chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vaccine was administered to total of 24 patients including 15 males and 9 females. HCP reported administrations were mostly for booster shots. No side effects reported. No treatment medications were reported.
5ml syringes that had been provided by Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Family has been contacted by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patient was reported.
GENERALIZED TONIC-CLONIC SEIZURE. OCCURRED AT ~1230 ON 2/4, THREE DAYS AFTER VACCINE, LASTED 5 MINUTES. STARTED WITH ALTERATION IN CONSCIOUSNESS (PATIENT NOT AROUSABLE, STARING INTO SPACED) FOLLOWED BY WHOLE BODY CONVULSIONS, SPONTANEOUS RESOLUTION, AND POST-ICTAL STATE WITH FATIGUE.
Patient was given Pneumococcal Prevnar 13 on 10/09/2012 IM in left deltoid.  Prior to this she was seen 09/14/2012 for Bee Sting reaction in the left arm near the area of the IM injection.  There was no apparent reaction remaining on her left arm prior to the vaccine administration.  Called office 10/15/2012 to report rash on left arm near injection site, was seen that same day for evaluation, approximately a  3" non-raised rash on left deltoid area, patient stated it was "getting better", she had not used any OTC meds to treat it, but mentioned it did itch.  Advised to use OTC Benadryl and/or topical steroid cream if desired for itching, and to return if the area gets worse.
nerve pain; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who experienced nerve pain, while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Oct-2019, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious nerve pain (neuralgia) unknown latency following the administration of RABIES (HDC) VACCINE.  It was reported that patient has been two weeks can not lift anything since receiving the shot.   Other relevant tests were not reported.  Final diagnosis was nerve pain.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.  Information on the batch number was requested.
inc pain & swelling down below elbow red, hot pimple @ site w/pustule;
The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023; No adverse event; Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7173b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown . The vial did not underwent temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case
syncopal episode p/last inject; rolled eyes up-slumped over-briefly unconscious, pulse to 58, BP to 90/50;
Enlarged lymph node on lower right side of face which continues to get larger by the day,  after 3months it is passing the size of a golf ball.  A needle biopsy pulled off 20 cc of turbid blood tinged fluid.   Local physicians are suggesting the lymph node should be removed.  I would never recommend anyone taking a covid vaccine shot.  I do have an overactive immune system.
little pain in right foot's toes/ pain in toes, pain has been going up through the calf; does not feel good; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little pain in right foot's toes/ pain in toes, pain has been going up through the calf) and FEELING ABNORMAL (does not feel good) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced PAIN IN EXTREMITY (little pain in right foot's toes/ pain in toes, pain has been going up through the calf) and FEELING ABNORMAL (does not feel good). At the time of the report, PAIN IN EXTREMITY (little pain in right foot's toes/ pain in toes, pain has been going up through the calf) and FEELING ABNORMAL (does not feel good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported. Patient called asking for recommendation and did not have any intentions on reporting the AE. Patient received first dose of Moderna COVID-19 vaccine on 10Sep2021. Next day patient started to experience a little pain in right foot's toes. The pain has been going up through the calf. Patient felt that the symptom was related to blood circulation because when patient puts leg up, pain stops and when places foot down again, pain continues hence the patient was afraid called to ask what medication should the patient take and how long should the patient wait to start taking it and also stated that the patient does not feel good.   Reporter did not allow further contact
soreness in his hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, all of his 4 COVID 19 vaccines have been from Pfizer, and with the previous ones he did not have any reaction at all, just soreness in his hand), for Covid-19 immunization, reaction(s): "soreness in his hand"; Bnt162b2 (Dose 1, all of his 4 COVID 19 vaccines have been from Pfizer, and with the previous ones he did not have any reaction at all, just soreness in his hand), for Covid-19 immunization, reaction(s): "soreness in his hand". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in his hand".  Additional information: Caller also mentioned all of his 4 COVID 19 vaccines have been from Pfizer, and with the previous ones he did not have any reaction at all, just soreness in his hand. His Pharmacist told him this new vaccine was different and he might experience more reactions.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201229835 same reporter/patient, different event/dose.;
Racing heart rate 30-45 minutes after injection. Also mild facial numbness on upper neck and jawline to ears. No difficult breathing at any point. Called 911 and pulled over. Evaluated by Fire/EMS and found no evidence of severe anaphylaxis. All vitals (except elevated heart rate) were normal.
