chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my second Moderna booster for COVID-19 on 4/27/2022. On the evening of 6/24/2022, I was extremely tired. When I went to bed that night, I had terrible sinus drainage. I have a history of sinus infections, so I thought that was possibly the problem I had. When I woke up on the morning of 6/25/2022, I got up and had a cup of tea and then  went back to bed for a while, because I felt extremely exhausted. I was coughing a little at this point, plus I had body aches and an upset stomach. I thought that maybe my upset stomach was caused by the sinus drainage. Later that day, I went to the store and bought TYLENOL sinus for my drainage. I then got back home, and I was still exhausted. I was still coughing a little and had body aches, plus I developed a headache. I took TYLENOL migraine, and it helped some with the headache and the body aches. The TYLENOL sinus I took also helped with the drainage; it didn't completely eliminate it, but it did reduce the drainage. When I woke up on 6/26/2022, I pretty much spent to whole day lying around. I had no energy or desire to do anything; I normally do my grocery shopping on Sundays, but I just couldn't, because I was too wiped out. I also had body aches and ran a fever of 100.2. I took another dose of TYLENOL sinus. It helped a bit with the fever, but it didn't help at all with the general malaise. When I woke up on 6/27/2022, I was still extremely fatigued. I went to an urgent care clinic and was tested for COVID-19, and I received a positive result. I then contacted my PCP, and he told me that he could prescribe me some antiviral pills to treat the COVID-19, but I would probably have to stop taking my blood pressure medication while I took the antiviral. I then told him that I would prefer to just get monoclonal antibodies, because I really did not want to stop taking my blood pressure medication. On 6/28/2022, I received monoclonal antibodies. I then went home and slept for a couple of hours. After I had supper that evening, I could swear that I was beginning to feel better. When I woke up on 6/29/2022, I most definitely felt much better. After a couple of days, I pretty much felt normal again, though the coughing lasted for maybe about 5 days longer. That being said, though, the coughing was never really severe. I did a home test for COVID-19 on 7/2/2022 and got a positive result. I took another home test on 7/4/2022 or 7/5/2022, and I got a negative result.
Blistering of the oral upper palate and gum swelling lasting approx 5 days Narrative:
Started 2 days few bite appearing rash, now individual lesions varying small papules, Pustules no fever mild viral SX.
pt recv vax & devel prolonged elevation of bilirubin; MD states has seen several newborns who recv Hep B vax w/elevated bilirubin-unable to pinpoint etiology of hyperbilirubinemia;
Sinus infection; he started feeling bad; This is a spontaneous report from a contactable consumer(patient). A 70-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date patient stated that he received his Pfizer COVID19 vaccine dose a couple of weeks ago, and is due for second dose next Wednesday. On Saturday patient started feeling bad, went to the rapid care. Patient does not have a fever but was diagnosed with a sinus infection. Patient was given a couple of medications which he doesn't currently have on him but from memory patient can remember: flonase, cough syrup, antibiotic, decongestant. Patient is wondering if that is okay to be given with the vaccine or if he could be refused his vaccine at the vaccination clinic. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
11/15/13 Diagnosed with pneumonia. Started AUGMENTIN. Had fever onset 11/14. Paracetamol given 11/14. 11/22/13 Rash on face, legs, thighs. Dx: urticaria. Stop AUGMENTIN. 11/23/13 Progression of rash. Admit to hospital. Given SOLU-MEDROL. Dx: Allergic to penicillin.
Patient returned to clinic, complaining of localized rash on left arm and swollen lymph nodes. Rash was localized on left arm warm to touch. Patient states it did not itch and was only visible on left arm. Patient did not have fever and lymph nodes was not painful. Mother states patient had similar reactions growing up, stating he was allergic to many things but did not know what. Mother was advised to let patient stay home from school and to watch for worsening symptoms and report to PCP if symptoms got worse. Mother was also advised to give patient OTC children's antihistamines to help symptoms.
Fever; chills; fatigue; body aches; sore arm; This is a spontaneous report from a contactable other health professional (patient). A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 24Dec2020 09:15 at single dose on left arm for COVID-19 immunization in hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, fatigue, body aches, sore arm from 24Dec2020 21:00. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.   No follow-up attempts are possible, information about batch number cannot be obtained.
