chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My right inner ear has hot flashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (My right inner ear has hot flashes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 HOT FLUSH (My right inner ear has hot flashes). At the time of the report, HOT FLUSH (My right inner ear has hot flashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
fainting episode w/in 2 mins of inject (had also fainted 1 yr ago when accompanying sibling who recvd inject-pt did not receive immun 1 yr ago; mom reported lt sided weakness & soreness, swollen glands, sore throat, sl temp (less than 101);
became positive for Covid; became positive for Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 30Mar2021 at single dose for covid-19 immunization. Medical history was and concomitant medications were not reported. On an unspecified date, the patient was supposed to get his/her second dose of vaccine, but patient had it cancelled because patient had suspected positive last week (date not specified) and asked how long do he/she had to wait before he/she can get his/her second shot instead of fact that he/she became positive for Covid. Patient had been told 90 days. The outcome of the events was unknown.   Information on lot number/batch number has been requested.
Received dose #1 of COVID-19 vaccine Moderna on 1/02/21. I was estimated to be 4 weeks pregnant at that time. Estimated due date 9/08/21. I experienced tenderness of injection site for approximately 48-72 hours after injection that resolved. Since 1/10/21 I began experiencing mild tenderness, redness, itching, and warm at the injection site again.
mom states pt devel hives on legs & stomach 1 hr p/receiving immun the following day hives progressed to back; No called us 4 dasy p/immun pt still had hives, but ehy were fading;
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 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 8:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:36 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 79.60.  No concomitant medications were reported.  On 31-Mar-2021, excursion time was 8 AM, temperature was 32 and 9 AM, temperature was 32. Total doses given for the day was 199, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. 4 vials were sent to clinic on 31-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. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medications were reported.
Hernia mesh implant inguinal started becoming sore after second shot; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 19Feb2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The relevant medical history included hypertension (HTN), asthma, penicillin (PCN) allergy and allergies (unspecified). The concomitant medications included olmesartan medoxomil (BENICAR), nebivolol hydrochloride (BYSTOLIC) and triamterene (MANUFACTURER UNKNOWN) all taken from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had hernia mesh implant inguinal that had become sore after the second shot on 22Feb2021 and was still hurting at the time of reporting. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event implant site pain was not resolved at the time of reporting.   No follow-up attempts are needed; information about lot number cannot be obtained.
Information has been received from a health professional and from a medical record which was reviewed concerning a four month old female infant who on 02-JUN-2008 was vaccinated with a first dose of ROTATEQ.  On 02-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ.  Concomitant therapy included Hib conj vaccine (OMPC) (manufacturer unknown), PEDIATRIX, PREVNAR and FLUZONE.  It was reported in the medical report that the infant visited the doctor's office on 18-JUL-2008.  The mother reported that her baby experienced mattering of left eye with redness for the last two days.  The infant also had runny nose.  She was treated with VIGAMOX one drop twice daily for five days and treated both eyes.  The infant had a very small bony prominence redness or pain noted.  The healthcare professional would continue to monitor the event.  No treatment was ordered.  The mom was instructed to call the office if symptoms worsen or had any new concerns.  On 06-AUG-2008 the patient  was seen in the doctor's office.  It was reported that the baby experienced fussiness, irritability.  Her nose was mildly congested and her throat was red.  The infant had a positive strep test.  Laboratory test result showed the infant's white count was elevated (14.4 10^3/uL).  She was treated with OMNICEF 125 mg per 5cc, 3cc a day for ten days.  On 10-SEP-2008 the infant came to the doctor's office and noted to have nasal drainage and fussiness.  It was reported that she had nasal drainage and fussiness for the last two days and had cough.  It was reported that the infant had mild right  ear effusion, sinusitis and mild external swelling of the ear canal.  She was treated with AMOXICILLIN 125 mg, 5cc three times a day for ten days.  The mother reported that on 10-OCT-2008 the infant was vaccinated with FLUZONE in the office in her thigh.  The infant came to the doctor's office on 22-OCT-2008 and it was reported that she experienced non productive cough, rhinorrhea.  There was no sign of infection.  At the time of this report the outcome of the events were unknown.  Additional information is not available.
dizziness, headache, sl vomiting, also some local erythema; had to leave work 2NOV92;
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a patient (age and gender not reported) who experienced allergy, while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, Exp. Date, route and administration site not reported). On an unknown date, the patient developed a non-serious tetanus toxoid (allergy) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Details of lab data not provided. Final diagnosis was tetanus toxoid allergy. It was not reported whether the patient received any corrective treatment. The event outcome was not reported. List of documents held by sender: none.
