chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 60 to 70 year old female with a history of anxiety attacks who during a routine visit with her physician was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin. It was reported that within thirty seconds of receiving the vaccine she developed a vasovagal response that included weakness and hypotension and recovered a half hour later (treatment not reported). The reporter indicated that the patient did not experience angioedema or anaphylaxis. It was reported that forty-eight hours later, the patient was on the internet and read that there was an interaction between aspirin and zoster vaccine live (Oka/Merck), she then suddenly felt gastrointestinal distress and malaise. It was reported that she visited a nurse practitioner and was ordered a gastrointestinal ultrasound that revealed the study was the same as her baseline (specifics not reported). At the time of this report it was indicated by the reporter that the patient was 90 percent recovered. A product quality complaint was not reported. Additional information was not available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007.  Information has been received from a pharmacist concerning a 60 to 70 year old female with a history of anxiety attacks who during a routine visit with her physician was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included ASPIRIN.  It was reported that within thirty seconds of receiving the vaccine she developed a vaso-vagal response that included weakness and hypotension and recovered a half hour hour later (treatment no reported).  The reporter indicated that the patient did not experience angioedema or anaphylaxis.  It was reported that forty-eight hours later, the patient was on the internet and read that there was an interaction between ASPIRIN and ZOSTAVAX.  She then suddenly felt gastrointestinal distress and malaise.  It was reported that she visited a nurse practitioner and was ordered a gastrointestinal ultrasound that revealed the study was the same as her baseline (specifics not reported).  At the time of this report it was ti was indicated by the reported that the patient was 90 percent recovered.  A product quality complaint was not reported.  Additional information was not available.  Follow up information received from the nurse practitioner indicated there was no further information to report.  Current patient status was not reported.  Additional information is not expected.
pt recv vax; extremely red, swollen; low fever; MD advised to watch closely; possibly may not be able to have pertussis;
Patient developed blood clots in left thigh. 1 removed- length of thigh.  1 removed length of belly button to left knee. A Stent was placed in groin area. There's now another one with limited blood flow. Xarelto is being used to help reduce clots.
Flu-like symptoms; Body aches; Minor aches in the arms; Nausea; Vomiting; Diarrhea; Rash; suspecting shingles; Suspected case of poison ivy; This case has been linked with wife's case US2020093437, reported by the same reporter. This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st February 2020, 1 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced influenza-like symptoms, general body pain, pain in arm, nausea, vomiting, diarrhea, rash, shingles and poison ivy rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and prednisone. On 22nd February 2020, the outcome of the influenza-like symptoms, general body pain and pain in arm were recovered/resolved. On 23rd February 2020, the outcome of the nausea, vomiting, diarrhea, rash, shingles and poison ivy rash were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, pain in arm, nausea, vomiting, diarrhea, rash, shingles and poison ivy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. On 21st February 2020, the patient experienced flu-like symptoms, body aches, with minor aches in the arms, nausea, vomiting, and diarrhea, rash. On 22nd February 2020, the flu-like symptoms body aches, and minor arm aches subsided. On 23rd February 2020, the patient did not have any symptoms. The Nurse Practitioner prescribed valacyclovir 1 gm three times a day for one week due to suspecting shingles. The patient's doctor prescribed Prednisone after suspected case of poison ivy contracted during an outdoor camping trip. The patient, wanted the information regarding Shingrix Vaccine Interactions with other medications and whether he should still receive the 2nd dose of Shingrix since the nurse practitioner he saw because of the rash that developed, stated it was shingles. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020093437:same reporter(wife case)
Pt suffered from vaginal bleeding - went to MD's office & it was confirmed she had a miscarriage. They said the baby had been dead for a while. Patient's fiance called the Rx concerned it was from flu shot.
On March 27, 2021 the patient developed some pleuritic chest pain and shortness of breath. he went to the Emergency Department at Hospital.
Pt came back to table w/in 30-45 seconds complaining about sudden dizziness, flush, lightheaded, sleepy.
Couldn't eat or drink; Vomited; Chills; Very confused; Responding in slow motion; She could not process conversation; Metallic taste in mouth; Dizzy; Bad stomach pains; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Very confused), HYPOKINESIA (Responding in slow motion), DYSARTHRIA (She could not process conversation), DYSGEUSIA (Metallic taste in mouth) and DIZZINESS (Dizzy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to many medications.).    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced CONFUSIONAL STATE (Very confused), HYPOKINESIA (Responding in slow motion), DYSARTHRIA (She could not process conversation), DYSGEUSIA (Metallic taste in mouth), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Bad stomach pains), VOMITING (Vomited) and CHILLS (Chills). On 24-Apr-2021, the patient experienced FEEDING DISORDER (Couldn't eat or drink). At the time of the report, CONFUSIONAL STATE (Very confused), HYPOKINESIA (Responding in slow motion), DYSARTHRIA (She could not process conversation), DYSGEUSIA (Metallic taste in mouth), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Bad stomach pains), FEEDING DISORDER (Couldn't eat or drink), VOMITING (Vomited) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
14 days after vaccines, onset of right shoulder and right wrist joint pain of moderate-severe intensity. Noted left shoulder joint pain also but not as intense. 3 months later, wrist pain gone but right shoulder pain continues but not as intense.
