chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from the patient's daughter refers to her 79 year old mother. The patient's medical history included herpes zoster in 2012 (reported as 4 years ago). Her concurrent conditions included iodine and penicillin (unspecified) allergy, diabetes, abnormal blood pressure and an unspecified abdominal disorder. Concomitant medications included an unspecified diabetic, an unspecified blood pressure and an unspecified abdominal medications. On 21-MAY-2014 at a local pharmacy, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously; dose, lot # and expiration date were not reported). Around 27-OCT-2016, the patient developed whelps on her back, which increasingly to spread until 30-OCT-2016. The reporter stated that her mother saw her primary physician on 31-OCT-2016, who confirmed that she had developed shingles again. The patient was given a ten day supply of an unspecified medication (in pill form) and an unspecified cream, to treat her shingles. The reporter did not know if the medications were helping since her mother just received them less than 24 hours ago. None lab diagnostics studies were performed. The outcome of the adverse event was reported as not recovered. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
pt recv vax 23JUL98 & mom took child to ER 24JUL98 w/leg red & swollen & hot to touch;no temp measured;2" diameter then spoke to mom 27JUL98;redness & swelling almost gone;
Patient fell on the left side of her arm. At the same time there may be a rash at the side. Sounds relatively bubbling and wounded. Office was seen and prescribed Levofloxacin.
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reportedly became dizzy during observation period. They were evaluated by EMS and sent home. There was no further intervention
became ill with cold like symptoms and fibromyalgia flare-up  and still on 1/5/2022 experiencing shortness of breath and cold symptoms (runny nose, headaches, fatigue, body aches) despite being treated with antibiotics and steroids
Arm was swollen, red and feverish to touch from injection site all the way to the elbow area by the following day. Patient was also running a fever of 102 degrees.
fever of 102F; administration of Kinrix to a 15 month old; 4th dose of DTaP; sinus sympomts (runny nose); having a cold; This case was reported by a nurse via call center representative and described the occurrence of cold in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2021) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Kinrix (unknown). In October 2020, less than a week after receiving Kinrix, the patient experienced cold and runny nose. On 22nd October 2020, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On 25th October 2020, the patient experienced fever. On an unknown date, the outcome of the cold, runny nose, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the cold, fever and runny nose to be related to Kinrix.  Additional details were provided as follows: The reporter stated that, aaftyer vaccination with Kinrix, the patient experienced fever of 102 farenite, sinus symptoms like runny nose, and diagnosed with cold. The patient received Kinrix at the age of 15 months old, which led to inappropriate age at vaccine administration. The patient received 4th on the series of DTaP, which led to inappropriate schedule of vaccine administered.  The reporter stated that, the patient pulling ears and MD confirmed that, the patient had no ear infection. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198844:same reporter
Muscle & body aches all over, fever around 102.1 degrees. Then 2 days later, as patient was trying to make breakfast while still very weak & getting over the illness, she fainted in the kitchen thus hitting her head on the floor.
Left hemibody weakness, severe dysarthria-- >NIHSS 27-- >R M1, R ACA occlusions. Underwent thrombectomy with NSGY.  MRI w/large R MCA stroke.
8:27 Hives, itching all over chest and on tongue, tongue swelling, slight difficulty swallowing. 8:30 epi administered/ benedrly 8:32 pseudo seizures begin off and on till the 27th
severe body aches, very bad chills, fever and headache. From the morning of the 20th until the morning of the 21st. Some body aches remain on 21st.
Patient presented to pharmacy on 10/24/23 complaining of redness, swelling and itching that has lasted for a month since her immunization. The redness was localized to the injection site, but her entire hand was swollen. Patient visited doctor and was given antibiotic for infection and a cream to help with itching. Patient was instructed to follow up with PCP if antibiotics do not correct the issue.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 11/23/2021 RECURRENT ASPIRATION PNEUMONIA
5 minutes post vaccine pt reported blurred vision. By 3:00PM pt requested her epipen. administered for her and called 911.   By 3:04 paramedics had arrived and took over.
