chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 6/14 my son received PREVNAR 13 vaccination, his body temp at the time was 99.4 was indicated as normal by primary pediatric and okay to administrator vaccine. On 6/16 my wife and I noticed small red spots under my son's chin, but didn't think anything of it. My mom who is a nurse we saw on 6/17 identified it as petechia, she told us to watch it if it continues. On 6/18/17 my wife and I noticed that petechia increased to all extremities, body, including feet, hands, ears, head, rectal, and groin areas. We went to urgent care and doctor mentioned it was something that ER needed to see. We went to hospital and blood work was done identifying low platelet counts of 7,000 normal range is 150k-450k. We were admitted, doctor also noticed bruising in the leg areas and low back which did not appear until we were in the ER. Additionally, my son had bleeding on his gums we thought was related to teething or him putting his hands in his mouth, but believe now related to diagnosis of ITP. He is being treated now with IVIG and bloodwork will be completed at 12pm, at the time of my writing this is 9am, infusion was started at 3:45AM. My son was completely healthly prior to his vaccination of PREVNAR 13. We have been staggering the vaccinations and have completed ROTO, DTAP, HEP-B and just now started the PREVNAR 13. I believe PREVNAR 13 caused this issue and was directly responsible for entry into the ER.
Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment mediations were reported.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676 (Patient Link).
2 mins p/vax pt c/o nausea & became pale & diaphoretic; sips of H20 given; did not vomit, unable to obtain accurate BP since cuff too large for arm;
Visibly swollen lymph nodes in underarm on the left, left side of neck (near the base) and under chin (on the left)
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 62-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the State currently. Also reported that no adverse reactions were experienced by any patients.
Information has been received from a registered nurse concerning a 5 year old male who on 24-JUN-2002 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#640555/0974L). Concomitant therapy included a fourth dose of Prevnar (Lot#485994) given IM in the left thigh. On 20-MAY-2007, the patient developed a rash all over. The patient was seen in the office on 24-MAY-2007 and was diagnosed with chickenpox. The physician treated symptomatically and there were no complications. No further information was provided. Follow up information from the nurse indicated that on an unspecified date the patient recovered. Additional information is not expected. This is one of several reports from the same source.
Muscle & joint aches; short-lived very mild headache; mild chills; fatigue; thirst; strong sleepiness, very mild nausea;
Patient was diagnosed with Covid 19 at a local nursing home, where she is a resident.  Patient was brought to the ER for aggressive behavior toward the NH staff.  She reportedly threw a food tray.  She was calm in the ER and stated that she was angry with the NH staff.  Patient was evaluated and placed into Inpatient status in our ICU for homicidal and suicidal ideations.
Sudden onset of chills and body aches beginning at 1pm on 4/5/21; temperature taken at 2pm was 100.8 and remained between 100 and 101 until 7pm.   Chills and aches subsided greatly by 5pm.   Had a COVID-19 test conducted at clinic around 5:30pm (results delivered the next day were Negative).  Returned home and took 2 Tylenol - which brought my temperature down to 98.8.   Took an additional 2 Tylenol before bed and woke up on Tuesday, 4/6 with no fever and no symptoms.  Note - both the nurse and doctor that examined me at clinic indicated that I was not the first patient that they saw with these symptoms approximately one week after receiving the first vaccination .
Child had 2nd MMR on 2/8/00 at 10:15am.  On 2/9/00 at 7:52am, had red raised area 2 1/2" in diameter and 1/2" thick.  Parent was advised to give benadryl and use cool compresses.
