chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported, no further information provided.; improperly stored; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 29-MAR-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (1 dose, lot # u026664 was evaluated and changed to the valid Lot #U026664, expiration date 24-FEB-2023 or lot# 1741817, expiration date 30-JUL-2022, oral, (exact dose number, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 dose, lot # u026217 was evaluated and changed to the valid lot # U026217, expiration date 02-NOV-2023 (exact dose number, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The nurse did not know which specific lot of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient. There were no additional adverse events reported or product quality complaint reported. Administered doses of vaccines experienced the temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There were no previous excursions reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001816: US-009507513-2204USA001821: US-009507513-2204USA001621:
W/in 12 hrs p/immun, experienced a high pitch cry, vomited once, fever of 101(R) & excess sleepiness. Seen in Peds office & was asymptomatic. No treatment initiated.
WITHIN 10 MIN OF VACCINE BEING GIVEN PT BROKE OUT IN HIVES ALL OVER BODY AND FACE. HE SAID THIS HAD ALSO HAPPEN WITH HIS 1ST SHOT BUT THIS TIME IT WAS QUICKER
Initial report received from a consumer on 07 Mar 2011: This patient was vaccinated with a dose of FLUVIRIN (batch number: 1116924P) on 29 Sep 2010. The patient was hospitalised on 27 Feb 2011 after a confirmed diagnosis of H1N1. The patient's condition progressed to pneumonia, and he was still in hospital. Final outcome of the events was not reported. A batch review has been requested for concerned FLUVIRIN batch under reference number 102701.
within 30 minutes patient complained of severe dizziness, nausea, chills, BP elevated to 144/94, 15 minutes later 138/97; 1 hour later 139/90
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  Concurrent medications included an unspecified inhaler used as needed.  In 2003, October 2005 and January 2006 the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (20 mg/ml).  In February 2007, approximately 13 months after vaccination with the 3rd dose of Hepatitis B vaccine, 16 months after the 2nd dose of Hepatitis B vaccine, and 4 years after the first dose of Hepatitis B vaccine, the subject had a negative result for sero-conversion (not responding to therapy).  At the time of reporting the event was unresolved.
Fussy w/episodes of screaming & crying lasting about 2hrs started 4AM day p/shot; Pt okay daytime  & had screaming episodes @ night, t105 x 3 days; On Pediaprophen q 6 hrs; Taken to MD found ear ok, Blood, Urine Culture negative;
All That you describe.  What are the risk of the PFIZER Vaccine.  injection site pain tiredness,  Severe headache, muscle pain, severe chills, slight fever, injection site swelling, nausea, pain in crest area and lung pain.  When taking deep breaths the lung issue would diminish.
I broke out a few days later with my right eye herpes zoster,  then a week later it hit my left eye. Red eye little bumps coming down eye into the face are.  It took 4 days to heal each eye. Using acyclovir pills and eye drops. I have not had this happen since I was a little girl, maybe 10 yrs of age.
Pt received Pfizer COVID Vaccine 3/9/21 at 13:25 At Clinic.  Lot #EN6205 Exp 6/21 to right deltoid.  No issues noted while patient dialyzing.  Pt came off treatment 16mns early due to concerns of transportation.  Pt a/o, VSS, pt in W/c no issues noted at discharge.  Pt's comorbid conditions per hospital discharge records: <20% EF, deteriorating health status, physician recommended hospice care but pt refused.  On March 11th, significant other notified facility that patient had passed away in his sleep and was found by workers at the rehab facility he was in.
pain in the arm/ Sore arm; Blood sugar was extremely high; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 11:30 (Lot number: FC3180) at the age of 72 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing), notes: Diagnosed about 15 years ago.; "Sciatica" (unspecified if ongoing), notes: Diagnosed about 5 years ago. The caller goes to the chiropractor. Concomitant medication(s) included: TRULICITY; PRADAXA; LISINOPRIL; DULOXETINE; CARVEDILOL; DIGOXIN; TRAMADOL taken for back pain; TYLENOL taken for headache. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Aug2021, outcome "unknown", described as "pain in the arm/ Sore arm"; BLOOD GLUCOSE INCREASED (non-serious) with onset 09Aug2021, outcome "unknown", described as "Blood sugar was extremely high". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Additional information: The caller had pain in the arm, like she was punched in the arm, like she did with the first one. The caller has type 2 diabetes and she gets her blood test every Monday and her blood sugar was 178. The caller's blood glucose was usually 122 and never over 125. Event: The sore arms lasted about a day. The caller later clarified and confirmed that she took her blood sugar this morning and she was always checking it on Wednesdays and took her Trulicity shot after it. The caller took Trulicity 1.5 mini open once a week and her blood sugar is always 122-133. Lot D389795, unknown, expiration date 12Jan2023. No AE(s) required a visit to emergency room or physician Office. Prior Vaccinations (within 4 weeks): No. AE(s) following prior vaccinations: None.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Pharmacist reported that on an unknown dates, multiple unspecified patients may have been administered ROTATEQ (dose, lot number and route were not reported), that went through an unsupported temperature excursion. Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1308USA011686 and 1308USA010000 via same reporter link. Additional information has been requested.
