chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave a 63 year old patient Fluarix, patient then came back and asked for another flu shot so they gave them FLUZONE QUADRIVALENT with no  AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves 63 year patient who received fluarix and then came back and asked for another flu shot so they gave them INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [batch number and expiration date not reported] via an unknown route and site for prophylactic vaccination on an unknown date (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was a case of an actual medication error due to extra dose administered (latency unknown).  At the time of report, no adverse event was 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.  There will be no information available on the batch number for this case.
03/15/2021: Scheduled/planned left total knee arthroplasty. No complications or adverse events noted.
01/12/22 presents to Surgery for "RIGHT CAROTID ARTERY ENDARTERECTOMY". PMHx of "asymptomatic high grade right ICA stenosis"
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip) and CHILLS (Chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip) and CHILLS (Chills). On 05-Mar-2021, the patient experienced HEADACHE (Headache). On 22-Mar-2021, DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Felt bloated Stomach intestines and grown, (whole area)), PAIN (Felt aches and pain all throughout the body), ARTHRALGIA (Severe pain upper left back and front hip), CHILLS (Chills) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-067006.
patient was given wrong vaccine by mistake, np which ordered vaccine stated it was harmless mistake and the pt will be fine.
p/vax pt lt arm at inj site sore w/small knot ; swollen extremely tender touch; warm to touch; throbbing; 8/15 cont warm to touch; swollen, red w/hard knot; 8/16 warm to touch, red, knot; tender touch;
Had booster of Pfizer Biontech on 10/1/21. No major effect.  On the  night of 10/11/21 I got tinnitus in left ear, hissing sound, 24 hours a day.  Seeing ENT doctor on 10/29/21.
Severe flu like illness; NOT to have my 2nd. scheduled shot; Bruise on arm at injection site/Huge area of bruising; Diarrhea; Very Sick; Side effects; Vomiting; Chills; Body aches; Fever; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising), DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects) and INFLUENZA LIKE ILLNESS (Severe flu like illness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was hospitalized with serious symptoms.) on 01-Feb-2021 and Infusion (Infusion of BAM, a monoclonal antibody.) on 02-Feb-2021.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Exhaustion). On 05-May-2021, the patient experienced VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Severe flu like illness) and INTENTIONAL DOSE OMISSION (NOT to have my 2nd. scheduled shot). At the time of the report, VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising), DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects), INFLUENZA LIKE ILLNESS (Severe flu like illness), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Exhaustion) outcome was unknown and INTENTIONAL DOSE OMISSION (NOT to have my 2nd. scheduled shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: (Positive) Postive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received included medical history details of the patient and new adverse events.
First dose had mildly sore arm only.  Second dose felt great initially, even exercised. Then about 14 hours after injection developed chills followed in a couple of hours by fever as high as 100.9, nausea without vomiting, and severe headache which felt like a severe migraine. I get migraines occasionally, This was quite severe but I hesitated to take my usual Maxalt so it's possible the headache just evolved without adequate treatment. I felt terrible for at least 24 hours and then moderately awful for another day. Laid on sofa for two days. *Also, please note that I was confused by question regarding health care facility and listed my PCP's office. However the vaccine was administered by health dept at a drive through location.
hepatic injury; This literature-study case was reported in a literature article and describes the occurrence of LIVER INJURY (hepatic injury) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:(Privacy)    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. On an unknown date, the patient experienced LIVER INJURY (hepatic injury) (seriousness criterion medically significant). At the time of the report, LIVER INJURY (hepatic injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVER INJURY (hepatic injury) to be related.    Concomitant product use was not provided by the reporter.    ?No treatment information was provided.  Company Comment: This literature case concerns a 59-year-old, female patient with no medical history reported, who experienced the unexpected serious AESI of Liver injury, at an unknown day after an unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.   This case was linked to MOD-2021-419607, MOD-2021-419608, MOD-2021-419609 (Patient Link).; Sender's Comments: This literature case concerns a 59-year-old, female patient with no medical history reported, who experienced the unexpected serious AESI of Liver injury, at an unknown day after an unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
pt recvd vax 29OCT93 530PM & next day c/o myalgias, joint aches, gradual onset h/a, scratchy throat, nausea;
the week following the second vaccination i was experiencing chest pressure and tightness in throat.  I went to a clinic, then pulmonologist, ENT, speech, cardiologist, heart cath done for mild pulmonary hypertension from the Echo..  Symptoms persisted all year.  PVCs were noted during an event monitor.  Nothing super significant was found among testing.  I tried to ignore it with continued symptoms.  This has drastically impeded my lifestyle.  I am / was a regular runner and rode a bike between both 6 days a week.  I am unable to do so now to that degree and I am symptomatic with activity.  The arrhythmia has got worse and I went back to physician and   waiting for appt with cardiologist.   I am not sure if this is 100% all having to do with the vaccine.  That is the only thing that was different when all of this began.   I have ran and been active since my early teens, no chronic health conditions.... no high blood pressure, not overweight, no diabetes, no chronic pain, no respiratory conditions, no medications other than supplements, low to no normal caffeine intake.  I went from running 30 miles a week and had ran 13 right before the second vaccine and within a few weeks was having a difficult time running 10, then 8 and kept getting less with chest pressure/pain , throat tightness and shortness of breath.  That has gotten better at times but not close to what it was
Within 24 hours, patient developed redness, swelling and warmth to the right thigh where injection was given. Erythema spread. Patient was seen in the clinic 2 days after DTAP vaccine. Site size was 8.5cm x 8.5cm. She was treated for cellulitis with Rocephin and Augmentin. It is not clear if she had an allergic reaction or cellulitis secondary to injection puncture site. It was resolved or very much improved on follow up office visit 6/1/01.
