chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per note at Office visit on 5/24/12 at 4:40 PM- Mom said cried for an hour, could not be consoled. No known fever. Noticed redness of both legs extending thigh to foot, red & bruised appearing (3PM). Slept a lot of the day but did feed a couple of times. Legs much less red at office visit - no swelling of extremities. Bilat exterior legs & abdomen are somewhat pinker than surrounding skin and the intensity of pink tone varied during the exam - Brisk capillary refill. To use APAP UAD PRN for fussiness, cool compresses to legs. If inconsolable or other concerns go to ER. To call tomorrow if further problems. I tried calling mom & also sent postcard to obtain info on recovery. No return call. 6-4-12 at 2:10 pm. Mom returned call and said pinkness dissipated that evening and except for being somewhat moody the rest of the week he was fine.
experiencing nearly all side effects; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experiencing nearly all side effects) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-May-2021, 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 COMPLICATION (experiencing nearly all side effects) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (experiencing nearly all side effects) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported.  Treatment medication was not reported.
Did not feel good; Heart racing; Her body felt very hot and she sweated profusely; Tiredness; sore arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Did not feel good), PALPITATIONS (Heart racing), HYPERHIDROSIS (Her body felt very hot and she sweated profusely), INJECTION SITE PAIN (sore arm) and FATIGUE (Tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Compazine). Concomitant products included TAMOXIFEN from 07-Jan-2021 to an unknown date for Breast cancer, ZOLPIDEM for Sleep disorder therapy.   On 08-Mar-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021 at 10:00 AM, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (sore arm). On 09-Mar-2021, the patient experienced FEELING ABNORMAL (Did not feel good), PALPITATIONS (Heart racing), HYPERHIDROSIS (Her body felt very hot and she sweated profusely) and FATIGUE (Tiredness). On 09-Mar-2021, PALPITATIONS (Heart racing) and HYPERHIDROSIS (Her body felt very hot and she sweated profusely) had resolved. At the time of the report, FEELING ABNORMAL (Did not feel good), INJECTION SITE PAIN (sore arm) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up contains significant information updated reporter's details, patient demographics, past medical history, batch number of two doses, time of vaccine administration and  concomitant medications.
11:07AM CLIENT'S MOTHER PHONED TO C/O REDNESS AND SWELLING TO ARM AREA OF INJECTION. STATES SHE HAD GIVEN MOTRIN. ALSO STATED CHILD HAD NEVER HAD REACTION BEFORE.
First day after - muscle fatigue, dizziness, general fatigue (not localized), lower back pain  Five days after - vertigo, nausea
Severe vomiting, fever, body ache, headache for 2 days. I did not receive treatment, just waited it out.
Developed a large swollen, reddened area at injection site on evening of 8/24/11. Hard, raised and warm with a diameter of 3". Next morning had a 103 degrees F temperature, nausea, lack of appetite, aches and headache. ADVIL reduced fever adequately. Recommended physician visit if localized reaction not resolved tomorrow.
This is a spontaneous report from a non-contactable consumer.  A 55-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced increased appetite afterward, decreased urination despite drinking more fluids than usual, and headache in front, then in back of head. Patient took acetaminophen. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient states that after she received her first meningitis B shot, about 5 hours later she had a headache, she felt unwell, her arm was swollen, hard, warm, and quite sore for around two weeks.
this morning woke up with tingling in her finger tips on the arm that she received the vaccine in; she has a birth control, Nexplanon, implanted in opposite arm and that site has pain in it as well; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route, administered in the arm, on 19May2021, as first dose,single, for COVID-19 immunization.  The patient's medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON) implanted in opposite arm for birth control. On the morning of 20May2021, the patient woke up with tingling in her finger tips on the arm that she received the vaccine in and wanted to know if this was a side effect of the vaccine. She also stated that she had a birth control implanted in opposite arm and that site had pain in it as well, which she has not experienced that before. The outcome was unknown for both the events.  Information about Lot/Batch number has been requested.
About 5 min after immunizations pt was sitting and just slumped forward, passed out, as soon as her head touched the table she looked up and said "what happened?" We lay her down for 10 min and gave water.
sicker than a horse; weakness; stomach upset; every bone in her body hurt, she would move a toe and everything would hurt.; dizziness; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sicker than a horse), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach upset), BONE PAIN (every bone in her body hurt, she would move a toe and everything would hurt.) and DIZZINESS (dizziness) in a 71-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.     Concurrent medical conditions included Pneumonia (Past history of pneumonia that left her hospitalized which is why she got vaccinated). Concomitant products included METFORMIN and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ILLNESS (sicker than a horse), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach upset), BONE PAIN (every bone in her body hurt, she would move a toe and everything would hurt.), DIZZINESS (dizziness), NAUSEA (nausea) and CHILLS (chills). At the time of the report, ILLNESS (sicker than a horse), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach upset), BONE PAIN (every bone in her body hurt, she would move a toe and everything would hurt.), DIZZINESS (dizziness), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
I experienced body aches, chills, headache, fever and my breast milk supply completely stopped.
