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 47-year-old female 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 12:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 12:44 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 47.13.  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.
feeling cold Narrative:  Pt called COVID-19 vaccine adverse reaction hotline to report symptoms of cold, fever, dizziness, headache one day following the first dose of the Pfizer COVID-19 vaccine, administered on 3/9/2021. Event has been reported to database system/VAERS.
Just over two weeks after getting the first dose vaccine, I noticed a reddened and warm to the touch oval (approx 8cm x 7 cm) on my upper left arm around the site of injection. Just below, there was a stripe (approx. 9cm x 2.5-3cm) of urticaria (textured, raised, reddened). There was no physical discomfort - no itching, pain, tenderness.  Oval patch resolved within 48 hours. Stripe within 72 hours.
Caller received a full dose for the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Caller received a full dose for the booster dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AC1AC3, 025A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (Diabetic).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Caller received a full dose for the booster dose). On 29-Oct-2021, ACCIDENTAL OVERDOSE (Caller received a full dose for the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  Patient reported the he did not know if he was immunocompromised, but he went for a booster dose  Patient stated that his daughter is immunocompromised and lives with them, and stated that they are considered health care providers because they take care of her daughter, who has down syndrome, and has had heart surgeries since before her vaccination  Patient also reported that he asked for Moderna but he doesn't know if the pharmacist gave her Moderna or maybe it was Pfizer, she said she gave him moderna but the lot number didn't look like the others and called was not sure if it was Moderna.
Day 7-Red, inflamed, hot to touch, itchy and bumpy around injection site on arm.  Redness extended from shoulder to elbow.  Arm very achy.  Arm was just a little sore after the shot for about two days then there was not discomfort at all until day 7.
heavy menstrual cycle started two days after receiving the vaccine and  still continues after 19 days. Menstrual cycles were regular prior to the vaccine.
Staff had her 2nd vaccine yesterday at 2:25 pm.  Middle of the night started chill, bodyache, no fever.  Now still having chill.  Took day off today.
This case was reported by a other health professional via call center representative and described the occurrence of convulsion in a 17-year-old male patient who received BEXSERO. On 20th November 2017, the patient received the 1st dose of BEXSERO. On 20th November 2017, 2 hrs after receiving BEXSERO, the patient experienced fever. On 22nd November 2017, the patient experienced convulsion (serious criteria GSK medically significant). On an unknown date, the outcome of the convulsion and fever were unknown. It was unknown if the reporter considered the convulsion and fever to be related to BEXSERO. Additional details were provided as follows: The reporter stated that patient's body temperature recorded was 101.89 degrees. The patient was recommended to go to an emergency room but the patient did not go to the emergency department. All questions were asked but GlaxoSmithKline representative provided limited information.
I went to the Health Clinic had my 2nd shot waited the 15 mins. Went home and was fine. The next day I had a small pain in my heart and it was uncomfortable. I thought it was going to go away. The Following month went to PCP where they sent you a Kidney Dr. and they detected a heart murmur.  I see my PCP every 30 days. I still have some discomfort  but I am doing well.
Pt. reported severe joint pain and black-out 3 days after injection. Unsure if related.
Nausea, shakiness, aches.  He vomited at 4:30 pm.
Patient received her first flu vaccine on 10/28/2021, then she came in on 11/11/2021 for her booster and she thought it was a flu booster but she was really suppose to be getting her COVID booster. We administered another fluzone HD. Patient called on Monday and the PIC was off so she called back on Tuesday 11-16-2021 and she said she was having severe flu like symptoms; body aches, headache, tired and weakness. She was not running a fever but said the symptoms were starting to go away, but the past weekend they were really bad. I told her to monitor herself and if they got worse she needed to be seen in at an emergency department.
this is 1 of 2 pt from this site to devel a 4 to 6 inch area of swelling @ the inj site immed p/vax;addtl info recv 13NOV96 also devel a 6 inch area of redness, hardness, & warmth @ inj site;pt recovered;
24 hours after patient developed hives . Was seen at urgent care . Given Benadryl and Prednisone if needed
tested positive for Covid after having both Pfizer vaccinations/symptoms included fever of about 101.5 and muscles aches; tested positive for Covid after having both Pfizer vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 27Dec2021, outcome "unknown", described as "tested positive for Covid after having both Pfizer vaccinations/symptoms included fever of about 101.5 and muscles aches"; DRUG INEFFECTIVE (medically significant) with onset 27Dec2021, outcome "unknown", described as "tested positive for Covid after having both Pfizer vaccinations". The patient underwent the following laboratory tests and procedures: pyrexia: (27Dec2021) about 101.5; sars-cov-2 test: (27Dec2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101884945 same reporter/drug, different patient
cold chills over most of body lasting about9 hours.  Very painful left arm all up and down whole arm lasting about 9 hours also
I woke up Wednesday morning with awful diarrhrea and at about 3:30PM I developed terrible heartburn. The heartburn would come and leave. I finally called my doctor and went in for a visit. I was referred to a GI specialist and they added Pepcid to my medications to try and help control the heartburn.
