chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 70-years-old male patient who experienced allergic reaction, while he received vaccine QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUBLOK QIV lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 27-Aug-2020, the patient developed a non-serious allergic reaction (hypersensitivity) unknown latency following the administration of FLUBLOK QIV. It was not known if it had been caused by the egg protein.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for allergic reaction.  There will be no information available on the batch number for this case.
On arrival to the emergency department, patient was febrile to 39.5, heart rate 90s, respiration 20, blood pressure 168/89 and SpO2 88% on room air which improved to 94% on 2 L nasal cannula.  Labs remarkable for WBC 15000, lactic 1.0.  NT proBNP 291 and creatinine 1.62.  Chest x-ray showed right infrahilar mixed interstitial opacity suspicious for pneumonia.  EKG demonstrated left bundle branch block.  Urinalysis was grossly positive for infection but contaminated with many squamous cells.  She was given Rocephin, azithromycin and Decadron.  COVID-19 PCR was positive.
Mom called following morning saying pt had redness on arm and also chest pain. After further questioning, said "chest pain when pushing chest" Recommended she have him evaluated by physician/ER and also page his doctor for their opinion. Asked mom to call back with update. No update received.
4 month old inadvertently given dose of Ipol and Pentacel, patient has already had dose of polio in Pediarex; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who was administered 0.5 ml dose of IPV (VERO) lot N1G511M in the right thigh, on 09-Jul-2019 and also recieved DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (Pentacel). It was reported patient has already had dose of polio in DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix) (also reported as Pediarex)  The patients past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was as actual medication error case due extra dose administered.  At the time of reporting, adverse reaction was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
IN THE HOSPITAL; A potential AE sent comment to the account from a vaccine recipient. Text: "Patient my friend is in the hospital after getting the shot! Was on oxygen 20 days and then headed back to the ER!!" 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was in the hospital after getting vaccine, was on oxygen 20 days and then headed back to the ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event in the hospital was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210354346-covid-19 vaccine ad26.cov2.s- in the hospital. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Rash covering entire body except head, rash is large/welp-like, followed by fever on 4/1/2011, uncharacteristic crying/sleep trouble since onset of fever, injection site is swollen and purple, prior to this, injection site couldn't be seen
24 hours after taking the shot I had flu symptoms that lasted about 24-36 hours. Since then I have suffered from constantly increasing deterioration of my joints throughout my body.  I  have to wear a brace on my left wrist, I have developed gout in my right hand, every joint in my body is painful and it seems to be increasing as time goes by.  I have not felt well generally since getting these shots.
Pt is 80 y/o female h/o CAD, hypothyroidism, dementia who presented s/p fall. Had COVID 2 weeks prior. In EC imaging showed left IT fracture. Underwent gamma nail on 10/5/22. Pt developed acute on chronic anemia and then pancytopenia. Hem/onc evaluated. She required PRBC transfusions. Ultimately underwent bone marrow BX. Will follow up w Dr. and will get CBC rechecked outpatient. Also TX for UTI during admission. Dc'd on lovenox 40mg daily x1 month per ortho. PT/OT/PMR evaluated. Family decided home w homecare, has 24/7 caregivers. Family in agrement w plan.
Genital lesions, consistent with herpes virus appeared. Treated with Metronidazole 500 mg and Valacyclovir HCL 1g. Outbreak went away.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Mild, Systemic: Hypotension-Medium, Additional Details: pt hx of vagal response to needles. passed out and fell foward. 0.5 inch laceration to left forehad as a result of forward fall from glasses hitting head and floor. Bleeding controlled by direct pressure. 98% osat. pulse 64. Bp was 128/90. slight headache. gave 2 tabs 500mg acetamiophen from pharmcy supply
Pain at site of injection, feels heavy. Symptoms started right after vaccine. Painful to move arm certain ways; has trouble driving, dressing, can't sleep on it. Has taken ADVIL but a month later and the pain still is there.
Had the vaccine and also got the shingles/suspected vaccination failure; Shingles on forehead and hairline; awful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the vaccine and also got the shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on forehead and hairline) and feels awful (Verbatim: awful). The outcome of the vaccination failure was unknown and the outcome of the shingles and feels awful were recovered/resolved (duration 6 weeks).   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient had the vaccine and also got the shingles on his or her forehead and hairline awful for 6 weeks. The patient stated that good thing he or she was alone in the pandemic isolation. The vaccine did not prevent shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
chills; weakness; he has loss his taste; he has loss his / smell; This case was reported by a consumer and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, weakness, taste loss and loss of smell. On an unknown date, the outcome of the chills, weakness, taste loss and loss of smell were unknown.   It was unknown if the reporter considered the chills, weakness, taste loss and loss of smell to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient was reporter's husband.  The patient experienced chills, weakness. At the time of reporting the patient lost his taste and smell. The reporter asked that if experienced side effect by the patient was common side effect.
Fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, expiry date was unknown) via an unspecified route of administration on 10Jun2021 as a 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reported stated that all their three children were vaccinated and two of them just had fever which was normal. The event assessed as non-serious. One daughter had severe headache which developed into uncontrollable throwing up. Since then, they were at hospital. She had been tested and had a lumbar punch, CT scan and X-ray were performed, and she was schedule for MRI. She never had migraine or anything before. The outcome of the event was unknown.  Follow-up attempts are needed: Information about batch/ lot number has been requested.
Refrigerator temp went to 33.6 for less than an hour and he received the 2nd covid vaccine when the refrigerator was back in temp range.  No symptoms of illness or side effects.
Pt presented with chest pain and was getting cardiac workup.  Pt developed who has paresthesia and left leg and right arm weakness on exam.  He had sudden onset of weakness since 11/29/2021.  Evaluated by Neurology and neurosurgery.  Working diagnosis is transverse myelitis vs compressive myelopathy (symptoms inconsistent with NMO); unclear etiology (possibly related to COVID-19 vaccine booster).  Most likely infectious or inflammatory in nature.  Compressive myopathy ruled out by neurosurgery evaluation.  Pt treated with  IVIG 50 gram  (0.5 g/kg/day) IV daily x 4 days, and methylprednisolone 1 gram IV daily x 5 days.  Generalized weakness improved over next 10 days, with new onset upper and lower extremity weakness on 12/9/2021; evaluated by neurology and neurosurgery however no evidence for acute spinal cord compression.  At discharge to skilled nursing facility, his generalized weakness was improving; pt  progressing well with physical therapy and occupational therapy.
This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program [Pfizer RXPathways] based on information received by Pfizer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in arm on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, it was reported that after the first dose, the patient had a red spot appear on the opposite arm. Patient also became itchy all over- back, arms, neck, eyeballs, etc. Benadryl helped a little with the itchy. 24 hours later the red spot was still there. The outcome of the events of became itchy all over- back, arms, neck, eyeballs, etc was recovering and other event of red spot appear on the opposite arm 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.
Approx 8:00 am, Thursday, March 1st 07 - Sunday March 4 07, genitals largely swollen, very red, painful, urination, painful if touches. Treatment BENADRYL 3/4 tsp every four hours baby powder.  Follow-up - Redness and swelling ingroin area acompanied by painful urination
Severe symptoms of arthritis causing extreme pain in wrist, fingers and joints since 2 days after 2nd dose. No over the counter meds or topical creams seem to work. Unable to sleep at night due to pain, lots of grip and strength in hands and wrist. Cortisone shot given by orthopedic doctor no relieve, earliest scheduled visit for new patient with Rheumatologist isn't until Dec 2021. XRAY shows arthritis in base of lower thumb joint and finger joints. Pain has progressed over the months.  Other joints in body inflammation as well. Knuckle joints swelling and inflammation. Xrays done and cortisone shots to reduce fluid buildup. No prior joint pain or issues prior to April 3rd 2021 after 2nd dose on April 1,2021 This is 100% vaccine related
I received the vaccine around 3:30 pm on 12/7. I had the usual arm soreness and arm swelling after the injection. Then around 11 pm on the night that I received the vaccine, I had trouble swallowing  with excessive salivation, difficulty breathing. I felt like the  difficulty breathing was a result of the excessive salivation and difficulty swallowing. I took two 25 mg BENADRYL along with 150 mg ranitidine. In addition, I had muscle aches in both legs which was not alarming.
Continuous tinnitus since around 12/26/2021.  It hasn't stopped for over a month now.  It's very annoying.
This case was reported by a healthcare professional and described the occurrence of jerking in a 5 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. There were no concurrent medications. On 6/9/06 at 09:00 AM, the subject received 1st dose of Pediarix in the left leg (lot AC21B051AA). On 6/9/06, the subject also received the 1st dose of Haemophilus influenzae tetanus conjugate vaccine (lot UB472AA) and 7-valent pneumococcal conjugate vaccine (lot B08633C) at unspecified sites of injection. On 6/9/06 at 3:00 PM, 6 hours after vaccination with Pediarix, the subject experienced jerking, a fever of 101 degrees F, inconsolable pain and crying. The healthcare professional reported that there was, no loss of consciousness associated with the jerking. The subject was treated with paracetamol which had no effect on the symptoms. The healthcare professional considered the events were disabling. On 6/12/06 the events were resolved. The healthcare professional considered the events were possibly related to vaccination with Pediarix.