The patient recived first dose was BNT162B2 and second dose was Moderna; The patient recived first dose was BNT162B2 and second dose was Moderna; felt nauseaous when eating; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization; Moderna (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 30Jun2023, outcome "recovering", described as "felt nauseaous when eating"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "The patient recived first dose was BNT162B2 and second dose was Moderna". Therapeutic measures were not taken as a result of nausea.  Additional information: She felt nauseous when eating. She is also anti-vaccines. If COVID prior vaccination: No. If COVID tested post vaccination: No and If other vaccine in four weeks: No.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Chills; Bad diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2022 13:00 (Lot number: Pfizer 9893) at the age of 78 years as dose 4 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PNEUMOCOCCAL VACCINE taken for immunisation, administration date 01Apr2022. Vaccination history included: Bnt162b2 (Vaccine Name: First Covid vaccine, Lot Number / Expiry Date: unknown/unknown/ NDC 59267-1000-1, Route, Anatomical Location: left arm , No. of Previous Doses: No, Date: 02Feb2021), administration date: 02Feb2021, when the patient was 78 years old, for COVID-19 immunization; Bnt162b2 (Vaccine Name: Second  Covid vaccine, Lot Number / Expiry Date: unknown/unknown, Route, Anatomical Location: left arm , No. of Previous Doses: one, Date: 24Feb2021), administration date: 24Feb2021, when the patient was 78 years old, for COVID-19 immunization; Bnt162b2 (Vaccine Name: First Covid booster, Lot Number / Expiry Date:  EW0196/unknown, Route, Anatomical Location: left arm, No. of Previous Doses: two , Date: 26Sep2021), administration date: 26Sep2021, when the patient was 79 years old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 03Apr2022, outcome "not recovered", described as "Bad diarrhea"; CHILLS (non-serious) with onset 04Apr2022, outcome "not recovered", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that she got her second booster shot yesterday and was now having diarrhea. The patient stated that she was having bad diarrhea. The patient stated that she was having chills.
I developed a severe headache that lasted all night and until 3 pm the next day, dizziness, runny nose, and sweaty and feverish.
Site: Pain at Injection Site-Severe, Systemic: pain radiating from shoulder-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
pt recvd vax 17OCT95 to report that 13OCT95 pt lt arm was swollen, had some rash & was warm to touch;said it involved upper arm to elbow said it was better (less swollen & hot) 17NOV95;
I started getting what seemed like eczema on my right hip crease. Then a few days later, the left hip crease. And a week later between my breasts. the rash was and raised but about an inch or so.  It is itchy and burns a little.
Afraid of falling and braking a bone; Dizzy when changing from sitting to standing position; orthostatic hypotension; Balance issues/Balance issues are continuing /didn't have his legs under him; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizzy when changing from sitting to standing position), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), BALANCE DISORDER (Balance issues/Balance issues are continuing /didn't have his legs under him) and FEELING ABNORMAL (Afraid of falling and braking a bone) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Stroke on 11-Feb-2021, Rehabilitation therapy (post stroke), Surgery and Stent insertion NOS (stent procedure on right carotid artery.). Concomitant products included AMLODIPINE and LISINOPRIL for Blood pressure high, HYDROCHLOROTHIAZIDE for Hair loss, ATORVASTATIN for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS POSTURAL (Dizzy when changing from sitting to standing position), ORTHOSTATIC HYPOTENSION (orthostatic hypotension) and BALANCE DISORDER (Balance issues/Balance issues are continuing /didn't have his legs under him). On 07-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Afraid of falling and braking a bone). At the time of the report, DIZZINESS POSTURAL (Dizzy when changing from sitting to standing position), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), BALANCE DISORDER (Balance issues/Balance issues are continuing /didn't have his legs under him) and FEELING ABNORMAL (Afraid of falling and braking a bone) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were provided.  Patient undergone CT scans, skull sonograms w/o any new revelations (Results not provided.)  Patient Prior to 4/14 was successfully completed rehabilitation of a 2/12 stent procedure on my right carotid artery.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Significant Follow up received on 12-Aug-2021,  Updated medical history stent procedure details & Lab data details in INarrative Updated
EXPIRED VACCINE ADMINISTERED (VACCINE GIVEN 20 MINUTES AFTER THE 6 HOURS EXPIRATION MARK FOR A PUNCTURED VIAL STORED IN THE REFRIGERATOR); This spontaneous report received from a pharmacist concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient not have any known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced expired vaccine administered (vaccine given 20 minutes after the 6 hours expiration mark for a punctured vial stored in the refrigerator). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (vaccine given 20 minutes after the 6 hours expiration mark for a punctured vial stored in the refrigerator) was not reported. This report was non-serious.
