chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after excursion; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in an 87-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, 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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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 (Patient administered doses of the vaccine after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event.  No treatment medications were provided.
Symptom: Nausea, dizziness, numbness in hands. Sign: syncope, dreaming, twitching/jerking, hypotension, hypoglycemia (BG 43). Syncope lasted for about 1 minute.
Information has been received from a registered nurse concerning a 14 month old patient who on 01/12/01 was vaccinated with MMRII.  Concomitant therapy included amoxicillin (dose, duration and indication not reported) which was being taken for the first time.  On 01/12/01, the patient developed cold symptoms.  On 01/16/01, the patient developed a rash which started on the buttocks and spread to the back and then covered most of the body.  Amoxicillin was discontinued when the patient developed the rash. On 01/24/01, the patient still had the rash and went to the emergency room with the rash and a fever. On 01/25/01, the patient was given diphenhydramine (Benadryl) which did not help to relieve the rash.  On 01/26/01, the patient went back to the emergency room with the rash and IGM was 640.  The nurse noted that as per the lab, anything over 10 would be positive for measles.  The nurse also noted that there were two other confirmed measles cases in their area and she was not sure if the patient had contact with the other two cases.  No further details were provided.   Additional information has been requested.
Improper storage of product in use; Called to provide patient information (Administered improperly stored vaccine); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)) and PRODUCT STORAGE ERROR (Improper storage of product in use) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Improper storage of product in use). On 08-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Improper storage of product in use) outcome was unknown.        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.   No concomitant medications was provided by the reporter. The vial was moved from the freezer to the refrigerator on 09-Jul-2021. The vials were first punctured on 11-Jul-2021. The vial was left in the refrigerator and on 08-Aug-2021 patient was given doses from the expired vial.  No treatment was provided by the reporter.   This case was linked to MOD21-128181, MOD21-128210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up information include an extra event was added as per MSA comment On 09-Aug-2021: Follow-up information include no new information
Shortly after receiving the vaccine the patient started shaking and was lightheaded. Paramedics came and while they were attending to him he began vomiting. After observing the patient for a while paramedics allowed him to leave the store with his family.
Exposed to varicella 2 weeks ago. Broke out in rash on trunk, arms, legs and face. There were about 25 to 30 lesions. Was given Benpadryl and Calamine lotion for itching.
Approx. hour after injection started with a nagging headache for over a week, chills, muscle aches, joint pains, fatigue, tireness, and nausea all lasting for over a week.  On 1/16/2021 vomited all day - no stomach cramps or any other indication of that being a "stomach virus".  Continued nauseated feeling resulted in cancelling a dental appt on Tuesday after injection.
Around 3am on 6/22/12 patient woke up acting normally. About 10 minutes later she had sudden loss of consciousness with pallor and shallow respirations. This lasted approximately 20min. She slowly became more alert and returned to baseline within 2 hours. Parents called 911 and she was evaluated in the ER.
pt reports never so sick in my life 11 days p/receiving flu vax;nausea, vomiting, dizziness, too weak to get out of bed for 1 day;did not go to any health care provider recovered over next 4 days
Patient felt sick with feverish chills, body aches. Large swollen, red mark extending down upper arm.
Injection site is hot to the touch; injection site reddish with a 2 inch circle; injection site itchy; pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache), VACCINATION SITE WARMTH (Injection site is hot to the touch), VACCINATION SITE ERYTHEMA (injection site reddish with a 2 inch circle) and VACCINATION SITE PRURITUS (injection site itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Headache. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FENOFIBRATE, METOPROLOL, CLONIDINE and PAROXETINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and HEADACHE (Headache). On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hot to the touch), VACCINATION SITE ERYTHEMA (injection site reddish with a 2 inch circle) and VACCINATION SITE PRURITUS (injection site itchy). At the time of the report, PAIN IN EXTREMITY (pain in arm) had resolved and HEADACHE (Headache), VACCINATION SITE WARMTH (Injection site is hot to the touch), VACCINATION SITE ERYTHEMA (injection site reddish with a 2 inch circle) and VACCINATION SITE PRURITUS (injection site itchy) had not 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.   No treatment medication was provided by Reporter
Dose 1: slight nausea for 24hrs Dose 2: slight stomach upset/heartburn/tired Dose 3: intense hives and itching began 10 days after shot. Hives and dermatographia continue to occur multiple times daily/still have not resolved. intense esophageal pain and stomach pain believed to be heart burn or indigestion occurred on days 2-4/5.
This case was forwarded by Crucell An initial report was received from a nurse on 01.Mar.2012 and concerns a patient of unspecified age and gender who, on 26.Feb.2012, received the fourth capsule of VIVOTIF (batch no: not reported). The patient's medical history and any concomitant medications were not reported. On an unspecified date, about 48 hours following the last oral typhoid administration, the patient experienced "orange leaking from the anus". No further information was available. At the time of reporting the patient had recovered. The event was considered non-serious.
Facial tingling on lips and around mouth on day 7.  Tingling continues to current day (post 19) and a fever blister appeared on my lip this morning.
6-8 hours after vaccination - had 3-5" generalized lesions with fever 103 degrees.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA Lot #: L018499, expiration date: 25-FEB-2017, Lot #: M017982, expiration date: 13-SEP-2017, Lot #: M022924, expiration date: 24-JAN-2018 and Lot #: L031196, expiration date: 05-FEB-2017, which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 09-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 09-Apr-2022) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and administrated on 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
Within 2 days of vaccine developed recurrent tumor in the left axilla on the same side as the vaccine; This is a spontaneous report from a contactable physician. A 79-year-old male patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date were unknown), via intramuscular, administered in Arm Left on 14Jan2021 12:00 (age at vaccination 79-year-old)  as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included primary cutaneous anaplastic large-cell lymphoma from an unknown date and unknown if ongoing. Patient had no disease for 2-3 years. The patient's concomitant medications were not reported. On 16Jan2021 the patient experienced within 2 days of vaccine developed recurrent tumor in the left axilla on the same side as the vaccine.  This has persisted for nearly 28 days after vaccine. Therapeutic measures were taken as a result of within 2 days of vaccine developed recurrent tumor in the left axilla on the same side as the vaccine. It was unknown if the patient was diagnosed with COVID or if the patient was tested for COVID. The outcome of event was not recovered/not resolved.   Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Case number PHEH2015US021213, is an initial spontaneous report received from a health care professional on 19 Oct 2015. This report refers to a 9 year old female patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) intramuscularly at a dose of 0.5 ml on 15 Oct 2015. The case was reported as non-serious. No adverse event was reported following this maladministration.
Vaccine placed in refrigerator on 22-Sep-2021 and administered on 03-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 22-Sep-2021 and administered on 03-Nov-2021) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 22-Sep-2021 and administered on 03-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 22-Sep-2021 and administered on 03-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Date of placed in refrigerator was on 22-Sep-2021. Vaccine did not undergone any temperature excursion. No  adverse events were reported for patient.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-504630 (Patient Link).
Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving DTaP vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 5-year-old male patient had received an injection of DTaP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and 10 minutes later, he developed anaphylaxis with symptoms of repetitive cough, sneezing and rhinorrhea. Corrective treatments consisted of Albuterol and diphenhydramine. The patient had a history of asthma, and milk allergy demonstrated by hives, lip angioedema, wheezing at three years of age after eating turkey with milk contamination. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03276, -03277, -03278, -03279, -03280 and -03281. Documents held by sender: None.
Allergic to the flu shot; This spontaneous case was received on 02-Mar-2021 from other non-health professional (consumer's daughter) via company (reference number: NUS2021US032466) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.  On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed allergy to the flu shot, reported as patient's daughter was even allergic to the flu shot and her mother was the same way (refer to the case 202101643).  The outcome of the event was not reported.  The reporter assessed the event of 'allergy to vaccine' as related to influenza virus vaccine polyvalent. Reporter stated that she's even allergic to the flu shot and ''my mother is the same way''.  The case was assessed as non-serious.  This case is linked with case 202101643 (due to the same reporter).  Company comment: The event of 'allergy to vaccine' is considered as unassessable to influenza virus vaccine polyvalent.; Reporter's Comments: Reporter stated that she's even allergic to the flu shot and ''my mother is the same way''.; Sender's Comments: The event of 'allergy to vaccine' is considered as unassessable to influenza virus vaccine polyvalent.
