chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Osteoarthritis has been worse; This case was reported by a consumer via interactive digital media and described the occurrence of osteoarthritis aggravated in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoarthritis.   On 21st May 2021, the patient received Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced osteoarthritis aggravated. On an unknown date, the outcome of the osteoarthritis aggravated was not recovered/not resolved.   It was unknown if the reporter considered the osteoarthritis aggravated to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that since they had received the vaccine on Friday, their osteoarthritis had been worse. The patient was questioning if it would continue and also if it was normal.
GOT RASH/HIVES PRIMARILY ON THE LEFT SIDE OF NECK AND UPPER CHEST.  IT DID MOVE SOME TO THE RIGHT SIDE BUT NOT AS BAD AS THE LEFT.  IT WAS RAISED AND ITCHY.  I WOULD USE A CREAM ON IT AND IT WOULD CALM DOWN SLIGHTLY.  IT ALSO AFFECTED BY BREATHING SLIGHTLY AS I COULD TELL I WAS GETTING WHEEZY AS IF MY ASTHMA WANTED TO START WHERE I WOULD NEED MY PUFFER BUT IT WOULD GO AWAY AFTER A FEW MINUTES AND THEN START AGAIN.  THAT PART ONLY LASTED A DAY.  THE RASH/HIVES ARE STILL WITH ME BUT MUCH BETTER.  I EXPECT IT TO BE GONE WITHIN A COUPLE MORE DAYS.
My sister got her first covid shot on 1/25/21.  On 1/27/21 she started a prescription for a diuretic for swelling from DVT in left leg.  On 1/29/21 she called me early in the morning to say she couldn't stand or walk.  She hasn't walked since.  No idea if this was natural progression of dementia.  She did walk into and out of cardiology appointment on 1/7/2021, and was weak at that time.
I had low grade fever and body aches, pain all over my body. I wasn't able to eat because I couldn't keep anything, I had loose stool.
12:32 (aprox) patient entered observation area 12:39 patient reported feeling dizzy; juice & crackers provided. 12:46 patient reported rash and itching to face, neck back. Mild rash noted. Moved to triage area for medical consult. Dr. responded 13:18 VS-130/74, HR 95, SpO2 97% on RA 13:19 Pt. given Zyrtec 10 mg p.o per Dr. and monitored 13:40 Rash resolved, patient without complaint; released home per Dr. 13:40
Patient, a previously healthy 19 year-old female college freshman died suddenly yesterday, approximately 10 days after receiving Gardasil & menningococcal vaccines. Vaccines were administered by a medical provider in her hometown while she was home for the Thanksgiving holiday, sometime around 11-28-08. She had a medical appointment pending for 12-8-08 (the day of her death) with the Student Health Service; medical clerk had entered "possible seizure" as the reason for making the appointment. Patient had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to bed at 10:30 PM on 12-7-08, in her dorm room with a roomate. She appeared to still be sleeping the next morning when her roomate left for class. Her body was discovered still in bed around 5 PM that day (12-8-08) with rigor mortis. No history of substance abuse, alcohol intake, or depression or other mental health issues. She was a happy, achieving student. This report is filed by a friend of patient's parents, who is a physician (board certified internal medicine & geriatrics). Report also filed online today with the FDA. Patient's mother can be reached at home for additional details. Memorial service & funeral 12-12-08 and 12-13-08. Only known past medical history requiring physician attention was facial acne.  12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx:  Biaxin.  Received from CDC via email: The patient had no previous health problems. She was a freshman and was seen at the college health clinic only once on 11/3/08 for sinusitis. She was on Yaz birth control pills and a topical acne medication. After the death, police questioned her roommate who said that the pt did go out on the evening of 12/6/08 and had a few alcoholic drinks, but not an excessive amount. She had a HA the next day and thought it was from the alcohol. She had a PCN allergy and was a non smoker.   12/11/2008 Records received from PCP.  HPV#1 1/18/2008.  HPV#2 3/28/2008. Vaccines deferred 7/29/2008 2' to oral prednisone usage for acne (with Bactrim).  Seen 8/15/08 for sore throat, runny nose. DX: Pharyngitis s/p steroid tx. Returned for vaccines 11/26/2008 in good health with normal exam. Additional record also received from health center for scheduled appt on 12/8/08. Pt reported 2 episodes (one 1 month ago and one on the day of death) of waking up in a cold sweat, having urinated in the bed, feeling the urge to vomit, dizzy with trouble reading. Appt made for ? seizure. Pt did not arrive for appt.  3/3/09 Autopsy report received.  COD:  Unable to ascertain after autopsy, microscopic, toxicologic and chemical evaluation.
At approx. 1pm, client received Flu one vaccine. 5cc-- 2 hours later came to report itching all over.
Initial report received from a healthcare professional on 18 October 2013. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number: unknown, expiry date: unknown) on left deltoid via intradermal route on 16 October 2013. Patients experienced site reaction of redness and itchiness 1-7cm on 16 October 2013. The events were resolved. List of documents held by sender: none.
soreness rt deltoid area, immed redness, numbness & tingling of fingers rt hand;
Injection site bleeding; Injection site nodule; Bruised and sore under the arm; Felt groggy; Bruised and sore under the arm; Lymph node was swollen; Tired fatigued; Joints hurt; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE HAEMORRHAGE (Injection site bleeding), INJECTION SITE NODULE (Injection site nodule), CONTUSION (Bruised and sore under the arm), SOMNOLENCE (Felt groggy) and AXILLARY PAIN (Bruised and sore under the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (Injection site bleeding), INJECTION SITE NODULE (Injection site nodule), CONTUSION (Bruised and sore under the arm), SOMNOLENCE (Felt groggy), AXILLARY PAIN (Bruised and sore under the arm), LYMPHADENOPATHY (Lymph node was swollen), FATIGUE (Tired fatigued) and ARTHRALGIA (Joints hurt). At the time of the report, INJECTION SITE HAEMORRHAGE (Injection site bleeding), INJECTION SITE NODULE (Injection site nodule), CONTUSION (Bruised and sore under the arm), SOMNOLENCE (Felt groggy), AXILLARY PAIN (Bruised and sore under the arm), LYMPHADENOPATHY (Lymph node was swollen), FATIGUE (Tired fatigued) and ARTHRALGIA (Joints hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was provided.
Patient and patient's daughter both describe increasing breathing difficult after receiving the first dose of the Covid-19 vaccine.  Patient states that his breathing is twice as bad after receiving the vaccine and that he can no longer walk greater than five steps without having difficulty breathing.
nasty sore throat with a lot of mucus, worsening to airway swelling, laryngitis, requiring hospitalization on day  4 for airway monitoring and IV medications including antibiotics, steroids and fluids. better after 18 hours of inpatient hospitalization and 1 more night in hospital for IV meds before going home. Required laryngoscope by ENT and 1 night in ICU for airway monitoring.
Could not breath, was admitted to Hosp on Aug 2, 2021 around 11a and passed away Aug 16, 2021
Site: Pain at Injection Site-Medium, Systemic: pt said his arm including wrist is numb after receiving vaccine-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Red, fluid filled blisters started on face then moved to arms and hands and in mouth. Grandmother states more than 10 blisters all together. fever of 101. Client was exposed to shingles prior to being vaccinated on 5/4/2016. physician said (per grandmother) client has light case of chicken pox.
Arm swelling; This is a non-serious spontaneous case, initially received from the pharmacist on 20-Oct-2018, concerning a female patient of an unspecified age.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported] for an unknown indication.  On an unspecified date, after vaccination, the patient developed swelling in arm.  The outcome of the event was not reported.   This case was cross-linked to the original case: 201804744 (same patient).; Reporter's Comments: A female patient of an unspecified age developed swelling in arm unspecified days after the administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of information regarding onset latency.
