chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-JAN-2014, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 12-OCT-2016, the patient was treated by a physician for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
My left arm was sore after the injection, which was to be expected. I drank plenty of fluids and engaged in gentle stretching exercises to help mitigate the soreness. However, as time has progressed, my left arm is in constant pain. I have limited ROM secondary to this. My strength has greatly diminished in this arm because it hurts to lift things or move things like I used to do. The constant pain is dull and achy by the injection site. If I try to lift my arm up, work out, lift anything? The pain turns into a sharp pain that radiates from the injection site and shoots up my arm into my neck. Some nights, if I roll over onto my left side while sleeping, the pain will wake me up. It never goes away and it is quite annoying. If I try to rub or massage the area, it feels bruised and is extremely painful. It makes it difficult to perform my job at times (RN).  It feels like muscle or nerve damage.
This spontaneous report was received from a nurse referring to a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions, medical histories and drug reactions/allergies were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (Lot # K006117, expiration date 14-JAN-2017), doses and routes were not provided. There was no concomitant medication reported. The temperature / time frame was 33F for 60 hours. No data logger was involved and no previous excursions were reported. No adverse effects were reported. This is one of three cases received from the same source. Additional information has been requested.
1. Burning sensation when vaccine was injected.  2. Five hours post-injection, at approx 1pm on 3/30/2021, I developed a MILD ITCHY RASH with small pink bumps similar to heat rash) on the inside of my left forearm only. It was still present when I went to sleep at midnight; did not reappear in the morning. Reappeared 3/31/2021 at approx 5pm milder than the previous day.
Patient got a prickly, itchy rash on her back that started within 24 hours of her injection and lasted about 4 or 5 days. She tried to treat with benadryl, but it didn't seem to help, but taking zyrtec did. She did not visit a doctor or go to an urgent care or ER.
pt recvd exp high fever, severe irritability for sever hrs & difficulty breathing according to mother; not seen by MD;
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 and expiry: 29-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049577, 20211049738 and 20211049134.
This spontaneous report has been received from a physician via a company representative referring to a currently 66 years old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history and concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, frequency, route administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient's body felt inflamed diffuse pins and needles sensation an unspecified amount of time after receiving the vaccine. The outcome of inflammation and paraesthesia was unknown. At the time of this report, the causality between the aforementioned events and ZOSTAVAX was not reported.
Pt's daughter called around 4:30pm on 3/11/21 (day 2 post vaccination on 3/9/21) reporting that pt woke up feeling nauseous all day & vomited profusely at 4:00pm. Advised to stay hydrated and take nausea medication patient had at home & to call back with any changes. If not improved in 6-12 hours, advised to call physician for evaluation.
Rash, erythema and 6.5 x 6 inch of blanchable erythematous rash on arm and warm to touch. began a few hours after vaccination for pneumo polysac 23 V.
Within 30-60 seconds after receiving the vaccine the patient passed out, within seconds regained consciousness, but reported inability to see. 911 was called, EMT did clear him as most likely vasovagal syncope. Contacted mom 10/24/18 and patient is back to normal. No medical attention was received.
Joint and muscle pain/ache in many areas of body. Knees, shoulder, ankle, foot, elbow, hands.
FEVER 100.0 TO 101.6. CHILLS AND FATIGUE.
Site was swollen, red & hot on palpation, > 10 cm (+) area on left deltoid.
I have BBT.... I have a blood clot, was sick for 4 days, bad headache, fatigue, I couldn't eat or drink anything, and fever. I woke up on the May 11th leg was hurting couldn't walk when to doctor they checked for swollen decided to do ultrasound and knew it was a blood clot.
R thigh with 1/2" hard, red, hot to touch area at inj site. High temp 102.6 A with wheezing audible with naked ear. Reported via phone to pediatrician-Rx for "steroid oint and wheezing medicine." No wheezing today. To recheck 8/29/03.