Basically I had a lot of fatigue, not so much body aches. They were there, but it was mild. The other part was difficulty breathing. Not labored per say but I couldn't take deep breaths of air. About a week or so before this, I went to the doctor and she diagnosed me with a sinus infection. I had post nasal drip and cough. It sounded good at the time. I did a 5 day regimen of CEFTIN (antibiotics) along with cough medication. A week and a half after this sinus infection I started feeling a new feeling of breathing issue, increase in cough and a lot deeper, phlegm, and heavy fatigue. My phlegm was milky. I used to get Bronchitis, and this was not like it at all. Just a pressure on my chest.
Tinnitus at all times of the day. High pitched sound that comes from inside my head some days and within my ears other days. These episodes are occuring daily.  As time passes the episodes are happening more frequently and for longer periods of time.
Due to a recent audit, we discovered that this patient was actually 11 y/o when she received Pfizer, not 12 years old, as parent had specified. Parent falsified birth date on intake form so that it appeared child was 12 years old, instead of 11.
Patient said when he received his flu shot (FLUARIX QUAD) and his PNEUMOVAX 23 he got sick. Went to his doctor and was diagnosed with cellulitis and was on two courses of antibiotics. Shots were given on 9-22-17.
Pfizer/ BioNTech: 04Oct2021, Dose Number: 3; Paxlovid: Treatment of COVID-19, 12Apr2022; Pfizer/ BioNTech: 04Oct2021, Dose Number: 3; Paxlovid: Treatment of COVID-19, 12Apr2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; SYMBICORT. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 13Apr2022, outcome "not recovered" and all described as "Pfizer/ BioNTech: 04Oct2021, Dose Number: 3; Paxlovid: Treatment of COVID-19, 12Apr2022". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Patient took Anti-viral for Covid-19 Treatment, Paxlovid from 12Apr2022, lot Number (FY4445).   No follow-up attempts are possible. No further information is expected.
I experienced severe weakness, fatigue on vaccination date 08/30/2021 after the vaccination with slight dizziness and nausea.  The next morning 08/31/2021 the symptoms became worse so I laid on the couch and napped throughout the day, my glucose was normal.   On the morning of 09/01/2001 I became VERY dizzy with severe nausea.  I took Zofran for the nausea but was unable to perform my duties at work at my full function.  My co-worker did all the bending and ?running around? while I sat or I would hold on to furniture and prop up against a wall when needed.  These severe symptoms would last for a total of 4 days and then started declining.  I went to see my PCP on 09/03/2021 @ 2:30pm and explained my current symptoms are I received my second dose of Pfizer.  Dr prescribed Medrol dose pack (steroid), more Zofran, and Antivert medication that I took.  On Monday, 09/06/2021 Dr called in a Z-pack medication due to I started having left sinus burning with a pressure.  He started me on the Z-pack case I had an upper respiratory infection.  I took the entire prescription of Medrol and Z-pack.  I am about80% better but still dizzy if i look to the left.  I just don?t feel like I did prior to the vaccination.
Hives/rash on arms bilaterally and face. High temp of 101.6
I woke up around Mar 6 feeling like I had the flu. I was nauseous, sore, my eyes hurt, headache, chills, sore throat, and was congested, but had no fever. These symptoms some every month and last about 4 days and go away but come again ever month since the last shot.
arm sorenes; headache; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient previously received ibuprofen (MOTRIN) for muscle pain after yard work.  The patient reported she was told that she can take a paracetamol (TYLENOL) but not to take ibuprofen after vaccination with the Pfizer-BioNTech COVID-19 vaccine. She reported arm soreness and headache on an unspecified date in 2021, stated that she took two pills of paracetamol yesterday. She was asking when she can take a ibuprofen again. She stated that she always took ibuprofen for muscle pain after yard work. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a steroid shot in my left knee on 6/10 at 8:00 am. By 10:30 am I was feeling off and having heart palpitations. I kept checking my pulse and blood pressure. My pulse was lower than normal (in the high 50's and '60s. It's normally 80-90.) I felt heaviness in my arms (both) and my chest but no pain. After eating lunch at 12:15 pm, I tried to just rest but continued to feel worse- more heaviness in my arms and chest with dizziness at that point. My mom took me to the emergency room. I was admitted around 3:30 pm. After tests and monitoring me, they determined it was a reaction to the steroid shot and that I should speak to my orthopedic doctor regarding future doses.
BOTH EYES STARTED ITCHING AND TURNED VERY RED. THEY BECAME SWOLLEN VERY QUICKLY AND THROAT WAS SWOLLEN ALSO. HER CHEST WAS BURNING.
a 7 month old patient was administered with GARDASIL 9; This spontaneous report was received from a physician referring to a 7 month old patient of unknown gender. The patient's pertinent medical history or concomitant medications were not reported.  In the morning of 05-NOV-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage regimen information was not reported).
