chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received Expired vaccine of monovalent primary series on 03-Apr-2023; Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023; Patient received first dose on 18-Jan-2022, second dose received on 03-Apr-2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Expired vaccine of monovalent primary series on 03-Apr-2023), PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Jan-2022, second dose received on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 03-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Expired vaccine of monovalent primary series on 03-Apr-2023), PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Jan-2022, second dose received on 03-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Expired vaccine of monovalent primary series on 03-Apr-2023), PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Jan-2022, second dose received on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (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 Expired vaccine of monovalent primary series on 03-Apr-2023), PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Jan-2022, second dose received on 03-Apr-2023).    No concomitant medications were reported.  Patient received first dose of Moderna COVID-19 Vaccine on 18-Jan-2022 (lot number 022J21A). Vial did not undergo any temperature excursions. No side effects have been reported to the HCP.  No treatment information was provided.
(Pfizer shot #2)? serious flu like symptoms including full body aches requiring pain pills for relief,  chills, severe headache, and sudden onset of lightheadedness accompanied by nausea . Felt like I was going to pass out and throw up simultaneously. Symptoms persisted for approximately 36 hours requiring me to miss work for two days.
Neurological electrical shock; dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of electric shock sensation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had twice in his/her life).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced electric shock sensation and dizziness. On an unknown date, the outcome of the electric shock sensation and dizziness were recovered/resolved.   It was unknown if the reporter considered the electric shock sensation and dizziness to be related to Shingrix.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that Shingrix vaccine had caused horrible problems. The patient experienced neurological electrical shocks all over the body and dizziness. The patient stated that the symptoms had lasted 4 months at the time of reporting. The patient did not wish to received 2nd vaccine. The follow-up would not be possible as no contact details available.
5/19/02-fever; 5/22/02-fever, nasal congestion; 5/23/02-blood culture (+) GPC treated with Rocephin for LLL pneumonia; 5/24/02-resistant pneumococcus, hospitalized with LLL pneumonia with cavitary lesions. Rx'd vancomycin; 7/2/02-immune work-up in progress. Prevnar given 9/20/01, 12/28/01 and 1/28/02.
Persistent diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Persistent diarrhea) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIARRHOEA (Persistent diarrhea). On 13-Jan-2021, DIARRHOEA (Persistent diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
> 24h from vaccines pt awoke from nap w/ hives, red blotches, all 4 extremities severely swollen. Seen, at ER s/p oral steroids, antihistamines, ibuprofen, monitored x 2 hrs. No resp involvement. Rx prednisolone 3 mL qd x 2d. Pt recovered completely.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient 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 11-Jan-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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case contains information for the 48 out of 100 adult patients described by the reporter. No concomitant information was reported. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11Jan2023, lot numbers unknown to the HCP. Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
full body aches; headache/headachy; fogginess/cloudiness; This is a spontaneous report from a contactable consumer reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 02Apr2021 (Lot Number: EP7533; Expiration Date: 30Jul2021) as SINGLE DOSE for covid-19 immunisation. Patient took the first dose of vaccine on 12MAR2021 (Lot number: EN6208, Expiry date: 30Jun2021), also at age of 46 years old for covid-19 immunization. He didn't have any kind of soreness after the first COVID vaccine. He had no tenderness, no side effects, nothing. For the first time it was about 13:30 in the afternoon and then the second time was he wanted to say about 10:00 am. He had both dose in his shoulders, one was in the left and one was in the right. Vaccine Administered at Military Facility was No. Vaccination Facility was Hospital. Prior vaccination (within 4 weeks prior) was none. The patient medical history and concomitant medications were not reported. Patient had the headaches and also had bad fogginess about 6 hours after the COVID vaccine was administered and the full body aches kicked in the next morning which was about 20 hours after the COVID vaccine was administered and then like he said the body aches went away and the only thing that has really lingered from time to time was the headaches. The body aches started on 03Apr2021 and were over by the following Monday, so 05Apr2021. The cloudiness and the headaches began on 02Apr2021 but he did not have the cloudiness anymore. He got headachy very easily now and he has never experienced that before. He got headaches really easy, they were lingering, but they were not migraines it was just an achy head in the background, in the distance, and he can tell it was something different. The outcome of event headache was not recovered, the outcome of event full body ache was recovered on 05Apr2021,the other event was unknown.  No follow-up attempts are needed. No further information is expected.
