chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/21/03 Menomune given. 8/21/03 at well check; aware of need for vaccine Menomune; vaccine given. HSP/Vasculitis was reported on 9/10/03; diagnosed by dermatologist. Started on Prednisone; moderate blood in urine. Biopsy: positive IgA vasculitis. Also on Amoxicillin. Discharge Summary received on 12/15/2004 states pt experienced acute renal failure. Information from 60 day follow-up report states: Developed HSP renal complications from vasculitis.
Unknown eye infection 9/10 days after shot on left lower eyelid. No history of any previous eye infections. Visibly infected, redness, swelling, itch.  Visited urgent care clinic, prescribed 10 course of doxycylcine, which cleared up infection.  Had follow up with eye doctor DO at regular eye appt in January, was given all clear. Reported to vsafe, who did not think it was associated with vaccine, then VAERS representative called and advised to make  report.
Pt c/o chills, fever, joint aches/pains starting around 5 PM each day since getting ZOSTAVAX. "Hurts all over like the flu" temperature as high as 101.5. This AM 99.6 feels ok during the day. Injection site good per patient. He called Dr this AM-waiting for return call. Office suggested he take buffered ASA.
Rash-measles like-bilateral top of feet/toes progressed to shins by morning-extremely itch until 10/31/21 Forearms bilateral rash-measles like, itchy, still slight 10/31/21 rash present torso-not itchy
Sore throat, hoarseness, body aches, rash, hives, all over body itching, skin rash, scalp rash, alopecia, nausea, joint aches - (knees, ankles and hips), muscle pain and stiffness, stomach upset, diarrhea, constipation, dizziness, shortness of breath, irregular heart beat, abdominal pain, cramps, bloatiness, sensitivity to temperature, irritability, mental confusion, fatigue, intolerance to eggs, and meat, vision disturbances. Symptoms come and go.
Cellulitis in his legs; Sores on his feet/feet have open sores; lot of problems; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis in his legs), WOUND (Sores on his feet/feet have open sores) and VACCINATION COMPLICATION (lot of problems) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 CELLULITIS (Cellulitis in his legs), WOUND (Sores on his feet/feet have open sores) and VACCINATION COMPLICATION (lot of problems). At the time of the report, CELLULITIS (Cellulitis in his legs), WOUND (Sores on his feet/feet have open sores) and VACCINATION COMPLICATION (lot of problems) had not resolved.            Concomitant medications were not reported by the reporter.   No treatment information was provided.  Patient had appointment to get the booster dose on 08-DEC-2021.  This case concerns a 94-year-old male patient with no medical history, who experienced the unexpected event of Cellulitis. The event occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. No treatment or other clinical details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow-up received contains no new information. Sender's Comments: This case concerns a 94-year-old male patient with no medical history, who experienced the unexpected event of Cellulitis. The event occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. No treatment or other clinical details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report was received from a registered nurse, referring to a 17 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 11-JAN-2018, the patient was vaccinated with one dose of RECOMBIVAX HB (adult formulation) (thimerosal free) lot number: M040422, expiration date: 07-JUL-2019, for prophylaxis (strength, route and dosage schedule were not reported). On 04-APR-2018, the patient received one dose of a pediatric formulation of RECOMBIVAX HB (pediatric formulation) (thimerosal free) lot number: N006321, expiration date: 08-NOV-2019. No adverse effects were reported.
Patient presented to clinic with large 6 cm in diameter round macular/raised red rash and site tenderness.
pt recvd vax; rash,small red spots on back,chest, shoulders;using calamine lotion;very itchy,dph suggested;has many allergies;
Initial report received from another manufacturer on 06 November 2008 who received the report from a healthcare professional. An unidentified male patient (age not reported) had received a flu vaccine (trade name, manufacturer, lot number not reported) and "became very ill" and convulsions. The patient sought medical attention. No additional information is available. Documents held by sender: None.
