chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abdominal cramping; vomiting; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 09Mar2021 08:45 (Lot number: EN6205) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing). Concomitant medication included: SANDOSTATIN LAR DEPOT. Past drug history included: Ibuprofen, reaction: "Drug allergy"; Vicodin, reaction: "Drug allergy". Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EN6200), in the left arm at 08:45), administration date: 16Feb2021, when the patient was 70 years old, for COVID-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 09Mar2021 20:00, outcome "recovered with sequelae" (2021), described as "Abdominal cramping"; VOMITING (non-serious) with onset 09Mar2021 20:00, outcome "recovered with sequelae" (2021), described as "vomiting". Therapeutic measures were not taken as a result of abdominal pain, vomiting.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 at 20:00, the patient reported that she experienced similar reaction which she had with octreotide each month which included abdominal cramping and vomiting. It was not as severe and only vomited once and lasted only evening and early morning. She also reported that her next reaction to octreotide lasted longer in hours then sick for six days. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
patient passed out shook a couple times and slid down in the chair then a few seconds later woke up scared and unaware of where she was. She was warm and clammy plus felt like she was going to vomit. All complete symptoms of syncope. I stayed with patient and placed ice pack on her back neck area and offered her a drink of water. after about ten minutes she was completely back to norm and i continued to watch her for 30 minutes. she states that she faints every time she receives a flu vaccine as well. she went home with mother after the waiting period.
Systemic: Seizure-Mild, Additional Details: Spouse called with report of a seizure several hours after vaccination
Patient awoke next morning after receiving vaccine with large and small joint polyarthralgia, stiffness, and weakness.
I was vacationing and on May 6th, I noticed I started having indigestion, runny nose and cough. No fever. I tested on 5-8-2022 at the pharmacy with on vacation. I could not come back home until I quarantined. I tested again on 5-17 and it was still positive. I flew back home on 5-18 after getting a letter of recovery from a doctor out of town. I am reporting my breakthrough case of Covid.
Chills, fatigue,slight headache right arm soreness at injection site, slight vomiting started in morning with the above except vomiting. Vomit Ed in late afternoon and started to feel better . All symptoms except soreness gone by the evening. Also loss of appetite till evening
After 2nd injection and more recently I noticed that My left arm is stiffer with severe joint p; joint pain and discomfort.; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number and Expiry date was not reported), via an unspecified route of administration, administered in arm left on 01May2021 at 12:15 (age at vaccination 55-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization with after the first injection, I noticed that I can barely move my arm. Lots of pain and hard join movement. The patient experienced after 2nd injection and more recently i noticed that my left arm is stiffer with severe joint pain and discomfort on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021634352 similar report from same reporter
A report has been received from a medical rep concerning a subject of unknown gender. Patient's medical history and concomitant diseases were not reported. The patient had been receiving FLUMIST quadrivalent (intranasal) started on an unknown date. Reporter stated that they had several breakthrough cases with influenza A and influenza B. Action taken for FLUMIST quadrivalent was not applicable. The outcome of the event of several breakthrough cases with influenza A and influenza B was unknown. Reporter considered the event of several breakthrough cases with influenza A and influenza B to be non serious. Corrected report 24-Apr-2015: Product type for FLUMIST changed from drug to vaccine and name of the manufacturer as MedImmune added on product screen.
Two days after she got her vaccination. She stated her heart was racing and I noticed she had tremors. She was also very sweating. I did take her temperature and she was not running a fever. It gradually got worse over 3 days then I took her to the doctor. I thought it was a thyroid issue, but the doctor did blood work and it came back normal. Doctor stated they think it might be from the vaccination.
About 50 hours after receiving second dose of Moderna covid vaccine, I noticed that my arm was itching. It was still sore from the vaccine. I was still running a temperature of 100.2. (My temperature had been up to 102.2 the day before.) I checked my arm and noticed swelling and redness from the injection site down to my elbow and extending on to the inside (medical aspect) of my arm.  I had read that similar reactions were not too unusual from the Moderna vaccine. However, I did not have this problem after my first dose of the vaccine. I did not call the doctor as it was Friday night.
4 mos old rcvd PREVNAR 13 injection in afternoon of 7-21-16. By 9pm same night baby had temp of 101 measured under the arm. Parent monitored child as fever persisted through 24hrs. Treated w/TYLENOL and MOTRIN. Watched for seizures.