No adverse event; Was vaccinated with ENGERIX-B instead ofGARDASIL 9.; This spontaneous report was received from an administrator and  refers to a patient of unknown age and gender. No information was given regarding the patient-s concurrent conditions, concomitant medications or medical history.     On 23-JUL-2019, the patient was vaccinated with  hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B) for prophylaxis instead of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number and expiration date were not reported). However, no adverse effects were reported.
Pain at injection site Flu symptoms Nausea Sore swollen  lymph glands left underarm which resulted in bruising
PATIENT CAME IN TO CLINIC FOR COVID -19 VACCINE. PATIENT WAS GIVEN "SECOND" DOSE. WHEN DOCUMENTING THE "SECOND" DOSE, A FLAG CAME UP STATING THAT THE FIRST DOSE NEEDED TO BE DOCUMENTED. STOPPED DOCUMENTATION AND ASKED THE SUPERVISOR WHY THE FIRST DOSE HAD NOT BEEN DOCUMENTED. THE SUPERVISOR DID SOME RESEARCH AND THE PATIENT HAD ALREADY RECEIVED THR SECOND DOSE. SOMEONE INADVERDENTLY TOLD THE PATIENT HE HAD TO START HIS VACCINE ALL OVER SINCE IT WAS MORE THAN 3 WEEKS SINCE HIS FIRST DOSE ON JANUARY 13. HE ACTUALLY RECEIVED HIS SECOND DOSE ON 3/20.
Contracted COVID in (withheld) on 01Jun at dinner. Became symptomatic 03Jun, had PCR test done 04Jun and results showed positive on 05Jun; Contracted COVID in (withheld) on 01Jun at dinner. Became symptomatic 03Jun, had PCR test done 04Jun and results showed positive on 05Jun; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose number unknown (booster), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID in (withheld) on 01Jun at dinner. Became symptomatic 03Jun, had PCR test done 04Jun and results showed positive on 05Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had PCR test done 04Jun and results showed positive on 05Jun.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Vaccination failure and Covid 19 cannot be completely excluded.
About 12 hours after my second dose of COVID, I began to have mild flu symptoms: 99+  fever, mild chills, aches, and fatigue (Tuesday) Nothing horrible, but definitely undesirable and had to lay down to rest in the afternoon - missed 2 hours of work. Felt badly the entire next day (Wednesday).  Woke up on the third day(Thursday)  feeling 80% better. By the end of Thursday, I was about 90% feeling better.  Friday, the fourth day was nearly 100% feeling fine.
Patient presented with fatigue and SOB starting about a week after vaccination.  Was admitted to hospital SOB. No evidence of TTS.  Progressive ARDS and death in 2 weeks after admission.  Microbiology negative. No aetiology identified.
Red, raised welt area that increased over 24 hour perior to the size of 5" X 8". The diameter of her arm increased by 4". Area was hot to touch and temperature strip to area was 103F. Oral temperature was 98.6. Also, had itching.
HEALTH ISSUES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced health issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of health issues was not reported. This report was non-serious. This case, from the same reporter is linked to 20221118772.
Patient was administered a Moderna Covid vaccine with  published expiry date 10/15/2021.  Pt. was monitored 15 min after injections.  Pt. tolerated well.  No complications or adverse reactions noted at this time.
Pt. receive PNEUMO-PS in Rt. deltoid on 10/25/11. In the evening of the 25th arm appeared swollen, red and tender to the touch. Rt deltoid continues to have the same appearance two days later.
