chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, 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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-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 (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 20 out of 50 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Lt arm swelling, erythema, rash. KEFLEX 250mg/5ml Rx on 4/20.
Swollen left shoulder lymph node. Size of a plum. Dr. told me that this was a known reaction to covid  vaccine and to do nothing.  Swelling has decreased.  Now size of a marble.
Patient reports that following administration of the vaccine, she had some erythema in the area surrounding the injection site. She states that it dissipated a few days following administration, but that a discolored patch (roughly the size of a fist) remained on her lower am. It seems to be a cosmetic issue as patient reports no pain or issues with site aside from that it persists. No treatment reported or requested.
Within 24 hours of PNEUMOVAX vaccine pt got red/warm rash, personal physician of pt decided to give antibiotics, rash went away within a few days, pt reports full recovery.
Initial report received from a healthcare professional on 14 January 2014. A female patient had received a dose of YF-Vax (batch number, dose number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives and shortness of breath. Laboratory tests and corrective treatment were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Patient was given the Shingrix vaccine, despite not being age 50 yet (1 month shy).
Mother describes pt complaining of a rash all over his body. Upon examination, child was found to have red papules over torso and face/head. Denies itching. Afebrile. Denies difficulty breathing on 9/5/01, but states child did complain of difficulty catching breath on 8/29/01. No medical treatment sought.
Fever or Chills  Fatigue  Muscle or body aches  Sore throat  Congestion or running nose
Rash on arm 4" x 3 " left arm itching. Reported starting after shot & still present after 3 days.
First day after vaccine: chills, fever, whole body aches, expected soreness at site of injection  Second day after vaccine: tightness in back of throat (maybe even already in chest, hard to pinpoint) that felt a little like choking  Third day after vaccine: moderate headache and general head discomfort, particularly behind eyes  No treatments for any of the symptoms, I've just been letting them each run their course and they've each only lasted about 24 hours so far.
HEART ATTACK; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack. The consumer reported as " My brother in laws sisters husband died in his living room, heart attack, double deaths". It was unknown if an autopsy was performed. On an unspecified date, the patient died from heart attack.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211254072, 20211254110, 20211253879 and 20211247927.; Sender's Comments: V0-20211254092-Covid-19 vaccine ad26.CoV-2.s- Heart attack. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: HEART ATTACK
I had some diarrhea - but I do get that quite often even before the shot. Noticed blood in the Urine at home and I called for an appt. Doctor at Kaiser.
About 12 hours after, fever-like systems; joint pain; fatigue; chills; aches; symptoms lasted two days - treated with Advil. Advil helped. It was gone after the two days. Had to talk to my employee to clear me to go back to work.
The patient has been in a fatigue since the vaccination.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 20Dec2021, outcome "recovering", described as "The patient has been in a fatigue since the vaccination.". It was unknown if therapeutic measures were taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's wife called and said pt's Right arm swelled up six inches below injection site. Onset symptoms 7am on 9/14/2011. The swelling went below elbow and was red and felt warm to the touch. I followed up with patient on 9/16 and is feeling better & swelling has gone down. I advised patient to take TYLENOL and BENADRYL.
Client received a flu shot at the school clinic in the right deltoid muscle at 1607 hours by student nurse. FLUZONE vaccine by Sanofi, Lot # UH454AD, Expiration 6/30/11. This nurse was notified (at the end of the clinic) by the nursing student's instructor, RN, that her nursing student reported leaking from the hub of the needle when she gave her first shot of the clinic. This nurse was contacted by the instructor the next morning and received the name of the nursing student who gave the shot that leaked. This nurse verified with the instructor that this nurse would follow up with the client's parents and physician. This nurse left a message on the client's phone to call back at 1151 hours. This nurse again left a message on the client's phone to call back (next day) at 1534 hours. This nurse spoke the client's mother at 1618 hours to report that invalid dose at the school flu clinic. This nurse advised to repeat the dose citing the Epidemiology and Prevention of Vaccine Preventable Diseases 12th Edition. This nurse advised that the client could get the repeat dose at the next school clinic or in this office, Department of Health Community Health Services. The client's mother, gave verbal permission to report the incident to the client's pediatrician. This nurse spoke with dr's nurse today to report the incident and the plan to revaccinate.
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown dates, an unspecified number of patients were vaccinated with an improperly storage doses at a temperature of 47 °F to 77 °F for 9 hours and 54 minutes of PNEUMOVAX23 (lot # M036728 and expiration date 20-MAY-2018) (lot # M039060 and expiration date 22-MAY-2018) for prophylaxis (dose and route of administration were not reported). The vaccine did not have a previous temperature excursion and this information was provided due to the data logger. No adverse effects were reported. There was no product quality (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004699: US-009507513-1704USA010790: US-009507513-1705USA004698:
Fever (lasted 4 days), Nausea & diarrhea ( lasted 7 days) extreme fatigue (lasted 10 days), muscle and joint aches (9 days), drowsiness (lasted 8 days)   This was much worse then the first injection. I could not complete ADLs such as work or household chores. The fatigue lasted the longest and was the worst symptom.