3/19/04- Pain at deltoid to shoulders, worse with activity. 3/23/04- worsened right arm pain down arm/ hand severe pain, not better with analgesia in valves trapezius and biceps.
pt recvd vax 5NOV93 & 13DEC93 pt underwent routine physical which revealed liver enzymes were elevated; AST, ALT, Bilirubin & GGT were all elevated; pt also noticed inc fatigue; hepatitis screening was neg for Hep A,B & C;
I received my regular COVID-19 vaccine on 4/29/2021 which was the Johnson & Johnson/Janssen vaccine. I did not have any known long term side effects; the only side effects I had were short-term - fatigue, body aches, low grade fever, and injection site pain. On 11/13/2021, I received the Moderna booster shot; within 12 hours, I had similar short-term side effects to the Johnson & Johnson vaccine, but the injection site pain lasted almost two weeks with severe lymph node pain. Four days after the shot, on 11/17/2021, my left ankle and foot became extremely swollen. The swelling kept coming and going over the next 24-32 hours, so I saw my primary care doctor the morning of 11/19/2021. My leg was swollen and hurting a lot in my calf and behind my left knee; my doctor was concerned about a blood clot, so she sent me the same day for an ultrasound at our local hospital. No major blood clots/DVTs were detected. The doctor told me to follow up in a few weeks if the pain and swelling continue and to take ibuprofen and wear compression socks. The pain has gotten worse, and ibuprofen doesn't help and the compression socks make the pain worse. I have a follow up appointment with my doctor this Monday, 12/13. The pain is so bad that I can't sleep and have difficulty focusing.
exp pain & burning p/vax by 7OCT96 was unable to move rt arm-unable to hold anything w/weight (i.e. coffee cup) in rt hand;felt weak, congested in lungs, dry cough;pt seen by MD;pt cont to have bruise & area tender;could not work d/t pain
Actually this is a positive event but did not know how to report a positive event. I had two warts in my right hand...probably more than 10 years. I burned them about 8 years ago but they soon came back; This is a spontaneous report from a contactable consumer (patient herself). A 54-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Left on 21Apr2021 13:15 as single dose for COVID-19 immunization. Medical history included blood cholesterol increased, skin papilloma, I had two warts in my right hand, probably more than 10 years. I burned them about 8 years ago, but they soon came back. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included atorvastatin (ATORVASTATIN) taken for an unspecified indication. The patient previously took azitromicin and experienced drug hypersensitivity. The patient had not received any other vaccines within 4 weeks prior to the COVID. It was reported that, actually that was a positive event but did not know how to report a positive event. Patient had two warts in her right hand probably more than 10 years. She burned them about 8 years ago, but they soon came back (28Apr2021). She took the first vaccine and one disappeared and the second one started to fade. She took the second vaccine and two weeks later both were totally gone. She had not done anything different in her life other than this vaccine and had those warts for many years. She could not find any other explanation that the vaccine. The patient had not received any treatment for adverse event. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot been obtained.
High fever, body aches, congestion, headaches, night sweats and runny nose.
pt recv vax;4 hr later,v violently;would not sleep,screaming;fever 103.4;hands/feet blue;jerking & squealing;gained 3lbs since vax;"blood around the brain";in coma at hosp;blind;to drain blood fr lt eye;"avial valve" malformation;
a large red swollen warm bump at injection site; a large red swollen warm bump at injection site; Painful to touch and to move arm; Large bruise noted at injection site painful to touch a week later; This is a spontaneous report from a non-contactable consumer reported for herself that:   A 24-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), via an unspecified route of administration, administered in Arm Left on 13Sep2021 at (Batch/Lot Number: FF2588) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization (Age at vaccination 24 years). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient medical history None. There were no allergies reported. There were no concomitant medications were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 was unknown. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. on 13Sep2021 at 19:30, the patient noticed a large red swollen warm bump at injection site. Painful to touch and to move arm. Persisted for approximately 3 days and Large bruise noted at injection site painful to touch a week later on unspecified date in Sep2021. No treatment was received. The event outcome was unknown.  No follow-up attempts are possible. No further information is expected.
2 day started itching all over by the 11th day broke out in hives all over chest and lower back. Took hydroxide that night at 9 pm
Soreness; Sweats; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Apr2021 at 11:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication and start date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 11:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 02:00, the patient experienced fever, headache, sweats and soreness. The events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, sweats and soreness were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
It started with general aches, which because the worst case of the chills I've ever had, my whole body hurt, I couldn't sleep for 24 hours, I had a fever of 102 degrees at the highest temp. My fever lasted until mid morning on 4/25. I wasn't nauseated but I had no desire to eat at all. I drank lots of water from the morning of the 23rd through to the evening of the 26th. No vomiting or diarrhea. Since then I have gotten the oddest headaches randomly that only last about 10-15 mins and then it's gone.
