chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs reported; expired dose of ROT ATEQ which also experienced a temperature excursion was given to a patient.; expired dose of ROT ATEQ which also experienced a temperature excursion was given to a patient.; This spontaneous report was received from a licensed practical nurse (LPN), referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 24-MAR-2022, the patient was administered with a third dose of an improperly stored and expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ), route of administration defaulted to oral, lot number: 1707486, expiry date: 20-MAR-2022(dose and strength were not reported) for prophylaxis (product storage error),(expired product administered). No additional adverse events (AEs) were reported (no adverse event).   There were reported temperature excursion of the administered vaccine: 05-JAN-2022 of 8.4 degrees Celsius (C) for 7 minutes, 27-JAN-2022 of 8.5 C for 11 minutes, 28-JAN-2022 of 10.3 C for 22 minutes and 18-FEB-2022 of 8.2 C for 3 minutes. It was not reported if Logger was involved.
Systemic: periocarditis-Medium, Additional Details: patient reports having instances of periocarditis starting in May of 2022.  Per shot records - 3rd dose of Pfizer vaccine given 10-13-2021, and the most recent booster Pfizer Bivalent given 10-13-22
Low grade fever 99.5; Muscle aches and pains all over body; Muscle aches and pains all over body; Injection site pain; This is a spontaneous report received from a contactable consumer (patient herself). A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE, Solution for injection, Lot no: En6203) via unspecified route of administration on an as unknown, single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient medical history and concomitant drugs were not reported. On 18Mar2021, the patient experienced low grade fever 99.5, muscle ache, pain all over the body and vaccination site pain. The clinical outcome of low-grade fever 99.5, muscle ache, pain all over the body and vaccination site pain was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information which included Protect Confidentiality was checked for the reporter since reported for self, patient's detail contact information was added in Patient Information field, for Lab Data: only 99.5 was retained in result field; Low grade fever was captured in notes field, in consolidated narrative: Prior to vaccination, the patient was diagnosed with COVID-19 was updated to Prior to vaccination, the patient was not diagnosed with COVID 19 per source  Prior to vaccination, was the patient diagnosed with COVID-19 was No, in consolidated narrative: Since the vaccination, the patient had not been tested for COVID 19 was removed since not reported in source.
Two days of strong neuropathy... felt like walking on broken glass, everything I touched felt like numerous razor blades.
Left sided mild facial droop starting 18 days after vaccination, seeming to be somewhat more pronounced the following day. Tingling sensation similar to Bells Palsy. Third day remains unresolved but not worse.
This spontaneous report as received from a Practice Manager (Health professional) refers to a patient of unknown age and gender. medical history and concurrent conditions were not provided. ON 08-MAY-2015, the patient received an expired dose of PNEUMOVAX23 0.5ml, lot # J008799, expiry date: 16-APR-2015 (dose and route were not reported). There was confusion reading the expiration date on the vial (product label confusion). "The vaccine was believed to had an expiration of 15-APR-2016 prior to administration. It was not until the Medical Assistance (MA) was charting that they realized the expiration date was 16-APR-2015". No adverse effect was reported. There was no concomitant medication provided. The reporter also stated that, she will contact her sales representative to request replacement for 7 unused vials with the confusing expiration date that they placed in the sharp container. Additional information has been requested.
Patient called into the virtual medical team to report shortness of breath, rapid onset of cough and red eyes after receiving flu shot in the office earlier in the day. Breathing difficulty had been present for 1 hour prior to calling. Advised to go to urgent care or ER within the next 20 minutes for evaluation. Did not have anti-histamine on hand to take.
Noticed redness and swelling over left deltoid 1 day after TDAP injection. Area is red, swollen and painful. Measures 6 cm x 8 cm.
Seen in our office on 7/19/19 hx fever 103x2days. On 7/9 broke out in rash on trunk 30 small red papules on trunk ? some with clear vesicles. Timing could be consistent with MMR or Varicella vaccine dischg home. To call increase fever inc rash
FLULAVAL QUADRIVALENT (influenza) vaccine given at 1225. Patient developed a rash at the injection site. Diphenhydramine 50 mg PO given at 1425 and rash resolved.
