chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Higly sensitive to thimerosal/ Allergic reaction; Itchy foot/very itchy all over his foot from the toes to the heal; Rash around the body, foot, leg, thigh; This is a spontaneous case initially received from a other non-health professional (consumer) on 09-Jan-2019, concerning a 72-year-old elderly male patient.  The current condition of the patient included high blood pressure (since unspecified date) and hay fever(sometimes when the pollen count was too high). The concomitant medication of the patient included losartan for an unknown indication.  On 25-Sep-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] for active immunization against influenza.   On 05-Oct-2018, 10 days after the vaccine administration, patient experienced an allergic reaction of an itchy foot and it has gotten worse. The patient saw a dermatologist, who recently did a patch test and it resulted that the patient was highly sensitive to thimerosal. It was very itchy all over his foot from the toes to the heal. As a treatment, the patient took prednisone for 15 days and it calmed it down but when he stopped taking the oral prednisolone the symptoms came back. At the time of reporting, the patient was using topical steroids as a treatment to reduce the itching: Betamethosane dipropionate, Cloderm (clotrimazole). The treatment medications made the events subside but it doesn't make it go away.   It was reported that, the patient was not hospitalized.  The outcome of the events was not-recovered.  The reporter assessed this case as non-serious.  Follow-up received from the other non-health professional (consumer) on 06-Feb-2019: The event generalised rash was added in the event tab. The narrative and case comment were amended accordingly.  Non-significant follow up received from the other non-health professional (consumer) on 18-Mar-2019. No new information was received, and hence no changes were made in the narrative.  Case re-opened for completion of full data entry: 06-Feb-2019.; Reporter's Comments: A 72-year-old male patient experienced allergic reaction and itching ten days after administration of Fluad (TIV). On an unspecified date after vaccination patient developed generalised rash. The company assessed the causality of the event allergic reaction as related to the suspect vaccine due to plausible temporal relationship between the event and suspect vaccine. The causality of the event generalised rash was un-assessable to the suspect vaccine due to lack of information regarding the onset latency of the event.
miscarriage 4/18/2021 - 10 weeks pregnant started bleeding on 4/17/2021
Gave GARDASIL in left arm - IM patient fainted - was in a chair. Didn't fall.
My right arm got really hot for about 4 days. My arm was swollen for a bout 4 days as well. I had to put ice on it.
Information has been received from a company representative concerning a 16 year old female who on 25-OCT-2007 was vaccinated with the second dose of Gardasil vaccine. On 25-OCT-2007 the company representative was at the office and saw the patient pass out after receiving the vaccination. An ambulance came to bring the patient away. The patient was awake when she was carried away on the stretcher. The patient's outcome was not reported. Additional information has been requested. Follow up information obtained on Dec 7, 2007. The physician reported that on Aug 28, 2007 the 16 year old white female patient (weight of 221 lbs. and height of 64 inches) was vaccinated IM with the first dose of Gardasil (yeast) (lot #654539/0742U). On Oct 25, 2007 the patient was vaccinated with the second dose of Gardasil (yeast) (lot #654560/1209J). On Oct 25, 2007 the patient passed out twice within ten minutes after receiving her second dose of Gardasil (yeast). The patient sough unspecified medical attention. Blood tests and an EKG were performed (with normal results). The patient recovered on Oct 25, 2007. The patient had no illnesses at time of vaccination and no pre-existing allergies or medical history. Additional information has been requested.
On Wednesday, after immunization, ached at vaccination site through the night even if was not laying on it. As soon as got home vaccination site started itching and was red; it was a 3x3 area and used Cortisone 10. On Thursday, woke up with a headache, nausea and lightheadedness; resolved by mid- afternoon. Put moisture on arm and took Advil but medicine did not seem to really help. On Friday woke up with chills so put blankets on. Chills lasted for about 30 minutes--could not get warm. The pain eased by the weekend but it did not disappeared. It has been 6 weeks and patient still is in pain and has mild itch. Arm periodically gets painful, sometimes nothing triggers the pain or sometimes movement causes it. For example, when patient picks up something she gets a short pain that does not last long.  On 9/28 notified doctor by mail but he did not have any suggestions. On 10/20 called doctor and next day got a call back from NP that prescribed Prednisone. Took first Prednisone on 10/22 and a few hours later got immense headache so stopped taking it. Patient also contacted neurologist on Friday and got a call back on Tuesday called and was asked to come in to the office; by then pain had dissipated. Today patient still has pain at vaccination site. Patient has called doctor and has appointment with PCP for follow-up. Patient recently recalled some symptoms she experienced out of norm after the vaccination that were out of norm. About 4 hours after vaccination patient go pain in heart that lasted for a couple of seconds. On Friday and Saturday, pain recurred 2-3 times for 10 seconds episodes. On Sunday, the pain lasted about 2-3 minutes then it was gone. Patient has never had a pain like that before even when she got her heart attack and has not had it since. Patient did not notice any other symptoms along with the heart pain.
diaphoretic, nausea, headache, slight tachycardic with HR 108. Zyrtec 10 mg PO  was given.
