chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a bump on their face/a bump just appear on their mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of ORAL DISORDER (developed a bump on their face/a bump just appear on their mouth) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL DISORDER (developed a bump on their face/a bump just appear on their mouth). At the time of the report, ORAL DISORDER (developed a bump on their face/a bump just appear on their mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported .  No treatment information was provided by the reporter. On 14Jan2022 went to see an HCP because patient developed a bump on their face, a bump just appear on their mouth.    This case was linked to MOD-2022-453484 (Patient Link).
a male patient was administered properly stored M-M-R II which had expired.; The patient's pre-employment titers done on 11-NOV-2019 were low for measles.; This spontaneous report has been received from a medical assistant referring to a 44 years old male patient. The patient had pertinent medical history included post-traumatic stress disorder. Concomitant therapy included fluoxetine. There were no drug reactions or allergies reported.   On unknown dates (reported when the patient was a child), the patient had received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, frequency, route and dose details were unknown) for prophylaxis. The patient's pre-employment titers done on 11-NOV-2019 were low for measles.        On 13-DEC-2019, the patient was vaccinated with the first dose in the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination series (lot # N032750, expiration date: 20-NOV-2019, subcutaneously in the left arm) which had expired for prophylaxis (expired product administered). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent (lot # N028745, expiration date 15-MAR-2020). No additional adverse effect reported.  The outcome of the pre-employment titers low for measles was recovering. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
SYMPTOMS INCLUDE TENDERNESS, SWELLING (REDNESS) AND PAIN IN THE UPPER ARM. SYMPTOMS ARE SPREADING TO SHOULDER AREA AND TO LOWER ARM. PATIENT CANNOT TAKE DIPHENHYDRAMINE, IBUPROFEN OR ACETAMINOPHEN. PATIENT ALTERNATED AN ICE PACK AND HEAT PAD TO REDUCE PAIN AND SWELLING. PHYSICIAN CALLED IN PREDNISONE AND TRAMADOL.
This case was reported by a healthcare resourced management company and described the occurrence of welts at injection sites in an unspecified number of subjects of unspecified ages and genders who was vaccinated with Flulaval (GlaxoSmithKline).  On unspecified dates the subjects received unspecified dose(s) of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, all of the subjects vaccinated at an unspecified healthcare provider's location experienced welts at the injection sites.  Each subject's welt was "about two inches across and looks very similar to a bug bite".  At the time of reporting the outcome of the events was unspecified.
Patient arrived at community clinic to receive his 2nd dose of Moderna. Unfortunately patient received a Pfizer vaccine and not Moderna.  Patient did not report any adverse reaction as of today.
Background: Pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
Got it again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a shingles).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Got it again). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-MAR-2023 This case was reported by the patient via interactive digital media.  The reporter stated that, he/she had the Shingrix shot and guess what, he/she had it again (Shingles).  He/She never had a reaction before to any another shot in his/her life.  He/She does not think that, he/she would get the second one. The reporter had stated that, you really need to test it more before you recommend it to everyone, to get it. Follow-up would not possible, as no contact details were available.
This spontaneous report was received from a pharmacist, via a company representative, referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unspecified dates, the patients were vaccination with a dose of ZOSTAVAX subcutaneous injection (dose, route, anatomical location and lot # were not reported). Subsequently, on an unknown date, the patients developed unspecified "Injection site reactions" and "a swollen arm" (unspecified arm). At the time of the report, the outcome and the causality between the events and ZOSTAVAX were unknown. Additional information is not expected since the physician cannot be contacted.
dizzy; breathlessness/could not breathe; rashes under her neck with itchiness; heart rate very high; weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), DYSPNOEA (breathlessness/could not breathe), RASH PRURITIC (rashes under her neck with itchiness), HEART RATE INCREASED (heart rate very high) and ASTHENIA (weak) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (dizzy) (seriousness criterion hospitalization), DYSPNOEA (breathlessness/could not breathe) (seriousness criterion hospitalization), RASH PRURITIC (rashes under her neck with itchiness) (seriousness criterion hospitalization), HEART RATE INCREASED (heart rate very high) (seriousness criterion hospitalization) and ASTHENIA (weak) (seriousness criterion hospitalization). The patient was hospitalized on 15-Apr-2021 due to ASTHENIA, DIZZINESS, DYSPNOEA, HEART RATE INCREASED and RASH PRURITIC. At the time of the report, DIZZINESS (dizzy), DYSPNOEA (breathlessness/could not breathe), RASH PRURITIC (rashes under her neck with itchiness), HEART RATE INCREASED (heart rate very high) and ASTHENIA (weak) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 180,140,120 (Inconclusive) checked 3 times and results are given above respectively.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Systemic: Fainting / Unresponsive-Severe, Additional Details: patient fainted after receiving the vaccine. She recovered after around 10 minutes.
