chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOMITING; DIARRHEA; NUMBNESS FEELING IN BODY AND LEGS; ACHEY; RASH; CHILLS; FEVER FLUCTUATING UP AND DOWN; HEADACHE; A BRUISE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included alcoholic, and other pre-existing medical conditions included the patient did not have any history of drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced a bruise. On 04-JUN-2021, the subject experienced vomiting. On 04-JUN-2021, the subject experienced diarrhea. On 04-JUN-2021, the subject experienced numbness feeling in body and legs. On 04-JUN-2021, the subject experienced achey. On 04-JUN-2021, the subject experienced rash. On 04-JUN-2021, the subject experienced chills. On 04-JUN-2021, the subject experienced fever fluctuating up and down. On 04-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a bruise, was recovering from rash, and numbness feeling in body and legs, had not recovered from fever fluctuating up and down, vomiting, chills, and headache, and the outcome of diarrhea and achey was not reported. This report was non-serious.
Information has been received from a nurse practitioner concerning a 19 year old female who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil (yeast). The patient was experiencing vomiting and diarrhea and had no fever prior to receiving the vaccination. Subsequently, the patient developed swelling of hands and feet and her face got puffy after receiving Gardasil (yeast). The patient sought medical attention and was treated with an unspecified antihistamine. Subsequently, the swelling went away, and the patient was considered recovered. Additional information has been requested.
High fever, lethargy, generally unwell, no desire to drink, followed by full body rash 3 days later.
I felt tired, very exhausted. I had some body aches and a headache. Then, my wife was diagnosed with mono. On 08/02/2021 I missed work and I got tested for it and I got diagnosed with it as well. I also got a Covid test and tested negative. They told me there was no medicine to treat it but I should rest and drink lots of fluids. On 09/01/2021 I had a thick bite and the doctor put me in antibiotics right away. They assumed I had Lyme disease because it was a bullseye. I was tested for it and it came negative. They did another Covid test and it was negative again.
1/22/22  Cough     Productive cough x 1 week.  Denies SOB, fever, or other symptoms   22 yr/o female with no chronic medical problems who presents to the emergency department complaining of cough.  Patient states that for the last week she has had a productive cough.  She denies any fever, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea.  She states that she is here for COVID-19 test because her mom was positive.  She has had 1 out of 2 COVID-19 vaccines.  She declines any additional work-up other than a COVID-19 test. Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Negative for ear pain and sore throat.    Respiratory: Positive for cough. Negative for chest tightness and shortness of breath.   Cardiovascular: Negative for chest pain and leg swelling.  Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Genitourinary: Negative for difficulty urinating and dysuria.  Musculoskeletal: Negative for back pain and arthralgias.  Skin: Negative for pallor and rash.  Neurological: Negative for dizziness and headaches.  Psychiatric/Behavioral: Negative for agitation and confusion.  All other systems reviewed and are negative.
The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient; The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient), PRODUCT STORAGE ERROR (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient) and NO ADVERSE EVENT (no adverse event) in a 97-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient), PRODUCT STORAGE ERROR (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient), PRODUCT STORAGE ERROR (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient) and PRODUCT STORAGE ERROR (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient).    Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.
PT EXP PAIN AND STINGING AT SOI AFTER RECEIPT OF ENGERIX-B.  TREATMENT:  PT COUNSELING.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 21-NOV-2015, the patient was inadvertently vaccinated with expired PNEUMOVAX 23, expiry date 30-AUG-2015, (lot#, dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information is not expected as the reporter did not wish further contact.
Light headedness and dizzy spells; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness and dizzy spells) and PAIN IN EXTREMITY (Arm soreness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Light headedness and dizzy spells) and PAIN IN EXTREMITY (Arm soreness). At the time of the report, DIZZINESS (Light headedness and dizzy spells) and PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event(s) of LIGHT HEADEDNESS AND DIZZY SPELLS and ARM SORENESS with RINVOQ was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Pt was given Pneumovax on 5/11/09, pt called on 5/13/09 and spoke to triage nurse asking if the following symptoms are normal after recieving the pneumovax.  Symptoms redness and swelling at site of injection and inability to move arm.  Pt was given appt to be seen and evaluated.  Pt seen by primary care doctor who advised was normal reaction.
This spontaneous report was received from a register nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on 26-OCT-2015, the patient was vaccinated with an expired dose of GARDASIL 0.5 ml intramuscular, lot # H021861, expiration date 09-OCT-2015. No adverse effects reported. Additional information has been requested.
