chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Zia had the Meningococcal vaccine Nov. 14, 2005 about 4PM  She was fine all night.  She woke up on Nov 15 with excruciating headache, stomach ache, and could barely walk.  She threw up before we went to the doctor.  She had a temp of 97.9 On Nov 14 and when we returned to the Dr. OFfice on NOv 15, she was 99.8  They took a throat culture and it was negative.  She was crying due the pain and agony. SHe could barely sit up she was so tired.  We were told to go home and drink liquids, she was severly dehydrated.  When we left the office she threw up again in the parking lot.  We went back into the Dr. Office and we were sent to St. Clair Hospital.  ZIa was again diagnosed with severe dehydration and by now her temp was 101.8.  Zia was put on an IV and blood was taken.  ALl tests came back negative.
Pt recv vax on 5/5/99; on 5/6/99 pt exp hives &rash from head to knees
This is a non-interventional study report. A subject (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The subject's relevant medical history included: "Chronic lymphocytic leukemia" (ongoing). The subject's concomitant medications were not reported. Vaccination history included: Pcv13, for immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "follow-up of 263 days from first SARS-CoV-2 vaccine, 3 subjects developed SARS-CoV-2 infection/Upper respiratory symptoms". Clinical course: A third subject had mild upper respiratory symptoms and convalesced at home. This subject had received 3 doses of BNT162b2 with undetectable titers before and after the third dose. The subject underwent the following laboratory tests and procedures: Antibody test: unknown results; Blood immunoglobulin G: unknown results; CD4 lymphocytes: UNKNOWN RESULTS; Absolute CD3+ T-cell count: unknown results; unknown results; Lymphocyte count: unknown results. The reporter considered "follow-up of 263 days from first sars-cov-2 vaccine, 3 subjects developed sars-cov-2 infection/upper respiratory symptoms" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events. Case will be reviewed further on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER_INC-202200582227 same article/drug/event; different patient; US-PFIZER_INC-202200582228 same article/drug/event; different patient.
Approx. 4 hrs post vaccination, left arm became red, firm (approx. 4" across upper arm, & 3" down) and very warm to touch.  Mother notified me.  BENADRYL P.O. & ice pack to area.  Unknown if child had a fever.  No decreased noted in activity, appetite or alertness.  Will cont to observe.
Information has been received from a physician concerning a 13 year old female patient who was vaccinated with a dose of Gardasil (Lot #658554/0928U).  Concomitant therapy included Menactra.  Five minutes later the patient came out of the room and reported that she was dizzy and lightheaded.  The nurse had the patient lay down for 15 minutes with her legs elevated.  It was reported that she did not lose consciousness nor was she cold or clammy.  The patient also had a TB test drawn.  At the time of this report, the patient's outcome was unknown.  It was reported the patient survived the incident.  It was also reported that the patient reported to the physician that she was scared.  Additional information has been requested.
Menveo is a two-part vaccine. It has a powder in one vile that is to be reconstituted with a specific liquid from another vile. It was discovered by our vaccine coordinator that there was half of a dose left unused on three separate occasions. This was discovered in the late fall/early winter 2022. This means that there are three patients of our practice who received incomplete Menveo vaccines and we have not yet identified them. Presumably, the powder was reconstituted in a separate diluent.  We had IT run a report of all patients in a certain window of time who received Menveo at our practice. We compared it with our handwritten logs that clinical staff use to track all vaccines.  Unfortunately, the best we could do was to rule down the list to 8 potential patients. I did submit a separate report about one of these patients a few months ago as that was the first patient potentially identified   We have done lots of reeducation with clinical staff since this time. We have also implemented a protocol that all pediatric vaccines must be double checked by a second clinical staff person before being administered. Our vaccine coordinator is also taking a manual inventory weekly to ensure that should a mistake be made, we are aware of it closer to the date or error. We have also discussed with the medical director that for state supplied vaccines we are going to phase out the use of Menveo (two vial dose) and go back to using a (single vial dose.)  The course of action is to place a call to each of the 7 patients who got Menveo in the suspected time frame and explain that while we are not sure they are under vaccinated, it cannot hurt anything to repeat the Menveo vaccine. That would ensure they are fully vaccinated.      Our medical director has advised that a repeat dose is appropriate and should be offered to anyone affected. PCPs have been alerted and agree with the plan for office manager to reach out to patients/guardians
Mom noticed redness/warmth at injection site the evening after he got the vaccine. Course worsened over the following 2 days. When examined - erythema noted on L anterior thigh, 11cm x 9.5cm with 0.5 cm central induration. Slight warmth to touch.