Feeling Sick; No energy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Sick), ASTHENIA (No energy) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced MALAISE (Feeling Sick), ASTHENIA (No energy) and HEADACHE (Headache). On 27-Jun-2021, MALAISE (Feeling Sick) and ASTHENIA (No energy) had resolved. At the time of the report, HEADACHE (Headache) had not resolved.            No relevant concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-248548 (Patient Link).
Moderate local swelling, crying for longer than 1 hour. Advised TYLENOL q 4 hours and local heat. Follow-up PRN.
This child had a rash, elevated temp, runny nose, cough, and swollen glands.
Woke up 10 days after Moderna booster shot with 2 different rashes all over body.  Received fungal cream and prednisone.  Neither worked. Primary care doctor sent me to an allergist who diagnosed me with dermatographia due to the booster shot.
Light headedness, stuffy ears. Using generic flonase twice daily.  Still have same symptoms.
pt recv vax in 1990 & shortly p/3rd dose pt devel some cramping & pain in lower legs;sx persisted & pt devel ataxia;pt seen by several MD's w/no clear dx;FEB95 sx persisted;f/u info from MD indicated that no knowledge of exposure to hep B
Small lump at site of injection since administration. Today felt tingling down right arm for a few seconds which resolved an dhas not returned.
On 10/15/21 pt went to ER - Seizure - New onset.  Started with stiffening/movement in the R arm, followed by significant R sided weakness.  Could not talk.  Brought into ED.  Symptoms resolved entirely. Lactate markedly elevated. He has a lac on the side of his tongue.  Should not drive for 3 months.  Will start Keppra 500 BID.  Given abnormal imaging, EEG would not change management at this point.  If there is any concern for subclinical seizures in the future, could consider EEG. Abnormal MRI - His MRI shows edema in the L posterior temporal/parietal lobe. Will get MRI brain w/ contrast. Given abnormality on MRI and elevated WBC count, which could just be from seizure, LP was done. Only 1 WBC. Headache - Had 3 days of headache, generally not feeling well, and body aches after receiving Shingles and flu vaccines on same day a little over a week ago, but then he was feeling better before headache returned.  HA on the L side. Only 3/10 currently.
Information has been received from a registered medical assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date in 2015, the patients were vaccinated with improperly stored VAQTA (dose, strength and route were not reported, lot# K008333). The temperature was possible out of range by 2 degrees to 3 degrees for short periods of time over a couple of days in April 2015. No adverse events were reported. This case is one of several cases received from the same source. Additional information has been requested. This case was initially received on 28-MAY-2015 and reported in 1506USA000576, 1506USA000576 has been deleted upon the follow up information received on 01-JUL-2015, in which the medical assistant stated no incorrect product storage happened. Now, case was re-created due to new follow up information was received from the medical assistant on 13-AUG-2015 and incorrect product storage was confirmed.
30 year old patient was administered Infanrix instead of Boostrix; Inappropriate age at vaccine Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 30-year-old female patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 23-JUN-2023, the patient received Infanrix. On 23-JUN-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: 30 year old patient was administered Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine Administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUN-2023 The reporter declined to provide initials of patient.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal. The reporter stated that a 30-year old patient was administered Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Client  moved at the time of the vaccine and the vaccine was injected in the top of the bicep instead of the deltoid
61 y.o female reported "hives" in groin area extending to lower extremity 2 days following injection. Later that day 11/4 noticed 1-2 on wrist / anticubital area. No reported SOB. wheezing or localized reaction @ injection site. Tx antihistamine / hydrocortisone, of recurrent hives.
Patient had vomited right after vaccine was given. Mom stated this happens every time he gets a shot.
