chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 28-AUG-2012, pt was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a health care provider at Emergency Department for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), 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.
Pt recvd DTP/OPV/PPD on 21AUG91 & pt noted to have urticarial rash on arms bilat & ant chest; DPH given;
On 3/2/21 Patient recieved her first dose of the COVID-19 Moderna Vaccination. She reported 4 days later that she started itching very badly over entire body. She tried taking anti-histamines with the reccomendation of her physician Dr.  She tried Benadryl, followed by Zyrec, and Allegra, and Pepcid with no relief for a couple of days. The itching was so bad she could not sleep and affecting her also during the day. She had another appointment over video with Dr.  again. Dr. prescribed on 3/12 a prednisone taper to take if needed. She advised to try to wait 14 days if she could to make sure the vaccine would be effective. She was still itching on 3/16 and started the Prednisone taper. She called this morning and she is still itching at the end of the taper on 3/23. The prednisone provided some temporary relief but now that the taper is almost done the itching is returning very severely. She reports itching on hands, feet, ankles, armpits, back, head, and scratching with some bleeding.
pt had episode of inconsolable crying lasting 2hrs;no fever;had recv APAP w/vax 5:30;wimpered in sleep for another 1-2hrs then recovered;
consistently feel extreme pain from injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "consistently feel extreme pain from injection site". Additional information: Patient wanted the vaccine removed from the body immediately. Having a severe manic episode when the pressures of society forced patient to get it. Consistently felt extreme pain from injection site. Patient was taking this matter very seriously.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT received COVID-19 (JANSSEN) vaccine at about 4:43 PM on 4/4/21. At about 4:50 PM, patient came to the counter and claimed to be feeling dizzy where upon I led him back to a chair. Before he could sit he fell down. We were able to prevent him from falling hard on his head. He was unconscious for about 20 to 30 seconds. H regained consciousness. We called 911 immediately. We monitored him until EMT's arrived. We gave him water and a pillow to rest his head. He was brought to the hospital by ambulance.
Pressure headache at front of head and temples the morning after my second dose. Discomfort moving my eyes around and increased sensitivity to light. Numbness in my left foot from the toe, along the inner arch to the heel (all along the inner side of the foot). The headache has gotten consistently worse (it has now been four weeks since this started). Went to the emergency room; ran blood tests for markers of inflammation and CT scan- all came back clear but symptoms are still worsening and ability to function is being impaired. Concentration, memory, executive functioning is all negatively affected. Ex: I forgot my friend's name, forgot which order to do tasks in, and am forgetting what I am doing while doing it.
Fever 102.2 Paroxysmal Rigors Myalgia Fatigue (Lack of Lymphadenitis in affected arm this time)  (Previously diagnosed with COVID-19 in July, 2020, Had active antibodies IgG and IgM at time of first vaccine done in December, 2020)
Swelling of left arm, armpit, breast, hand, etc.  Bump  that was palm size  around injection site. Redness, and fever of upper arm. Soreness of arm  progressed to frozen shoulder in spite of stretching exercises. The pain has been a  constant  ache and increase to sharp  when moved. Decreased my ability to take care of everyday chores and personal care.  Sought help through my rheumatologist who recommended physical therapy and steroid shot to reduce inflammation. Have been attending therapy sessions for 12 weeks as well as seeing a message therapist  since May.  Finally was able to get in to see an Orthopedic specialist for the injection. He also prescribed a Medrol pack to help reduce the inflammation.  Forgot to mention in a previous section that I had  some shoulder discomfort previous to the injection from lifting weights a couple of years ago. I still don?t have full range of motion but it?s getting better.
Evaluation of painful itchy rash on her face, elbows, hands, knees, feet, and palms 16 days post immunization with SPV and AVA #3. Upon speaking with SM on 23 Sep she reported that she stopped taking her steroids approx 10 days ago and has had a few outbreaks of the lesions, however she stated they are not as bad as they were initially.
The patient described her arm to be red in a significant portion of her arm around the injection site. The actual area the needle went in felt like a small hard spot, and her whole arm surrounding it was red and itchy. I asked her if it hurt, or felt warm or how it felt and she described it mainly as itchy which made me feel it was a reaction to the vaccination. I suggested benadryl and to monitor and if symptoms progressed any further to seek medical attention. Upon follow up, the patient had only been taking zyrtec and said the swelling did seem to be improved upon and did not seek any medical attention and she did not seem concerned anymore
A pt was vaccinated with a 1st and 2nd dose of varicella virus vaccine live in March and May of 1998, respectively. After each dose, the pt's varicella antibody titers were low. The pt's employer requires that the titer be greater than 1.9. Additional information has been requested.
