chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medications were reported.   No treatment details were reported.  This case is created for 46 out of 189 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
No adverse effect reported; received improperly stored VARlVAX; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 25-SEP-2019, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose and route of administration were not reported) for prophylaxis (lot number: S005078 and expiration date: 19-FEB-2021 or lot number: R019237, expiration date: 04-JUL-2020). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect reported.  The temperature excursion was from -14 degree Celsius to -10 degree Celsius (-9.74 Celsius). Time frame was unknown by the reporter. There was no previous temperature excursion noted. The digital data logger was involved.   Both lots of varicella virus vaccine live (oka/merck) (VARIVAX) that underwent the temperature excursion were added since the office did not know which lot was given to the patient.
I had nerve pain and leg jumping in my right leg starting at 3 am Monday, the day after the injection throughout the day. It stopped by 24 hours after that.
This spontaneous report was received from a healthcare professional via Poison And Drug Center (PDC) regarding a 4 year old male patient. Information on medical history, current conditions and concomitant therapies were not reported. On 16-JUN-2018, the patient was inadvertently vaccinated with GARDASIL 9 once (Strength, dose and anatomical location were not reported) of lot # N023828 with an expiry date of 25-JUN-2020 for prophylaxis. The outcome of wrong drug administered and drug administered to patient of inappropriate age was unknown.
pt recvd vax & mom states pt showed signs of soreness in both arms as pt did not want to use them;no redness or swelling either arm;woke up from sleep, screaming t105.1R using digital thermometer;pt given APAP & tepid bath then t102;fussy
Flu-like symptoms: Sore joints, sore skin, aches, chills, weakness, stiffness.  No thermometer, so don't know about fever.  I took two Tylenol, took a nap, woke up a few hours later feeling much improved.
Expired Moderna was administered on 11/19/2021 lot# 046C21A. Patient was called back to the clinic and vital signs were taken and were within normal limits. Patient showed no s/s of any distress and when asked he states no s/s. Provider was notified and also Moderna manufacture and they will update with guidelines. Patient was release back to facility.
flu like symptoms; sweating; fever; chills; body ache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 02-Jul-2021, HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.            Concomitant medications include birth control. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-280149 (Patient Link).
HBP reported AE related to GARDASIL 9. Reported a 2-month-old patient received GARDASIL 9 at their previous pediatric office; patient is now at new pediatric clinic from which the HBP was calling from. Reporter unsure of when the patient received the; This spontaneous report was received from a physician, referring to a 2-month-old patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified day the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.
severe sinus pressure; severe chills; nausea; pain at injection site; This is a spontaneous report from a contactable consumer(Patient). A 25-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and known allergies reported as none. The patient's concomitant medications were not reported. The patient experienced severe sinus pressure, nausea, severe chills, pain at injection site on 16Feb2021. No treatment received. The outcome of the events were recovering. There was no Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VAQTA pediatric formation 25/0.5 (dose, lot # and route unspecified). Information regarding medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Pt received 2nd Boostrix (Tdap) 10-25-07 within 2 months of vaccine that was given 08-15-07. Pt has not had any adverse reaction.
experienced fatigue with the first 12 hours of administration; experienced severe headache with the first 12 hours of administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of fatigue in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE RHA 3V (BACULOVIRUS) (FLUBLOK) for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm) and FLUBLOK (unknown arm). On an unknown date, less than a day after receiving Arexvy, the patient experienced fatigue (Verbatim: experienced fatigue with the first 12 hours of administration) and headache (Verbatim: experienced severe headache with the first 12 hours of administration). The outcome of the fatigue and headache were not reported.   It was unknown if the reporter considered the fatigue and headache to be related to Arexvy.     It was unknown if the company considered the fatigue and headache to be related to Arexvy.   Additional Information: GSK receipt date: 16-Oct-2023 A healthcare provider informed of an adverse event when she received Arexvy concomitantly with Flublok.  Both given in the same arm, about an inch apart.  She experienced severe headache and fatigue with the first 12 hours of administration. The follow-up could not be possible as no contact details were available. It was unknown if the reporter considered the fatigue and headache to be related to Flublok.
