chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injections were given intramuscularly in the left arm.  RN was still in the room speaking with mother when patient lost consciousness and slumped over on the table.  This occurred approximately 2-3 minutes after vaccines were administered.  Patient regained consciousness in 10-15 seconds.  HR was initially 60 beats per minute following the incident, but recovered to 90s within 30 seconds.
Myalgia, Fever chills, fatigue, injection site discomfort Narrative:
Pt felt dizzy and got diaphoretic after getting the vaccine. Was found in the grocery isle about 10 minutes after receiving vaccine.
Patient had nausea and vomiting. She was also red, hot, lightheaded and dizzy. The 9dizziness didn't occur the first vaccination, this is a new symptom. 9:15am b/p 140-84 HR was 62, applied cold compress to head. Gave IM benadryl 9:23. Patient had nausea and vomiting for about 24 hours with first vaccination, the heat and redness resolved at 9:32am. The nausea still remained, gave ice to base of neck. Checked b/p at 9:35 128/88, HR 60. The dizziness resolved, patient stood up after and felt dizzy again. Patient tried snack, but was too nauseous at 9:50. 9:55am B/P 124/88, HR 64. Patient states that she felt okay to drive. No dizziness, no heat. Patient went home.
Can a patient get the 2nd dose on 47th day (5 days past 42 days ) after his 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Can a patient get the 2nd dose on 47th day (5 days past 42 days ) after his 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Can a patient get the 2nd dose on 47th day (5 days past 42 days ) after his 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Can a patient get the 2nd dose on 47th day (5 days past 42 days ) after his 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  The patient was asking if he can get the second dose on 17-May-2021, 47th day after the 1st dose. The pharmacist asking if he can get the second dose past 42 days and mentioned she was not comfortable giving the patient giving his 2nd dose as it is five days past 42 days after 1st dose. The Pharmacist declined to give any of the patient details, his first dose details.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2018 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # N011491 with expiration date: 11-APR-2018) (dose was not reported), intramuscularly for prophylaxis (expired product administered). No adverse effects reported. This is one of the two cases received from the same reporter. Sender's Comments: US-009507513-1808USA008168.
This spontaneous case was initially received on 07-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced patient given expired AFLURIA vaccine, medication error. For relevant test results see appropriate report section.
Pharmacy gave us 3 different expiration dates when we received our vaccine, we gave the vaccine expired and did not know it was expired until 2 days later.
CHIEF COMPLAINT:   Per pt, had syncopal episode and passed out, hitting head. + LOC. no head/neck/back pain. Neighbor called 911 d/t pt being unable to stand up. SOB and weakness x5 days. Dx with PNA last month and was on abx/steroids with no relief.   HISTORY OF PRESENT ILLNESS:     Patient reports that he is feeling extremely weak had episode where he passed out.  Also reports that he had left leg weakness which improved after a couple of hours.  He denies any left arm weakness. Denies dizziness, numbness, confusion, difficulty speaking, changes in speech or vision. No  fever, chills, diaphoresis, or swelling/pain of lower extremity. Nothing makes better or worse except as previously mentioned. The course is variable. ongoing for 5 days with poor po intake. denies uti sx.
p/vax p5 exp inj site inflammation; pt also devel severe flu-like symptoms;h/a;joint pain;T101; tx: tylenol;
This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details reported as follows: This case was reported by medical assistant (MA). The age at vaccination was not reported. Two months after first dose SHINGRIX, the patient received 2nd dose. The patient experienced fever of 102 degree F, which lasted for 24 hours. The medical assistant talked on phone with the patient during first 24 hours to see how she was feeling and told her to drink water and take fever reducing medicine. The patient also self-reported this case with Centers for Disease Control and Prevention (CDC). Lab Comments: On an unknown date, lab test were performed.
This spontaneous report as received from a pharmacist refers to an 85 year old female patient. The history drug included vaccinated with PNEUMOVAX 23. On 22-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J004387, expiration date: 04-JAN-2015) injection 25/0.5 Y, (dose and route were unknown). On 23-SEP-2014, the patient developed cellulitis after receiving a 5 year booster dose of PNEUMOVAX 23. The patient sought medical attention. The patient was given clindamycin for the event. The outcome of cellulitis was reported as recovering/resolving. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to 13 months old child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Itchy throat, nunny nose, hoarse voice, very reddened sclera.
Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 23-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 23-Jul-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
After his 6 months shows he was having a fever i took him to the hospital, was discharged and gave him Tylenol. He also had been with eczema red rashes on his face (which I thought was part of eczema but wasn't),  ear infections more than usual. At around 8-10 months I noticed him always sick with colds and suddenly stopped talking back, lost of emotions, no eye contact, no laughing, lost interest and communication. At 12 month for sure he was at a loss for words, completely silent. He was referred to clinic to get a diagnosis and by two years of age he was diagnosed with autism. He had high pain tolerance, lack of communication, was behind in speech and motor skills. Short attention span and too hyper. He has seen psychologists, is currently taking various  therapies and at age four now is on Meds.
At 2 am i woke up with chest pains chills body aches bad headaches i never felt this bad in years
Within 5 minutes after inoculating on her left arm ( after Menveo, Tdap and Flu )  PT complained of being thirsty and in a lot of pain.  At this point pt was moved to a chair from the exam table, soon after patient turned her head to the left and became pale and drowsy.  Managed to answer a few questions with her eyes closed.  This went on for 5 minutes.  Her heart rate was in the low 60's with 02 at 97-98 on room air  but stayed at 99 % on 02 /mask.  Temp was 98.2  . Patient was observed in exam room for a full hour and improved.  We sat her up and she remained asymptomatic .  She was then moved to Nurses's station , left office without any symptoms and was ambulatory.
10APR95 t105.1, appetite down, lethargic; seen by MD in ER; CBC, BC, RDVP, enteroviral culture; 11APR95 rash all over;no appetite only one wet diaper 24hr period; adm to hosp 5% dehydration; MMR react; spinal tap neg;
A consumer report has been received. The report concerns a 10 year old, female consumer, who had been receiving Nasal FLUMIST, 0.2 Millilitres, Once/Single administration. FLUMIST started on 06-Dec-2012. The patient experienced mild fever, mild sore throat, mild general weakness, mild stuffed up and mild runny nose which started on 09-Dec-2012. At the time of reporting, the event of fever, sore throat, general weakness, stuffed up and runny nose was ongoing. The report was considered to be non-serious.
This spontaneous report received from healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting ROTATEQ (lot number J011334, expiry date 13-MAY-2015). It was reported that the excursion products were supported. On 05-MAY-2014, the patients were vaccinated with ROTATEQ (lot number J011334, expiry date 13-MAY-2015) (dose unspecified) for vaccination post excursion. Concomitant therapy was unspecified. No product quality compliant was involved. No adverse effects noted by any patient. The outcome of event was unknown. No additional information was available. This is one of the several reports from the same reporter. Additional information has been requested.
79 yo woman received Pfizer Covid vaccine #1 on 2/23/21. She has been experiencing diffuse body pain-especially her hands. Patient had a ground level fall requiring sutures for a head lac on 1/25/21. The diffuse body aches and pains seem to pre-date the vaccine. Certainly, vaccine related reactions such as myalgias can be expected from the vaccine and may have exacerbated her symptoms. MD recommended, based on the above, for patient to receive the 2nd dose of Pfizer vaccine. However, patient can be reassured that she can safely get the second covid vaccine to finish her immunization. She may take pain medication as needed after the vaccine is given to relieve pain.
Patient received vaccine Monday, Nov. 10, '14. Received a call at 1 pm Nov. 12, '14 reporting hives on stomach, back and arms.
p/vax pt seen in MD office d/t a rash on entire body w/20-30 lesions @ different stages;hlth care professional noted definitely dx as chickenpox;
6" red hive on right thigh-pt complained of itching. No fever, no shortness of breath-only local reaction at injection site. Pt given Decadron eloc.
receiving first dose of Shingrix 12 months ago / second dose was interrupted due to being diagnosed with canc; This case was reported by a consumer via call center representative and described the occurrence of cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix 12 months ago and that the second dose was interrupted due to being diagnosed with cancer.  The consumer underwent chemotherapy and had been cleared to receive Shingrix vaccine. The reporter did not consent to follow up.
received Boostrix and Menveo twice; Boostrix on 5/12/2021 and 3/16/2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number gc5ng, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number amva640z, expiry date 30th November 2022) for prophylaxis.   Previously administered products included Menveo (received on 12th May 2021) and Boostrix (received on 12th May 2021).   On 16th March 2022, the patient received Boostrix (intramuscular) .5 ml, Boostrix Pre-Filled Syringe Device and Menveo (intramuscular) .5 ml. On 16th March 2022, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced extra dose administered and drug dose administration interval too short. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 1st dose of Menveo on 12th May 2021, 0.5 ml, batch number:amva435a, expiry date : 31st March 2022,  intramuscularly in left arm and 1st dose of Boostrix 12th May 2021, 0.5 ml batch number: 33at7, expiry date: 7th November 2022, intramuscularly in right arm. It was stated that, the patient accidently received his Boostrix and Menveo vaccine twice, which led to extra dose administered.   The patient received Boostrix in right arm and menveo in left arm. The patient received boostrix earlier than recommended which led to shortening of vaccination schedule. The patient had no symptoms related to this adverse event.   The patient consented to follow up.
This spontaneous case, initially received on 07-Nov-2018 from other health professional (nurse), concerns a 26-year-old adult male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252227 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case (201805343) was cross-linked to case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (26-year-old) was added. The route of administration (intramuscular) and anatomical location (right deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Feeling unwell; Diarrhea; Tired; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old female patient received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Mar2021 at 14:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), levomilnacipran hydrochloride (FETZIMA) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and multivitamins (MANUFACTURER UNKNOWN); all from an unknown date taken for an unknown indication. On an unknown date in Mar2021, the patient experienced feeling unwell, diarrhea and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling unwell, diarrhea and tired was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment(12Oct2021): This follow-up report is being submitted to amend previously reported information: Product name updated from conmirnaty to BNT162B2. In narrative, BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) updated to BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore arm, headache, malaise and runny nose for 5 days, symptoms resolved with OTC vitamin c and anti-histamine
Tingling lips; Red hot face; Fever of 99-102; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown) via an unspecified route of administration in the  left arm on 08Apr2021 at 17:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Other medical history included multiple sclerosis (MS). Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diroximel fumarate (VUMERITY) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient underwent body temperature check and the result was 99-102 with unspecified units. On 10Apr2021 at 16:00, the patient experienced tingling lips, red hot face, fever of 99-102, headache and chills. Therapeutic measures were taken as a result of the events of fever, headache and chills which included drinking lots of fluids and taking Tylenol but the fever does not break. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of tingling lips, red hot face, fever, headache and chills were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills, headache, cold hands, shoulder and chest soreness,  muscle ache, joint pain, fatigue, climbing temperature.
This spontaneous report was received from a male consumer reporting on himself who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unknown date, he started having shingles in the middle of his back, he thought it was sunburn but once it started spreading he sought unspecified medical attention. VALTREX and HIDROCODIN were prescribed as a treatment for the experience. At the time of the report, the patient's outcome was unknown. The relatedness for shingles in the middle of his back was unknown for ZOSTAVAX. Additional information is not expected.
received diluent without the powder; received diluent without the powder. Was revaccinated; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date 8th October 2023) for prophylaxis.   On 27th September 2022, the patient received the 2nd dose of Shingrix. On 27th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter called to report that, at the time of reporting, a patient received Shingrix diluent portion without the powder.  After this shot, the patient was revaccinated with a Shingrix full dose.  This was patient´s Shingrix second dose on Shingrix´s schedule. The reporter consented to follow up by email. Additional Supportive Information: The reporter called to report that, at the time of reporting, a patient received Shingrix diluent portion without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.