chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT DEVELOPED A REALLY SORE ARM, RED, A LITTLE WARM TO THE TOUCH EXTENDING FROM VACCINATION SITE TO THE OTHER SIDE OF HER NECK, PART OF CHEST. IT WAS RECOMMENDED TO ICE AND TAKE TYLENOL, AS WELL AS HER REGULAR MELOXICAM. IF SYMPTOMS WORSEN OVER THE NEXT 24-48 HOURS SHE IS TO GO TO EMERGENCY ROOM FOR TREATMENT.
17 year old received Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Moderna Vaccine) in a 17-year-old male patient 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 (17 year old received Moderna Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Moderna Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    This case was linked to MOD-2021-065070 (Patient Link).; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Pt went to MD on Monday with red puff areas that were spreading, MD diagnosed pt with cellulitis and wrote for Bactrim RS for 7 days.
Full body rash, redness and inflammation lasting 3 days. Exhibited symptoms primarily in face and chest.
My blood pressure was high the next day 152/103. It's normally 128/88 or 130/90; This is a spontaneous report received from a contactable other-healthcare professional (patient). A 61-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:00 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR), celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. The patient previously took demerol and experienced drug hypersensitivity. Patent received vaccine facility in pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced my blood pressure was high the next day 152/103. it's normally 128/88 or 130/90 on 17Apr2021 06:00. No treatment was received for the events. The patient underwent lab tests and procedures which included blood pressure measurement: high 152/103 (It's normally 128/88 or 130/90) on 17Apr2021. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
My symptoms started with a tickle in my throat and I felt kind of ok on Sat. Sunday it was getting worse. I was traveling for work. On Monday I felt even worse but urgent care was already closed. I thought it was allergies so I was treating it with my allergy medication. The next morning I felt worse and even possibly from the allergy medication. I went to urgent care on Tuesday morning. My oxygen level was 93. I was given PAXLOVID. I started it on Tuesday and completed it on Saturday the 22nd. I was having a very difficult time swallowing because I couldn't even drink liquid; my throat was very irritated. Mon and Tues I couldn't drink much. Wed I could drink a little. Thru/ Friday I could drink a lot more. The PAXLOVID was definitely working because I was feeling better after each dose. The only side effect I experience of PAXLOVID was the metal taste in my mouth. I'm feeling now like I'm at the tail end of it, I don't feel back to normal enough feeling still a little fatigued and have a slight temperature. After I talk for a while I cough a little bit. I also lost my voice entirely at one point and that is why I initially thought I had strep.
Otitis Media; acute upper respiratory infection; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 3-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2023 as dose 2 (maroon cap), single (Lot number: FT9142) at the age of 3 years intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP),SINGLE, Anatomical site of injection: Left thigh, Route of administration: Intramuscular, Batch/Lot number: FX5095), administration date: 24Feb2023, when the patient was 3-year-old, for COVID-19 immunization, reaction(s): "they gave to patients that were used beyond use date/ patient received FX5095 BUD for first vaccine", "they gave to patients that were used beyond use date/ patient received FX5095 BUD for first vaccine"; flu vaccine (DOSE 1, SINGLE, Manufacturer: Sanofi, Batch/Lot#: UT7723MA, Route: Intramuscular, Anatomical site of injection: Left thigh, No. of previous doses: 0), administration date: 24Feb2023, when the patient was 3-year-old. The following information was reported: OTITIS MEDIA (non-serious) with onset 24Mar2023, outcome "unknown"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 24Mar2023, outcome "unknown", described as "acute upper respiratory infection".  Additional information: No specific relevant test for thromboembolic events with thrombocytopenia was done and the patient did not provide information regarding the reported adverse event(s) with the use of the product.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300152548 Same reporter, patient, product, different dose and events;
pt. recd. vax & exp. bloodshot,dry eyes w/ no drainage. Placed on cortisone therapy.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # H020901, expiration date: 05-JUL-2015), dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt expressed red raised hard area, extremely painful and last for 3 days; resolved on its own
dec89 pt vax 2nd hepta B. 72 hrs later pt devel flu-like illness w/ generalized aching and fatigue plus pain in wrist and hip joints.  sx remitted after about 5 days.  patch test w/ thimerosal was neg.
Began having joint pain 1 week after flu shot and was also unable to move my head due to neck pain. Went to ER with low-grade fever and was sent home. on 9/17/18, returned to the ER due to continued low-grade fever and severe joint pain. Ran a number of tests, the only positive of which was the BORRELIA (LYME) AB IGG/IGM test. My doctor doubts that it was positive at the time, as the next two times it was given on 10/23/18 and 1/15/19. I proceeded to take 3 rounds of dioxycycline for 10 days, then another 10 days, then 3 weeks, running into January. The infectious disease specialist was not sure it was Lyme when I visited her on 1/15/19 (see test above). All tests came back negative, except for the C-Reactive Protein, which was 6.56. Next, I saw a rheumatologist in March, who tested my C-reactive protein again, and i t was over 8. My ANA also came back positive 160:1 with a speckled pattern. This has been tested twice more since then with the same result. My C-reactive protein continues to be steadily above 8, with joint inflammation, rashes, and low-grade fever continuing.