Test: Nasal swab through CVS. Result: Positive; Test: Nasal swab through CVS. Result: Positive; The first few days of my cycle had a lot of clotting. The clots were large and very painful to pass; My cycle ended on September 4th but today I started bleeding again; This period was very heavy and painful; cramping; This period was very heavy and painful; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 42-year-old female patient received bnt162b2 (Comirnaty, Lot number: not reported, Expiration date: not reported, Age at vaccination: 42-year-old) via an unspecified route of administration in Left arm on 08Aug2021 03:00 PM as DOSE 1, SINGLE for COVID-19 immunization. Medical history included PCOS. Concomitant medications were not reported. No other vaccine in four weeks. Other medications in two weeks was none. No covid was prior vaccination. Covid was tested post vaccination. Known allergies was none. On 29Aug2021, patient experienced Nasal swab through CVS: Positive (Drug ineffective and Covid-19), The first few days of my cycle had a lot of clotting. The clots were large and very painful to pass, My cycle ended on September 4th but today I started bleeding again, This period was very heavy and painful (heavy period and period pains), cramping. Lab test included Nasal swab: positive on 29Aug2021. No treatment received for adverse events. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
My lips and outer mouth area were very numb for about an hour after  receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Lot number: EW0161) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs; "Thyroid Medication" (unspecified if ongoing), notes: Verbatim:Thyroid Medication. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin; Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine.The following information was reported: HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "recovered", described as "My lips and outer mouth area were very numb for about an hour after receiving the vaccine". Therapeutic measures were not taken as a result of hypoaesthesia oral.  Additional information:Patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Other medications in two weeks included HRT [hormone replacement therapy] and thyroid medications.Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19
NAUSEA, NUMBNESS AND TINGLING IN LEFT ARM. OCCURRED WITHIN 15 MINUTES WHILE PATIENT WAS STILL IN STORE WAITING AFTER HER IMMUNIZATION
Starting that evening after receiving the vaccine, my entire body including the left arm became warm. The left arm injection site became very sensitive to touch and swollen, and the symptoms lasted for about a week.
IN JUNE OF 1999, GENERAL HEALTH STARTS DETERIORATING.  BACK PAIN, CHIROPRACTOR.  10/99 ACUTE SINUSITUS, ANTIOBIOTIC.  12/99 SINUSITUS, ANTIBIOTIC. HEADACHE, CHILLS, WEAK, TIRED.  4/00 FATIGUE, WASHED-OUT, DIARRHEA, LOSS OF APPETITE, NO ENERGY, SLEEPING ALOT.  11/00 SINUSITUS, BODY ACHES, FATIGUE, ANTIBIOTIC. 1/01 ACUTE SINUSITUS, ANITBIOTIC. FATIGUE, NO AMBITION, DOESN'T EXERCISE NOW.  5/01 STOMACH DISORDER, DIARREHEA. WORSENING DEPRESSION, INCREASISNG, CHANGING ANTI-DEPRESSANTS AND SLEEP MEDICATION.  6/01 INCREASING NAUSEA, DIET OFF, LOSING WEIGHT. COLONOSCOPY, UPPER G/I.  7/01 DIARRHEA NOW TWO MONTHS. CANNOT DO ANYTHING.   ASKS TO BE HOSPITALIZED.  BLOOD TESTS, PANCREAS ENZYMES, CT SCAN ABDOMEN, SMALL BOWEL SERIES. ELEVATED LIPASE, DEPRESSION .  3/02 PAIN UPPER BACK AND FLANK, LEFT SIDE, POSSIBLE STONE, FATIGUE, DEPRESSION, WEIGHT GAIN.  2 SMALL KIDNEY STONES.  2/03 FREQUENT DIARRHEA, CHILLS, CANNOT EAT.  7/03 INVOLUNTARY WEIGHT LOSS, FATIGUE, DEFICIENT TESTOSTERONE LEVELS.  2/04 RECURRENT HEADACHE, EARACHE, ANITBIOTIC, GENERAL STIFFNESS, FATIGUE.  6/04 STOMACH PROBLEMS, DIARRHEA I WEEK, INVOLUNTARY WEIGHT LOSS, ABDOMONAL TENDERNESS.  ALL COMMENTS TO THIS POINT ARE FROM PRIMARY CARE PHYSICIAN.  DURING SAME PERIOD, I HAD TWO SLEEP STUDIES, VISITED NUEROLOGIST, TWO BRAIN SCANS DUE TO SEVERE HEADACHES. ALSO TREATED BY PSYCHIATRIS WITH INCREASING AMOUNTS OF ANTI-DEPRESSANTS, STIMULANTS, EARLY-ONSET ALZHEIMER DRUG.  RECEIVED PSHYCHOLOGICAL TESTING BY ANOTHER PSYCHIATRIST. DIAGNOSED WITH AN ACQUIRED LEARNING DIABILITY. DETERIORATION IN MEMORY, COGNITION, SPATIAL ABILITIES.    CEASED WORKING AS OF 7/01/04 DUE TO COMPOUNDING AND CONFOUNDING ILLNESSES.  ALTHOUGH 1998 AND 2004  BLOOD TESTS FOR LYME DISEASE WERE NEGATIVE, MORE AND MORE PEOPLE AROUND ME SUGGEST I HAVE SIMILAR SYMPTOMS.  FRIEND REFERS ME TO INTERNIST THAT DIAGNOSED HER FRIEND WITH LYME AFTER MANY YEARS OF BEING TOLD SHE DID NOT HAVE IT.    ON 7/12/04 I VISITED THIS DOCTOR.  AS I EXPLAIN MY PROBLEMS AND MENTION THAT I HAD THE LYME VACCINE IN 1999, HE ASKS IF I WAS AWARE OF A LAWSUIT AGAINST THE MANUFACTURER.
