chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient in her 40's. On 29-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot# reports as J007786, exp 25-SEP-2015), 1 dose in the unknown arm for unknown indications. The patient's relevant medical history includes no allergies to vaccines. Her concomitant medications and past drug history were unknown. On 29-SEP-2013 the patient had edema at the injections site, the site swelled to the size of a silver dollar, some itching and then the whole arm swelled like a balloon. She was treated with Benadryl which did not help the swelling. It was unknown if there was any laboratory data. As of 29-SEP-2013 it was unknown if she would have another PNEUMOVAX23 injection and she continued to have edema at the injection site, itching, and her whole arm was swollen. This pharmacist reports similar events for 4 patients. This was the first of 4 reports. Additional information has been requested.
52 y/o with past medical history of Allergic Sinusitis who presents with palpitations post vaccination. Patient states that this is the 1st dose in the two-dose Pfizer series. Patient states that vaccination was received in the left arm. Patient denies reaction to vaccinations in the past. NP and Paramedics at patient side. Patient initial vitals with noted hypertension (147/88 BP) all other vitals within normal limits (98 HR, 97% RA, 14 Resp). Patient states that palpitations come and go but denies chest pain or difficulty breathing. EKG obtained with NSR. Due to persistent palpitations, NP asked police to call fire rescue. Fire rescue arrived on site and elevated patient, patient noted to be tachycardic (123 HR) and crying. Patient refused transport for further medical evaluation. Patient states that her mother recently died of Covid 15 days ago and she believes her symptoms are related to that. Patient provided and signed the Against Medical Advice form. Staff aware. Patient escorted to the main door by paramedics.
About 40 minute from receiving a flu vaccine, the patient's husband contacted the pharmacy to informed us that the patient was experiencing a reaction to the vaccine. Some of her symptoms include: rash all over her body, disconfort, malase, weakness. The husband took her to the emergency department, were she stayed overnight.
w/in 24hr of vax lt leg, pt devel 5 inch x 4 3/4inch area redness, severe induration extending from lt thigh to cover lt knee joint;
On the first day I  had pain on injection site. The second day I had muscle aches, fever and chills.
Myalgia & Fever Narrative: sore arm for a week. fever the next day after 1st vaccine that lasted 24hours.
Received flu shot on 10/10 sometime between 9am and 11am. Apprx. 6pm on 10/10, complained of very intense headache, nausea with dry heaves, profuse perspiration, and temp. Symptoms lasted 12 hrs.
First began with soreness in arm and neck, then symptoms got worse as the day progressed. By 4:00 PM that day, I had a temperature of 101.3, severe body aches, chills, shaking, weakness and difficulty breathing. I became dizzy and my skin hurt. It really felt like my skin was 10X's more sensitive than normal, I couldn't touch my face or leg without flinching in pain. I felt like I was burning from the inside out. I have had the flu before and this felt worse than any case of the flu I've ever had. I took 3 200mg ibuprofen and a sleeping aid and went to sleep finally. I slept for 8 hours straight, woke up and felt a lot better. However my body still feels sore, almost like whiplash in a way.
Sore arm with rash/swelling at injection site, lasted a week.  Fever and chills that evening through the night.  Extreme fatigue, slept for 18 hours.  Abnormal menstruation (spotting for 8 days prior to actual period, started 2 days after vaccine)
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. In 2015, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-AUG-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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.
Moderna COVID-19 Vaccine EUA; swelling, redness, itchiness, and soreness in the arm that got the shot 7 days after the short. the area is also warm and sensitive to touch
Severe Fever, all over body aches, skin sensitivity, nausea, headache, fatigue
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: After given Moderna and Flulaval shot within 15 minutes, husband informed that the patient was shaking.  Checked BP 4-5 times but not all recorded, all within normal range 150/86 initially but other numbers 130 something over 70 something. Temperature within 98.5. at all times.  She reported no vomiting, visual changes, tingling, numbness but initially felt unable to move her legs.  After 30-45 minutes, she was able to go to bathroom with husband's assistance and was able to go home after 1 hour
This is a 59-year-old man with a history of alcohol use disorder quit in 2019, chronic hepatitis C received treatment in 2020, chronic liver cirrhosis with known varices, GI bleed in 2019, diabetes with last A1c 8.4, chronic hypertension, chronic anemia of chronic disease-microcytic, chronic thrombocytopenia, GERD, presented to the hospital after he was found down by family.   Found down Fever, cough, vomiting COVID 19 positive Suspected dehydration Elevated dimer Leukopenia - Given 1L IVF and feeling better. - D-dimer 0.66 - UA neg.  - Influenza neg - Patient COVID test did return positive. He has no respiratory symotoms and is doing well on RA. Stable for discharge home. Encouraged rest. Also advised quarantine for 10d from positive test.         History of alcohol use disorder History of hepatitis C, treated Chronic hypertension Chronic cirrhosis without acute decompensation Known esophageal varices History of GI bleed Chronic GERD Chronic thrombocytopenia Chronic microcytic anemia of chronic disease Chronic transaminitis, elevated AST, ALT Chronic type 2 diabetes with acute hyperglycemia, A1c 8.4 Resume PTA meds for chronic conditions   Urticarial Rash on back and neck - Looks like a atopic dermatitis as itching. Will give triamcinolone cream BID.
