chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 01-MAR-2014, the patient was inoculated with ZOSTAVAX at an Urgent Care as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 01-APR-2014, the patient was treated at the same Urgent Care for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Mother called to say child had broke out in chickenpox.  Wanted info on vaccine (received 10-15-03) and risk to pregnant sibling and infant in the home.  Pregnant sibling will consult w/OB provider
This non-serious initial spontaneous case, was received from other non-health professional, concerning a 78-year-old, elderly, male patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after the vaccination, the patient complained of muscle aches and coughing. He also had rash on his face and was tired. The outcome of the events was not reported. The reporter considered the causality of the events as related.
Extreme join pain isolated to the knuckles and finger joints. Felt like extreme arthritis for over a week. Slowly moved out of the right hand, but left hand stayed painful for a few more days. Finally isolated to a single knuckle. Fully resolved after about 2 weeks.
Fatigue, Shortness of Breath, Dizziness, Brain Fog, Irritability,   Rapid Heartbeat, High Blood Pressure, Headache, Hallucinations, muscle soreness.
Fever, chills, pain swelling of entire arm fever 102 lasting 12 hours, aches, lethargic, overall sickness feeling.
Information has been received from a registered nurse concerning an unknown number patients whoafter the age of 12 weeks were vaccinated with an oral first dose of Rotateq (human bovine). No problems were reported. It was not reported if medical attention was sought. There was no product  quality complaint involved. Additional information is not expected.
her respirations were affected; patient was in the pool and began to shiver/shivered uncontrollably; Initial information regarding an unsolicited valid serious case via Agency (Reference number- 00442513) was received from a consumer and transmitted to Sanofi on 22-Jan-2021.  This case involved a 78 year old female patient who was in the pool and began to shiver/shivered uncontrollably (Chills) and her respirations were affected (Respiratory disorder), while she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included FLUZONE HIGH DOSE on an unknown date in 2016 for prophylactic vaccination and had a reaction to the Vaccine in 2016. Got the shot in the morning and in the afternoon her arms/ upper extremities were flailing uncontrollably. She could not control her arms. Took her to urgent care 2 days and they gave her fluids 2019 She got the regular dose vaccine in the morning. She was treated with rehydration for 2 days and recovered without sequelae.  The patient's medical history, medical treatment(s), concomitant medications and family history were not provided.  Caller would like to know what were the ingredients in the Sanofi Flu vaccines between 2015 to present. Caller stated his wife had a reaction to the Vaccine in 2016.   On an unknown date in 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination. She got the regular dose vaccine in the morning.  On an unknown date, the patient was in the pool and began to shiver/shivered uncontrollably (Chills) and her respirations were affected (Respiratory disorder) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient had to go to the hospital a couple of times and was in intensive care for 2.5 days, followed by a week in the hospital.  Seriousness criteria included hospitalization for all the events.  Details of laboratory data were not reported.  The patient was in a rehab facility for a few more weeks as a corrective treatment.  The event outcome was reported as unknown for both the events, at the time of reporting.  There would be no information available on the batch number for this case.; Sender's Comments: This case involves a 78 year old female patient who developed Chills and Respiratory disorder following the vaccination with FLUZONE QUADRIVALENT. The time to onset was unknown. The patient's past vaccination(s) included FLUZONE HIGH DOSE. Further information regarding concurrent condition during vaccination, concomitant medications, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Pt recvd HIB vax; next day pt devel t104; MD was not sure if vax was related to the fever; no further details were provided; MD reported another pt exp a similar rxn following HIB vax;
Patient reported to medical department approximately 36 hours after Anthrax vaccination. He complained of 6/10 right arm pain and aches around vaccination site and noticed firmness and redness on upper right arm upon waking in AM of 4/12/2020. He took acetaminophen for pain and felt chills and felt warmer despite taking medication. No discharge from the arm and no other complaints. Patient denied any symptoms of chest pain/discomfort, difficulty breathing, cough, nausea/vomiting/diarrhea. Denies GI, MSK, and neurological symptoms. He was alert and oriented x3. Admitted to ICU for treatment and observation. IV placed and infused 2 Liters NS. Given Ceftriaxone 1 gram IV and started on Doxycycline 100mg TAB, given twice a day with meals on Day 1 and 2 with no significant improvement. Started Clindamycin IV in PM of 4/13/2020 and showed good results. 4/14/2020, Day 3, patient improved with resolution of cellulitis. Diagnosis: Cellulitis. Discharged with Clindamycin 150mg capsule, to be taken as 2 capsule every 6 hours, x12 days.