For 3 solid days, I had EXTREME pain . I was unable to lie down for 3 days and nights following the 2nd Moderna injection. The location of the pain was anywhere I had had issues before physically. Example: I had knee surgery...(my left  knee felt like it was burning!  Anywhere on my body that I had a surgery was burning ?? every joint in my body was burning. I had to stand and rock back and forth for three days. I could not lie down! I had some left over pain pills from an ongoing r arm issue( which was also BURNING after the 2nd Moderna Covid shot), that I took (Hydrocodone) to try and relieve some of the pain, but it didn?t even address the pain level one bit! I was miserable. I am terrified to get the booster shot. I did not go to the doctor. What?s the point? They won?t report it.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # M007764, expiration date 30-JAN-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Product quality complaint was not involved. The administered dose of vaccine was stored in the temperature of 33 degrees Fahrenheit for 4 days and 19 hours. There were no previous temperature excursions reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
inappropriate vaccine schedule; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: This case was reported via chat.  The age at vaccination was not applicable for this report. The age group adult selected as per vaccine specification.  A pharmacy tech reported that a patient was outside the six month window for the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up.  The reporter declined to provide information.
At 3:30 PM on February 12, 2021, after receiving the Moderna second dose at 10:45 AM, I developed a very bad headache and overwhelming fatigue.  The headache worsened, and by 4:30 was throbbing.  Around that same time, I developed muscle aches in both arms, shoulders, back and knees, not unlike the onset of flu.  My temperature, normally 96.7, , was rising through the evening to 97.3, 97., 97.6, and 97.9 during the evening.   I was nauseous and had lost my appetite.  My temperature was rising and by 7:30 was 98.  I went to bed at 7:30 and woke up at 11:00 PM.  My heart was pounding, the backs of both of my arms were hot to the touch.  I checked my smartwatch and my heart rate was elevated to 110-120 bmp sustained.  My resting heart rate is normally 60-70.  I was short of breath and had shaking chills.   I woke my husband and asked him to help me - I was scared.  My heart rate remained very elevated through the rest of the night and well into the following day but the shortness of breath subsided.  It did not come down below 90 until the later afternoon of February 13, 2021.  The headache did not resolve until Sunday morning, February 14.  I am still quite tired and a little achy, but all other symptoms have resolved.  I considered going to the ER but decided it was an expected reaction to the  vaccine.
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 46-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 14-Feb-2021 at 3:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 3:43 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 46.07. Concomitant products were not provided. Treatment medications were not reported.  Batch number 031L20A vial underwent temperature excursion on 14-Feb-2021 with temperature 35 degrees Fahrenheit from 03:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976 (Patient Link).
1405: pt. was found slumped in her chair in the waiting room.  She was escorted back into the patient care center where the vaccine was administered. She was placed in a chair where she was moving her head back and forth d/t her dizziness. 1414: Patient requested to lay down on the floor. 1420: patient requested to be escorted to the restroom.  RPH escorted her to the restroom.  Got halfway to the bathroom and she got down on her knees d/t feeling dizzy. She spent 15 minutes in the bathroom and at 1435 she went home. She claimed she felt better. The next day the RPH called the patient and she said she feels better.  Not dizzy any more nor did it return when she left the pharmacy the day before.
Sore weak thumb joints with a popping sensation (this also occured after initial vaccine doses). Swollen sore armpit (lymp nodes?) only on left side side of vaccination (this was a new symptom with just this booster dose).
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 22-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Fever-Medium, Additional Details: patient thinks the reaction is from flu shot, however, appears like its actually a somewhat common reaction to the shingles vaccine
Mother phoned 12/11/07 stating when patient woke up at 9AM had a fine generalized rash over entire body.  No fever.  Has been on Amoxicillin & Albuterol for URI since 12/3/07.  Hx of asthma & eczema.  Referred him to another facility.  He was seen there on 12/11/07, dx with macro-papular type eruption.  Unsure if secondary to varicella vaccine.  Benadryl ordered TID & to return if no better.  Pt never returned.  Phoned 1/4/08, spoke with grandmother & he is doing fine.