Pt. called on 12/9/10 stating she has experienced progressive symptoms of muscle weakness and soreness (back, neck and injection site), fatigue, headaches, dry mouth and flushing since she has received the influenza vaccine 2 months prior. Has not seen physician for symptoms as of 12/9/10.
According to mother had itching about 30-40 minutes after admin with hives on trunk and limbs, eye swelling. Patient stable with improvement of symptoms today, no concern for anaphylaxis or emergency services during follow up  visit.
"Covid Arm" - Pt's arm developed patchy, itchy rash after vaccination.
Information has been received from a Licensed Practical Nurse, for HPV vaccine, a Pregnancy Registry product, concerning a teenager female who on 16-AUG-2011 intramuscularly received the third dose of HPV vaccine (lot# unspecified). The nurse reported that the patient's mother just called the office to report the patient was approximately 3 weeks pregnant (positive pregnancy test, LMP approximately on 19-AUG-2011, EDD: approximately on 25-MAY-2012). The nurse reported this patient had not been seen in the office for years and was no longer a patient. They did not vaccinate her with HPV vaccine. It was unknown if the patient had sought any medical attention. Follow up information has been received. The health care professional did not have any information of this patient. Additional information is not expected.
Child woke up day after receiving vaccine, crying "it's hot" and digging at her arm. Instructed to take child to PMD. Took to walk in, was told the rash was an allergic reaction. Gave Benadryl and told to watch her breathing.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills Narrative:  Other Relevant History:
Patient received vaccine at approximately 3:00.  Patient c/o feeling light headed, nauseated and showed signs of being disoriented.  Patient was evaluated by EMS which were onsite to monitor individuals after being vaccinated.  EMS stated that the patients vitals were WNL but was going to transport patient to ER for further evaluation.  Patients status is unknow at present time.
experienced an injection site reaction; swollen arm; red arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 63-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 9e5ke, expiry date 30-JUN-2024) for prophylaxis.   On 06-OCT-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced injection site reaction (Verbatim: experienced an injection site reaction), swelling arm (Verbatim: swollen arm) and erythema of extremities (Verbatim: red arm). The outcome of the injection site reaction was not reported and the outcome of the swelling arm and erythema of extremities were resolved (duration 24 hrs).   It was unknown if the reporter considered the injection site reaction, swelling arm and erythema of extremities to be related to FluLaval Quadrivalent 2023-2024 season.     It was unknown if the company considered the injection site reaction, swelling arm and erythema of extremities to be related to FluLaval Quadrivalent 2023-2024 season.   Additional Information: GSK receipt date: 18-OCT-2023 The reporter was the health care professional (pharmacist). The patient received a dose of FLULAVAL and experienced an injection site reaction.  The patient had a swollen and red arm which last for 24 hours then resolved. The reporter consented to follow up.
Patient presented to ED for abdominal pain, nausea and vomiting. during CT of the abdomen and pelvis a finding suspicious for DVT in the left external iliac vein and left common femoral vein.  External venous  doppler  was done to confirm DVT. impression : Acute DVT throughout the left lower extremity extending from  the left lower calf to the left common femoral vein. Patient has been admitted to Medical floor for care
No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) 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 UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    Concomitant drugs were not reported. It was reported that patient received bivalent booster dose. It was reported that patient received Dose 1, Dose 2, 1st booster and 2nd booster of monovalent Moderna COVID-19 vaccines. Treatment medications were not provided. This case was reported for Patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-648802, US-MODERNATX, INC.-MOD-2022-648805, US-MODERNATX, INC.-MOD-2022-648807, US-MODERNATX, INC.-MOD-2022-648808, US-MODERNATX, INC.-MOD-2022-648809, US-MODERNATX, INC.-MOD-2022-648812 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648802:same reporter US-MODERNATX, INC.-MOD-2022-648805:same reporter US-MODERNATX, INC.-MOD-2022-648807:same reporter US-MODERNATX, INC.-MOD-2022-648808:same reporter US-MODERNATX, INC.-MOD-2022-648809:same reporter US-MODERNATX, INC.-MOD-2022-648812:same reporter
Fatigue Soreness in left arm; Fatigue Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 02Feb2021 at 06:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Feb2021, the patient experienced fatigue soreness in left arm. The patient did not receive any treatment for the events. The outcome of the events was recovering.
No adverse symptoms. Patient received PREVNAR 13 and PNEUMOVAX 23 at his Dr's office. When he came to the Pharmacy he stated that he never had a Pneumonia vaccine and was given and extra PREVNAR 13 vaccine, even though he didn't need it.
The primary symptoms are  rash and itching. The primary symptoms do not include shortness of breath, cough, abdominal pain, diarrhea, dizziness, palpitations, angioedema, urticaria, hives or throat swelling. The current episode started 13 to 24 hours ago. The problem has been gradually worsening.  The rash is associated with itching.  The onset of the reaction was associated with a new medication.
