chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date).    The case was for Patient 5 out of 12 Patients.  No concomitant medications were reported.   It was reported that the vial size was 2.5 ml. On 12-Jun-2023, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The reporter asked to escalate the case to Tier-2 for a lot analysis.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Live Significant follow-up appended: Reporter added, Patient details updated, Suspect product details updated, Event verbatim updated and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Patient 1
NONE  Patient had Pfizer shot in May and wanted second shot. She thought she had Moderna and so we gave Moderna
Throwing up all day-started 2hrs after the vaccine.; This is a spontaneous report from a contactable non health care professional, patient. A 44-years old male patient received BNT162B2{COVID-19 MRNA VACCINE BIONTECH} [batch/lot number# 6205], via unspecified route in the left arm on 03Mar2021 for COVID-19 immunisation. Medical history included high blood pressure, dilated ventricle, ascending aorta dilation and left ventricular hypertrophy. Concomitant medication included lisinopril HCTZ (unknown manufacturer). The patient experienced "Throwing up all day" which started two hours after receiving the vaccine on 03Mar2021. The patient underwent Nasal Swab test twice, on 07Mar2021 and 13Mar2021, both reported as negative. The patient had not been diagnosed with COVID-19 before vaccination. The patient underwent PCR test for COVID-19 after the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have any allergies related to medication, food, or other products. Patient received anti-nausea medication as a therapeutic action for the event. The clinical outcome of the event was reported as recovered. No follow-up attempts are needed. No further information is expected.
developed congestion, sore throat 10/19/21- tested positive for COVID on Binax rapid antigen test 10/21/21 reports loss of taste/smell, remains at home
About 3 weeks after second does the person tested positive for Covid; About 3 weeks after second does the person tested positive for Covid; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. About 3 weeks after second does the patient tested positive for covid. The adverse events result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included monoclonal antibodies. The outcome of events was unknown.  Information on the lot/batch number has been requested.
7 am 12/28/22 felt leaning towards rt. side, couldn't control rt. arm, extended to rt. leg and facial droop.  went to ER by 7:45 AM, started stroke protocol, CT scan done, given TNK.  transferred to main hospital, admitted to hospital. continued improvement and went home 12/30/22
12 hours later, severe shivering, body aches . 18 hours large red patch, heat, pain when moved, body aches. 36 hours minor shivering. 48 hours redness and body aches reduced. 60 hours later, reactions have resolved (yay!)
Consumer missed second dose, on 55th day today; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer missed second dose, on 55th day today) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer missed second dose, on 55th day today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer missed second dose, on 55th day today) outcome was unknown.        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.
hot flash; migraine; red rash; aches around body; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flash), MIGRAINE (migraine), RASH ERYTHEMATOUS (red rash) and MYALGIA (aches around body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 011M20A and 002B21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM (XANAX), ALBUTEROL [SALBUTAMOL], DULOXETINE HYDROCHLORIDE (DULOXETINE HCL) and TRAZODONE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced HOT FLUSH (hot flash), MIGRAINE (migraine), RASH ERYTHEMATOUS (red rash) and MYALGIA (aches around body). At the time of the report, HOT FLUSH (hot flash), MIGRAINE (migraine), RASH ERYTHEMATOUS (red rash) and MYALGIA (aches around body) outcome was unknown.            No treatment medications provided.
Shingles started on upper body right side on 11/25/2020, all healed by 01/05/2021 PHN had been slowly receding, since the vax PHN has increased in pain and irritation  and getting worse
SINCE 3-2-90 PT EXP STIFF NECK, FEVER, VOMITING, SORE THROAT, SWOLLEN GLANDS, PAIN IN EARS WHICH ARE FULL OF FLUID. TREATED /W/ AMOXIL,TYLENOL 3,TYNATAN.SORE THROAT GONE. SOME SYMPTOMS PERSIST.
Developed normal side effect symptoms from the booster within 24 hours such as fever, chills, arm soreness, axillary lymph node were swollen.  (Did not have any symptoms with the first two moderna vaccines).   On 01/02/2022 developed severe itchiness to back of neck and shoulders, with rash/hives present.  Both itching and rash/hives are still present today. If I ignore the rash, it disappears within 30 minutes from that area and appears elsewhere.  Saw. Dr.  (allergist/immunologist) he diagnosed me with spontaneous idiopathic urticaria and told me to take Allegra BID, Xyzal BID, 6-day taper of solu-medrol. No difference with rash after 2 weeks check up. He told me to continue with the Allegra and Xyzal, and also prescribed me Doxepin to take QN.  Been taking those not sure if rash is getting better or same..   Of note, my father got his moderna booster back in November 2021  and developed similar rash as mine a week after his vaccination as well. He saw his PMD and was given solu-medrol 6 day taper for that rash,  and to this day he still has the rash.
