chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-Apr-2022 and initially stored in the refrigerator 05-Apr-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) 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 EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-Apr-2022 and initially stored in the refrigerator 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-Apr-2022 and initially stored in the refrigerator 05-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that vials with a manufacturing date of 01-Dec-2021 and the expiration date of 01-Apr-2022 with the lot number 026L21B were stored in the refrigerator on 05-Apr-2022 and were administered to patients from 06-Apr-2022 to 09-Apr-2022. It was further reported that patients did not experience any adverse reactions at that time. No treatment medications were provided.
second Imovax dose approximately 23 hours early, on day 6 rather than day 7; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a first dose of suspect RABIES (HDC) VACCINE lot NIK302M, expiry date- 28-Oct-2019 via intramuscular route in unknown administration site and on an unknown date on day 6, she received second dose of RABIES (HDC) VACCINE (batch number, expiry date, route and site of administration were not reported).  It was a case of actual medication error due to Inappropriate schedule of vaccine administered.  It was unknown if any adverse event was occurred.   The patient was supposed to present to another Pharmacy for her second dose on Day 7, but instead presented on day 6 and received dose 2 of Imovax. The patient received her second Imovax dose approximately 23 hours early, on day 6 rather than day 7.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
I had a weird feeling. I had a heart attack a few years ago. I got the EMS because I thought I was having a heart issue. When I got to the ER, my heart rate was high. They tried several different medicines to slow it down. But nothing worked. They wound up having to stop my heart and to restart it again. They did an EKG and blood work. It was not a heart attack.
8/15/07 - Pt received Tdap vaccine approx 8 AM. PC from mother reports pt "doesn't feel right". Informed to go to ER. 6/16/07 Spoke to mother; dx with allergic reaction to Tdap. On Atarax and steroids. TO see MD today. PC to mother - saw MD today, reports was to hospitalize but no beds available. (Some shortness of breath). 8/17/07 PC to mom. Reports signs and symptoms have improved. No SOB; on steroids and Atarax now.
Nausea  Fatigue Fever Headache  Body aches  Severe hot flashes  Sweating
This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLUARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced allergic reaction to FLUARIX. The reporter declined to provide further details on product, patient and the adverse event.
pt recv vax 5DEC94 & exp a recurrence of fever, nausea, achiness & flu sx which were more severe than w/1st inj;
Patient was waiting for his 30 minutes after vaccine was administered. when 30 minutes were up pt stated feeling a chest pain going across his chest. Vital signs taken everything within range.  MD looked over pt. MD ordered an EKG and glucose check. MD states EKG came back normal. Blood sugar level read hi meaning greater that 550. Pt states he had just had lunch prior to visiting the clinic,  pt states taking his medication. MD advised pt to go to the ER to get his sugar controlled, pt refused going by ambulance states his wife will drive him to the ER.
Vaccination with TDaP, MCV4, HPV9. All three given, visiting with client for approx. 1 minute post when fell face first off exam table. Immediately resp. to verbal stimuli. Epistaxis (R) nare. Stopped w/in 5 min with pressure. Monitored HR, orthostatic BP x 40 min. Water provided. Parent called for pick up and discharge instructions.
parents noted pt shaking as if cold for 10-15mins; pt was alert & responsive during episode, elevated temp @ home; pt brought to clinic, t39.1; given APAP; PE was nl x/erythematous areas; presumed rxn to DTP vax;
Started having diarrhea about 4:00 am on Friday, Feb 12-lasted about 4 hours.  Headache,chills, nausea started about 8:00 am.  Still having headache and chills.  Have not gone to doctor
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 1:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 1:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.77  Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 9AM temperature was 35 total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. Vaccine BUD date was 19-May-2021.  On 27-Apr-2021 no hourly temperature recordings available.  The vial was only punctured right before administration and dose was drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received regarding a case in litigation from a physician concerning a female patient who in 2007 was vaccinated IM GARDASIL vaccine (yeast). A physician reported that after the patient was vaccinated, she experienced serum sickness. No further information is available at this time.
Technician cleansed the correct area over the L deltoid yet injected into the joint space/upper deltoid less than 1 in from the acromion process. Pt. felt the injection at the time, looked and saw it was in the wrong space, made statement as such to the technician. Technician apologized, placed a band-aid and departed.  Pt began immediate treatment at home with APAP, infra-red head, and ROM exercises. Despite continued self care after 30 days joint became more restricted and painful. Condition continues to deteriorate.
