chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart attack; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) 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.   Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was reported that reporters brother got the vaccine and had a heart attack the next day or 2. It was reported that reporter had a friend who was diagnosed with terminal cancer.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of Myocardial infarction, the next day or two after the mRNA-1273 vaccine, dose number not provided. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of Myocardial infarction, the next day or two after the mRNA-1273 vaccine, dose number not provided. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Immunizations on 9/18/07 Diarrhea started 9/22/07. Continued next day. Went to on call-9/23/07 doctor over weekend. Lost 2oz-14.4 started. Pedialyte. Follow up 9/24/07-no vomit diarrhea continues
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Date the vial was initially stored in the refrigerator was on 01-Dec-2021 and the vial did not undergo any temperature excursions.  It was reported by the reporter that, some patients had reported flu-like symptoms after receiving the vaccination, but she did not have details on that.
Rash on both hands mainly on fingers. Red, bumpy, and itchy. Because just a couple hours after the vaccine and I have never had this happen to me before.
About 3 to 4 hours after vaccine I had a fever and started feeling nauseous eventually started vomiting and that led to a systemic lupus reaction that covered me head to toe in hives. Injected with epinephrine about 16 hours later.
My son was diagnosed with Type 1 Diabetes in April, 2022.  He had been getting regular bloodwork to test for the  proper absorption of lamictal, a medication for his (mild) seizure disorder.  I was able to look back at his glucose level from this bloodwork and found that the spike in Glucose starting happening in the fall of 2021, peaking in January 2022 and staying high until he was diagnosed in April 2022.  The only change in his life in September of 2021 was the Pfizer COVID vaccine - on 8/31/21.  App. 1 month after the 2nd vaccine and has antibodies began to grow, the attack on the insulin creating pancreatic cells began.  I see a direct correlation.  Someone needs to know about this.
8 minutes after vaccine was administered she started to feel lightheaded and like she was going to faint, also felt shaky.  Was given water and laid down.  Her sister felt faint as well and she was concerned about her.  Was fine after 8 minutes.  No vitals taken.
Immediate swelling at injection site; left lower thigh, post vax of IPV. Ice applied to area. Tylenol given by mother. Pt's mother phoned on 9/13/00 and reported that the swelling had gone by the evening of 9/14/00 and infant had no further problems at injection site.
The patient complained that her arm was painful and numb around the injection site since receiving the second dose of Gardasil 9. This was persistent over a month later. I recommended that she take OTC ibuprofen and follow up with her primary care physician.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient ever tested positive for COVID-19.     On 17-Sep-2022 at 4:18 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 17-Sep-2022 at 4:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Concomitant medication information was not provided. The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle and no adverse reactions were reported. No treatment information was provided.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 2:22 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 2:22 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021 at 2:22 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. The patient did not have any adverse events and did not require any medical attention. No Problems reported from patient.   This case was linked to MOD-2021-366281 (Patient Link).
Patient received second dose of Pfizer 7 days prior to scheduled second dose.  NO symptoms or adverse reactions noted.  observed for 15 minutes with EMS.  Medical Consult on site counseled patient on signs and symptoms of when to call PCP.  Observed leaving with parent with no signs of distress. No treatment given by EMS, no transport to hospital needed.
Approx 5-6 hrs after immunization, donor experienced headache, malaise, and shakiness. Went to ER.
Employee became short of breath associated with tingling of fingers and then developed stridor approximately 20 minutes after vaccination. Epinephrine was administered and she was sent to the ER.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-JUL-2013, the patient was vaccinated with GARDASIL injection, as a first dose of human papillomavirus (HPV) series (strength, dose, route of administration, lot # and expiration date were not reported). On 04-JAN-2017, the patient was vaccinated with GARDASIL 9 injection, lot # L040054, expiration date 26-DEC-2017, as a second dose. No adverse effect was reported. No product quality complaint was involved. The outcome of the event was not reported. The relatedness between the event and suspect therapies was not reported. Additional information has been requested.