This case was reported by a healthcare professional and described the occurrence of swelling of limb in a 6-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history included birth twin. There were no concurrent medications. On 17 October 2006 the subject received 4th dose of Infanrix in the right thigh. On 17 October 2006, the subject was also injected with inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) in the left thigh. On 20 October 2006, 3 days after vaccination with Infanrix, the subject experienced swelling of the right limb, injection site redness and injection site warmth at the site of Infanrix injection. the subject was seen at a physician's office. At the time of initial reporting, 20 October 2006, the events were ongoing. The healthcare professional considered the events were probably related to vaccination with Infanrix.
Fever developed 4-6 hrs after vaccine and continued to next morning. Loose stool with intermittent vomiting. No rash.
Patient was only 17 at the time of dosing. Patient is a grocery store worker and is in the eligible phase. However, the age was not caught in the computer system or the pharmacy checking system. We will follow up with patient for the next 3 weeks.
The pt went to ER after vomiting at 19:00. She was sent home. She then became light-headed, dizzy, with nausea and blurred vision. Also vomited x 1 and had diarrhea at 21:00 and 05:00 on 05/19. Nausea subsided afternoon of 05/19.
Patient contacted clinic after visit to notify us of a shooting pain at the time of the vaccine in the right arm.  Stated that she had some soreness in the shoulder and difficulty using her arm.  We recommended alternating heat and cold compresses, tylenol and/or ibuprofen for the pain and to follow up in 1 week.  We reached out to patient a week later and she stated it was improving.  Recommended continued use of analgesics, heat, cold PRN and contact clinic for worsening or if there is no continued improvement.  We did not hear back from patient for almost 3 months (April).  At that time, she said that she still had shoulder pain and some limited ROM - offered referral to ortho provider.
Patient was given PNEUMOVAX 23 IM vaccination in the right arm at approx. 11am on 9/20. Patient began to experience pain, swelling and redness of injection site and surrounding tissues at approx. 9pm on 9/20. Patient reported back to pharmacy the morning of 9/21 at approx. 9am and took ibuprofen and diphenhydramine and by 11:30am was feeling much better - pain had reduced significantly. Patient was also given FLUZONE HD IM vaccination in the left arm at approx. 11am on 9/20 with no adverse effects on that arm.
Got sick from after taking the covid shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Got sick from after taking the covid shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Got sick from after taking the covid shot). At the time of the report, MALAISE (Got sick from after taking the covid shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
large lump under chin. She describes the lump size as a golf ball; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (large lump under chin. She describes the lump size as a golf ball) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced SWELLING (large lump under chin. She describes the lump size as a golf ball). At the time of the report, SWELLING (large lump under chin. She describes the lump size as a golf ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment details were not reported.
pt was in and out of fainting was given water and a granola bar..pt had white lips and vison blurry hasn't eaten since breakfast no hx of fainting in the past
pt recvd vax; 21oct94 at 9:30pm, became fussy; t 100;3am; t 103;apap given & cold sponge; to pmd next day; all tests neg;pmd thought related to vax & advised acellular vax at age 4;
RED CIRCULAR RASH ON UPPER LEFT ARM AT INJECTION SITE. WARM TO TOUCH AND ITCHY. I WOKE UP WITH IT ON MY ARM THIS MORNING. I HAVE NOT PUT ANYTHING ON IT. I'M JUST KEEPING AN EYE ON IT TO SE IF IT GETS WORSE.
9MAY95 collapse - very pale, apnea 4 1/2 hr p/vax pt was seen later by neurologist;
PARTIAL DOSE ADMINISTERED; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) NEGATIVE. On 14-APR-2021, Laboratory data included: Antibody test (NR: not provided) 21 (POSITIVE). On an unspecified date, the subject experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Fever, body aches, skin sloughing at injection site, rash with yellow bumps.
Upon administering the vaccine , patient. Became very dizzy , and we had her lie down . She then complained of chest tightness , throat tightness , and difficulty breathing . An epipen was administered and paramedics were called . She was taken to the hospital where she was monitored and released . I spoke with her husband when they were home , and he indicated that she was fine
3 spots on lungs; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunization. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "3 spots on lungs".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administered a Dose of Heplisav-B that Underwent a Temperature Excursion; Initial Report Received 24-Sep-2021  A nurse reported that a 91-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 30-Aug-2021, a dose of HEPLISAV-B (Lot # 935840, Expiration Date 11-Sep-2022, NDC # 43528-003-01) was administered in the left deltoid.   It was reported that the HEPLISAV-B administered had undergone a temperature excursion.  No adverse reactions were reported by the patient at the time of report.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient began having flu-like symptoms (fever, chills, vomiting, dizziness) the day after administration that lasted for four days.
