chrisvoncsefalvay/vaers-outcomes huggingface dataset:
high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), VOMITING (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), CHILLS (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), DECREASED APPETITE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) and HEADACHE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), VOMITING (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), CHILLS (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), DECREASED APPETITE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), HEADACHE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) and NAUSEA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), VOMITING (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), CHILLS (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), DECREASED APPETITE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.), HEADACHE (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) and NAUSEA (high fevers (102 F), vomiting, chills, loss of appetite, severe headache, and nausea.) outcome was unknown.
Day 8 following vaccine developed localized reaction at injection site; hard red itchy lump approx 3" diameter.
Fever, muscle aches, sinus headache, joint aches, extreme fatigue, sweating,  headache, injection site pain, low back pain. All came in less than 24 hrs after injection. It felt like all the covid symptoms at once from when I had the virus initially in April 2020. I?ve been tested for antibodies twice in the last twelve months, once in June 2020, and once in January 2021; both time positive for at least Igg antibodies. Was re-exposed to the virus in Feb 2021 and had two negative tests a week apart from each other. The first test was 5 days after re-exposure.
Patient complained lips tingling & tongue was swelling. Onsite EMS was called vitals  HR 82 BP 132/87. 25 diphenhydramine was given She felt better and went home.
Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.
Feeling like a little pain in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25May2021 11:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset 25May2021, outcome "unknown", described as "Feeling like a little pain in my neck".  Additional Information: Patient state that  patient just got a Pfizer Vaccination (Unspecified Vaccine) today about 11.00 and now the patient was feeling like a little pain in neck and patient did not t know if that was caused because of that or that normal. Consumer stated that the patient took should any medication like Tylenol if the patient needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
second doses of Moderna Covid-19 vaccine too close to the first dose; A spontaneous report was received from a pharmacist concerning 2 patients who received a second dose of Moderna's COVID-19 Vaccine (mRNA-1273) too close to the first dose/ inappropriate schedule of product administration.   The patients' medical history was not provided. No relevant concomitant medications were reported.  The patients received their first of two planned doses of mRNA-1273 on 14 Jan 2021. On 02 Feb 2021, the patients received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.   The event, second dose of Moderna's COVID-19 Vaccine (mRNA-1273) too close to the first dose, was considered resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect schedule of product administered for mRNA-1273 with no associated AEs.
Tongue and lips tingling 10-15 mins after vaccine,  the nurse on site took pulse/ox, blood pressure, blood sugar, and looked at my face and neck to see if she could see a reaction from the outside.  These symptoms stopped 1 hr after vaccine. Then, very slight rash on neck and chest the next day (2/28) red spots (no itching), no treatment. Today (3/1) the rash is lighter and many spots are gone.
Vomiting, acting lethargic and strange, "like she was awake but dreaming and not aware of her surroundings" per mother. Vomiting continued until approximately 03:00 AM on 07/02/2014.
7-10 days- rash papulovesicular, mild chest and back pruritic. Received Hep A vaccine on 05/24/05.
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of POOR QUALITY SLEEP (Poor Sleep) and PAIN IN EXTREMITY (Sore Arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY SLEEP (Poor Sleep) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, POOR QUALITY SLEEP (Poor Sleep) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment medications provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-357638, MOD21-144365 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-357638:mother case MOD21-144365:mother dose 1 case
Initial and follow-up information has been received from a dermatologist and a medical assistant concerning a 14 year old female with no medical history and no known allergies who on 16-JUN-2010 (also reported as approximately one month ago by the dermatologist) was vaccinated with the first dose of GARDASIL (lot # 662452/0671Y). There was no concomitant medication. The medical assistant reported that the patient did not have any rash on the day she received the vaccination. On 14-JUL-2010 the patient was seen by the physician in their office. The patient at that time had a rash all over her body and was referred to the dermatologist. The dermatologist reported that she did not administer the vaccine for the patient and it was given at another health care facility. On 17-JUN-2010, I day post vaccination with GARDASIL, the patient developed papules on her buttocks, shoulder, and girdle area. Dermatologist stated the patient was seen at her office and she performed a skin biopsy of the left buttock and the result was necrotizing folliculitis. The patient was placed on VALTREX therapy of 1 gram twice a day "last Friday". The patient was going to coming into the office on 28-JUL-2010 at 10:00 AM to have suture removed from her left buttock. The dermatologist stated she had never seen a case of herpetic necrotizing folliculitis from the GARDASIL vaccination before and this child had mounds of papules. At the time of the report, the patient had not recovered. The second dose of GARDASIL was scheduled 19-AUG-2010. Additional information has been requested.
Swollen Lymph Nodes in armpit on left arm. After a month of swollen nymph node and pain, Patient was put on Augmentin and switched to Amoxicillian antibiotics.  Continues to swell, pain and bruising.  No resolution as of today
Broke out with hives over both legs, buttocks, back, feet on day one (two days after injection.  Antihistamine help to reduce but came back next morning much worse.  Not bumps, like day before, but all running together.