slept soundly for 16hrs; woke up screaming w/102 fever; constant screaming & fever; gradual loss of motor skills; 16MAY to ER loss of leg movement; first wk of JUN G tube for feeding purposes;
inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees with no adverse event reported; inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg F with no reported AE; Initial information was received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old female patient who inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg f with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (vero).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 09-Feb-2023, the patient received a dose 4 of 0.5 ml of suspect  diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) (lot UJ682AAA) (with unknown expiry date) via intramuscular route in left leg for immunization.  On 09-Feb-2023 the patient developed a non-serious event of inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg f with no reported ae (poor quality product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  On an unknown date the patient developed a non-serious event of inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg f with no reported ae (product storage error) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg f with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA056272:01495184
Second Dose: blood pressure went to high; Second Dose: started to black out, if his partner had not been there for him he might be dead right now; Second Dose: blood pressure dropped to 89/56; Second Dose: too weak to walk very far; Second Dose: diarrhea; Second Dose: Nausea; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 09:00 at single dose for COVID-19 immunisation at the age of 66-year-old. Lot number was EN6198. Medical history included ongoing hypertension (10-15 years), ongoing degenerative arthritis since 2010, ongoing Rheumatoid arthritis since 2015, pain, prostate infection (treated with antibiotic; stopped taking the antibiotic and all of his medications), pneumonia in Sep2020 (unrelated to the Covid 19 virus, hospitalization). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Feb2021 at single dose in left arm for COVID-19 immunisation at the age of 66-year-old and he experienced nausea, slight diarrhea, tiredness; lot number was EM9810. Concomitant medications included adalimumab (HUMIRA), methotrexate, hydrocodone. On 18Mar2021, the patient experienced nausea and diarrhea. The patient received ondansetron 4mg tablets, take 1 by mouth every 4 hours as needed for nausea. On 20Mar2021, the patient experienced black out, if his partner had not been there for him he might be dead right at the time of report, it was a bad, bad experience (life-threatening), blood pressure dropped to 89/56 and too weak to walk very far. The patient drank lots of fluids and they were able to get his blood pressure back up, the doctor almost sent him to the hospital to get fluids. Then his blood pressure went to high and he had to get it down. The patient had gone to pick up some groceries and he started to black out. He had to ride in the motorized cart around since he was too weak to walk very far. The patient has had to ride the motorized cart before because he has degenerative arthritis and rheumatoid arthritis. The patient got into his van to leave and he could not drive home. It was only 7 miles but he felt like he would have blacked out and it would have been dangerous; he called his partner and he came to get him. On 21Mar2021, the patient experienced blood pressure went to high. On unknown date, blood pressure resulted high, cystoscopy (urine came back positive for infection), Covid 19 virus test (negative). On 20Mar2021, blood pressure dropped to 89/56. On 22Mar2021, blood work was performed (unknown results). Doctor recommended that he should stop taking his arthritis medications and pain medication. The doctor told him those medications might interfere in getting the Covid 19 vaccine; the patient took immune depressors. The patient did not recover from weakness and nausea, the patient recovered from diarrhea; the outcome of other events was unknown.
This is a spouse. Medical Center do not have this patient's medical record and is reporting the reaction on her behalf based on available information. Patient reported she was  having brunch 4/11/21 am and started feeling very dizzy (was dining outside) and her son informed her  that she was very pale.  Her stomach started to rumble and threw up. Son called  the ambulance due to "low pulse" and "loss of consciousness". She was treated at ER with iv fluids and anti-nausea medicine and was discharged that day (4/11/21) around 1pm with diagnosis of "Vagal Response".  She recalled being in the ambulance around 4/11@11:10am.
Individual began to experience abdominal pain and cramps, with a fever and chills, and nausea and vomiting about 6 hours after being vaccinated. Member did not go to class the next day. Service member did not seek medical care. Returned to normal 48  hours later. Vomiting stopped after that first night but the other symptoms persisted for 48 hours.
The day after I was groggy and tired but my ears had a sense of pressure in them. After a few weeks the pressure worsened. I then when to an ENT where I was diagnosed with Eustachian Tube Dysfunction and will now be having tubes put in my ears. For all 20 years and 8 months of my life I?ve never had this issue, but one day after receiving the COVID shot, I started to experience ear issues.
Extreme malaise and dizziness, patient had difficulty getting out of bed and missed two days of work.
Migraine, fatigue, memory loss, confusion, disorientation starting 1-2 days after and persisting day 4.