chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When administered, patient felt a shooting pain from deltoid muscle to middle finger on her hand of same arm. Since then, she has experienced a dull, achy pain in her arm and cannot put weight on arm or pick up heavy items without discomfort.
1st dose 07Sep2022, 2nd 10Jan2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 7th September 2022).   On 10-JAN-2023, the patient received the 2nd dose of Twinrix. On 10-JAN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 07Sep2022, 2nd 10Jan2023). The outcome of the drug dose administration interval too long 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: 26-APR-2023 The pharmacist reported that an adult patient received standard Twinrix second dose late.  The reporter declined to provide more information. The reporter did not consent to follow up. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
one evening of MILD facial loss of control on one side / numbness on that side of my face--similar feeling to several hours after receiving shot(s) of dental novacaine a bit of a droopy smile on one side the night of the shot, though when I smiled for someone a few hours after the shot, both sides of my smile were even   My mother noticed that one side of my face was droopy though when I spoke with her over video conferencing. But I noticed the next day that I had better control of my facial muscles on the left side. The night of the shot, I also felt some numbness/mild pain around my left ear and on the tip of my nose and on my cheek and a new sensation (numbness) on the left side of my brain. Also that night though, I sang a short song and had a loss of control of the tune--like my voice was really changing (unusual). Now, I feel some barely perceptible numbness on that same side of my face sometimes but really feel fully capable of everything and like this doesn't really matter except to let others know that it can happen.  I am very happy to be vaccinated and want the second shot if it's okay!!!
This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a 45-year-old female patient who received FLUARIX QUADRIVALENT 2017-2018 season (batch number 34RE5, expiry date 30th June 2018) for prophylaxis. The patient's past medical history included chronic pancreatitis. Concurrent medical conditions included multiple allergies (Cefoperazone and Granisetron). Concomitant products included PREVENAR 13. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season (intramuscular). On an unknown date, unknown after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional details were provided as follows: The age at vaccination was not reported. There was a temperature excursion for FLUARIX QUADRIVALENT 2017-2018 season, which led to incorrect storage of drug. The information regarding this event has not been submitted to the US Food and Drug Administration and has not been reported to the agency. No culture was performed. No treatment was required.   Follow up information received from Nurse on 18th July 2018: The patient details were updated. On 19th October 2017, the patient received 1st dose of Fluarix Quadrivalent 0.5 ml. Fluarix was given after multiple shot of temperature excursions but not exceded the manufacturer's allotted time slot. No adverse events were reported. This was an accidental medication error without harm. The VAERS details were updated.
redness swelling rash like warm beginnings day after injection (~8 hours) reaction still not resolved on day 6 after injection
PCR confirmed Monkeypox; Case reference number US-BN-2022-004663, is a spontaneous case report initially received from a physician via company (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history was not provided.  The patient's concomitant medication was not provided.  On an unspecified date, the patient was negative to human immunodeficiency virus (HIV).  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and unknown anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, an unspecified amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at unknown dose, route of administration and unknown anatomical location.  On an unspecified date, reported as one month after the second Jynneos dose, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox.   At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and related to Jynneos vaccination.   Additional information received from the physician via company on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668, US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) one month after second dose of Jynneos vaccine was administered. Monkeypox is unlisted per the CCDS v1 and the PI. Concomitant medications and medical history were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) one month after second dose of Jynneos vaccine was administered. Monkeypox is unlisted per the CCDS v1 and the PI. Concomitant medications and medical history were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-21 and 15-Nov.  No treatment information was provided.
Patient complained of tingling sensation in the hands, uncomfortable enough that she had difficulty sleeping.  It started Wednesday night.
Narrative: "On review of this incident, and the patient's record, I see that he has a history of a seizure disorder that is managed by a neurologist. Prior to today, he had last filled his prescription for Keppra in October 2021, suggesting adherence may have been imperfect or he may have run out of the medication. There were no reports of seizures in the clinical trials of the Pfizer vaccine. I believe it is likely a coincidence that he suffered a seizure today, 1 hour after his Covid vaccine"  Doctor 5/20/22 note
I saw my doctor on April 6th, 2021 and he said that the vaccine was the reason I wasn't feeling well.
Patient states that she experienced dizziness after receiving Zostavax vaccine. No other symptoms reported.
8 days after receiving DTaP vaccine, felt tingling sensation around waistline. Over the next few days the tingling (and numbness) grew worse, progressing down to my toes. Admitted to hospital 4/29/12 and discharged 5/5/12. 4 MRIs and 2 months later, I was diagnosed with post vaccination transverse myelitis.