Severe headache, severe body ache, blurred vision, nausea, fatigue, lasting 3 days. Previous hx of active Covid 19 in November of the year, no long lasting symptoms from either vx or disease
This spontaneous report as received from a Registered Nurse concerning a 4 month old patient who on 12-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Itches; Swollen; Real bad rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), SWELLING (Swollen) and RASH (Real bad rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PRURITUS (Itches), SWELLING (Swollen) and RASH (Real bad rash). At the time of the report, PRURITUS (Itches), SWELLING (Swollen) and RASH (Real bad rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment for the event was not reported.
Information has been received from a physician concerning a female who was vaccinated on an unspecified date with her third dose of GARDASIL. Sometime during the summer 2007, the patient experienced lightheadedness and dizziness after receiving the vaccination. The patient sought medical attention at the doctors office. Subsequently, the patient recovered from lightheadedness and dizziness. No further information is available. Additional information has been requested.
Pain at injection site which has not resolved since the immunization was administered.  Patient reported pain at office visit today (4/27/15) but did not contact any health care provider regarding the ongoing pain in his deltoid.
I have been running a small fever of about 100 degrees give or take.  I have also had what seems to be faster than normal heart rate.  A little short on breath.  A little bit light headed. My left arm near my wrist has had some aching.  No treatments for anything as of now.
sore throat; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) 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.   In March 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 19-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) outcome was unknown.            No Concomitant medications were provided.  No Treatment medications were reported.
There were no adverse events reported by the patient. The incorrect vaccine was administered to the patient, inconsistent to her age. The patient was 4 years old and received the Pfizer-BioNTech 5 years+ vaccine.
Fluzone High Dose was left out at a room temp of 70 F for 1 hour and given to a patient with no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown demographics who received a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number, expiry date was not reported  which was left out at a room temp of 70 F for 1 hour.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.   At the time of the 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
E87.1 - Hypo-osmolality and hyponatremia R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction R56.9 - Unspecified convulsions
Patient reported that they had never received a COVID vaccine before.  RN administered dose one in the primary Pfizer series per patient request. RN later determined that patient has received previous covid vaccinations on the following: 7/6/21 Pfizer Primary LOT EW0196 7/18/21 Janssen LOT 1A2288 4/8/22 Pfizer Primary LOT FK9893 10/10/22 Pfizer Bivalent LOT FP7138
admitted to ER for unexplained syncope, seizure like episodes and brief loss of consciousness. Over the next 36 hrs, while hospitalized, I continued to experience sever sycopal episodes, rapid decline in Blood pressure, hemoglobin/ hematocrit levels, critically elevated bun, bun/ creatine levels, vomiting copius amounts of blood as well as passing it through lower GI tract resulting in bloody stools. Treatment included infusion of four units of packed red blood cells, IV hydration with NS x 4 liters, albumin for treatment of shock r/t acute blood loss. Endoscopy performed by experienced Gastroenterologist determined that findings unremarkable to explain sudden rapid decline resulting in such blood loss.
Patient waiting his 15 minutes after receiving 1st dose. Became limp in chair, face pale. He responded to his name and other simple questions within 30 seconds of onset but continue to appear pale and reported feeling  light headed. Stated that he has fainted before after giving blood, etc; His blood pressure then was 110/60 and pulse 68-72. @nd blood pressure a few minutes  was 82/40. He continued to feel light headed with nausea. Decision was made to take him to the Emergency department as vaccine clinic was in hospital. Patient was admitted then to the Emergency room.
