chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On January 11, 2023, she woke up with a fever. The highest her fever got throughout the course of the illness was 103-degrees. We alternated TYLENOL and ibuprofen for the fever. We made an appointment with her pediatrician who saw her that same day. They tested her for Flu, Strep, and COVID-19. She tested positive for Influenza A. She was prescribed TAMIFLU. Her only symptoms for the first two or three days were a fever. Around day three or four, she began to develop nasal congestion and cough. She also developed Viral Conjunctivitis, fatigue, and decreased appetite. She was out of school a little over a week. She returned to school on Friday, January 20, 2023.
Approximately 3-days after receiving the injection, I first began to experience a gradually increasing, dull chest pain, where this pain finally reached a steady-state level of 2/10 on 10/17/2021 involving a hand-sized area under my left breast.  Additionally, accompanying this discomfort was a slight  increase in my shortness of breath at rest and on exertion.
sore arm after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after second shot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified. Concomitant products included INSULIN GLARGINE (LANTUS), METFORMIN, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, EMPAGLIFLOZIN (JARDIANCE), CARVEDILOL and MORPHINE SULFATE (MORPHINE SULPHATE) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm after second shot). At the time of the report, PAIN IN EXTREMITY (sore arm after second shot) outcome was unknown.            No treatment medications reported.
The morning after receiving the Moderna booster (I had previously received the moderna 1st and 2nd doses in Jan and Feb 2021) I woke up early with severe pain in both shoulders. Not long after the pain began radiating across my chest and back. Later that morning the pain became more intense so I visited the Emergency Room. Numerous tests were done after which, I was then transported to Hospital for more tests and overnight observation. I was diagnosed with pericarditis, prescribed a 7 day course 600mg Ibuprofen and a 90 day course of  0.6 mg Colchicine (twice daily). One week later during a visit to my PCP for follow-up,  I mentioned during the visit my pulse had been irregular.  PCP's nurse practitioner then ran an EKG. I was immediately sent back to the Orlando Health and more tests, AFIB was then diagnosed.
1. Patient felt face become hot, then developed a fever. Possible drop in blood pressure 2. Extremely dizzy & nauseous. 3. Passed out 4. After she came to, she drank 5 cups of water- extremely dehydrated. 5. Symptoms lasted 3 weeks
Approximately 10 minutes post vax, the pt was in the car and began clenching teeth, arm flexing, non-responsive for approximately 20 seconds. Then immediately became responsive and alert. Complained of feeling dizzy, and lightheaded. Examined within 10 minutes and had normal exam including vital signs and neurologic exam.
On 26-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 VACCINATION SITE SWELLING (swelling of the injection site). On 03-Mar-2021, the patient experienced CHEST PAIN (mild chest pain) and DYSPNOEA (shortness of breath). At the time of the report, VACCINATION SITE SWELLING (swelling of the injection site), CHEST PAIN (mild chest pain) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
bacterial respiratory infection; positive for COVID; positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 14Nov2021 (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "unknown" and all described as "positive for COVID"; RESPIRATORY TRACT INFECTION BACTERIAL (non-serious), outcome "unknown", described as "bacterial respiratory infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Dec2021) negative; (20Dec2021) positive. Therapeutic measures were taken as a result of respiratory tract infection bacterial on 10Dec2021. It was reported that, he was otherwise healthy and tested again for COVID since family members tested positive on 17Dec2020.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received her 2nd Moderna COVID vaccine dose on 2/26 at 2:00PM.  She started with urticaria at approximately 4:30PM.  She took a dose of cetirizine that helped to alleviate the urticaria.  She then started to develop tongue swelling around 10:00 PM, but noticed it to worsen around 1:00 AM today, which prompted her visit to the Emergency department. Tongue swelling/possible angioedema
This spontaneous report was received from a nurse, regarding an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-OCT-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB PED 10x3 DS (lot #, dose, frequency were not reported)  for prophylaxis. However no adverse event were reported.
