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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:21 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 31.27.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 9 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, 8 AM: 34, 9 AM: 36, 10 AM: 40, 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 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.
got COVID-19 after getting the Pfizer vaccine; got COVID-19 after getting the Pfizer vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19 after getting the Pfizer vaccine". Additional Information: Respondent and husband both got COVID-19 after getting the Pfizer Vaccine. The reporter considered event was caused by suspect product. 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-PV202200019371 same reporter/drug/event, different patient;
No adverse effects reported; one patient was administered improperly stored PROQUAD; This spontaneous report was received from an administrator, concerning to a 4-year-old patient of an unknown gender. Information about the patient's concurrent conditions, pertinent medical history and previous drug reactions or allergies was not provided. The concomitant medications included sterile diluent.  On 04-OCT-2019, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) therapy type recombinant human albumin, lot number S003861, expiration date 08-AUG-2020 (dose number, route of administration and anatomical location of vaccination were not provided), for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  On an unknown date, the vaccine was exposed to a temperate excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees for 420 hours and from 15 Fahrenheit degrees to 46 Fahrenheit degrees, where the highest temperature was 34 Fahrenheit degrees, for 106 hours. The previous temperature excursion reported was from 6 Fahrenheit degrees to 14 Fahrenheit degrees for 200 hours and from 15 Fahrenheit degrees to 46 Fahrenheit degrees, where the highest temperature was 34.268 F, for 18 hours. The call was placed because of a Digital Data logger report.  No adverse effects were reported.; Sender's Comments:  US-009507513-1911USA000877:
The patient experienced chest pain and was hospitalized June 29, 2019.  He went to ER.  Troponin was elevated and was transferred to another hospital so that Cardiology could see him.  Diagnosed with pericarditis.  Patient had received the Smallpox Vaccine June 18, 2019.  Pt has been referred to Cardiology and followed by PCM as well.
I found out I was pregnant four days before getting the  Covid Vaccine.  I wa a mandated to get the vaccine or lose my job.  I got on that Wednesday. At 1:00am in the morning until Friday evening. I had very bad cramping and stomach pains I was in tears.  I took another orinagncy test and was still pregnant.  I went to  the dr. The following week and I was only 1/2 weeks pregnant when I have already tested positive so that would mean I should have been  6 weeks at the time of my drs visit.  After blood work and sonograms I went back to the dr. Two weeks later and was  5 weeks pregnant. My husband I were so happy and then the same week I miscarried and suffered severe pain again
Patient had received her Covid vaccine 15 min later she reported feelingi a scratch throat and tongue starting to swell. Vital signs taken, pt reported she has had h/o allergic reactions to some antibiotics and foods. Pt assessed no signs of tongue swelling pt stated she gets white coat syndrome. given 25 mg of Benedryl and remained on site for 45 min at which time she declined to stay longer. advised to call 911 if problems occured
Patient was given HPV4 vaccine at around 3pm. She had been sitting looking through toy box and when she stood up, around 3:10pm, she collapsed, sat down on the floor and bumped back of head on counter. We helped patient to lie on the floor, until she responded to physicians calling her name (less than 1 minute). Vitals were pulse 60, BP was 100/74, finger stick BS 81. Thereafter, we helped pt to examining table, gave juice and granola bar. Vitals at 3:45pm, pulse 56, BP 92/60, temp 98.9 (complained of chills). Dr. did a re-evaluation of the patient. She also complained of headache. Physical exam was unremarkable which included exam of head. Left in care of mother, taken to car in wheelchair. To call or go to ER, if any significant neurological deficit, fever and anything concerning.
A non-serious report of administration of expired product has been received from a Registered Nurse concerning a 22-year-old female who received FLUMIST.  Medical history and concomitant medications were not reported.  On 08-Jan-2009, the patient received FLUMIST that expired on 24-Dec-2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  On 03-Feb-2009, the reporter confirmed that the patient did not experience any late-occurring adverse events.  Additional information received on 20-Mar-2009 included Product Complaint Investigative results.
I had chills on May 19th that started around 3 am and then I had fever ranging from 99F to 100F that  I checked around 11 am. After taking a nap, around 2 pm my heart rate increased to 130 bpm and didn't come down for an hour. So I went to emergency room. Heart rate ranged from 110 bpm - 130 bpm for 5-6 hours. Then it reduced down close to 100.  No medication was given
Information has been received from a physician concerning a 4 month old female with no medical history or allergies who the morning of 14 Sep 2006 was vaccinated with a first PO dose of rotavirus vaccine s(lot 653754/0139F). Concomitant vaccination administered that day included a dose of Hib vaccine. A dose of poliovirus vaccine, and a dose of Dtap. There was no illness at the time of vaccination. On 15 Sep 2006 the patient developed severe diarrhea. The diarrhea episodes were every twenty minutes through the night. It was reported that the patient had eleven days of frequent watery non bloody diarrhea without a temperature, vomiting, emergency room or hospital visit. The patient recovered on 26 Sep 2006. Medical attention was sought. No laboratory diagnostic tests were performed. There was no product quality complaint involved.
The following day after my vaccine I was dizzy & nauseas. I started having horrible ear pain & ringing in my ears. I started to feel better after 3 days, but the ear pain was consistent. After a month went to doctor and nothing was found, the pain would come and go but there is a constant ringing.
I woke up with a headache all over the head. Head felt like it was going to explode. I took 2 extra strength Tylenol. I took another Tylenol before I went to bed. I had trouble sleeping. June 24th woke up with a headache and thought it might be blood pressure so didn't take anything that day. Went to bed with headache and took Tylenol at bedtime and still had trouble sleeping. Next day the same thing. The 26th headache was worse and not much sleep and called my PCP but they weren't open. 27th was feeling really bad, no appetite, blurry vision, nauseated, blood pressure getting really high and headache really bad. Called daughter and went to the ER 200/88. They ran some tests and gave me a bag of fluid and IV cocktail, and headache eased up from what they gave me and sent me home. They diagnosed it as migraines. I got home and ate soup and crackers and the headache returned but my blood pressure eased up. The headache continued and then I went to my PCP she treated for sinus infection and headache didn't go away. They gave me migraine medication and I took 2 doses and it didn't go away. In the main time Doctor's are still trying to figure out what's going on. Neurologist thinks it's a migraine she gave me 10 pills, I took the Ubravely and I took 6 pills and it didn't help. So I stopped taking it and called the Neurologist back. Still having the headache for 2 months. DPHT is what the Neurologist thought it could be and put me on Topamax which I've been taking and hasn't helped. Sept. 15th I go back to the Neurologist. Currently no one knows what's causing the persistent headache.
Five minutes after being administered the vaccine, the patient stated not knowing where she was and also stated to feel dizzy, but did not faint. The parent became concerned, and a bystander called emergency services. EMS arrived, after which the patient stated to start feeling better. Parent refused EMS services. Both parent and patient left without further incident. No history of adverse reactions to vaccines listed on the intake form. Unclear if this was a true adverse reaction to the vaccine or whether this was due to other circumstances.
Dr, suggested MRI of the brain and they noticed tumor; extreme lethargy; brain fog; imbalance; This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) at age of 52-year-old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced extreme lethargy; brain fog, imbalance etc. for days after 2nd dose in 2021. Dr, suggested MRI of the brain and they noticed tumor. The events resulted in doctor or other healthcare professional office/clinic visit. No hospitalization prolonged.  The outcome of events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Redness, itching, swelling, red ring around injection site, 10 days after vaccination
Information has been received from a pharmacist, referring to a 55 year old female patient with diabetes. Information about medical history and concomitant therapy was unknown. On 11-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (0.5ml, lot # R011632, expiration date 02-FEB-2020; strength and frequency were unknown) intramuscular (reported as in the vasculature) for prophylaxis (reported as inoculate against pneumococcal). On the same day, immediately after withdrawing the needle, the patient bled 1-5 milliliters of blood for 30 seconds before clotting. The pharmacist reported concern whether inadvertently piercing a vessel (it was also reported as the patient experienced bleeding more than what the pharmacist would normally expect so she thought the vaccine might have been inadvertently administered into the vasculature) (vascular injury and incorrect route of product administration). On 12-NOV-2018, the patient experienced fever, headache and vomiting. The vaccine was administered per pharmacy standing order and not at the specific recommendation of the patient's physician. The outcome of bleeding, vomiting, headache, fever and vascular injury was unknown. The causality assessment was not provided by the reporter.