Fever for 48-72 hours(99-101), chills--uncontrollable sweating. A couple of dizzy spells.  Janssen-J&J
Systemic: Frequent firm bowels 5 to 8 times daily for 2-3 weeks-Severe, Additional Details: Pt also felt spacey during the day.
legs feeling weak; weak, lethargic, out of it; Headache; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (weak, lethargic, out of it), MUSCULAR WEAKNESS (legs feeling weak), CHILLS (Chills), VACCINATION SITE PAIN (sore arm) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and INSULIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 10-Mar-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 11-Mar-2021, the patient experienced VACCINATION COMPLICATION (weak, lethargic, out of it). On 12-Mar-2021, the patient experienced MUSCULAR WEAKNESS (legs feeling weak). At the time of the report, VACCINATION COMPLICATION (weak, lethargic, out of it), MUSCULAR WEAKNESS (legs feeling weak), CHILLS (Chills), VACCINATION SITE PAIN (sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Treatment of events was not reported.
fatigue; fever; aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Feb2021 (Lot number: EL1283) at the age of 48 years as dose 2, single for covid-19 immunisation; influenza vaccine (FLU), intramuscular, administered in arm right, administration date 27Oct2021 (Batch/Lot number: unknown) as unk, single. Relevant medical history included: "Anxiety" (ongoing), notes: GAD; "Knee surgeries", start date: 1993 (unspecified if ongoing), notes: Knee surgeries, Onset date: 1993,1995,1999, Pertinent details: L knee all repair, L knee arthroscopy X 2; "Knee surgeries", start date: 1995 (unspecified if ongoing), notes: Knee surgeries, Onset date: 1993,1995,1999, Pertinent details: L knee all repair, L knee arthroscopy X 2; "Knee surgeries", start date: 1999 (unspecified if ongoing), notes: Knee surgeries, Onset date: 1993,1995,1999, Pertinent details: L knee all repair, L knee arthroscopy X 2; "Bunionectomy", start date: 1998 (unspecified if ongoing), notes: Onset date: 1998,1999,, Pertinent details: R and L Bunionectomy; "Bunionectomy", start date: 1999 (unspecified if ongoing), notes: Onset date: 1998,1999,, Pertinent details: R and L Bunionectomy; "Covid-19", start date: 27Dec2020 (unspecified if ongoing), notes: Stop date: Went back to work 08Jan2021, Pertinent details: Fatigue lasted @ least 3 minutes brain fog lasted until may 2021. Concomitant medication(s) included: LEXAPRO taken for anxiety, start date: 2012 (ongoing). Vaccination history included: Bnt162b2 (First dose: , Anatomical location: Left arm, Route of administration: Intramuscular, Lot number: E11284 30Apr2021), administration date: 29Jan2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "fatigue", "fever", "aches". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SANDOZ-ESTRADIOL, start date: Oct2021; PROGESTERONE, start date: Mar2020. Past drug history included: Lovenox, reaction(s): "known allergies: Lovenox". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I have a rather severe reaction to the shot. A few hours after the shot my arm welled a lot and was very painful. I had trouble raising my arm even an inch. I took an ADVIL PM so I hopefully could sleep last night. That worked fairly well. This morning my arm was extremely painful. The swelling had moved from the vaccination site toward my inner arm and went down to my elbow. In addition, right after I got up I walked to the kitchen and started to feel faint. My husband was there and he took me to a chair. My blood pressure had dropped to 105/56. I gradually began to feel better. My arm is still very sore and swollen. I thought you should know my reaction so others can be informed. I am only glad the shot was in my left arm instead of my right arm.
Fever for 2 days post vaccine, diffuse headache and mild pharyngitis, chronic back pain, discharged AMA to go see his other oncologist about chemo as that helped improve his back pain last month
Increased heart pressure, feeling of chest tighness, chest palpitations and occassional shortness of breath.  progressively worsening.  Initiated Lisinopril 10mg/day on 8/20.  Heart pressure drops from >160/110 to 125-140/80-100 for 12-14 hours then increases to 160/110.
Moderna Covid 19 vaccine EUA  Chills, fever, body aches, cough, sore throat, headache, nausous stomach
After sitting about 15 minutes, patient said he felt lightheaded.  He was pale and a little clammy.  Gave patient water & stayed with him, because "he might faint".  Blood pressure was taken.  Initially was low, subsequent readings improved.  No Epipen was given.  He was talking & seemed to be improving.  He was nervous, so 911 was called.  He was much better by the time the EMTs arrived.  The entire event including EMTs was @ 20 minutes.  He felt well enough to shop in the store after.
