chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 10-MAY-2017 from an attorney in the form of an initial legal complaint regarding a female patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 24-SEP-2012 the patient was vaccinated with ZOSTAVAX vaccine, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-AUG-2015 the patient was treated for a rash that was diagnosed as shingles. She was prescribed acyclovir and hydrocodone-acetaminophen to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Systemic: Patient says cheek felt swollen;no viual swelling-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient stated left cheek/jaw felt swollen/left leg felt numb/tingly
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. On 02-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23-10PK 0.5 ml SD PFS LLokwTip, (lot number L040181, with an expiration date of 18-AUG-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 had a temperature excursion. The lowest temperature excursion was of 32 Fahrenheit (F), (0 Celsius degrees) for a total of 80 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Initial report was received from a health care professional on 01 October 2012. A female patient of unknown age with no reported medical history had received FLUZONE HIGH-DOSE (lot number not reported) and after an unspecified amount of time her "right arm swelled and was red, warm and painful. On 27 September 2012, the patient was seen at the reporter's health department facility who said it looked "like an abscess and was firm to the touch but not warm." The following day, the patient was seen by a doctor who told her it was reaction to the HD vaccine. Concomitant therapy and corrective treatment were not reported. No further information was available at the time of the report. The patient outcome was not recovered. Documents held by sender: None.
A pharmacist reported that 80% of the residents in 2 long term care facilities received vax and became violently sick.
Right deltoid red swollen 12 x 11 cm < 48 hours onset. Non tender. Tx Benadryl/Tylenol
Redness at injection site, spreading to upper arm and chest area - swelling, burning - shortness of breath and pressure in chest.
rushed to the hospital / almost lost my unborn baby; When I was pregnant I was given the tdap vaccine; This prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Tdap Vaccine at an unknown time during the pregnancy. On an unknown date, 5 hrs after receiving Tdap Vaccine, the patient experienced hospitalization (serious criteria hospitalization) and vaccine exposure during pregnancy. On an unknown date, the outcome of the hospitalization and vaccine exposure during pregnancy were unknown. The pregnancy was lost to follow up.   It was unknown if the reporter considered the hospitalization to be related to Tdap Vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. When patient was pregnant was given the tdap vaccine and 5 hours later was rushed to the hospital. The stated she patient almost lost her unborn baby. No further information was provided.
3/28/03 - Mom called and reported that yesterday (3/27/03) she noticed her child's arm swollen - red, hot to touch - size of a baseball - states she panicked and called her pediatrician - MD told her to massage the area and use warm compresses - mother state her arm is much better seen today - redness and swelling left deltoid - size of golf ball - rash runs down to 1" above elbow - not crying or complaining of pain.
Approximately 6 hrs. after injection, tongue started to swell, and salivary glands started swelling, and lymph nodes under jawline started swelling.  Took Prednisone 20 mg. to try to stop swelling- and benadryl 25 mg. and ibuprofen.  After another hr. sores started breaking out on the right side of the tongue and down the throat on the tongue. Same side as injection.  Took another 1/2 Prednisone 20 mg. and a half Benadryl 25 mg. The next morning @ 9:00 all of these symptoms had subsided and I was okay.
The patient was vaccinated with improperly stored vaccine of GARDASIL 9; This spontaneous report was received from a nurse and was referring to a 25 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitants medications were not reported.  On 24-AUG-2020, the patient was vaccinated for prophylaxis with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 0.5 ml (Dosage regimen, route of administration and anatomical location were not reported, lot number: S008151 and expiration date: 20-NOV-2021).   The improperly stored of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced a temperature of 48.39 F for 1 hour and 45 minutes, without a previous temperature excursion and was call because a digital data logger. No additional adverse event details available. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S008151; expirationdate: 21-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Felt sick; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick) and FATIGUE (Fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020 and COVID-19 in December 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (Felt sick) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Felt sick) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The reporter called in on behalf of their husband who have received both the doses of the Moderna COVID-19 vaccine. On 10-Mar-2021 the patient received their first dose and on 07-Apr-2021, the patient received their second dose.  Following the first dose of the vaccine the patient felt sick and fatigue. The reporter also informed that these side effects subsided after a few days.   Reportedly, the patient had previous COVID-19 infections in July and December of 2020.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069672 (E2B Linked Report). This case was linked to MOD-2021-069672 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069672:First Dose of husband
Nursing staff reported patient was experiencing apnea, lethargy, and periods of unresponsiveness in addition to shaking at 11:00AM following vaccine. Patient was previously admitted to hospice earlier in the week and was lethargic prior to administration per nursing report. Patient's healthcare provider was notified which is the response to answer 21- I do not know if patient was seen in clinic but provider was made aware of the situation and will be managing follow-up.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 07-JAN-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  Subsequent to her zoster vaccine live (ZOSTAVAX) inoculation (date unknown), the patient was treated by a healthcare provider for shingles.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would 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 would continue to suffer such losses, and damages in the future. The outcome of the event was not reported.
adverse event: Chest pain, depression, hot flashes, chronic fatigue, brain fog, Amenorrhea   treatment: Hormone Replacement (birth control) outcome:  Premature Ovarian Failure
bout 10 minutes after vaccine pt face seemed flushed and red (pt stated felt warm and throat seemed tight) no swelling - gave 50mg benadryl and ice pack seemed better before leaving pharmacy 30 minutes later
2/9/2023   I noticed some discoloration on my left breast. I went to the gynecologist, and she sent me for a mammogram.  I was also prescribed an antibiotic. It took 2 weeks to get the appointment. On 3/1/2023   when I went for the Mammogram, the discoloration had gone down and I was told it  looked like cellulitis. I also had an ultrasound that showed inflammation. I was prescribed another week?s worth of antibiotic. I had a repeat Ultrasound on 4/12/23 and everything looked clear and good, and it is all gone.
administered only diluent portion; administered only diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA602A, expiry date 13th May 2023) for prophylaxis.   On 29th July 2022, the patient received Menveo. On 29th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The registered nurse asked that how to proceed if by accident they administered only the diluent portion of Menveo. The reporter consented to follow-up. Additional supportive information: The patient was accidently administered only the diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient said about 2 hours after shot. He experienced in his non-immunized arm (Right) that his hand became rigid and numb. He had pain in hand. His hand was curled and not able to bend fingers for about 18 hours. He did not seek Medical help for this condition. He said he tryed to splint but it felt worse and had more pain. He said it did gradually get better but was not able to pick things up with fingers for the 18 hours
12 cm x 11 cm erythemous area on right deltoid- down arm - slightly painful
heavy feeling in arms and legs.; Fatigue; headache,; general malaise; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 19Mar2021 at 14:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Mar2021 at 17:00, the patient experienced fatigue, headache, heavy feeling in arms and legs and general malaise. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fatigue, headache, heavy feeling in arms and legs and general malaise. The clinical outcomes of the events fatigue, headache, heavy feeling in arms and legs and general malaise were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
hives-forearms, stomach-left side only-not itchy, Hives on left side of stomach, Hives on face, couldn't see them but felt them; both forearms-itchy; face skin in extremely dry; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives-forearms, stomach-left side only-not itchy, Hives on left side of stomach, Hives on face, couldn't see them but felt them), PRURITUS (both forearms-itchy) and DRY SKIN (face skin in extremely dry) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced URTICARIA (hives-forearms, stomach-left side only-not itchy, Hives on left side of stomach, Hives on face, couldn't see them but felt them), PRURITUS (both forearms-itchy) and DRY SKIN (face skin in extremely dry). At the time of the report, URTICARIA (hives-forearms, stomach-left side only-not itchy, Hives on left side of stomach, Hives on face, couldn't see them but felt them), PRURITUS (both forearms-itchy) and DRY SKIN (face skin in extremely dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included lotion.
she could not do anything, she could not eat anything; diarrhea; she got it at 1PM and 1AM she woke up aching from head to toe with all of her joints hurting/The joint pain was in her elbows, wrists, knees, ankles; vomiting; The joint pain was in her elbows, wrists, knees, ankles; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she got it at 1PM and 1AM she woke up aching from head to toe with all of her joints hurting/The joint pain was in her elbows, wrists, knees, ankles), EATING DISORDER (she could not do anything, she could not eat anything), VOMITING (vomiting), DIARRHOEA (diarrhea) and ARTHRALGIA (The joint pain was in her elbows, wrists, knees, ankles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (she got it at 1PM and 1AM she woke up aching from head to toe with all of her joints hurting/The joint pain was in her elbows, wrists, knees, ankles), EATING DISORDER (she could not do anything, she could not eat anything), VOMITING (vomiting), DIARRHOEA (diarrhea) and ARTHRALGIA (The joint pain was in her elbows, wrists, knees, ankles). At the time of the report, MYALGIA (she got it at 1PM and 1AM she woke up aching from head to toe with all of her joints hurting/The joint pain was in her elbows, wrists, knees, ankles), EATING DISORDER (she could not do anything, she could not eat anything), VOMITING (vomiting), DIARRHOEA (diarrhea) and ARTHRALGIA (The joint pain was in her elbows, wrists, knees, ankles) had not resolved.