Received the flu shot. Stated that she was fine. Left area and fainted about 10 minutes later. Has had a history of fainting when given a shot (never had flu shot before). Paramedics arrived and verified that the patient was ok. She had regained consciousness shortly after fainting. No treatment given.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored Oral, ROTATEQ lot # K019370, expiry date 16-JUL-2016 and K009900, expiry date 04-MAY-2016. No adverse effects reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Her account of what happened: ?I HAD MY COVID VACCINAE AT APPROXIMATELY 3:50 P.M. AND SHOFTLY AFTER THE VACCINE I STARTED TO FEEL HOT AND THOUGHT I WAS GOING TO PASS OUT, SO I ASKED IF THERE WAS SOMEWHERE I COULD LAY DOWN, I WA GIVEN SOME WATER AND A SNACK IF NEEDED. THE NURSES CHECKED MY BP AND IT WAS ELEVATED 150/100. I THEN DEVELOPED CHEST HEAVINESS AND THEN BP WENT HIGHTER. CHEST HEAVINESS SUBSIDED BUT THEN DEVELOPED A HEADACHE, BP CHECKED AGAIN AND WAS UP TO 160ISH/100, I ASKED FOR SOME TYLENOL AND TOOK 650 MG, I WAS OFFERED BENADRYL AND DECLINED. THE THE BACK OF MY THROAT STARTED TO FEEL STRANGE AND I COULD NOT MAKE A SWALLOW SENSATION UNLESS I TOOK A DRINK OF WATER. I THEN ASKED FOR THE BENADRYL AND TOOK IT. MY BP WAS THEN UP TO 180ISH/112 AND I THEN STARTED TO FEEL COLD AND HAD CHILLS. AT THE TIME AN ACT WAS CALLED AND I WAS TAKEN TO THE ER AND PLACED IN TRIAGE THEN THE WAITING ROOM. THEN WAS FINALLY TAKEN BACK TO THE ER AND WAS GIVEN IVF'S, IV BENADRYL,PEPCID AND PREDNISONE WITH RESOLUTION OF SYMPTOMS AND DISCHARGED HOME WITH 2 DAYS OF STEROIDS AND PEPCI, BENADRYL. HIGH BP CHILLS CHEST HEAVINESS HARD TO SWALLOW HOARSENESS?
Fever, difficulty breathing, dizziness, weakness. High blood pressure-155/86, fast heart beat-pulse 98. Flusing of the face. I took a Zyrtec (antihistamine) and after 1/2 hour I started to feel better.
Immediately after the first injection, my left ankle swelled and was painful. Swelling lasted for four to five days, pain lasted over one week longer. Only possible remnant of the problem is a painful knot near the Achilles tendon.  The knot shows no sign of diminishing.  Second injection scheduled for June 1, 2021.
She had vaccine on 1/19 and started with diarrhea, fatigue, body aches, severe headache on 1/20 or so These lasted a few days Then on 1/24, her R arm felt itchy.  Over the next few days, redness and mild swelling
Local reaction at injection site of influenza vaccine immediately. Given in left arm. Red and hot. As day went on, site became swollen. By 8 pm, site was 2x normal size. 6 am on 10/14/2015, woke up with pain in left axilla. Found this site was swollen to 2x the normal size. The is pain in axilla. By 7 pm on 10/14/2015, lymph nodes in left supravicular area are swollen also.
18 hours later, very tender injection sites, redness, and low to mid grade fever. 101.5/102. Extreme fussiness. TYLENOL worked extremely well. Just thought I'd report the fever in case the data helps.
Pt waited the 20 minutes and when she came back, there was a 1 1/2" x 1/2" raised welt/hive. She said it did not itch. The welt was red.
eyes are swollen; This is a spontaneous report from a contactable health care professional (patient's son). A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 25Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient has no trouble breathing but his eyes are swollen on an unknown date in Feb2021. The reporter wanted to know if this could be an allergic reaction and what medication the patient can take for it. The outcome of the event was unknown.   The lot number for BNT161B2, was not provided and will be requested during follow up.
4/1/21:  began at 12pm: severe headache at base of skull. strong low back pain. began at 1pm: chilled feeling and shivering. stopped 3pm. began at 3pm: low temperature (97.2) then by 4pm fever of 100.2.   began at 4pm: very strong shaking. stopped 5pm began at 3pm: nausea, vomiting, dry heaves.  stopped at 7pm began at 5pm: extreme dizziness with ringing in ears. stopped 6pm began at 9pm: mixture of strong, odd smells and lack of taste for food or drink. stopped 9:30pm 4/2/21: headache, low back pain, lower fever (99.8) all day 4/3/21 strong fatigue upon waking. normal temperature. headache and low back pain still present, but not as strong
Patient reported fainting while working, probably due to vaccine because he's not aware that anything else could have caused it. He was in the store manager's office when I was paged to come. He didn't report other symptoms.
Large red itchy spot on site of injection. Applied BENADRYL cream to area. Presently still visible and red.
Small pin holes of about 40 in left arm and 8 in right arm.  Small blood spots dried but seem to be healing.