chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported.; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse referring to an female child.Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 18-APR-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R026548, and expiration date  17-SEP-2020 strength, dose detail and route were not provided) for prophylaxis (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX)was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 7.64 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 1 hour. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008214:
devel pos vax abscess 1 wk p/vax parent noted a pustule over site w/subsequent purulent discharge; no fever, otherwise doing well; rx'd Duricef; wound culture neg;
G47.36 SLEEP RELATED HYPOVENTILATION OR HYPOXEMIA 4/17/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/26/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXIA 4/14/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Myalgia, Fever, chills, fatigue, diaphoresis, left axillary pain, red spot on dorsal surface of toe Narrative:
This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 26-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
upper lip began swollen 24 hrs p/HBC; pt given DPH & swelling dec;
Patient received vaccine on 11-17-16. She called pharmacy to report as rash dark red about size of 2 quarters. She was using hydrocortisone cream on it for itching. No other problems.
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, the  MOB 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.
complaint of palms of both hands turning red, her right palm started itching, left palm started tingling. patient given Benadryl 50 mg PO x once. Redness reduced; itching and mild tingling of hands persisted.
every time she drinks something it makes her stomach turn.; can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently; wakes up in cold sweats at night; she became "queasy",; the chills like a burning cold sensation inside of her body; nausea; fever; headache; pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in right arm), FEEDING DISORDER (can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently), COLD SWEAT (wakes up in cold sweats at night), NAUSEA (she became "queasy",) and CHILLS (the chills like a burning cold sensation inside of her body) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine on 16-Mar-2021 and Pfizer COVID-19 vaccine on 07-Apr-2021.    On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (pain in right arm), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache). On 21-Aug-2021, the patient experienced FEEDING DISORDER (can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently), COLD SWEAT (wakes up in cold sweats at night), NAUSEA (she became "queasy",) and CHILLS (the chills like a burning cold sensation inside of her body). On 24-Aug-2021, the patient experienced VOMITING (every time she drinks something it makes her stomach turn.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 18-Aug-2021, PAIN IN EXTREMITY (pain in right arm), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache) had resolved. At the time of the report, FEEDING DISORDER (can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently) and COLD SWEAT (wakes up in cold sweats at night) outcome was unknown and NAUSEA (she became "queasy",), CHILLS (the chills like a burning cold sensation inside of her body) and VOMITING (every time she drinks something it makes her stomach turn.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 22-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.         The patient was not taking any concomitant medications.  Patient stated that the doctor ordered some tests for her, but the results were not come back yet and mentioned her doctor thought the events could be associated with a stomach bug but was unsure.
ARM AND SHOULDER PAIN; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm and shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm and shoulder pain. This report was non-serious.
Information has been received from a physician concerning a female patient, who about a month ago (approximately June 2004) was vaccinated with a dose of varicella virus vaccine live. The physician reported that the patient plans to conceive a child in the near future. The physician had blood work drawn to see whether she had developed chicken pox immunity. The lab results showed that the antibody detection was low and therefore the patient would not be protected if exposed to chicken pox. However, it was noted that there was a disclaimer on the laboratory result sheet which stated that the test may not detect vaccine acquired antibody levels, just natural exposure immunity. The physician noted that the patient did not receive the vaccine at their office so he did not have a lot number. There was no further information provided regarding the adverse event. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
t104 R 12JAN97;welts noted by mom under arm 10AM;gradually covered body-seen in ER 12JAN97 3PM;dx viral exanthem versus varicella;one area welts still visible;episode of shaking, blank stare, biting of lip;EMS called;ear red;
1/6/17 spoke with patient. Informed of fever, redness, warmth at site. Arm sore. Encouraged ice packs, MOTRIN, and to see MD. 1/19/17 spoke with patient. Saw MD treated for cellulitis, BACTRIM X 10 days. Condition has improved.
Patient was dehydrated and did not eat the whole day before getting her vaccine. she felt dizzy and about to faint after.  gave her a bottle of orange juice to drink, called the ambulance and they took her to the hospital.
Pt contacted pharmacy 2 days post vaccine complaining of redness and pain in left arm near vaccine site that was increasing in size. She was encouraged to contact her primary the following morning to be seen to rule out a cellulitis requiring treatment (or any other potential issue). She followed up later that following date stating she had seen her provider who had given her an Rx for amoxicillin to start in a few days if symptoms did not start to improve. Pt states she refused in-office steroid injection. She followed up with pharmacy the following day, which was day 5 after receiving the vaccine to say she had seen another provider (which sounds like it may have been a teledoc appt) who was fine w/ the pt starting the antibiotic they already had and gave no further treatment protocol. Pt was not happy with this the last time we talked (on day 5) and states that she will be following up with another provider.
