chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated he developed "sunburn" - like rash on face, trunk & arms & upper legs. Did not itch or burn he took BENADRYL Saturday - Sunday rash resolve.
Information has been received from a 24 year old female consumer for the Pregnancy Registry for GARDASIL concerning herself with a history of methicillin-resistant staphylococcal aureus infection in August 2007 who on 24-DEC-2007 was vaccinated with her first dose of GARDASIL (lot# not reported). On 03-MAR-2008 the patient was vaccinated with her second dose of GARDASIL (lot# not reported). There was no concomitant medication. On 10-MAR-2008 the patient found out she was pregnant with 3 positive home pregnancy tests. She also had an examine with the nurse practitioner to confirm she was 9 weeks pregnant. Her estimated LMP was 05-JAN-2008 and her outcome was not reported. Follow-up information was received from a physician concerning the 24 year old female patient with a history of eczema, carpal tunnel and anemia. No previous pregnancies. On 15-APR-2008, ultrasound was performed with result within normal limits. On an unspecified date, the patient developed anemia during pregnancy. On 13-NOV-2008, the patient delivered a liveborn male infant by cesearean section due to cephalo-pelvic disproportion. Infant weighed 9 pounds 11 ounces. The infant's apgar score was 9/9. The infant was normal, with no congenital anomalies. There was no infection or illness during pregnancy. The infant's delivery by cesearean section due to cephalo-pelvic disproportion was considered an other important medical event. Additional information is not expected.
After one week from receiving the vaccine, my arm started itching and was sore. The day after it was swollen and itchy (red swollen area similar to hives) about 5" x3" on the site of the shot. I applied hydrocortisone 1% cream a few times. The swelling went away after 5 days, but some itching and light redness remains as of today (3/12)
Fever (103 degrees); extreme shivers; night sweats (needed to change nightshirt and bedclothes); foul odor in urine and perspiration; no appetite; nausea; muscle pain; sore arm; extreme fatigue; light headedness; no energy. Lasted until Sep 17, 2018.
Swollen glands in my neck; This case was reported by a consumer via interactive digital media and described the occurrence of lymphadenopathy cervical in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, 2 days after receiving Shingles vaccine, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the lymphadenopathy cervical was not recovered/not resolved.   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient had swollen glands in neck since the second day after shingles vaccine. The patient asked it was day 4 at the time of reporting, was that normal. The contact details were not reported hence follow up not possible.
Patient reported redness around injection site that started for 1 week and lasted for a few days then resolved.
symptoms of COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (symptoms of COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (symptoms of COVID-19) (seriousness criterion medically significant). At the time of the report, COVID-19 (symptoms of COVID-19) had resolved.        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.   No treatment information was provided.  No concomitant medication was provided.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant FU-Reporter provided event details on her own; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.
VACCINE ADMINISTERED PAST MFD EXPIRATION DATE OF 11/30/2022; ADMIN ON 12/5/22
Swelling, painful right thigh, unable to bend knee and redness to knee. Treated with Benadryl prn. Allergic reaction.
The patient self scheduled his follow up appointment for his second dose of Moderna not knowing there was a 28 day waiting period.  He scheduled his appointment at 21 days and was administered the second dose at 21 days.  Patient was completely fine after injection and educated on what to look for if any symptoms arise.
Started as pain deep in left breast. Radiated under left arm and up to lymph nodes on left side of neck within two weeks. Left side of neck and under arm slightly swollen Pain, burning and throbbing have been intermittent with worst occurring the week Startinng May 15. Has been slowly lessening
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional.(medical assistant). Linked cases: 2018SA182256, 2018SA182252, 2018SA182253, 2018SA182254, 2018SA182255 (same reporter). This case involves female Infant patient who experienced vaccine reached 52.8f, for 43 minutes, while he/she received vaccine IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 04-Jun-2018, the patient received a  dose of suspect IPV (VERO) lot N1K931M, via intramuscular route. It was a case of actual, medication error due to product storage error. Reported that vaccine reached 52.8 F, for 43 minutes and on 04-Jun-2018, product reached 48.2 F for greater than 30 minutes. It was not reported whether adverse event occurred or not. The patient outcome is reported as Not Applicable. This case involves unknown number of patients who were vaccinated with a dose of REVAXIS (Batch number, expiry date, dose, dose in series, route and site of administration were unknown) on unknown dates (reported as one Revaxis vaccine was given on 09-May-2017, three were given on 10-May-2017 and other there were given with no details available).
Error made by healthcare provider, 0.2ml given by healthcare provider. Client was called at 4:42pm on 3/2/2021 and incident was explained. PT understood situation and will be returning  on 3/3/2021 around 9am  to  receive  right dosage. Pt requested for a manager to escort to vaccination station and oversee vaccination process. Pt also requested for a spanish speaker or interpreter.
pt recv vax 4DEC96 & 7DEC96 pt devel a rash all over body consisting of @ least 150 pox;
sees black, dizzy, blurriness, clammy skin, diaphoretic  84,16, 82/42 86/58, 99, 16, 98%   given juice, icepack-- felt better  no meds, no previous fainting episode
WELT AT INJECTION SITE, WIDTH OF A LEMON (2 1/2 BY 1 INCH).
Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 16 year old female who on 24-SEP-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM. Subsequently, the patient was found to be pregnant. On 10-OCT-2008 the patient was 6 weeks gestation. The last menstrual period was approximately 29-Aug-2008. The estimated due date is 05-Jun-2009. The patient sought medical attention by calling the nurse. Follow-up information was received from another registered nurse who reported that the patient was vaccinated with a first dose of GARDASIL (lot# 660616/0570X) 0.5 ml IM on 24-SEP-2008. Concomitant therapy included prenatal vitamins (unspecified). At the end of September 2008 or beginning of October 2008, the patient underwent a routine ultrasound without result provided. At the end of November 2008, after Thanksgiving, the patient experienced spontaneous abortion (less than 20 weeks). The outcome of the patient was not reported. Upon internal review the spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Information has been received from an office manager concerning a 65 year old female who on 19-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # 659149/1383U). Subsequently the patient experienced fever chills, painful red arm. The patient called office for medical attention. Subsequently, the patient recovered on an unknown date. Follow-up information was received from the healthcare worker concerning the 65 year old female. It was reported that the patient, with no relevant medical history, who on 19-NOV-2008 was vaccinated IM into the right deltoid with a first dose of PNEUMOVAX 23 (lot # 659149/1383U). There was no illness at time of vaccination. On 20-NOV-2008 the patient experienced "right deltoid 3x2 inch redness, fever, 100-103.2 F and equilibrium bad". The patient visited a physician for medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of PROQUAD lot # M036295 or lot # M040143. The PROQUAD was reconstituted with properly stored sterile diluent (MERCK). No adverse effects were reported. The digital data logger was involved in recording the excursion. This is one of six reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA001493: US-009507513-1708USA005168: US-009507513-1708USA005169: US-009507513-1708USA005166: US-009507513-1708USA005167.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about October 2015, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about November 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified patient. On an unknown date of 2014 (also reported as since 08-AUG-2014), the patient was vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received pediatric vaccine in error (0.3ml, Lot: FK5127).  Realized error, per clinical guidance, had pt return and administered correct vaccine.
Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    No concomitant medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Best used date was 30-Jul-2021, Patients did not report any side effects.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Tested positive for COVID in 12/2020. I felt nauseated for days, throwing up often. My doctor told me to take Zofran. That helped my nausea and throwing up. Slept with ice pack as I had a terrible headache that would not go away. All symptoms resolved within a week.
chills; FEVER; This case was reported by a consumer via (Shingrix) interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2021, the patient received Shingrix. On 11th September 2021, 1 days after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received shot Shingrix a day ago of reporting day and next day experienced chills and fever. The patient reported that the adverse events were gone at the time of reporting. The patient enquired about how long did these side effects last. Follow-up would not be possible as no contact details available.
Information has been received from a 24 year old female who on approximately 06-AUG-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL. There were no concomitant medications. The patient stated that she might be pregnant. She has not been tested, but she is "showing symptom" of pregnancy. The patient reported that if she was pregnant," it happened within the past month". Additional information has been requested.
Got vaccination, got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the vaccination, but got shingles anyway. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022; No adverse event; Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022).    No concomitant information was reported. The reporter was unsure of which injection in the series was this for the patient.  The vial was initially stored in the refrigerator on 15-JUL-2022. The vial did not underwent any temperature excursions. No other adverse reactions reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-632600 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-632600:same reporter
Pt. states that after receiving the 2nd dose of Moderna 03/03/2021 , started experiencing symptoms 03/14/2021 of pain at the injection site (Right). Primary visit 8 weeks PT, "Nerve" medication, and muscle relaxers.
Went to annual exam on 07/21/2021, lab resulted pointed to hypothyroidism, doc wanted me to retest at the end of SEP/2021. Approximately 08/29/2021, severe, rapid onset of insomnia began. I saw my doc on 09/16/2021 where she ran more labs, results came back still pointing to hypothyroidism. 75mcg Levothyroxine was prescribed, I took one dose on 09/29/2021 and reacted 12 hrs later, intermittent rapid heart rate and hot flashes round the clock. I didn?t take anymore. I requested name brand 75mcg Synthroid and took that 10/01/2021, 10/02/2021, 10/03/2021, same reactions, so I stopped taking Synthroid. Doc prescribed 25 mcg Levothyroxine, I took 10/09/2021, 10/10/2021, and 10/11/2021, experienced same reactions so I stopped that dosage. Doc ordered EKG on 10/12/2021, results were Sinus Bradycardia. I had a phone visit with the endocrinologist on 10/18/2021, who ordered monthly thyroid checks and based on results to cut the 75 mcg in half and take one half in the morning and one half at night. I had Graves Disease/hyperthyroidism in 1997, and hypothyroidism in 2009.
Unable to lie down without chest pain and rapid heart rate. Treated with high dose anti-inflammatory medication for pleurisy and myocarditis for 2 weeks. Symptoms subsided, but occasionally reoccur.
Flublok was given to a 16 months old/ no ae; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is a linked case with 2019SA331932 (same reporter)  This case involves a 16 months old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] via unknown route and site of administration (lot number and expiry date not reported) on an 04-Nov-2019.  The patient's medical history, treatment(s) vaccination(s), family history not reported.  It was a case of actual medication error due to product administered to patient of inappropriate age.  At the time of report no adverse event was reported.   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 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.  Information on the batch number of FLUBLOCK QUADRIVALENT was requested.