Severe Covid arm - no reaction in store when I had the shot, (and I waited 20 or more minutes).  It started in the evening around dinner time.  I could not roll over onto my left side while sleeping and it STILL is very sore today.  I took pics.  It is not red nor is there any rash, it is just SWOLLEN like a golf ball and hurts to move the arm and touch it.  I purposefully received the Moderna this time as I had Covid arm from my first injection of the Pfizer vaccine back on 3/10/21 (LOT EN6204).  I did not know it was Covid arm then, but I do now.  I received the injection in the left arm again this time.  Last time, it did go away after a few days but so far these are the only two injections that did this to me.
Sore arm, fatigue, pain at shoulder blade, rib cage , and back on the right side, pain in left shoulder at injection site, pericardial thickening, vs a  trace  pericardial effusion (fluid and inflation around heart), mildly enlarged lymph node
Information has been received from a health professional for the Pregnancy Registry for GARDASIL, concerning an 21 year old Caucasian female with a history of 4 previous pregnancies and 2 live births and one spontaneous abortion at 12 weeks from LMP who on 28-APR-2008 was vaccinated with a second dose of GARDASIL (lot #658282/1263U). The patient's last menstrual period was 10-MAR-2008 and estimated delivery date is 15-DEC-2008. On 16-MAY-2008 and 17-JUL-2008 the patient underwent ultrasound and the result indicated within normal limits. On 06-AUG-2008 maternal serum alpha-fetoprotein screening was performed and the result was negative. Subsequently, on an unspecified date in June 2008 the patient experienced nausea and was treated with ZOFRAN 4 mg PRN. No out come was reported. Also, on an unspecified date in September 2008, the patient developed a UTI and was treated with MACRODANTIN 100 TID. No outcome was reported. Additional information has been requested.
Patient called four weeks after administration date and stated her arm still hurt. Also stated she could not lift arm above her head.
Patient reported Syncope/Fainting on site EMS was required. BP 112/72 Oximetry 100 HR 72.  Refused care released against medical advice.
I also feel arm soreness once in awhile at the site the injections were made.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Apr2021 10:00 (Lot number: EW0170) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "I also feel arm soreness once in awhile at the site the injections were made.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive  any other medications within 2 weeks of vaccination. Family Medical History: None The patient had  no relevant test done. Patient did not had treatment for AE. Patient did not had Covid prior vaccination. Patient  Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101729613 similar report from same reporter
Pt. received vaccine 11/28. Symptoms did not develop until 12/1. Red lump, swollen upper arm, hot rash, pt. passed out taken to ER.
6/19 5:30pm started running fever 101.5, chills, cough, chest hurting when coughing. Took Advil.  On 6/20 temp was 101, had nausea, had loose bowel movement, chest hurting when coughing (felt "tight"). 6/21--fever 101, no diarrhea, felt fatigued. 6/22--no fever, but suddenly nausea came and diarrhea, never vomited. Patient noticed a red rash had developed from ankles to mid-calf, spots further up to hip. Still fatigued. 6/24-rash still there, patient given steroid shot and given rx for oral prednisone.
@ exam PT in good st of hlth; appr 10min p/vax PT presented fine macular generalized red rash urticarial type; eye swelling; PT to ER & tx; hospitalized x4 days: rash improved, but was on & off; had eye swelling; d/c w/out complications;
Originally patient received 0.1ml dose of Moderna vaccine. Patient called and returned to the vaccination site where they were administered 0.5 ml of Moderna vaccine (as instructed by HD in patient's left arm. This was pt first dose.
mild soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mild soreness in her arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tuberous sclerosis complex, Physical impairment (right side of patient is paralyzed,but she can walk) and Mental disability. Concomitant products included LAMOTRIGINE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (mild soreness in her arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (mild soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sore arm,; fatigue,; nausea,; diarrhea; abdominal cramps,; body aches,; headache; tiredness; This is a spontaneous report from a contactable other healthcare professional. A 21-year-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 24Aug2021 14:45 (at the age of 21-year-old), in the left arm, as dose 2, single for COVID-19 immunization. The patient's medical history included Penicillin allergy from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced drug hypersensitivity from an unknown date and unknown if ongoing. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 02Aug2021 16:30 (at the age of 21-year-old), in the left arm, as dose 1, single for COVID-19 immunization. Patient did not take any other vaccine within four weeks and received other medication within two weeks. Patient had not been tested for COVIID before vaccination and patient had tested for post vaccination as negative. On 25Aug2021 at 07:00, the patient experienced sore arm, fatigue, nausea, diarrhea, abdominal cramps, body aches, headache, tiredness. Treatment was not taken. On 24Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test negative. The clinical outcome of events was unknown.  Information about lot/batch number has been requested.