redness and swelling at injection site,  large lump on arm at injection site,  burning sensation down arm 6 days post vaccination. Still not feeling 100% myself 6 days after vaccination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 05Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient did not receive any other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
rash day of vax 31DEC-in after hr clinic 4JAN T100.4 mom states temp 99-105, rash head to toe 6JAN98;4JAN97 TC negative, ears nl;
1 of 3 pt's who exp swelling, erythema, & pain @ inject site beginning w/in 24 hrs post vax & ending p/ 2 wks; tx APAP & ice packs;
Received only the lyophilized powder portion of shingrix after being reconstituted with normal saline; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 25-year-old female patient who received Herpes zoster (Shingrix) (batch number 259GZ, expiry date 15-MAY-2025) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Received only the lyophilized powder portion of shingrix after being reconstituted with normal saline).  The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter reported that a patient that was immunocompromised received only the lyophilized powder portion of shingrix after being reconstituted with normal saline. No reactions were reported.  The reporter consented to follow up. The patient received only the lyophilized powder portion of shingrix after being reconstituted with normal saline, which led to wrong solution used in drug reconstitution.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O16M20A and O12L20AOA) for COVID-19 vaccination.     No medical history reported by the patient.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), WARFARIN SODIUM (COUMADIN) and POTASSIUM for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Other) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 18-Feb-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: +20 (Inconclusive) Inconclusive.         No treatment information was provided.    This case was linked to INC.-MOD-2021-117907 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-117907:
Patient felt minor pain the day of the vaccination. The next day, the patient noticed fever and chills and more severe pain. The patient noted muscle pain as well as neck pain. The patient also noted difficulty breathing on the day after administration, causing her to use her inhalers more frequently. The patient went in to see her primary care physician and was examined. Four days after vaccine administration, the patient still reports general malaise, but no specific side effects like described above.
Itching - severe for 3 days then lighter for each day thereafter - intensifies in the evening.
Information was received on 10-APR-2017 from a medical assistant who was reporting on a female patient of unknown age. No medical history or concomitant medications were reported. The medical assistant reported that on an unknown date, the patient received a dose of VARIVAX (lot M028553, expires 06-JUN-2018) (dose and site not reported) that had gone through a temperature excursion. Diluent lot number was either M044953, expires 27-FEB-2019 or lot M017324, expires 25-SEP-2018 (medical assistant was unsure of which lot of diluent was used). The vaccine was stored between 6 degrees F and 14 degrees F for 5 hours and 47 minutes. No adverse effects were reported. Additional information has been requested.
I have had 3 mild shingles episodes/Suspected Vaccination Failure; I have had 3 mild shingles episodes; rash on right cheek; lower part of the butt and had 10-15 small blisters; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine (on an unknown date received first shingles vaccine that was available on the market on 2010). Concurrent medical conditions included heart disorder. Concomitant products included cardiovascular system drugs (Heart Medication) and aciclovir (Acyclovir).   On an unknown date, the patient received the 2nd dose of Shingrix (left arm) and the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: I have had 3 mild shingles episodes/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: I have had 3 mild shingles episodes), rash (Verbatim: rash on right cheek) and blister (Verbatim: lower part of the butt and had 10-15 small blisters). The outcome of the vaccination failure, shingles and rash were unknown and the outcome of the blister was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, rash and blister to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, rash and blister to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 07-NOV-2023 The patient was self-reported.  Patient reported he had a heart condition and takes medications for this condition and, he had other medical conditions, and he takes medications for these conditions as well. Patient reported he did take medications that affect his immune system, and he was given Acyclovir topical ointment. Patient reported that he got the 1st dose of Shingrix vaccine sometime during the year the vaccine came out, in 2017 and he got the 2nd dose of Shingrix on late 2017 or early 2018, he got both doses at a local pharmacy.  Patient reported since then he had 3 mild shingles episodes.  Patient reported that on all 3 cases he had the rash located at the same spot and all episodes were identical because they were located at the same spot, and it was the size of a half a dollar coin.  The rash was located at the right cheek, on the lower part of the butt and had 10-15 small blisters. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter did not consent to follow-up.
This spontaneous report as received from a consumer refers to his grandmother of unknown age. On an unknown date the patient may have vaccinated with a second dose of PNEUMOVAX 23 (lot#, expiration date, route and dose were unknown) because she was unsure if she ever received the first dose. No adverse effects was reported. Additional information has been requested.
Severe headaches, trouble with concentrating, and shaking, redness, temperature dropped to 94 on 2nd day, went up to 95 on 3rd, and has continued to be 96.
Could not speak; Headache; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (Could not speak), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced APHASIA (Could not speak), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, APHASIA (Could not speak), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.
Patient received MMR, Varicella, Hepatitis A and PREVNAR 13 on 29 November 2010 around noon at the Immunizations Department. On 30 November 2010, patient had runny nose, cough, and a fever of 102.5 F. Parents took child to Emergency Department. Patient had 103 F fever when he had a febrile seizure in the ER per parent around 8:20pm. Child was treated in ER and released home with recommendations to use TYLENOL and MOTRIN for fever management. On 1 December 2010, patient followed up with Dr at the Clinic. Patient was evaluated, parents counseled on dehydration and fever management, and provided with TYLENOL and MOTRIN. On 2 December 2010, parents took child to Emergency Department because child appeared ill and continued with fevers. In the ED the child had a fever of 102.9 F, had 6 breathing treatments without improvement, had + RSV lab work and pneumonia on the right lower lobe. Patient was admitted, treated for 4 days, and discharged on 6 December 2010 with Albuterol and Amoxicillin. Patient to follow-up with Clinic on the 8th and 15th December 2010 for pneumonia and RSV.