chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; one patient was administered improperly stored PROQUAD; This spontaneous report was received from an unspecified administrator and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 30-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R030798 and expiration date: 22-APR-2019 (exact dose, frequency and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported.  The vaccine was stored in between 6 degrees Fahrenheit (F) and 14 F for 420 and in between 15 F to 46 F for 106 hours. There were previous temperature excursions: in between 6 F to 14 F for 200 hours and in between 15 F to 46 F for 18. The improper storage was recorded by Digital Data Logger.; Sender's Comments:  US-009507513-1911USA000877:
was exposed to temperatures outside the refrigerator and administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was 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 were received as follows: It was reported that Flulaval QIV was exposed to temperatures outside the refrigerator for 7days. It was stored in the refrigerator afterwards for 1 month and then administered to the patient, which led to incorrect storage of drug. No reactions reported. The reporter consented to follow up via email.
I started to feel exhausted, fatigue and a fever of 99 then rose to 100. By the third day I had real bad diarrhea. About a week into feeling these symptoms I started a Z-pac. I loss my appetite and nauseated from eating for about 2 weeks.
Mom noticed dime size knot to LL at imm site became larger after several hr swelling and redness noted today (approx 40 mm) Child was assessed at well child visit by MD 10/8/04 with inst cont monitor. Mom denies fever, diff breathing or behavior
Pt reports large reddened, swollen area about 1.5" below Td injection site which appeared 1 day after after injections. She was seen by her primary physician who ordered oral antihistamines.
Within the first 5 minutes dizziness. Did not last. approximately 15 second. My head felt foggy from that point forward for 3 days. (March 10 - March 13, 2021) On Saturday 13Mar2021 I slept from 130pm-1030 pm, I awoke used the restroom, drank some water then slept from 1100pm - 0730 (Sunday, 14Mar2021)   Ever since, I have had problems with my left arm/shoulder muscle, and the injection site has been itching. It hurts to make circles with arm, or to move it in different ways. This also affects lifting items.
Itchy swollen area at injection site that occurred 8-9 days after shot  Started itching then grew red and swollen resolves in 4 -5 days
I had my vaccination on 10/03/2022. On 03/09/2023 I started to have a severe headache and nasal congestion. I tested COVID-19 Positive on 03/10/2023 and I contacted my physician. I was prescribed Paxlovid. I did get COVID-19 rebound but the Paxlovid worked well. I feel good on 04/06/2023.
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant product use was not provided by the reporter.  On 10-Jun-2023, the vial was initially thawed.  On 14-Jun-2023, the vial was administered.  Treatment information was not provided.  This case contains information for the 11th patient out of 30 patients described by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up information received included Suspect details and narrative was updated.
Per patient via phone call on 6/1/21: Woke on Sunday,  5/23/21 with high fever, sweats and swollen veins on hands. Went to ED on 5/25/21. At that time, he thought he had an infection "eating him away from the inside". Now he believes, after thinking about it, that it must be a reaction to the COVID vaccine he received on 5/21/21.  He stated that he still has weak, cramping hands and swollen veins in his hands.
Very high fever of 104.6 and radiating purple and red circles around each entry point.
c/o rash/hives on face about 30 min post vaccination. No respiratory distress. c/o mild itching. Rash decreased by the time patient returned to the clinic. On exam, mild macular erythema upper nose/between eyes/brows area and left upper eyelid. Mild erythema around R temple area.   Patient given Benadryl and observed for 20 min.  Rash/hives resolved. Pt discharged home.
Day after vaccination pt reported bodyaches, malaise, mild respiratory symptoms. By 10/25 had blurred vision, urinary retention, then collapsed and required intubation. Became comatose. subsequent evaluation showed evidence of ADEM syndrome, with MOG antibodies. Pt currently in long-term rehab, some improvement but still on vent, little neuromuscular function
Pt recvd vax & devel diptheria & was hospitalized for a prolonged period of time;
This spontaneous report as received from an other health professional refers to a 12 month old patient. On 09-JUL-2014 the patient was vaccinated with M-M-R II (HSA, lot # J015503, Exp 05-DEC-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
"a little pain on the arm"; arm "a little bit swollen"; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN ("a little pain on the arm") and VACCINATION SITE SWELLING (arm "a little bit swollen") in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN ("a little pain on the arm") and VACCINATION SITE SWELLING (arm "a little bit swollen"). On 12-Mar-2021, VACCINATION SITE PAIN ("a little pain on the arm") and VACCINATION SITE SWELLING (arm "a little bit swollen") 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 were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-260254 (Patient Link).
Sleeping with parents, parents noticed shaking, noticed that something was wrong. Had seizure-like activity lasted about 20 minutes. Taken to hospital by ambulance.
