chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021 at 3:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Jan-2021 at 3:31 PM, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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.   Age of patient was reported as 47.30 years. No concomitant medications were reported. On 6-Jan-2021, at 03:00 PM vial underwent temperature excursion with temperature 35. This vial was moved to fridge on 5-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021. Product moved to clinic on 6-Jan-2021. 03 vials were sent to clinic. Condition of vaccine prior to administration was not frozen. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
taking paxlovid for 5 days; taking paxlovid for 5 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic sinus infections in the past" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "taking paxlovid for 5 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative days 5 and 10; Positive, notes: Positive on days 12 and 16. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 12Apr2022 to 17Apr2022. After taking paxlovid for 5 days, she felt better. The patient returned to work on day 10. Then on day 12, she got sick again  worse symptoms than the first time she got sick. She have been sick since then and on day 20. The also tested negative days 5 and 10. And then she tested positive on days 12 and 16.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt inadvertently recvd DTP via SC route; exp severe reaction @ site consisting of erythema, hot to touch & blistering 4-5cm in diameter 9 days following immun; no treatment initiated; pt recovered;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE SLEEP APNEA ACUTE RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY SHOCK, UNSPECIFIED 12/16/2022,  11/22/2022,   11/30/2022,  1/17/2023,  2/16/2023  -- RECURRENCE OF SAME SYMPTOMS
Shots given 10/22/08, 10/31/08 t 101.2 pt on Amox for an Rash began 11/2/08 saw Dr. 11/3/08 suspect secondary to MMR, 11/4/08 saw Dr., wheezing; - dehydrated,  Febrile illness with URI CXR done 11/6/08 labial furuncle started pt on Bactrim.
Stomach problem she has been having. She stated that it was not related to the vaccine; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced stomach problem. It was reported that patient for the second dose had to cancel her appointment due to a stomach problem she has been having. She stated that it was not related to the vaccine. She wanted to know how long will need to restart the vacation process all over again. The outcome of event was not recovered at the time of report.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events abdominal discomfort and suspect drug BNT162B2 cannot be excluded
pt recv vax 9DEC98 & a few weeks later pt devel diarrhea characterized by loose, green, foul smelling stools;pt was seen by MD on 5JAN99;a stool specimen was positive for rotavirus antigens. No treatment was initiated and the infant recovered. Follow up 6/14/02: during internal auditing of all files, it was deemed necessary to amend the report by updating the adverse event coding (added lab test abnormality).
Excessive fatigue  Excessive pain  and underneath my arm  extending to my breast.  On the hour, acute  stabbing  pain underneath my arm. So painful that I contacted healthcare facility for advice.  Chills and  weakness all over my muscles/body nerves.
Both vaccines resulted in the same symptoms, which began about 12 hours after administration.  It started with a migraine and then extreme cold chills, fever near 103, and nausea, which caused vomiting.  In both cases, the vomiting was only during the fist night.  In both cases the fever lasted about two days, on and off.
A report was received from a healthcare professional on 03 December 2003, concerning a 2 year old male vaccinee who was inadvertently administered Fluvirin on 02 December 2003. On 02 December 2003, the vaccinee inadvertently received Fluvirin.  No adverse effects were reported at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Case number PHEH2014US016472, is an initial spontaneous report from a nurse received on 15 Aug 2014. This report refers to a 10-year-old male patient. Past medical history and concomitant medication was not reported. The patient received intramuscular dose of Men A lyophilized component of MENVEO (batch number: M13054) that was erroneously reconstituted with a sterile diluent instead of Men CYW-135 liquid component on 15 Aug 20154. No adverse event reported following this medication error (wrong solution used in drug reconstitution).
NO adverse effects noted per patient. A 17-year-old male received Moderna.   He was given both doses. He knew he had received it at age 17 and his parents were aware that it was a moderna vaccine site only day of visit and he stated they wanted him to have moderna because less side effects were reported with moderna verses pfizer. It was missed on the first day of first dose, parents reuquested him to get the second dose because he did well with the first dose.
Very sore shoulder on the arm of the injection. The muscle was so sore/tender it caused extreme pain if touched or if the arm was raised. Pain was severe enough that it was difficult to sleep. Pain lasted for approximately 2 days.