Report A0357280A (formerly 2002000436-1) describes possible rheumatoid arthritis or osteoarthritis in a 46 year old female who received Lyme disease vaccine recombinant OspA (LYMErix). There was no relevant medical history or concurrent medication. The vaccinee did not have gout, psoriasis, Crohn's disease, or history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. In June 2000 (exact date unknown), the vaccinee received her third injection of LYMErix. The vaccinee reported to the physician that she began to experience joint pain in her knee, neck, shoulder, and legs in January 2001, approximately 6 months post immunization. On physical examination, no joints were noted to be warm or swollen. Serology for Lyme disease was positive initially, then negative. erythrocyte sedimentation rate was increased. Bone scan demonstrated mild arthritis changes in several joints. The physician stated that the diagnostic considerations were osteoarthritis, rheumatoid arthritis, polyarthralgia, polyarthritis secondary to LYMErix injections. The arthralgia was treated with celecoxib and ibuprofen. The reporter stated that the arthralgia was moderate in severity and was possibly related to LYMErix administration. As of 2/4/02, the arthralgia persisted. The adverse events of rheumatoid arthritis and osteoarthritis do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.
lost voice, sore throat, coughing, sneezing, dizzy, nauseated all within the two and half weeks since I received it .
Patient was found dead in his apartment. I'm not clear on details, but he was having some issues the week prior to being vaccinated. He was in acute distress when his attendant care worker came to give him his medications the day before.
Nausea, dizziness, fatigue, head spins, sounds echoing in ears, dazed
paralyzed 13 hours later; daughter does not have full strength in her legs; left arm goes numb; has shortness of breath; always feels cold; chest pain; cannot feel hot or cold; She reports her daughter has to use braces and a wheelchair and is unable to work/she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld; This is a spontaneous report from a contactable consumer (patient's mother). A 33-years-old patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 14Apr2021 (33-years-old at the time of vaccination) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, the patient was paralyzed 13 hours later, she reports her daughter has to use braces and a wheelchair and is unable to work/she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld), daughter does not have full strength in her legs, left arm goes numb, cannot feel hot or cold, has shortness of breath, always feels cold, chest pain. She states her daughter has been in and out of the hospital and is still having issues 2 months after the Pfizer covid-19 vaccine injection. She reports a cardiologist saw "something" on an EKG and that her daughter has also seen a neurologist and several other doctors. On an unspecified date, the patient underwent lab tests and procedures which included electrocardiogram. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
I experienced a breakthrough case of COVID-19 with a severe runny nose, coughing, congestion and body aches.
After getting the flu shot, patient became hypotensive and bradycardic. Pt given pressors which stabilized his blood pressure. Pt had to be intubated. Symptoms resolved 2 days later and pt was extubated. Pt now awake, alert, and oriented. It was determined the pt had anaphylactic shock due to the vaccine.
No adverse event; expired lot of PNEUMOVAX 23 was administered to 69 year old patient; This spontaneous report was received from a pharmacist and refers to a 69-year-old male patient.   No information regarding patient's medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAR-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # U022984, expiration date: 29-JAN-2023, 0.5 milliliter once (route of administration and anatomical location were not reported) for prophylaxis (expired vaccine used). No further information and no additional adverse event were provided (No adverse event).
1 week after receiving the 1st  Moderna dose, an intense itch started on right arm at injection site. Cortizone-10 cream was applied to calm the itch.  Approximately an additional 1 week later, a large spotty rash appeared on the upper arm. Both symptoms seem to be improving as of 1/30/21 today.
This spontaneous report has been received from a licensed practical nurse referring to a 4 year old patient of an unknown gender. There was not information regarding the patient's pertinent medical history, drug reaction, allergies or concomitant therapies. On 11-JAN-2017,  the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, and frequency were not provided), lot # M034584 and expiration date 27-JUL-2018, for prophylaxis. The vaccine doses were exposed to a temperature excursion of-7Celsius (C) degrees for a time frame of 1 hour and 20 minutes, also she stated that there was not previous temperature excursion; this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011002: US-009507513-1701USA005479: US-009507513-1701USA011003:
Symptoms lasted approximately 12 hours (1.9.21: 0230am - 1430pm) T: 101, chills, moderate muscle/joint aches, fatigue, headache. Took Ibuprofen 400mg x1.  6 weeks pregnant at time of 2nd COVID vaccine dose, estimated date of delivery 9.5.2021.