12 hours after receiving the vaccine, my legs became numb and I wasn't able to move in my recliner.  My husband had to pull me up from the chair and walk me to the bedroom, which was approx. 20 feet from the room the I was  in.  I wasn't able to move for the next 12 hours.  After the 2nd 12 hours was over, I was able to move again, but I was very nervous (scared to death) about getting the 2nd Pfizer vaccine.  Please advise me on what I should do.
Patient reported a spotty rash on left arm from the site of the vaccination downward (approximately 5 inches in length).
Information has been received from a certified medical assistant concerning many patients that were vaccinated on unspecified dates with an unknown dose of GARDASIL and experienced sore arm after vaccination. Attempts are being made to obtain identifying information to distinguish the individual patients. This is one of two reports received from the same source. Additional information has been requested.
Quickly developing bad rash all over body. Arms, legs, stomach, diaper region, face. Got worse over the course of 3 days.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 78 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus. Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for arthralgia. The following information was reported: DIARRHEA (non-serious) with onset 19Sep2021, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset 19Sep2021, outcome "unknown", described as "Headache"; WEIGHT DECREASED (non-serious) with onset Sep2021, outcome "unknown", described as "I have lost a lot of weight recently". Therapeutic measures were not taken as a result of diarrhoea, headache, weight decreased. Additional information: Are there any prior vaccinations (within 4 weeks) reported as no. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
PT reported skin feeling like it had "bee stings," eczema, weak muscles (PT described muscles would "sink"), body convulsion, and lower back pain. PT did consent to follow up.
Pregnant; Blood Screening "High Protein Level"; Initial Report Received on 27-May-2022 and 21-Jun-2022   An obstetric nurse  reported to the HEPLISAV-B pregnancy registry that a pregnant female  received one dose of HEPLISAV-B.  The patient reported that she had a titer test run by the obstetrician and was advised to get a vaccine as she did not have immunity.    On the same date the obstetric nurse contacted the HEPLISAV_B pregnancy registry, the husband of the pregnant patient also contacted the pregnancy registry and was transferred to medical information.    The husband also reported that his wife, a 28 year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant and subsequently had high levels of protein in her blood.  No relevant medical history or concomitant medications were reported at the time of vaccination by the obstetric nurse and the husband.  The last menstrual period (LMP), estimated date of delivery (EDD), pregnancy history, and pregnancy risk factors were not reported.    On 14-Apr-2022, the pregnant patient (# of weeks of gestation unknown) received one dose of HEPLISAV-B (Lot # 937231, expiration date 14-Jan-2023, NDC # unknown) intramuscularly in the left arm.  The obstetric nurse additionally reported that on 26-May-2022, the pregnant patient returned to the pharmacy for her second dose and was advised that she would be given a different vaccine as she is pregnant.  The "RSS" provided information to the obstetric nurse about the pregnancy registry and informed her that her patient would be eligible to enroll.  The "RSS" was encouraged to provide the registry information to the patient.    The patient's husband reported that on an unknown date, after receiving the HEPLISAV-B injection, the patient had a blood screening and had a "high protein level." Therefore, she will be followed by a "high risk doctor." No other adverse reactions were reported.  No further information was provided.  Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
It is presumed pt waited the 15 minutes in the waiting room after his vaccine as instructed. However, he was found down in the parking lot - had hit his head on the sidewalk, and had a profusely bleeding head wound which required he be seen in the urgent care for wound care which included staples. He denies recalling the event, so it is unsure whether he fell, had a seizure, or if it was a syncopal event. Pt's partner reported he was likely in alcohol withdrawal d/t history of alcohol abuse and last drink 3 days prior.
On 9/25/14 patient received a flu shot at pharmacy. Approximately a week or 2 afterward she stated here arm still hurt and was instructed to take ibuprofen. Patient returned on 11/5/14 stating her arm still hurt and had been evaluated at an urgent care clinic. She states she has bursitis.