Severe pain in the hips, knees and elbows; It could be reaction to gradasil 9; Erythrocyte sedimentation rate elevated; C-Reactive protein increased; This spontaneous report was received from a nurse practitioner intern via a company representative referring to a 13-year-old female patient who is also the daughter of the reporter. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were reported as unknown.   On an unknown date in August 2011, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, frequency, batch/lot # and expiration date were not reported) for adolescent immunization (prophylaxis). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TETANUS TOXOID) (dTAP) (dose, strength,  route, frequency, batch/lot # and expiration date were not reported) for prophylaxis.   On an unknown date in August 2011 (after about 3 weeks from the time of vaccination) the patient experienced severe pain in the hips, knees and elbows (Arthralgia) (hospitalization), erythrocyte sedimentation rate elevated (red blood cell sedimentation rate increased) and c-reactive protein elevated (c-reactive protein increased).  On an unknown date in August 2011, the patient had to be hospitalized due to the events, where she stayed overnight and received acetaminophen (TYLENOL) for pain relief. During hospital stay, the patient underwent laboratory tests of erythrocyte sedimentation rate and C-reactive protein which were elevated but definitive cause for pain was not found. The patient's mother was told that it could be a reaction to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Vaccination complication). On an unknown date in 2011 the patient got discharged from the hospital (shortly after the hospital stay) got completely recovered from the events.   The patient did not complete the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series due to the events. Outcome of the events were reported as recovered. Causality assessment was not reported.
Breakthrough Case of Covid-19; Breakthrough Case of Covid-19; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. The reporter is the patient. A 63-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 11:00 (Lot number: EW0217) at the age of 63 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 15Feb2021 11:00 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 26Jan2021 11:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type B Diabetes" (unspecified if ongoing). The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient took concomitant medications. The following information was reported IMMUNISATION (medically significant) with onset 03Nov2021 11:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022 17:00, outcome "recovering" and all described as "Breakthrough Case of Covid-19". The event "breakthrough case of covid-19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: PCR, COVID Test (02Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The most recent COVID-19 vaccine was administered from a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
About 24 hours after vaccine, I experienced blurry vision, headache and confusion. It resolved within about 3 hours.
ABOUT TWO DAYS AFTER THE VACCINATION, I NOTICE SMALL ITCHING SPOT ALL OVER MY BODY. TOP LIP WAS THE MOST BOTHERSOME.  BOTH MY FEET FELT LIKE NEEDLES FOR ABOUT 2HOURS.  BUT EVEN TODAY, 2/14/2021, THE ITCHING HAS CONTINUED.  DOES NOT ITCH TO THE POINT THAT MAKES ME WANT TO SCRATCH; BUT NOTICEABLE. BOTH ARMS AND LEGS MOSTLY.  I HAVE NOT NOTICED A RASH.  I HAVE NOT TAKEN ANY MEDICATIONS FOR THIS ITCHING.  I AM HOWEVER WORRIED ABOUT TAKING THE 2ND DOSE.  AS A MATTER OF FACT, I AM LEANING AGAINST TAKING THE SECOND DOSE.
Patient presents to ER with chest pain,  worse with deep inspiration, lying flat or leaning forward.  Pain is better when sitting up straight.  Vomiting x 1 episode. First Moderna shot on 4/9/21.  Chest pain started on 4/11/21.  On 4/14/21, pain was worse, so came to ER.  Patient admitted to hospital, cardiology consult, pulmonology consult.  Patient is treated with colchicine 0.6mg twice daily, NSAID and metoprolol 25mg twice daily.  Follow up with cards in 2 weeks.  Much improved on day 2.
Swelling in the injection arm (left) between under arm and breast.  Soreness and itching in the injection sight and arm. Soreness started the night of 4/22/22.  Itching and swelling started the next morning 4/23/22.  This was my booster shot.
Report 2001018872-1 describes injection site swelling in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). Allergies were not specified. The pt's medical history included liver transplant in 1986 and hemodialysis since 4/01. She rec'd carvedilol (Coreg), azathioprine (Imuran), acetylsalicylic acid, alprazolam (Xanax), iron, allopurinol, and Prednisone.  On 7/2/01, the pt rec'd her first 40 mcg dose of Engerix-B. The pt rec'd one 20 mcg dose in the L deltoid. No adverse events were experienced. On 8/3/01, the pt rec'd her second 40 mcg dose of Engerix-B. Again, the pt rec'd one 20 mcg dose in the R deltoid and one 20 mcg dose in the L deltoid. Ninety minutes post vaccination, she experienced baseball-sized swelling of the L deltoid with dime-sized hematoma at the injection site. Sixty minutes later, she experienced golf ball sized swelling of he R deltoid. Ice was applied to the site and the pt was evaluated in the ER. As of 8/3/01, the outcome of the adverse events was unknown.