About mid-May I began to experience frequent intermittent chest pain, first 1-2 times a week, then almost daily.  It came on as a pinching over the aortic arch area, and would last up to 5 minutes at a time. It was not associated with exertion, no palpitations or SOB. No previous history of cardiac issues, but this did at times combine with dizziness, and once with  extreme gut cramping almost causing me to lose consciousness while driving. I contacted my PCP. She saw me and referred to a cardiac specialist, for more evaluation. This process took several months. The cardiologist concluded my pain was likely "stress" from work(?) and had no further reason to test or treat.
Moderna COVID-19 Vaccine EUA - 2nd shot March 10; Mar 11 to March 27:  Fever on and off, muscled fatigue, bitter taste, unable to eat solid foods, chills, shaking when holding spoon, finally called ambulance to go to ER o March 28 after having difficulty breathing for 2 days.  Admitted to ER on March 28.  Gotten progressively worse March 29 to April 1 (intubated on April 1 or 2?) -  Kidney / Liver failure.  Transferred to ICU on April 2.  Patient currently on life support (per ICU Doctors, Lung Failure, Kidney Failure, Liver Damage).
AS I CAME BACK, LOSS OF HEARING, EYESIGHT AND MUSCLE HURT.
Subsequent to receiving the second dose of varicella virus vaccine live laboratory evaluation revealed negative seroconversion following two doses.
4 seizures; anaphylaxis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEIZURE (4 seizures) and ANAPHYLACTIC REACTION (anaphylaxis) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Seizures. Concomitant products included ACETAMINOPHEN, ATOMOXETINE HYDROCHLORIDE (STRATTERA), CLONIDINE, DIAZEPAM (VALIUM), FLUOXETINE HYDROCHLORIDE (PROZAC), LEVETIRACETAM (KEPPRA), ONDANSETRON (ZOFRAN [ONDANSETRON]), OXYCODONE and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced SEIZURE (4 seizures) (seriousness criteria hospitalization and life threatening) and ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criteria hospitalization and life threatening). On 09-Apr-2021, SEIZURE (4 seizures) had resolved and ANAPHYLACTIC REACTION (anaphylaxis) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SEIZURE (4 seizures) and ANAPHYLACTIC REACTION (anaphylaxis) to be related.    Hospitalization unknown meds.  This is a 19 -year-old, male patient who received Moderna COVID-19 Vaccine) (batch no. 037B21A) and experienced seizures and anaphylactic reaction  one day after receiving second dose of vaccine. Medical hx includes seizures Some relevant conmeds atomoxetine, clonidine, diazepam, fluoxetine, levetiracetam, and oxycodone were provided. Very limited information has been reported at this time. No further information is expected   Reporter did not allow further contact; Sender's Comments: This is a 19 -year-old, male patient who received Moderna COVID-19 Vaccine) (batch no. 037B21A) and experienced seizures and anaphylactic reaction  one day after receiving second dose of vaccine. Medical hx includes seizures Some relevant conmeds atomoxetine, clonidine, diazepam, fluoxetine, levetiracetam, and oxycodone were provided. Very limited information has been reported at this time. No further information is expected
10/7/2022 Started with a cough.  Cough got worse 10/8.  10/9 Tested with an At Home COVID-19 test, positive.  Went to Walk in clinic.  Tested there with Rapid COVID-19 test, positive.  Doctor recommended participant go to the Hospital.  Proscribed Paxlovid but cautioned to consult with PCP due to possible medical interaction.  At Hospital I received a one-time infusion of I believe Remdesivir.    Release from hospital after infusion and had a pill for coughing proscribed.  Over the next 10 days there was a few instances of mild fever hitting 99 degrees, cough diminished.