Diarrhea; Nausea; Shivering; Fever; Headache; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 1st dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced nausea. On 11th March 2020, the patient experienced diarrhea. In March 2020, the patient experienced shivering, fever and headache. On 10th March 2020, the outcome of the shivering and fever were recovered/resolved. On 11th March 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the nausea and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the shivering, fever, headache, nausea and diarrhea to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient was a citizen who received her first dose of Shingrix vaccine at Hospital. The patient received the vaccine at noon.  At the night, she experienced shivering, fever and headache. On Tuesday,1 day after vaccination, she recovered from shivering and fever, but she experienced headache and nausea.  On Wednesday, 2 days after vaccination, she recovered from headache, but she experienced nausea and diarrhea.  She was still experiencing nausea and diarrhea. She had taken local medications. The reporter did not consent to follow-up
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
Developed symptoms consistent with bells palsy 2 days after COVID vaccination. includes decreased sensation to right side of face, right facial numbness, right eyebrow droop, weakness on right side of face including forehead  Placed on prednisone taper, with improvement of symptoms back to baseline
Feeling sick; Running a low grade fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) and PYREXIA (Running a low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, 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 an unknown date, the patient experienced MALAISE (Feeling sick) and PYREXIA (Running a low grade fever). At the time of the report, MALAISE (Feeling sick) and PYREXIA (Running a low grade fever) outcome was unknown.            No concomitant medication information was provided No treatment medication information was provided
Patient had headache with dizziness about 30" after injection. 90" later had sudden onset left-sided Chest pain with difficulty breathing. Patient's chest pain was so bad she thought she was going to die. Was transported to ER via ambulance, had cardiac workup, blood clot workup (had left leg pain the day before incident). Was discharged home on zanaflex and motrin with diagnosis of Chest Wall pain about 4  hours later. Follow up on 1.15.2021 at 1000 and patient doing better but still has chest pain. Will not be getting 2nd COVID vaccination.
got sick; Initial information was received on 18-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who got sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient not gotten one in 22 years. Got it every year and got sick from it. stopped getting it when retired and no flu since.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
shingles; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the arm left on 18Apr2021(at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression and latex allergy. The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 not long after the vaccination, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with valacyclovir. The clinical outcome of the event shingles was recovering.  No follow-up attempts are needed. No further information is expected.
Received injection at 3:30 Tuesday 2/9. By early evening I felt symptoms - fatigue and general muscle aches. By Wednesday morning (2/10) the symptoms persisted, but I went to work. By noon   I had many of the same symptoms I experienced when I contracted COVID in December (9th). Headache, body aches all over, severe fatigue, loss of appetite and chills. Only this time it was worse than I remembered from December. I went home at noon, went to bed. Got up around 6PM and tried to eat, but had no appetite at all. I went to bed at 6:30 PM Wednesday and woke up at 7:00 AM Thursday with only a couple of bathroom trips. Today (Wednesday) symptoms have subsided significantly. Almost gone. Will work tomorrow.
Arm soreness, extreme tired, chill, fever, ache, pain, and terrible headache, 100.2 F for a day.  Took Tylenol and felt better. Rash after two day
Very strong headache, high fever and shivers/chills. Experienced nausea, dizziness  and stomach pain. Body pain, bone hurt especially arms.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, EXTREME FATIGUE Narrative:  MISSED ONE DAY OF WORK
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733(CLUSTER) and 2023SA057309(CLUSTER).  This case involves adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
I started experiencing a lot of pain in that arm. I still cannot lift my left arm and it still hurts now. It started within hours of receiving the first dose. I called my doctor and they just said sometimes you have pain. I didn't have a good range of motion. The arm is finally getting better where I can lift higher than before. I did not receive treatment but I have been experiencing pains in my joints and in my legs. I am still having those now. I do not know the connection. It has improved where I can do more with my arm. I can't lift it straight up still. I did have my 2nd and 3rd dose of Moderna and continue to have left arm and leg pain but I am not sure if it is related. My PCP has done labs to rule out any conditions. He said he wasn't really sure of the cause. He did prescribe some pain medication.
This spontaneous report as received from certificated medical assistant referring an unspecified number of patients whom on an unknown date, were vaccinated with a dose of VAQTA, the reporter was unable to provide lot #/expiration dates and administrations dates for the vaccine. It was reported that the vaccine was exposed to 1 F for 3 hours. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Patient was accidentally given a 3rd dose of the COVID vaccine. She initially denied history of getting the COVID vaccine and then after being given the dose she realized that she had already gotten 2 doses of the pfizer vaccine back in February. No adverse events noted after standard post-injection monitoring.
Hearing loss in left ear (complete loss). Right ear hearing is diminished. This was confirmed by two hearing tests. Not gradual but sudden onset. Was told it is permanent.
A little sore arm after third dose; Second dose on 07-APR-2021 and the third dose on 19-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little sore arm after third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-APR-2021 and the third dose on 19-AUG-2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Autoimmune disorder. Concomitant products included RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for an unknown indication.    On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (A little sore arm after third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-APR-2021 and the third dose on 19-AUG-2021). On 19-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-APR-2021 and the third dose on 19-AUG-2021) had resolved. On 21-Aug-2021, MYALGIA (A little sore arm after third dose) had resolved.            Patient took Skyrizi injection in Feb 2021 (600mg) and May 2021 (300mg) and she was scheduled to have another Skyrizi injection in Sep 2021.  Treatment Information was not provided.   This case was linked to MOD-2021-307186, MOD-2021-307235 (Patient Link).