Pain all over, pain at injection site, fatigue, muscle aches, runny nose, stuffy nose, chest congestion, mucus, sinus drainage, all turned into sinus infection.
patient was walking out of store and started to pass out. Her husband was able to prevent her from falling. Had patient sit down and drink water until she felt better. pharmacist monitored
Patient had the second Moderna vaccine shot at 9.10 am on Sunday 02/28/21. Patient felt dizziness at 10.00 am on Monday 03/01/21. She felt the ceiling and wall around her were spinning. She rest in bed for half an hour and dizziness was gone. Patient felt dizziness again at 2.30 am on Tuesday 03/02/21. Body temperature was 97.1 degrees F. Patience rest in bed for few hours, dizziness was gone. No blood pressure values were recorded. Patient felt dizziness again at 10.00 am on Wednesday 03/03/21. Body temperature was 96.8 degrees F, Blood pressure was 128/68.
Pt recv vax on 3/10/99; on 3/12/99 pt exp dec appetite, vomiting, irritable, fever (100.5), full fontanelle; tx=Pedialyte
1 to 2 weeks after vaccination developed moderate/severe itchiness from head to toe.  Shortly after started developing red rash that resembled hives but then the hives turned into blisters.  Started on chest and then move to back, down my back, and then around to my stomach and the top of my thighs.  There were several hundred blisters covering these areas. They were very itchy.  I tried self care by taking benadryl and applying hydrocortisone cream and calamine.  Went to clinic on 2/18 and was prescribed a strong course of prednisone and Allegra.  After a few days new lesions stopped.  Itching started subsiding.  5/17 most of the lesions have healed but some are still not healed all the way.  Red marks and some scars remain where some of the lesions have healed.
Mother of patient stated that symptoms started after 1st shot with cold like symptoms, fever, no tiredness after 2nd shot symptoms were weakness, lethargy and fever. After 3rd shot symptoms were depression, anger, lethargy and vomiting. Mom stated that patient has lost 15 lbs in lost 3 months. Her dr now saying cause is HPV shots.
Respiratory distress on exertion; Chills; Joint pain; first dose of BNT162B2 administered in left leg; first dose and second dose received on same day (08Mar2021); first dose and second dose received on same day (08Mar2021); This is a spontaneous report received from a contactable Other Health Professional (patient). A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration in the left leg and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: 8732) via an unspecified route of administration in the right arm on 08Mar2021 (at the age of 69-year-old) at 11:00 as a single dose for Covid-19 immunization in hospital. The patient had no allergies and medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included an unspecified blood pressure medication (within 2 weeks of vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced respiratory distress on exertion, chills and Joint pain. Patient did not receive any treatment for the events. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
Weak leg muscles which started 2 days after vaccine.  Extreme fatigue which began 2 - 3 days after receiving vaccine and lasted for 2 - 3 days.  Took Advil and felt much better.
1 of 3 pts immunized from same lot who devel a purulent inj site rxn w/erythema & swelling approx 0.5 inch diameter; pt vax 11MAY94; seen by MD 19MAY; approx 0.5cc purulent fluid drained from site; no cultures done; rx'd w/augmentin;
Diarrhea; Body ache; Spike fever of 99; not a low grade fever; Headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for immunization. When probed for the due date for the next shot, consumer stated it was on 08Jan2021. Medical history included anxiety, acid reflux and eyes just not really great. Concomitant medication included topiramate (TOPAMAX) at 25 mg, daily for weight loss, fluoxetine for anxiety, omeprazole (PRILOSEC) for acid reflux. The patient experienced body aches, spikes fever of 99, it was not a low grade fever, headache on 18Dec2020, and diarrhea on 19Dec2020. Patient received acetylsalicylic acid (EQUATE, lot number: think it was 0B3076C, Expiry Date of Equate: Dec2022, NDC# 4903552378) for events body aches and the headache and the spike fever. It's Equate pain reliever, a (Company name) brand and it was 325 mg. Outcome of events body ache and headache was not recovered, and outcome of other events was unknown.
DAY OF VACCINE: SORENESS AT INJECTION SITE MORNING AFTER VACCINE (1/12): BODY ACHES, CHILLS, MILD HEADACHE, FATIGUE, INTENSE SORENESS AT INJECTION SITE/ AFTERNOON & NIGHT (1/12): MORE FATIGUE AND SOME NAUSEA. 2ND MORNING AFTER VACCINE (1/13): SOME FATIGUE AND LIGHT NAUSEA. 2ND AFTERNOON AFTER VACCINE (1/13): NO SYMPTOMS. TOOK TYLENOL (EXTRA STRENGTH) & ADVIL.
broke up redness/ still red; swollen; still soreness; extremely tired and weak for a few days; recovering color seems to go away but comes back, it's weird; chronic headache and after the shot became worse; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (broke up redness/ still red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (still soreness), FATIGUE (extremely tired and weak for a few days) and HEADACHE (chronic headache and after the shot became worse) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A Not sure) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE, GABAPENTIN and CALCIUM for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HEADACHE (chronic headache and after the shot became worse). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (broke up redness/ still red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (still soreness), FATIGUE (extremely tired and weak for a few days) and DYSCHROMATOPSIA (recovering color seems to go away but comes back, it's weird). At the time of the report, INJECTION SITE ERYTHEMA (broke up redness/ still red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (still soreness), FATIGUE (extremely tired and weak for a few days), HEADACHE (chronic headache and after the shot became worse) and DYSCHROMATOPSIA (recovering color seems to go away but comes back, it's weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information information reported was Ibuprofen but only the first day.
had a booster rabies vaccine of two doses at that time; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age patient who had a booster rabies vaccine of two doses at that time, while he/she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In September 2018, the patient received a  dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route.  It was a case of actual medication error due to Incomplete course of vaccination.  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 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.
