chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after thaw process) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients age was reported as 19 years 2 months.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event was unknown.  On 10-Jun-2022, the vaccination facility was notified of an audit that was done and it was informed that vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines. The patient got Moderna vaccine with NDC code: 80777-0273-99.  It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.  It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:Crosslink case
Needle came out of the syringe whlie applying vaccine; A spontaneous report was received from a healthcare professional concerning a 59 year old male patient who was participating in the mRNA-1273 Emergency Use Program and experienced the needle came out of the syringe while applying vaccine.   The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications reported included two diabetes medications and HMG COA reductase inhibitor.  On 11-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot 011L02A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 11-Jan-2021, the needle came out of the syringe while applying vaccine and it came off in the patient's arm. It is unknown how much of the vaccine the patient received but reports there was a lot of liquid on his pants and arm.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event, needle came out of the syringe while applying vaccine was considered recovered on 11-Jan-2021.  The reporter did not provide a causality assessment of the event needle came out of the syringe while applying vaccine.; Reporter's Comments: This report refers to a case of  incorrect dose administered  for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of Incorrect dose administered. Reported event is unlisted for mRNA-1273  and causality was assessed as not applicable.
Information has been received from a nurse referring to a patient of unknown age and gender. On 11-JUN-2015 the patient was vaccinated with an expired dose of M-M-R II (lot # J006953, expire date 07-JUN-2015, 0.5 ml) subcutaneously (Expired vaccine used). No adverse effects were reported. Additional information has been requested.
Double the dosage as a second dose; Diarrhea- GI effects; Lethargy; Headache; Nausea; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Double the dosage as a second dose), DIARRHOEA (Diarrhea- GI effects), LETHARGY (Lethargy), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Double the dosage as a second dose), DIARRHOEA (Diarrhea- GI effects), LETHARGY (Lethargy), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, ACCIDENTAL OVERDOSE (Double the dosage as a second dose) had resolved and DIARRHOEA (Diarrhea- GI effects), LETHARGY (Lethargy), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No relevant concomitant medications were reported. No treatment information was provided.
Restlessness, fatigue, headache, muscle aches, cold and hot sweats, exhaustion
Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Sep-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, 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 (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 31-Aug-2021 , the vial was initially stored in refrigerator. On 05-Sep-2021 at 11 A.M the vial was first punctured and kept in refrigerator. On 06-Sep-2021 vial was discarded after 4:30 P.M.  Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-311145, MOD-2021-311380, MOD-2021-311249, MOD-2021-311257, MOD-2021-311374, MOD-2021-311226, MOD-2021-311286 (Patient Link).
Patient presented to our emergency department on 3/21 with COVID  pneumonia.  Patient was treated with antibiotics and dexamethasone but was not a candidate for remdesivir.  Hospital course was prolonged due to hypoxia requiring oxygen.  Patient discharged to home with oxygen to use during exertion.
occasional sl itch @ lt upper arm site on 17th & 18th;late afternoon on the 18th dec noticed as a 2 1/2" hot, red area;7AM on the 19th a red area was 3 1/4";seen in ER;
she was not feeling well; Diarrhea/diarrhea up until yesterday and is unsure if she has it today; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea/diarrhea up until yesterday and is unsure if she has it today) and MALAISE (she was not feeling well,) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021 at 5:00 PM, the patient experienced DIARRHOEA (Diarrhea/diarrhea up until yesterday and is unsure if she has it today). On an unknown date, the patient experienced MALAISE (she was not feeling well,). At the time of the report, DIARRHOEA (Diarrhea/diarrhea up until yesterday and is unsure if she has it today) had not resolved and MALAISE (she was not feeling well,) outcome was unknown.            Patient mentions that two weeks prior to the booster shot she took some antibiotics  No Treatment Information were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow up received contains Reporters address added, Mentioned about Booster dose, Event & Event Outcome updated
Erectile Dysfunction; Bruising at the injection site; Itching of bilateral palms of his hands; This case was reported by a consumer via call center representative and described the occurrence of erectile dysfunction in a 57-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24th March 2021, the patient received Boostrix (intramuscular). On an unknown date, less than 2 weeks after receiving Boostrix, the patient experienced erectile dysfunction (serious criteria GSK medically significant), injection site bruising and itching both hands. On an unknown date, the outcome of the erectile dysfunction, injection site bruising and itching both hands were unknown.   It was unknown if the reporter considered the erectile dysfunction, injection site bruising and itching both hands to be related to Boostrix.  Additional details were provided as follows: The case was reported by the patient's spouse. The patient experienced bruising at the injection site, itching of bilateral palms of his hands, and erectile dysfunction.  The patient went to the doctor regarding the bruising and was told it might last one to one half weeks longer. The reporter did not consent to follow up.  All the information was not available.
