chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Influenza vaccine for prophylaxis. Previously administered products included Influenza vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine for the past nine year). On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced injection site pain. Rechallenge with Influenza vaccine was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 8 of the 9 cases reported by the same reporter for the same patient.
m.d. rpt pt vax w/varicella in 8/95 & in 4/98 pt exp chickenpox over the entire body & fever of 100
The night patient got vaccination she had abdominal pain, muscle aches and sinus congestions. She was also exposed to a positive covid 19 case and is going for testing 12/21/2020.
Delayed reaction began 8 days after injection.  Left arm 3-4 inches below the injection site in my bicep area became red, itchy, hot to the touch, tender, achy.  The itching stopped within 2 days.  The hotness lingered for about 6 days.  The redness took 15 days to diminish.  My bicep area continues to this day to be tender to the touch, achy, and has a constant tight feeling.
This case was reported by a physician via call center representative and described the occurrence of adverse drug reaction in a child male patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to DTaP vaccine. Additional details were reported as follows: This case was reported by the physician for her son. The age at vaccination was not reported. In 1986, the patient had a reaction to a DTap vaccine (unknown manufacturer). However the reporter was not clear on which vaccine the patient received or when. The reporter disconnected the call before any contact information could be obtained. The reporter stated that she was not able to sue the company and had to go through vaccine court and was not allowed to have an attorney and she had to wait 7 to 8 years. No additional information was available.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a healthcare provider at pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a health care professional for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-AUG-2011, the patient was treated (by an unspecified healthcare professional) at a medical center, for a persistent and severe vesicular rash which was diagnosed as herpes zoster.  The patient was prescribed acyclovir for management of his painful symptoms. On or about 28-NOV-2011, the patient sought subsequent treatment from the medical center, for a persistent vesicular rash, which was diagnosed as post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient was prescribed hydrocodone for management of his painful symptoms and chronic pain. 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
administered expired doses to some patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired doses to some patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired doses to some patients). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered expired doses to some patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment product information was not provided.
large local reaction, redness, pain, swelling, present after injection. Approx measurements 10 cm x 5 cm. Pt presented back to clinic 48 hours after injection.
Pt had reaction at injection site of left arm with swelling, edema, radiation of site swelling to elbow that lasted 48 hours before starting to subside.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Severe, Systemic: Nausea-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient received vaccine and within minutes felt light headed and a lump in throat - given water & benadryl at store.  Light headedness decreased but later in afternoon patient had rapid heartrate and went to ER for treatment.
tunnel vision, felt like passing out, diaphoretic, brought to obs, given water, felt better and sent home. VSS
Day 1: after injection itching. Day 2: wheals, rash over left upper and lower arm, intense itching.
On Sunday 7/28 at 4pm after workout, developed slight red spot 7 inches from vaccination site; there was no welting.  By next morning, affected area expanded in size and it was oval shaped (5 by 3 inches), there was slight welting, bright red, not itching but could tell there was fluid behind it, puffy, and swollen.  Patient went to Urgent care and doctor said that the location of area was odd, verified that it was not an insect bite; patient told to take Benadryl and prescribed (Methylprednisolone).  Patient started taking medicine the next morning. Developed a welt underneath eye--pink and dark pattern.  Patient went to Urgent Care again since was getting worse.  Per doctor, it did not look like shingles but pattern was so patient prescribed steroid shot.  Patient also received another prescription for ointment on arm (Triamcinolone acetonide 0.025%).  Patient did not take Benadryl again since made her worse. Patient has follow-up appoint tomorrow.   In arm, redness and swelling has decreased.  Welts on eye resolved after steroid shot.   Arm itches when puts the ointment on.  Patient is at 75% recovery.   Doctors did not do any testing and patient has never received the Zostavax vaccine.
Information has been received from a registered nurse, concerning a 25 year old female who on an unspecified date was vaccinated with a third dose of GARDASIL (lot no. not reported). The nurse, who is the friend of the patient, reported that "after the patient received the third dose of GARDASIL she started to experience a headache and the patient stated that it was the worst headache she ever had. The nurse also reported that she followed up with the patient who stated that the headache has gone away but now she is extremely tired". Patient sought unspecified medical attention. Additional information has been requested.
7:30 pm 10/15/09 Patient fainted, appeared lifeless, possibly not breathing, recovered at about 7:35 pm EMS arrival 7:40 pm (taken to hospital for check up at 8:00pm).