Ready to pass out (ER visit); Profuse sweating (ER visit); Severe disorientation (ER visit); This case was reported by a pharmacist via call center representative and described the occurrence of presyncope in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna covid vaccine with an associated reaction of presyncope (had a similar reaction when patient took the Moderna Covid shot for the first time and experienced presyncope).   On 13th December 2022, the patient received the 1st dose of Shingrix. In December 2022, 20 hrs after receiving Shingrix, the patient experienced presyncope, sweating and disorientation. In December 2022, the outcome of the presyncope, sweating and disorientation were recovered/resolved.   It was unknown if the reporter considered the presyncope, sweating and disorientation to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-DEC-2022 Reporter's Comment: The reporter was the registered pharmacist who was the mother of the patient. The patient received first dose of Shingrix yesterday and 20 hours later had a severe reaction including ready to pass out, profuse sweating and severe disorientation. The patient had similar reaction when she took the Moderna Covid shot for the first time. The patient was okay now and she had no such reaction. The reporter just trying to find out if there was a common ingredient or product that exists in both products that could be responsible for the commonality of reactions. The reporter believed that her daughter filed a report with organization today to let them know of the reaction.  The EMS people indicated that it was apparently a response to the Shingrix. Emergency room visit required. The patient was concerned about taking the second shot due to reactions and she was feeling much better.  The healthcare professional did not have the lot or expiration date. The reporter reported that her daughter might have reported this so this might be a duplicate report. The reporter consented to follow up by email.
1st dose 2 yars ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax 5 to 7 years ago) and Shingrix (received first dose about 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: The patient mentioned that she has not yet received her second dose, for unknown reason.  Nothing else was reported. The reporter declined to give name, date of birth. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Vision problems; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 02Apr2021, outcome "unknown", described as "Vision problems".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial and follow up information has been received from a physician and a registered nurse (R.N.) concerning a 16 year old female patient who on 15-JAN-2007 was vaccinated IM in left deltoid with her first dose of GARDASIL vaccine. On 19-JAN-2007 the patient developed red and swollen arm in the injection area. The physician advised patient to take TYLENOL. On 22-JAN-2007 the patient reported that her tonsils were swollen. She felt really tired and that her leg was hurting and she could not put weight on it. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow-up information indicated that on 16-JAN-2007 patient had heart palpitations and on 19-JAN-2007 in AM she had swollen throat, right leg pain (previously reported as starting on 22-JAN-2007, not site of injection), felt tired (previously reported as starting on 22-JAN-2007). The patient recovered in one week. Additional information is not expected.
This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a 62-year-old male patient who received SHINGRIX (batch number LT533, expiry date unknown) for prophylaxis. On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 29th June 2018, 1 days after receiving SHINGRIX, the patient experienced shortness of breath, headache, loss of energy, chilliness, sleeplessness, feeling unwell, stomach cramps and chills. On an unknown date, the outcome of the shortness of breath, headache, loss of energy, chilliness, sleeplessness, feeling unwell, stomach cramps and chills were recovering/resolving. It was unknown if the reporter considered the shortness of breath, headache, loss of energy, chilliness, sleeplessness, feeling unwell, stomach cramps and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that at midnight after receiving the second dose of SHINGRIX the patient experienced short of breath, stomach started cramping, headache, chills, could not keep warm, almost went to the emergency room, did not sleep the rest of the night. The patient saw their cardiologist the next day.  The patient was still not feeling back on his feet yet and lacks energy to do things.
Expired vaccine dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04220A, 024m20A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.
is still having lingering symptoms./now her immune system is angry and sometimes side effects last longer; now her immune system is angry and sometimes side effects last longer; she is feeling anxious; She thought her lymph nodes were swollen near her clavicle and up the neck and under her arm/swelling in lymph nodes under arm/swelling in lymph nodes in her neck and by her clavicle; swelling in lymph nodes in her neck and by her clavicle; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 50-year-old female patient received bnt162b2 (PIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200; Expiration Date: Jun2021) via an unspecified route of administration, administered in arm left on 26Feb2021 (age at vaccination 50-year-old) as dose 2, single for covid-19 immunisation. The patient medical history included sarcoidosis from an unknown date and unknown if ongoing. She has been in remission for 25 years. The