A report has been received from a Physician via Medical representative concerning an 8 years old, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient developed fever, cough. They tested positive for Influenza. Doctor did not know the date each patient developed the symptoms, but her said it was 3 months after receiving FLUMIST (Intranasal) in Oct-2013. Patient were treated with TAMIFLU and recovered. The reporter considered the event to be non-serious.
Body ache, headache, chills/shakes/lightheadedness, lethargy, increased pain in back and other existing condition area- frozen shoulders, trigger fingers thumb tendon.
felt awful like they had the flu for 48 hours post vaccination; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar event for 3 patients. This is 2nd of three report.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced felt awful like had the flu for 48 hours post vaccination on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082161 same reporter/drug/event, different patient;US-PFIZER INC-2021082186 same reporter/drug/event, different patient
On 6/8/00, the pt received the 6th dose in the series of the Anthrax vaccine. On the 9th, the back of his arm was red and felt warm to the touch. It also felt sore. The following day, the region was swollen along with the back of the forearm. Two days later it is the same. Slowly improving.
This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 17-AUG-2015, the patient was vaccinated with a first dose of GARDASIL (lot# K004204, exp. date: 12-JAN-2017). On 28-DEC-2015, the patient was vaccinated with a second dose of GARDASIL (reported lot# L014198, exp. date: 05-SEP-2017). On 29-FEB-2016, the patient came into the office to receive the third dose of GARDASIL 9. The nurse stated, that she did not intend to administer this dose. No adverse effect was reported. Lot# L014198 was determined as not valid for GARDASIL but valid for GARDASIL 9. Additional information has been requested.
Patient stated that the day after she received the vaccine - she "blacked out" on two different occasions.
ADMINISTRATION OF VACCINE WITH A DOSE THAT WAS FROZEN TWICE; This spontaneous report received from a health care professional concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of vaccine with a dose that was frozen twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine with a dose that was frozen twice was not reported. This report was non-serious.
pt said tongue and lips felt funny - no breathing issues-  some pressure in her chest-  within 10 -15 minutes of vaccine  her blood pressure was 167/82 at one point but lowered to 125 /80 within 30 minutes  she took 50mg of liquid benadryl  she did not want to go to er since no breathing issues - she said she would go to hospital if she felt bad later
Information has been received from a consumer concerning a 14 year old female who was vaccinated with a dose of MMR II when the patient was a preschooler (date, dose and route unspecified). The patient's mother reported that the patient developed a fever of 107 F after receiving MMR II within an unspecified period of time. The patient sought medical attention at an office visit. The patient fully recovered (date unspecified). A product quality complaint was not involved. Follow-up information was received from the physician's office staff who stated that the office did not report the adverse event and does not feel it was warranted. The event occurred over 13 years ago and the patient had a virus accompanied with a fever. No further information is expected.
18 year old male patient received an expired dose of Typhim vaccine with no reported adverse event; Initial information received on 05-May-2021 regarding an unsolicited valid non-serious case received from a physician via Other Health Care Professional.  This case involves a 18 year old male patient who was administered expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and TETANUS VACCINE (TETANUS VACCINE) for Immunisations.  On 24-Apr-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R1B743M and expiry date: 23-Mar-2021) (Injection) (Frequency: Once) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Reporter relationship: health care professional (HCP); Product used: used   At the time of report no adverse event was reported.  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 the 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.
7/8/21 itching throat, watery eyes, headaches, neck stiffness started next morning after 2nd dose,  7/14/21 continues to have symptoms of headaches, neck pain and stiffness
Within an hour of the injection my face started getting hot & red and very itchy. I took 50 mg of Benedryl a little after 11:00. I went home at 1:00 due to drowsiness. Saturday morning my face was still hot, red & itchy so i took the Benedryl through out the day. The symptoms were much better on Sunday.
