chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse Event; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022) and NO ADVERSE EVENT (No adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2022, the patient received second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 23-Aug-2022, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022) and NO ADVERSE EVENT (No adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022).    No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
SIDS death on 17NOV93 sl fever since 16NOV93 APAP;
Information has been received from a pharmacist referring to a 68 year old female patient with chronic obstructive pulmonary disease (COPD). The patient had no drug reactions or allergies. On 31-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as 1011434 with expiration date 03-JUL-2016, dose 0.65 ml) subcutaneously. Concomitant therapies included unspecified benzodiazepine, unspecified estrogen vaginal cream, unspecified thyroid medication, omeprazole (manufacturer unknown), unspecified narcotic medication, SPIRIVA and budesonide, SYMBICORT and unspecified antidepressant. The  pharmacist reported that a patient developed a "raised red spot" that was "scaly" and "tender to touch" at the injection site "that evening" on 31-JUL-2015 after receiving ZOSTAVAX. The patient called the pharmacist "yesterday", on 03-AUG-2015 and the pharmacist informed the patient to apply hydrocortisone cream to the injection site. Then "today", on 04-AUG-2015, the patient was seen in the pharmacy. No lab diagnostics studies were performed. At time of the report, outcome of the events was reported as not recovered. The causality was not provided. Additional information has been requested.
he experienced arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "he experienced arm pain". Additional information: The patient received his 2nd dose 30Apr2021, and he was currently experiencing body pain. He wants to know if he can take a pain reliever similar to Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was exhausted and I did not feel well. My glands under my arms and between my legs, the pain was insane. The pain kept me up at night. My bloodwork was awful, my platelets and white blood count was so high. I had blood work 3 different times and it my blood work was horrible all 3 times. The blood work and symptoms finally subsided. I had a severe outbreak of herpes worse than I ever had. I went to my PCP, and she ordered lab work. I still wasn't feeling well weeks later so I went to another PCP, and she ordered and EKG because my blood pressure was high. That PCP thought I was having a reaction to the booster. She referred to me to a hematologist and the hematologist agreed that I was having a reaction to booster. I finally started to feel better, and my symptoms finally went away. I have a follow up in April for blood work again.
pt recvd vax 9aug94 at 1:30pm;1-2 hrs later was fine;slept longer than usual;when mom checked  2 1/2 hrs later,could not get him to wake up;burning up w/ fever of 105.4;called PMD 5:30;was told give meds & bath;to er;given meds;rxn to vax;
Reported 11/9/21:  soreness in the arm beginning day of injection 10/22/21, but the first couple days thought it was just normal post-injection soreness. Pain began to be intermittently and progressively worse. Pain is in the anterior left upper arm from bicep/deltoid to about elbow area. Reports left upper arm numbness upon waking and states there is now decreased ROM. EE reports it is painful to open doors, lift arm away from body, pull up pants, do patient care.  Ice not helpful. Heat helps briefly. OTC Tylenol and ibuprofen didn't help. Plans to be seen at Clinic on 11/10/2021.
bruise & knot (5x3cm) @ inject site lt deltoid temp 103 ax; bruised area warm to touch & tender;
Just received the 1st dose and stated that she is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Just received the 1st dose and stated that she is pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Oct-2020 and the estimated date of delivery was 11-Aug-2021. On 22-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Just received the 1st dose and stated that she is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 22-Apr-2021, EXPOSURE DURING PREGNANCY (Just received the 1st dose and stated that she is pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was  provided.  No treatment medications were reported.
I haven't had an afib episode since the one Nov. 18  which I think most believe was from my 11/2/22  bypass operation.  I received the rvs and flu vaccines 10/11.  Going to bed I felt just wiped out and slept immediately.  My tracker watch recorded 5 afib episodes between 12:30 and 3:00 with the bpm ranging from 43 - 179.  I was unaware of any change.  I woke without any concerns or the feeling of being wiped out like when I went to bed.  I've been active and fine since and have no concerns or reoccurrence of afib.  The only thing different that I can suggest is the vaccines or combination.  Previously I have never had problems with any vaccines.   (I received the vaccines at Pharmacy.  The clinic listed is my care provider.)
Since the 1st shot, I have experienced  a sudden onset and increasingly worsening pain in my left wrist.  The immediate reaction at the time of the shot was strong tingling in my left arm. The next day, I felt sore all over my body, as well as cold/flu like symptoms for 2 days.  But the wrist pain has been getting worse, and consistent.   I broke that wrist 10 yrs  ago, and may have some slight work related carpel tunnel.   With that in mind, I can say that the current issues and pain I?m dealing with have been acute and severe since I received the first dose of the vaccine.  I just received the second dose 3 days ago, and still my wrist is hurting.  I am careful to make sure I don?t put too much weight on it, and often wear a wrist brace.  I am currently waiting to see my primary care doctor to seek medical attention.