Sudden pain in upper right arm when lifting arm; depleted range of motion; pain radiating down right arm to hand; right arm bicep pain when lift, move around; loss of grip in right hand when pain radiates. No treatment. Condition has persisted since second vaccine dose; no lessening.  Note:  Received Moderna booster 12/09/2021--no change in condition, i.e., neither worse nor better.
Asymptomatic but according to her apple watch, her heart rate went up  to 100 to 120 from the hour of 10 pm to 11 pm the day after getting the vaccine. The patient showed me the record of the out of range number at the pharmacy.
Flu-like symptoms, which include chills & headache; Extremely painful body aches; Inflammation from my hips down to my leg; I could hardly walk.
Healthy no current illnesses.  Had stage 1 uterine cancer April 2021. Scans post hysterectomy negative for cancer was in readmission. Scan November 11, 2021 metastatic uterine cancer to upper abdomen.  Patient notified results  11/22/21. Gynecologist oncologist would refer to Cancer Clinic for treatment plan. 12/2/21 gynecologist oncologist reviewed plan with patient and refer to hematologist oncologist to manage chemo. Port placement scheduled for 12/16/21. Hematologist oncologist appt on 12/14/21 discusses hospitalization for AIM regimen chemo and to start chemo after Christmas.  On 12/15/21 patient taken to emergency room by son due to lower abdominal pain and patient suspected appendicitis. Patient cancer  metastasized to lower right and and other scattered areas through abdomen. Patient admitted and port placed as planned next day 12/16/21.   Chemo initiated 12/16/21-12/20/21.
Rash all over the body, fever.  Amoxicillin and hydroxyzine was called in.
On 9/27/23: Unable to walk for 5 days due to vertigo and nystagmus. Still will balance issues. Fever x 5 days. Treated with amoxicillin, fever resolved.
Per patient: Redness, heat and swelling at injection site started about one week after Covid19 injection.
started 24 hours after vaccine, resolved by 72 hours after vaccine. urinary frequency, urgency, increased urine output, lower abdominal/pelvic discomfort
After my second dose vaccine, I had recurrent headaches, felt dizzy. They had me lie down this time since I had the same symptoms on my first vaccine. I continued to feel dizzy and started to feel pain to my left side of my neck, it was a pinching, stabbing pain. I also felt a little SOB and they gave me an EPI-pen shot and I rested for awhile. My doctor told me to take Benadryl before the injection so I did. I was prescribed Prednisone for 5 days and I went home. On the following day I went to see my PCP and I was administered an intramuscular injection of Benadryl and my symptoms slowly started to go away.
Asthma exacerbation: wheezing, difficulty breathing. Epinephrine (1:1000 1 mg/ml) 0.5 mg sq given, 8 mg Decadron IM, albuterol/atrovent respiratory treatment and ambulance transfer to closest hospital
Fever; There is a knot in her arm where she got the shot; It itches; chills all day at work; A spontaneous report  was received from a consumer concerning a female patient of 49 years old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced chills,fever,vaccination site swelling and vaccination site itching.  The patients medical history was not provided .Concomitant medications reported included BAGASLAR,FIAST,METFORMIN,AMITRYPTILINE,ATORVASTATIN,HYDOCHLORTHIAZIDE used for unknown indication.  On 12 jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 041L20A) vaccine intramuscularly in the left non-dominant arm for prophylaxis of COVID-19 infection.  On 12 jan 2021, She had chills all day at work. There is a knot in her arm where she got the shot. The bump or knot is growing bigger and it itches. She still has the chills every now and then. On 13 jan 2021,patient experienced a fever of 100.8F Treatment for the event included Ibuprofen.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  the event fever were considered resolved on 13 jan 2021.  The outcome of the event chills were considered not resolved.  The outcome of the event vaccination site swelling and vaccination site itching was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded