chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient explained past history of syncopal episodes after injections. At 1103 AM on 01/17/2022 she got Moderna booster vaccine dose 0.25 ml. (Lot 22j21a) and immediately said she wanted to lie down. Provider laid patient on the floor and at 1106 AM her Pulse was 55 BP was 85/55 Her hands were cold. She remained alert oriented as said she did not want 911 to be called. There was no wheezing no itching no shortness of breath. No swelling, no redness of face or tongue, or any other allergic type reactions. Her Vitals at 1110 were pulse were last recorded at 11:25am of 102/69 and 61 respectively. She was given juice and[INVALID]s and was able to eat without problems and she sat for an addition half hour until she felt good enough to go home. Faint with needle injections.
Severe headaches, began spotting after first dose for 2 days. After receiving second dose on 09/24/21 began spotting the next day on 09/25. Spotting has led to bright red bleeding, heavy flow of menstrual cycle, severe cramping; has been ongoing for a month.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 8-week-old patient of unknown gender. On 15-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
PT PASSED OUT WITHIN 2-3 MIN OF JANSSEN COVID-19 VACCINE ADMINISTRATION. COMPLETELY NONRESPONSIVE.  ADMINISTERED 0.3MG EPINEPHRINE AUTO INJECTOR INTRAMUSCULARLY TO PT'S RIGHT OUTER THIGH AT ~3:27PM.  PT IMMEDIATELY RESPONSIVE AFTER EPINEPHRINE INJECTION. 911 CALLED. EMT & PARAMEDIC ARRIVED. PARAMEDIC CHECKED BP, HR, & BS- ALL NORMAL.  I STRONGLY ADVISED PT TO GO WITH PARAMEDIC TO ER.  PT REFUSED TO GO TO ER ASSURING PARAMEDIC AND MYSELF HE WAS FINE.  PT LEFT PHMCY AT ~3:41PM.
day p/vax had SOB x 48hr;did not report to MD until past time for next shot (1yr later);sx resolved on their own;
Patient came into office 8/9/19 at 345pm for the varicella vaccine per Dr Patient at 4pm went stiff & turned pale per mom 911 was called v/s done prior to EMS 99% RA 53 bpm
SWELLING AND REDNESS AT THE INJECTION SIGHT TRAVELED DOWN THE LEFT ARM TO THE LEFT HAND. PATIENT ALSO EXPERIENCING  A "PRESSURE SENSATION BEHIND THE LEFT EAR" AND A "SENSE OF PARTIAL HEARING LOSS"
Itchy red rash on neck; Itchy red rash on neck; This is a spontaneous report from a contactable other health professional. A 25-years-old female patient herself received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 15:15 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization.The patient's medical history included generalised anxiety disorder.The Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE) taken for an unspecified indication, start and stop date were not reported. The patient previously took clindamycin and experienced drug hypersensitivity. No treatment was received for the adverse events. The patient experienced itchy red rash on neck on 26Jan2021.12:00 AM. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Administration facility. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Around 11PM I started feeling not great went to bed, I woke in the morning with a fever over 100 so I took some TYLENOL I do have anxiety, so I did also take a XANAX. I felt like I was going to faint which I have done with a previous dose, so I went to the bathroom with my phone and laid on the cold tile floor. I was on the floor about an hour before I call 911 and they sent paramedics. When the paramedics arrived, they brought me back into my bedroom. They took my pulse and blood pressure and stated they didn't believe that I needed to go to the hospital that I was just experiencing the effects of the vaccine and would be better off staying home. I was pretty sick yesterday and went to stay with my sister and felt better today when I woke up.
Redness and swelling developing hours after vaccine. Itchiness at injection site. Approximately 10 cm in size, reaction site with significant redness and swelling with flu shot from same lot #.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: warmness in chest,tightening of throat, no difficulty breathing but \"funny feeling\", able to complete sentences, able to answer questions, patient is alert-Mild, Additional Details: patient describes tightening of throat, warmness of chest, no difficulty breathing but \"funny feeling\" (cottony feel according to patient) when swallowing. patient is alert, able to answer questions and able to complete sentences. pharmacist on duty immediately called 911, have epipen ready. per 911 dispatcher, rph must answer some questions first, but paramedics arrived immediately to the scene and took over. patient interviewed by paramedics and patient walked with paramedics out of building.
patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Menveo: only diluent administered; Menveo: only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA9345) for prophylaxis.   On 22-JUN-2023, the patient received Menveo. On 22-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo: only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Menveo: only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2023 The nurse reported that a college student was administered only the liquid component of Menveo (booster dose) and the powder was not administered. The reporter did not consent to follow-up. On the day of reporting, the patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
About 2 weeks after getting the vaccine, patient had chest pains. He can?t communicate, due to his stroke. But he got his moms attention and he directed her to a doctors office. The doctor med-vacced him to the Er.   They said he was in heart failure but didn?t have a heart attack. They also said he had no blockage. He was in very serious condition for a few weeks and we thought he was going to die. His family set up hospice for him. He was on oxygen and couldn?t catch his breath.  They said his heart was enlarged and it was only working at 10%. Also, they said a blood clot on his heart. There was fluid around his heart and lungs.
Generalized urticarial rash. BENADRYL, PRELONE, ZANTAC, and ALLEGRA. Spoke to mother today 10/31/08 who states that child is better.