fatigue; muscle aches; testicular pain; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 30Mar2021 at 13:00 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine, the patient was not diagnosed with COVID-19. The patient took unspecified concomitant medications. The patient did not have any allergies to medications, food, or other products. On 31Mar2021 at 07:00 the patient experienced fatigue, muscle aches, and testicular pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcome of fatigue, muscle aches, and testicular pain was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19 immunization.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Ovarian cyst burst. Afterwards I wasn't able to get out of bed for 5 weeks because of extreme exhaustion, painful pelvic and abdominal cramping (not related to IBS), extreme G.I. bloating, brain fog and inability to stand for longer than 5 minutes. I had to use a wheelchair wherever I went. My OBGYN and Gastroenterologist have put me on various medications to help the symptoms calm down, but I am still experiencing the bloating, mild exhaustion, brain fog, mild occasional cramping and some headaches. Issues have not been resolved.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: GSK receipt date: 9-Feb-2023 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix earlier on the day of reporting, which led to expired vaccine used.
PATIENT DOES NOT HAVE A MEDICAL PROVIDER AND HAS STRUGGLED WITH URINARY RETENTION FOR MORE THAN 5 YEARS. PATIENT STATED THAT 1 WEEK AFTER HIS FIRST DOSE OF PFIZER HE HAS BEEN ABLE TO URINATE WITHOUT ANY ISSUES. WHEN ASKED TO RATE HIS CONDITION HE STATED, HE WAS AT 1 PRIOR TO VACCINATIONS AND NOW IS AT AN 8.
SkinRash, Rash, UrticariaPruritus & RASH METHYLPREDNISOLONE Medrol dose packs UNITS Unknown, DIPHENHYDRAMINE 1 TAB HS PRN ,CALAMINE Small amount UNITS QID
Extreme shortness of breath, dizziness, nausea, chest pain. All symptoms lasted 48 hours.
Hives, burning skin, inflammation, itching, pain. BENADRYL 50 mg at home started 10/29 continued till present 11/04. Prednisone PO 11/4.
For the last 3 weeks her hip has been hurting bad; pain at the injection site; the same night of the vaccine she had body soreness; Headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site), MYALGIA (the same night of the vaccine she had body soreness), HEADACHE (Headache), FATIGUE (tired) and JOINT SWELLING (For the last 3 weeks her hip has been hurting bad) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site), MYALGIA (the same night of the vaccine she had body soreness), HEADACHE (Headache) and FATIGUE (tired). On an unknown date, the patient experienced JOINT SWELLING (For the last 3 weeks her hip has been hurting bad). At the time of the report, INJECTION SITE PAIN (pain at the injection site), MYALGIA (the same night of the vaccine she had body soreness), HEADACHE (Headache), FATIGUE (tired) and JOINT SWELLING (For the last 3 weeks her hip has been hurting bad) outcome was unknown.            Concomitant product included insulin pump. Treatment medications information was not provided.   This case was linked to MOD-2021-235348 (Patient Link).
PT STARTING DEVELOPING A BRUISE ABOUT 3 DAYS AFTER SHOT GIVEN, BRUISE HAS NOT GONE AWAY YET 8-24-12 3:12PM.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ, 2 ml, orally. No concomitant medications were reported. On an unknown date the patients were administered improperly stored ROTATEQ. No adverse events were reported. Outcome of administering the improperly stored ROTATEQ, was unknown. There was no product quality complaint involved. This is one of the two cases received from the same reporter. Additional information has been requested.
PEDIARIX given in (L) thigh, baby developed hives on feet and redness on (L) thigh, rash diminished within 5 minutes.
