chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 67 year old female, weight 146 lb, with allergies to ANCEF and related antibiotics, and a history of cancer 14 years ago who at 10:30 AM on 05-JUN-2008 was vaccinated with a "regular dose" of ZOSTAVAX (Oka/Merck) (lot#: 659409/0409X) in the left deltoid. Concomitant therapy included VESICARE and unspecified eye drops. At 5 PM on 06-JUN-2008, 30 hours after receiving ZOSTAVAX the patient developed hives on her trunk of body and groin, which were very itchy. The hives went away completely on the morning of 09-JUN-2008. The patient also noted that the injection site was sore and red. Subsequently, the patient recovered. The patient did not seek medical attention. Additional information is not expected.
45 min after flu injection, participant reported numbness and  to left arm and fingertips. she was advised to follow up with physician if pain persists. Participant stated she felt fine and after assessed by the nurse.
Immediately upon receiving the vaccine, patient complained of throat closing and trouble breathing. Difficulty with speech observed. Patient immediately self-administered own Epi-Pen. On-site EMS assessed patient, who was slightly hypertensive and tachycardic, and administered IVF, Benadryl and solumedrol, and 4L O2 by NC. Patient was transported by ambulance to the nearest emergency room,, where she was reportedly observed and discharged to home.
Feeling sick after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling sick after COVID vaccine) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included EMICIZUMAB (HEMLIBRA [EMICIZUMAB]) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Feeling sick after COVID vaccine). At the time of the report, VACCINATION COMPLICATION (Feeling sick after COVID vaccine) outcome was unknown.            No Treatment Medications details were provided.  This is a spontaneous case concerning a 28-year-old, male patient with relevant concomitant medication of Emicizumab (Hemlibra), who experienced the unexpected, non serious event of vaccination complication (vaccination related malaise). The event vaccination complication (vaccination related malaise) exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The concomitant medication of Emicizumab (Hemlibra) remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 28-year-old, male patient with relevant concomitant medication of Emicizumab (Hemlibra), who experienced the unexpected, non serious event of vaccination complication (vaccination related malaise). The event vaccination complication (vaccination related malaise) exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The concomitant medication of Emicizumab (Hemlibra) remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Woke up to uncontrollable shivering.  Lasted about 30 minutes. Felt warm,  but no fever then.  Also upset stomach and dizzy. Took Tylenol and went back to sleep.  Woke up again a couple hours later and was very hot.  Low grade fever of 99.8.  Stomach more irritated.  Chewed Gaviscon, drank water, sat up for awhile and went back to sleep.  Morning felt better, although very groggy.
Varivax administered 3/26/2008.  Pt. returned to office on 4/17/2008 with diagnosed varicella disease <20 lesions.
Participant had mild systems after her first dose, mild generalize pain. About 5 min after her second dose, developed generalize rash, numbness of tongue, audible wheezing and stated was getting difficult to breath. Administered 0.3 mg of epi in opposite deltoid. Responded well to epi, improved respiratory status.  BP taken after epi administration was 215/140 and came back quickly to normal limits for her. EMT came started an IV and administered Benadryl. Taken to hospital. O2 sats were < 80 but came up quickly in the ER. In the ER received Solumedrol, another dose of Benadryl and Pepcid. She was released about 2 hours after arrival. She has called her provider to report the incident and waiting for a call back. Is also going to see an alergist.