Chills, muscle aches, subsequent nausea, sore throat, headache, increased heart rate (120 bpm), vomiting about 12 hours after shot.
Arm pain, 24 hrs. post vaccination. Persistent, with increased area of pain and intensity with movement of arm.  Duration of about 20 days.  Seasonal shot given in the same arm without issue.
Joint swelling and rash. Resolved with ibuprofen and ZYRTEC.
Weird reaction after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Weird reaction after receiving vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Weird reaction after receiving vaccine). At the time of the report, VACCINATION COMPLICATION (Weird reaction after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over, profuse sweating w/no fever, chills, all over inflammation & swelling, hives upper extremity, petechial rash, and the next day after the vaccine, the patient started experiencing swelling in R-axilla (lemon size). 3 days after vaccine all symptoms have resolved except swelling in right axilla.
Patient was asked to stay seated for 15 min after getting her shot. But less than 5 minutes after receiving her shot she walked to the pharmacy counter, we asked her if she is feeling OK, she gazed at the staff and fell on the floor.  We kept her head elevated and made sure she was responsive (OB managed to remember her name and asked to call her mother). We called 911, measured her blood pressure 115/80 mmHg her HR:117 bpm. EMT took her to the hospital when she was still not feeling well.
pt recv vax & 6 months following vax ELISA test revealed that pt failed to seroconvert (0.03); No further details were provided
She is out of breath when she goes for her regular walk; I just don't feel good; She has no energy; She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),; She has constant headache; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (She is out of breath when she goes for her regular walk), MALAISE (I just don't feel good), ASTHENIA (She has no energy), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 06-Nov-2023, the patient experienced DYSPNOEA (She is out of breath when she goes for her regular walk), MALAISE (I just don't feel good), ASTHENIA (She has no energy), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (She is out of breath when she goes for her regular walk), MALAISE (I just don't feel good), ASTHENIA (She has no energy), PYREXIA (She believes that she has long hauler side effects: Low grade fever 98.9 F to 99.9 F (Her normal temperature is 97.8 F),) and HEADACHE (She has constant headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2023, Body temperature: Low grade fever 98.9 F to 99.9 F, normal temperature is 97.8 F.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. She stated that after all the other Moderna shots, she had similar side effects but with previous shots the side effects lasted only 4 days. After the shot on 06-NOV-2023, the side effects did not go away. It has been 15 days now. When she takes 2 Tylenol the fever goes away, but it comes back the next day. She stated that she drunk hot tea and coffee but not water. She stated that may be the adult dose she got was too much for her small body. She weighs as much as a teenager.   This case was linked to MOD-2023-750595, MOD-2023-750581 (Patient Link).
With the first injection I had a swollen gland on my left collarbone.Second shot nothing until I had a horrible cough in January of 2022 suspect of omicron and result of that was diagnosed with Bells Palsy.
approx 2 days p/vax pt devel vomiting, no fever, possible sz activity (30 sec) witnessed by mom;was evaluated in ER & found to be nl;mom did not bring child to f/u appointment;
Starting having facial paralysis/crawling sensation; speech slurred; left eye not blinking appropriately.  Reported to ED on 11/4/09. Prescribed acyclovir and prednisone, artifical tears.  12/18/09 MR received for DOS 11/04/09. DX: Facial palsy. Pt s/p vaccine with numbness on L side of face, drop of L side of face and crawling sensation. Pt with facial palsy on L side of face. Tx: Zovirax, steroids, tear drops. Pt discharged in stable condition. DOS 11/05/09. DX: Bell's palsy.  Pt presented for F/U. Paresis 75%, upper eyelid not closing, no movement of R facial muscles, disarthria and oral stage dysphagia. Neurologist opinion: adverse event more likely coincidence rather that due to vaccine. Tx: ice massage. Pt scheduled for F/U.
12yo patient given incorrect formulation of PFIZER, given 5-11yo formulation (10mcg)
a bad rash around 1/2 his face and in his eye; shingles; a bad rash around 1/2 his face and in his eye; his face swelled up bad; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 36-year-old male patient.  A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown), as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown), as dose 1, single for covid-19 immunisation. On an unspecified date on 2021, days after getting the 2nd dose of Pfizer his face swelled up bad and a bad rash around 1/2 his face and in his eye. The patient's doctor said it was shingles. He had to be given viral medications to help heal it. He still suffers from it and he's only 36 years old. Therapeutic measures taken as result of events. The outcome of events were not recovered.  The response included We have received an adverse drug event report in which your product, covID-19 Vaccine, has been identified as a suspect drug. In accordance with FDA guidelines, we are forwarding the attached information to you for your action as appropriate. fwe receive additional relevant details pertaining to this case, we will forward the information to you.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after vaccine, I got really sick and couldn't raise my left arm. My arm was sore at the injection site and was swollen, it tripled in size. My arm turned purple, I was running a fever, and had stomach issues with vomiting and diarrhea. I felt like I was in a fog for over a month. Eventually my arm started oozing liquid about 9 days later. I went to my doctor the next day and eventually over time, I got on 3 rounds of antibiotics. My arm is discolored and purple and it is very noticeable. It is blotchy and has a raised spot to this day. I was diagnosed with Cellulitis. I was born with an infection in my eyes and partially blind in my left eye. The shot triggered my eye issues and it immediately started watering. My doctor said it was the worse case of dry eye. With every COVID vaccine I had made it worse. I have had 3 COVID vaccines. I am now still on steroid eye drops. I was taking taking steroid eye drops 3 times a day and now I am down to 1 time a day. I am also on a second eye drop prescription as well as the steroid eye drops. I also have to buy OTC eye drops that is expensive. I never had to have any kind of eye drops before vaccination.
