chrisvoncsefalvay/vaers-outcomes huggingface dataset:
coughing; nasal started dripping and burning; nasal started dripping and burning; Headache; aching; wants to puke all the time; arm was sore; Nauseous; Weak; tired; Chills; sweat; left arm is swollen; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 29Mar2021 at 07:30 (Batch/Lot Number: ER8733) (at the age of 60 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma. The patient had no family medical history relevant to the adverse event. The patient did not undergo any relevant tests. The patient had no concomitant medications. The patient had no history of all previous immunisation with Pfizer vaccine considered as suspect. The patient received no vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced arm was sore, nauseous, weak and tired, headache, aching, wants to puke all the time, chills on 29Mar2021; coughing, nasal started dripping and burning on 29Mar2021 at 21:00; left arm was swollen, sweat on an unspecified date in Mar2021. The patient did not have the cough anymore. The patient was fine all day until 9:00 pm. The events did not result in physician's office visit or emergency room visit. The outcome of events nauseous, weak, nasal started dripping and burning was not recovered; outcome of events arm was sore, tired and chills was recovering; outcome of events headache, aching, wants to puke all the time, left arm was swollen, sweat was unknown; outcome of event coughing was recovered on 30Mar2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist referring to an unspecified number of patients of unknown age and gender on pediatric dialysis. On an unknown date, in the past, the patients were vaccinated with the complete hepatitis b vaccine (recombinant) (manufacturer unknown) series (dose, route and lot not reported) pediatric doses, but did not respond. These pediatric dialysis patients then received additional doses of pediatric hepatitis b vaccine (recombinant) (manufacturer unknown) and still did not respond. Nurse manager told the pharmacist that these patients received a total of 8 to 10 doses of unspecified pediatric hepatitis B vaccine (with no response). Nurse told the pharmacist that these patients received a total of 8 to 10 doses of pediatric hepatitis b vaccine (recombinant (manufacturer unknown) (with no response). Antibody titers for hepatitis B were negative. At the time of the report, the outcome for the adverse event was unknown. Additional information has been requested.
8 days after the injection a bright red warm goose egg size lesion appeared at the site of the injection.  It enlarged to cover the whole deltoid within a few days and then gradually resolved (starting with central clearing) over 7-8 days.  It was very itchy.  Warmth/heat over the lesion resolved over 3-4 days.
on 3/10 I started having terrible ringing in my ears and head i have been to doctors. It did not help, I am now going to a acupuncturist for help. it is helping but as of today 3/15 my head is still ringing but less so with the help of acupuncture.
Normal physical, and vaccine given 10-20-23 at 1:36pm.  Complained of arm pain 6:30pm, I gave Tylenol and ibuprofin.  At 8:30pm he was playing video game with his siter and felt lightheaded.  He walked to fridge to get a drink of water, started walking back to his room.  I was in bed and heard what sounded like a tree fall on the house, then heard my daughter yelling for me.  I walked in dining room and he was laying face down in a large pool of blood.  He was unconscious approx 5 minutes.  Ambulance was called-he regained consciousness.  Vitals and blood sugar were good.  Opted to watch him every2hrs at home and get treated Sat 10-21-23.  Went to ER he had a fractured nose, Lt brow contusion, 3 chipped teeth, and an abnormal EKG.  He is set-up for a heart monitor for 10-27-23 and nose surgery 10-31-23.  Perfectly healthy 16yr old before this vaccination.
PATIENT REQUESTED DOSE OF JANSSEN VACCINE,  Pt provided Immunology report indicated on 05/11/2021 had negative covid antibody test even after 2 doses of moderna vaccinE.  Per prescriber. PATIENT was recommended to get J&J vaccine. REPORTING THIS SINCE IT IS OUTSIDE OF NORMAL GUIDELINES.
After receiving the first dose of the Moderna COVID19 vaccine, my menstruation completely stopped for 90 days. Prior to vaccination, I had never missed a period. Each occurred very regularly every 27-28 days.
Pt received Tdap, HPV and Menactra and then slumped over into mother's arms motionless, then jerked involuntarily and was layed down with eyes open & unresponsive.  About 10 sec. later pt. jerked again and sat up crying and wanting to know what was happening.  Pt was kept approx. 20 min.  VS stable and accucheck done- 131.  Was allowed to leave after taking po fluids.