From Pt chart:PT WAS UP TO THE WINDOW AT 0335 WITH COMPLAINS OF CHILLS, BODY ACHES AND GENERALIZED PAIN. PT VS = 100.1-106-20 120/85, ANXIETY NOTED AND REPORTED "FEELS LIKE A HAVE A BUG". PT DID JUST HAVE THE FLU AND PNEUMONIA VAC. ON SAT. SHE THINKS SHE IS HAVING A REACTION. PT GIVEN ATIVAN FOR ANXIETY AND TYLENOL FOR TEMP AND BODY ACHES AT 0340. SHE RETURNED TO HER ROOM AND WITH IN LESS THAN 15 MINUTES, HER ROOM MATE WAS AT THE WINDOW TELLING STAFF THAT THE PT WAS IN THE TOILET THROWING UP. STAFF OBS.'ED PT VOMITING LARGE AMOUNT OF DIGESTED FOODS.
Janssen COVID-19 Vaccine EUA  - Muscle aches starting within 3 hours of vaccination, growing worse for 24 hours before receding after 36 hours - Headache starting within 5 hours of vaccination, ending by 20 hours post-vaccine (upon waking next morning)  - Fever of up to 100.6 F starting 7 hours after vaccination, gone by 20 hours post-vaccine (upon waking next morning) - Fatigue starting within 3 hours of vaccination, lasting ~48 hours - Nausea off and on between 7 and 10 hours post-vaccine
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Rash with pustules and itching on hands, face, torso Treatment: Medrol 4mg 6 day course, Triamcinolone Acetonide (0.5 %) cream as required Over 90% resolved in 7 days Minor pustules remaining after 30 days
Post vax, the pt experienced a severe allergic reaction. The arm swelled up without development of abscess. It was noted she had the vaccine previously without any reaction.
Patient started having seizures after 15 minutes of receiving the vaccine.  The EMS was called.  The pt was place on oxygen due to O2 dropping.  The EMS took the pt to hospital
Local reaction:  Circular redness, swelling, erythema, and tenderness at site to approximately 7 cm in diameter.  Noticed approximately 20 hours after injection (1/10/21 approximately 8 am).  Began improving on 1/11/21 evening.  Mostly gone morning of 1/12/21.
Allergic reaction over a year.  She has scabs on her arm and on her back.
Left arm pain starting the day of the receiving the pneumonia vaccine. Pain at the site, that shoots down the arm. No weakness, numbness, or change in color of the arm, no bleeding, underlying mass, or swelling. Tylenol and low dose benzo was given in the ED, sling applied for comfort. Possible underlying nerve irritation or periosteal inflammation per ED doctors note.
This case was reported by a pharmacist and described the occurrence of migraine in a 45-year-old female subject (also a pharmacist) who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included MOTRIN. On 8 October 2008 at 11:30 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 8 October 2008, approximately 40 to 60 minutes after vaccination with FLULAVAL, the subject experienced migraine, fatigue and tiredness. The pharmacist considered the events were disabling. At the time of reporting the outcome of the events was unspecified.
This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient did not have pertinent medical history. The patient had gluten intolerance and drug reactions to tipepidine, opioid analgesics, barbiturates, beta lactam antibiotics. On 22-SEP-2016, the patient was vaccinated with ZOSTAVAX one vial, subcutaneously (lot# and expiration date were not reported). Concomitant medications included digoxin, torsemide, sildenafil, allopurinol, sertraline, ELIQUIS, Metoprolol, TAZITA XT, potassium. On 22-SEP-2016, the patient experienced redness and intermittent "shooting pain" at the injection site. The patient informed pharmacist she had applied BENADRYL cream and an unspecified lidocaine cream to the injection site, with no improvement. No lab diagnostic studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Had 2 min seizure went to ER. EUAI negative.  Diagnosis Febrile Seizure.
Patient was given / second dose / 1 month after receiving the first dose; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was given the 2nd dose of Shingrix early. The 2nd dose was given 1 month after receiving the 1st dose, which led to shortening of vaccination schedule.  There were no symptoms reported. The reported had no other information to report.  The reporter did not consent to follow-up.
tingling in jaw after the vaccine; This is a spontaneous report A non-Contactable Consumer reported information for himself and his wife. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient reported that he and his wife both had tingling in jaw after the vaccine. The outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021075995 Same reporter, same product, same event, different patient
Shot given in shoulder very painful. Next huge swollen cyst like knot. Next day very painful with fever in swelling. Went to Dr who referred her to bone and joint specialist. He thought shot was given in joint. Took ALEVE for about a week.
Patient should have been given a MMR#1 instead of a PROQUAD- pt did not have any negative reactions, however the parent was made aware of the mistake on our part (and was told the risks of febrile seizures after the vaccine, no reaction occured). The employee who made this mistake no longer works here.
A non-serious spontaneous report of pregnant inadvertently received FLUMIST was received from a physician concerning herself, a 34-year-old female. The patient received FLUMIST on 24-Aug-2010 at 13 weeks gestation. The subjects last menstrual period was in Jun-2010 and the estimated date of delivery is 20-Feb-2011. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Three days post vaccination the patient developed a blister. The blister broke and the patient now has a 1cm diameter scar.
pt recv vax 29JAN96 & exp mild flu like sx w/n/v, tiredness, lightheadedness, achiness & fever;
Pt  was receiving his H 1 N 1 nasal spray and after about 10 minutes began to feel hot and syncopal and nausea and near fainted.