1 patient received FLUZONE QIV T 8 days after 06-Apr-2022 (when product was no longer suitable for use): 8 days after a temperature excursion with no adverse event; Initial information received on 10-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional. This case is related to case id: 2022SA168646  This case involves an unknown age and unknown gender patient, that 1 patient received fluzone qiv t 8 days after 06-apr-2022 (when product was no longer suitable for use): 8 days after a temperature excursion with no adverse event while receiving vaccine influenza quadrival a-b multidose vaccine preserved [Fluzone quadrivalent multidose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b multidose vaccine  preserved suspension for injection (lot number, strength, expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  Influenza quadrival a-b multidose vaccine preserved TT experienced 3 temperature excursions. Conditions of excursions were on 6-Apr-2022 8.1 C 8 minutes 8-Apr-2022, 9.6 C 59 minutes 11-Apr-2022 9.1 C 56 minutes and cumulative total time of 123 minutes.   There was a minor excursion of 8.1 C for 8 minutes; states when she called Merck, they told her that they round to the nearest whole number, so they did not consider the event on 06-Apr-2022 to be an excursion. Caller stated that this will affect her influenza quadrival a-b multidose vaccine preserved since it was only suitable for use for 1 week beginning after the first excursion. Caller asked if 1 week started on 06-Apr-2022 or on 08-Apr-2022. Agent informed caller that Sanofi does not round to the nearest whole number; informed caller that 8.1C would still be considered a temperature excursion and 1 week would begin on 06-Apr-2022.   On 14-Apr-2022, the patient received influenza quadrival a-b multidose vaccine preserved T 8 days after 06-apr-2022 (when product was no longer suitable for use): 8 days after a temperature excursion (product storage error) with no adverse event (unknown latency).  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 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.
17 year old received the vaccine; A spontaneous report was received from a consumer concerning a 17, year old female patient who received mRNA-1273 for prophylaxis of COVID-19 infection.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 15- Jan- 2021 for prophylaxis of COVID-19 infection.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The event, drug administered to patient of inappropriate age, was reported.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Symptoms began around 6pm and gradually worsened? sneezing, runny nose, cough, sinus congestion, fever/chills, body aches (arthralgias, myalgia), headache, site injection pain (which was immediate upon injection, I bled- not a good administration), polyuria/difficulty sleeping overnight, I felt like I was very sick with the flu.
Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 26-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided)), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Arm continued to be sore.  Itchy rash developed day 8 after vaccine at injection site
pt recv vax 6JUN96 arm became swollen, red & very painful, low fever x 2wk;pain & numbness in fingers saw MD 13JUN who said give more time;saw MD 19JUN still pain & numbness in arm & fingers;pt put on med small knot still on arm
Pt experienced dizziness, sweats , chills and vomiting about a few minutes after receiving the shots.   Pt remained in the pharmacy about 20 minutes before returning to normal condition.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was given 2nd dose of Covid Vaccine, and instructed to remain seated for a minimum of 15minutes after vaccination. Patient had fainted, fallen out of her chair and scraped her face on the carpet. Ambulance was called. Patient was placed in supine position, and remained conscious while awaiting ambulance. EMTs determined patient should go to ER based on vitals.
This spontaneous report was received from a mother refers to her 15 year old son (who is also the patient). On an unknown date in JUN-2012, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date in AUG-2012, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). The patient was yet to receive the third dose of the vaccine and it was well beyond the time frame for dosing listed in the Pl and no side effects was reported. This is one of the two assistant received from the same reporter. Additional information is not expected.
On March 6,  low grade fever, body aches March 10, heart palpitations started, still having palpitations seeing cardiologist March15, joint pain in right knee, the knee was swollen and hot to touch, could barely walk on the leg. within two weeks pain has stopped  March 18 blister on top of palette and nerve endings on face painful.  I believe it was shingles.   Took Valtrex which help stop the pain and blister
This spontaneous report was received from a registered nurse, referring to a female patient of unknown age. Concurrent conditions and medical history were not reported. On an unspecified date approximately in October 2007 (reported as approximately 8 years ago) the patient was vaccinated with the first dose of GARDASIL intramuscular injection (strength, route, lot # and expiration date not reported). Concomitant therapies or vaccines were not reported. The reporter informed that the patient presented to the office on 16-OCT-2015, and received the second dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
severe allergic reaction; Swollen lymph nodes; unable to move her left side of her body; muscle and joint pain; muscle and joint pain; total numbness of her body; severe migraine; Headache / head pain; Injection site redness; Injection site swelling; arm was hurting a lot; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in the left arm on 06Apr2021 at 13:30 (at the age of 89-years-old) as a single dose for COVID-19 vaccination. Medical history included seizures from 1970, serious migraines (would guess this was diagnosed about the same time as the seizures) from 1970, broken leg and ankle (diagnosed 4-5 years ago, she can't walk), severe arthritis (this was diagnosed about 5 years ago), Blood pressure high, and uses a walker and a wheelchair (prior to getting the vaccine). There were no concomitant medications. On 07Apr2021, the patient experienced severe allergic reaction, swollen lymph nodes, unable to move her left side of her body, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and injection site swelling. In Apr2021, the patient experienced arm was hurting a lot. The patient went to the emergency room because she couldn't move the left side of her body, had a really bad migraine, and her head started hurting, but she didn't stay in the hospital. Treatment for the event migraine included acetaminophen (TYLENOL) but that was not doing anything. Shots of prednisone was offered for migraine but the patient refused. The outcome of the events allergic reaction, swollen lymph nodes, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and arm was hurting was unknown. The outcome of the events unable to move her left side of her body and injection site swelling was recovering.  Information about lot/batch number has been requested.