Large swelling under left armpit that extends to bottom of breast and looks like it may include a portion of the left breast.  Doctor and myself are assuming this is a lymph node swelling event, precipitated by the Pfizer booster shot.  We will check at the doctor's office, if swelling doesn't go down in a few weeks.  In other words, I contacted my primary care physician (who was on vacation) and this was advice given to me by the attending doctor
The pt., a medical student, received a pneumococcal vaccine instead of a meningococcal vaccine.  There was no adverse reaction.
Headache; Headache , joint pain , muscle pain; Muscle pain; Chills; Fever; Tenderness to touch at left arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness to touch at left arm), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Headache , joint pain , muscle pain) and MYALGIA (Muscle pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced TENDERNESS (Tenderness to touch at left arm), FATIGUE (Fatigue), ARTHRALGIA (Headache , joint pain , muscle pain), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, TENDERNESS (Tenderness to touch at left arm), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Headache , joint pain , muscle pain), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-031736 (Patient Link).
Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6199), as dose 2, single (Lot number: ER8733) and on 30Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 15Jun2022 to 20Jun2022 for COVID 19 Treatment.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Pfizer-BioNTech COVID-19 Vaccine EUA injected into left arm at 10:15 am on 17 Feb. Soreness at the injection site was the only symptom immediately following the injection. At about 3:00 am the next morning, I experienced extreme nausea and chills. I fainted when I tried to get out of bed to go to the restroom. All of 18 Feb, I experienced the following symptoms: headache/migraine, fatigue, dizziness, loss of appetite, muscle aches/soreness, fever, and severe pain in my left arm.  As of today, 19 Feb, I am experiencing headache, lightheadedness, and mild pain my left arm.
Extreme fatigue/sleepiness 5 days Fever day 2 101.5, day 3 99 Aches 3 days Chills sweats 4 days Pain at site
Initial unsolicited report received from a nurse via company representative on 14 October 2015. This case involves three patients (age and gender not reported) who were vaccinated with a dose [route and dose series not reported] of FLUZONE HD (batch number, expiry date and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date following the vaccination, patients experienced severe reactions, felt sick for several days and had extensive arm pain in the arm of the injection. Laboratory investigation and corrective treatments were not reported. Patient had recovered from the event felt sick and the outcome of other events was not reported. List of documents held by sender: none.
sore arm; Headache; Rash around neck; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. After 2nd dose of vaccine (on an unspecified date), the patient experienced sore arm, headache, and 48 hours after, the shot developed a rash around neck. The patient received Benadryl as treatment for rash. Outcome of events was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
caught a bad cold soon after I was vaccinated, and when the cold was slightly over. It left me with severe pain inside my rib cage spreading to my back. The doctor did tests. They found I had damage to my liver. I wanted to report about the Flu shot that was given to me. I went to the emergency room and my doctor about this. They told me they don't think my condition came from the Flu shot. They did not run any special tests to prove that it didn't. I know I never had anything wrong with my liver before. I don't drink or smoke. I know I did develop this problem until after I was given the Flu shot.
pt recvd vax; chills, aching all over; severe h/a; t of 100;
Subject, a 29 year old female, with a history of 4 previous Anthrax vaccinations, developed redness, swelling and pain at the injection site after receiving Anthrax vaccination number 5 (no lot number provided) on 06Jun00. She was seen again after 24 hrs and the symptoms had begun to improve. No committee assessment form was provided but medical notes states that the subject recovered. No other vaccination information was provided. There were no concomitant medications to report. The pt was treated with Ancef, Keflex, Motrin and Tylenol. Additional information will be provided, as it becomes available.  Reported on: 08Feb01.
Information has been received from a medial assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M007764 with expiration date 30-JAN-2018, lot # M011117 with expiration date 07-DEC-2017) (dose and route unknown). The vaccine was exposed to temperature excursion of 32.7Fahrenheit degree (F), 34.2F, 35.0F, 35.4F for 123 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Felt hot (no fever), coughing, bones aching. Next day, lt arm felt bruised, lt shoulder & neck hurt. Today, couldn't turn neck.
The next day (05/06/2021) of my second COVID Vaccine I woke up with my face completely numbed and severe headache on the right side of my forehead.  Couple hours after feeling started going back to my face but headache stayed.  Went to my primary doctor and prescribed Butalb - Acetaminophen 50-300 cap.  Returned to primary with same headache and and MRI was prescribed, nothing came out in the exam, referred to neurologist and MRI under contrast was prescribed with Gabapentin 100 mg.  Came back for MRI results with neurologist and told me that exam is fine but unfortunately is not much to do for COVID vaccine effects since this is a new virus still under investigation and only solution is continue to manage headache with Gabapentin.  Doctor wanted to increase the dose to 300 mg but I didn't take the dose increase since this concern me.  I really want the headache to go away and not manage it.