Fever, redness at site 1st 1-2 days, now redness is growing leg is sore.
Pt tolerated vaccine well, later complains of shoulder pain for last 6 weeks since vaccine.
Patient received Dose 1 of Moderna on April 21st 2021. Patient did not disclose this information. Patient was given the Johnson and Johnson one shot vaccine on August 10th at 13:07 as he requested. When patient was input into database his first dose of Moderna was discovered.
Paralysis and drooping of left side of face, puffy left cheek.  Dx - Bell's Palsy.
2nd COVID vaccine injection hit my bursa/ She suspect that it was given in her non deltoid muscle in the left arm; Arm pain/ having pain in arm for 2 months post the second shot/ had pretty severe reactions/ pain in arm feels as got punched in the arm still; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd COVID vaccine injection hit my bursa/ She suspect that it was given in her non deltoid muscle in the left arm) and MYALGIA (Arm pain/ having pain in arm for 2 months post the second shot/ had pretty severe reactions/ pain in arm feels as got punched in the arm still) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 001C21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd COVID vaccine injection hit my bursa/ She suspect that it was given in her non deltoid muscle in the left arm) and MYALGIA (Arm pain/ having pain in arm for 2 months post the second shot/ had pretty severe reactions/ pain in arm feels as got punched in the arm still). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd COVID vaccine injection hit my bursa/ She suspect that it was given in her non deltoid muscle in the left arm) and MYALGIA (Arm pain/ having pain in arm for 2 months post the second shot/ had pretty severe reactions/ pain in arm feels as got punched in the arm still) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Action taken with mRNA-1273 in response to the events was not applicable  No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-jun-2021 patient details city postcode  and age sex were added
sinus infection; This is a spontaneous report from a Pfizer-sponsored program via a patient. A 60-years-old female patient received pregabalin (LYRICA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation (age at vaccination unknown). The patient medical history and concomitant medications were not reported. Historical vaccine included ZOSTER (Shingles Shot) on 21Nov2020. The patient experienced sinus infection on an unspecified date. She had to be on amoxicillin for 7 days, she also stated that she got her Pfizer COVID shot on March 21st and will get her next dose on April 18th. The action taken in response to the event for pregabalin was unknown. Outcome of the event was unknown.  Information on the lot number has been requested.
Not for nothing, but six weeks after I had my second Moderna shot on February 27, 2021, (Lot 001A21A) I became violently ill on the first week of April with stomach pain, loss of appetite, headache, chills, vomiting, diarrhea, and I  lost seven pounds in four days of hell.   Six weeks after I received my Moderna booster shot (Lot 037C21A) on October 20, 2021 ( which is half the dose ), I have had very similar symptoms but not as bad. None of the vomiting nor diarrhea and I only lost three pounds.  I find this curious and was wondering if this was an expected side effect.
chills; fever (100.0F); headache; Fatigue; This is a spontaneous report from a contactable consumer. A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in left arm on 09Feb2021 at 13:30 (at the age of 31-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: EL3247) as dose 1, single administered in left arm on 19Jan2021 (at the age of 31-years-old) for COVID-19 immunization. The patient medical and concomitant medication history were reported. COVID-19 prior vaccination was reported as no. Patient had no allergies. Patient did not received other vaccine in four weeks. Patient did not received other medications in two weeks. Facility type vaccine at Workplace clinic. Adverse event start on 10Feb2021 at 03:00 AM. The patient experienced chills, fever (100.0F), headache and fatigue. The patient underwent lab tests and procedures which included body temperature: 100.0 fahrenheit on 10Feb2021. COVID-19 tested post vaccination was reported as no. The outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
report had been received from a literature source, a regulatory authority concerning a 18 years old male patient, enrolled in a study. The patient presented with anaphylaxis within a few minutes after receiving LAIV3, yellow fever, inactivated poliovirus and typhoid vaccines. Action taken with the suspect drug, FLUMIST was unknown. The outcome of event, anaphylaxis was unknown. Assessment of seriousness criteria of the event was as follows: Important medical event. The company physician assessed the causality for the event, anaphylaxis with the suspect drug of FLUMIST as yes.