WARM, REDDENED INDURATED AREA 75mm X 75mm ON LEFT DELTOID, FIRST NOTICED BY MOTHER 2 DAYS AFTER INJECTION.  PRESCRIPTION OF BENADRYL GIVEN.
Sore throat; Cough; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous; Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 12:00 (Lot number: FFA587) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorders" (unspecified if ongoing), notes: Other medical history: Major depressive disorders; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites; "Known allergies: cats" (unspecified if ongoing), notes: Known allergies: cats; "anxiety" (unspecified if ongoing), notes: Other medical history: anxiety; "add" (unspecified if ongoing), notes: Other medical history:add; "insomnia" (unspecified if ongoing), notes: Other medical history: insomnia; "PCOS" (unspecified if ongoing), notes: Other medical history: PCOS; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites. Concomitant medication(s) included: BEYAZ; VYVANSE; BUPROPION; XANEXTRA; ZOLOFT; AMBIEN. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 19Dec2021, outcome "not recovered" and all described as "Unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous". The event "unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous" and "unusually heavy and longer menestral periods in excess of one week and extremely heavy bleeding compared to previous" was evaluated at the physician office visit.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No, Since the vaccination, has the patient been tested for COVID-19: No, Device Date : 13Mar2022.  Follow-up attempts are completed. No further information is expected.
In May 2021, I went to see my Cardiologist. He noticed my blood pressure was low. He ordered a stress test. I failed the stress test. And he then ordered a catherization - it showed I had the calcium build up in my heart. The doctor said the valves in my heart were not opening properly. He gave me medication, Isosorbide mononit ER 30 mg, but it caused me to have pain in my heart and chest. So I discontinued the medication. I have another appointment in November 2021. Prior to the Pfizer I do not remember having low blood pressure. I think I have recovered from the AEs, except I tire easily.
Red circle at injection site and other red circle on same arm appeared eight days after first shot. Itchy.
The Patient was in observation and felt faint and weak. She advised the Medic and an assessment was started. The patient was noted with a low BP. She was laid down and a response from the local ems system was started. The patient felt better, refused RX and TX, and signed out AMA.
Vaccine administered after temperature excursion; This case was received via an unknown source (no reference has been entered for a Regulatory authority or license partner) on 04-Apr-2021 and was forwarded to Moderna on 04-Apr-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      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.   No concomitant medications were provided. No treatment details were provided.
Patient presented my office with reports that she had been having some fatigue, lack of energy, lightheadedness since getting the vaccines 2 weeks prior to clinic visit.  She had been the ER twice for complaints of chest pain radiating to the left elbow and neck.  Cardiac enzymes have been undetectable in no acute ischemic changes on her EKG.  Husband also had reported some nystagmus which was present on her clinical exam.  She sees Dr. for her primary care
Chest pain over pectoral region; Tachycardia (normal HR =70BPM); 100-120 BPM at rest; Heat flashes; Chills; Rise in body temp (99.1 degree F); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 16:30 (Lot number: FF8839) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, Batch/Lot No: Pfizer EK4176, anatomical location: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 10Jan2021, when the patient was 24 years old, for COVID-19 Immunization; Bnt162b2 (dose 2, single, Batch/Lot No: Pfizer EN5318, anatomical location: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 31Jan2021, when the patient was 24 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Chest pain over pectoral region"; TACHYCARDIA (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Tachycardia (normal HR =70BPM)"; HEART RATE INCREASED (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "100-120 BPM at rest"; HOT FLUSH (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Heat flashes"; CHILLS (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Rise in body temp (99.1 degree F) ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, tachycardia, heart rate increased, hot flush, chills, pyrexia.  Additional information: Seriousness criteria-Results in death was reported as no, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store, the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reporter as no, List of any other medications the patient received within 2 weeks of vaccination: No. Adverse event: Tachycardia (normal HR =70BPM) 12 hours post booster shot =100-120 BPM at rest, Rise in body temp (99.1 degree F) ,Heat flashes, Chills ,Chest pain over pectoral region Symptoms occurred within 30 hours of booster Pfizer vaccine (9 months after 2nd shot). Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19? No. Other medical history: NA  Follow-up attempts are completed. No further information is expected.
Developed hives on her arms/trunk 3 hours after vaccine administration.  Continued to have hives every day until seen on 12/3.  Hives spread to include facial redness and swollen upper lip