chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone HD that was left outside of the refrigerator and exposed to 60-65F for 2 days; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age who Fluzone HD that was left outside of the refrigerator and exposed to 60-65F for 2 days (product storage error) while treated with vaccine while he/she received vaccine influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] (batch number: : UJ567AA and expiration date 30-Jun-2020) via an unknown route in unknown administration site for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event incorrect product storage (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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 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
mom stated pt awoke w/high pitch scream & color was bad advised to take pt to ER;pt had drainage @ back of throat; glands were swollen, color flushed, pale, blue corner of mouth & temple
Developed fever 3-4  hours after shots. Has persisted x 3 days. Had rash on torso, back, face, extremities (no hives). Has been very fussy and crying, but non-toxic. Doesn't want to nurse well.
8 hrs after shot felt extremely tired  Sleeping that night had chills woke up in cold sweat  Was combination of dreaming and hallucinating  Next day entire body was soar. Notable pain in kidneys.  Still every tired and head pressure
pt recvd vax; 03nov95 pt died;autopsy showed that COD was acute myocardial infarction secondary to dilated cardiomyopathy;MD felt that pt's demise was not related to hep B;
The injection was administered very high up, at my shoulder. Pain started that evening. For the past 14 days I have had very limited ROM and severe pain in my left shoulder/deltoid - especially when abducting my arm away from my body. Going to see my doctor on 11/15.
Breakthrough case admission after 2 vaccines Pfizer 3/8/21 lot# EN6202;  Pfizer 3/29/21 lot# ER2613
This is a spontaneous report from a contactable consumer or other non-HCP. A 49-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 16, 2021, single dose, for COVID-19 immunisation. Medical history included Hashimoto's syndrome. Concomitant medications included thyroid replacement medication. After receiving the first dose of vaccine, patient experienced tiredness, body aches, next day 102ºF. Thursday all subsided but felt a little groggy from what she experienced. Since Saturday, she has had pins and needles in extremities. Last night it got bad and then today it's equally bad. Also has heartburn all over her stomach and chest. Concerned about the pins and needles. She asked if this could be Guillain Barré syndrome. The outcome of the heartburn, pins and needles in extremities: unknown; other events tiredness, body aches, fever recovered on an unspecified date 2021. No follow-up attempts needed. Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.
Within 90 minutes of receiving the vaccine, abdominal pain and cramping started. Within 24 hours of receiving the vaccine, intestinal bleeding started. Pain, cramping, and bleeding persisted at 48 hours and oral prednisone was started. This report is filed at approximately 50 hours post vaccine.
Mom states approx 2.5 hrs post vax developed elevated temp of 105.4(r), & unconsolable all evening, lethargic & pale;
Patient was given the wrong vaccine for his age.  Patient was administered the Fluzone High Dose that is not approved for under the age of 65.
Localized skin/tissue reaction with erythema, mild edema and mild-mod pain.
Severe chills with uncontrollable shaking that lasted 4-5 hours. Fever up to 103.7F for 24 hours. All over skin tingling and pain that lasted 24 hours. Treated with Tylenol and ibuprofen alternating every 3 hours. Applied cold compress to back of neck.
Both times arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR081302   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had no reaction with the first shingles shot but arm was hurt for a while. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR081302 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081302:Same reporter.
pt had syncopal episode 12 hours after receiving the vaccine with no dizziness, chest pain or warning signs prior
Information has been received from a licensed practical nurse concerning an 18 year old female who was vaccinated with Gardasil (Lot# 653735/0688F). On 12-FEB-2007, the patient lost consciousness and hit her head after receiving her first dose of Gardasil. The patient was taken to the emergency room but was not admitted. The patient also developed local site reaction. On 13-FEB-2007, the patient visited the office and complained of pain at the site and it was warm to the touch. Unspecified medical attention was sought. Subsequently, the patient recovered from lost consciousness, hit head, local site reaction and pain and warmth at injection site. Additional information has been requested.