-BODY ACHES, FEVER, CHILLS, HEADACHE, DIARRHEA, LEFT ARMPIT SWOLLEN (SIZE OF A BASEBALL)
I am the epidemiologist  reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/29/21 after the completion of a full Pfizer vaccine series (Dose 1 on 1/24 and Dose 2 on 2/14). The patient later died on 5/04/21.  Pre-existing conditions listed as:  OTHER CHRONIC DISEASES, IMMUNOCOMPROMISED CONDITION.   Comments:05/04/21:Patient was admitted to the hospital on 4/28/2021 for COVID-19 infection, pneumonia, and acute on chronic renal failure. He was transferred to the ICU on 4/29/2021 due to acute hypoxic respiratory failure requiring intubation. Despite maximum therapies, the patient's respiratory status did not improve. He remained mechanically ventilated from 4/29 through 5/4. On 5/4, the patient became hypotensive and bradycardic. The patient died at 10:45.
Received Moderna Covid vaccine in Left Deltoid at 5:44PM, proceeded to exit area and told PHN that she felt hot and asked for water. Given bottle of water and sat with PHN for 10 minutes. PHN observed patient for vasovagal symptoms. Patient reported that felt better after sipping water. Patient proceeded to waiting area. Patient also told PHN that she had anaphylactic reaction to flu vaccine in 2011. PHN told her due to this she would need to wait for 30 minutes after injection. At 6:05PM PHN checked on patient and she reported that she was starting to get hoarse. PHN called 911 and moved patient to more private area. BP 130/86, P80, R24 and patient was beginning to wheeze. Epipen delivered at 6:18PM. Rescue squad arrived and transported patient to ER.
Janssen (J&J) COVID-19 and Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 4/20/2021 and Janssen (J&J) COVID-19 on 6/17/2021. Presented to the ED for decreased responsiveness. Reported COVID positive per nursing home. Admitted for sepsis and pneumonia due to COVID-19. Patient requiring increased oxygen requirements. Treated with: vitamin C, zinc, and antibiotics. DNR on arriaval. Expired 1/23/2022.
joint pain all over her body/ beginning in the feet and working its way upwards towards the rest of the body; began to experience flu like symptoms; fatigue; body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 30th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th September 2019, 8 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue and general body pain. On 2nd October 2019, the patient experienced joint pain. On an unknown date, the outcome of the influenza-like symptoms, fatigue and general body pain were resolved with sequelae and the outcome of the joint pain was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, general body pain and joint pain to be related to Shingrix.  Additional details were received as follows: The patient after vaccination experienced  flu like symptoms described as body aches and fatigue that resolved after a few days. The patient also began to experienced joint pain all over her body, which was described as intermittent, beginning in the feet and working its way upwards towards the rest of the body. The patient consented to follow up.
Flushing and pressure feeling in my head/face and ringing in my ears increased immediately after injection. Then proceeded to get a slight noticeable increase in heart rate.   After setting for approximately 15 minutes I was released to leave. I mentioned to them that I just lived down the street and told them if I had any further issues or symptoms I would call them.  Approximately 30 minutes later I was having a slight lightning of the throat or airway and some slight tightness in breathing.  This tightness continued for approximately 2 hrs. I called the clinic and was attempting to get there recommendations but the nurse had left. I was told to get the ambulance personnel. As a prior EMT I felt that an ambulance was not needed at this time. I took 2 ea   Benadryl tablets and those symptoms lessened. Some numbness in lips and face, and felt heart beating in lips. That all subsided as well after taking Benadryl.  Still trying to get with a provider that could give me advise moving forward. The doctor was busy with an Emergency.