Dizziness and chest pain resolved with in 30 minutes. Vasovagal response to Flu shot
Mother states he started getting fussy, felt warm.  Temp 103 degrees.  Vomitted at 7:30 PM. Got Tylenol down him at 9:00PM.  Put him in bath every couple hours through the night. Tried given him ginger ale through the night and he would vomit it back up.  This morning temp around 100 degrees.  Recommended mother call doctor in case there was something else the doctor wanted.
PATIENT GOT 0.2ML OF   PFIZER vaccine 30mcg/0.3ml,NDC:59267-1000-01 INSTEAD OF 0.2ML OF PEDIATRIC  VACCINE IN ERROR.  PATIENT IS DOING FINE. I FOLLOWED UP WITH THE MOTHER. SHE SAID THE KID IS ACTUALLY FINE, JUST THE SORENESS OF THE ARM  ON THE DAY OF THE VACCINE.
Information has been received from a registered nurse concerning a 22 year old female with irritable bowel syndrome, migraine headaches, and no drug allergies, who on 16-AUG-2007 was vaccinated intramuscularly in the left arm with 0.5mL first dose of GARDASIL (Lot# 0469U). Concomitant therapy included ibuprofen and LEVSIN, reported as "Levicid." Subsequently the patient experienced no outward signs but experienced pain on her entire left arm. She was treated with ibuprofen every 6 hours but the pain did not resolve. The patient called the office. No laboratory diagnostics were performed. The patient had an appointment to be seen on 21-SEP-2007. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
The patient has a "negative titer for Hepatitis B".; This spontaneous report has been received from an employee concerning a 20 year old non-pregnant female patient. The patient's concurrent conditions were not provided. She had no concomitant medications or pertinent medical history.  On unspecified dates, the patient was vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX) and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (routes of administration, anatomical locations, lot numbers and expiration dates were not provided), as routine vaccination for the prevention of measles, mumps, rubella, varicella and hepatitis B. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (route of administration, lot number and expiration date were not provided).  On an unknown date in September 2019, the patient had a measles, mumps, and rubella; varicella virus and hepatitis B titer, and the results showed that the patient had immunity to measles, mumps, rubella and varicella. The results also showed a negative titer for Hepatitis B (hepatitis B antibody negative). It was reported that the patient did not seek medical attention and no treatment was given for the event.  The outcome of hepatitis B antibody negative was assessed as not recovered.   The causal relationship between the suspect therapies and the event was unknown.
Small lump under left arm that is approx. the size of a quarter.  No itching or bruising at the site.  Member was firing M4, M-9, & MCS 870 Modular Combat Shotgun from 0715 to 2359 with both arms on the 27th of Feb 2008.  No other problems with vaccination site at this time.
Fever between 100-101 and body aches for about 6 hours the days after booster
no adverse reaction.  unknown if patient received 0.2ml of adult or pediatric pfizer
Given correct dose of Hep A, given incorrect dose of Flu vaccine. Given 0.5 mg instead of 0.25 mg.
Dizziness; Increased heart rate; Shortness of breath with exertion; Nausea; Abdominal pain; Numbness; Tingling in hands and feet; Tremors; Felt feverish; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 34-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 28th October 2021, less than a day after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced dizziness, heart rate increased, exertional dyspnea, nausea, abdominal pain, numbness, tingling, tremor and feeling hot. On an unknown date, the outcome of the dizziness, heart rate increased, exertional dyspnea, nausea, abdominal pain, numbness, tingling, tremor and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, heart rate increased, exertional dyspnea, nausea, abdominal pain, numbness, tingling, tremor and feeling hot to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by a nurse for herself. The patient received Fluarix and within three hours developed dizziness, increased heart rate, shortness of breath with exertion, nausea, abdominal pain, numbness and tingling in her hands and feet, tremors and she felt feverish but did not have a fever. The reporter consented to follow up. The patient had nothing else to report.