I have had lower left abdominal pressure with occasional pain that has not let up in 3 months. It's not debilitating but it is persistent. Occasionally it is accompanied by an ache or pain in my upper left abdomen just above my ribs. I saw a doctor in early February and the pain feels similar to ovulation pain but when it did not go away so I called my doctor. She sent me for further testing. I had a transvaginal Ultrasound which was inconclusive. My doctor did complete a urinalysis test for a UTI, and it was negative. Less than a week later I began having much more severe symptoms and it was determined that I had a UTI. I was prescribed an antibiotic. The medication temporarily lessoned the symptoms but did not make them go away. My physician recommended me schedule an appointment for a Transvaginal Ultrasound which had no findings. A short time later upper abdominal pressure began and would come and go. The provider indicated that she would prescribe something else but I have not been able to make contact to have the medication prescribed. My symptoms have not gotten better so I do plan to follow up with the provider.
no know adverse effects; via the intramuscular route in error; Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concomitant medication, current condition and medical history of the patient was unknown.  On 14-MAY-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA (recombinant Human albumin) (lot# N032749, expiration date 20-NOV-2019; strength and dose were unknown) diluted with sterile diluent (MERCK STERILE DILUENT) via intramuscular route in error for prophylaxis (incorrect route of product administration). No known adverse effects.
some of the Fluzone High-Dose leaked out  with no AE; she didnt see a crack and the needle tip was on tight but a fair amount of liquid leaked out and she wanted to know should she re-inject because she is not sure if the patient received all of the injection  with no AE; I felt a little (liquid) on my glove and I saw a little (liquid) on her arm with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who reported some of the fluzone high-dose leaked out, she didnt see a crack and the needle tip was on tight but a fair amount of liquid leaked out (Syringe issue) and she wanted to know should she re-inject because she is not sure if the patient received all of the injection (Underdose) and i felt a little (liquid) on my glove and i saw a little (liquid) on her arm (Exposure via skin contact), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot: UJ285AB, Expiry date: 02-Jun-2020) via unknown route used for prophylactic vaccination.  On an unknown date, (Unknown latency) at the administration of FLUBLOK HIGH DOSE VACCINE, patient reported that some of the fluzone high-dose leaked out, she did not see a crack and the needle tip was on tight but a fair amount of liquid leaked out (Syringe issue) and she wanted to know should she re-inject because she was not sure if the patient received all of the injection (Underdose) and i felt a little (liquid) on my glove and i saw a little (liquid) on her arm (Exposure via skin contact).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Events outcome was not applicable.  At the time of the report, no adverse event was reported.   No further information was reported.
Moderate swelling and redness (approx 1/3 thigh) surrounding injection site on right thigh. Advised mother to monitor pt for worsening symptoms. Benadryl as needed and cold compresses for pain/discomfort.
A non-serious spontaneous report of administration to a pregnant woman was received from a health professional concerning a 31-year-old female. Neither relevant medical history, obstetrical history nor concomitant medications have been reported for this patient. On 16-Jan-2012, FLUMIST was administered to the pregnancy patient. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
This case was reported by a consumer and described the occurrence of exacerbation of insomnia in a 28-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), HAVRIX. A physician or other health care professional has not verified this report. The subject's medical history included insomnia. Previous and/or concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown arm given on 30 October 2006. Concurrent medications included Unknown. On 30 October 2006, 30 November 2006 and 30 April 2007 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (unknown, unknown arm). On 30 April 2007 the subject received 2nd dose of Havrix (unknown, unknown arm). In May or June 2007, at an unspecified time after vaccination with Engerix B and Havrix, the subject experienced exacerbation of insomnia. On 30 October 2006 and 30 November 2006 after vaccination with Engerix B, the subject experienced injection hurt going in.  On 30 April 2007, after vaccination with Engerix B, the subject experienced injection hurt going in and injection site hemorrhage. The subject reported she has history of insomnia for years and reported that after her last dose of Havrix and Engerix B vaccines, she experienced a worsening of her insomnia. She did not know the brand names of the hepatitis A and hepatitis B vaccines, but when she consulted the Department of Health regarding this event, they referred her to GSK for information, thus she assumes they were GSK brands. She was vaccinated for prevention since her family member has a liver transplant due to hepatitis B virus. She noticed a worsening of her insomnia in either May or June 2007, a after her last doses of Havrix or Engerix B vaccines that were given 30 April 2007. She has seen her doctor for medication for her insomnia but she has not discussed with her doctor that the worsening of insomnia might be due to the vaccines. She only recently began to suspect the vaccines. Subject stated the worsening of insomnia has been disabling since cannot work but it has not been physically disabling. She has not been hospitalized for treatment. The subject also reported events with Engerix B, of injections hurt, especially the last dose, with the last dose, blood spurted out of the injection site. She thought this was due to the nurse being distracted as they were discussing politics at the time of the injection. The blood spurted out was just treated by covering the injection with a bandage. Both these events has resolved on unknown dates. At the time of reporting the outcome of exacerbation of insomnia was unresolved; injection hurt going in and injection site hemorrhage resolved on an unknown date.