It was a burning sensation on the skin, not too deep and didn?t last too long. Started on left arm on the wrist bone. I only noticed it during the nighttime when I was sitting down. Next day, it was on the top of the fingers. Next day, it was across 3 left toes. Also appeared on top of the breast and left side of breast and body. Surface skin area and doesn?t last long. I did go to the doctor on 12/10 and Dr. scheduled me to see a neurologist in March. After that point, I felt it on the back of the right leg and on the top of the right leg. It reminds me of the heated seat of cars. It didn?t last that long, but I have felt this several times. The left fingers and left toes have the same sensation again. It?s not as often now and the steroid (10mg of Prednisone) has calmed it down, but it?s still ongoing. Not debilitating but wondering if this is a side effect of the vaccine.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 17-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
w/in 12 hrs p/vax pt exp inject site reaction @ DTaP site; nl deltoid circumference 18 cm; swelling was 24 cm; significant erythema @ the site-13x10cm; seen in office; no tx initiated; reaction persisting;
Arthralgia, Fever, Metallic taste in mouth Narrative:  Metallic taste in mouth, fever 101,  arthralgia; took tylenol; recovered  Other Relevant History:
Cold & shaking with chills, Body and muscle aches with pain from my head to my toes. My fingers even hurt too.
a couple hrs p/shot given pt became drowsy & hard to wake up & refused to eat, moaned during sleep; inconsolable, high pitched screaming 90% of the day; restless through the noc; t103-104; APAP given q 4 hrs; next morning pt acting ok;
This case was reported by a nurse via sales rep and described the occurrence of taste metallic in a 24-year-old female patient who received FLULAVAL Quadrivalent. On 22nd October 2017, the patient received FLULAVAL Quadrivalent. In October 2017, less than a week after receiving FLULAVAL Quadrivalent, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was unknown. It was unknown if the reporter considered the taste metallic to be related to FLULAVAL Quadrivalent. Additional details were reported as follows: The reporter was immunization coordinator. The patient experienced metallic taste for 20 to 30 minutes. The lot number was different for both patients. This case has been linked with case US2017GSK163228, as reported by same reporter for same events.
Patient required hospitalization due to breakthrough infection. Patient received Pfizer vaccine (2nd dose in series) on 02/10/21. Hospitalized from 09/01/21 - 09/07/21. Below is copied from discharge summary:   PATIENT is a 79 y.o. male with PMHx of hypertension, hyperlipidemia, and diabetes mellitus who presented to the ED on 09/01/2021 with shortness of breath. He was found to be COVID (+) with new 2L oxygen requirement and was subsequently admitted for acute hypoxic respiratory distress in the setting of COVID requiring supplemental oxygen. He was started on IV Solumedrol 40mg (1mg/kg) BID and high dose statin. He required increased supplemental oxygen to 5L during PT/OT evaluation on 09/01/21 and subsequently required an increase in supplemental oxygen from 2L to 4L. Remdesivir was initiated on 09/02/21. Lantus 10 units was added for more adequate hyperglycemic control on 09/02/2021. Lantus was increased to 15 units for uncontrolled hyperglycemia 09/03. Potassium elevated at 5.5 EKG normal. Lokelma 10g PO TID started on 09/03. Procardia 60mg started 09/03 for hypertension. Patient was cleared by PT on 09/02. On 09/04/2021, the patient's basal insulin (Lantus) was increased form 15 units to 25 units given his continued hyperglycemia overnight. His blood pressure has been better controlled and his potassium returned to WNL on 09/04/2021. The patient has been resting comfortably on 4 L nasal cannula during the days and having good oxygen saturations in the mid 90s. He has occasionally been put on Venti mask for overnight sleep given episodes of anxiousness and patient preference, but overall his oxygenation status has been improving. 9/6/2021 the patient had not been able to have a bowel movement for 5 days, and after having his bowel regimen escalated to Pericolace 2 tabs bid, Miralax, and mag citrate he was able to have 2 bowel movements evening of 9/6. The patient is being transitioned from IV solumedrol 40mg q12 h to oral prednisone po as of am 9/7/2021. He continues to have improvement in his subjective shortness of breath and his oxygen requirements. He will be discharged late afternoon of 9/7/21 with home oxygen and prednisone taper. It was explained to the patient and his son to closely monitor has oxygen saturation at home and that he would likely need to stay on 4 L of nasal cannula oxygen to maintain his oxygen saturation >=90% for now and will gradually be able to taper off as he recovers. Understanding was voiced and patient and family were agreeable to discharge.