No additional Adverse Event; HCP reporting a patient was administered VAQTA that was improperly stored.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-SEP-2022, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once at a dose of 0,5 milliliter, lot number W003118 with expiration date 13-JUL-2023, administered for prophylaxis (route of administration and anatomical site of application were not provided) (product storage error), which had a temperature excursion of 32.29 fahrenheit (F) for 1 hour 32 minutes 0 seconds. No additional adverse event reported and there was no previous temperature excursion.
Noticeable headache, body aches, uncontrollable chills, rapid heart beat, some nausea.
Myalgias, fatigue, weakness, esposidic paralysis in arm and leg muscles, deep muscular heat, deep muscular pain in back, neck, legs, arms and chest; no endurance; dizziness; labor breathing; headache; low temperature: 95-97F; muscle aches; muscle cramps; difficulty with words and concentration; difficulty getting up stairs and up out of chairs; body weakness; malaise. Follow up 4/13/04: Last Wednesday, 4/7/04, doctor concluded that patient had chronic hepatitis (did not specify type) as a result of vaccine received on 11/13/03. Mentioned that it was not communicable. Blood test in March showe liver enzymes were elevated just like in December.
Swelling; Tingling; hand swollen; This is spontaneous report from a contactable Pharmacist.   A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EH9899, Expiration Date Mar2021, intramuscular in deltoid, on an unspecified date at 0.3 mL, single for COVID-19 immunisation. Medical history was none.  There were no concomitant medications. On an unspecified the patient experienced swelling, tingling, and hand swollen. The events were non serious. Therapeutic measures for the events included treatment with BENADRYL. The outcome of the events swelling and tingling was unknown. The outcome of the event hand swollen was recovering. Causality provide by the Pharmacist: "Most probably."
This case was reported by a physician and described the occurrence of decreased therapeutic response in an adult male subject who was vaccinated with ENGERIX B. On unspecified dates, the subject received 1st and 2nd doses of ENGERIX B (unknown) and received the 3rd dose in July 2007, completing the vaccination series. At an unspecified time after vaccination with ENGERIX B, the subject experienced decreased therapeutic response. The physician reported the subject did not develop a seroprotective titer of ant-hepatitis B surface antigen antibody after he was tested in December 2007 and showed inadequate protection. At the time of reporting, the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with ENGERIX B.
heaviness and pressure on her chest which got worse and worse. She went to the ER; heaviness and pressure on her chest which got worse and worse. She went to the ER; chest pain; sick; acid reflux; This is a spontaneous report from a contactable consumer. This consumer reported for a 58-Year-old female patient (Mother) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Apr2021 at single dose for covid-19 immunization. Medical history was chronic bronchitis and allergies. Concomitant drug was not reported. Caller is calling for her 58 year old mother who received the 1st dose of the Pfizer COVD Vaccine on 05Apr2021. She mentioned that she was totally fine on the 1st day, but after 20 hours, she felt a heaviness and pressure on her chest which got worse and worse. She went to the ER and stayed there for 8 hours. Her mother had chronic bronchitis and allergies, so they did bloodwork on her, had an EKG, and other test but everything was normal. She was given a ventolin inhaler and was sick the whole week with chest pan and acid reflux. She is scheduled to receive her 2nd dose on 26Apr2021 and the ER told her to call Pfizer and ask if it was okay for her to take the 2nd shot. She mentioned that her mother was fine now. Outcome of the event heaviness and pressure on her chest was not recovered, for other events was unknown.  Information on the lot/batch number has been requested.
Patient was hysterical and crying during administration of vaccinations. After the vaccinations were administered she was informed to sit in the chair for 10-15 minutes, but she insisted sitting on the floor. A few minutes later she began to lose consciousness. She was laid to floor and regained consciousness immediately. Blood pressure was slightly low 90/50 and slowly increased to 108/90 from lying, to sitting, to sitting in chair, to standing, to walking.
Dizziness 6:00 PM. Nausea/vomiting 7:00 PM.
Information has been received from a physician and a 68 year old female licensed practical nurse who on 10/30/02 (also reported as November 2002 by the physician) was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent, 0.5mL, in her arm (lot # NDC0006 - invalid). On 10/31/2002, the patient's arm was swollen from her elbow to her shoulder and it was hot and painful to the touch (also reported as local soreness by the physician). The outcome was not reported. The patient sought unspecified medical attention. Additional information is not expected.