Was going over vaccine signature sheets to put in system and noticed the Pentacel lot number is really a Tdap lot number. You do not receive Tdap until you are 11 years old age. CALLED CDC AND SPOKE WITH SOMEONE SHE STATED THAT ADACEL IF WAS MISTAKINGLY GIVEN AS 1 2ND OR 3RD DTAP DOSE IT SHOULD BE REPEATED AS A DTAP AS SOON AS POSSIBLE. TDAP SHOULD STILL BE GIVEN AT 11 STILL.
This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as: since August 2014) unspecified number of the patients were vaccinated with ROTATEQ oral (dose, lot # not provided). On an unknown date in 2014 (reported as: since August 2014) the patients were vaccinated with doses ROTATEQ that had been exposed to supported temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Myalgia, FATIGUE, PAIN AT INJECTION SITE Narrative:
Vile scary nauseating metallic taste in my mouth, still  Here a week later!  Fever and chills were no match for this awful taste   I felt like I was poisoned!
As we discussed my 22 year old son got the Pfizer vaccine last week and 24 hours later he had a seizure; He fell over and was foaming at the mouth; He fell over and was foaming at the mouth; Eyes rolled up; This is a spontaneous report from a contactable consumer (patient's parent) and another consumer. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization; and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at  for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer vaccine last week and 24 hours later he had a seizure. He fell over, eyes rolled up, and was foaming at the mouth, his roommate rolled him over and called. He went to the hospital and was screened for different possible drugs which all came back negative. He did say he took an Adderall that day to help study. Very odd and no history of seizures. ER documented it as a likely seizure. He recovered fully within several hours of the episode. They are trying to decide whether or not he should get the second shot and also asked if there have been any other issues like this. The events occurred in 2021. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.
Infant received Hepatitis B vaccine following birth on 7/30. Resident ordered Hepatitis vaccine again on 8/4/09 at 09:35, RN requested Hepatitis vaccine on 8/5/09 at 0025 when baby transferred without realizing that it was given.
On 11/15/2022 I felt tired congested and not myself. On Wednesday woke up very congested, sore throat, cough, and fatigued. Took at home COVID-19 test. Went to urgent care the afternoon of Wednesday and was prescribed antibiotics. I began antibiotics and got no relief. On Saturday I called my insurance's health line. The nurse I spoke with forwarded my case to a nurse practitioner and I was prescribed PAXLOVID. Began PAXLOVID on Saturday and began feeling better on Sunday. My symptoms have improved marginally everyday since beginning the PAXLOVID.
This spontaneous report as received from a vaccine coordinator refers to an unspecified number of patients of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, these unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX, (lot # M015926, expiration date 28-JUN-2017) for prophylaxis. No adverse effects were reported. The vaccines were exposed to the temperature of 13.9 degree Fahrenheit for a time frame of one hour, which was recorded by a data logger. No previous temperature excursions were reported. No product quality complaint was involved. 09-DEC-2016, it was reported that no patients' were affected. Merck's temperature and stability data indicated that the affected vaccines were viable and not compromised. This is one of the two reports from the same reporter.   Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA002560.
Fever of over 101 for three days, cried almost non-stop. Food allergies, eczema, and asthma started within one month.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K011495, expiration date 22-JUN-2016). No adverse effects were reported. This specified not number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24/34 and R. The total cumulative excursion time (hour), the highest recorded (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 176, 48 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Immune Thrombocytopenia Purpura; the only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series; This is a spontaneous report from a contactable physician. A 31-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. Medical history included eczema, no known allergies. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on 23Dec2020 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seen in the ED for petechiae and ecchymoses on 15Jan2021. She had not taken any recent medication or had any illness previous to this event. The only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series. Lab assessment showed platelet count decreased to 22,000 cells per cubic microliter (normal over 140,000). She had no other findings to describe cause of her decreased platelet count by lab or clinical exam. Provided a diagnosis of immune thrombocytopenia purpura, in the ED setting, she started pulse dexamethasone 40 mg/day for four consecutive days with a follow blood count showing resolution on day 4 of her treatment with a platelet count of 230,000 cells per cubic microliter. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Steroids as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of event immune thrombocytopenia purpura was recovered in Jan2021.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of immune thrombocytopenia purpura due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including platelet count at baseline and during therapy with subject drug, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Moderna COVID-19 Vaccine EUA  Foggy, fatigue, very achy.  A little diarrhea.  Unable to sleep but exhausted.  Slight fever and chills.
LEFT TO WAIT THE FIFTEEN MINUTES AND FAINTED APPROXIMATELY FIVE MINUTES IN A CHAIR IN WAITING ROOM
Mother called on 3/24/03 with a report of the pt's left leg being red, hot, swollen and a fever of 101F, over the weekend. She was seen by MD.