It was reported that a 2 year old female was vaccinated with Fluzone SV '99-'00 on 11/30/99. On 12/1/99, the pt's mother complained pt developed a fever of 101.3F. On 12/2/99, additional complaints consisted of erythema, macular rash, swelling, warmth and pain at the injection site on the left thigh. The pt also reported pain in her knee.
Beginning at approximately 11am the day after vaccination, experienced chills, headache, extreme fatigue, swollen and sore arm at vaccination site, general body aches, and significant nausea.  Symptoms resolved by the following morning.
At night after vaccine, needed cold compresses for several pain in arm around injection site.  Next day had shaking chills all day, intense body aches, fever peaked at 101.1 with acetaminophen 1000 mg every 6 hrs.   Slept well second night.  Today still with fever on awakening100.6,  body aches ,  arm pain is slightly improved.
After injection on Friday, headache, fever, tired, achy.  Very tired through weekend.  On Monday she developed painful deep breathing , tightness in chest, more achy,  extremely low energy,  warranted emergency visit for chest x ray and EKG.  Still has debilitating exhaustion a week later.
I Had vaginal bleeding that lasted about a week, but I haven't had a period in 2 years.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Abdominal Pain-Mild, Systemic: Headache-Mild, Systemic: Nausea-Medium, Additional Details: Patient was anxious/nervous when getting signed in. About five minutes after patient was immunized, she started feeling "itchy" on her arms. Patient stated she had an epipen in her purse. She did not drink or eat anything while at the pharmacy. Patient stated she was nauseous so I gave her a bucket. She did not vomit while at the pharmacy. She requested the ambulance to come get her. The ambulance came and took her to the hospital.
Red, warm, raised area on thigh started 10/20/2020. Evaluated in clinic by Dr. 10/23/2020. No treatment necessary.
Early flu-like symptoms - aching all over and slight fever on and off for two days, starting the morning of the day after the injection; headache the day after the shot.
PATINET REPORTED SWOLLEN ARM AND REDNESS NEXT DAY AFTER THE VACCINTION. SHE HAS NEVER EXPERIENCED SYMPTOMS LIKE THIS AFTER ANY VACCINATION. REDNESS WAS BELOW THE INJECTION SITE, NOT AT THE INJECTION SITE. SWELLING WENT DOWN AFTER FEW DAYS BUT REDNESS IS STILL THERE AS OF 07/19/19. SHE ALSO REPORTED PAIN IN HERR ARM AS WELL.
Left leg swelling, redness and hot to touch. Was treated in ER with Benadryl and Decadron.
One hour after getting the vaccine,my face and neck swelled,but I had no breathing problems. Then 4 days after vaccine I experienced  a strange buzzing feeling in my brain,and Tinitus  ring in my ears,with sinus pressure. It lasted less than 10 minutes,and stopped. On the fifth day after vaccine,I noticed High Blood Pressure symptoms,and went to ER. On 8th day after vaccine,I I went to hospital for High Blood pressure again,and was put on medication!
AFTER ADMINISTERING THE VACCINES WITH THE NECESSARY PRECAUTIONS, INTRAMUSCULARLY IN BOTH ARMS, THE PATIENT REFERS FEELING DIZZY. WHEN THE FATHER WAS TRYING TO MOVE HIM TO HAVE HIM LAY DOWN, THE PATIENT SEEMED TO HAVE A TONIC SEIZURE AND RIGIDITY, EYES ROLLED BACK AND LOSS OF BLADDER CONTROL. AFTER LAYING HIM DOWN AND LIFTING HIS LOWER EXTREMITIES, THE PATIENT RECOVERED CONSCIOUSNESS AND SLOWLY STARTS FEELING BETTER.