About 3 months after 2nd dose, noticed pvc's several per minute, including some short runs of trigeminy. Would notice occurring for several hours one day, then  none for a few days.   Then would experience repeat of this pattern.  Normally have occasional pvc's, noticed once in a few days to weeks.  The more frequent pvc's were happening every few days for about a month.  Then went about a month with the more normal rhythm.  Having some the more frequent pvc's again today.
Swelling with localized fever, itching and quarter-silver dollar sized lump under skin after initial swelling and lump at injection site had subsided
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored ROTATEQ orally (dose, lot# and expiration date were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
At first I became increasingly lethargic then started having bad back pain. The pain became increasingly worse which was in my whole spine. This pain was like nothing I had ever experienced before. It was not relieved by pain meds, stretching or sleep. The excruciating pain did not allow me to sleep. This pain lasted for 5 days and has just barely started to subside. I feel like my back is bruised like I had been in a car accident.
Patient was watched for 1 hour after receiving the 2nd vaccine due to face and neck tingling, chest pressure and racing heart. On the second day follow up to patient, all symptoms had resolved.
Syncope, Dizziness.  Pt reported symptoms of dizziness after vaccination that did not improve in observation.  Pt taken to private observation room.  BP 133/76, HR 77, RR 16 -- > 133/75, 76, RR 16.  Pt laying on bed communicating and resting.  Pt symptoms resolved and pt was released from the vaccination site.
This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 04-OCT-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # M040146 and expiration date 26-DEC-2017) at a temperature of 15°F to 46°F and time frame 14 hours 30 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
My upper shoulder where the injection site was administered is swollen and movement is at 25%. Feels like my Bursa is inflamed due to pain and lack of ability to use left arm. I wake with shoulder pain every morning. I went to my Physician and was told if pain continues then schedule MRI.
Headache, Diarrhea, RIGHT ARM NUMBNESS, LOSS OF APPETITE Narrative:
Swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), ENALAPRIL, HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include topical gel for arthritis.  Treatment information was not provided
Patient admitted ~48 hours post vaccination due to dehydration and weight loss in months post left partial glossectomy, left neck dissection, free flap reconstruction and flap reconstruction on 12/31/2020
The day after the vaccine I experienced fatigue.  The Saturday following the vaccine I developed a sore breast.  I saw the Dr the following Tuesday and was dx'd w/ Mastitis.  I was put on Keflex and antibiotics and warm compresses.
Seizure occured 20-30 minutes after basketball game. Had episode where she held breath while standing and had a blank stare. Patient then fell to the  ground and had jerking movement in upper extremities. lasted about 5 seconds. complained of dizziness afterwards.
Fever of 102, beginning in the evening post vax. This has continued for approximately 5 days. Urticaria began 3 days post vax.
Patient tested positive for Covid-19 01/25/2022.  Patient was admitted to Medical Center on 02/24/2022 after a fall with multiple intracranial hemorrhage and HTN urgency.  Patient had bilateral frontal and right temporal subdural hematoma, right frontal parenchymal hemorrhage, trace parafalcine subdural hemorrhage.  Patient started on comfort measures on 02/28/2022 and expired on 03/04/2022.
This spontaneous report was received from a late 60 years old female patient via company representative. The patient's pertinent medical history and drug allergies were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency and route were unspecified). Concomitant medications were unspecified. On an unknown date the patient experienced shingles after receiving ZOSTAVAX. Sought medical attention and treatment received were unspecified. The outcome of shingles was reported as recovered on an unspecified date. The causality of shingles was not reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
patient did receive an expired adacel dose with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age male patient who receive an expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (latency: on same day). Information on the batch number was requested.  Reporter stated originally she reported that no patient's received an expired dose, however after speaking with her MA(medical advisor) it became known that a patient did receive an expired ADACEL dose.  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The day after my 2nd shot I had extreme body aches for approximately 24 hours and also developed a rash under my left breast, that almost 2 weeks later has not cleared up completely.   It looks like hives and it itchy. I have sought no medical treatment for this issue as of yet.