Very Sick; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very Sick) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced ILLNESS (Very Sick) and CHILLS (Chills). At the time of the report, ILLNESS (Very Sick) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were unknown
Outbreak of chickenpox. Pt has vesicle on chin and its a little red and swollen. Maintaining a temp of 99.1. Mother is giving her Motrin. Mother was worried yesterday but pt has only four lesions.
Collapsed; Hit her head; Arm feeling more warm; Hot flashes; Arm feeling sore, and bothersome; Felt tired throughout the day; Fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 12-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Collapsed) and HEAD INJURY (Hit her head) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced FALL (Collapsed) (seriousness criterion hospitalization), HEAD INJURY (Hit her head) (seriousness criterion hospitalization), FEELING HOT (Arm feeling more warm), HOT FLUSH (Hot flashes), MYALGIA (Arm feeling sore, and bothersome), FATIGUE (Felt tired throughout the day), PYREXIA (Fever) and CHILLS (Chills). The patient was hospitalized on 08-May-2021 due to FALL and HEAD INJURY. At the time of the report, FALL (Collapsed), HEAD INJURY (Hit her head), FEELING HOT (Arm feeling more warm), HOT FLUSH (Hot flashes), MYALGIA (Arm feeling sore, and bothersome), FATIGUE (Felt tired throughout the day), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.Treatment medication was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   This case was linked to MOD-2021-118931 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
MINUTES  AFTER VACCINATION, PATIENT HAD AN INTENSE HEADACHE, AND FATIGUE. PULSE, BP NORMAL. MAINTANED CONSCIOUSNESS. GAVE WATER AND SNACK. WAITED IN STORE FOR ABOUT AN HOUR BEFORE LEAVING.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (dose and route were not reported) lot # M024261 and expiry date: 30-JUL-2018 for prophylaxis. It was exposed to a temperature of 32 Fahrenheit to 35 Fahrenheit (33.1 Fahrenheit) for a time frame of 1 hour. There were no previous temperature excursions. No adverse effects were reported. No further information was provided.
Edema to right orbital socket, swelling above right eye. Fever, warm to touch. Dry skin.
16 year-old patient received Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old patient received Moderna vaccine) in a 16-year-old patient of an unknown gender 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old patient received Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old patient received Moderna vaccine) 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 did not provide any causality assessments.   No medication history was reported.  HCP reported patients did not experience any adverse reaction.   Reporter did not allow further contact.
a patient was given an expired dose of Ipol with no reported adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information  Reference number- 00429748) was received from a Other Healthcare Professional and transmitted to Sanofi on 14-Jan-2021.  This case involved a 15 year old male patient was given second dose of an expired dose of ipol with no reported adverse event (Expired product administered), while he received IPV (VERO) [IPOL] (lot number- P1F541M and expiration date- 07-Dec-2020) via unknown route at unknown administration site for prophylactic vaccination on 05-Jan-2021.  The patient presented a record that he had one Ipol dose on 16-Dec-2005 (other dosing details not reported).  Medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) VZV (VARICELLA ZOSTER VACCINE) chickenpox vaccine, Hepatitis A, HPV; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  At the time of reporting, the patient had no adverse event.  Also reported that they would also like to know what the next steps should be carried forward. Somehow it was overlooked.The doctor gave the vaccine (Ipol) on 05-Jan-2021. The doctor said that they have to have the kid come back in and get another one (Ipol vaccine).   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 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.
Inflammation in back and sciatica. Severe pain and treatment with X-rays and steroid and muscle relaxant.  Unable to stand or sit without severe pain.
She screamed during vaccinations. Hours later she was lethargic, hot, and flushed in the face and body. She just wanted to sleep. The next day (about 26 hours later from immunizations) same symptoms however had a 103.0 rectal temperature. Doctor on-call said to bring her to the ER at the hospital. She constantly wanted to be held, just slept, seemed drowsy, lethargic, had a abnormal cry that sounded like she was in pain. She was not her normal self. Also didn't want to eat. Hospital said to continue administering infants Tylenol for the fever. She resumed to normal after 3 full days after the immunizations.