Swollen, red, warm  and itchy area at injection site that started six days after vaccine.  Still experiencing symptoms to date of this report.
Had fatigue, fever, body aches, headache, soreness and redness at injection site, stiffness of neck.
Information has been received from a Licensed Practical Nurse concerning an 18 year old female patient with unspecified medical history, drug reactions or allergies, who on 17-DEC-2009 was vaccinated with a first dose of GARDASIL (route and lot # unknown). Concomitant medication was unspecified. On 18-DEC-2009, the patient experienced a headache that lasted for a month. The Licensed Practical Nurse reported that the patient decided not to complete the rest of the GARDASIL series and she ended up having to take ADVIL for one month as needed for the headache. It was unspecified if lab diagnostic studies were performed. The patient did not seek medical attention. At the time of the report the patient recovered. Additional information has been requested.
After 12 hours I developed full body chills and shivers. Uncontrollable. A fever. Body aches and joint pain. Extreme headache.  Extreme sweating when my fever would break each time. This went on for another 24 hours. Fever was as high as 103.8.  Shivers and chills were very extreme.  Stayed in bed for 33 hours until it passed.
This spontaneous report as received from the director of a health department via a company representative refers to an unspecified number of patients (reported as four other female and male patients) of unknown age. It was reported that on an unknown date the patients experienced fainting after receiving vaccination with an unspecified dose of GARDASIL (route, lot number and expiration date not reported) for prophylaxis and others unspecified shots (unspecified dose/frequency and unspecified manufacturer). The outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of fever in a child patient who received PEDIARIX (batch number UNKNOWN, expiry date unknown). On an unknown date, the patient received the 1st dose of PEDIARIX (intramuscular). On an unknown date, the dose was an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be almost certainly related to PEDIARIX. Additional details provided were as follows: The patient experienced high fever. Limited information was provided by the sale representative from the physician. This was 1 of the 4 cases reported by the same reporter (US2016038398, US2016038401 and US2016038403).
26 minutes after receiving the vaccine patient complained of headache, weakness of limbs and visual disturbances. Had not eaten or drank fluids since 12noon today. Given water and a belvita cracker which he consumed without issue.  Continued to monitor VS were stable (BP 118/76 and pulse 106) and pulse ox  98%. When symptoms continued past 1 hour with no significant improvement EMS were called and patient was transported to the Emergency Room.
Patient was inadvertently administered Janssen (Johnson & Johnson) COVID 19 vaccine at our mobile vaccination clinic despite being out of the approved age group, given that patient is 17 years and 11 months old. To date patient has reported NO adverse events after vaccination.
2 DAYS AFTER RECEIVING PREVNAR, LUMP NOTED AT SITE OF INJECTION.  NEXT DAY PINK PATCH DISTAL TO INJECTION SITE AND PAIN TOP OF LEFT SHOULDER ON ABDUCTION.  NO ORAL SX, FEVER, ARTHRALGIAS/MYALGIAS ELSEWHERE.
Rash; Hives; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received second dose of BNT162B2 (PFIZER COVID 19 VACCINE; Solution for injection, Batch/Lot Number: FC3180; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in Arm Right on 11Aug2021 (age at the time of vaccination was 55-year-old) as single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 for COVID-19 immunisation on 16Jul2021 with Lot Number / Expiry Date: FA7485/ 31Oct2021 on right Arm reaction included sick, Fever, Pain, Eyes dilated, Sweating, Aches and Neoplasm malignant from Feb2019 to an unknown date. The patient's medical history included cancer, Bladder operation from 01Apr2021 to an unknown date had surgery to take his bladder out. There were no concomitant medications. The patient experienced Rash, Hives on 13Aug2021, Tested positive for covid-19 on 11Aug2021. The patient underwent lab tests and procedures which included pyrexia: 100 on an Unspecified date Fever of a hundred, Sars-cov-2 test: positive on 11Aug2021. Therapeutic measures were taken as Benadryl for hives. Patient did not require a visit to Physician Office or Emergency Room. Prior Vaccinations within 4 weeks no other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  number of COVID-19 vaccine was unknown. The outcome of event for Rash and tested positive for covid-19 was unknown, outcome for Hives was Not recovered.  Follow-up (31Aug2021): Follow-up attempts are completed. No further information is expected.