Injection was put in the fatty tissue and not in the actual muscle tissue  - it may have been administered too low in my arm. Everything was fine for first five days - and I noticed where the shot mark was and I noticed a lighter ring around it and about 3 or 4 days later - ring around it that was four inches in size- it was warm to the touch; swollen. Inner part was bright red and about five inches out it was lighter - it looked like an infection. I sent a photo to my doctor and asked him and was put on antibiotic  - about a week - just in case. It may have helped a little - after the antibiotics, I could still see it was there (although no swelling anymore).
nausea; sweating; body aches; swollen axillary lymph nodes; headache; fingers and ribs hurt; fingers and ribs hurt; chills; potential reaction with facial serum resulting in facial swelling; This is a spontaneous report from a contactable other healthcare professional(patient). A 33-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot number: EL0142 and Expiration date: 12Jan2021), via intramuscular route of administration in right arm, on 12Jan2021 at 10:00, as a single dose for COVID-19 immunisation.  The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot number: EH9899 and Expiration date was not reported), via intramuscular route of administration in left arm, on 22Dec2020 at 13:45, as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, was not the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient had no allergies to medications, food, or other products. The patient medical history and concomitant medications were not reported. On 13Jan2021 at 12:00, the patient experienced nausea, sweating, body aches, swollen axillary lymph nodes, headaches, fingers and ribs hurt, chills, sweating that lasted day, potential reaction with facial serum resulting in facial swelling. The adverse event resulted in in Doctor or other healthcare professional office/clinic visit. The treatment was received for events, steroid cream for face. The outcome of the events was reported as recovered on unspecified date.  Follow-up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Employee presented 5th day post injection with red, swollen and hot left upper arm at 9am, spreading to upper shoulder.  Complains of itching.  Advised to see provider.
As per the HPI in the admitting H&P:  Patient is a 67 YO male presenting to with concerns for SOB. PMH includes atrial fibrillation, COPD, asthma, type 2 diabetes, gout, CHF, HLD, and vaccinated x2 prior. Patient has been feeling short of breath the last 2 weeks. Patient admits to testing positive for COVID 12/16. Patient admits to fatigue, SOB, orthopnea, LE edema, diarrhea. In the ED pt is currently requiring 100% FIO2 non rebreather.   Labs notable for: Covid positive ABG 7.35/43/80/23 Glucose 618, A1c 12.1 Beta hydroxy 3.5 Lactic acid 2.1 Sodium 130, when corrected for glucose appears to be within normal limits AST 59 ALT 51 Troponin 0.76, 0.84 D-dimer 882 WBC 16.5 with 0.16 left shift TSH 0.39, free T4 1 Blood cultures pending EKG notable for sinus tachycardia and nonspecific ST changes. Rate 109 Echo 2019 EF 55 Chest x-ray notable for bilateral scattered opacities. Possibly pneumonia CT E 12/16 for cirrhotic appearing liver with superimposed diffuse hepatic steatosis   ICU H&P: Patient admitted to ICU for close airway monitoring setting of a covid infection. Per EMS patient was at 54% on room air. IPAP 14, EPAP 8 with an FI02 of 100%. Patient is accepting of intubation if he continues to decline. At this time patient confirms past medical history and medication use. He has taken none of his medications today.  If the patient continues to decompensate decision-makers required. Plans to consult social work.    Infectious disease following. Per ID patient not clear as to actual date of onset of symptoms therefore not clear if Remdesivir will be of benefit. Pt is is agreeable to proceed with baricitinib therapy.
Patient was administered a subcutaneous 0.5 ml Jynneos injection to her right arm. Patient was unable to receive the injection intradermally. No adverse reactions occurred. Reporting due to administered subcutaneously.