Nausea; Chills; A spontaneous report was received from a nurse concerning a 83-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea and chills.   The patient's medical history was not provided. The Concomitant medications reported included atorvastatin, losartan, sertraline hydrochloride.  On 23 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011V201A) via intramuscularly in an unknown location for prophylaxis of COVID-19 infection.After three days on 26 Jan 2021, patient developed nausea and chills.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, nausea and chills were considered as unknown.
Administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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 age at vaccination was not reported. Mediacal assistant reported that, they had administered an expired dose of Twinrix to the patient (1 month out of the expiration date as reported), which led to expired vaccine used. When asked about expiration date and lot number HCP (health care professional) stated this was urgent and she was not the person who administered the vaccine.    No more details were reported. The reporter consented to follow-up via email.
Diarrhea, nausea, queasy stomach, sour stomach, headache, fatigue
patient stood up and walked to the corner of the consultation room. just in a few minutes he fainted. i helped lower him to the ground, he woke up as soon as he head landed on the floor and he laid on the floor with his feet on a chair. then when he felt better he sat in the chair. waited the 30 minutes and he felt better and left. i called him in the evening and he said he was fine.
After two weeks developed rash under both arms, itchy and swollen. Took children's  benadryl elixor with positive results.
tested positive for Covid; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable female consumer(patient) reported for herself.  A unspecified age female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection) via unspecified route of administration on 05Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On10Apr2021 patient tested negative for COVID-19 but on 13Apr2021 patient started showing signs of COVID-19. On 18Apr2021 again tested and resulted positive for COVID-19. The patient second dose would be on 26Apr2021. The Health department had stated that she could go back at normal routine on (24Apr2021) and wanted to know if that's too soon to get her 2nd dose of Vaccine. The outcome of the event reported was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Around 2am Wednesday  (34 to 36hrs after injection) I was aroused to a semi conscious state by sever trembling from chills where I could all so feel extremes heat coming from different areas on my body. I recall it felt as though someone was putting a hot compress on my leg, but the sensation would jump around. I had a sever headache localized in the center front.  The following morning I had taken Tylenol for the headache and to reduce my fever, but I could not get my down to below 101.0(F) even with continues doses.    Exhaustion, and mind fog all day.
no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported) lot # R033252, expiry date 29-JUN-2020, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit degrees (F) (34 F) for 24 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002834: US-009507513-1907USA003060: US-009507513-1907USA003059: US-009507513-1907USA003062: US-009507513-1907USA003058:
The patient stated that she received VARIVAX sometime in 1996 and when she got a titer done this week for work, it came back as "low" so she just received another dose of VARIVAX.; This spontaneous report has been received from a female consumer of unknown age concerning herself. Her concomitant medications, pertinent medical history, and drug reactions/allergies therapies were not reported.  On an unspecified date in 1996, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX). On an unspecified date in June 2022 (reported as this week), she got a titer done for work, and it came back as "low". So, the patient just received another dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). The outcome of the event antibody test abnormal was unknown. The patient did not want to continue with additional information for adverse event (AE).  The causality between the event antibody test abnormal and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not reported.
Initially, a UTI developed. As the UTI resolved, double pneumonia took hold.  At the hospital they then discovered multiple clots in the legs.
On 1/18/15 customer came in and stated she got a rash and itching on whole upper arm around injection site. By this time it was improving with less redness but still visible.
death Narrative: unclear of details, s/p spine surgery on 2/2/21 and discharged on 2/6/21
Mild red rash and itching below injection site on left arm.  Took Certizine.
Extreme redness at site, blisters and shingles like area below site, soreness in arm, hives.
Rash is more evident now; Skin rash on face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin rash on face) and RASH (Rash is more evident now) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included GABAPENTIN, METFORMIN, LISINOPRIL, OMEPRAZOLE, THYROID (ARMOUR THYROID) and AMLODIPINE for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced RASH (Skin rash on face). On an unknown date, the patient experienced RASH (Rash is more evident now). At the time of the report, RASH (Skin rash on face) and RASH (Rash is more evident now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Non-significant follow up was received on 29-MAY-2021.Contact Information was updated
13mm x 11 mm (L) thigh cellulitis KEFLEX 250/5ml 10 ml po 2 x daily x 10 days.