swollen glands; headache; This is a spontaneous report from a Pfizer sponsored program from a contactable male consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen glands and headache on an unspecified date with outcome of unknown. He does not like to take the second dose because he got several side effects such as swollen glands and headache. He got his first dose on 17Feb2021. He was scheduled to have his second dose on 10Mar2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Saddle PE with symptoms that only started 2 days prior. No other symptoms to suggest that it was there for a long period of time. Saw Dr. on 10/25 for issues with Knee.  Patient has SOB that started on 11/4-11/5. Came to hospital on 11/6, negative for DVT. Massive saddle PE with right heart strain. AAOX4.
Bivalent Booster was supposed to be given. Pt was given Reg Pfizer vaccine
Little sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A202A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little sore at injection site). At the time of the report, VACCINATION SITE PAIN (Little sore at injection site) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products included Blood Pressure and Cholesterol medications.  No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Added second dosage regimen.
Information regarding Prevnar was received from a healthcare professional  regarding an unspecified number of patients who were perceived as crying more and louder with Prevnar versus other vaccines. Additionally, the Prevnar injection seemed to be more painful when given than the other vaccines. Dates were not provided. It was reported that a HCP felt that when giving the Prevnar injection, it seemed to be painful than the other vaccines and that the children were crying more and louder with Prevnar. The reporter did not specify dates, outcomes or the number of patients experiencing these events; additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Breakthrough case admission after 3 vaccines Pfizer 3/29/21 NO LOT#;  Pfizer 4/21/21 NO LOT#;  Pfizer 11/28/21 Lot# FH8028
nausea; I'm so tired; numbness in leg; pain in leg; weak; I don't feel good; received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021), HYPOAESTHESIA (numbness in leg), PAIN IN EXTREMITY (pain in leg), ASTHENIA (weak) and FEELING ABNORMAL (I don't feel good) in a 46-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.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021). On 17-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in leg), PAIN IN EXTREMITY (pain in leg), ASTHENIA (weak), FEELING ABNORMAL (I don't feel good) and FATIGUE (I'm so tired). On an unknown date, the patient experienced NAUSEA (nausea). On 16-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021) had resolved. At the time of the report, HYPOAESTHESIA (numbness in leg), PAIN IN EXTREMITY (pain in leg), ASTHENIA (weak), FEELING ABNORMAL (I don't feel good), NAUSEA (nausea) and FATIGUE (I'm so tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.
Moderna COVID-19 Vaccine EUA Severe dizziness - lasted  2-3 days Fever (102.5 F) - lasted 6-12 hours Chills - lasted 6-12 hours Nausea, vomiting, diarrhea - lasted approximately 12 hours Body aches - lasted 24 hours Injection site pain - lasted 4 days Headache - lasted 24 hours
Swelling in the injection site (it?s red, itches and it?s the size of a tennis ball), chills,  headache, back ache, neck pain.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 31-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 4:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 31.51.  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 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 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 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.
-Swollen, painful  lymph node in armpit  for one week after injection  -menstrual cycle came 2 weeks early that month (Jan) -Breasts swollen, enlarged at least one cup size and tender starting Feb 13th. -Menstrual cycle late in February, with  exaggerated and prolonged pre-menstrual symptoms.