About 15 minutes after the flu shot, complaint of discomfort her face and ear are tender. Having problems breathing. Epi-pen 0.3 mg IM were given in left arm. Ambulance was on the way. She later transported to ER. Blood pressure was low. After being stabilized in hospital, she was discharged with treatment of Prednisone 20mg onece daily for 2 days. Information from er summary states tachycardia, hypertension. msv
I went to get the flu shot which I faithfully have taken every yr. for the last 10-12 yrs. I have never suffered a reaction before, however this yr. I had every problem that could possibly happen. I had fatigue, muscle pain, sore throat, respiratory illness, cough and general malaise. These were so extreme, that it caused me to miss work. Today, 10 days later, I am finally felling myself. This happened to 4 of my friends as well, as we were advised to take the high-dose. I volunteered at a concert, only to hear many people coughing, and they all apologized saying they contracted this right after this high-dose shot.
localized reaction at the injection site, 23cm x 29cm; itching and extending towords elbow; 5cm, typical local redness at the site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION (localized reaction at the injection site, 23cm x 29cm), VACCINATION SITE PRURITUS (itching and extending towords elbow) and INJECTION SITE ERYTHEMA (5cm, typical local redness at the site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching and extending towords elbow) and INJECTION SITE ERYTHEMA (5cm, typical local redness at the site). On an unknown date, the patient experienced INJECTION SITE REACTION (localized reaction at the injection site, 23cm x 29cm). The patient was treated with DOXYCYCLINE HYDROCHLORIDE (DOXY [DOXYCYCLINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency; PREDNISOLONE for Itching, at a dose of 5 milligram three times a day; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Scratch and Local reaction, at a dose of UNK, qd and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Local reaction and Scratch, at an unspecified dose and frequency. At the time of the report, INJECTION SITE REACTION (localized reaction at the injection site, 23cm x 29cm), VACCINATION SITE PRURITUS (itching and extending towords elbow) and INJECTION SITE ERYTHEMA (5cm, typical local redness at the site) had not resolved. Not Provided      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 medication provided
feet were inflamed.  not treated.  Got better after three days.  Also hand were inflamed. for one day
Sore arm; Fatigue; A spontaneous report was received from a (Consumer) concerning an unknown age, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and fatigue. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 41L20A) unknown route and site for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced sore arm and fatigue. Laboratory details not provided. No treatment details were reported. Action taken with mRNA-1273 in response to the events was not reported.  At the time of the report, the outcome of the event was unknown.
Patient did not have an adverse reaction to the vaccine after administration. However when pharmacy finished the clinic for the day and started processing the shots, the patient insurance flagged it as too soon and upon review of patient profile, he got his first dose on 3/27/21 but patient mistakenly wrote that he got his first dose on 3/10/21 on his consent form therefore the second dose was administered much earlier than the recommended 4 weeks window. Because patient got his second dose earlier than the recommended  time frame, it is considered an adverse event to the vaccine and pharmacy felt the need to report it on VAERS.
Less then 1/2 hr after obtaining the shot I began having a severe headache & with in hour I had chills, nausea which turned into vomiting & diarrhea throughout the night and into the next day 11/6/09.
PATIENT EXPERIENCED REDNESS AND SWELLING FROM SHOULDER TO ELBOW, AREA WAS VERY SORE/TENDER AND PATIENT COMPLAINED THAT IT FELT WARM.
Woke up roughly 13 hours after injection with chills and low grade fever which lasted about 36 hours. Very dull, bad headache that lasted about 4 days.  Diarrhea, nausea and loss of appetite lasted  6 days. Brain fog for about a week, so far. I also noticed my skin tone and texture was off for about a week.
This spontaneous report as received from a pharmacist refers to a 79 year old female patient with no known allergies. Patient's medical history and concurrent conditions were not reported. On 10-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L000461, Expiry date: 08-MAR-2016), (dose was not reported), subcutaneous for prevention of shingles. Concomitant therapies included XALATAN, XANAX and MOBIC. Subsequently on an unknown date in July 2015, the patient experienced recurring calf pain. The patient sought medical attention by visiting the physician. On 15-JUL-2015 the patient started therapy with prednisone (formulation not reported) 40 mg daily for five days as a treatment for the calf pain. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
t104 R, refused to eat or drink; pt lay around w/very little activity; taken to ER 11PM; adm to hosp 3AM 7AUG91; mom states pt was limp, pale; t102 R;
big and itchy rash at the injection site (right arm); big and itchy rash at the injection site (right arm); a bit of pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (big and itchy rash at the injection site (right arm)), VACCINATION SITE RASH (big and itchy rash at the injection site (right arm)) and VACCINATION SITE PAIN (a bit of pains) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (big and itchy rash at the injection site (right arm)), VACCINATION SITE RASH (big and itchy rash at the injection site (right arm)) and VACCINATION SITE PAIN (a bit of pains). At the time of the report, VACCINATION SITE PRURITUS (big and itchy rash at the injection site (right arm)), VACCINATION SITE RASH (big and itchy rash at the injection site (right arm)) and VACCINATION SITE PAIN (a bit of pains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Event outcome updated.