Deep joint pain (hips, fingers and ankles toes). Mild fever, and headache. Lethargy
was also diagnosed with intussusception again on 24-APR-2020.; The patient was diagnosed with intussusception on 15-APR-2020.; This spontaneous report was received from a Registered Nurse, referring to a 6-month-old male patient. The patient did not have any pertinent medical history, drug reactions, allergies, or concomitant medications.  On 12-DEC-2019, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 tube, administered orally (lot number S001101 which has been verified to be valid, expiration date reported and validated as 21-OCT-2020). On 13-FEB-2020, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 tube, administered orally (lot number 1660685 which has been verified to be valid, expiration date reported and validated as 21-MAR-2021). On 15-APR-2020, the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 tube, administered orally (lot number S013436 which has been verified to be valid, expiration date reported and validated as 30-JAN-2021). All the vaccines administered as prophylaxis.    On 15-APR-2020, after he received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (also reported as later in the afternoon), the patient visited the emergency department, an ultrasound was performed and was diagnosed with intussusception. On an unspecified day in April 2020, the patient recovered from intussusception. On 24-APR-2020, a second visit to the emergency department was reported,  an ultrasound was performed, and he was also diagnosed with intussusception, and then, the same day, the patient status was reported as recovered.   The patient was not admitted to the hospital on either of the visits. The events resolved without treatment both times. The causal relationship between the suspect vaccine, and the intussusception was not reported.
A few hours after the injection, I started feeling severe joint and back pain. Around 5 PM is when I started feeling a tingling feeling in my hands, feet, and around the outside of my mouth. I still have a loss of feeling in my feet after returning to work today, 1/25/2021, and I was promptly sent home after informing my management. I still have some loss of feeling around the corners of my mouth, and most of the feeling has recovered in my hands.
Patient received their first pediatric covid vaccine on 1/4/22. Upon returning to the pharmacy for their second dose on 2/8/22, the patient's father stated that the patient experienced side effects for 8 days following the vaccination. Patient's father stated that on day 2 after receiving the vaccine, patient experienced a "dry throat" and dry cough. On day 3, patient had a fever, motrin was given to break the fever. On day 4 - day 8 patient continued to have the dry cough. Patient still received the second covid vaccine on 2/8/22.
The day i received the first dose of the moderna shot i started getting nauseas  during the night. I woke up and was very tired feeling. I felt like flu like symptoms for the next few days. I was in bed Friday, Saturday, and Sunday i went to ER due to throat, face and neck swelling. It was hard for me to swallow. They gave me an IV and administered Benadryl and something to help with my throat. In about 30 minutes i could swallow much better. I still feel tired and just have no energy at all. I went to see my doctor and i will not be getting the second dose of the moderna shot.
I have kidney disease. My kidney function went from 2.7 to 7.4. It put me into 7th stage renal failure. The doctors checked my blood twice. The first time they checked it was at 7 and the second time it was at 7.4. They decided to do a kidney biopsy. My kidneys were showing that they received a form of trauma. After that, the only thing that can be done is to monitor me. I was admitted into the hospital because my body was shutting down. Every two weeks I need to go in and have my blood checked. I have dropped down into the 6's now.
This spontaneous report was received from a medical assistant refers to a 12 year old female patient. On 13-AUG-2013, the patient was vaccinated with an expired dose of GARDASIL, (lot number 0636AA, expiry date 11-AUG-2013, route not reported). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
patient experienced the arm pain at the injection site for all of her Pfizer Covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 89-year-old female patient received bnt162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6203) at the age of 86 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diabetes diagnosed many years ago; "Hypertension" (ongoing), notes: Hypertension diagnosed many years ago. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "patient experienced the arm pain at the injection site for all of her Pfizer Covid vaccines".  Additional information: The caller's mother experienced arm pain at the injection site after the Pfizer covid vaccines and the patient did not seek medical help and only took Tylenol. The caller has the patient's shot information from 2021. The caller had three covid vaccines and the booster. Both the caller's mother and she both had the same shot on same day but the caller's mother is ok except for arm and body discomfort at the injection site and the caller is not concerned about that. For the injection site pain, reporter states it is unknown for the dosages for those vaccines as the dose is not written down and it was probably 0.1 but she would have to find out. Clarified that the patient and the caller both experienced pain with all of the Pfizer covid vaccines which is normal and the patient's first Pfizer dose was on 07Mar2021 with lot EN6203; the next was on 28Mar2021 with lot that starts with EL926 and the caller can't make out the rest of the information and thinks it says 60 but it is not that legible. States for the patient, the rest of the dates, lots and other vaccine information is not handy but then states the patient had a 3rd Pfizer vaccine on 30Sep2021 and it has lot 30145BA. Due to the caller stated the patient experienced the arm pain at the injection site for all her Pfizer Covid vaccines, the patient's first dose is populated into the formal suspect product field. The reporter and the reporter's mother both had the Pfizer covid vaccine on 16Oct2023 so it is probably the same lot number.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353420 same reporter/patient/vaccine/event, different dose;US-PFIZER INC-202300353419 same reporter/patient/vaccine/event, different dose;US-PFIZER INC-202300347242 same reporter/patient/vaccine/event, different dose;
Dose administered after 12-hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12-hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12-hours post puncture). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12-hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist stated a vial that was open on Friday 05 Nov 2021 given on 08 Nov 2021 to a patient.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.