Sore arm; chills; body aches; pain under left arm pit; headache; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 60-years) as a single dose for COVID-19 immunisation. The medical history of the patient included high blood pressure. The patient did not receive any concomitant medications with in 2 weeks of vaccination. The patient had no known allergies to food, medications, or other products. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 60- years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 17:00, the patient experienced the events sore arm, chills, body aches, pain under left arm pit and headache. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm, chills, body aches, pain under left arm pit and headache was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
He received his Moderna vaccine and was sitting in waiting area with his spouse for his 15 minute post vaccine wait. RN was alerted that he did not feel well. RN #1 assessed him and gave him 10ml of Benadryl liquid due to his complaints of itchy/scratchy throat and difficulty breathing. Heart rate was 80 and respirations were 20. He reported he last ate at 8pm the night before and was too nervous to eat breakfast. RN #2 provided him with fruit juice and sliced apples. He reported feeling better and then two minutes later complained of feeling hot and cold and foggy headed and not right with some anxiety. RN #1 called local EMS/Fire Rescue and they arrived to assess him. Vital signs were within normal limits. He was transported to Hospital for further evaluation. He was alert and oriented and able to ambulate to EMS/Fire Rescue vehicle.
Information has been received from a physician concerning a 24 month old male with no known drug allergies and a history of varicella zoster who on 09 JAN 1996 was vaccinated with a first dose of varicella virus vaccine live (lot #609296/0441B) in the left thigh. On 30 JAN 1996, the patient developed a vesicular rash on the right cheek of buttocks, also reported was a facial lesion. Since that time the patient developed multiple occurrences of the same symptoms. On 09 JAN 2001 it was reported that the child is a healthy 8year old, who continues to experience a facial cheek lesion, first 21 days after vaccination, then on 21 JUL 1997, 14 APR 2001, and on 04 JUN 2001. Treatment was given and the symptoms subsided. The patient was treated in April 2001 with acyclovir (Zovirax). On 29 JUN 2001, the patient was treated with cefadroxil (Duricef). There were no isolates present, however the attending doctor intended to have an isolate analysis performed. It was noted that the physician believes that the patient has recurrent herpes zoster related to her vaccination with varicella virus vaccine live. On 08 JAN 2002 the patient was seen by the physician with another facial cheek lesion. On that day, a specimen was collected with 3 capillary tubes as well as a swab with part of the blister on it. On 15 JAN 2002, it was reported that the swab specimen collected was inadequate to process for PCR. However, the capillary tube sent from the right cheek vesicular rash was negative for VZV through PCR analysis. On 08 JAN 2002, it was reported that the patient did not have a recent exposure to chicken pox. The patient's outcome was unknown. Additional information has been requested.
Patient called to notify clinic that she went to the ER three times and was told that she probably had an allergic reaction or a Staph infection from her vaccination.
felt a little funny; felt a little queasy and sick; felt a little queasy and sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 (Lot number: EL9L66) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt a little funny"; ILLNESS (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "felt a little queasy and sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:The first shot she felt a little funny towards the end of the day and felt a little queasy and sick and the next day was fine but it was not one to write home about.  No follow-up attempts are possible. No further information is expected.
Sore muscle and flu symptoms the night of and morning after: dizziness, fatigue, nausea.
This spontaneous report as received from a registered nurse refers to a 11 year old patient (unspecified gender). On 20-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling, erythema and warmth involving most of the thigh and buttock at injection site.  Induration and warmth subsiding by day #2.  Exaggerated immune reaction vs. allergy.
7 days after vaccination, patient woke up with right side weakness and confusion.  Was hospitalized and found to have CVA (ischemic).  No intervention given.