concomitant medications included LOSARTAN, AMLODIPINE BESILATE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), METFORMIN and METOPROLOL TARTRATE taken for an unspecified indication, start and stop date were not reported. Historic vaccine includes BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263) via an unspecified route of administration on 05Feb2021 (age at vaccination 50-year-old) as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced a is still having lingering symptoms /now her immune system is angry and sometimes side effects last longer, now her immune system is angry and sometimes side effects last longer, she is feeling anxious. On 11Mar2021, had swelling in lymph nodes in her neck and by her clavicle and she thought her lymph nodes were swollen near her clavicle and up the neck and under her arm/swelling in lymph nodes under arm/swelling in lymph nodes in her neck and by her clavicle. The patient did go to her primary care provider a couple of days ago because it has been lingering. The patient primary care provider said that the vaccine causes your immune system to be angry and that is what has caused the swelling and he thinks it will subside. The patient underwent lab tests and procedures which included colonoscopy, electrocardiogram, mammogram, ultrasound biliary tract, x-ray: good on Jan2021 prior to receiving the vaccine. The outcome of the events still having lingering symptoms/now her immune system is angry and sometimes side effects last longer, now her immune system is angry and sometimes side effects last longer, she is feeling anxious was unknown, the swelling in lymph nodes in her neck and by her clavicle was recovering and her lymph nodes were swollen near her clavicle and up the neck and under her arm/swelling in lymph nodes under arm/swelling in lymph nodes in her neck and by her clavicle was recovered on 31Mar2021.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse, concerning to a 14 year old male patient. His medical history and concurrent conditions were not reported. On 02-FEB-2016 at 13:00, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies were reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
Initial misuse report receive from a healthcare professional on 18 March 2013. A patient was administered ADACEL through subcutaneous route. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Started shingle symptoms in the upper leg next evening after she received the vaccination. She saw the doctor on third day after vaccination and he diagnosed it as shingles and gave her Famvix and Tylenol #3.
Initial Pfizer vaccine given within the 90 day period after monoclonal antibody infusion.  Nov 1,  2021 infusion given.
Headache; Feeling tired; Chills; Fever; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199) via unspecified route of administration in the left arm on 16MAR2021 at 13:30 hours (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patients medical history includes thyroid issues from unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medication, food, or other products. The concomitant medications included levothyroxine (UNKNOWN MANUFACTURER), TYLONOL and ibuprofen (UNKNOWN MANUFACTURER) all for unknown indications from an unknown date. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 16Mar2021, the patient experienced headache about 30 minutes to an hour after receiving the vaccination and shortly after that she felt tired. Later that night she had chills followed by fever & muscle ache. No therapeutic measures were taken for the reported events. The clinical outcome of headache, feeling tired, chills, fever and muscle ache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored doses of VAQTA Lot  # L015460, expiration date: 20-JUL-2017 and Lot # K010577, expiration date: 01-SEP-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received flu vaccine IM LD and Pneumonia vaccine IM LD on 10/7/02 per LPN. Patient returned to clinic on 10/9/02. 4" band, swelling, erythema, tenderness left arm. Well demarcated. Reported pain, no rash, left breast and left buttock. Called on 10/10/02 and reported resolved after Benadryl.
Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 29-JUN-2020, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S034636, expiration date on 14-NOV-2020), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA003647: US-009507513-2007USA002536: US-009507513-2007USA003645: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
"problems with her eyes"; sore arm; swollen on the lids; eyes are "red rimmed"; thinks it's conjunctivitis; tired; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION ("problems with her eyes"), PAIN IN EXTREMITY (sore arm), SWELLING OF EYELID (swollen on the lids), OCULAR HYPERAEMIA (eyes are "red rimmed") and CONJUNCTIVITIS (thinks it's conjunctivitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Aspirin) and Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), VALSARTAN (DIOVAN), LEVOTHYROXINE SODIUM (SYNTHROID) and ALLOPURINOL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Mar-2021, the patient experienced EYE IRRITATION ("problems with her eyes"), PAIN IN EXTREMITY (sore arm), SWELLING OF EYELID (swollen on the lids), OCULAR HYPERAEMIA (eyes are "red rimmed"), CONJUNCTIVITIS (thinks it's conjunctivitis) and FATIGUE (tired). At the time of the report, EYE IRRITATION ("problems with her eyes"), PAIN IN EXTREMITY (sore arm), SWELLING OF EYELID (swollen on the lids), OCULAR HYPERAEMIA (eyes are "red rimmed"), CONJUNCTIVITIS (thinks it's conjunctivitis) and FATIGUE (tired) outcome was unknown. Not Provided          Treatment information does not provided. The action taken with the drug was not applicable.