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (route, lot number and expiration date were not provided). One year later, on an unknown date, the patient was vaccinated with the second dose of GARDASIL (route, lot number and expiration date were not provided). On an unknown date, there was an inappropriate schedule of drug administration as the patient received the first and the second doses of GARDASIL one year apart. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Itching of entire body; Profuse sweating at night; Insomnia; This is a spontaneous report from a contactable other healthcare professional, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 01:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included hypersensitivity reactions and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within 2 weeks prior to the vaccination. On 15Apr2021, the patient experienced itching of entire body, profuse sweating at night and insomnia for 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event insomnia was resolved with sequelae on 29Apr2021, after the duration of two weeks while that of the events itching of entire body and profuse sweating at night were resolved with sequelae on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with Fluzone 1 wk after injection,  had sudden death. 1 & 2 days before death  c/o  fatigue, low back pain and upper shoulder pain.
Patient had both shots ringing in ears started prior to 2nd vaccine, unclear other cause being referred to ENT
inadvertently administered monovalent instead of bivalent vaccine. No side effects/adverse effects noted by patient
Information has been received from a physician concerning a 16 year old who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot Number "657780/06170U"). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection site reaction on the upper arm. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
I had some spotting that started late February 2023. My gynecologist and I were keeping an eye on this as I am past the age of having a menstrual cycle. I had an ultrasound in March 2023, that showed I had a thickening of my uterine wall.  My gynecologist and I decided that I should undergo a surgical procedure, DNC to help alleviate the spotting.  I did have DNC, done in April 2023. I have a follow up visit this Thursday to see how well the procedure went.
Fever (High, 101.8), Chills, Headaches, fatigue, tinnitus, vertigo.  Took Tylenol to reduce fever, and allergy pills.  The fever and chills went away after a couple of days. But the headaches and fatigue lasted about a week and half along with the vertigo. Today is the 31 day after the second shot I got, I still have vertigo,  severe tinnitus and headaches, especially during the night. I have not been sleeping well for two weeks.
Patient reported his symptoms started at noon today: he has a lump/sore on tongue (1/16 inches big), slightly raised, bleeds (has been bleeding for hours per patient) He had soup for lunch, was not too hot. Patient had his Moderna booster today around 9am and he believes his symptoms are from the vaccine because he remembers this happening with his first and second Moderna vaccines as well. This happened 3-4 days after 1st covid shot and 2-3 days 2nd shot. It went away on it's own. It was a blood filled blister that popped and was bleeding.   No pain. Patient denies mouth pain, no skin rashes, redness of gums, no fevers, no facial swelling, no difficulty of breathing, no teeth injury, no throat pain, no tongue or lip swelling, no white patches.
Heat and redness at injection site post 24 hours after immunization of Pentacel given in Left leg.  Mom states it continued to increase in size of her palm and firm to touch.  Prescribed Cephalexin 250mg/5ml 2.5ml PO BID x 10days and Mupirocin 2% ointment topical to be applied BID.  Encouraged to do warm soaks.  Asked mom to bring child back to clinic if no improvement.
This spontaneous report as received from a medical assistant, refers to the 14 patients of unknown age and gender. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
arm Soreness after receiving the first dose; This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient reported arm soreness after receiving the 1st dose of Shingrix. The reporter did not consent to follow up. This case has been linked with case US2020251651, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020251651:same reporter
Cellulitis with moderate pain R arm (injection site area, redness on  R upper arm) as diagnosed by attending physician.   Bactrim DS x 7 days, currently redness/swelling getting better.
Left axillary lymph nodes swelling and pain;  Left arm pain Headaches Cough Dyspnea with exertion Body aches
LEFT FLANK PAIN INITIALLY, RESOLVED THE FOLLOWING DAY, THEN LEFT HIP PAIN, RESOLVED THE FOLLOWING DAY. LEFT KNEE PAIN WITH WALKING, IMPROVING.