Patient received shots at approximately 9:56am and at 10:04am had a seizure
This spontaneous report was received from a physician assistant student via a company representative referring to an 18 year old male patient. Concurrent conditions, pertinent medical history or concomitant medications were not reported. On an unknown date in 2013 (reported as summer of 2013), the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose, route of administration and frequency were unspecified) and he experienced a rash. Then, on an unspecified date, the patient was vaccinated with a second dose of GARDASIL (lot#, expiration date, dose, route of administration and frequency were unspecified) and he experienced a more severe rash. It was stated that the patient chose to not get his  third dose of GARDASIL because of the described reactions to this vaccine, that there was not intervention to prevent serious criteria (reported as "I did not think so"), that rash was not significant disability or incapacity and that no PQC was involved. At the time of the report, the outcome of rash was reported as recovered on an unknown date. The relatedness of GARDASIL with rash was not reported. Additional information has been requested.
On the 18th I had a sharp burning sensation on my right lower leg above the ankle that lasted a few seconds. The next day I felt a lump the size of a quarter above my ankle on my right leg. By that Monday the foot, my ankle and slightly above that was swollen. I saw my doctor on the 22nd because it wasn't getting better it was getting worse, and they couldn't figure out if it was a blood clot so they had me have a vein ultrasound and they said I have a superficial blood clot in a vein on my right leg. So since then I been on baby aspirin, elevated my leg, my swelling is going down, and I still have some tenderness on my ankle and the top of my foot but I use a warm compress to keep that at bay along with some ADVIL.
Injection site on left arm was swollen, red, hot to the touch, and painful. Other symptoms were lethargy, chills, abdominal cramping, lack of appetite, and muscle aches.
Large , itchy rash on shin and lower left leg after 1st shot.  Still exists after 2nd shot.
bump on the injection site after the first two doses; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump on the injection site after the first two doses) and MYALGIA (sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0321AG2A and 032121A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL DIHYDRATE (PRINIVIL), ACETYLSALICYLIC ACID (ASPIRIN 81) and TOLTERODINE L-TARTRATE (DETROL) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (bump on the injection site after the first two doses) and MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (bump on the injection site after the first two doses) and MYALGIA (sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-371568 (Patient Link).
1MAR91 mom reports pt had severe h/a 1.5 hrs post vax; To ER examined & observed for 2 hrs w/o further s/s; Fever x 2 days of 101 orally; No underlying ear infect/disease;
pt recvd vax 3PM;6PM recvd a call form mom stating pt had woke up from nap w/red area to upper trunk of body w/swelling & redness to neck & ears;to ER dx w/urticaria;tx w/DPH
The TD vaccine was given to my son in his right upper arm. The next morning he complained of the left arm being very sore and sore to the touch. The next day Sunday he can bearly move the left arm. I have applied heat pad to the sore arm.
Heartburn, initially mild but became worse and annoying; Lymph nodes under both his arms but notable on the left arm where the injection was given; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn, initially mild but became worse and annoying), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under both his arms but notable on the left arm where the injection was given) and LYMPHADENOPATHY (Swollen lymph nodes) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 022C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (Heartburn, initially mild but became worse and annoying), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under both his arms but notable on the left arm where the injection was given) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (Heartburn, initially mild but became worse and annoying), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under both his arms but notable on the left arm where the injection was given) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Body temperature: normal (normal) Normal. On an unknown date, Oxygen saturation: normal (normal) NORMAL.         Concomitant medications were not reported.  A after receiving the booster dose, patient experienced heartburn which initially started as mild and patient did not give much attention. But it gets worsened and more annoying 4 to 5 days ago. Patient reported that it is still coming and ongoing. Patient also had a swollen lymph node under both his arm and he describes it like the size of half of plum and filled with fluid.  Treatment medications also include antacids.
Wife called & stated the day after his pneumonia shot (12-1-10) he woke up & his (R) arm was swollen. The swelling was going down but awoke this morning & swelling was worse & included under his (R) arm. Advised to see MD - has appt. today with Dr.