Patient presented today with concern of swelling, redness, pain, and heat radiating from his left arm.  Profile shows that he received MODERNA VACCINE on MAY 1st to his left arm.  Patient stated that he noticed swelling on May 8th which is over a week after from his vaccine date.  The patient states he will seek proper diagnosis from a healthcare provider since he can't really remember what else could have caused this. He said its painful and will find more information from a provider.  It is unlikelythis be a vaccine site related reaction since its been over a week  he received the injection. Typically a patient presents with vaccine site related issues within the first 72 hours.
leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine with no reported adverse event; leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00764055) and transmitted to Sanofi on 10-Sep-2021.  This case involved an unknown (age and gender) patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine (underdose) and their symptom (syringe issue)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 08-Sep-2021, the patient received first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ704AA and expiry date: 30-Jun-2022) (Frequency = once) via intramuscular route in the left deltoid for prophylactic vaccination leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine (underdose) and their symptom (syringe issue)  It was reported"Caller asked how to proceed in this situation. Caller states that a nursing student prepared and administered the vaccine from a prefilled syringe and that the needle was not twisted on tight enough. The nurse that was present stated that "the vaccine leaked out where the needle connects to the syringe". Caller states that the cause of the leak was due to human error and that there have been no other issues with FLUZONE HIGH-DOSE QUADRIVALENT prefilled syringes. Caller states that she can be contacted if additional patient information is needed. Caller did not wish to provide specific patient information at this time. Caller states that she may be contacted in the future if it is necessary".  This case was vaccine underdose and syringe leak (latency: same day)  At the time of reporting, no adverse event
Patient received Pfizer for his second vaccine. He was supposed to receive a second Moderna vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with MMR II inadvertently instead of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
-extreme nausea/ stomach pain -severe pain at injection site (> 3 days) -chest tightness -fever / chills  -hot to touch -body ache   -lethargic  lasted 3 fulls days before symptoms subsided (tylenol/motrin)
Chest pain, SOB, pain in right side of neck, pain in right ear, pain in right arm, light headed.
Extreme fatigue, chills, fever, nausea, worst headache I've ever had (since suffering from Lyme disease). The skin irritation is intense; it feels as if every touch is rubbing sandpaper on my skin. The past two nights I have had extreme night sweats. At the injection site, swelling is so severe my tight shirts don't fit. Red, itchy, I almost feel as if deep damage is being done to my arm muscle. I am gradually getting better, but have lost all my appetite and just don't want to eat or drink anything. This is day 4. I can drag myself through work, the headache is gone, and the skin irritation is better but still nauseous. At least I'm losing weight. If I had known how sick this vaccine would make me, far worse than the first shot in the series, I would have skipped it and just gone hoping that the first shot would be enough to prevent the shingles. I'm not even sure I had chickenpox to begin with, so I might even have had natural immunity. This shot has made me the sickest I've been since I had Lyme Disease.
Narrative: COVID infection following COVID vaccine series 01/29, Pfizer, dose #1 (Non-agency) 02/20, Pfizer, dose #2 (Non-agency) 08/03 pt cc: cough, fatigue, headache, dyspnea, severe weakness, chills, diarrhea, exposure: possible wife or daughter 08/06 COVID swab, result: detected 08/06 ED admit dx: covid pna admit to medicine LOS: 2 days 08/12 Another ED admission with direction admission to medicine dx: COVID19 with progressively worsening 08/24 CXR impression: Similar left tension pneumothorax. Redemonstrated left-sided chest tube has its tip projecting over central left lung zone. 08/25 fungitel interpretation negative result: 31 08/26 PT result 14.6, APTT result: 39.3, INR result 1.30, antiXa unfrac 0.32 08/26 lactic acid result: 2.02 08/26 procalcitonin result: 0.55 08/26 troponin i result: 2.469 08/26 MRSA result: not detected 08/27 SARS-CoV-IgG result: 2.23 08/29 CXR impression: Limited study. Increased moderate pneumomediastinum. ET tube tip about 4.4 cm above the carina. No obvious pneumothorax seen. Extensive airspace disease on the left appears mildly increased. Mild right perihilar infiltrate appears similar 08/30 CXR impression: Slight further increase in pneumomediastinum. 2. More prominent burden of airspace opacities, as above. 3. Tubes and lines as above. 08/31 ABG (ventilator) i-Ph 7.17, I-pco2 47.5, i-Po2 72, iHCO3 17.2, 08/31 FIBRINOGEN result: 161 08/31 DDIMER result: 14.59 08/31 ESR 4 08/31 lactic acid 8.13 08/31 ANTI-XA UFH result: 0.26 08/31 decease
Knot/swelling on (R) arm. Diarrhea that evening and info next day. 8-27-08 not temperature. Off work early, due to soreness and knot about size of golf ball.
pt recvd flu vax & pneumovax ins ame arm on 28OCT; on 29OCT had devel cellulitis @ inject site;
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received PREVNAR 13 and influenza vaccine (FLU), via unspecified routes of administration in the left arm on an unspecified date (reported as in October) at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient had muscle pain in both hips and upper arms on an unspecified date. He had four blood tests and three MRI and everything was normal. The patient was now seeing a pain doctor. It was reported that the most severe pain was in his left shoulder and at the injection site. Outcome of the events was unknown. Information on the batch number has been requested.