MUSCLE ACHES; HEADACHE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced low grade fever. On 22-MAY-2021, the subject experienced muscle aches. On 22-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills on 22-MAY-2021, and had not recovered from low grade fever, headache, and muscle aches. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of upper respiratory tract infection in a 76-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced upper respiratory tract infection and incomplete course of vaccination. On an unknown date, the outcome of the upper respiratory tract infection and incomplete course of vaccination were unknown. It was unknown if the reporter considered the upper respiratory tract infection to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX on the left arm. The patient stated that she had an upper respiratory infection 6 months ago from the date of reporting. The patient reported that she had been unable to get her 2nd dose and was now past the 6 month period, which led to incomplete course of vaccination. The reporter consented to follow up. No further information was given.
morning there was the "face" (not clarified) like rash/ rash es was spread; Dizzy; kind of shingles; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 13Apr2021 at 16:05 (reported as 4:05 o'clock in the afternoon) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On the morning of 14Apr2021, the patient reported to experience "face" (not clarified) like rash "10:30" (not clarified) and by end of the day the patient felt dizzy, rashes was spread, kind of shingles (as reported). Outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Patient is 25 weeks pregnant and received both doses of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is 25 weeks pregnant and received both doses of the Moderna vaccine) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L02A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Jun-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is 25 weeks pregnant and received both doses of the Moderna vaccine). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 13-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is 25 weeks pregnant and received both doses of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
First dose administered 4/15/21, and second dose was administered on Day 59 (approximately 17 days beyond the window set by the CDC)
light case of shingles; This spontaneous report was received from a 84-year-old female consumer referring to herself. Her concurrent conditions, medical history and concomitant medications was not reported.     On an unknown date in 2009 (also reported as ten years ago), the patient was vaccinated with a single shot of zoster vaccine live (ZOSTAVAX) via unknown route (route also reported as injection) for prophylaxis (strength, dose, unit, anatomical location, lot # and expiration date was not reported). On an unknown date in February 2017 (also reported as two year ago), the patient experienced a "light case" of shingles (herpes zoster). The outcome of herpes zoster was reported as recovered/resolved. Causality assessment of the event was not provided.
no additional AE; expired dose of MMR II administered to a patient; This spontaneous report was received from a certified nursing assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reaction or allergise was provided.  On 13-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) one dose, lot # S013683, expiration date 05-MAY-2021 (route of administration was not provided). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (lot # T002841, expiration date 10-JUL-2022). No adverse events were reported.
Patient's left arm began to hurt at about 12:30PM and by 4PM the same day, her arm was swelling about 4 inches around the site of injection. Her arm was also starting to feel numb. The pharmacy advised her to put ice on the swelling and take benadryl. By Thursday morning, her arm was still swollen so she called her doctor and she was advised to take Benadryl and Zyrtec. By Friday, patient was feeling much better & the swelling had gone down.
8cm redness and swelling left arm. Benadryl and cold compresses recommended.
Patient received Pfizer COVID vaccine on 1/13/21 (lot # EL1283), 2/3/21 (lot # EN5318), and 11/20/21 (lot # 30145BA). On 5/29/22, patient was admitted to our facility with  hypovolemic shock, acute hypoxemic respiratory failure, COVID-19 infection, UTI, and laceration of fourth toe. Patient was transferred from facility to med/surg. on 5/30/22 and was discharged back to adult family home on 6/1/22.
Patient developed pain at the site of injection. He developed redness and swelling on 08/03/2012.
no adverse events asked for Pfizer booster - patient accidentally recieved moderna.  Using our interperter we explainned the error and the basic simlarities & differences between pfizer & modera. Patient said it was OK & she felt OK.  I explained if she had any questions / concerned to call health department.  She said she will.  Dr (Privacy) called. He said have patient call health department if she has any questions/concerns.  This was done
7 DAYS:  FEBRUARY 14, THROUGH FEBRUARY 19.  Minor effects on day 7, February 20. Severe stomach cramps, severe headach, feverish, nausea, extremely tired/fatigued, chills, diahrea, no appetite.
35 years old was given vaccine in error; This non-serious case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received Herpes zoster (Shingrix) (batch number CRSXF, expiry date 23-AUG-2025) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included escitalopram.   On 14-JUL-2023, the patient received Shingrix .5 ml. On 14-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 35 years old was given vaccine in error). The outcome of the inappropriate age at vaccine administration was resolved.   Additional Information: GSK Receipt Date: 02-NOV-2023 35 year old patient was given the vaccine in error when it was not indicated which led to inappropriate age at vaccine administration. The patient had not reported any side effects at the time of reporting. The reporter enquired was there anything patient should be watching out for at this time.
within an hour of receiving the shot, my ankles, face and arms began to swell and turn red.  Over the next few hours the swelling continued till the point that my skin was tight and it was painful.  The day after the shot I had fluish symptoms as expected but i also had severe joint pain and a migraine.  The swelling did not go down even with taking benadryl and otc water pills.  The fluish feeling and migraine subsided after 3-4 days but the joint pain continued.  it was severe to the point it was painful to walk/move.  After a week of no relief on the swelling & pain, i discussed it with my healthcare provider & she suggested taking charcoal so i did that for a week and the swelling went down slowly.  it took 3 weeks for the swelling to go away on charcoal & about 4 months for the joint paint to go away although i still have problems with pain in my knees today.
I experienced a breakthrough case of COVID-19 with sneezing, headaches, sore throat, sore ears, fever and chills, body aches, congestion and coughing.
Systemic: Fainting / Unresponsive-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient fainted about 12 minutes after receiving vaccine. She had numbness in her left hand and started to feel sick to her stomach, then fainted. She became responsive, and slowly started to feel better. Patient vomited a very small amount approximately 3 minutes after becoming responsive, then felt better immediately.
sister got COVID several times/they're getting sick from COVID; sister got COVID several times/they're getting sick from COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "sister got COVID several times/they're getting sick from COVID".  Clinical Course:Caller stated that pretty much people in his family has been taking the COVID vaccine; her sister got COVID several times, and her niece, nephew, etc. My family got sick. My neighbor took this. I got sick. And my sister told me they're getting sick from COVID  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.
Information was received from a 65 year old male consumer who was vaccinated with ZOSTAVAX one injection on 11-FEB-2010. On 30-SEP-2013, the patient came down with shingles. His doctor prescribed famciclovir 500 mg, 3 times a day; hydrocodone-acetaminophen (manufacturer unknown); and LYRICA 75 mg, 2-3 times daily. The patient reported that the pain stayed while the visible signs of shingles went away. Additional information has been requested.
A 21 year-old, male patient with a medical history of no known allergies) developed blood in the urine and burning with urination after he received IPOL (lot number Z0547-2) intramuscularly in the right arm, Typhim VI (lot number Z0443-2) intramuscularly in the left arm, YF-VAX (lot number UE945AA) intramuscularly in the left arm, TD vaccine (Massachuttes Biologics Labs, lot number TD151) intramuscular in 2007. He went to his local MD (name not available to reporter) and had "tests" done. The reporter was not sure of the date of the onset of the symptoms, information of the treating physician or test done. The patient did not have any illness at the time of the vaccination. At the time of the report, the patient's recovery status was unknown.
Breakthrough case admission after 2 vaccines Pfizer 3/3/21 lot# EN6202;  Pfizer 3/24/21 lot# ER2613
No additional adverse events reported; Improperly Stored dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 11-year-old patient. No information regarding the patients' pertinent medical history, drug reactions, allergies, or concomitant therapies was provided.  On 25-MAY-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, lot # 1687292, expiration date 25-MAY-2021 (route of administration was not provided) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of above 47 Fahrenheit degrees (F) (also reported as 46.9F) for 84 hours and 30 minutes. The digital data logger was not involved in recording the temperature excursion details. There were no previous excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Since the 1st dose my period is missing; Could not sleep all night; I had normal reactions; Hot flashes; Severe headache; Fever; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Since the 1st dose my period is missing), INSOMNIA (Could not sleep all night), HOT FLUSH (Hot flashes), PAIN IN EXTREMITY (Sore arm) and UNEVALUABLE EVENT (I had normal reactions) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism.   On 02-Jul-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 03-Jul-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Fatigue). On 04-Jul-2021, the patient experienced HEADACHE (Severe headache). On 05-Jul-2021, the patient experienced HOT FLUSH (Hot flashes). On an unknown date, the patient experienced AMENORRHOEA (Since the 1st dose my period is missing), INSOMNIA (Could not sleep all night) and UNEVALUABLE EVENT (I had normal reactions). At the time of the report, AMENORRHOEA (Since the 1st dose my period is missing), INSOMNIA (Could not sleep all night), HOT FLUSH (Hot flashes), PAIN IN EXTREMITY (Sore arm), UNEVALUABLE EVENT (I had normal reactions), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, Heart rate: 95 bpm (High) Heart rate is 95 bpm (normal rate is about 60 bpm).         Treatment information not provided. List of concomitant medications were not given.   This case was linked to MOD-2021-246762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Non-Significant follow-up
Day after 2nd vaccine, developed chills, fever of 99.4, and overall body aches