Pregnancy; Initial Report Received on: 25-Sep-2020  This report was received from the HEPLISAV-B Registry.  A female patient (age, race and ethnicity not provided) reported to the Registry staff she had received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.   No medical history was reported.   No concomitant medications were reported.  Dosing information of HEPLISAV-B (Lot #, expiration date and NDC #) was not reported.  On 25-Sep-2020, the Registry Staff received an email from the patient stating that she had been vaccinated with the HEPLISAV-B vaccine while pregnant from work. She expressed interest in enrolling in the Registry. Multiple emails were sent to the patient requesting for her phone number or to call the toll-free study number to assess enrollment eligibility but were unsuccessful.   The Registry Staff reported that no further follow-up would be conducted by the Registry and that permission for the company to follow-up with the potential patient was not obtained.  At the time of the report, no adverse events were reported. The action taken with HEPLISAV-B was not reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (Lot#L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided. Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Extreme Tinnitus, dizziness, neck pain and stiffness, painful Lymph nodes under right jaw and in right neck area.  Grinding/popping  sound in neck area when rolling head around.   Went to Urgent care on 8/192021 for extreme dizziness and was prescribed Meclizine.   Went to eye dr on 8/26/2021 and all was good there.  Dizziness has gotten better with Meclizine.  Painful lymph nodes and stiff neck remains.
Approx. 0129 Vaccine administered at pharmacy. Approx 0130 Felt itchy in my stomach, face and eyes, began feeling nausea in my stomach with a funny taste in mouth. Approx 02015 Face slightly puffy and itchy. Called pharmacy, spoke to a pharmacist who said I was having an allergic reaction and to take some BENADRYL. That if I begin to have difficulty breathing or my face swells any larger to get to the ER. Approx 0330 Felt itchy in my hands and back. 0350 purchased BENADRYL and took 25 mg. As time went on I felt sick like I had a stomach virus or the flu. Later that nite and early the next morning I began feeling a burning in my chest and throat with shooting headache pains. 4/9/15 informed my doctors office who advised me to come in the following morning at 9:00 am if I still feel sick. I took a total of two BENADRYLs 6 hours apart. 04/10/15 Approx 0130 am still feeling sick like flu: Burning in my chest and throat. 4/10/15 Doctor appoint at 9:00 am.
Fever, shortness of breath, headache at back of head, sweating, extreme cold feeling, dizziness, muscle fatigue (2 days).
the patient had the first dose in August of 2017, and the second dose was administered in April of 2021,; Information has been received from a medical assistant, referring to a 15 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in August 2017, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis.        Later in April 2021, the patient was received the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  The reporter would like to know about revaccination regarding hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Chief Complaint  via EMS patient reports non productive cough, nausea, weakness.  Telehealth PCP on Fri, placed on albuterol.  Cath on Friday thru right wrist.  Fever.  Denies CP, SOB.  +COVID vacc.  History of Present Illness  Patient is an 80F w/ medical history of COPD (no home O2, no PFTs found), recently discovered multi-vessel CAD (per cath 10/22), CKD stage 3, T2DM w/ peripheral neuropathy, HTN, HLD, small bilateral PEs in 1/2021 (?Unprovoked, off AC) who presented to the ED w/ complaints of cough, myalgias, sore throat, and worsening shortness of breath.  She subsequently tested positive for Covid while in the ED.  She has a negative Covid test from 10/17 and feels that symptom onset was on 10/23.  She feels that her symptoms have worsened leading to presentation today when she was unable to get out of bed and do her usual housework.  She is vaccinated for Covid though she is unsure when this was as they came to independent living where she lives to administer them.  She feels like maybe it was last winter or so but really is not sure.   She states that she was recently supposed to have shoulder surgery, however, there were concerns regarding her heart and evaluation led to cardiac cath on 10/22/2021 during which she was found to have multivessel coronary artery disease.  She was scheduled for an appointment for CABG evaluation at hospital on 10/29.     Her primary concern at this time is regarding her 10 pound miniature schnauzer who is in her apartment without anyone to look after them.  She was on the phone when I first met her talking with her son who she says is millionaire and can do anything.  He is actively working to find arrangements for her dog. In the ED, she was hypoxic to 88% on room air with max temperature of 38.7 degrees Celsius.  Currently on 1 L by nasal cannula.  CT PE was negative for pulmonary and was not, however, it was significant for a small right pleural effusion, infiltrate in RUL (new from CT PE 1/2021), and stable right hilar mass.