my feet went numb/hands went numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "my feet went numb/hands went numb".  Additional information: After the patient's Pfizer Covid vaccination, his feet and hands went numb. After two more boosters, He can't walk without assistance.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300122061 same patient different dose/drug/event;US-PFIZER INC-202300123168 Same reporter/patient, different dose/AE.;
exposed to bat; headache; weak; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-health care professional via Agency (Reference number- 00884090) and transmitted to Sanofi on 03-Dec-2021.  This case involves a 27-years-old male patient who experienced exposed to bat (animal bite), headache and weak (asthenia), after receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history included Animal bite in 2018.  Patient's past vaccination(s) included first 2 doses of IMOVAX pre-exposure regimen 20-APR-2018 (lot M5651M, expiry date: 01-Oct-2018) and 27-APR-2018 (lot N1B902M, expiry date: 01-Mar-2019) however this pre-exposure series was interrupted by a rabies exposure. Patient's states he then began the IMOVAX post-exposure regimen; patient received post-exposure IMOVAX on 12-MAY-2018 (lot N1B902M, expiry date: 01-Mar-2019), 15-May-2018 (lot N1B902M, expiry date 01-Mar-2019) and 19-May-2018 (lot N1B902M, expiry date: 01-Mar-2019). Patient received a different brand of rabies vaccine (states it was manufactured by GSK) on 26-May-2018 (lot 643011E, expiry date 01-May-2020). Patient states in total, he received 6 doses of rabies vaccine during this. On 22-Nov-2018 (lot N1G401M, expiry date 01-Jul-2019). Patient states he then had another exposure to rabies and received post-exposure IMOVAX on 25-NOV-2018.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (HRIG) for Immunisation.  The patient's past medical treatment(s) and family history were not provided.  On 02-Dec-2021, the patient received a 1 mL dose of suspect RABIES (HDC) VACCINE (lot M5651M, expiry date unknown) via an unknown route in the right arm for prophylactic vaccination  On an unknown date, the patient developed a non-serious exposed to bat (animal bite), headache and weak (asthenia) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Details of laboratory data not reported.  On an unknown date, the patient received TYLENOL [PARACETAMOL] as corrective treatment for event (headache).  It was not reported if the patient received any corrective treatment for the events animal bite, asthenia.  At time of reporting, the outcome was unknown for the events.
Pain in upper arm never left.  Pain continues to present (May 29, 2010) and includes radiating pain in right shoulder, right elbow, and pain extends down to tendons in right hand. Pain has resulted in a referral to an orthopedic which now includes 3 visits, and two cortisone shots, that last of which only caused more pain.  Told to get an MRI, possible partial tear in rotator cuff, physical therapy suggested.  xrays for bones are fine.  Onset of pain began at time of the seasonal flu shot...wondering if there is a correlation.  Much pain and inconvenience and cost involved.
I'm miserable; This case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine (received 1st dose in 2009).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was not recovered/not resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: The age at the vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had received 1st dose of shingrix in 2009 and experienced shingles. The patient had just received 1st dose of two and felt miserable, hopefully it would be better in a couple of days. The reporter hoped this series would work.
weakness in the legs; This case was reported by a nurse via call center representative and described the occurrence of lower extremities weakness of in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced lower extremities weakness of. On an unknown date, the outcome of the lower extremities weakness of was recovered/resolved.   It was unknown if the reporter considered the lower extremities weakness of to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that she experienced leg weakness that lasted for about one month after the dose. The reporter reported that she had not gotten the 2nd dose of Shingrix till the time of reporting because of how she reacted to the 1st dose of Shingrix. The reporter was about to get a new physician and was okay if any follow up was sent to herself at the time of reporting.
No additional adverse effects reported; a patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis (concentration, number of administered dose, route and anatomical location of administration and vaccination scheme frequency were not reported; lot number T014835 and expiration date 17-JUL-2021). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was below 36 degrees Fahrenheit: 35 Fahrenheit for a time frame of four hours and 20 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
7 days after receiving the vaccine, I developed intense, deep muscle pain and swelling. The arm where I received the vaccine was very hot to the touch. The next day, I had chills and a mild fever, along with swollen and sore arm. Through the weekend, I developed redness in splotches that were similar to hives in appearance. My arm has been intensely itchy. On Saturday, 2.20.21, the lymph node under my left arm became very swollen and painful. I am currently still experiencing a mildly sore arm (pain has lessened since yesterday), arm is still very hot to the touch, still have red rash/hives and my lymph node is still very painful.
Patient reports bleeding heavily from vaccination site. He went to bed that night and awoke at 3am unable to breathe temporarily. He was clammy/sweaty and awake for 2 hours. On Sunday, 6/20 he ran a fever of 102 degree F, had an extremely sore vaccination arm, and felt a general malaise.