TINGLING IN TOES / TINGLING IN FOOT; NUMBNESS IN FOOT; CRAMPS IN LEGS / CRAMPS IN BOTH FEET/ MUSCLE SPASM IN THIGHS; PAIN THE FOOT AND THIGHS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient was previously treated with ibuprofen for pain, and acetylsalicylic acid for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Pain scale (NR: not provided) 11/10 intensity. On 07-MAY-2021, the subject experienced tingling in toes / tingling in foot. On 07-MAY-2021, the subject experienced numbness in foot. On 07-MAY-2021, the subject experienced cramps in legs / cramps in both feet/ muscle spasm in thighs. On 07-MAY-2021, the subject experienced pain the foot and thighs. Treatment medications (dates unspecified) included: ergocalciferol, and magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in toes / tingling in foot, numbness in foot, and pain the foot and thighs, and the outcome of cramps in legs / cramps in both feet/ muscle spasm in thighs was not reported. This report was non-serious.
Report of body aches, fever, swelling,  dry throat, redness and pain at the injection site day 1 post vaccination.  Treatment: Tylenol, Outcome: no improvement does not interfere with ADLs.
Not sleeping well. Wakes up through the night on the hour. red thigh. Fever.
After receiving my second dose, I was seen by my primary doctor for suspected Celiac disease (which came back positive). I had a strange medical episodes during the bloodwork (April 15th) that they originally assumed was anxiety. Symptoms were shortness of breath, lightheadedness, and loss of feeling in extremities. I?m a first responder and did not feel this was anxiety, but didn?t argue and forgot about it until it happened again.   I had my second episode on April 20th, and debated going to the ER for it. A third episode on April 23rd did put me in the ER. I proceeded to have more episodes on almost a daily basis after that and started monitoring blood pressure, pulse, blood sugar, and food intake at home (some of my bloodwork levels were off due to the celiac). I purchased a heart rate monitor, a blood glucose meter, and a smartwatch to monitor some of my symptoms. Both devices (monitor and watch) would later flag me as having a suspicious heart rhythm (heart monitor could be for fast/slow rhythm or for arrhythmia, smartwatch flagged me as Afib twice). I could not recreate these results when my husband wore the devices.  Episodes could be as brief as 45 mins or last more than 12 hours. I have a high pain tolerance and illness tolerance, and had to leave work several times due to my symptoms (extremely abnormal for me).   After several more appointments with my primary doc and another visit to the ER (where they did another EKG, an X-ray, and more bloodwork), things were still coming back inconclusive.  After about April 28th, I started having significant chest pain with my episodes. The ER checked me for possible clotting related to the heart issues and my birth control pills. My arrhythmia could not be captured on their devices.   My doctor has since diagnosed it as suspected myocarditis (pending more testing). We?ve ruled out all possible things related to my Celiac diagnosis, and can?t seem to find a cause for this. I had a few things I brought to her attention that may be the cause (pinched nerve at chiropractors, covid vaccine) and she says it may be the vaccine, and said I should report it to you.
Had excessive crying at time of the injection; This non-serious spontaneous safety report, with case number 02270452/02270446, was received by partner, on 18Oct2022 and forwarded on 19Oct2022 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Crying".  Further information is expected.
Pt was given inj of vaccine at 11:15 Right deltoid. Pt "fainted or seized", lost consciousness. 11:20 BP 96/60, P 60, R 20, passed out. 11:25 BP 100/62, P 62, R 16, BENADRYL 50 mg IM. 11:30 BP 100/58, P 60, R 18, passed out, seizure?. 11:35 BP 100/52, P 64, R 18, passed out?/seizure. 11:40 EMT arrived. Sent to ED, stabilized-called ED to state unclear if seizure or syncope. No EEG done in ER. Followed up next day "doing fine". Suggest possible follow up with neurologist.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 79-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain. On an unknown date, the outcome of the influenza-like symptoms and pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. In 2018, the events were resolved. For tolerance to next dose, refer case US2018126941. This case has been also linked to case US2018GSK130832 (unspecified number of patients), reported by the same reporter.
Tdap administered 1/21/16 when patient had received Tdap 9 years earlier. Current recommendation is for one dose Tdap in a lifetime. Patient experienced no adverse reactions following vaccination.
report a side effect; 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 ADVERSE EVENT (report a side effect) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (report a side effect). At the time of the report, ADVERSE EVENT (report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Heart failure. Myocarditis.  I was perfectly fine, but then started having swelling of my lower extremities and by June I wasn't able to fit into my shoes with my socks on.  I am now on Valsartan, metoprolol, chlorthalidone and furosemide. I was taking nothing and was absolutely fine prior to the vaccine.