Information has been received from a respiratory therapist, pediatrician, nurse and office assistant via pediatric medical records concerning a newborn male patient with no known drug allergies who was born on 04-MAY-2009 by C-section (WAES# 0908USA03124). It was reported that on August 2008, the mother was vaccinated with a dose of GARDASIL (lot not reported) while pregnant. According to the reporter, the patient was born with "3 holes in his heart". It was unknown if the patient and her baby sought medical attention. The respiratory therapist stated that her baby was "doing OK right now". Nurse did confirm patient had a caesarian delivery on 04-MAY-2009 and he was a healthy male child. On 07-May-2009, a direct bilirubin test was performed with results of 0.23. Also on this day a blood urea nitrogen was performed with results of 7 and a total bilirubin was performed with results of 8.39. On 08-MAY-2009, a total bilirubin (7.73), direct bilirubin (0.19) and indirect bilirubin (7.54) were performed. There was no concomitant medication reported. It was reported that on 11-May-2009 that the baby experienced jaundice. According to the office assistant who pulled the baby's chart it was reported that at the office they had a report verbal only, noted in the chart from the pediatric cardiologist. It was reported that the baby was seen on 17-May-2009 and had a septal defect. The reporter stated that the cardiologist was going to "give it time to see if it was self-correcting, and scheduled a follow-up evaluation for the baby in six months". At that day the physician's office did not have any follow-up evaluation from the cardiologist. The office assistant provided cardiologist information. On 29-May-2009, the patient had a well child visit with no complaints. On 02-June-2009, the baby was seen for loose stools and fussiness. On 10-JUL-2009, the patient had his 2 month well child visit. On 31-JUL-2009 the baby was seen for upper respiratory infection and cough, which resolved on approximately 14-AUG-2009. On 21-AUG-2009 the baby was seen for a questionable earache. At the time of the report the outcome of the baby's cardiac septal defect, diarrhea, earache, Hyperbilirubinemia, irritability and jaundice were unknown. Upon internal review, "3 holes in heart" was considered to be a congenital anomaly. Additional information has been requested.  All available medical records will be provided upon request.
bell's palsy; A spontaneous report was received from a consumer concerning her husband, a 59- years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bell's palsy (Facial Paralysis).   The patient's medical history included diabetes. Concomitant product use was not provided by the reporter.     On 10 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A)Intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed the event bell's palsy and was considered to be medically significant. No treatment information was not provided.    Action taken with mRNA-1273 in response to the event bell's palsy was not reported  The outcome of the event bell's palsy was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Vaccine booster administered on 11/12/2021, expiration date was 11/7/2021. Mistook expiration date to be 11/17/2021.  No adverse event or outcome to recipient.
Day of second shot, pt arm felt sore.  2 days later pt start feeling  flu like symptoms. 6 days after shot pt starting feeling numbness down right side. Had to go to ER and was informed he was having a stroke.
pt recv vax in PM 10DEC96-had OM & low T;had simple sz x 1 & T104.4 in ER:
Severe worsening of ringing in the ears Increased pain in joints and body Significantly Worsened fatigue Migraine  or daily headaches
Arm is swollen / only swollen in the upper portion of the arm, where he had the injection; This spontaneous case was received on 31-Aug-2023 from a other non-healthcare professional (consumer) via Communications (reference number: SEQW23-01955) and concerned a 82-year-old, male patient.  The patient's concurrent condition included pain. The patient's concomitant medication included ibuprofen, used for pain.  On 30-Aug-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, anatomical location: upper arm, route of administration: not reported) for immunization against influenza disease. The batch number reported was 370275 and expiry date: 02-May-2024.  On the same day, reported as six hours after receiving Fluad Quadrivalent, the patient had his arm swollen. It was only swollen in the upper portion of the arm where he had the injection. The patient could move the arm. The patient did not receive any treatment for the event.  At the time of initial reporting on 31-Aug-2023, the patient had not recovered from the event.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The event of swollen arm is assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The event of swollen arm is assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Seizure at approximately 03:30 am. TX includes being taken to hospital for evaluation.
4 months old patient receiving KINRIX instead of Pediarix; 4 months old patient receiving KINRIX; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th October 2020, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th October 2020, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, 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 details were provided as follows: The patient received dose of Kinrix at the age of 4 months instead of Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 6 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021159292:Same reporter US-GLAXOSMITHKLINE-US2021159295:Same reporter US-GLAXOSMITHKLINE-US2021254893:Same reporter US-GLAXOSMITHKLINE-US2021254941:Same reporter US-GLAXOSMITHKLINE-US2021260746:Same reporter
8 hrs after Tdap given, arm was sore. 36 hrs after injection, area below injection site was red & swollen - 2 inch x 3 inch area 1 inch below injection site. 6 days after injection, area below started itching.