Patient received Moderna Covid 19 vaccine lot# 031A21A expiration 08/28/2021 0.5ml to right deltoid at 09:45 a.m. on 03/10/2021. Patient verbalized No known drug allergies. Patient was asked to wait in parking lot area for monitoring of adverse reaction. At approximately 09:49 a.m monitoring officer called to RN that patient needed assistance.  RN, LPN, EMT-P,   LPN and , LPN went to assess patient at her vehicle. Patient reports "she feels like her throat is tingling, itching, and closing up and just weird." Patient also reported that "she could feel her throat swelling." RN assessed for any rash or swelling and patient only with chest redness but no rash.  RN assessed vitals. BP 138/90, HR 92, Respirations 14. Patient educated on epi injection and possible side effects and patient verbalized understanding. EMS contacted to come assess.  At 09:51 a.m. Epinephrine Injection (Auto Injector) 0.3mg given to right thigh w/o difficulty. Lot# 0FM534, Exp 09/2022.  Patient monitored. Patient stated  at 09:55  "I can already feel my throat getting better and it doesn't seem to be swelling anymore."  EMS arrived at approximately 09:57 to assess patient. Vitals taken by EMT at 10a.m. BP 184/129, HR 88, O2 sat 100%, Respirations 16. EKG performed by EMT . Results were normal.  EMT assessed patients throat and patient continues to report "the swelling and tingling is getting better and I do not feel short of breath." EMT recommended ER visit since epi was administered for eval. Patient declined and states "she feels better and knows what to do if reaction starts again." EMT recommended patient to take Benadryl when she gets home and to go to ER with any additional problems. RN checked vitals again at 1012 a.m. BP 172/120, HR 80, Respirations 16. and asked patient to continue to wait for 20 more minutes for additional monitoring.  Vitals at 1031 a.m BP 168/110, HR 78, Respirations 16. Patient continues to report  "she is feeling much better and ready to go home. Patient left at 10:33 a.m.. Spouse driving. RN contacted patient same day at home at 1353. Patient stated she took 50mg of Benadryl at home and is resting and feeling much better and questioned if she could still get her second dose of moderna vaccine. RN educated she should talk with her Primary Care physician regarding any additional vaccines. Patient verbalized understanding.
A week after his second vaccine  ankles started swelling up. He was waiting for symptoms to go away on their own. On July 25 his face started swelling and on July 27 his lower back started swelling. He went to the doctor on July 29 and his labs came back with high protein in his urine. We was admitted to the hospital on Aug 9 with nephrotic syndrome.
had shingrix still have break outs; have shingles break outs; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (recurrent shingles and had them well over a dozen times).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had shingrix still have break outs) (serious criteria GSK medically significant), shingles (Verbatim: have shingles break outs) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-Mar-2023 The reporter reported the case via interactive digital media. The patient had recurrent shingles and had them well over a dozen times.  The patient had the Shingrix vaccine and still had break outs. The reporter said it was painful. The patient was hoping one day that the chicken pox could be eradicated so people do not had to suffer from shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
This spontaneous report was received from a professional nurse referring to unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R-II Lot # L023113 - Expiration date: 24-DEC-2016, (strength, dose and route were not provided). No symptoms were reported. The reporter stated that duration of the improperly storage was about a time frame of 3 hours, and reported temperature was 58 degrees F. The vaccines did not undergo a previous temperature excursion. There was no data logger issue reported. This is one of several reports received form the same reporter. Additional information has been requested.
Swelling of mouth, tongue, lips and eyes, wheezing, and extreme exhaustion. Occurred approximately 1-2 hours after vaccination and lasted about 24-36 hours. Took Benadryl and slept most of the time that symptoms lasted.
Side effects that started with pain in arm where injected, then achiness in whole body, chills  was sleepless that night.  The next morning (4/25) felt very tired, no energy, overall felt sick with flu-like symptoms, and stomach ache.  Fever up to 101.6F.
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 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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 36.38 for dose administered on 15-Apr-2021. No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-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).
Information has been received from a physician concerning a 4 year old female patient with no pertinent medical history and no known drug allergies who on 07-SEP-2010 was vaccinated intramuscularly with a dose of MMR II. There was no concomitant medication. Later that evening, the patient was crying because of pain at site of injection. On 08-SEP-2010, the patient recovered from pain at site of injection. No lab diagnostics studies were performed. Patient sought unspecified medical attention. Additional information has been requested.
male adult who received Shingrix first dose 2/27/2020 and he has never received second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (on 27-FEB-2020, the patient received the 1st dose of Shingrix,batch number 3L3PR, expiry date 01-DEC-2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: male adult who received Shingrix first dose 2/27/2020 and he has never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 13 Jul 2023: The pharmacist technician had patient who received Shingrix first dose and he had never received second dose. The reporter consented to followup via email. Till the time of reporting the patient did not  received 2nd dose which led to incomplete course of vaccination.
This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 51-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included systemic lupus erythematosus (diagnosed about 2 years before the reporting date). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown. It was unknown if the reporter considered the ringing in ears to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. Now, the patient had ringing in her ears. Her physician did not know if it was connected or not, but this was the only recent change. The patient was generally in good health. This case has been linked with US2019AMR040982, reported by same reporter.
24JUL96 from 11-4AM crying very irritable-crying when held;APAP given t103; no appetite;29JUL96 pt better-poor appetite;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 09:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Abdominal aneurysm" (unspecified if ongoing); "atopic dermatitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Symptoms started 02/03, classic exacerbation of NMO. Saw MD on 02/08 and started steroids. Symptoms continued to progress. Hospitalized 02/14, now greeting high dose IV steroids and starting plasmapheresis tomorrow
It was reported that a pt (4 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.