chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose: real bad headache; second dose: fever; second dose: chills; second dose: real bad body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EM9809) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 27Mar2020, stop date: 20Apr2020, notes: He had on Covid 27Mar2020 and was cleared on 20Apr2020 prior to the shot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3249), administration date: 15Feb2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "felt like they had stuck Covid in him", "head pain", "pain all over body", "diarrhea", "nose stopped up", "nose running", "sore throat", "sick". The following information was reported: HEADACHE (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), described as "second dose: real bad headache"; PYREXIA (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), described as "second dose: fever"; CHILLS (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), described as "second dose: chills"; PAIN (non-serious) with onset 08Mar2021, outcome "recovered" (11Mar2021), described as "second dose: real bad body aches". Therapeutic measures were not taken as a result of headache, chills, pain. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient stated that he had the second shot and it lasted 2.5-3 days. He had real bad headache, chills, fever and real bad body aches. He had been in the hospital for COVID prior to the first dose. He had on COVID on 27Mar2020 and was cleared on 20Apr2020 prior to the shot. He knew what COVID felt like. He wanted to know how to get through this pain. The patient stated that he recovered completely from real bad headache from the second dose in about three days. The fever from the second dose lasted for about two days and he recovered completely. He took Aleve for the fever. It took about two days to recover completely from chills from second dose. He recovered completely from real bad body aches on third day.   No follow-up attempts are possible. No further information is expected.
sx began w/t102 @ 4PM on 5NOV91; pt seemed fine that PM, but became irritable & resless during the noc; Later pt arm was hard & red; mom gave APAP & sponge bath & applied cold pack to arm; pt then slept;
Dizziness, SOB, high heart rate, heat flash (right after both vaccines) Episode of severe tachycardia (190's HR), severe chest pain, SOB (second vaccine) tachycardia at rest ever since second vaccine
Pt developed redness and swelling to left thigh, an area of 7cm x 7cm developed over a 2 day period. Treatment was cool compress, Motrin and Keflex.
pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Ovarian cyst ruptured on 23-Nov-2020 and Abortion spontaneous on 18-Jan-2018. Concurrent medical conditions included Asthma since 1992 and Psoriasis in 1998. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 15-Sep-2020 to an unknown date, CALCIUM from 15-Feb-2019 to an unknown date, MONTELUKAST SODIUM from 15-Aug-2019 to an unknown date and ACETYLSALICYLIC ACID (BABY ASPIRIN) from 15-Jan-2021 to an unknown date for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 07-Oct-2020 and the estimated date of delivery was 14-Jul-2021. On 05-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2020, Ultrasound foetal: normal (normal) normal. On 08-Nov-2020, Pregnancy test: positive (Positive) Positive. On 30-Nov-2020, Ultrasound foetal: nothing notable in the result of the scan (normal) nothing notable in the result of the scan. On 19-Dec-2020, Prenatal screening test: nothing notable in the result of the scan (normal) nothing notable in the result of the scan.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient gave birth to live full term baby from her previous pregnancy on 21-Dec-2018. No treatment information was provided.
