chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose Mar2020, not yet received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in March 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Mar2020, not yet received 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient had not receive her second dose. The reporter did not consent to follow-up. This case was linked with case US2023055327, reported by same reporter for himself. Till the time of reporting, the patient receive second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023055327:Same reporter.
pt recv vax JUN96 & in AUG96 pt varicella antibody test results were borderline;it was reported that the pt had a small fever & chills;
Patient was not due for polio and received that as part of the component of pentacel.  Due date according to system for polio 03/10/2025
no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 046H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-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 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). On 08-Feb-2023, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) outcome was unknown. At the time of the report, 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 (Dose administered after 30-day Use By Date).    No concomitant medications were reported.  Individual vials or unbroken cartons reported as not sure, at least 1 and Vial size was 2.5 milliliter.  It was reported date the vial was initially stored in the refrigerator was said 30 days from the beyond use date but do not had specific day.  It was reported beyond use date was 05-Feb-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
2 days p/vax lt arm gen area erythema, induration over vax site;
Menstrual cycle happened a week early in the middle of birth control pack and then got a second period a week late; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. 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. On an unknown date in Apr2021 the patient's menstrual cycle happened a week early in the middle of birth control pack and then got a second period a week later. On an unknown date in Apr2021, 20 hours after the vaccination, the patient experienced extreme fatigue. 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 menstrual cycle happened a week early in the middle of birth control pack and then got a second period a week late and extreme fatigue were resolved on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 30 hour post vax, the child became hypotonic and rolled eyes to side. The parents called 911 while waiting for ambulance, the pt had another episode. The pt was seen at the ER, no more episodes have been reported. The child appears normal.
Patient fainted after receiving vaccine FLU AND TEST MEDICATION PPD. Patient eyes rolled back and was unresponsive, but awake.
Caller reporting a temperature excursion at -2.1C due to a refrigerator malfunction with no adverse event; product with inappropriate storage administered to the patient with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2022SA143416(CLUSTER).  This case involves a 52 years old female patient who was reporting a temperature excursion at -2.1c due to a refrigerator malfunction with no adverse event and product with inappropriate storage administered to the patient with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine rge (cho) (Shingrix).  On 23-Mar-2022, the patient received a dose of 0.5 ml suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot C5873AA, expiry date 30-Jun-2023 ( strength, formulation - not reported) via intramuscular route in the right deltoid for Immunization.  On 23-Mar-2022, the patient reported a temperature excursion at -2.1c due to a refrigerator malfunction with no adverse event (product temperature excursion issue) and product with inappropriate storage administered to the patient with no reported adverse event (product administration error) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken with diphtheria, tetanus and acellular pertussis vaccine was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01068650: 01068813: 01068814: 01068816: 01068817: 01068827: 01068828: 01068830: 01068831: 01068832: 01068834: 01068835: 01068838:
Narrative: NOT RESOLVED AS OF 1/28/2021 Symptoms: & SORENESS AT INJECTION SITE
Pt reported to the ER on 03/15/2002 with fever (104 deg. F), cough, runny nose. Mother gave Tylenol and Motrin.
Patient noticed a large, red, itchy rash roughly 4 inches in diameter at the site of injection. Patient applied ice and the rash improved, shrinking in 2 inches in diameter.
This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23 (lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for varicella virus vaccine live (oka/merck) (VARIVAX) reconstitution was stored properly. Doses of varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), pneumococcal vaccine, polyvalent (23-valent)( PNEUMOVAX23), hepatitis b vaccine (recombinant) (RECOMBIVAX HB), and hepatitis a vaccine, inactivated (VAQTA) were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported.  Follow-up information has been received from the physician on 23-JAN-2018. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with MNSC and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. The following initials are patients who received vaccines that were stored in refrigerator and these patients are being contacted to be re-vaccinated.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1801USA010002: US-009507513-1801USA010003: US-009507513-1801USA010004: US-009507513-1801USA010005: US-009507513-1801USA010006:
Started running a fever and having chills and extreme joint pain around midnight the morning of March 31. Have continued to run a fever all day(March 31). Fever lowers some when alternating ibuprofen and Tylenol. Also experienced muscle soreness especially in my legs, back and neck. Joint pain that made it difficult to walk and chills. I also experienced moderate pain in my arm at the injection site which interfered slightly with mobility
Patient experienced a covid arm: red rash, swollen, hot to the touch and hurt a great deal.  She started experiencing the covid arm the night she received the shot.  It lasted until Monday Night.
ACUTE DVT OF LEFT ILIOFEMORAL VEIN 1/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
52-year-old female with a significant smoking history here with a 4-day history of upper respiratory symptoms.  Started with a cough, chest congestion and fatigue.  Had diarrhea a few days ago. Son who is 32 is also sick.  No sick contacts at work.   Patient states that she just came back from vacation.  She was around her parents who are also symptomatic.   She has a significant smoking history but has never been fully diagnosed with COPD. (Approximately 32 pack years)   She has tried Nothing, which  has not helped.   In general, the problem is worse compared to when it started.   COVID-19 contacts? No   Loss of taste/smell? No   COVID Vaccinated? Yes
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 06-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 that were exposed to temperatures outside of the recommended range during an unknown number of excursion hours. This is one of several reports from the same reporter. Additional information has been requested.
Fevers x 24 hours, Aches x24 hours, Wheezing X 24 hours Drooped face and numbness x few days.
Had mild cellulitis at the injection site - 10 days of Augmentin was the treatment - saw doctor on the 19th. I also experienced stiffness and swelling in my joints as well as ringing in my ear and dizziness. Those symptoms cleared on their own after about 1-2 hours. By the time I got into see my doctor they had stopped. The medicine cleared the cellulitis. I was using coconut oil on dry skin at the time  of the symptoms starting to deal with eczema.