Approximately 5 hrs after receiving 1st vaccine my heart rate increased and I felt faint for approx. 15 min. I called MD and he said it couldn't be from the vaccine. After my 2nd vaccine I had identical symptoms of my heart racing and faintness about 5 hrs after receiving the vaccine which lasted 20-30 mins. The following month I was treated for panic disorder. From that time to now I have been on and off antidepressants and cloxozapam and hospitalized for panic disorder and depression. Currently I am on an antidepressant and cloxozapam. Annual follow up on 03/22/04: "Pt has not recovered from adverse events.  I am still being treated for panic disorder and depression.  I have improved with medication, but still not to the state of health I was before the vaccine."
I am in pain because of the outbreak on my skin; I can't sleep; Severe allergic reaction to your 1st dose; I am in pain because of the outbreak on my skin; This spontaneous case was reported by a patient and describes the occurrence of PAIN OF SKIN (I am in pain because of the outbreak on my skin), INSOMNIA (I can't sleep), ALLERGY TO VACCINE (Severe allergic reaction to your 1st dose) and RASH (I am in pain because of the outbreak on my skin) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-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 PAIN OF SKIN (I am in pain because of the outbreak on my skin), INSOMNIA (I can't sleep), ALLERGY TO VACCINE (Severe allergic reaction to your 1st dose) and RASH (I am in pain because of the outbreak on my skin). At the time of the report, PAIN OF SKIN (I am in pain because of the outbreak on my skin), INSOMNIA (I can't sleep), ALLERGY TO VACCINE (Severe allergic reaction to your 1st dose) and RASH (I am in pain because of the outbreak on my skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. The patient had lost wages for a job that patient was on probation for a year. The patient had bloodwork twice by two different locations. Patient went to dermatologist. Patient was in pain because of the outbreak on skin and could not sleep. Patient was trying to overcome pain just to go to work. Treatment information was provided. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Pt had first COVID immunization 2/2/2021 and started having calf pain in her right calf 2/6/2021. Pt was dx with DVT 2/10/2021 in ER.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZATHIOPRINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive rapid test 48 hours after a negative test; Positive, notes: positive rapid test 48 hours after a negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm was sore right away.  By the evening, about 7 hours later, neck and head started hurting. Patient drank glass of water and went to bed later.   The next day, patient was very sore; everything was sore including tips of fingers, tips of toes, every muscle and every joint. Patient has never been sore to that degree even when had the flu.   Patient tried to stay hydrated and patient does not take pain medication but had to take aspirin.  Patient reports that even rolling in bed was painful.  Patient did not contact doctor or pharmacist.   Per patient, it took about 3 days to feel like had some energy and move around.  The site of injection was 3 inches wide now it looks like a bruise that is fading.  Pain on wrists going back to normal.   Recovery at 90% or more.  Psoriasis is forming in places that did not have them beforelike on forehead. Patient received Flu shot 5-6 weeks prior and 1st dose of shingles in August.
23AUG96 fever 104.7, rash;fever dec to1 03.0;dx as vax rxn to MMR;c/o fever 104.7, rash, LOM;P140,tachycardia;
Had some crazy nosebleeds beginning 4 days after my first dose. I ended up pulling a gigantic blood clot out of my nose during the first one. It was terrifying. I?ve had 6 nosebleeds since my first dose and I?ve never had issues with nosebleeds before. They last a long time too and each one comes with a clot. I also have bruises all over my legs and that have appeared randomly and if I get cut I take forever to stop bleeding.
12-14 days after my first dose of the  Pfizer vaccine I experiences severe increase in what has been very mild tinnitus (from hearing loss) After  the second dose (lot EN6200)  on Feb 21, 2021 tinnitus  became unmanageable causing insomnia, anxiety and blood pressure spike to 155/80. Was treated with Amlodipine --pressure came down but tinnitus not resolved.
Pt is a transfer from Facility with stroke-like symptoms including dizziness, syncope, altered mental status, nausea and lightheadedness. She has had a URI for the past month that includes a productive cough.  She was found to be COVID positive, and CTA revealed a right vertebral artery occlusion.