Information has been received from a physician concerning a 60 year old male patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On approximately 03-OCT-2016 (reported as "four weeks ago"), the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) in an unspecified arm (dose, route, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On approximately 24-OCT-2016 (reported as "one weeks ago"), the patient received an unspecified influenza virus vaccine in his left arm. On 29-OCT-2016, the patient developed an unspecified rash on his right arm. The patient sought medical attention by calling the physician on an unspecified date in October 2016, no laboratory studies were performed and no treatment was given for the adverse event. No product quality complaint was involved. The physician stated that the rash resolved "within 24 hours" on 30-OCT-2016. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information is not expected because the reporter did not consent for further follow up.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date).    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 pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD. Total 42 dose was administered after 30-day Use By Date. The Bivalent 6m-5y vial of 0.4 mL (Lot number: 216K22A) was initially stored in the refrigerator on 23-Dec-2022. The vaccine was administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb2-023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 8th of 42 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient 1)
Since 10/14/2013 to 11/20/13 I had stopped taking NuvaRing due to the symptoms, and everything was not adding up. 11/16/2013 I decided to take a at home pregnancy test and results took less than a min, Positive. I was worried! I still had been bleeding all this time. Reason why I stopped NuvRing and if on 10/14/2013 they took a test and it was negative, then how was I pregnant. Made a doctors apt 11/20/13.11/20/2013 @ approx 11AM that I found out I was 9 weeks pregnant. Why was I a
pt presents to ED with SOB, wheezing, nasal congestion/rhinorrhea, fever; pt had a positive COVID test; admitted; started on steroids and ABX; pt had brief periods of improvement then worsening oxygenation; transferred to CCU; continuous BiPAP; pt was DNI; pt passed away of hypoxia in the hospital
fever; chills; aches; felt awful; This case was reported by a other health professional via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, chills, pain and feels awful. On an unknown date, the outcome of the fever, chills, pain and feels awful were resolved with sequelae.   It was unknown if the reporter considered the fever, chills, pain and feels awful to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Office manager called stating that her sister received her second dose of Shingrix about a year ago (probably in the morning) and began experiencing fever, chills, aches and felt awful in the afternoon because she had to go home from work. Within 24 hours the symptoms were gone. The lot number and expiration date not available.  Caller states that her sister wanted to report this but the clinic that she went to said not to bother. Clinic name was unknown.  The reporter consented to follow up. This case is 1 out of 3 cases reported by the same reporter.
Pt received shingles vaccine 5/17/13 had redness, swelling and pain lower elbow cam to have nurse check 5/21/13. Inj site with shingles lesion, painful
Excursion of 31.8 degree fahrenheit and vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 3-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 30-JUN-2023) for prophylaxis.   On 16-MAR-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: Excursion of 31.8 degree fahrenheit and vaccine administered). The outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 16-MAR-2023 The reporter reported that the patient received dose of FluLaval (Quadrivalent) which had been in excursion where it reached the temperature of 31.8 degree fahrenheit which was below freezing. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The FluLaval Quadrivalent vaccine temperature was exposed to 31.8 degree fahrenheit, which led to incorrect storage of drug. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023041460:Same reporter US-GSK-US2023041463:Same reporter
numbness of my face, both cheeks; weak; Numbness in feet; weirdness in the leg; Rashes underneath her boobs and is itchy; swelling under armpit; Supper supper tired; chills; Pain in the arm; Rash around the injection site; Minor headache here an there; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), HYPOAESTHESIA (Numbness in feet), FEELING ABNORMAL (weirdness in the leg), RASH PRURITIC (Rashes underneath her boobs and is itchy) and SWELLING (swelling under armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), VACCINATION SITE RASH (Rash around the injection site) and HEADACHE (Minor headache here an there). On 12-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in feet), FEELING ABNORMAL (weirdness in the leg), RASH PRURITIC (Rashes underneath her boobs and is itchy), SWELLING (swelling under armpit), FATIGUE (Supper supper tired) and CHILLS (chills). On an unknown date, the patient experienced HYPOAESTHESIA (numbness of my face, both cheeks) and ASTHENIA (weak). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), HYPOAESTHESIA (Numbness in feet), FEELING ABNORMAL (weirdness in the leg), RASH PRURITIC (Rashes underneath her boobs and is itchy), SWELLING (swelling under armpit), HYPOAESTHESIA (numbness of my face, both cheeks), ASTHENIA (weak), VACCINATION SITE RASH (Rash around the injection site), HEADACHE (Minor headache here an there), FATIGUE (Supper supper tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Pt had a TBI 4 months ago playing football.  He also gave a history of syncope with previous injections, as he had received multiple Metamizole  injections in the past with syncope.   After vaccination patient experienced syncope in few mints. We helped the patient to be stable and send him out emergency department for further evaluation  and care. At ED his diagnosis was vasovagal syncope. No further workup. No meds. In follow-up by a provider for vaccination site  staff the next day, he was stable and was advised to establish primary care , to have a full assessment.   Also, advised to seek medical attention if he experience any concerning symptoms.  patient was released from the emergency department  in stable condition with no adverse reaction.