My arms were hurting and very heavy. Then tingling began in feet and hands. It later turned to numbness burning and hot end cold sensations.    zit also looked like a rash in my body. I had blurry vision. I also had joint and muscle pain that js and was extreme. Continued symptoms followed numbness, on my face and tongue. And most recently muscle twitches all over body.
No adverse effects; the patient received ROTATEQ following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 28-OCT-2019, the patient received Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot #, expiration date, strength and dose were unknown) orally for prophylaxis following a temperature excursion (product storage error). The vaccine was exposed to lowest temperature below 36 degrees Fahrenheit/2 degrees Celsius (35 degrees Fahrenheit) for 430 minutes. No previous excursion was reported. No data logger was involved. No adverse effects were reported.
Ct to receive 0.1cc  PPD ID instead received Adult Td 05.cc ID in left forearm on 8/16/04. Father of Ct. reports edema, redness and pain at injection site. Tx with cool compresses, Benadryl/Tylenol for discomfort.
Severe pain and swelling R leg started on 10/14/21 after a 5 hour car ride; 4 additional hours in car next day creating increasingly worse leg cramping. Tried ice, elevation, ibuprofin. By 10/18/21, after a day in bed, I went to the ER at the urging of primary care. Diagnosed with a massive DVT in R leg and multiple pulmonary emoboli throughout my lungs. No personal or family history of blood clots. From ER admitted for 4 days for treatment of DVT and lung clots. Now on Eliquis.  Of note, I had pretty severe COVID on October 2020 and participated in the trial. I do not currently know which arm I was in or if I received the monoclonal anitbody infusion or placebo.
15 minutes after the vaccination I passed out and a week later I lost feeling in my leg and had to go to the ER and now I'm currently wheel chair bound with no diagnosis but all the doctors can say is it from the COVID 19 vaccine.
I had a sore throat, low fever in the 100s, cough, and my nose was running like a faucet. I tested positive for COVID-19 at home. I spoke to my doctor and she prescribed me PAXLOVID. After I took the PAXLOVID my nose stopped running but I couldn't stand the taste.
About two hours after my COVID Moderna booster shot and flu shot, I began experiencing severe pain in my upper left arm, far worse and far earlier than after my first two regular COVID Moderna vaccines.  The next morning, I woke up with a mild headache that got progressively worse during the day until it was nearly unbearable in the evening.  It was as severe a headache as I have ever had, and I have had full-body migraines.  This definitely was not a migraine.  I went to bed early without any dinner, and the headache began to diminish around 4:00 and 5:00 AM, so I got very little sleep.  Today the headache is gone, but my left arm remains sore, and my doctor reported it is also warm.  I have never before had any adverse reaction to a vaccine besides slight pain at the injection site.
Pt recvd APAP & 2 hrs p/inject began fever 104, screaming, lt leg swollen red & painful from hip to foot; crying cont 14DEC & Sunday 15DEC w/soreness of leg; pt cont to have mild tremores lasting 30 sec;pt had 2 seizures;
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient was diagnosed for first Pulmonary Embolism on 05/12/2021 & second Pulmonary Embolism on 05/18/2021
Information has been received from a nurse concerning a female with no pertinent medical history, who on 09-AUG-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 11-AUG-2007, two days after she was vaccinated she developed nausea, chills and a low grade temperature. There were no laboratory or diagnostic tests performed. The patient called the office. Subsequently, the patient fully recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a nurse concerning a 19 year old white female with no known drug allergies and a cold with no temperature at the time of vaccination who on 09-AUG-2007 was vaccinated intramuscularly into the left deltoid with a 0.5 ml dose of GARDASIL (Lot #0469U). Concomitant therapy included hormonal contraceptives (unspecified). On 11-AUG-2007 (reported on 10-OCT-2007) two days after she was vaccinated she developed severe nausea, chills and a low grade temperature. The patient called the office. On 12-AUG-2007, the patient fully recovered. Additional information has been requested.
While attempting to speak pt collapsed on the floor. This was followed by muscle spasms. Smelling salts were used to revive the pt.
Patient passed out about 2 minutes after receiving vaccine and stated that he did not eat anything before coming in.
Pt recvd vax 9DEC91 & state had itching @ inject site 8 hrs p/vax; woke up next morning w/migraine h/a not relieved w/ASA or Motrin;
Swollen, sore armpit lymph node same arm as injection  Chills, fever, body aches