chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has not received the second dose  (60 days after the First Shot); Episodes of Weakness  4 to 5 times daily after first vaccine; Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine; Chills; Headache; Fatigue; Fever of 99.9; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Episodes of Weakness  4 to 5 times daily after first vaccine), HYPOTENSION (Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Learning disability. Concomitant products included GABAPENTIN, BROMAZEPAM (LECTOPAM) and BUSPIRONE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever of 99.9) and NAUSEA (Nausea). On 02-Apr-2021, the patient experienced ASTHENIA (Episodes of Weakness  4 to 5 times daily after first vaccine) and HYPOTENSION (Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine). On 30-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose  (60 days after the First Shot)). On 16-Jun-2021, ASTHENIA (Episodes of Weakness  4 to 5 times daily after last vaccine) had resolved. At the time of the report, HYPOTENSION (Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose  (60 days after the First Shot)) had resolved and CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever of 99.9) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 50/39 (Low) low and 60/140 (Low) low. On an unknown date, Body temperature: 99.9 (High) high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment details not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Updated contact details, patient demographics,events and event outcome.
A 26 year old female patient reported visual changes in the right eye which consisted of distortion 10 minutes after she received H1N1 and TUIBERSOL 5 TU on 26 January 2010 at 5:00 PM. The visual changes and distortion lasted approximately 10 minutes. Later that evening, the patient complained of numbness and tingling in the fourth and fifth finger of the left hand and of the left nostril which lasted approximately 10-15 minutes. Per the reporter, the patient recovered. Concomitant therapy included birth control and "ATAROL". List of Documents held by Sender: none.
sore arm; This is a spontaneous case received from a contactable consumer (patient's daughter). A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation and the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included immune compromised and couple drinks every single night. Concomitant medication was not reported. On an unspecified date, patient stated that she had a sore arm with the other 2 COVID-19 vaccines. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
BLOOD CLOTS AFTER BLOWING NOSE; This spontaneous report received from a patient concerned a 67 year old white and non hispanic or latino patient of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, non-smoker, and non alcohol consumer, and other pre-existing medical conditions included: the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient experienced blood clots after blowing nose. About 4 out of 7 times, when the patient blew the nose, the patient got a lot of blood clot. It always happened in the morning and the patient had not a runny nose at those times. There were also no nosebleeds. The patient discussed it with rheumatologist, but they did not say much about it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots after blowing nose. This report was serious (Other Medically Important Condition). Sender's Comments: V0.20220236868- covid-19 vaccine ad26.cov2.s - Blood clots after blowing nose. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
administered expired menactra with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. (GMI number: 01217750)  This case is linked to case A200410725.  This case involves a 17-year-old female patient who had administered expired Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 26-Jul-2022, the patient administered expired Menactra vaccine 0.5 ml once lot U6952AA via unknown route in the right arm for Immunization with no reported adverse event (expired product administered, latency same day).  It was reported that Office manager report a MA administered expired MENACTRA. She states no side effects have been noted. She would like to know if the patient needs to be re-dosed.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
after 5 weeks, arm is still (at times extremely) sore, from back of shoulder to top of hand, frequent headaches--not normal
Vaccine on 6/13 and developed nausea, vomiting, chills, undocumented fever, headache, myalgia, and dizziness.
Gout real bad in both feet; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout real bad in both feet) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Heart disease, unspecified, Atrial fibrillation, Heart block NOS, Shortness of breath and Heart enlarged. Concomitant products included APIXABAN (ELIQUIS), ISOSORBIDE, METOPROLOL, SPIRONOLACTONE (SPIRONOL), FUROSEMIDE, POTASSIUM and BENAZEPRIL for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout real bad in both feet). At the time of the report, GOUT (Gout real bad in both feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications : Conoylos 0.6mg twice first day and then once a day.
Body ache; Headache; Fever; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number.  No concomitant medications were reported. On an unspecified date, the subject experienced body ache, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and body ache was not reported. This report was non-serious.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided   This case was linked to MOD-2021-395985 (Patient Link).
Dry mouth, heart palpitations, pt stated BP feels like its going up. Became flushed, pink cheeks paramedics took her to hospital.