Patient passed away; This spontaneous case was reported by a nurse and describes the occurrence of DEATH (Patient passed away) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 07-Nov-2021 The patient died on 07-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Reporter reported that patient passed away on 07 Nov 2021 and it could be due to age and comorbidities.  Company comment: This case concerns a 83-year-old, female patient with no reported medical history, who experienced the unexpected fatal event of death. Death occurred on 07-NOV-2021, 5 days after receiving the first dose of mRNA-1273. The rechallenge is not applicable considering the outcome of the event. No autopsy results were provided; the cause of death was not reported. Patient´s age could be a confounding factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 83-year-old, female patient with no reported medical history, who experienced the unexpected fatal event of death. Death occurred on 07-NOV-2021, 5 days after receiving the first dose of mRNA-1273. The rechallenge is not applicable considering the outcome of the event. No autopsy results were provided; the cause of death was not reported. Patient´s age could be a confounding factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
After receiving the vaccine I had a little bit of fatigue, and I felt slightly nauseated. I was fatigued for one day. The next following week on Monday I was good. I had no headaches.
Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil 0.5 ml injection.  Concomitant therapy included TETANUS TOXOID (USP 23) also given on the same date.  Subsequently, the patient experienced "some sort of adverse reaction".  The outcome was not reported.  No further information was provided.  No additional information is available.
This spontaneous report as received from a female patient of unknown age. On 18-DEC-2013 the patient was vaccinated with PNEUMOVAX23 vaccine. On December 2013 (reported as unspecified the patient developed a reaction (unspecified amount of hours after vaccine administration) and swelling on her shoulder the size of a football. The outcome of both events were unknown. The patient did not seek any medical attention. Additional information is not expected.
COVID arm: rash directly below injection site (red, itchy, warm and firm to the touch, slightly painful)
1400ish itchy palms felt like I was going to pass out when I got up to walk a few steps to the pharmacy to get some Benadryl. Also felt slightly short of breath. Seen in ED and discharged home.
6APR94 febrile seizure t103.9 R; seen in ER @ hosp supportive care;
Suspected vaccination failure; but a light case; Shingles, flare ups; pain; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (received first dose of Shingrix and experienced Shingles) and pain (received first dose of Shingrix and experienced Shingles pain).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles, shingles and pain. On an unknown date, the outcome of the suspected vaccination failure, shingles, shingles and pain were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient stated nobody knows true pain until they have had a bad case of shingles. The patient was confined to apartment for 5 weeks by choice due to everyday pain. One year ago, this past September and for 1 year after, would have flare-ups. The patient never knowing when or where but the patient still consider him/herself one of the lucky ones as after that painful year, the patient had not had any more pain connected to shingles. The patient's doctor had told the patient some continue the rest of their lives. This was so sad to think it would be never ending and the patient pray for the many it happens too, so suggested people to receive 2 shots required, about 2 months between. The patient had 1st shot and then the patient kept putting off getting the 2nd shot, and the patient suffered. When the patient was able after, the other shot was the first place the patient went but sadly, the patient had it more than once, even with the required shots but a light case. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt explained to have fever, but was unable to tell how high the fever was. Pt does not have a thermometer at home.
Lower lip swelling; This is spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received BNT126B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), administered in right arm on 19Mar2021 01:15 PM as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Age at vaccination was 53-year-old (reported as 53).The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications received within two weeks of vaccination included gabapentin, sertraline and levothyroxine, all from unspecified date. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM), from unspecified date and it was reported as known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 the patient experienced lower lip swelling. No treatment was received for the event. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not resolved.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.