A golf ball size swelling in armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 multivalent nos (COVID-19 VACCINE MULTIVALENT NOS MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "recovered", described as "A golf ball size swelling in armpit". It was unknown if therapeutic measures were taken as a result of swelling.  Additional information: After receiving the Covid-19 Vaccine (unsure of the manufacturer and believes it was the bivalent formulation; also reported as "Vaccine, is bivalent: False"), the patient had a golf ball size swelling in armpit for about a week after receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient said she had awful side effects, it was like she had Covid-19 all over again. Apparently she had it in November. She followed up with her doctor.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not provided. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider at the physician's office, for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was unknown. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
4th day of: severe Soaking night sweats, aches at joints, headache, fatigue, clammy, diarrhea,
Started to get body aches. Woke up next morning couldn't move. Felt like I had the  flu. Didn't get out of bed until 3Pm. Those symptoms went away. Still stayed sick with cold like symptoms and cough. Racing heart and light headed ness started on 9/16/2013. went to dr on 9/18 said no flu. On 9/21/2013 racing heart, insomnia and extreme heat radiating from body from waist up but no fever. On 9/23/2013 racing heart, extreme fatigue now and burning skin with no fever. Took Tylenol cold once and acetaminophen and ibuprophen throughout.
Ever since having her first Covid shot by Moderna, my mother is coherent,  interactive, and engaged. She had a stroke in March 2015 and has had dementia ever since,  slowly declining annually,  and now she still has dementia,  but is much more aware. Moderna may be on to something for dementia/alzheimers medication help.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 16-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (lot # R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
Information has been received from a nurse concerning a 78 year old female with allergies of KETEK, PERCOCET and sulfa who was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 in 1999 (IM, lot number not reported) and the second dose (IM, lot number 662667/1435X) on 04-JUN-2009. ON 05-JUN-2009 the patient experienced injection site reaction, her right arm swelled from right shoulder to elbow and was red and warm to touch after she received the second dose of PNEUMOVAX 23. Medical attention was sought via telephone visit. No lab diagnostic study was performed. At the time of report, the patient was recovered. The patient had a history of injection site streaking and swelling of arm while on prior therapy with ZOSTAVAX (MSD, WAES0906USA03788). This is one of several reports from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted while waiting 15 minutes after vacination patient has abrasions on chhek nose and forehead from carpet where he fell patient recoved quickly  staff cleaned wounds and gave water patients wife said he was better and just wanted to go home so they left the store patient walked out on own accord
5x5.5 inch erythematous induration that is warm to touch and mildly tender; It is in the right lateral deltoid.
Vaccines given 7/26 at 4:15 pm, 07/27afternoon. Mom noticed left arm swollen, red, non-tender, warm to touch, Shoulder to elbow, Redness gone 07/29 but still swollen.
Nursing attempted to vaccinate patient, but dull needle and did not penetrate skin. A new vaccine was administered.
patient reported dizziness,  near syncopal episode and body aches. Dizziness still present 6 days after administration.
contracted Covid after vaccination; contracted Covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Formulation: solution for injection, Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE: 1), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "contracted Covid after vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. It was unknown if therapeutic measures were taken as a result of drug ineffective. The lot number for bnt162b2 was not provided and will be requested during follow up.
MMR recvd 19AUG(2 mom states whelp appeared @ inject site soon p/shot; cool clothes applied local rxn immed & swelling subsided; 20AUG92 local rxn was red knot size of quarter; no fever; taken to MD; 22AUG92 to ER sl swelling & redness;
Right leg red and swollen down leg, warm to touch.  Seen Dr.  Take Tylenol and apply ice packs.  Mother called office on morning of 06/11/2003.
Patient stated her Right arm where she received both the Influenza and Pneumococcal vaccine was swollen like a "grapefruit". Tmax 99 took Ibuprofen and iced site. Stated looks like "cellulitis". Patient referred to call her MD to be seen.
have received an expired FLUZONE QIV vaccine with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (Healthcare professional).  This case is linked to case 2022SA375602(CLUSTER).  This case involves a 80 years old female patient who received an expired Influenza quadrival A-B vaccine [Fluzone QIV] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Sep-2022, the patient received first dose, 0.5 ml of suspect Influenza quadrival A-B vaccine, pre-filled syringes (lot UT7411JA 30-Jun-2022) via intramuscular route in the deltoid NOS (not otherwise specified) as Immunization.  On 08-Sep-2022 (latency: same day), the patient has received an expired Fluzone QIV vaccine with no reported adverse event (expired product administered).  One of the boxes of Fluzone QIV NP pre-filled syringes that was received on 01-Sep-2022 contained multiple lot numbers and that up to 10 pre-filled syringes had already expired on 30-Jun-2022. Also, as many as 6 other patients may have received expired Fluzone QIV NP vaccines earlier in the week.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.