Information has been received from a consumer concerning her 9 week old daughter who on 2/27/01, 5/1/01, and 1/9/02 was vaccinated with a first, second, and third dose of HIB conjugate vaccine (lot numbers 638138/1548K [also reported as 1548KO], 639437/0929L, and 639437/0929L respectively). Concomitant vaccination on 2/27/01 included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated and an RV shot. The patient's vaccination history was noted to include a first, second, and third dose of hepatitis B virus vaccine on 8/14/01 (lot # 640323/0753L), 11/19/01 (lot # 640323/0753L), and 1/9/02 (lot # 641449/1230L) respectively, a dose of MMR on 4/1/02 (lot # 638706/0745L [also reported as 0745LO], and a dose of varicella virus vaccine live on 1/9/02 (lot # 638244/0466L). After vaccination on 2/27/01, the patient experienced a severe urinary infection. The patient was sent to the hospital and remained there for two days. The mother also reported that each time the patient had a shot (any shot), she experienced a rash around the diaper area and a fever. While in the hospital the patient was given antibiotics to treat the urinary infection. The mother was told to just wait through the fevers. The patient recovered from the urinary infection but will be given a series of tests to determine what vaccine or ingredient of the vaccine she is allergic to. It was noted that therapy with HIB conjugate vaccine was discontinued. A product quality complaint was not involved. Additional information has been requested. Follow up on 03/22/04 states: "Additional information was received from a physician which indicated that the Hib conj vaccine (OMPC) was not administered in his office. No further information is expected."
Seizures. Loss of gross and fine motor skills, speech sounds. Brain damage. Was put on phenobarbitol for 6 months. Seized again after his last course of immunizations 4/18/1997. Currently the pt has tried DSMA to get rid of Mercury in his system. 12/28/05 - Review of medical record confirms diagnosis of seizure disorder. Additional conditions noted, but without onset dates include moderate developmental delay, flattened occiput, s/p colitis, and R otitis media. He still receives therapy sessions at least 1-2/preweek at hospital (rehab).  He has no speech & loss of motor function in legs & hands.  Thank you for doing the follow up with patient.  (Toxic Mercury levels in a developing infant can lead to life long difficulties.  It has affected every aspect of his life.  He needs help dressing, feeding and talking every day.  Mercury is not, even in small amounts, of any benefit to a young child. Thimerisol as a shelf life additive is not good.  Thanks for removing it from current vaccines.
Immediate onset with redness and lump (swelling) at injection site in the right arm followed by flu-like symptoms including a fever that spiked at 100.8 degrees Fahrenheit. Patient was treated with hydrocortisone to treat the redness, pain, and swelling at the injection site.
Friend in vehicle  stated participant briefly lost consciousness, when awoke was lethargic; incontinent of urine;  B/P 90/60, pulse ox 98% Denise hx. of seizures ;  EMS  assessed participant; participant refused to go to  E.D. with EMS, however, stated would have boyfriend take her to E.D. In f/u phone call, stated had lab work done on E.D. and fluids administered, and released home with no further issues.
I talked to the pt on the phone and this is what she relayed to me. She said she had never had the flu vaccine before but her doctor had recommended that she get one because she had a record of getting colds and had pneumonia twice. She said she had received a pneumonia vaccine previously without complications. The vaccine was given where the pt works. She said about 1 hour, post vax, she started having a stiff neck and feeling nauseated. She went home since she had received the vaccine at her workplace. She began taking Advil. She said she never took her temperature but did feel hot. She said she started feeling hot and cold and then 2 days later, she developed a cough. She went to the doctor on 10/23/01 and he told her she had the flu. She also said she had an ear infection and possibly a respiratory infection. She had started taking OTC cough medication. The doctor gave her a prescription for an antibiotic and Flonase. He told her the antibiotic would not work on the flu. When I talked to her, she was already starting to feel better but sounded congested over the phone.
Menveo given instead of Hib vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA165A, expiry date 15-MAY-2023) for prophylaxis.   On 05-APR-2023, the patient received Menveo. On 05-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Menveo given instead of Hib vaccine). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 05-APR-2023  A medical assistant reported that a patient was accidentally given a dose of Menveo instead of the Hib vaccine.  They provided information about the vaccine and patient. The vaccine administration facility was the same as primary reporter. They accepted to receive follow-up via e-mail. The patient received received Menveo instead of Hib vaccine, which led to wrong vaccine used.
Severe chills, muscle aches, injection site pain, swelling, redness, itching, extreme fatigue
pt states that arm was sore/painful the next day. Says his right arm 2 months later still hurts at injection site, especially if touched.  Has shooting pain / pain in arm from right trapezius down to right hand finger times along with numbness.  States has not seen doctor yet. Took his primary Dr's info.  Contacted Dr office and employee is coordinating office getting him in to be checked out and aware of the adverse event from the booster shot.  Patient denied have any other sort of accident to neck/back/arm that could account for the pain and numbness.