28FEB97 joint pain in legs;inflamed nodes both sides of neck;h/a & fever 102;
This case was reported by a non-health professional via sales rep and described the occurrence of injection site erythema in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The office manager reported that 5 patients recently experienced severe injection site reactions as redness and swelling at the injection site. A few of the patients returned to the office for evaluation. This was reported to the field rep off the cuff and the reporter provided very little information but said she would compile all the patient's information for follow up. An registered nurse was also present at the time of the report. This case has been linked with 4 cases, reported by the same reporter.
Red, hot, swollen leg at injection site and surrounding 4 inch area of thigh. Dx: cellulitis. Tx: Augmentin 400mg bid x 10 days.
This spontaneous report has been received from a medical assistant referring to an unspecified patients of 49 and 50 year old. Information regarding the patients' medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. On 30-JAN-2018, the patients were vaccinated with PROQUAD for prophylaxis (strength, dose, route, anatomical location, lot number and expiration date were not provided). No adverse effects were reported.
She got shots on 11/05/2020 she was perfectly healthy that day although they did not check her temperature at that check up before shots. The next day she started crying a ton, acting in pain so I was giving her tylonal.1.25 ml every 4 hours. She felt warm so I checked her temp rectal and it was 102. That was with tylonal given less than 2 hours ago. She started coughing all day and having breathing issues. Not drinking her bottles. So that night of 11/06/2020 i took her to hospital because something didn't seem right. They diagnosed her with upper respiratory infection. When we got discharged her temp was still 100.4
Patient received both vaccines in the same arm, 1 inch apart. The evening of the vaccinations, patient stated he felt feverish and took some Tylenol OTC. On Sept 07, 2017, patient noticed his arm was very inflamed and red and symptoms are down to his elbow. He went to the emergency when he had a large inflamed blister all to his wrist. Doctors treated him with Cefdinir 300mg TID x 10 days. His symptoms are now subsiding slowly.
Got COVID, confirmed by rapid test.  Sore throat, cough, runny nose, slight headache and sharp muscle pains. No fever or chest involvement
Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well). At the time of the report, MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
After 1st shot, I had a typical for me site reaction.  Soreness for a couple of days and then nothing. After the 2nd shot it started out the same, but by day 2 it became hot and red.  Today, day 3, the redness is much bigger and very itchy as well as being swollen and hot.  I have started to use cortizone on it.  I am worried, but haven't called the doctor yet.
Immediate pain, burn, ache, redness, edema. Current-unable to sleep on Lt side and arm.
4/08/21- extreme headache/pain/head pressure  4/12/21- ER visit- medications given: Benadryl, Toradol, Ativan.  4/14/21- severe body tremors/ shaking/ uncontrollable body movements. 4/15/21- ER visit- medications given: Ofirmev, Gadavist, Zofran 4/20/21- headaches start to subside, neck pain and stiffness begins. Along with insomnia, panic attacks, heart palpitations, dizziness. 4/21/21: medications: medrol steroid pack, and z-pack. 4/25/21: tinnitus begins, extreme ear fullness, and sinus blockage.  None of these symptoms have improved  5/05/21: visit to ENT. Prescribed prednisone. 10mg for 5 days. No improvement. 5/12/21: primary doctor prescribed Xanax for sleep. 7/05/21: All symptoms still persists. Added symptoms on this date are not body tingling, numbness in feet and legs, sharp body pains in knees elbows and toes..
7 days post injection, red, itchy lumps appeared at the injection site.  Day 8 post injection, diffuse swelling, but no longer multiple lumps.  Area measures approximately 2.5x1.5 inches, is uniformly inflamed, uneven circular shaped,  and is bright red.  Redness has spread slightly since onset likely due to gravity (downward migration is slight).    Day 2 experienced extreme fatigue, no other symptoms Day 3 sore at the injection site, no other symptoms Day 4 sore at the injection site, no other symptoms Days 5-7 no symptoms.
My face turned red. it looked like I had a sunburn. It lasted for a few hours on Thursday evening.  It went away in the morning of Friday 02/05/2021, but it returned in the evening. It didn't hurt, burn, nor was it itchy. I just felt hot.  My cheek temp was 100 degrees while the rest of my body was normal body temp 97-98 degrees.
RED ITCHY SPOT ON BODY AFTER  4 DAYS OF GETTING 2ND DOSE OF SHINGRIX