Low grade fever, malaise, headache, mild body aches, sort of out of it at times.  Stated feeling bad within 2hrs of shot.  Tx-rest, lots of sleep,  Tamiflu. Felt bad for 2days.
I went to pharmacy to get my flu shot and noticed shortly after it was really red I didmt pay much attention woke up this morning amd I have a horrible raised rash amd it is very hot to the touch and sore.
Information has been received from a 65 year old female registered nurse concerning of herself with hypertension, hypercholesterolaemia, allergic reaction to AUGMENTIN and lincomycin who on 05-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot not reported). Concomitant therapy included LIPITOR, DAYPRO, estrogens, PREMARIN, hydrochlorothiazide, glucosamine, vitamin D (unspecified), potassium (unspecified) and aspirin. On 06-MAY-2009 the patient developed a flat, itchy rash at the injection site of the left upper arm. The injection site was swollen and tender. The patient added that she had a headache on 06-MAY-2009, which had resolved. At the time of reporting on 07-MAY-2009, the patient's flat, itchy rash at the injection site, the swollen and tender persisted. No further information is available.
injection site itching; injection site rash; swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (injection site rash) and VACCINATION SITE SWELLING (swollen at the injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARBIDOPA, LEVODOPA (SINEMET), ROSUVASTATIN, PANTOPRAZOLE and DONEPEZIL for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (injection site rash) and VACCINATION SITE SWELLING (swollen at the injection site). At the time of the report, INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (injection site rash) and VACCINATION SITE SWELLING (swollen at the injection site) outcome was unknown.        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.   Treatment medication was not provided by the reporter.
I had my vaccination on 09/22/2022. On 01/01/2023 I started having a little big of a cough and not feeling well. I tested COVID-19 negative on 01/01/2023. I felt worse the next day and tested COVID-19 positive on 01/02/2023. I spoke with my physician on 01/03/2023 and was prescribed PAXLOVID.
Cardiomyopathy; diagnosed with heart problems; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: May2021, for covid 19 immunization. The following information was reported: CARDIOMYOPATHY (medically significant) with onset Aug2021, outcome "unknown", described as "Cardiomyopathy"; CARDIAC DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "diagnosed with heart problems".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events cardiomyopathy and cardiac disorder and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
(L) medial thigh rash 8 cm x 5 cm with localized non joint swelling rash is on medial thigh in between hip and knee. Ice, ibuprofen (OTC) hydrocortisone 1% OTC, Childrens BENADRY (OTC).
Pt came in around 9:10 am on 9/19. Left arm was red down to the elbow. Felt warm to the touch. Pt said was painful when he touched the affected area. Iced area with no relief. I advised pt to immediately go to  immediate care since he felt redness was spreading. Immediate care doctor stated area was infected and gave pt cephalexin, an antibiotic. Will follow up with patient tomorrow.
There was NO adverse event. She is 17 years old (underage) and received the Moderna - 1st dose vaccine.
1/28/21 5:35 p.m. extreme fatigue (useless), 1/29/21 Muscle pain in both upper arms all day, 1/30/21Intense joint pain in left hip continued 1/31 and 2/1 plus painful to walk, sit down and get up again,  Unable to lead with (before vaccine) good left leg to go up stairs and now am unable to walk on my own because of the hip joint pain and must use a walker or furniture to get around.  Muscle pain in upper left arm has continued and frequently in the upper right arm.  I am scheduled for the second dose of Moderna  Covid-19 vaccine and am  concerned about having same.
Had HA and was nauseated 7/29 eve. Continued with HA 7/30 and not feeling well. Pt had 2" red, swollen area at injection site with itching and vesicle the size of pencil eraser at site. Tx BENADRYL every 6-8 and TYLENOL every 4-6 hours PRN. F/u call on 7/31 much better, no HA today, redness and swelling gone and blister, now small scab.
5/10/04 Bruising on child began. 5/20/04 Petechiae noted on arms/legs/head. CBC with differential test revealed platelet count at 2 (thrombocytopenia). Hospitalized - 1st dose of immunoglobulin. 5/21/04 2nd dose of immunoglobulin as platelets at 4. 5/22/04 Platelet count at 37 - released from hospital.  Nurse follow up on 07/29/04 states: "ITP." Per annual report-We have not had any problems for over a year now. I am concerned about the MMR booster that she is to receive at 5 years of age, however. Also perhaps it would be better for children to have their vaccines spread over a period of time. As you can see, on 4/19/2004, my daughter was vaccinated against 5 diseases at one time.
Employee received vaccine 12:30p on 10/17/18, she felt her RUA itching on her drive home. On the 10/18 @ 7:30 AM she had redness and hives on her arm. She took her own BENADRYL every four hours. On 10/22/18 the hospital resource nurse sent her to the ED for hives on her face and neck.