It was reported in a published article, that 2 children developed invasive Hib disease, after being partially immunized with a median of 1 dose of PedvaxHib (OMPC) (manufacturer unknown) (range 1-2 doses). It was reported that 2 infants died because of nontypeable H influenzae invasive disease. No further information was available at the time of this report. Upon internal review, invasive Hib disease was determined to be an other important medical event. Additional information has been requested.
Pfizer on 3/16 and 4/6. Positive on 12/7
On 1/21/09 at the time of immunization, baby was seen and diagnosed with URI/(L)otitis media. Afebrile. During night of 1/22 developed fever of 102. On 1/23/08 about 7:30am had grand mal seizure. taken by ambulance to ACMH ER. temp 103.9 in ER. treated with antipyretics. dishcarged. Dx: acute febrile seizure/(L) otitis media. f/u PCP 2-3 days.
sore arm; joint pain; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EL1283), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller received both doses of the PFIZER-BIONTECH COVID-19 vaccine. With the first shot she only had a sore arm for 2 days and joint pain for over a week. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
SEVERE HEADACHE, WEAKNESS, FATIGUE, NAUSEA, VOMITING, SLIGHT MUSCLE ACHE.  3 HRS. TX: 800 mg IBUPROFEN SYMPTOMS UNDER CONTROL WITHIN 1 HOUR AFTER TX.
This is a spontaneous report by a contactable physician through a Pfizer sales representative reported one behalf of physician for an elderly patient who received PREVNAR 13 single dose intramuscular, on an unknown anatomical site for routine vaccination on an unknown date. Relevant medical history and relevant concomitant medications were unknown. Vaccines taken within the last four weeks were unknown. Vaccines given on the same day were unknown. On an unknown date the patient had severe swelling at the site of injection. Relevant sibling information was unknown. Relevant lab data was unknown. At the time of the report the clinical outcome of the above mentioned event was unknown. Follow-up (30-JUN-2013) Follow-up attempts completed. No further information expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was sick and had suspected clinical vaccination failure, and suspected covid-19 infection. The reporter stated, "I had a niece and her family who had been vaccinated and caught COVID 3 times. The last time she was very sick". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000217868 This case, from the same reporter is linked to 20220239628.; Sender's Comments: V0. 20220239490-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Information has been received from a registered nurse concerning a 6 1/2 month old male patient with no allergies or drug reactions and no pertinent medical history who on an unspecified date was orally vaccinated with 2 mL of the third dose of ROTATEQ (Lot# and expiration not reported). There was no concomitant medication. Nurse reported that the patient was administered ROTATEQ and 24 hours post vaccination developed erythema multiforme. Nurse stated that the third dose was not administered with any other medications. No laboratories were performed. The patient sought the physician. No treatment was given for this adverse event. The patient recovered on an unspecified date. Follow-up information has been received from a registered nurse concerning a mixed (AA/C) 16 week old patient, with no known illness at the time of vaccination, who on 20-MAY-2011 was vaccinated with a second dose of ROTATEQ (Lot #, dose and route not reported), a second dose of PENTACEL (lot # dose and route not reported) and a second dose of PREVNAR 13 (lot # dose and route not reported) and on 26-JUL-2011 at 11:30 am he was vaccinated with the third dose of ROTATEQ (Lot # 669963/1724Z). Vaccine given within 4 weeks of MERCK vaccination included PENTACEL (lot# C3840AA) L thigh at 1:00pm and PREVNAR 13 (lot #E97569) R thigh at 1:00 pm. The registered nurse reported that on 27-JUL-2011 the parents noticed 2-3 mosquito size bumps (late pm). On 28-JUL-2011 the bumps changed in color looking dusky in the center and multiplied to approximately 10 on abdomen and arm. No further information is available.
Eccymosis to Left forearm/upper arm, approx 3 inches below site of vaccine administration.  Noted 24 hours after vaccine was given.  CBC was drawn that was within normal limits.
Event: Client was administered a COVID-19 vaccination that is not approved at this time for use under 18 years of age. Outcome: No signs or symptoms of adverse reaction noted during monitoring period after receiving the vaccine.