Donor in the Center today and received a rabies booster at 3:51pm Donor returned to the center at 5:20pm having a severe anaphylactic reaction states started around 5pm. Donors hands and face were severely swollen and red, along with hives on neck,  arms, and back of legs. Donor states that she feels like something stuck in her throat.  Donor advised immediately to go to the ER. Donor was here with her boyfriend and he was hesitant to take her to the ER because he states they do not have insurance. Again advised to go to the ER immediately. Donor left the center to go to the ER.
Patient was waiting the 15-20 minutes after the shot. He was sitting down and passed out. He fell out of his chair and hit the floor. Patient was sweating and pale. Patient regained consciousness. He drink a soda and we gave him a cold compress.
Fever DELTOID PAIN, TENDER, CHILLS, SWEAT Narrative:
Started having fever and chills after being exposed to friend who had COVID-19. Took a home COVID-19 test and was positive. Contacted doctor and was prescribed PAXLOVID. Started feeling better and tested negative for COVID-19. Then 1 week later felt sick again and tested positive for COVID-19.
Vaccinated 9/19/02. Sent to ER 9/21 with cellulitis left upper arm, central bullous lesion. Put on Keflex. Induration about 4cmx5cm on 9/25/02.
This spontaneous report was received from a registered nurse concerning an approximately 5 year old male patient. On 09-JUL-2013, the patient was vaccinated with 0.5 milliliter (ml) of improperly stored  M-M-R II (HSA) (lot number and expiry date reported as H015833 and 24-AUG-2014 respectively), subcutaneously in the right upper leg. No concomitant medications were reported. No adverse effects were reported at the time of reporting. Additional information is not expected.
Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection  ,chills ,fever  ( on Wed 6th pm) fatigue
pt recvd vax & exp OM; also exp cerebellar ataxia & was hospitalized; repeat CAT scan revealed a small infarct in the pons;
Fever 99.3; Body aches; Fatigues; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Jan2022 at 15:00 (Lot number: 33036BD) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: HTN; "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Postmenopause" (unspecified if ongoing); "Hay fever" (unspecified if ongoing); "Pre-diabetic" (unspecified if ongoing) and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medications included: CHLORTHALIDONE, COREG, ALLEGRA, POTAS and unspecified multivitamin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EK5730; Route of administration: unspecified), administration date: 23Dec2020, when the patient was 55 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EK4176; Route of administration: unspecified), administration date: 13Jan2021, when the patient was 55 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 15:00, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 08Jan2022, outcome "recovering", described as "Fever 99.3"; PAIN (non-serious) with onset 08Jan2022, outcome "recovering", described as "Body aches"; FATIGUE (non-serious) with onset 08Jan2022, outcome "recovering", described as "Fatigues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain and fatigue.  Additional information: 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 COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
On July 4, 2022 I had stomach problems that resulted in vomiting and diarrhea. I then had body aches, headaches, I thought I was getting a cold. I took a home COVID-19 test that came back positive. I called my doctor shortly after getting my results and he advised I take vitamin A, C, D, E and zinc, I turned down the PAXLOVID as I felt I was at the tail end of the virus. I have had a fever for the past couple of days.
I am an RN, and received the Pfizer BioNtech covid-19 vaccine (EK 9231) on 1/11/21, I had a mild headache that continued to get stronger, and on the 17th I began to have pain starting from my left shoulder to the top of my head on the left side (the same side of the injection). By the 18th I had complete numbness and burning on my left side. The 18 & 19th the headache was very strong.
Patient reported a mild fever, tenderness at the injection site and redness with swelling that involved the bicep.
Had a local reaction at time of immunization, i.e. hives, itching. Reported to MD and given EPI.2m1on on site and instructed patient to take Benadryl 25mg at home. Less than 24 hours later, had episode of seizure brought to clinic per ambulance and sent to hospital for follow up tests.
- Rapid Heart Beat along with Chills and Fever starting around 4/8/21 6:00 pm.  -At 9:45 pm,  Fever was 102.1. Took Tylenol ( 500 mg x2).  - At 10:30 pm, Pulse rate was 145 bpm and fever was 101.9. - On 4/9/21 4:30 am, after urinating felt dizzy and fainted. Called 911 and went to the Emergency Room. Was treated there for syncope.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INJECTION SITE PAIN (Sore arm). At the time of the report, INJECTION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081447 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081447:Case for dose 2
Fatigue.  Swelling and redness in place of injection. Arm is severely sore, can?t move without being in pain, sensitive to touch.