Metallicy; Sense of taste is distorted; Fever; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallicy), TASTE DISORDER (Sense of taste is distorted), PYREXIA (Fever), NAUSEA (Nausea) and PAIN (Body aches) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and PAIN (Body aches). On 13-Apr-2021, the patient experienced DYSGEUSIA (Metallicy) and TASTE DISORDER (Sense of taste is distorted). At the time of the report, DYSGEUSIA (Metallicy), TASTE DISORDER (Sense of taste is distorted), PYREXIA (Fever), NAUSEA (Nausea) and PAIN (Body aches) outcome was unknown.            Concomitant medications were not reported. Treatment details not provided Action taken with mRNA-1273 in response to the events was  not applicable
Flushing; This is a spontaneous report from a contactable pharmacist. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular, administered in the right arm on 09Feb2021 (at the age of 66-years-old) (Lot Number: EN8982) as dose 1, single for COVID-19 immunisation. Medical history included hypertension, cancer, reflux, and enlarged prostate. Concomitant medications included amlodipine, calcium, clindamycin, clomiphene, famotidine, finasteride, furosemide, potassium, lanreotide, lidocaine/prilocaine, ondansetron, sildenafil, tamsulosin, triamcinolone, vitamin B12, vitamin D3, zoledronic acid (ZOMETA), and prednisone. The patient has known allergies to epinephrine, CT contrast, medrol, lovastatin, losartan, and adhesive. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient did not have COVID prior to vaccination. On 09Feb2021, the patient experienced flushing. The patient had not been tested for COVID post-vaccination. The outcome of the event was recovering/resolving.   No follow-up attempts are possible. No further information is expected.
pt recv 1st vax;subsequently exp pain back,knees & buttocks;2nd dose & exp same sx following each dose;did not seroconvert,was adm booster dose;exp same sx & "clicking in neck",low back pain,abnl in skin on arm w/ "circumscribed areas;
Pain with rash at injection site (R) deltoid) on Thurs (Oct 4). Pt states redness at site started to show up more than 24 hr after shots was given with fever at this time. Pt had both Pneumococcal and flu shots on same site. Temp was 100.0 (F) at triage. Doxycycline 100 mg BID.
Roughly 1 hour, post vax, developed chest tightness, SOB, itchy rash, with pruritus, mild wheezing and periorbital edema but vitals stable. Received Epi, Benadryl and albuterol nebulizer. Resolved, sent home with prednisone.
Hives. Zyrtec for 5 days. Resolved by 3/6/21
This spontaneous report as received from a Licensed Practical Nurse. On 28-MAY-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015) for prophylaxis. The nurse reported the dose of VAQTA were exposed 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
I broke out with a mild case of Chicken Pox,  first on side of leg, then a day later 12 spots on my belly, a few on the neck, one in my ear, a couple on my arm. no pain unless I touch them, they did not itch much.
Information has been received from a physician assistant concerning a 26 year old female with no medical history or allergies who was vaccinated intramuscularly with all three GARDASIL vaccine (lot# not reported) on time last year, in 2007. This month (OCT 2008) the patient was diagnosed with HPV(strain not known). It was reported that a PAP test was performed, outcome was unknown. Concomitant medication included Drospirenone (+) YAZMIN. The patient sought medical attention at physician's office. At the time of report the patient is recovering. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to an unspecified numbers of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-mintues. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 6 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot#K004480, expiration ate 05-FEB-2016 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
AFTER 30MIN OF MONITORING. CLIENT REPORTS FEELING OF SLIGHT THROAT CLOSING, LIGHT HEADACHE AND NAUSEA WITH SLIGHT HAND TREMORS.  MONITOR NURSE MADE NP AWARE.  NP ASSESSED THE CLIENT.  HEART RATE AND PULSE OX WAS MONITORED. CLIENT DENIED ANY SOB OR DIFFICULTY BREATHING. HR WAS 168 AND IMMEDIATELY DROPPED TO 68, THEN 79.. PULSE OX WAS 93% RA THEN INCREASED TO 97-98% RA. NP ADMINISTERED BENADRYL 25MG, 5-10MIN LATER NP GAVE CLIENT COKE COLA.  CLIENT MONITORED ANOTHER 30MIN AND THEN STATED  THAT ALL REPORTING SYMPTOMS WERE RELIEVED,  AND STATED THAT SHE NO LONG HAD ANY SYMPTOMS.   HR UPON DISCHARGE WAS 87 AND PULSE OX WAS 98%.  NP GAVE PATIENT AFTER CARE INSTRUCTIONS AND INFORMED HER TO CALL 911 OR GO TO ER IF SYMPTOMS RETURNED.  CLIENT VERBALIZED UNDERSTANDING OF ALL INFORMATION.