Swelling of left arm at the injection site and also below it down to the elbow. Soreness, stiffness, tenderness of upper left arm. Two sites of swelling - not one continuous site. Never had a symptom as severe as this with any shot, so this is why I am reporting it.
Patient reports feeling dizzy, lightheaded, then lost consciousness for approx. 20 secs., skin color pale then reddish, eyes rolled back.  Patient then regained consciousness.
Given an Expired Dose of Heplisav-B; Initial Report Received on 08-Mar-2022  A nurse practitioner reported that a 72-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 08-Mar-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934599, expiration date 22 Feb-2022, and NDC # 4352800301) in the left deltoid. No adverse side effects were reported by the patient.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via Novartis pharmaceutical corporation. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "sore".  Additional information: Patient stated that she recently had COVID-19 vaccine, and was a little sore.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Fever, chills, fatigue, muscle pain, aches, arm that shot was given in was very painful the day after getting the vaccine. Going on the second day after injection, fever broke and other symptoms are still present but beginning to resolve.
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 16-NOV-2011 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2012 the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Rash, whelps over abdomen, neck and eyebrows. symptoms started 10/17/2022 around 9am.  Went to urgent care clinic that evening and received steroid injection and instructed to take benadryl otc for 48hrs.  Wednesday 10/19/2022 same symptoms appeared and was seen by primary. Methylprednisolone 4mg for 5 days, loratadine 10mg and hydrocortisone cr 1% 30gm given for this and appointment was made with an allergist.
Patient demonstrate a very large site rxn > 3" diameter with some elongation down arm. Had erythema, itching and warmth.
This spontaneous report as received from a nurse refers to 4 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with M-M-R II that underwent an unsupported temperature excursion. No adverse effect reported. Lot number H074607 (expiration date 01-MAR-2014) is an invalid not number for M-M-R II. Additional information has been requested.
Area pain x 2 days on the 3 day sore throat, fever, headache and cough.
pt's arm was red, swollen and warm around the injection site for the pneumovax.  her entire upper arm was involved.  she went to urgent care and they told her it wasn't cellulitis but was a localized vaccine reaction and prescribed an antibiotic and steroid.
Fever, chills, body aches, sore arm, headache - lasting 24 hours
On the day of the booster in May I had severe body aches and headache but no fever this time and I was lethargic.  These symptoms lasted only about 24 hours.  On June 27, 2022, my heart was racing out of control (up to 263pbm) for over an hour and I went to the ER and they put the heart monitors on .  They determined it was Super Ventricular Tachycardia  (SVT).  This happened again on June 29th but I did not return to the ER because I  was able to use maneuvers they taught me to bring my heart rate down.  They are still trying to determine the cause.  It also turns out that after more testing  it was also determined that I had three blood clots.  They are called Pulmonary Embolism.  I went back to the ER on July 19th.  The end result of that is I am now receiving blood thinners, anti-coagulants.  The doctors are still trying to figure out why this happened.  They have discussed with me the boosters and vaccines and the possibility of being related.  I have another appointment for more blood work with a specialist in a couple of weeks, October 3rd with hematologist.  I have not had another major event since.  I am seeing a cardiologist, electro cardiologist, pulmonologist, and a hematologist to help try and determine cause and treatment.
