chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness/Lightheadedness-Medium, Systemic: Fainting/Unresponsive-Medium.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298573, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 (same reporter). This case involves a patient of an unknown demographics who received 5 mL dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route (site of administration not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose and incorrect product storage. It was reported that patients were injected with previously frozen 5 mL FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. It was unknown whether patient experienced any adverse reaction after vaccination. 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 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. Documents held by sender: none.
Within a couple of weeks of getting the second vaccine, I began having pain in my hips. I then consulted with an osteopath, who confirmed that I had joint inflammation and that I should cease doing certain activities. The pain then moved to my knees in July 2021, and that subsided after a month and a half. I then began having right shoulder pain in September 2021. I went to see an osteopath in April 2022, because the shoulder pain was so severe that it impeded certain activities. At the time of this writing, I am  in physical therapy. I also put an ice pack on my shoulder 3 times a day. Both of these have helped.
Patient reports fainting at 0600 on 5/25/11; reports weakness and fever of 99-101. Reports no treatment given so far. Informed her to see primary care provider for follow-up.
second shot>40 days/"My second dose onlt can be get after 40 days later; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second shot>40 days/"My second dose onlt can be get after 40 days later) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second shot>40 days/"My second dose onlt can be get after 40 days later). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second shot>40 days/"My second dose onlt can be get after 40 days later) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was provided.
About 5 minutes after receiving vaccine, pt complained on itchy throat and tig of throat. Benadryl 50mg liquid given.
Vaccine Breakthrough Case - led to hospitalization and death   Vaccinated Moderna: 2/12/2021 & 3/12/2021  The individual tested positive for COVID-19 on several respiratory tests beginning on 9/10/21. Her symptoms began on 9/8/21, and she was admitted to the hospital on 9/10. She was found to have double pneumonia. The patient also had acute respiratory distress syndrome. The patient unfortunately passed away on 9/24/21.  The case has a positive test from 6/18/21, because she was supposed to go in for a procedure, but was asymptomatic at the time and tested negative on 6/23/21.
w/in 10min post vax felt, light headed w/some SOB-sl diaphoresis noted SOB several hrs post vax; resolved w/o use of inhaler & self medicated w/o DPH
patient described feeling unwell about 30 seconds after administration while reviewing recommendation to stay near the pharmacy for 15 minutes. She lost consciousness and fell out of chair. I caught her and lowered her to the ground, contacted store management and helped monitor her for about 30-45 minutes. The patient felt well, confirmed she felt safe walking, and called a family member to drive her home.
WEAKNESS; HYPERTENSION; HEADACHE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS)  (VAER reference number 422221)  concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Company is unable to follow up for Batch/Lot number of the case. No concomitant medications were reported.  On an unspecified date, the subject experienced weakness, hypertension, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, hypertension and headache was not reported. This report was non-serious.
Vaccine on Friday; Saturday around noon lymph nodes got tender & swollen. Then on Sunday became large (size of eggs), painful.  Located in : Left interior Arm, L armpit, hand, Left neck up to ear, breasts, Left wrist, Right hand.   Monday at 10 a.m. went to doctor.  Ran tests  to make sure nothing else was underlying.  Came back negative.  Started on hydroxovisil to reduce swelling.  2/10/21 physician called to notify that lab results were all negative so they feel it is due to  COVID-19 Vaccine.
This spontaneous report as received from a registered nurse refers to a currently 18 years old female patient. The patient was vaccinated with three doses of RECOMBIVAX HB (dose, lot number and route not provided) on unspecified dates as a child. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced low hepatitis B antibody titers. The patient had sought medical attention via office visit and no treatment was given. The patient performed hepatitis B antibody titers test. The outcome of low hepatitis B antibody titers was reported as not recovered/not resolved. Additional information is not expected.
The patient developed a red, circular mark at the injection site starting 1-2 days following shot. The patient states the area was warm to the touch and only slightly painful when touched. She was seen by her Primary Care Physician and she suspected Cellulitis and the injection site and was given a course of Cephalexin to treat. The patient states the area has begun to heal and is getting smaller.
4-week-old patient mistakenly received the FLUZONE QIV-PFS with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 weeks old male patient who had mistakenly received the influenza quadrival a-b vaccine [Fluzone Qiv] with no reported adverse event while receiving vaccine   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 07-Mar-2023, the patient received 0.5ml dose of suspect influenza quadrival a-b vaccine Suspension for injection(strength, lot number not reported via unknown route in unknown administration site for Immunization.  On 07-Mar-2023 the patient developed a non-serious event of 4-week-old patient mistakenly received the fluzone qiv-pfs with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day) following the administration of influenza quadrival a-b vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown  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.
Red raised circular rash at injection. Treatment: Benadryl Outcome: Rash has not spread, does not interfere with ADLs.