Rash on 9/23/04 generalized. Pt was seen 9/25/04. Diagnosed with Varicella.
needle stick; the needles that come with the product do not contain safety caps; This case was reported by a pharmacist via call center representative and described the occurrence of needle stick/puncture in a patient who received Rabies NVS (RabAvert) for prophylaxis. This case was associated with product complaint.  On an unknown date, the patient received RabAvert at an unknown dose. On an unknown date, immediately after receiving RabAvert, the patient experienced needle stick/puncture and pharmaceutical product complaint. On an unknown date, the outcome of the needle stick/puncture and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the needle stick/puncture to be related to RabAvert.  Additional information received were as follows: The age at vaccination was not reported. The lot number and expiry date was unknown. It was unknown, whether the patient received RabAvert for pre exposure or post exposure prophylaxis. The pharmacist on the line reported because the needles that came with the product did not contain safety caps, there was a safety event. The reporter clarified further as a needle stick. The reporter consented to follow up. The caller had no information on the person involved in the event and assumed it occurred at the primary address, but did not know for sure.
Vaccine was adminsitered at approximately 1:10pm. He was fine. When he stood up he fell forward onto his mother's back then his chin hit the counter and he then fell face down on the floor. Mom and pharmacist rolled him over and elevated feet. His arms stretched out and hands were drawn down. He came to but was confused. He asked what happened. We told him. At that point he started to freak out. He said he was not feeling well. RPh gave him some water and tech got a cold paper towel that mom held on his head. He felt better so we tried to sit him up. He started to panic because he did not want the vaccine. He said his heart was racing and hands/legs felt numb. RPh asked if he could feel her touching his leg, he said yes. RPh told him to take deep breaths and walked him thru multiple breaths to help calm him. Mom said he has anxiety and is scared of needles. She said this was a panic attack. He said he felt worse and thought he was gonna pass out again. We laid him back down and asked if he wanted to go to the ER. He said no but wanted them to come check him out because he felt wierd and started to shake. RPh instructed technician to call 911 for EMS. Manager got an ice pack for chin. EMS arrived and evaluated him and determined it was in fact anxiety/ panic attack due to vaccine. After they left he had a couple more episodes where he felt as if he would faint and turned pale. RPh made sure to lay him down and had mom get him something to eat. It was 1:45 and he had only eaten a snack. He felt better after a soft drink and peanut butter cookies. RPh escorted patient and mom to car. RPh checked on them at 3:15. Mom stated he was good and had been resting and she was watching him. RPh checked again at 7:15 and he was fine.
rapid heart beat and pulse of 128; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (rapid heart beat and pulse of 128) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (rapid heart beat and pulse of 128). At the time of the report, TACHYCARDIA (rapid heart beat and pulse of 128) outcome was unknown.            No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
vaccine killed my mother; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (vaccine killed my mother) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The reporter was really upset and stated that the Moderna COVID-19 vacine killed his mother. The caller was demanding to talk to the scientists behind the Moderna COVID-19 vaccine and also wanted information about why ingredients like graphene, mercury are inside the vaccine. He also stated that the vaccine is causing the variants and that the people taking the poison it's genocide and that he observed the ingredients under a high power microscope.  Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced serious unexpected event of DEATH in an unknown timeframe after the unspecified dose of mRNA-1273 vaccine. The information regarding autopsy and cause of death was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Non significant follow up received.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no medical history reported, who experienced serious unexpected event of DEATH in an unknown timeframe after the unspecified dose of mRNA-1273 vaccine. The information regarding autopsy and cause of death was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Pt recvd 2 doses of Engerix-B & 30JUL92 reported developing a raised pustular rash on arms & chest;
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial did not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains no significant information.
Was pregnant at time of vaccination. Only in 1st trimester, Maybe 6 weeks. After the shot I had extreme diarrhea till I was 16/17 weeks. Then I had a sever rash all over my face in the second trimester. All things I never experienced with my first pregnancy. I had extremely low potassium and magnesium to the point of needing medication at the ER. Delivered and she was 7.7 pounds. I was pregnant again, found out 1/20/2023 and went into cardiac arrest 1/21/2023. Confirmed non viable 2/9/2023 and took miscarriage medication 2/11/2023. I?ve never had a miscarriage before. Drs don?t know if I already had a PE on my lungs prior or from CPR my husband administered during my SCA. I?ve seen many drs and still cannot determine why this happened to me. I?m a perfectly healthy 30 year old with no family history of LQTS.