Injection site hard and red, loose, watery stools 5 or 6 times a day.
Arm is red; Running a fever of a 102.7; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date for COVID-19 immunisation. It was reported that when the patient got his Pfizer shot on Saturday, the second dose. His arm was red and running a fever of a 102.7 but the rest of him was fine. The patient didn't think its anything. Outcome of the events was unknown.  Information about lot/batch number has been requested.
About an hour after vaccine pain in arm, up to shoulder and up to back. Pain worse this morning. No treatment.
This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a patient who received FLUARIX QUADRIVALENT for prophylaxis. On 18th October 2018, the patient received FLUARIX QUADRIVALENT. On 18th October 2018, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced vomiting, nausea and diarrhea. On an unknown date, the outcome of the vomiting, nausea and diarrhea were unknown. It was unknown if the reporter considered the vomiting, nausea and diarrhea to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at the vaccination was not reported. The reporter was reached out to by their medical director because they had a patient presented the day before reporting within 1 hour of receiving the vaccine with what was considered grade 3 gastrointestinal symptoms (vomiting, nausea and diarrhea). This typically was not a side effect they had seen with flu vaccine, but they realized it was listed. This case was linked with the case US2018GSK192188, reported by the same reporter.
Patient arrived for COVID-19 vaccination at 14:30 on 08/16/21. Patient had previous serious reaction to Moderna COVID-19 mRNA Vaccine on 03/08/2021 requiring hospitalization. CDC guidelines for use of Janssen COVID-19 vaccine following allergic reaction to mRNA vaccine was utilized. Patient pre-medicated with Pepcid 20mg and diphenhydramine 25mg prior 30 minutes prior to arrival at the pharmacy and the patient's mother was present. Epi-pen was on hand as well.  After recieving the vaccine, patient reported nausea and cold extremities. Patient developed erythema on the chest, back and throat. Patient reported feeling "hot" and experienced diarrehea. Patient reported difficulty swallowing and was transported to ER for further treatment. Epi-pen was not utilized in pharmacy, and patient's time in the pharmacy was approximately one hour before transit to ER. Patient reported via text message experiencing muscle pain and a migraine. Patient was stable at Hospital and reported receiving diphenhydramine, promethazine, methylprednisolone, magnesium, epinephrine, Toradol, and IV fluids. Patient is currently hospitalized at the time of this report (one day later). Patient was NOT contacted by the VAERS system previously regarding her adverse event on 03/08/2021 with the Moderna COVID-19 mRNA vaccine. Patient's VAERS for that event is 1247355.  I submitted two reports regarding that adverse event.
about a day or 2 later after the fluzone hd the patient arm started to ache. It is affecting the mobility of the arm and affected his sleep. He says he gets some relief when he put a pillow under his arm to sleep. this ache has been going on for at least 10 days at this point.
unresponsive, possible seizure, flushed skin, clammy, slight foamy mouth
We had a patient who reported a massive heart attack four days after the vaccination; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient experienced we had a patient who reported a massive heart attack four days after the vaccination. It was reported that. We had a patient who reported a massive heart attack four days after the vaccination, but it wasn't looked by the doctor at because it wasn't within the 48-hour time frame. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Myocardial infarction and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Narrative:  58yr transferred from hospital to another hospital for further management of COVID-19 (symptoms: cough, chills, sore throat, and tested positive for COVID-19 5 days prior) in setting of requiring new oxygen supplementation upon arrival to hospital at 1-2L NC and elevated inflammatory markers, and bilateral opacities on CXR. PMH (high risk conditions): HTN. COVID Vaccination Status: Janssen March 2021. COVID Therapeutics: Dexamethasone 6mg daily. Discharge at day 2-stable condition and no longer required oxygen by day 1.