Information has been received from an office manager referring to an unspecified amount of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # K016263, expiry date: 26-JUN-2016, orally, dose unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
The vaccines were administered around 11:00 am on Monday, February 13th. By the late afternoon on the 14th, had several red welts forming on the fronts of each of his thighs. We called the pediatrician's office, described what was happening, and were told to administer Benadryl and Motrin and to apply hot compresses if he was in pain. By Thursday afternoon, the rash was certainly not improving. Rather, it's nature had changed. The tops of his thighs were still very red and swollen, and he had smaller red bumps all over the fronts of both thighs. (They were larger than pimples, but smaller than the original welts.) We contacted the pediatrician's office and were told to bring him in on Friday morning. We did. Dr. saw him and conceded that he had rarely seen a reaction like his. He gave us a strong cortizone cream to apply. It is a little over a week later, and his rash has lessened in color and texture, but is not gone.
The day after the vaccine, I started to experience severe uterine cramps and bleeding heavier than my usual menstrual period. What is unusual about it is that, according to my birth control pill schedule, I was not expecting to get my period until at least six days later. This may or may not have been a direct effect of the vaccine, but I though that I should report it just in case.
Began being dizzy; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6198) via an unspecified route of administration in the left arm on 26Feb2021 at 17:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included heart attack in 2014 (with stents), shingles, penicillin allergy and sulfa drug 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 aciclovir (ACYCLOVIR) from an unknown date until 24Feb2021 for shingles, rosuvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (kASPIRIN); both taken for heart attack from an unknown date and was ongoing and also other unspecified medications. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 01Mar2021 at 17:30, 72 hours after vaccination, the patient began being dizzy to the extent that the patient could not think straight and was nauseous. The events did not result in doctor or other health care professional office/clinic visits, and the emergency room/department or urgent care. 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 began being dizzy and nauseous was resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Shortness of breath; Tightness in chest; Tickle cough; Patient took first dose on 25 Mar 2021 and second dose on 01 Aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest), COUGH (Tickle cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 25 Mar 2021 and second dose on 01 Aug 2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 25 Mar 2021 and second dose on 01 Aug 2021). In 2022, the patient experienced DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and COUGH (Tickle cough). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE (DELSYM) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and COUGH (Tickle cough) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 25 Mar 2021 and second dose on 01 Aug 2021) outcome was unknown.            No concomitant medication was provided.  It was reported that Albuterol and Delsum but continued to cough and it worsened. Physician suggested to stop Rinvoq and last dose was on 06 Jul 2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of shortness of breath and Tickle cough with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the event of tightness in chest was not provided.
Vaccine reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccine reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccine reaction). At the time of the report, VACCINATION SITE REACTION (Vaccine reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment medication were reported.
5 by 5 erythromelia, tender, warm local reaction to Tdap.  Treatment: KEFLEX 500
Information has been received from a mother concerning her 21 month old white male son with a history of ear infections and no allergies, who on 04-MAR-2005, was vaccinated once with a subcutaneous 0.5ml dose in the right thigh of varicella virus vaccine live (Oka/Merck) (Lot# 648944/0894P). There was no concomitant medication. It was noted that the patient was healthy child at the time of vaccination and that there were no adverse events following prior vaccination. On 22-AUG-2005 the patient experienced shingles covering the right side of his chest and back and his stomach. At the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from the patient's mother indicated that he was given acyclovir (ZOVIRAX) and that he had no complications and no secondary infections or problems. It was reported that the patient recovered. Additional information is not expected.
Severe Dermatitis Condition. Spread all over my body and the legs are heavily affected. I applied Hydrocortizone ointment but no reduction. Also applied moisturizing cream (REMEDY). (Received Twinrix Inj - from pharmacy). **Note I do not have health insurance as i come from a foreign country on 29th August 2008.
Initial unsolicited case received from a physician on 05-Nov-2015. This case was linked to 2015SA179107 and 2015SA179115 (same reporter and same vaccine). This case involves a patient (age and gender not reported), who was vaccinated with an intramuscular dose of FLUZONE HD (batch number, dose number and site of administration were not reported) on unspecified date in 2015. Medical history and concomitant medications were not reported. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On an unspecified date in 2015, after vaccination the patient experienced respiratory failure and was on a ventilator. On an unspecified date, patient was hospitalized. Laboratory examinations and corrective treatments were not reported. The outcome of the event was reported as unknown. Case was considered as serious due to hospitalization and life threatening event. Documents held by sender: none.
Vomiting; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and FATIGUE (fatigue) 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 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting) and FATIGUE (fatigue). At the time of the report, VOMITING (Vomiting) had resolved and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Telephone contact report received on 17-06-2021 does not contain any new information