Large, hot itchy hives first developed 1 week post vaccine. Started around bra line, then under arms, left arm (opposite vaccine site) and thighs.  Worse around entire left bicep. Subsided 1 week later with prescription steroids, antihistamine etc.
Pain and swelling at sight of injection, pain in neck, fever, excruciating headache.
Developed a fever blister within 24 hours after receipt of the GARDASIL vaccine and about 48 hours after start of fever blister, developed painful submental lymph node.  Lesions, vesicle start: 03/06/2008, comment: cold sore on chin, right below lower lip; Lymphadenopathy, posterior cervical chain start: 03/08/2008; Lymphadenopathy, submaxillary/submental start: 03/08/2008.
This spontaneous report as received from a consumer reporting on her 15 year old female daughter who in July 2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). The patient's mother stated that her daughter had not received doses 2 or 3 of the GARDASIL series until this time. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 25-FEB-2016 the patient was vaccinated with expired third dose of RECOMBIVAX HB (dosing details were not reported) lot # K014697 expiry date 04-FEB-2016. The reporter did not specify dates of administration for the first and second doses of RECOMBIVAX HB. No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
lips started tingling; general not feeling; feeling funny; having allergic reaction or side effect; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA ORAL (lips started tingling), VACCINATION COMPLICATION (general not feeling), FEELING ABNORMAL (feeling funny) and ALLERGY TO VACCINE (having allergic reaction or side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 20-Mar-2021, the patient experienced PARAESTHESIA ORAL (lips started tingling) and VACCINATION COMPLICATION (general not feeling). 20-Mar-2021, the patient experienced FEELING ABNORMAL (feeling funny) and ALLERGY TO VACCINE (having allergic reaction or side effect). At the time of the report, PARAESTHESIA ORAL (lips started tingling) and VACCINATION COMPLICATION (general not feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Patient with a past medical history of smoking, recent URI, newly diagnosed diabetes this admission presented with 3 days of right lower extremity pain. She had also had COVID infection in August 2020. She was pressured by employer to recieve COVID Pfizer vaccine 1/25/2021 and 3/18/2021. She had headaches and body aches with the COVID infection and also the covid vaccines. About 1 week prior to admission she had a URI and tested negative for Covid antigen. 3 days prior to admission she had worsening pain of right lower extremity and discoloartion. She is uninsured and has no PCP, so she came to the ER. She was diagnosed with ischemic right leg secondary to arterial thrombosis. Arterial catheterization by cardiologist on 8/27/2021 provided incomplete removal of thrombus. Orthopedic surgeon perfomed above knee amputation on 8/30/2021. The patient was discharged home with xarelto and plavix, but patient could not afford xarelto, so free samples of eliquis were provdied by family practice clinic. THe patient was notified of a free clinic where she could follow up.
Headache started, never subsided, blurred vision, dizziness, nausea, dry cough, sore joints and muscles,  sore throat, sore nose, sore ears, tremors,  extreme fatigue, chills, sweats
Besides the usual feeling of lazy, tired, feeling like I need to refresh, chills, body achiness.  My lymph nodes in the arm pit burned ached, diarrhea. At 4:30 my lower lip itched swelled briefly, then left. I slept a lot. Wed (day 2) Chills, diarrhea, sweaty. Red raised injection site still, ache burning. Body aches. Thur diarrhea. Slept 11 hrs. Fri -normal.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, subcutaneously, lot # M022401, expiry date 01-NOV-2017 (dose and anatomical location were not specified) for prophylaxis. The administered doses of PROQUAD underwent a temperature excursion between -15 Celsius degrees and -10 Celsius degrees for 747 minutes. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Atopic dermatitis from all over the body; unable to sleep at night; cannot perform daily functions; This spontaneous report was received from the patient's husband and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  In July 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route, frequency, vaccination site, lot # and expiration date were not reported), for prophylaxis.    In the same date, the patient experienced atopic dermatitis from all over the body, unable to sleep at night (insomnia) and cannot perform daily functions (loss of personal independence in daily activities).  At the time of reporting, the patient had not recovered from dermatitis atopic, loss of personal independence in daily activities and insomnia. The reporter did not provide a causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  and the events.
My son received the vaccine on 06/26/2021. Gagging started on July 4 with vomiting. The vomiting would last a couple of days. He would be hungry and he couldn't eat. He experiences abdominal pain with eating or drinking water. He has a high pain tolerance from other surgeries he has had in the past. The routine is he will be sick for 5 days, he will be okay for a couple of weeks and he will be sick for 5 days. When he gets so dehydrated, we take him to the ER for IVs. He has been to numerous doctors/specialists for a diagnoses but they can't find anything wrong. We feed him purified food which he has difficulty swallowing. Water, PEDIALYTE, juice is all difficult for him to swallow. He was tested for allergies and he is very allergic to certain medicine and unable to process.