Janssen vaccine administered at 10:15 AM.  Patient complained of heavy tongue and "feeling funning back of the throat" after a minute or two of the vaccine.  On or about 5 minutes after, patient continued to complain of heavy tongue and back of throat dry and "getting worse".  Nurse Stat called then transferred to ED.  Speech became slurred and had a fearful disposition stating her throat was getting worse.  She also complained of feeling itchy.
got covid vaccine 1/5/21 and had no SE, has not had covid illness before; developed red, itchy, swollen area surrounding injection site 1/13/21
Bloating; For the past 15 days constant diarrhea; For the past 15 days abdominal pain and cramping; Pretty bad abdominal pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Pretty bad abdominal pain), DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Bloating), DIARRHOEA (For the past 15 days constant diarrhea) and ABDOMINAL PAIN (For the past 15 days abdominal pain and cramping) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ABDOMINAL PAIN (Pretty bad abdominal pain) and DIARRHOEA (Diarrhea). On 21-Feb-2021, the patient experienced ABDOMINAL DISTENSION (Bloating), DIARRHOEA (For the past 15 days constant diarrhea) and ABDOMINAL PAIN (For the past 15 days abdominal pain and cramping). On 12-Feb-2021, ABDOMINAL PAIN (Pretty bad abdominal pain) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABDOMINAL DISTENSION (Bloating), DIARRHOEA (For the past 15 days constant diarrhea) and ABDOMINAL PAIN (For the past 15 days abdominal pain and cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Lab Test was performed and patient was normal.
Every day debilitating headaches. I have to take OTC Excedrin all day or Tylenol but it is not relieved completely. EXTREME fatigue. Spouts of pain in my forearms that randomly happen then go away. Tingles in my face and majority in my forehead.
Patient was questioned for any allergies, if patient was immunocompromised, pregnant and if the patient had any questions. Patient said no to all of the questions asked. Patient was administered the moderna booster dose at 11:40am on 01/06/2022. Patient notified me that she felt dizzy, chest tightness, and stated, "I feel weird. It feels like you're out of your body experience starting at 11:55am. 12pm vitals as follows: 98% O2, pulse of 69 bpm, temp of 97 degrees Fahrenheit, blood pressure was 116/70, and had respiratory rate of 11:40. I don't know how to explain it." Patient was taken outside to relax  at 12:10pm. Patient was eating blueberries to eat. Romberg test was performed on the patient. Negative Romberg test. Cranial nerve VII intact. No vision changes. Patient continues to complain of intermittent and mild migraine w/o aura. At 12:22pm, patient stated, I'm feeling way better than earlier. I don't have any more symptoms, but I still have my migraine every now and then.