Hoarseness then hives that ended that night (on face). Wheezing started 10/15/03, used Albuterol inhaler and Claritin-D and reg. until Dr visit 10/19/03. Rx Prednisone Z-Pak.
sore arm; sick as a dog; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ILLNESS (sick as a dog) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391120A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and ILLNESS (sick as a dog). At the time of the report, PAIN IN EXTREMITY (sore arm) and ILLNESS (sick as a dog) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, SARS-CoV-1 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment done for side effects of initial vaccine. After the dose patient has tested positive for COVID on 19uly2021.   This case was linked to MOD-2021-262234 (Patient Link).
Severe thrombocytopenia developing 1 week after 1st Moderna vaccine. Pt got first vaccine April 12 or 14 (she can't remember which) and is due for her next May 10 or 12 (though she is not getting this dose per Hem/onc note). Plt down to 3K (from 258K on 3/29/21). This has required 2 hospitalizations with multiple transfusions, bone marrow bx, high levels O2. She is currently in the hospital and her oncologist noted on 5/4/21: "this is covid vaccine related until proven otherwise (she got her 1st Moderna shot one week before plts plummeted); would not get 2nd dose; should be reported to VAERS."
Since receiving the second dose of the vaccine patient have not had her period; feel very crampy and bloated; feel very crampy and bloated; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration on 23Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 02Mar2021 at 08:30 am (at the age of 45-years-old) as a single dose for COVID-19 immunisation. It was reported that, the patient typically had very regular menstrual cycles. On an unknown date in Mar2021, after receiving the second dose of the vaccine patient did not have her period. She felt very crampy and bloated but have not gotten it. Unfortunately, she could not recall the date of her last period but it has definitely been more than 28 days. It had been about a month and a half. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested negative for COVID-19. On 15Apr2021, the patient underwent nasal swab and the result was negative. The clinical outcome of the events patient did not have her period, felt very crampy and bloated, was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt got vaccines in AM. Has had multiple flu and 4 other covid vaccines in past with no issue. Noted a couple hours later her left arm felt heavy and "clogged". Noted her throat felt itchy and funny. Called and was advised to be evaluated for possible reaction. Took benedryl prior to ER. By the time she got to ER, felt at baseline and no worsening symptoms. Today was called to check in. She is feeling totally fine. Left arm has redness at injection site of flu shot but no pain or itching. Denies any other symptoms.
Dose 1: Pfizer, Dose 2: Pfizer, Dose 3: Moderna; COVID 19 Treatment.; COVID 19 Treatment.; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Product Quality Group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Mar2021 at 15:00 as DOSE 1, SINGLE (lot number: ER 873c), administered in the left arm and on 13Apr2021 at 15:00 as DOSE 2, SINGLE (lot number: Er8735) at the age of 39 years, administered in the left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 09Dec2021 as DOSE 3 (BOOSTER), SINGLE (lot number: 031h21a), administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "ezcema" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment."; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" described as "Dose 1: Pfizer, Dose 2: Pfizer, Dose 3: Moderna." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2023) Positive, notes: Initial day of Covid/ Treatment of COVID-19. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Mom reports temp of 103 evening p/DTP seen in ER on 24DEC fever dec doing well following ER visit;
Information has been received form a registered nurse concerning a 19 year old female with a history of migraine who on 28-JUL-2008 and 06-SEP-2008 was vaccinated with a first and second dose of GARDASIL (Lot # was not reported) intramuscularly in the deltoid. Concomitant therapy included YASMIN. Subsequently, the patient experienced dizziness, "weakness all over", nausea, and a headache led to a migraine about 24 hours after the second dose of vaccination. The patient sought medical attention via a telephone call. No laboratory or diagnostic tests were performed. On an unspecified date the patient reported the nausea subsided but weakness and headache persisted. The patient was instructed to call back if symptoms did not resolve.  Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 14th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st September 2018, 7 days after receiving SHINGRIX, the patient experienced shingles and skin lesion. On an unknown date, the outcome of the shingles and skin lesion were unknown. It was unknown if the reporter considered the shingles and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The reporter received SHINGRIX vaccine on left deltoid. The patient noted a lesion on her right forearm. On 24th September 2018, the patient was diagnosed with Shingles. Transferred to medical information.