Area around injection site was red and warm.  Redness extended 3-4 inches in circumference.
I had a high fever and chills, and nausea for a couple weeks. After feeling better I started to feel like my head was swimming in the head.
On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient; No adverse event; Patient received vaccine past the 30 days use by date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 days use by date), PRODUCT STORAGE ERROR (On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient) and NO ADVERSE EVENT (No adverse event) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 082B22A and 082B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 days use by date), PRODUCT STORAGE ERROR (On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient) 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 (Patient received vaccine past the 30 days use by date) and PRODUCT STORAGE ERROR (On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient).    No concomitant medications was reported.  On 09-Aug-2022, the vial was initially stored in the refrigerator and 3 vials were in a carton and one was selected with a dose administered to a patient on 15-Sep-2022.  The patient received the vaccine in her right arm shoulder deltoid muscle. The vial did not undergo any temperature excursions. Vial size was 5.5ml.  No treatment drug details was reported.
- Uncomfortable feeling in chest around 8pm on 4/24, tried to sleep it off - Couldn't sleep very well, and woke up with a tightness of chest and unable to draw a full breath - Went to county ER and was advised I was suffering a heart attack (non stemi)  (troponin levels were over 7,000)  - transferred to hospital for further diagnosis and treatment - Had a echocardiogram, cardiac catheridisation and MRI, which found that I had inflammation of my heart muscles - treated symptoms with medication and was discharged after an overnight stay
Sever chronic  fatigue; Chronic joint pain; Chronic  muscle pain, that  has lessen is not that  severe; Her life has been turn up side down; Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away; Having  back pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Her life has been turn up side down), URTICARIA (Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away), BACK PAIN (Having  back pain), FATIGUE (Sever chronic  fatigue) and ARTHRALGIA (Chronic joint pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 012l20a and 010m20a.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced FEELING ABNORMAL (Her life has been turn up side down), URTICARIA (Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away) and BACK PAIN (Having  back pain). On 23-Nov-2021, the patient experienced FATIGUE (Sever chronic  fatigue), ARTHRALGIA (Chronic joint pain) and MYALGIA (Chronic  muscle pain, that  has lessen is not that  severe). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. On 23-Nov-2021, BACK PAIN (Having  back pain) had resolved. At the time of the report, FEELING ABNORMAL (Her life has been turn up side down), URTICARIA (Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away), FATIGUE (Sever chronic  fatigue), ARTHRALGIA (Chronic joint pain) and MYALGIA (Chronic  muscle pain, that  has lessen is not that  severe) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   This case was linked to MOD-2021-398471 (Patient Link).
The patient felt weak. They couldn't stand up and went to the ER. The ER didn't find anything abnormal is the blood work and feel that it is a reaction to the Shingrix vaccine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 2:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 2:02 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.41 for dose administered on 03-Mar-2021 and  68.49 for dose administered on 31-Mar-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 degrees Fahrenheit at 9 AM, 34 degrees Fahrenheit at 10 AM and 35 degrees Fahrenheit at 1 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021.Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
The patient came in for booster COVID-19 vaccination at our health unit and was inadvertently injected with an outdated vial of vaccine which was expired with Shelf Life Extension since September 2021. Appropriate administrative tasks and report was made through our channel and patient was reassured of no harm would come from having this vaccine. It is worth noted that the expired vaccine was kept in -80 degree celsius freezer at all time and as we consulted with our infectious disease specialist who consider that it is possible that this dose is still valid, we explained the situation to the patient and offer option to get another booster dose in the next 10 to 12 weeks.
After administering the dose at 5:40PM, I noticed that vial BUD was for 10:15PM on 08/08/21 and not 08/09/21 as I had initially read it - one dose had already been given today from the vial by a pharmacist who came in before me to a different patient. The pharmacy manager instructed me to give the patient a dose from a new vial, and I did so.   So, he received one expired dose and one "fresh" dose.   The patient has not currently reported any adverse effects.
Pt recvd vax & devel redness & swelling (size of an orange); c/o pain @ inject site (when sitting);