I tested positive for COVID-19 on 7/03/22. I had a stuffy nose, headache, body aches, and a scratchy throat. I went to the ER, and they did a COVID-19 test, and they called me a couple days later and let me know I tested positive. The headaches lasted for well over a month. I was prescribed some medications, but I am unable to recall the names.
Initial report was received on 13 November 2012 from a healthcare professional. This case was originally part of a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients) who tested PCR positive for influenza A/H3N2. The two adolescent patients were captured in case number 2012-05659 and the ten unidentified patients (previously reported as nine patients) were captured in case numbers 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072, 2012-06073. In addition this case was previously part of the six elderly patient's case 2012-05658. The other elderly patient cases have been captured in case numbers 2012-10691, 2012-10692, 2012-10694 and 2012-10695. A 73 year-old female patient had received on 11 October 2011 a dose of FLUZONE, lot number UH454AC (route and site of administration not reported). The patient participated in an influenza surveillance program. The patient's approximate treatment date and "collection date" was 29 February 2012. According to the reporter, the type of influenza was flu A and the subtype of influenza was H3N2. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Cough 24 hours prior to vaccine. Approx. 6 hours after vaccine, started with 102 fever & increasing redness & swelling at injection site. Seen in office 5/4 - redness extended entire (L) arm wrapping around to sides over to shoulder & to midline of chest . Treated with KEFLEX.
severe unconsolable crying for more than 3 hr on 1st day p/receiving vax; also had red swelling @ inj site of DTP 1st 24 hr;
Large red rash on injection site, swollen, warm to the touch, hardness, itchiness, discomfort/pain when moving arm or laying on it - all around the area of injection site - started on March 14  and has continued with the same effects listed though it has become more red since then- treatments I've tried are icing the area (throughout the day)and antihistamines (at night only) provides temporary relief but symptoms comeback
She's been having pain on her lower back area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "She's been having pain on her lower back area". Therapeutic measures were taken as a result of back pain.  Clinical course: Caller states she had her 1st Pfizer vaccine dose yesterday. Caller was told at the vaccination site to not take Ibuprofen and she could take acetaminophen in 7 days. She also takes a sleeping aid and Flexeril  for ongoing treatment. Are these ok to take. Patient already got the 1st shot and she was advised that she can only take Tylenol. She's been having pain on her lower back area. She was told to stay away from Ibuprofen and take only Tylenol. Caller wanted to know if she can take Lidocaine instead. She mentioned that she'll just take Tylenol since PMI is already closed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother falsified the patient's DOB in order to make patient eligible to receive Pfizer's Covid 19 vaccine. She provided the pharmacy with a fictitious DOB, when in reality the patients actual DOB is different, of which we verified via 2 independent resources; the patients insurance and primary care physician at.   We have made multiple attempts to reach patients mother to verify the true DOB, but have been unsuccessful.
I had just given the patient a Hep A injection and was putting on the band-aid when she said, "I think I'm going to pass out".  I started laying her back on the table and her eyes rolled back and head and arms started shaking in seizure like activity.  It last a  few seconds, then she popped up and said, "What happened?"  Her father was in the room at the time and held her.  Her B/P was 120/80; Pulse 64.  She was alert and oriented, color was good. The RN for our office came and looked at her and spoke with her father. She was not given Epinephrine due to the immediate vagal response to the shot given and the medication most likely had not circulated in her body yet.  Her father called their primary care office, and they told him to bring her up immediately which he did.  I asked him to follow up with me and he said he will.
A few months later after I was fully vaccinated I had a breakthrough of COVID-19. I started to have nausea, diarrhea and respiratory issues for a couple of days. I did a at home rapid test and it was negative and I went to the doctor on the 4th day and I tested positive for COVID-19. They sent me home the next day with a 5 day Paxlovid and I started to get better about seven days later but I am still facing some lingering symptoms.
A report has been received from a Health Professional concerning a 5 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that the patient was administered with the expired FLUMIST. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Moderna COVID-19 Vaccine EUA" Sx: Tenderness, Swelling, Erythema, elevated temperature at injection site (Right Deltoid). Swelling spread down right extremity to the hands/fingers.
Pt reported redness, rash and pain at injection site. She is reporting pain in left arm as of 11/27/18.
inadvertently given an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On 4th January 2022, the patient received Boostrix. On 4th January 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: On 4th January 2022, the patient was inadvertently given a dose of Boostrix vaccine which was already expired on 1st of October 2021.  The patient had not yet been redosed. The reporter gave consented to follow up.
Client developed redness, tenderness, swelling approximately 2-3 hours after administration of the Pneumovax and Fluviron vaccines. Is currently taking clindamycin to treat cellulitis.
Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case 26 year old patient who received vaccination with 0.5 ml expired dose of ADACEL (frequency once, batch number U5316AA, expiry date 30 Apr 2018) via intramuscular route in the left deltoid on 12 July 2018. It was a case of actual medication error due expired vaccine used. Patient had no treatment. It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.