The patient is a 81 y.o. male admitted to hospital on 11/12/22 due to complaints of chest pain.    Per Hospital Admission Information: Patient is a 81 y.o. year-old male, who presented with Chest Pain.  Patient is an 81-year-old male who presents with complaints of chest pain, left-sided that started prior to ED arrival.  No radiation, no shortness of breath.  He reports relief in pain after receiving nitro at the sending facility.  He states he is concerned because present pain is similar to when he had a heart attack last year.  He reports a hx of cardiac stents x4 placed Sept and Oct of 2021.     Hospital Course and Diagnoses: 1. Atypical chest Pain             -In the setting of COVID-19 and likely GI related             -Recent negative cardiac stress test 4/22/2022, last cardiac catheterization 10/8/2021             -Cardiology evaluated and no plans for any ischemic work-up.  Consider adding Imdur 30 mg daily if symptoms persist     2. Acute hypoxemic respiratory failure/COVID-19 with superimposed pneumonia, likely bacterial (resolved)             -Required 2 L of oxygen during hospitalization is not on oxygen at baseline             -COVID-19--- (dx on last admission) Date of onset of symptoms:  11/2/22 Symptoms present on admission: weakness/ cough Date of covid positive test:  11/6/22 Vaccination status:  3 vaccines Imaging: Patient with CTPA findings consistent with bronchiectasis and interstitial subpleural changes in both lower lobes and in the anterior left upper lobe assistant with interstitial pneumonia. no chest x-ray performed this admission to date Oxygen requirements on admission: none Current oxygen requirements:none Medical therapy: Decadron, ceftriaxone azithromycin Consultants following:  none Anticipated special isolation end date: 11/16/22 -isolation has been discontinued Sputum cultures normal flora after 48 hours   3. Transaminitis, hepatic steatosis -improved             -Daily hepatic function panel.             -Gastroenterology assisted with management last hospital stay.             -Gallbladder ultrasound -11/7             -Normal HIDA scan.             -May also benefit from an EGD as OP, however gen surg does not think it is prudent to do that at this time d/t COVID   4. Acute on Chronic Renal Failure             -Resolved             -Continue to monitor     5.  Generalized weakness             -Continue PT/OT 6.  Obstructive sleep apnea             -CPAP ordered   7.  Rheumatoid arthritis             -Chronic steroid use   8.  Obesity with BMI 34             -Once medically stable encourage weight loss   9. GERD             - Seen by gen surg - hold on EGD for now given COVID             - Optomized PPI IV BID             - Small frequent meals encouraged             - HOB elevated - avoid lying down during the day             - Avoid acidic and GERD promoting foods             -Cardiac, anti-reflux diet
Pt received KINRIX Tuesday 5/19 and mom called to report large hard/swollen area by site of injection.
Jan 10th 2022 - Nausea, Vomiting, Heart was racing, sitting down my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.  I did not seek medical care for this event. April 8th 2022 - Nausea, Vomiting, Heart was racing, mild chest pain and shortness of breath,  my heart rate went from 70's/80's up to 120's/130's, with no movement or doing any activity.   The friend i was with called 911 and i was transported via ambulance to a local hospital with labs and ekg, no significant findings, potential bladder infection was prescribed antibiotics From June 2022 through September 2022  - i Continued to have multiple episodes weekly (anywhere from 1 to 7 episodes a week), episodes typically included multiple of the following symptoms: Nausea, Vomiting, Dizziness, Shortness of Breath, Chest Pain, fatigue, brain fog, air hunger like i could not get enough oxygen in, feeling of impending doom like i was going to die, and my heart racing, at one point my heart rate got up to 186 as i was laying down trying to go to sleep.
Felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt really tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced FATIGUE (Felt really tired). At the time of the report, FATIGUE (Felt really tired) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-293529 (Patient Link).
Erythema surrounding area of injection site  up to 6 cm. No other symptoms.
Woke up with a bad headache at 02:30 am on 04/02/21.  Did not take anything.  Went back to sleep.  Woke up a few hours later and had headache most of the day along with feeling like I had the flu with achy muscles.  Took 2 Advil every 4 hours - for 12 hours.  No fever.  My left arm was also very sore where the shot was administered.  These symptoms lasted through the day.  By the next day, I was back to normal with the exception my arm which was still very sore.
Developed a rash and fever. Started on 9/9/15. Was seen in a urgent care on 9/12/15. Tested for strep which was negative. Put on Amoxicillin. Rash continued so went to doctor on 9/16/15. No other symptoms noted. Diagnosed with auto immune dermatitis and physician stated in notes it could have been a reaction/side effect from the meningococcal vaccine.
Patient describes as arthritis pain at elbow in arm where vaccine was given. "Very painful", not a light ache. Usually doesn't complain about mild pain, but this was very painful. Upon follow-up on 1/20/15, pain was still present but has improved. Slight swelling. Experienced sleep loss due to pain while he was sleeping. Patient took acetaminophen upon recommendation from pharmacist.
Vomiting and diarrhea for 14 hours.  Significant muscle, bone and joint pain for 2 days.  Waves of fever and chills. Had my wife not been home I would have called an ambulance because if I had gotten any sicker I may not have been able to rescue myself.