Moderna COVID-19 Vaccine: Five (5) days after the vaccination patient noticed itching, redness, swelling, and a hard lump 3 inches in diameter.  These symptoms remained for 2-3 days and are improving and resolving on day 8 post vaccination.
After getting the first shot for HPV from her pediatrician my daughter started to feel lethargic and have a lack of appetite. This happened gradually. We made the connection to the shot because her older sister had the same reactions after getting her HPV vaccine. We submitted a VAERS report for her separately (report #134951). We did not have patient get her other scheduled doses of the HPV vaccine after she showed this reaction. There are no other events or diseases we could connect to the sudden start of her symptoms. Patient's reaction was how we finally connected her sister's symptoms to the HPV shot, as that was the only common event preceding the onset of these symptoms. Sister had 3 shots and has severe symptoms, patient only had 1 shot and the symptoms were worse in the months following the vaccination, but have become less severe over the last several months, but have not disappeared completely.
Patient developed soreness and redness in upper arm in the evening after receiving the immunization earlier in the afternoon. The redness got worse and patient had a liitle pain radiating behind arm. Patient used ice for the swelling but did not really help. The patient came into pharmacy on 7-9-2019 and a slightly raised, warm to touch red area on upper arm was noticed. He went to see his physician on advisement on 7-9-2019 and was diagnosed with cellulitis and prescribed an oral antibiotic. The doctor told patient that he probably developed this condition due to the injection. The patient was told that if he wasn't better by 7-12-2019 then the doctor would admit him into the hospital for IV antibiotics.
A patient received DTaP, DAPTACEL instead of TdaP, ADACEL, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number-00581241) and transmitted to Sanofi on 28-Apr-2021.  This case involves a 10-year-old male patient who received 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5621AA and expiry date: 23-May-2021) via an intramuscular route in the left arm and a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP] (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP] on 28-Apr-2021 (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  This was a case of actual medication error due to wrong vaccine administered (latency was same day).   At the time of reporting, no adverse event reported.  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.
Initial report received from healthcare professional on 11 October 2013. A patient with unknown demographics whose medical history and concomitant medications were not reported received dose of FLUZONE INTRADERMAL (route, dose, from, frequency and batch number not reported) on an unspecified date. The patient received vaccine and developed rashes that covered body. Laboratory investigation and corrective treatment were not reported. At the time of report, the patient was not recovered from the event. Documents held by sender: none.
Patient received vaccine that was stored in freezer for 19 days prior to moving to refrigerator.
Blood in "my" semen; Every time "I" ejaculate, blood comes out.; Outside the window period 19-42 days vaccine administrated(16days); This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Feb2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa (sulfonamide allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) all for an unknown indication from unknown date and unknown if ongoing. The patient previously received BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Feb2021 at 12:00 as a single dose for COVID-19 immunisation. On 06Mar2021 at 12:00 the patient experienced blood in semen and every time the patient ejaculate, blood comes out. The patient went to a Urologist and they could not find anything wrong and it did not happen until the patient received second vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blood in semen and every time the patient ejaculate, blood comes out was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
clinic on 11-9-2021 for Pfizer Pediatrics. 15 year old was given peds dose. Discovered 11-10-21 & reported 11-10-21 was administrator
Anxiety; Rapid Heart Beat; Diarrhea; Hot Flashes; Unbalanced; Teeth hurt; eyes hurt; jaws hurt; Gums hurt; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), HEART RATE INCREASED (Rapid Heart Beat), DIARRHOEA (Diarrhea), HOT FLUSH (Hot Flashes) and FEELING ABNORMAL (Unbalanced) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ANXIETY (Anxiety), DIARRHOEA (Diarrhea), HOT FLUSH (Hot Flashes), FEELING ABNORMAL (Unbalanced), TOOTHACHE (Teeth hurt), EYE PAIN (eyes hurt) and PAIN IN JAW (jaws hurt). 17-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid Heart Beat), GINGIVAL PAIN (Gums hurt) and CHILLS (Chills). At the time of the report, ANXIETY (Anxiety), HEART RATE INCREASED (Rapid Heart Beat), DIARRHOEA (Diarrhea), HOT FLUSH (Hot Flashes), FEELING ABNORMAL (Unbalanced), TOOTHACHE (Teeth hurt), EYE PAIN (eyes hurt), PAIN IN JAW (jaws hurt), GINGIVAL PAIN (Gums hurt) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.