chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; patient was  vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 23-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Patient develops SOB , swollen face, upper/lower extremities and pain at the site of the injection
Vaccine  administered to  patient  a handful of  days beyond the use date of  the product. No  adverse reactions reported
Pt passed out.  Experienced extremely low blood pressure.  Pulse couldn't be detected for a couple of seconds.  Pt woke and was clear and coherence. Paramedics saw pt and provided IV fluids.  Pt left under own power.
Myalgia, Fever, Employee reports: "Fever~102*, chills, body aches & headace." Narrative:
13cm x 13cm erythema of L arm.  9cm x 10cm erythema of R arm  Seen 4th day after vaccination.
Patient requested Janssen vaccine, did not inform staff that she had already received Janssen in March 2021.  Patient did not subsequently  report any adverse reaction
Fever 99F up to 100.4F for 4 hours, generalized achiness especially left arm at site of injection, redness and warmth of localized area above elbow.
Redness, heat at injection site. Initially after general malaise- No SOB, (+) f/cH.
fever after second shot; headache after second shot; severe nausea (when she moves just a little bit, it has gotten worse, and only feels somewhat okay; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever after second shot), HEADACHE (headache after second shot) and NAUSEA (severe nausea (when she moves just a little bit, it has gotten worse, and only feels somewhat okay) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History Information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (fever after second shot). 09-Apr-2021, the patient experienced HEADACHE (headache after second shot) and NAUSEA (severe nausea (when she moves just a little bit, it has gotten worse, and only feels somewhat okay). At the time of the report, PYREXIA (fever after second shot), HEADACHE (headache after second shot) and NAUSEA (severe nausea (when she moves just a little bit, it has gotten worse, and only feels somewhat okay) outcome was unknown. Not Provided          No concomitant medications were reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076945 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever after second shot), HEADACHE (headache after second shot) and NAUSEA (severe nausea (when she moves just a little bit, it has gotten worse, and only feels somewhat okay) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History Information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (fever after second shot). 09-Apr-2021, the patient experienced HEADACHE (headache after second shot) and NAUSEA (severe nausea (when she moves just a little bit, it has gotten worse, and only feels somewhat okay). At the time of the report, PYREXIA (fever after second shot), HEADACHE (headache after second shot) and NAUSEA (severe nausea (when she moves just a little bit, it has gotten worse, and only feels somewhat okay) outcome was unknown. Not Provided          No concomitant medications were reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076945 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076945:Crossed linked
RHEUMATOID FLARE OF THE RIGHT ANKLE, KNEE AND HIP  NEUROPATHY FLARE OF THE RIGHT FOOT AND CALF
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 11-MAY-2012, the patient was inoculated with ZOSTAVAX at a Clinic for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On 13-OCT-2016, the patient was treated by a healthcare professional and was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, 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 pre-existing conditions and activation of latent conditions; lost wages; loss of earnings capacity, and other losses and damages and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown, excepting for the events of emotional distress and pain that was reported as not resolved. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related. The reporter considered the events as serious for the following reasons: Hospitalization, life-threatening, disability and medical significant.
Patient received 2nd dose of COVID vaccine, stayed near pharmacy for 15-20 minutes, then left store. She called saying she and her husband went to get lunch afterwards, she started not feeling well, they got up to leave, and she had seizure. They called EMS and was having tests done to confirm seizure. Patient came to store to inform us of adverse reaction.