Information has been received from a registered nurse concerning a patient who was vaccinated with ZOSTAVAX. Subsequently the patient developed a rash around the injection site. The patient sought unspecified medical attention. Subsequently, the patient recovered from the rash around the injection site. Additional information is not expected.
-Received shot on a Thursday afternoon.  In the middle of the night, woke up with body aches. -Woke in the morning (Friday) with a fever of 100.4 and severe body aches/pain. Skin was also sensitive to the touch. Fever spiked  at 100.5 and lasted for 24 hours.  -On day 2 (Saturday) after the fever broke, began experiencing pain in the genital area and when using the bathroom. By the evening, pain increased and two dark red marks were visible on vulva area. Went to Urgent Care Center. Was told it was "Yeast Infection" and was given "Fluconazole." They ran Vaginosis Screen and Urine Analysis w/o Micro.  Vaginosis screen results: Not Detected for candida, garnerella vaginalis, and for trichomonad vaginalis. Urine analysis results- everything was fine.  - On Sunday, pain increasingly got worse when going to the bathroom-stinging/burning and the two marks on vulva area changed in presentation/color.   -On Monday- Went to the OB-GYN in a lot of pain and discomfort.  Doctor told me I had deep ulcerations/ lesions.  Re-ran Vaginosis Screen, ran HSV 1/2 Detection by PCR, and HSV 1 and 2 IGG to rule-out. Everything was negative. Prescribed an acyclovir ointment and methylPREDNISolone. Symptoms/pain from the ulcers went away about 5-6 days after seeing OBGYN. I have never EVER experienced anything like this before and have never had ulcers in the genital area before. Not sexually active.
For about a month my lungs felt a bit "heavy", as if I was bogged down by some asthma (I rode my bicycle on 10/5 for about 16 miles. Normal mileage. Lungs "felt heavy" all week.  Rode again (16 miles) on 10/13).  On 10/14 I was hurting. Starting coughing.  During this time I felt I had bronchitis. Late in this cycle breathing became more difficult. I had a "vertical" back pain (parallel to my spine) on the right side that hurt when I breathed.  Thought it was due to too much coughing; a muscle spasm.  When I finally checked myself into ER, I could only inhale about 1/3 of normal before the pain stopped the inhalation.  Couldn't draw a full breath, was exhausted and very weak.
At 4 hours ? headache, weakness, malaise, nausea She received 1st CoVid vaccine 7/9. She was ill within 4 hours, peaked with 102.5 fever at 12 hours and was bedridden through Day 3 post vaccination. She has gained back some of her strength, but the nausea has remained and so severe that she is barely able to function or sleep at night. Three nights now she has not slept until 2 or 3 in the morning because nausea is at level 9 along with migraine and many hot flashes. She is vomiting 1x day. Through Day 8 post vaccine. Days 9 -12 no vomiting but continues to be bed ridden with severe debilitating  nausea, migraine, weakness and multiple hot flashes.
Pt complained of 101.5F fever yesterday (9/20/01), half dollar-sized at localized area almost a golf ball-sized reaction per mom. Pt had redness and swelling, painful area, and was tired and quiet.
2nd dose of vaccine was given prior to recommended date (day 15 vs day 21).
3-24-21 3PM  PT STATES SHE 'FEELS JITTERY WITH HEDACHE'.  NO SOB/DYSPNEA, NO PAIN, NO DIFFICULTY SWALLOWING. A/O, PINK, W/D, RESP WITH EASE. PT STATE SHE' WAS ANXIOUS ABOUT GETTING THE SHOT'. REASSURANCE GIVEN. NO ACUTE OR OBVIOUS DISTRESS NOTED. 3:15PM PT STATES SHE 'FEELS BETTER' AMBULATORY TO EXIT WITH FRIEND TO DRIVE HER HOME. GAIT BRISK AND STEADY. 3-25-21 8AM TC: STATES SHE 'FEELS FINE NOW'.
The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, 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 13-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial was initially stored in the refrigerator on 01-Sep-2022. BUD was reported as 01-Oct-2022. The vial did not underwent any temperature excursions.  No treatment medications were reported.
Dizziness; This is a spontaneous report from a contactable consumer. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown) via unknown route of administration on unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. After vaccination, the patient had experienced dizziness (on Tuesday) on unspecified date. It was better yesterday but was bad today. The outcome of event was not recovered.    Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.