Patient has a history of dizziness with shots, so they elected to get the Johnson and Johnson shot so that they would only need one shot. Patient received the vaccine in the counseling area, and the shot itself went as usual. About 15-45 seconds after the shot the patient stated that they began to feel dizzy. The patient then tried to lower himself to the floor. As soon as he started, he lost consciousness and fell forward out of his chair. He got some carpet burn in the area surrounding his eye. About a dime sized area above and a quarter sized area below. His head also mildly bumped against the wall. As soon as he passed out, 911 was called as a precaution. He was responsive within the minute, stating he was fine. He lost consciousness soon after for about 30 seconds before becoming responsive again. He was able to hold a conversation upon awakening. Patient states this is normal for him to experience. He has some discomfort with the carpet burns but reported no pain from bumping the top of the head. We offered some Neosporin for the carpet burns but patient stated that medication smells can sometimes make him dizzy, so we did not use any. We did provide him with some bandages for the area. I advised him to wash the area with soap and water at home. We kept him in the pharmacy for a half hour keeping conversation with him to make sure he was all right. He was able to stand on his own without issue after 25 minutes, he did not have any issues with dizziness at this point. After the wait and with patient being back to baseline, they wanted to get home and proceeded to go home. Before they left, I did verify that he was not the one driving home. Ii advised them to seek any medical attention if he has any further such issues. Patient came back after about 45 minutes asking what to use to clean wound. I recommended Neosporin, we did provide patient with both Neosporin and rubbing alcohol.
Arm is very sore and red extending approximately 2 inches beyond injection site 2 days post injection. I also had a fever of 102, chills, severe headache, extreme fatigue, and full body aches the day after injection.  All symptoms, with exception of redness in arm subsided on 2nd day. Please note I also received pneumonia vaccine along with Shingrex vaccine.
Information has been received from a pharmacist concerning a female patient with yeast allergy, who on an unspecified date was vaccinated with RECOMBIVAX HB (manufacturer unknown). The pharmacist reported that the patient had a severe reaction after receiving the vaccine. On an unspecified date, the patient recovered. The patient sought unspecified medical attention.
Woke up in night 12-15-09 - metallic taste in mouth. Dry mouth, thirsty, tired. R leg weak and tingley feeling, decreased appetite - mild nausea - still has all the symptoms - Referred to doctor asap.
Pt called Health Department to report that she was hospitalized for a "large blood clot" in her lungs that they had to dissolve. Pt further states she was hospitalized from 6/14/2021-6/22/2021. Pt also verbalized she will now be on Warfarin for the rest of her life.
Skin was still discolored; Injection site warm to touch; entire arm was itching; Injection site was pink; Injection site swelling; Pain and soreness at site of injection; A spontaneous report was received from a consumer, who was also a 50-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain and soreness at the site of the injection, noticed site of injection was pink, swollen, warm to touch and entire arm was itching.   The patient's medical history was not provided by the reporter.  No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received their first two planned doses of mRNA-1273 (batch number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 and 25 Dec 2020, the patient experienced pain and soreness at the site of the injection. On 30 DEC 2020, she also noticed that site of injection was pink, swollen, warm to touch and entire arm was itching.  Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, pain and soreness at the site of the injection, swollen, warm to touch, arm itching, were not reported; injection site was pink, was reduced over the weekend (unspecified date).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
C/O "Severe congestion that quickly escalated to fever, chills, body aches, headaches & worsening congestion".
Arm itching really bad; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm itching really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Arm itching really bad). At the time of the report, PRURITUS (Arm itching really bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: TCR
patient received second dose of Moderna vaccine on 4/10/2021, and he developed his first symptoms 7 days after.  He ultimately came to hospital with sob, diagnosed wtih bilateral PTE.  no clots noted in his legs bilaterally.  He did well, was on Room Air throughout his stay, which was less than 24 hours and went home on Eliquis for Anti-coagulation.
Narrative:  COVID infection following COVID vaccine series 04/25, MODERNA, dose #1 05/27, MODERNA, dose #2 12/21 COVID swab, result: detected 12/16 pt cc: productive cough, dyspnea, myalgias, loss of taste, and smell, chest pain exposure: unknown 12/21 FIBRINOGEN: 447 12/21 DDIMER: 0.51 12/21 TROPONIN I: <0.016 12/21 SARS-COV-2 Variant Sequencing: pending 12/21 CXR impression: No acute airspace disease. 12/21 pt admit to ED cc: "productive cough, shortness of breath, myalgias, and loss of taste and smell. Admits to chest pain, but mainly with coughing" DX: COVID infection LOS: 1 DAY
expired twinrix administered; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comment: The reporter reported that, a patient was administered with an expired dose of Twinrix.  No adverse event was reported. The adverse event was reported by the supervisor of the facility to the sale representative. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient was administrated with an expired dose of Twinrix, which led to expired vaccine used.