Rash in inner part of left leg and a few days later in outer part. At first rash was like an allergic rash but later it developed into a red bright with lots of red points and some blisters, very itchy. As of today the rash has not resolved but is better.  8/23 went to my PCP who prescribed Triamcinolone Acetonide 0.025% cream 15GM.  At time of visit I did not associate vaccine with rash. It just happened 2 days ago. I proceeded to call the pharmacist and made another appointment with my NP
Aa 64yrs Male who presented to emergency department with shortness of breath. Of note HPI taken from record and report as patient unable to participate as intubated and sedated. On 8/9 the patient developed gradually worsening shortness of breath with increased work of breathing associated with slurred speech, nausea, and vomiting. Of note the patient's son reports that the patient started not feeling well after his shingles vaccination on 8/9. In the emergency department the patient was hypoxic requiring intubation. CXR and CT scan notes RML and RLL pneumonia. Empiric antibiotics and IVF given. He was admitted to CICU for close monitoring and further management.
Wheezing, required inhaler use at 15 min after shot, again 2 hrs later, again 8 hrs later. Arm swelling and pain. One hour of fever. Body aches and pains. Lethargy and fatigue. Anxiety. Nightmares. Headache. All of the above continued for 7 days except inhaler use; still wheezing but not used inhaler.
Our son has had and still have many issues after receiving the FLUZONE shot. Dizziness, sleeping at school, not being able to sleep at night, hallucinate, muscle fatigue, fainting, depression, can't compete in physical sports, weight gain, nervousness, anxiety. He was the fastest runner in his class, now he can't keep up with his peers. Very disheartening. I have taken him to specialist with no answers to date, 06/27/2017.
Fever/chills, headache, weakness, dizziness, fatigue, loss of appetite. Woke feeling feverish around 1:30 am (about 16 hours after vaccination). Began feeling better around 5:30 pm (about 34 hours after vaccination). Symptoms not as bad as after first dose and didn't last as long. As of 8:30 am on second day after vaccination (49 hours), feel about 90% back to normal.
When I went to doctor, I had pain in my nodules and my neck started losing range of motion and it was very painful. It triggered my neck injury. The doctor examined my lymph nodes and prescribed me a muscle relaxer. I'm still using muscle relaxers 3 times daily and wear a neck brace.
Child has been experiencing physical tics in her hands, arms, legs, eyes (blinking), stuttering , and head movements.  This has been occurring since the beginning of March and continues.
pt vax hepta B. pt devel flushing, malaise, and low grade fever. serology for Lyme disease was pos. but a definitive diag of lyme disease was not made.
Wife states that the next day following injection, patient was covered in hives from neck to waist, including both arms. Hive rash was extremely itchy and is still visible after one month. As per wife, MD was notified and patient encouraged to get second dose. Patient was instructed to take Benadryl or Zyrtec, for symptoms.
Syncope x 3 in the early morning hours (around 3am) about 14-15 hours after vaccine. She had had headaches that is intermittent, throbbing, phonophobia but no photophobia, from back of head to top of head and behind eyes, taking Advil or Excedrin intermittently with relief for a week prior to covid19 vaccine.  Syncope, longest lapse was two minutes, her sister found her. She went to Medical Center ER at 0400, was assessed and scanned, neg CT scan of head, and was discharged home.  Has felt some fatigue today due to not sleeping early the night before, has returned to school since concussion, with normal learning, and denies  any exertional physical activity due to pre-existing torn ACL, torn medial meniscus L knee.  After evaluation by ER, was given IV fluids, determined cause to be dehydration.
Patient contracted COVID-19 and was hospitalized on 07/16/21 after receiving the COVID-19 vaccinations.
Flu-like symptoms, 101 F fever, fatigue, weakness, chills & flushing neck pain, pruritus, erythema & eccymosis at injection site (large surface area).  Progress report on WORM
Pain and swelling at the injection site that began a few hours after the injection was given. He was given ULTRAM 50mg Q6 hr PRN pain #10.
Patient had a temp of 99.9 that night. her temp went up to 100.9 the next day and she was complaining of leg pains, vomited and had diarrhea. She was brought to the doctors office on 3/2/15 (3 days after her immunization was given, and was diagnosed with possible Viral Gastroenteritis. She was brought to ER that night because her temperarature went up to 102 despite fever medications. She tested negative for RSV, Influenza and Strep in the ER. Mom called the Pmds office the next day because the patient is still running a fever and had developed some greenish nasal secretions Zithromax was prescribed over the phone. Her fever broke on 3/8/15. She was brought back to the Pmd's office and was diagnosed with an upper respiratory tract infection.
Positive COVID PCR, and other housemates are positive.  No symptoms at this time.