TIRED; ALMOST PASSED OUT; MIGRAINE HEADACHE; NAUSEA; SHIVERS/CHILLS; SHAKING; WAS UP ALL NIGHT; SORE ARM; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included strong reaction to vaccine such as the flu vaccine., and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced was up all night. On 06-MAR-2021, the subject experienced sore arm. On 06-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 F. On 06-MAR-2021 15:00, the subject experienced shaking. On 06-MAR-2021 15:00, the subject experienced shivers/chills. On 06-MAR-2021 23:00, the subject experienced migraine headache. On 06-MAR-2021 23:00, the subject experienced nausea. On 07-MAR-2021 05:00, the subject experienced almost passed out. On 08-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine headache, shaking, almost passed out, shivers/chills, fever, and nausea on 07-MAR-2021, and tired on MAR-2021, was recovering from sore arm, and the outcome of was up all night was not reported. This report was non-serious.  Version created to amend previously reported information on 17-Mar-2021. Upon review the following information was amended: reporter causality (WAS UP ALL NIGHT).; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
huge red rash; rash: a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (huge red rash) and VACCINATION SITE PRURITUS (rash: a little itchy) in an 81-year-old female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (huge red rash) and VACCINATION SITE PRURITUS (rash: a little itchy). At the time of the report, VACCINATION SITE RASH (huge red rash) and VACCINATION SITE PRURITUS (rash: a little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.
Fever; Body aches; Headache; chills; This is a spontaneous report from a non-contactable consumer (patient) reported that a 50-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on left arm on 22Jan2021 17:00 at single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included eletriptan hydrobromide (RELPAX), atorvastatin (LIPITOR). The patient previously took first dose of BNT162B2 on 31Dec2020 at 05:00 PM for COVID-19 immunization. On 23Jan2021, patient had fever, body aches, headache and chills. The patient received treatment with TYLENOL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Redness and swelling near injection site. Right arm 14 x 14 cm erythematous patch, warm, blanching and mildly tight.
She got her vaccine, was fine, her friend left her around 3:30 that afternoon and after she left she started to feel joint pain, and felt really weak and tired.  She looked at the AE sheet and felt that was what it was.  As she got up and started to walk she was dizzy, did not feel right, thought she was going to pass out.  She laid down, woke up and it was dark out and wanted to know if her sugar was low as she is hypoglycemic, and she checked her blood sugar.  She felt that she was too low, passed out and hit the corner of the door frame.  When she woke up her head hurt terrible, headache, and she knew that she had hit something.  She was confused, and decided that she better get some juice.  She got up again, fel felt bad again, and passed out and hit the doorframe with her hip.  She came too and felt she needed to get to the refrigerator to get some juice, and broke her glasses, and decided to get somebody.  She crawled to get her phone, got her girlfriend who had a key to her house.  It took them 25 minutes to get to her.  They got to her and she just stayed on the floor as she did not want to fall again.  She slowly got up, clung to a chair and got into the chair and everything was spinning, nausea and feeling like she was going to pass out but not as bad as the other times.  They decided to call a nurse and called Hospital and asked to speak to a nurse.  They put her through and they could not talk to her as they did not have a PCP there and they are not associated with any clniic.  Her mind was not thinking too well, and they knew a doctor at another place and they called it and they told her to call an ambulance to get to the hospital.  She told her friend to take her to the hospital where she went to Hospital.  She was admitted to the hospital and she was there until Saturday afternoon.  She said that she had a reaction to the vaccine.  She had RSV 5 years ago and they feel that her system recognized that and that it was so strong that it caused this reaction.  While she was in the hospital her BP went down to 55/44, and when she got that low she felt like she was like she was at home, they put her head down and it improved.  It was 145/___.  Normal is 120/55-60.  They just watched her while she was in the hospital.  Late Friday afternoon at around 3:30 they did not admit her and they told her that she would have to pay for her medicines.    She is still not feeling well, she is still nauseated at times, and dizzy at times, possibly related t the concussion she experienced when she fell.