Diarrhea; Cramps; Chills; Nausea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), CHILLS (Chills), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), CHILLS (Chills), NAUSEA (Nausea) and ARTHRALGIA (Joint pain). At the time of the report, DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps), CHILLS (Chills), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Vaccines administered on 11/24/04, client just informed clinic of her adverse event on 1/6/05.  On 11/24/04 client developed "itchy" feeling to entire body with tightness in her chest approx. 30 minutes after she left the clinic.  Client's mother drove client to the local Emergency Room and there, client was given Benadryl and Prednisone and all symptoms resolved with no further complications. No loss of consciousness with the reported symptoms.
extreme crying >3 hr duration; local rxn erythema & swelling; afeb 98.3; seen in ER 12 hr p/vax-sepsis w/p unremarkable x/WBC 32.8; f/u visit 24hr, leg resolved, fussiness; WBC 19.9
Symptom: Fever start: 10/31/2006 - Comment: Undocumented, no temperature taken. Symptom: Chills Start: 10/31/2003 - Comment: Have occurred 'off and on'; Symptom: Nausea w/vomiting - Start: 11/02/2006 - Comment: Patient vomited twice on 11/2, just feels mild nausea today; Symptom: Tenderness Start: 10/31/2006 - Comment: In the right deltoid and the right upper arm; Symptom: Numbness Start: 10/31/2006 - Comment: Patient reports vague 'numbness' in the right upper/arm; Symptom: Swelling Start: 10/31/2006 - Comment: Noted over the entire deltoid and spreading down the right arm but not below the distal bicep.
no adverse event pt just received 2 full doses and 2 boosters instead of 3 full and one booster like she was eligible for
9:45A immunization (H1N1-inactivated). 10:45A flat (macular) rash, red L ear ear to R ear and posterior neck. T-97.4 Axillary. 11:05A rash gone 11:25 returned to classroom.
Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022; Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022 at 4:24 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient ethnicity was reported as private. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
pt did not devel any measurable antibody level p/3 doses of Hep B vax;
This spontaneous report was received from a Certified Medical Assistant concerning a 20 year old female patient with penicillin allergy. The patient's medical history included hives. On 17-JUL-2013 the patient had a mumps virus antibody immunoglobulin G (IGG) titer drawn with a result of 0.91 which was equivocal (MARRS # 1310USA004796). On an unspecified date, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). ON 24-JUL-2013, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported).  On 17-JUL-2013 the patient experienced a negative titer for hepatitis B. The result of an unspecified test on 03-SEP-2013 was the patient had immunity. The outcome of the event was unknown. Additional information has been requested.
Pt, was sitting in post observation post 1st dose of Pfizer vaccine. Pt has no hx of anaphylaxis. Pt began to feel numbness in left arm radiating up to left side of throat. Pt a bit lightheaded. Pt given juice and water and felt better. Numbness resolved after juice and water. Pt call. Pt finished appropriate monitoring time and ambulated out of facility with steady gait in no distress.
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 15-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA002267: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Lymph nodes right arm pit swollen huge and painful 8/17-8/29, went down but still slightly swollen 9/6. 8/29 started having chest pain, high blood pressure, dizziness, shortness of breath, migraines, shaking. Went into the ER 9/1 to make sure my heart was ok.
Patient immediately noted bruising over right deltoid and had mild pain at right deltoid and in post right upper arm. Posterior arm became very swollen, painful, and warm.
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who was vaccinated with a 0.5 ml fourth dose of QUADRACEL (formulation Suspension for injection) (Batch number: C5325BA, expiration date: 14-Nov-2019, site of administration: right thigh and route was not reported) on 15-Aug-2017. Concomitant medications included was ACT-HIB via right thigh and PREVNAR 13 via left thigh. The patient medical history medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. Nurse reports that female child 15 months received QUADRACEL injection for order for routine DTaP vaccination. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm.  Went to ER and it spontaneously resolved while staff was telling me how they would treat it.  Gave me Metoprolol 5 mg IV with 500 IV fluids and discharged.  Then on 2/6/21 I slept poorly and felt very jittery and had more chest pressure but pulse was regular.  then on 2/8/21 at 6:00 am I awoke and felt terrible with chest pressure.  Took my blood pressure at home and it was  193/103, and I was very shaky.  Went to  ER where they did blood work, X-ray, and monitored my heart and blood pressure for 4 hrs.  Gradually my blood pressure came down, and my blood work and X-ray probed to be WNL.  I was discharged without medication change but had echocardiogram scheduled and follow-up  appt. with Cardiologist, on  zoom.  He started me on Flecainide 100 mg bid, and stress test on  2/24/21 and follow-up appt. with him on 3/3/21.  I also had a follow-up appt. with my GP the day after the first ER visit and she ordered more labs, and the echocardiogram.  I have continued to have feelings of fluttering and pressure in my chest off and on and they continued after my second vaccine.  But my heart has remained regular since starting the Flecainide.  But my blood pressure went up to 150/85 on 2/9/21 and again to 142/81 on 2/10/21 both times with feelings of jitteriness and pressure in my chest.