2nd dose given on 2/23/21.   Both times I got "Covid arm".  It started quicker after the second dose, but the first was more severe.  A red welt like rash began a few days after the first.  It grew into a large red circle and lasted about 3 weeks.  Towards the end it was itchy.  After the second dose, it started appearing the next day, along with a low grade fever (under 100).  It was not a red and resolved in about 2 weeks, but it was itchier than the first one.
This spontaneous report as received from a nurse refers to a 68 year old female patient. On 25-SEP-2013 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency, route unknown, lot# J003703, expiration date 27-MAR-2015). On 25-SEP-2013 the patient was accidentally administered VARIVAX instead of ZOSTAVAX. The patient didn't seek medical attention. No adverse effect was reported. Additional information has been requested.
Patient following visit in afternoon spiked temperature to 102.3, thus mother brought him into the ED given medical history of sickle cell sc disease. When he arrived, he was noted to have a temperature to 101.2. T max was 104.1 that evening while hospitalized. He also was c/o right thigh pain on admission with shaking of that leg. His blood culture was no growth. UA wnl. He did have XR of the bilateral legs that were within normal limits.
Reported redness around the injection site developing into a rash and low grade fever. Dr prescribed Augmentin for treatment on 12/7/15.
Round, raised and hard red rash at shot site on left arm, very itchy, painful and as big as a desert plate. Also, 2 days of severe body aches and one night of extreme night sweats. And a sore throat.
3rd dose of flu vaccine given to patient. No adverse events except parents made appointment for nurse visit vaccine only for Flu #2, however Flu #2 already given 1 month prior in October 2017.
pt recvd vax; pt exp hip & knee pain w/ 1st dose; w/ 2nd dose pt exp recurrence of jt pain;
Patient presented with fever (temperature 102.1 F), shortness of breath, loss of appetite and fatigue. Patient also reported chronic diarrhea due to his ulcerative colitis.  The patient was treated with remdesivir, dexamethasone, and oxygen. Patient's symptoms have improved and no longer has a fever, shortness of breath, and is less fatigued.
Respiratory and cardiac arrest, extensive resuscitation attempted with short return of heart beat followed by cardiac arrest that did not respond to resuscitation and resulted in death.
2 yo child received Dtap #4 in left deltoid on 08/20/14 at 10:00 am. MOC called RN to report left arm swelling about "1/2 the size of a tennis ball and a rash (red and bumpy around the site of injection" on 08/21/2014. MOC stated arm was not hot and child was acting normally.
My daughter received her first injection of the Moderna COVID-19 vaccine on 8/11/2022. Later that day, I noticed that she seemed lethargic and quieter than usual, and she's usually a very active kid. She also had a reduced appetite. These symptoms continued on 8/12/2022, 8/13/2022, and 8/14/2022. On 8/15/2022, she seemed to be back to her normal self. While she was sleeping that night, though, she was restless. She woke up on the morning of 8/16/2022 with a fever of 102 and complaints of pain in both legs and an inability to walk. I gave her ibuprofen, which alleviated the leg pain. She then perked up and was able to walk. Once the ibuprofen wore off, though, the stiffness came back. This cycle also continued on 8/17/2022 and on 8/18/2022 (the time of this writing). We have kept her out of school all three days. We also had her evaluated by her pediatrician on 8/17/2022. The pediatrician could not find any obvious cause for the pain and suspects that it's virus-related. She asked us to monitor my daughter's situation, give her ibuprofen as needed, and follow up with the pediatrician on 8/19/2022. I don't know if this is related to my daughter's current situation, but I think it's worth mentioning that she had nasal congestion just prior to her vaccination.
swelling on his face; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 24Feb2021 (Batch/lot number unknown), as dose 1 single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, after the first dose, the patient experienced slight swelling on his face. The patient was asking if it was normal or if it was a side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd Engerix-B & on the same evening exp tingling in legs, h/a, fever, insomnia; events resolved;
Received the vaccine in our office around 4:30 pm and was told to wait by our staff to wait in the waiting room for 15 minutes to make sure that he had no reaction to the vaccine. Later that night his arm became swollen from his shoulder all the way to his hand. It was hot to the touch, red and very painful. His mother, Dr., appropriately treated the reaction at home and contacted Dr. yesterday, 7-12-18, and asked us to report the adverse reaction.
Following vaccination, it was reported that the pt developed a febrile seizure. The pt was hospitalized on 1/31/99 for three days. The pt was switched to DT for further immunizations with no seizures Follow-up information is requested.