The injection was administered in the left tricep versus deltoid. In the morning  following the injection, the patient experienced generalized malaise, muscle pain at the site of injection and fever. This lasted for 2 days. In the night following the injection the patient experienced an injection  site reaction - greater than 5 inches in diabetes area that is swollen, warm, red and painful to the touch. Following application of cold compress, some relief is notable not the area is still red, warm, swollen and tender to touch.
swollen eyes; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on 03May2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter wanted to check if swollen eyes are a side effect of the covid-19 vaccine since the patient experienced it when he woke up after getting the vaccine last 03May2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccine administered at 10:55.  Patient presented with symptoms at approximately 11:20.  Complained of throat closing, tightness, angioedema, difficulty speaking, itching all over. The medical records states anaphylaxis.
This spontaneous report was received from a Licensed Practical Nurse concerning a patient of unknown age and gender. Information about concurrent condition and medical history was not provided. On 22-OCT-2015, the patient was vaccinated with an improperly stored dose VARIVAX (lot # L013063, expiration date 14-APR-2015 or lot # L026408, expiration date 15-JUL-2015) (dose and route were unspecified). Concomitant therapy was not reported. No adverse effect was informed. This is one of two reports received from the same source. Additional information has been requested.
FROM MID-SEPTEMBER AFTER TAKING THE SECOND DOSE OF THE VACCINE, MY LEFT HAND AND LEFT SIDE OF MY LOWER BACK AND LEFT KNEE STARTED FEELING STIFF AND PAINING. I HAVE READ SOME ARTICLES AND ABOUT POSSIBLE SIDE EFFECTS OF THE COVID19 VACCINE AND IT MENTIONS REACTIVE ARTHRITIS AS A RARE POSSIBILITY. THIS SEEMS TO BE THE CONDITION IN MY LEFT HAND. I HAVE NEVER HAD ARTHRITIS BEFORE. THE ARTICLE SAYS THAT THIS WAS TREATED BY ADMINISTERING 1 ML COMPOUND BETAMETHASONE FOR LEFT KNEE INFLAMMATION AND WAS CURED IN 2 DAYS. THE LEFT HAND CONTINUES TO BOTHER ME SPECIALLY THE RING FINGER WHICH CANNOT BEND . THE OTHER FINGERS FEEL SWOLLEN.
On 10/27/2017, the patient developed seizures. Has no prior history of seizure disorder. She was hospitalized at Hospital. She was diagnosed with autoimmune encephalitis. She has had a prolonged hospitalization and is currently in Hospital rehabilitation program.
Information was received on 24-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX on or about 07-NOV-2011 at a medical facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-AUG-2014, the patient was treated by her physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster. or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Extreme joint pain in the shoulder, radiating into the elbow and down the arm to the hand.  Complete loss of range of motion without excruciating pain.
chills; a lot of fatigue; body ache; loss of appetite; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), FATIGUE (a lot of fatigue), PAIN (body ache) and DECREASED APPETITE (loss of appetite) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (chills), FATIGUE (a lot of fatigue), PAIN (body ache) and DECREASED APPETITE (loss of appetite). On 12-Feb-2021, CHILLS (chills), FATIGUE (a lot of fatigue), PAIN (body ache) and DECREASED APPETITE (loss of appetite) had resolved. Not Provided     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment.
the injection was given high on my arm, very near shoulder bone.  very painful going in(unlike first shot) within 2 hours i could not raise or bend my right arm and the entire arm was painful to the touch ice, heat, Tylenol, Ibuprofen were used for 4 days went to an Urgent Care on day 2 to discuss symptoms and treatment-Dr. advised same course of tx as above I believe the injection was given too close to my shoulder/bursa-it was not 2-3 fingers from my shoulder bone