Suspected vaccination failure; Shingles outbreak; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included had no immunocompromising or immunosuppressing conditions.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles outbreak). 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 Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2023 The physician reported that the patient over 65 years old experienced a shingles outbreak after the completion of the full 2 dose series. The patient had no immunocompromising or immunosuppressing conditions. The outcomes of Shingles outbreaks was unknown and all other information was unknown. 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 reporter consented to follow up. This case is 1 out of 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR089457:Same reporter US-GSK-US2023AMR089463:Same reporter US-GSK-US2023AMR089464:Same reporter US-GSK-US2023AMR089465:Same reporter
Patient was seen in the observation area together with his Mother who drove for him for his first dose of Covid-19 vaccine.Patient stated that all of a sudden he felt heat all over his body, tingling sensation, felt nauseous then threw up. Applied cold compress on the back of the neck, lowered down the seat of the car and elevated his feet, encouraged to do pursed lip breathing, had him sip small amount of water. Extended their stay for to 30 minutes for further observation. Symptoms was resolve, left without any difficulties, Educated to call 911 if symptoms comeback and becomes worse. ER precaution initiated. Pt acknowledge understanding.        Patient was seen in the observation area together with his Mother who drove for him for his first dose of Covid-19 vaccine.Patient stated that all of a sudden he felt heat all over his body, tingling sensation, felt nauseous then threw up. Applied cold compress on the back of the neck, lowered down the seat of the car and elevated his feet, encouraged to do pursed lip breathing, had him sip small amount of water. Extended their stay for to 30 minutes for further observation. Symptoms was resolve, left without any difficulties, Educated to call 911 if symptoms comeback and becomes worse. ER precaution initiated. Pt acknowledge understanding.      Patient was seen in the observation area together with his Mother who drove for him for his first dose of Covid-19 vaccine.Patient stated that all of a sudden he felt heat all over his body, tingling sensation, felt nauseous then threw up. Applied cold compress on the back of the neck, lowered down the seat of the car and elevated his feet, encouraged to do pursed lip breathing, had him sip small amount of water. Extended their stay for to 30 minutes for further observation. Symptoms was resolve, left without any difficulties, Educated to call 911 if symptoms comeback and becomes worse. ER precaution initiated. Pt acknowledge understanding.     Patient was seen in the observation area together with his Mother who drove for him for his first dose of Covid-19 vaccine.Patient stated that all of a sudden he felt heat all over his body, tingling sensation, felt nauseous then threw up. Applied cold compress on the back of the neck, lowered down the seat of the car and elevated his feet, encouraged to do pursed lip breathing, had him sip small amount of water. Extended their stay for to 30 minutes for further observation. Symptoms was resolve, left without any difficulties, Educated to call 911 if symptoms comeback and becomes worse. ER precaution initiated. Pt acknowledge understanding.n/a
Case number PHEH2013US010532, is an initial spontaneous report received from a medical assistant on 09 May 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M11072 and expiry date: Jun 2014) at dose of 0.5 ml, intramuscularly on 19 Feb 2013, which was stored below 36F. The vaccine reached 34.5F multiple times since 07 Feb 2013 for collective total times of 9-hours and 20-minutes. No adverse event was reported following this administration error.
tremors; tingling in her tongue; sugar levels have been very low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number=1), for COVID-19 immunisation. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "tremors"; PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "tingling in her tongue"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "sugar levels have been very low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient received the second dose of Pfizer's COVID-19 vaccine on 04May, last week she began to feel tremors in her body, tingling in her tongue and her "sugar" levels have been very low, it's the first time anything like this has happened to her. She wants to know if this could be related to the vaccine. The patient declined to be transferred to the safety unit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within a few hours of the second dose: My hands began itching and then swelling , still itching and becoming blotchy. Could not even bend fingers.  Ice water and Benadryl, by morning I could slightly bend my fingers and the itching had subsided but it was 24 hours  before they were nearly normal.
Mom reported fever 103 F night of vacc. followed by quarter-sized red area of vaccine.
This spontaneous report as received from a registered nurse refers to a 11 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 31-DEC-2015, the patient was inadvertently vaccinated with a dose of GARDASIL 9 injection (strength, dose, route of administration, lot number and expiration date were not reported). The reporter confirmed that the vaccine administered was not GARDASIL. There was no adverse effect reported. Additional information is not expected as no consent for correspondence contact was reported.
Accidental Skin Exposure; Achiness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 30th April 2020) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2020AMR114059).   On 25th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced pain. On 25th June 2020, the patient experienced exposure via skin contact. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and exposure via skin contact were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was provided as follows: The patient described achiness as dose one hurt a lot more than dose two. The health care professional noted the patient experienced what was described as a significant amount of liquid that ran down her arm during vaccination with dose two of Shingrix, which led to exposure via skin contact. No additional information provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR114059:for 2nd dose
I don't know if it is directly caused it but I started having severe joint pain in my left knee. I normally walk 5 miles most days and I do walk several times a week but I noticed I couldn't walk Sunday at all. I could walk outside a little bit but managed with just 1/10 of mile walk and limped in and it got progressively worse and I was having to use a roller stand to get around the house without an aide device. So on Tuesday I called my doctor and went to see her and since I have had blood clots in my right leg she ordered a Sonogram doppler test which came back normal and the nurse called today for me to take steroids' that she ordered from the pharmacy since she thinks it might just be inflammation. I will start those in the morning and take them for about 6-7 days. My knees have been bothering me for several years but walking helps loosen that up but not now with this new joint pain.
rash around the injection site of the left arm and extending down to her elbow; little red bumps; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a 94-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 29-AUG-2023, the patient received Arexvy (intramuscular, left arm). On 30-AUG-2023, 1 days after receiving Arexvy, the patient experienced red rash (Verbatim: rash around the injection site of the left arm and extending down to her elbow) and papular rash (Verbatim: little red bumps).  The outcome of the red rash was not resolved and the outcome of the papular rash was not reported.   It was unknown if the reporter considered the red rash and papular rash to be related to Arexvy.     It was unknown if the company considered the red rash and papular rash to be related to Arexvy.   Additional Information: GSK Receipt date: 31-AUG-2023 The reporter was the son of the patient, he reported his mother received the Arexvy Vaccine and the next day they observed a rash around the injection site of the left arm and extending down to her elbow.  When asking to describe the rash he stated there were little red bumps, the mother did not stated it was itchy.  The reporter gives permission to contact the healthcare professional. The reporter consented to follow up.
Felt real cold and then hot then cold again; Lethargic; Didn't want to eat; Felt run down; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt real cold and then hot then cold again), LETHARGY (Lethargic), APPETITE DISORDER (Didn't want to eat) and FATIGUE (Felt run down) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 040A21A) for COVID-19 vaccination. No Medical History information was reported.On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt real cold and then hot then cold again), LETHARGY (Lethargic), APPETITE DISORDER (Didn't want to eat) and FATIGUE (Felt run down). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt real cold and then hot then cold again), LETHARGY (Lethargic), APPETITE DISORDER (Didn't want to eat) and FATIGUE (Felt run down) outcome was unknown. Concomitant medication was not provided by the reporter.Treatment medication was cold compress.This case was linked to MOD-2021-382394 (Patient Link).
This spontaneous report overheard from a company representative from 2 nurses refers to a child patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot and expiration date were not reported) instead of VARIVAX (Merck). No adverse event was mentioned. Additional information is not expected.
7PM pt had a sz & turned blue;pt was taken to hosp ER T99;
Pain; Bowel movement changes; Normal aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), BOWEL MOVEMENT IRREGULARITY (Bowel movement changes) and MYALGIA (Normal aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), BOWEL MOVEMENT IRREGULARITY (Bowel movement changes) and MYALGIA (Normal aches). At the time of the report, PAIN (Pain) and MYALGIA (Normal aches) had resolved and BOWEL MOVEMENT IRREGULARITY (Bowel movement changes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment medication was not provided.
Patient was seen in the ED and hospitalized multiple times after second dose of vaccine, tested positive for COVID on 2/22/2021. Patient passed away on 8/11/2021
29-year-old female with a history of breast augmentation who experienced bilateral axillary lymphadenopathy, lethargy, malaise, myalgia and transient tenderness to injection site. On set of symptoms occurred at least one week following receipt of meningococcal, hepatitis A, and TDaP vaccines. Pt. reported she had an episode of localized unexplained edema to her left lower extremity, upper portions 6 days prior to vaccine receipt; etiology not explained. Patient evaluated by her primary care provider, who ordered an ultrasound that was done on 31 May 2016. Results of ultrasound revealed enlarged lymph nodes on the left, largest 18X10 cm with several other nodes, but all normal appearing. Repeat breast U/S June 24 2016 demonstrated improvement with size 1.6x0.49x.0.84; a R node (axillary) measured at 1.04x1.23x0.41. She was scheduled for biopsy, but the lymphadenopathy resolved. A lab workup for inflammatory and rheumatic markers ESR, CRP, RA, nuclear Ab, SLE profile and celiac disease were all normal. Lymphadenopathy is an expected adverse effect of immunization.
Woke up with chills, headache, and sore muscles. Did not take my temperature, but felt flushed. Felt lethargic the whole day after the shot (2nd dose of Moderna COVID-19 vaccine).
redness, swelling and itching that started about 21 hours after immunization was given.  Redness and swelling from right shoulder to about an inch above elbow that is warm and with slight hardness.  Keflex given 500mg three times a day for 10 days