Swollen supraclavicular lymph node noticed 24 hours after vaccination on the same side as the arm the shot was given. Extremely sore in my arm and neck
Day after vaccination, developed fever, anorexia, nausea, lymphadenopathy, rash.  Tx with Tylenol or Advil.
Patient reports he received his Anthrax booster (dose #8) and two days later developed swelling at the vaccination site, malaise, chills, nausea, vomiting, and diarrhea which lasted for 24 hours prior to resolving spontaneously without treatment. He denies generalized cutaneous, pulmonary, neurologic, and cardiovascular symptoms. Of note, he also complained of adverse reaction following prior doses of Typhoid vaccine. He has tolerated prior doses of Anthrax.
Pt came to the hospital related to increase amount and frequent urination and fatigue. She was admitted for hyperosmolar state and started on short and long acting insulin. Pt also asymptomatic for covid. Pt discharged home.
fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            No details provided in the chatbots only asked fever normal after second shot
States 2 hrs p/ injection was dizzy, felt like passing out, shaky, weakness-followed w/ diarrhea. Pt states is sensitive to eggs, but not allergic.
Starting 10/08/2021, I was sleeping and my heart started pounding which woke me up. I did some deep breathing and went back to sleep. Then, it happened again and I repeated the breathing exercises and went back to sleep. After I was woken up the 3rd time, I went to the ER. They did blood tests and monitored me. They did not find anything and discharged me. About 1 week later, my doctor put me on a heart monitor and it caught one episode of atrial fibrillation. The doctor put me on baby aspirin. I have not had any episodes since.
Fever, chills, muscle and joint aches. Redness and large lump with swelling at injection site.
Mild pain in jaw and then emanating to facial muscles. AT times felt more like tingling. The feeling when novacain  wears off. Left side
Within a few days of receiving my 2nd dose of the Pfizer Covid19 shot, I experienced shortness of breath and chest pain. All the tests I took indicated I did not have myocarditis so my doctor told me I likely had anxiety. I refused the dye test because members of my family have had adverse reactions to injected dyes. My symptoms finally went away in the first part of August. I took my normal flu shot in Sep or Oct and my symptoms returned, although they were less severe--I had never had a reaction to a flu shot before. I finally agreed to take anti-anxiety meds hoping it would clear my symptoms. My shortness of breath gradually went away. Then on 12/21/2021, I got the Moderna Covid Booster shot and by 12/23/2021 my shortness of breath and chest pain returned. They have not gone away as of 2/1/2022. I have continued taking my anti-anxiety meds daily--they seem to have no impact on my symptoms.
Itching of entire body 4-5 days after vaccination on 11/22/06. Has continued on and off since then.
blood clot; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B,(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. prednisone (PREDNISONE), route of administration, start and stop date, batch/lot number and dose were not reported for allergies Medical history included weakened immune systems and ongoing allergies. It was reported that patient wants to know if there is any reported interactions between the use of prednisone and receiving the COVID-19 vaccine manufactured by Pfizer. She was informed that the vaccine might not work as well for patients taking prednisone. The patient has been on Prednisone for 10 years, caller heard that when the patient has been on Prednisone for that long the vaccine does not work. The patient is taking Prednisone to treat some allergies. Patient also has blood clots and wants to know if patients with a history of allergies should take the COVID-19 vaccine manufactured by Pfizer, and how could she know if she would have an allergic reaction towards the vaccine. The action taken in response to the event for Prednisone was unknown. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable physician received via Pfizer-sponsored program. A 45-years-old male patient received 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 in May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient previously received 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 immunisation. On an unspecified date in 2021, the patient tested positive for COVID. The event tested positive for covid assessed as serious (medically significant). Caller stated, the patient was basically saying he was having COVID symptoms, so like nasal congestion, runny nose, not severe, not shortness of breath or chest pain, just mainly URI symptoms, fatigue, just feeling the initial COVID symptoms, not really severe, but having COVID symptoms. Caller states she knows the symptoms were still going on, the exact day she was unsure. Caller confirms all symptoms began sometime in July2021 in the last week and was persisting. Caller states it was not serious from a medical standpoint. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events of  DI ,Covid 19 and suspect drug BNT162B2 cannot be excluded
Headache, Myalgia, Arthralgia, severe fatigue Narrative:  Other Relevant History:
On the morning of 12/4, I woke up with an itch on my neck and noticed a red, raised scar. Later in the day, I noticed that the palms of my hands were red as well. I bought an anti-itch cortisone ointment (with hydrocortIsone USP 1%) which helped relieve the itch a bit but the itch seemed to be all over my neck and head.  In the middle of the night on 12/5, I woke with an itch all over my body. I realized that I had hives that were showing across my neck, stomach, back, and hip area. They looked like red patches with lines on them that were raised. I was desperate for a cure and ended up getting a Benadryl - I took 2, put on some of the cortisone ointment, and went to bed.  Throughout the day on 12/5, my hives moved all round my body with raised red patches/itchiness, mostly on my torso. I also noticed that bits were starting to appear on my face. I tried to treat with more Benadryl, cortisone ointment, and ice.  I did a bunch of research online and started to figure out that this is probably driven by my booster shot. Prior to this, I have never had hives or strong allergic reactions. I have not eaten anything funny or changed up my routine. I also read online that turmeric curcumin and vitamin D might help and took some of that as well.  On 12/6, I had a virtual appointment with a PA who also believed this was driven by my booster shot. She advised me to take 20mg of Zyrtec every morning and some Benadryl through the day and continue the cortisone ointment.  It is also worth mentioning that I started my period cycle on 12/2 (only 3 weeks after my previous cycle). The period is heavier than I normally have had in the past year. Before this, I have been pretty regular on 28 days. period
shingles; Information has been received from a lawyer concerning a case in litigation and refers to a 61 year old female patient. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On 09-OCT-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis, at a pharmacy. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 17-FEB-2015, the pt was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a foreseeable, direct, and proximate consequence of Company's actions, omissions, and misrepresentations, the pt suffered shingles and other related health complications. In addition, the pt required and would continue to require healthcare and services. The pt had incurred and would continue to incur medical and related expenses. The pt also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The pt's direct medical losses and costs include physician care, monitoring, and treatment. The pt had incurred and would continue to incur mental and physical pain and suffering. The outcome of the event was not recovered. The causality was related.  The event of shingles was considered to be disabling.
0-9 hours after injection: slight soreness and feeling of heat in arm of injection. 9 hours after injection: chills. 16 hours after injection: nausea, light headed, fever, headache, soreness and achiness in arm of injection - took Tylenol. 24 hours after injection: symptoms started to get better, headache still present. 40 hours after injection: headache still present- still taking Tylenol and by 48 hours symptoms almost completely gone. (Continuously took Tylenol every 6 hours or so)
woke 6am on 3/11/22 with shivers, cold hands/feet, sore muscles throughout body, nausea, fever of 99.1. After rising, immediately started sweating, tunnel vision and threw up 3X. Dry heaves continued for 3-4 mins, along with extremely painful stomach cramps and back ache. Eventually subsided, ate 1/2 banana and water along with 3 ibuprofen. Slept approximately 2 hours. Woke with headache, but  no fever.  At 3pm, fever was 102.1, chills again. Eventually subsided to just fatigue, soreness, headache rest of day/eve. 3/12/22 - woke with red bump rash on neck, chest, stomach, groin, back. - Fever gone.
shingles in her waist / still have it / second dose / administrated on November 19 2020; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number E9Y5M, expiry date 19th June 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 19th November 2020, the patient received the 2nd dose of Shingrix. On 20th November 2020, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The pharmacist reported that patient had shingles in her waist after the administration of the second dose of Shingrix. The patient still had shingles on day of reporting. The reporter consented to follow up
The patient did not experience any adverse reaction or events. The  VAERS form is being completed due to age requirement of 18 years + for Moderna. The patient was 17 years and 9 months when the vaccine was administered.  The provider will follow CDC guidance for Off label Use. Patient was informed, no adverse events reported.
She received a 0.5ml dose after getting J&J because we were under the impression she was immunocompromised and then we found after the shot she was not immunocompromised- there was confusion with the care giver and the patient.  They are aware and are ok.  It doesn't appear that she had any adverse issues
Diffuse rash over head/trunk. First noted by mother on 4/24/03 at noon.