Pt. got the flu shot at 1:10 P.M. After 10 to 15 minutes when pharmacist checked on her, pt. is on the floor but conscious. Pt. is clammy and complain of dizziness. Pt vomited. 911 called. Paramedics came and took over. Pt was fine after few minutes.
received only liquid portion; received only liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 26th April 2022, the patient received Shingrix. On 26th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comments: The patient received only liquid portion of Shingrix, without being reconstituted. The reporter wanted to know if they had to be revaccinated since it did not seem like a full dose and in case revaccination needed, which would be the recommended interval between doses. The reporter did not have any demographic details from patients since she send them over to the manager. The reporter provided batch number but was not sure if it was for liquid portion or lot number from the box.  The reporter consented to follow up. Additional Supportive Information: The patient first received only liquid portion of Shingrix, without being reconstituted, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This is 1 of 7 link cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022AMR073093:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter US-GLAXOSMITHKLINE-US2022AMR073092:Same reporter
At about 10 PM I started getting body aches and that eventually went away. I have been having insomnia since it first started on 03/27/2023.
Mild cough and blisters in mouth and cheek on the right side . Started with congestion
Starting 06/06/2022, I started with a mild scratchy dry throat. That afternoon, I developed a rare and end of inhalation dry cough. In the morning the same day I was out with some people at a retreat that I had been at since 06/01/2022 (at least 6 people tested positive for COVID there: the first person tested positive on 06/03/2022). I tested myself that morning and was negative. On 06/07/2022, I tested myself and was positive, then tested myself again and I was positive. I ended up confirming the positive test at a local medical center via a PCR test and wanted to go there to get PAXLOVID. They prescribed me PAXLOVID and I started it that afternoon. I had a low grade temp at that time (101.1). This was the only time I had an elevated temperature. My dry cough was gone by 06/08/2022. My scratchy dry throat persisted for about 4 days. I completed the 5 days of PAXLOVID as prescribed. I never had fatigue or shortness of breath. On 06/10/2022, I still tested positive after feeling well. Yesterday, 06/13/2022, I tested myself and was negative.
patient received 0.5ml instead of 0.25ml dose.  No adverse affects.
Patient stated she received first Pfizer vaccine on 5/4. She stated 15 minutes later she was light headed so they told her to stay another 15 minutes. She complains of headache, rash under both breasts and wrists, and a couple red spots on arm, also nausea. she stated rash is very itchy and went to pharnacist and was told to take Benadry. She stated she will take it when she gets home. RN reviewed supportive care. An RN will follow up with her tomorrow.
pt recvd vax 3JAN96 4PM & mom reports by 730 still laying on couch-lethargic, eyes glazed, legs hurting, wouldn't walk (inj given in lt arm);no fever;face flushed;TC to ER instructed if worsen to come in;920AM 4JAN96 almost back to nl
She verbalize she develop pain in left leg and dizziness.  She was evaluated onsite by Fire Rescue and released home feeling better at 9:51 am.
Nausea, vomiting, vertigo, swollen tongue, sweating, fever, HTN 12 hours after the vaccine.
Initially, erythema at injection site, then clear filled vesicles (blisters) that eventually broke open & healed. Advised to treat with OTC Claritin & Advil by physician.
Mildly increased heart rate (90 bpm, normal 60 bpm) and pervasive feeling of anxiety.
get shingles even after the vaccine / Suspected vaccination failure; Shingles; 2 of the patients were female and not yet 50; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: get shingles even after the vaccine / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and inappropriate age at vaccine administration (Verbatim: 2 of the patients were female and not yet 50). The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 16-AUG-2023 The patient was in late 40s. The reporter asked if the vaccine itself could cause a case of Shingles. Reporter stated that she had three patients still get shingles even after the vaccine and discussed that might be a possibility at some point, but she indicated that she believed it might had been a result of the vaccine itself. The reporter discussed that the adverse events that include flu-like symptoms including myalgia, fatigue, headache, shivering and fever and when asked if these might had been the symptoms that the patient experienced, she stated no, and stated what they experienced, was indeed a case of shingles. Reporter discussed that the indication was for patients over 50 years. The reporter did consent to follow up. The patient below 50 years received Shingrix, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. This case was 1 of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR112288:same reporter US-GSK-US2023AMR112314:same reporter
Patient reports inability to move left arm for 20 hours post vaccine. Did have pain and sensation of feeling in left arm. Reports having to use right arm to move left arm for use.
No additional AEs reported; a patient received her first dose of GARDASIL 9 two years ago and did not receive the second or third dose recommended in the series; This spontaneous report was received from a pharmacy technician referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.    In June 2019 (reported as two years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. The patient did not receive the second or third dose recommended in the series (inappropriate schedule of product administration). No additional adverse event was reported.
This spontaneous report as received from an other refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ, oral for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1707USA010451: US-009507513-1707USA010526: US-009507513-1707USA010527: US-009507513-1707USA010529: US-009507513-1707USA010530: US-009507513-1707USA010531: US-009507513-1707USA010532: