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild
I did not have an adverse event after receiving the vaccine. I tested positive for COVID-19 on 01/01/2023. I contacted my doctor and got a prescription PAXLOVID. I tolerated the medication without any issues. Later I tested positive for an upper respiratory infection with a cough. My doctor wants me to try to fight it off without any medication.
5 hrs post vax, child became shaky, lasted approx 30 mins. Limp, no fever per mom - taken to ER and seen by MD - supportive care. Dx - Seizure.
Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant. Concurrent medical conditions included Immunocompromised (immunocompromised patient).    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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP reports patient received Pfizer Covid-19 Vaccine as third dose in her pharmacy on 6 Oct 2021 as patient was immunocompromised.  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-344241 (Patient Link).
Information has been received from a 74 year old female consumer with no pertinent medical history and an allergic reaction to LEVAQUIN and AUGMENTIN and a history of shingles about 50 years ago, who on 26-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). There was no concomitant medication. On 01-MAR-2008, the patient developed two cold sores, 4 days after receiving a dose of zoster vaccine live (Oka/Merck). Medical attention was sought via a phone call. There was no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information is not expected.
Patient received 1st dose of Shingrix on 8/18 by RPH, patient called Monday to say that her  arm was red and sore, RPH advised that this was a common reaction and to ice, take pain medication, but to watch it and if it progressed to contact her provider as well as us so we can initiate proper treatment. Wed 8/21 patient arrived at the pharmacy in drive thru to pick up an antibiotic rx for confirmed cellulitis by her provider.
Within 30 I experienced accuse pain in my urinary track from my prostate to my left kidney.
can not swallow or sip water; shortness of breath/difficulty breathing; pain in the trachea; pain in the gland; pain goes to the back of the brain; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 28Jul2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 25Jun2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization and experienced a lot of pain in the joints, the shoulder and the neck. On 29Jul2021, the patient experienced cannot swallow or sip water, shortness of breath/difficulty breathing, pain in the trachea, pain in the gland and pain goes to the back of the brain. The course of events was reported as follows: About 3 hours ago, in the morning, the patient started to experience some shortness of breath, difficulty breathing, pain in the trachea, pain in the gland, which was quite strong and the patient could not swallow or sip water. The pain went to the back of the brain. The patient wanted to know if these symptoms were normal. He was 100% sure that these were due to the vaccine, because he had never experienced anything like this. When he went to see his PCP the day before yesterday he told him that after the first dose of the vaccine he had a lot of pain in the joints, the shoulder and the neck, and the PCP stated that several of his patients also had those symptoms. The clinical outcomes of the events cannot swallow or sip water, shortness of breath/difficulty breathing, pain in the trachea, pain in the gland and pain goes to the back of the brain were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt recv vax; later same day, became red, swollen & tender; pt hosp w/ cellulitis on 23jun95; WBC= 30,000; tx w/ IV atbs; discharged 5 days later; arm still tender;
Headache, Myalgia, Arthralgia, NauseaVomiting, local pain/swelling at injection site, fatigue Narrative:
vaccine was used after the thirty day being opened We have used the IPV for a patient for 2 weeks after it should have been discarded / no AE; vaccine was used after the thirty day being opened We have used the IPV for a patient for 2 weeks after it should have been discarded / no AE; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient (with unknown demographics) who received vaccines IPV (VERO) [IPOL] (lot number and Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to incorrect product storage and deteriorated drug administered.  At a time of reporting no adverse event reported.  It was reported that vaccine was used after the thirty day being opened We have used the IPV for a patient for 2 weeks after it should have been discarded  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 and Module VI of the 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.