Initial report was received on 04 September 2012 via a search of the scientific literature. The following is verbatim per the report: "Background: Annually, over 2 million are administered influenza vaccinations. As of the 2010-2011 influenza season, the safety of the influenza vaccine was actively monitored nationally. Possible associations between potential adverse events of interest and influenza vaccination were evaluated at the end of the influenza season. Objectives: The goal of this study was to determine the safety of the 2010-2011 influenza vaccinations in the population treated. Methods: Integrated automated databases were used to identify patients who were diagnosed with Guillain-Barre Syndrome (GBS), idiopathic thrombocytopenic purpura (ITP), and Bell's palsy from 10/1/10 to 3/31/11 as identified by ICD-9 code. The influenza vaccination status for these patients was determined using the Immunization Package database in addition to the integrated automated and prescription databases. Adverse event rates in the risk period (within 1-42 days) were compared to rates in the non-risk period (43 days or after) in terms of incidence rate ratios (IRR) using the self controlled case series method. Only vaccinated cases were included. Seasonality was included to account for possible fluctuation of disease occurrence over the calendar time. Results: Approximately 2.1 million received the influenza vaccines (including 42,375 high-dose vaccines) from 10/1/10 to 3/31/11. A total of 38 GBS, 81 ITP, and 575 Bell's palsy post-vaccinated cases were identified. No significant risks for GBS (IRR = 2.07 and 95% CIs =0.59-7.24), ITP (IRR = 0.71, 95% CIs = 0.32-1.59), and Bell's palsy (IRR = 0.90, 95% CIs = 0.67-1.22) were observed for patients who received the regular dose influenza vaccines. Similarly, no significant increased risk for Bell's palsy (IRR = 1.13, 95% CIs = 0.21-6.02) was observed for patients who received high-dose influenza vaccines. There were no GBS and ITP cases after high dose vaccines. Conclusions: There was no evidence of increased risks of GBS, ITP, and Bell's palsy following 2010-2011 influenza vaccinations in the population treated in the health care system. The reporter for this case is the same as for case number 2012-08478. Documents held by sender: None.
Pfizer-BioNTech COVID-19 VaccineExperienced dizziness/vertigo right before going to bed around 12:30 AM (a couple days after my injection). Laid on the floor for about 15 minutes, but it would ramp back up if I tried to get up & move. Was able to get to my bed & sleep it off overnight. So far, doing better this morning.
Pt received ADACEL syringe injection on 9/24/12 her arm became inflamed, swollen, red, itchy irritation. Pt has latex allergy. Treatment from MD - BENADRYL and fluocinonide - 0.25% cream.
Patient whom is underage received the Moderna vaccine at our facility on January 03, 2022. We realized the mistake when they came for the second dose on February 18, 2022. Mother stated the only reaction the patient had to the vaccine was a sore arm with no complaints. The second dose was not  administered at this time due to needing a next course of action from a doctor from the  CDC. The mother was aware of being notified that following Monday with the recommendation. We called her today, February 22, 2022 to let her know that the patient can get 0.3 mL of Pfizer 12+ as the second dose.
Headaches, dizziness, extreme fatigue, nausea and vomiting, rash similar to chickenpox, swollen lymph nodes, knee pain. Made a doctor's appointment and was tested for lyme's disease (negative result). Was told the side effects from the vaccine would wear off soon.
I have experienced mild to moderate itching from 10/08/11 to the present.  I have also experienced mild hives.  The areas affected are my arms and shins.
48 Y female with PMH of GERD, anxiety, HTN, HFpEF, HTN, h/o recurrent VTE/PE on pradaxa who presents 8/2/2021 with shortness of breath, cough, fever admitted for COVID pneumonia.    COVID 19 Disease, Acute hypoxemic Respiratory failure - Symptom onset on 7/30, COVID positive on 8/2. No fever at this time. Received J&J vaccine - Patient ambulated on RA without desaturation. No oxygen ordered at discharge. Recommended checking pulse oximeter and if O2 less than 90% to call advice line.  - Received Decadron 6mg IV 8/2. MD recommended increasing Decadron to 10 mg daily given co-morbidities. Decadron decreased to 6 mg po daily to complete 10 days (date range 8/2-8/11) - Received Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement or 5 days (8/2 - 5/5)  - On pradaxa per below - continue isolation per CDC guidelines.    PHT associated with prior methamphetamine use - continue PTA Tadafil and Ambrisentan. - Followed by pHTN program   OSA - Continue CPAP qHS   Recurrent VTE/PE - Continue PTA pradaxa   Anxiety - continue PTA Amitriptyline/Gabapentin   GERD  - Continue PTA Protonix   HTN/HLD/HFpEF, not in acute exacerbation - continue PTA Atorvastatin, Lasix, Aldactone.    Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  COVID pneumonia