Patient arrives by private vehicle with left anterior chest discomfort.  Patient received the first dose of her 2 part COVID-19  Pfizer vaccine series this morning. Shortly after receiving the vaccine she developed left anterior chest pain under her left breast.  Patient was evaluated by EMS personnel at vaccine clinic, and refused transport at that time. Shortly after, patient then arrived by private vehicle to Emergency Department with chief complaint of chest pain, left shoulder blade pain, and some shortness of breath per nursing notes. She reports she overall did not feel well.  She felt sweaty and short of breath shortly thereafter.  She denies having had the COVID illness in the past  **At time of submission of report, patient is still in ED with results pending**
gained 5 pounds after each dose; really bad edema; foot's all swelled up; enlarged heart; rapid heart beating; feels like she's going to die; soreness of the arm; throwing up; This is a spontaneous report from a contactable consumer (patient).  A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 06Apr2021 (Batch/Lot Number: ER8735) (age at vaccination 56 year) as single dose for covid-19 immunisation.  Medical history included ongoing blood cholesterol increased for over 25 years , stress, anxiety, post-traumatic stress disorder. Concomitant medication(s) included atorvastatin (LIPITOR) for blood cholesterol increased.  The first dose of vaccine was administered on 16Mar2021 (lot EP753T) in arm left and patient reported weight gain (5 pounds). After having the second dose of  vaccine, on 03May2021, patient experienced enlarged heart, and rapid heart beatings.  Patient reported she had to go twice to the hospital, had to call 911, had to get a doppler on her chest, she's been to the cardiologist 5 times just in the last month. Caller states she has to go for a cardiogram on the 16th and may have to have open heart surgery. Patient reported that since having the Covid shot, she's had nothing but trouble. She's not just having soreness of the arm and throwing up. Patient reported that next day, she gained 5 pounds, she retained water or something, she has really bad edema, her foot's all swelled up now. Patient underwent EKGs, Chest X-rays, where it says she has an enlarged heart, rapid heart beating, she had a doppler heart monitor for 3 days. Caller states she has to get a cardiogram, an MRI. Caller states she has heart rhythm problems she feels it in her body. Caller states the doctors didn't say she had heart rhythm problems, but she feels fluttering in her heart. Outcome of events was unknown.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient stated that he was feeling fine after vaccine adminstration. However, he went to go sit down and fainted. He presented like he was having a seizure. Patient was positioned upright. He regained consciousness. He has a hx of panic attacks and this isnt the first time a adverse rxn like this has occured. 911 called to double check vitals. I have him Orange juice and a wet towel because he was sweating. He walked out of store with 911 personal on his own accord.
Pain in left arm. Difficulty breathing. Coughing and choking. Wheezing. Intermittent fevers. The pain in arm subsided after two days. The fevers are still occurring. Coughing is still occurring.
improperly stored vaccine involved in a temperature excursion was administered to a patient.; No additional AE reported; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, which was improperly stored and involved in a temperature excursion (Product storage error). The patient received 1 unspecified dose, lot # W006595, with an expiration date on 10-OCT-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  The dose of b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed to a temperature excursion of 57.49 degrees Fahrenheit (°F) during a time frame of for 1 hour 45 minutes. No adverse events were reported.
This spontaneous report received from a market research program from a consumer refers to a 38 year old male patient. On an unknown date the patient was vaccinated with PPV23 (manufacturer unknown) (dose, lot no. unknown). On an unknown date the patient reported bad experience. The outcome of event was unknown. The causality of event was not reported. Additional information is not expected because the patient did not give consent for follow up.
Severe loss of muscle strenth in waste, legs, knees, ankles......difficult to stand and walk.  Severe joint pain in both knees and ankles.  Extreme swelling in both ankles and feet.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown gender and age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with the first doses (one dose) of VARIVAX (Merck) (dose, lot/batch#, expiration dates were not reported). It was reported that since 1996, when VARIVAX (Merck) was approved and only one dose was indicated, about 25 percent of vaccinated patients ended up with the wild type of chicken pox (dates unspecified). The outcome of the event was unknown. The relatedness between the event and VARIVAX (Merck) was not reported. This is one of the several reports from the same reporter. Additional information is not expected as the physician did not wish to be contacted.