My arm hurt where shot was given, especially when reaching or using. Also had slight headaches which I never have.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported) for the prevention of shingles. Other suspect and concomitant therapies were not reported. On an unknown date after receiving ZOSTAVAX, the patient experienced rash generalized. It was unspecified it the patient sought medical attention, if treatment was given for the rash generalized and if lab diagnostics studies were performed. The outcome of rash generalized was unknown. The relatedness between rash generalized and therapy with ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to 2 patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unspecified date, the patients were vaccinated with doses of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, after receiving GARDASIL, the patients developed reactions "similar" to the patient, who experienced soreness "1 to 2 inches in diameter" around the GARDASIL injection site (captured in MARRS# 1509USA002672). The outcome of the event was not reported. The relatedness between GARDASIL and the event was not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Approx 5 min after receiving the HPV vaccine (influenza vaccine was the first administered) , pt experienced a syncope episode. Was unresponsive for approx. 30 sec. Responded to sternal rub. Some memory loss that resolved approx. after 5 min. EMS called due to initial disorientation, patient urinated on self when lost consciousness, sustained head injury from fall. Vitals stable- BP 130/80, Pulse OX 98%, HR 60-80, 19-24 breaths/per min.
Patient describe  "numbness of tongue". No respiratory distress observed. Patient vital signs assessed and found to be within normal limits. Patient reassessed and found to be within normal limits. She reported numbness went away. 11:10am: BP 131/82, HR 89 bpm, SpO2 99%, RR 14. 11:25am: BP: 121/76, HR 72bpm, SpO2 99%, RR 14.
Debilitating and radiating pain in upper arm (of injected arm) when movement of any kind of the hand, forearm, or shoulder. This pain was persistent on a daily basis until around two and a half months later then it lessened to finally dissipating.
head hurts; body is sore all over.; This is a spontaneous report from a contactable healthcare professional. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021 at 06:30, the patient experienced that her head hurts and her body was sore all over. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if therapeutic measures were taken as a result of the events. The clinical outcome of the events head hurts and body sore were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient c/o swollen tongue. Vss. Patient is aox4. 50mg benedryl given IM. 5 mins later, VSS. Patient stated symptoms have not improved. Patient noted itchy throat and itchy tongue. 0.5mg IM epi given. Paramedics called. Patient is aox4. NAD noted.
Problem breathing, vomiting, right arm pain. Person who completed form called about 2:30 injections given around 10:30. Told pt to go to ER.
Arm became pain, red, swollen, warm to touch & within 8 hours, developed a shingles rash on right side of neck & chest, severe ear pain, throat feels swollen
pt recvd vax; 29oct94 devel systemic sxs;burning sensation about lips,cold sores,rhinorrhea,eruptions on inner aspect of lt thigh,petal edema, fever & fatigue;2nov94  to er;arm red,swollen & erythematous w/ inc pain & T 99.6;apap & pred
This patient had a 4 inch diameter, red, swollen area at the site of injection, warm to touch. The patient still irritable , no fever.
Starting one week after the first dose (day of birth) of Hepatitis B, parents noticed redness at injection site.  It progressed to a fluid filled vesicle.  It then opened and resolved.  It has subsequently contined to be red and new vesicles continue to form in that same area and then resolve and form again.  Baby is now 4 months old and this continues to happen.
herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 84 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster.  The outcome of herpes zoster was unknown.    The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from November 1997 through April 1999. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Vaccination history: A dose of hep B virus vaccine was given on 11/3/97, 1/9/98 and 3/30/98. A first, second, third and fourth dose of Haemophilus B conjugate vaccine and diphtheria toxoid (+) pertussis vaccie (+) tetanus toxoid were given on 11/3/97, 1/9/98, 3/3/98 and 4/21/99. Poliovirus vaccine was given orally on 11/3/97, 1/9/98 and 4/21/99. A tuberculin purified protein derivative test and MMR II were given on 9/28/98. A dose of Haemophilus B conjugate vaccine was given on 4/21/99. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). Upon request a complete copy of medical records is available. No further info is available.
10 cm of ecchymoses/induration associated malaise, myalgias, arthralgias and fever.
Patient was in post vaccination area and complained of feeling warm, anxious, and blurring vision. Pt is diaphoretic, pale, HR 90, RR 22, BP 104/62, asked if he could lay down. RN assisted to lay down in fowlers position. 1627 patient reports that he is starting to feel better. RN advised to lay there for a few more minutes.  RR 14, HR74, sat up at side of cot, still feeling okay, RN assisted to stand, still felt okay, transferred to chair and gave  some water to drink. 1638 BP 108/64 states he is feeling okay and ready to leave. Verbalized understanding that if he  feels worse or has any problems after leaving that he should contact his doctor or call 911.   Patient left at 1641.