Adverse reaction after 45 minutes ? right neck pain, dull headache, slight dizziness
patient tested positive for COVID; patient tested positive for COVID; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program Pfizer First Connect.  A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 17Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 27Dec2020, the patient tested positive for COVID.  The clinical outcome of patient tested positive for COVID was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events Drug ineffective and COVID 19 cannot be ruled out.
She got sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She got sick) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She got sick). At the time of the report, ILLNESS (She got sick) outcome was unknown.            The concomitant medication was not reported by reporter. Patient stated that someone she knew got the Pfizer and she herself had the Moderna and she got sick after the second dose, and she could not find the number for Moderna. The treatment medication was not reported by reporter.
received two 2nd doses on same day; A spontaneous report was received from a physician concerning a 84-year old, female patient who received Moderna's COVID-19 vaccine and was administered two second doses on the same day (MedDRA PT: extra dose administered).    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.     The patient received their first dose of mRNA-1273 on 20-JAN-2021.  On 18-FEB-2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On 18-FEB-2021, the patient received two doses on the same day. One dose was given at the health department. One dose was given at the reporter's clinic. A total of three doses were given.    Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, extra dose given was considered recovered/resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 14:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Apr2022 at 12:00 as dose 4 (booster, single) (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "recovering", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT HAS PAIN IN THE LEFT ARM (DELTOID MUSCLE AREA) AFTER RECEIVING PFIZER BOOSTER
Pt. states arm was sore for approx 10 days after Pneumo shot. Went away and now she can't move arm again.
After leaving the clinic and sitting down at his desk, patient says he felt dizzy and his hands started feeling tingly/numb.  He had someone drive him back over here and waited for a provider. At 1:59 BP 153/100, rechecked at 155/97, O2 98%, 94bpm. Lungs clear, no rash, no swelling. After about 2 hours the dizziness stopped and he left.  Pt had multiple vaccines including 1st rabies dose on 6/1/19, said he had the same reaction. Dizziness was gone same day but tingling in hands lasted 2 days.  7/18/19 he received the 2nd MMR with no reaction.
pt recv vax; w/in 1 hr became very irritable, & crying & by 12 noon had episode of projectile v;crying persisted (whining & whimpering), did not sleep well;4 episodes of v;sz lasted 11am to 9pm;resolved;to cont series of vax per mom;
10 days after vaccine administered, patient developed chest pain and shortness of breath. He was seen in the ER and found to have cardiac enzyme elevation. Hypokinesis noted on echocardiogram. Diagnosed with myocarditis. 4 day hospital stay. Normal cardiac cath. 1/04/09 On 7 Dec 2006 called regarding patient, who had an episode of myopericarditis in 2004 and since has had 2 episodes of pleurtic chest pain associated with dyspnea. He has been evaluated in the ED twisce since the initial adverse event in 2004; in Sept 2005 and in May 2006. Since then he has been doing well.
pt was sitting in pharmacy waiting area after receiving first shingles dose and complained of feeling flush; about 10 minutes later, he was  sweating and complained of nausea; Shortly thereafter, he put his head back, his eyes rolled back and he became very pale; i tapped his shoulders and called his name - he responded with mumbling; EMS was called; EMS arrived and reported the following vitals - 99% on room air, HR 54, BP 87/46; oriented x 3; ultimately,  they transported him to the hospital
soreness at the site of injection; Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INJECTION SITE PAIN (soreness at the site of injection) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness at the site of injection). On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, INJECTION SITE PAIN (soreness at the site of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose increased: 20 (High) Blood sugar elevated from 10 to 20 points..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Anaphylaxis; A spontaneous report was received from a consumer concerning a 61-year-old female patient who experienced anaphylaxis and Anaphylactic reaction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 27 Jan 2021, 3 minutes prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 030L20A) intramuscularly (arm location not provided) for prophylaxis of COVID-19 infection.  On 27 Jan 2021, within 3 minutes, the patient was hospitalized for anaphylaxis.  The patient reported she had never before experienced this type of reaction. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was unknown.; Reporter's Comments: This spontaneous report concerns a 61-year-old female patient who experienced anaphylactic reaction. The event occurred on the same day, 3 minutes after the administration of mRNA-1273 vaccine (Lot number: 030L20A, expiration date: unknown).  Treatment administered was not provided and outcome is unknown.  Based on the information provided which shows a temporal association a causal association, between the reported events and the administration of mRNA-1273 vaccine cannot be excluded.