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 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, 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.   Concomitant products were not provided.  The age of patient was provided as 53.02.  On 20-Mar-2021, Excursion time was 09 AM, temperature was 34, 10 AM temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.    Temperature recordings were taken using a 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.
pt recvd vax & w/in 30-40 mins p/hep B vax pt eyelids fluttered & eyes made nystagmus like movements;
Patient had a syncope episode post vaccination.  Patient had a know needle phobia and stated passed out one time when had blood drawn.
I just today did my 6 week report for you, then I remembered something might be of interest. I got my second moderna shot February 1.  I visited a urologist two weeks ago  and did a urine test. I was surprised to find my glucose at 250. I have never been diabetic nor has anyone in my family. I've never been diagnosed as borderline diabetic.  I gained 13 pounds during the pandemic and have since lost six and I am overweight, so conceivably, I could well be diabetic.  I am reporting this  you in the event someone else has had the same.  I am having bloodwork done the first week in April
RASH; PAIN; LYMPH NODE SWELLING;  CANKER SORE
Irregular menstrual bleeding.  Received the first vaccine shot in the series on 4/9/2021. Had a normal menstrual cycle beginning  4/19/2021 for 5 days.  Then I began having bleeding, not spotting on 4/29-4/30.  I revived the final vaccine shot on 5/7/2021. I then began menstration on 5/8/2021. By 5/9/2021 between 4am and 5am menstrual bleeding became profound and significant, exceeding 3 sanitary napkins within a two hour period.
Difficulty breathing, compulsive dry cough, felt tight and constricted in upper chest and airway, tongue felt thick and mouth has strange taste, vision blurry, after half an hour also a lot of burping and fingertips felt numb. After an hour and a half, nurses took blood pressure and was very high, plus slightly elevated heart rate. Clinic called EMT who took blood pressure, was 180/110.  My normal BP is around 130/75.   Heart rate around 95 (normally 65).  I declined going to emergency room because I could breath, even though it was agitated and coughing a lot. I did not want to go where there might be a lot of sick people.
did not receive a full dose; liquid leaked out of the patient's arm; Inadvertent exposure to vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number AE2J4, expiry date 30th March 2023) for prophylaxis.   On 22nd September 2021, the patient received the 1st dose of Shingrix. On 22nd September 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: The pharmacist reported that patient who did not receive a full dose of Shingrix because while administering it, most of the liquid leaked out of the patient's arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The pharmacist does not know how much of the vaccine the patient received. The reporter consented to follow up.
1day later noted metalic taste in mouth, tongue felt big in her mouth- lasted 10 daysMight have improved with Benadryl 25 mg; tongue felt big in her mouth; This is a spontaneous report from a contactable physician. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: unknown); via intramuscular route of administration on 11Mar2021 at 10:45 (at the age 45-year-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus and pollen allergy. Concomitant medications were not reported. It was unknown if the patient had any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 12Mar2021, one day after vaccination, the patient experienced metallic taste in mouth and tongue felt big in her mouth which lasted for 10 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken and included treatment with BENADRYL 25mg. The clinical outcome of the metallic taste and tongue felt big in mouth was recovered on 22Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
shoulder pain where the site is; swelling up under my arms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: FC3183) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously had first dose of BNT162B2 (Lot number: EW0176) on an unknown date for COVID-19 immunization. The patient experienced shoulder pain where the site is, swelling up under my arms on an unspecified date. Patient stated, received second Pfizer vaccine yesterday and had the shoulder pain where the site was but had swelling up under arms. Patient didn't have that the first time. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
No adverse symptoms reported; The patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies.     On 06-MAR-2020,  the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) by oral route, lot #1660112, expiration date 18-OCT-2020 for prophylaxis (dosage schedule were not reported) following a temperature excursion (product storage error).  The vaccine involved was stored in a highest temperature above 47 degrees Fahrenheit (°F) (52.1°F) for 15 minutes and above 47 degrees Fahrenheit (°F) (55 °F) for 21 minutes, as recorded by a data logger. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Site swelled to size of golf ball, bright red, low-grade fever. Did not give Benadryl. Gave dose of Tylenol. Started swelling Saturday am.
Subsequently post vax, the vaccinee experienced a very sore arm that became red and which formed a hard area. The vaccinee reported receiving a deer tick bite around 4/28/00 on her right flank. She was treated with doxycycline and the event resolved. She reported another deer tick bite on 5/11/00 between her great toe and second toe. On 5/13/00, she developed a red blister with white center, about 1/4 " in diameter that swelled and itched severely. She continued to take Benadryl to manage the itch.
Patient got 1st dose Moderna at store (number) and 2nd dose Pfizer at store (number). I have no part in this incident. Vaccine was administered by an agency Nurse. Patient told my clerk, she did not feel well after second dose and went to her Drs office. She said she was in a diabetic coma and she does not have diabetes. She also said to my clerk shes not saying this is related to the vaccine.
Congestion, coughing, muscle aches, tiredness, headache, fever and chills.
Itching throat, feeling of funny sensation in the throat BP:  170/108; 144/96( rechecked) HR: 86 Sp02: 100% Patient self administered her Benadryl 25mg prior to EMS arrival. Patient refused to go the hospital. Seen and cleared by EMS.
Beginning day after influenza vaccine, pt queasy, nauseous, diarrhea, weak. Continued for 10 days. She saw her Primary Physician. He said probably reaction to flu vaccine. No fever, no local redness or swelling. Pt still under treatment.