Patient presented to the ED for right sided chest pain in the setting of recent febrile illness. The day before admission patient began developing constant sharp pain in the right side of her chest with radiation to her right arm. The pain was not relieved by position, but was worsened with exertion. A STAT ecg was obtained which was concerning for some ST elevations in precordial leads. Troponin was elevated to >50,000. Limited TTE revealed an EF of 38% with septal hypokinesis. Patient had a previous echo as a dizziness workup in 2020 that was normal.    Patient was urgently taken to the cath lab showed no evidence coronary disease, but did show an LVEDP of 25. Patient was admitted to the cardiology service after cath for work up of suspected viral myocarditis.    On interview after cath, patient confirms hx of viral illness over the past week. She states that she only developed a cough recently, and her main symptoms were malaise, body aches, and high fevers. She denies any rashes, illicit drug use, alcohol use, recent abx, gi illness, or recent travel.   She developed cardiogenic shock, biventricular failure with confirmed lymphocytic myocarditis via biopsy. A decision was made to place on VA ECMO and Imprella for LV venting (5/6). She arrived intubated/sedated. ECMO at 43000 RPM/ 3.9L, impella P2/1.0L, lidocaine gtt for VT (now weaned off) (EP consulted) .  She was decannulated from ECMO 5/11 and Impella 5/13. She received 1 g of Solu-Medrol and was started on Colcrys 0.6 for Endomyocardial biopsy showing lymphocytic myocarditis. Her course has been c/b 9 mins of ventricular standstill on 5/6 and frequent ventricular ectopy, now resolved off lidocaine. Also endorsed sustained SVT for which she received Adenosine x 3 with return to SR 5/12. Was on dobutamine gtt through this episode. Started on PO beta blocker. TTE now showing recovery of LV function.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 12-NOV-2015 at time- 16:25, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L004754 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.6 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
I received shortness of breath; sore throat; tiredness and I took TRELEGY. I still feel symptoms.
A few days after I got the shot, I started to experience very sharp throbbing pains in both of my legs. This pain then continued to other areas of my body (I was having throbbing pains in my wrists, ankles, and lower back) Very scary. My doctor said that I should not still be experiencing side effects this many days out from getting the vaccine, and advised me to go to the ER. The pain has still not fully gone away, as I still will get random throbbing pains from time to time.
I caught COVID-19 on 6/29/2022. I started with sinus issues, congestion, and a little bit of a runny nose. On 6/30/2022 the symptoms were more intense. On 7/1/2022 I had mild body aches. I spoke with my doctor, and they prescribed me with PAXLOVID. I have been taking vitamin D supplements as well. The symptoms went away on 7/2/2022, but I continued to take the PAXLOVID and vitamin D.
Injection site pain; headache; nausea; chills; low-grade fever; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318) dose 2 via an unspecified route of administration in left arm, on 16Feb2021 at 11:00 AM (at the age of 24-year-old) as single dose for COVID-19 immunisation at Workplace clinic. Medical history was none. No known allergies. Concomitant medication included nitrofurantoin (MACROBID) received in two weeks. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318) dose 1 via an unspecified route of administration in left arm, on 26Jan2021at 03:00 PM (at the age of 24-year-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. On 16Feb2021 at 10:00 PM, the patient experienced Injection site pain, headache, nausea, chills, low-grade fever. No treatment was received for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient states that approximately 3-4 weeks after receiving her PRVENAR 13 shot she realized she was having deep muscle pain due to her PREVNAR 13 shot after watching a lawyer commercial on TV. Patient admits when RPH asked how she was feeling approximately one week after her shot, patient stated she was fine. Now patient feels like she is having deep muscle pain that sometimes involves tingling and sometimes radiates up her right arm into her breast. Patient has increased pain when bending down to pick something up and when she puts on a seat belt when sitting in the passenger's side of a vehicle. Patient believes pain is increasing and has self treated with ibuprofen and VICODIN.
Progressively worsening numbness, tinglin, and weakness, eventually diagnosed with Guillain-Barre syndrome when she was 31 weeks pregnant. She has had a prolonged and ongoing hospitalization/inpatient rehab admission with multiple admissions and readmissions. She delivered her child but the baby also prolonged required hospitalization.
Rash at site started after 11:00 PM on 9/24/14. Rash resolved 10/1/14. Fever.
Most of the dose leaked out of the client's arm during administration. The nurse was certain that less than half a dose was given. The dose was repeated in the other arm and full dose was administered.