Muscles cramping. Constant movement of muscle in arm, mid drift and legs - on going. Diagnosed by Dr.
Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.
Pneumovax administered 11/12/08. large area of erythema/swelling/fever to 102 deg., intense pain
Breakthrough case admission after 3 vaccines Pfizer 6/9/21 lot# Ew0172;  Pfizer 6/30/21 lot# EW0182;  Pfizer 1/3/22 Lot# FJ1611
After the second dose (2/27/2021), less than a week later, I started having major heart palpitations. I may not have put that on the v-safe check in because I did not relate it to the vaccine at the time. But this is all new to me, it never happened before. On March 3rd 2021 I had a severe reflux attack as well. My blood pressure was also sky high which has never happened to me before. The heart palpitations were very scary. I went to the ER for that after my vaccine and they gave me a beta blocker and set me up with a cardiologist. I am not on BP medications for this issue and still have heart palpitations even with medication now so I am not recovered.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history was not reported. On unknown dates the patients were vaccinated with VARIVAX (Merck) (strength, dose, route and lot # not reported) which was improperly stored. No adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
The client reported seeing occasional black spots in her vision. The client stated closing her eyes helped relieve this. The client also reported that her hands felt numb after receiving the vaccine, but felt normal now. The client stood up unassisted at 12:00PM. She denied any dizziness. The client reported persistent intermittent "spots" in her vision. The client stated she was ready to go and left the vaccination site at 12:07PM ambulating unassisted with a steady gait.
No symptoms or adverse events noted.  Patient is traveling in June of 2022 with her family. Her parents requested to get her first dose of the vaccine early since she is traveling. Ok'd per Dr. to give a couple of months early.
Patient is pregnant and had a prenatal diagnosis of a child with a cleft lip.  Patient's estimated due date of Mar 21, 2010.  An ultrasound diagnosing the cleft lip was done around Nov 13, 2010.
pt recv vax & 7 to 10 days post vax pt devel a rash which was not serious;
I received my fist dose of Moderna vaccine on 2/4 My platelet count was 186 on 2/17 I received my second dose of Moderna on 3/9 My platelet count dropped to 73 when checked on 3/12/2021   My platelet count dropped to 33 when checked on 3/29 I received a 2-week course of Prednisone starting on 3/29  My platelet count increased to  58 when checked on 3/30 My platelet count increased to 114 when checked on 4/2  My platelet count increased to 196 when checked on 4/8
Lymph node excessive swelling and pain and redness and sores in both underarms. Did not heal for 3 weeks.  Weakness, lethargy, weight gain
her nurses reconstituted lyophilized Menveo vial with saline instead of the supplied liquid CYW-135 component.; her nurses reconstituted lyophilized Menveo vial with saline instead of the supplied liquid CYW-135 component.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA946A, expiry date 31-JUL-2024) for prophylaxis.   On 22-AUG-2023, the patient received Menveo. On 22-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: her nurses reconstituted lyophilized Menveo vial with saline instead of the supplied liquid CYW-135 component) and inappropriate dose of vaccine administered (Verbatim: her nurses reconstituted lyophilized Menveo vial with saline instead of the supplied liquid CYW-135 component).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 23-Aug-2023 Nurse supervisor reported that one of her nurses reconstituted lyophilized Menveo vial with saline instead of the supplied liquid CYW-135 component.   At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The lyophilized vial of Menveo was reconstituted with saline instead of the supplied liquid CYW-135 component and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Headache, Myalgia, Fever, NauseaVomiting, arm pain, chills Narrative:  Other Relevant History:
Wednesday 09/15/21 overnight into Thursday morning, patient noticed a rash developed at the injection site and started to spread up until Friday. The rash was about 6-7 inches long and 2-3 inches wide, red/warm to touch.  Patient also experienced Monday afternoon malaise and fever of about 100F for couple hours. By Tuesday afternoon, patient "felt fine". On Friday afternoon, patient was unable to reach her PCP but left a message. Instead, patient went to see an urgent care doctor and was told the rash was a giant hive that had developed at the injection site. She was prescribed Levocetirizine 5mg and Triamcinolone 0.1% cream to treat the rash. On Saturday afternoon, patient has since applied the cream three times and taken one tablet of the Levocetirizine. She says the rash at the exact injection site is fading but minimal change overall since just started treatment. Patient will see a dermatologist on Tuesday and will have a consult.
nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered".  Additional information: Patient had the two original vaccinations and one booster for COVID, the last one being Oct2021. Patient experienced nausea and vomiting for all three and really took about three days to recover from each shot. Patient tried the Moderna shot last week and still got sick but not quite as badly. Patient was wondering if suffered an allergic reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
MOM REPORTS SINCE THESE VACCINES THIS CHILD DEVELOPED SEVERE HEAD ACHES AND SEIZURES.  HAS HAD NUMEROUS DOCTOR VISITS RELATED TO THIS.