Headache, Myalgia & Fever Narrative: Employee reports injection site redness, fever (100.8F), chills, headaches, and body aches. Reports no known exposure to COVID-19 and no one in houshold is sick. Reports taking Tylenol for symptom relief.
Received flu shot at approx. 2:30 pm on 10/7/04. At 5:30 am on 10/8/04 ankles, feet and injection site swollen.  Pitting edema of ankles and feet. Reported to Employee Health and instructed to go to Work Med for full evaluation by Nurse Practioner.
Per Dr., pt developed cellulitis after the Tdap vaccine at the injection site due to the "pharmacist's technique".
Stated after receiving vaccine in the morning no issues, but started to develop pain in left arm around 5:00pm. Unable to have full range of motion without pain, did warm compress last night. pain appears to be improving since last night.
Pt reported he had a fear of needles after entering the clinical services room. We talked through the steps that I would be performing and he confirmed that he was okay. I verified who he was and the IMZ he was receiving and proceeded through the process. He appeared well after the shot was given, but after he left the clinical services room, I noted that his sister was fanning him with a hat on the bench outside the pharmacy. I asked the patient to return to the clinical services room. He informed me that he was feeling "hot" and patient was diaphoretic. I asked him if he was dizzy and he responded no. I instructed him to lie down on the floor and elevated his feet on a chair. No vitals were taken. He denied any chest tightness, difficulty breathing, swelling/tingling of the tongue, lips, or throat, and he denied any need to drink water. He remained in this position for 5 minutes and stated he felt fine. He got up slowly and proceeded to sit for another ten minutes. He reported to me that he felt fine after this time and denied wanting additional medical treatment. I called him an hour later to determine how he was feeling and he stated he was feeling much better
The patient reported the development of rash to trunk and neck as well as itching the day after the COVID19 vaccine was given.
A year ago, I noticed I was having ongoing fatigue. On 08/29/2022, from testing and blood work, they saw that my PSA was elevated. I was diagnosed with prostate cancer. I had doctor visits and they told me what my options were. It's ongoing.
Information has been received from a physician concerning a 66 year old male patient with no known drug reactions or allergies and not recent exposure to chickenpox or shingles and a history of chickenpox who "approximately 6 to 12 months ago" in September 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown) at an unspecified pharmacy. On 11-AUG-2010 the patient experienced herpes zoster virus rash. The rash was not in the site of injection. The distribution of the lesion was the dermatome. The patient was seen by the physician "this week" where the patient was diagnosed with shingles. At the time of the report, the patient had recovered. The patient sought medical attention by a doctor visit. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. The lesion samples were collected on 18-AUG-2010. Two samples were taken from vesicles in the thigh. A Varicella Zoster Virus Identification Polymerase Chain Reaction Test was performed on 20-AUG-2010. The PCR result from the scab specimen identified the presence of WT VZV. No further information is expected.
collapses with heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via public post.  This case involves patient with unknown demographics who collapsed with heart problems while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA035806(CLUSTER).   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer at (unknown: formulation, strength, dosage, route, lot number, expiry date, route in unknown administration site) as prophylactic vaccination. Information on batch number was requested.  It was reported that the patient was a referee of game. On unknown onset and latency, the patient collapsed with heart problems (circulatory collapse) following the administration of influenza vaccine. This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses with heart problems).  At time of reporting, the outcome was Unknown for the event collapses with heart problems.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case involves patient with unknown demographics who collapsed with heart problems while receiving vaccine Influenza vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history and concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022; Inadvertently administered the vaccine 11 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21a, 013A21A and 012M20A) for COVID-19 prophylaxis.     Allergies (medications, food and other products): None.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had no medical history related to both acute and chronic illnesses at the time of vaccination. It was unknown if the patient had any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were reported. It was reported that the vial was initially stored in the refrigerator on 27-May-2022 and the vial had not undergone any temperature excursions. It was unknown if the adverse events had caused patient to seek medical care (office visit, urgent care, emergency room, hospitalized). No treatment medications were reported.
After the 2nd Vaccine, I started to have pain under my armpit and in pelvic and groin area. Symptoms did go away and there were no issues. After the booster shot that I received I experienced the same pain in the same areas however over the few weeks it became increasingly worse to the point that I needed to go to the ER. In the ER, bloodwork showed that my identifiers for lymph node activity were extremely high and was referred to a Hematology Oncologist specialist. My symptoms have improved however I am still experiencing pain under my armpits and in my groin area however it is no longer debilitating. I went to the doctors and saw CRNP, starry sky liver syndrome due to right sided abdominal pain and it is usually due to an autoimmune disease however they cannot find anything.
a report has been received from a Pharmacist concerning a 23 year old, female subject, who had been receiving FLUMIST (intranasal). She had two previous pregnancies with one live birth and one spontaneous abortion. Concomitant medications included ascorbic acid, biotin, minerals nos, nicotinic acid, retinol, tocopherol, vitamin B nos, vitamin D nos and ondansetron hydrochloride. FLUMIST (intranasal) started on 23-Oct-2014. Inadvertently administered FLUMIST to a pregnant woman in a Flu Clinic, which started on 23-Oct-2014. The patient was eight weeks and 2 days pregnant a time of vaccination. She has not reported any adverse effects. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a pregnant woman is unknown. The date of the patient's last menstruation was 26-Aug-2014. The estimated date of delivery is 02-Jun-2015. The report was considered to be non-serious by the reporter.
Patient fainted the next morning while sitting in temple. Faint was sudden, there was no onset of symptoms prior to this event. Patient reported feeling otherwise healthy/fine.