chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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. On or about 21-MAR-2014, 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, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
tired shortly after shot on same day. that evening had chills, body aches, and dizziness. next 2 days felt exhausted and body aches. better after 48 hours.
4 day history of fever to 104.8, headache, joint pain, rash to all extremities, nausea, chest pain, shortness of breath. Seen in ER given IV fluids. Will treat with prednisone.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient received bnt162b2 (BNT162B2 NOS), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (paxlovid).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Chills, body aches and fatigue. went to bed that night slept for 12 hours, woke up the next morning and felt fine.
Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse (patient). A 35-year-old female patient (weight 55.79 kg, height 160 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK5730) intramuscularly, in the left deltoid, at single dose, on 23Dec2020 at 12:30, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were none. On 25Dec2020, the patient felt extremely tired (fatigue). On 28Dec2020, the patient had headache and minor cough noticed. On 29Dec2020, the patient experienced back pain and she said that it felt like sunburn soreness more than anything else. She said that she literally slept 3 days in a row (29Dec2020, 30Dec2020, and 31Dec2020).  On 31Dec2020, the patient lost her sense of smell and developed dizziness. On 01Jan2021, the patient experienced nausea and lost her sense of taste. COVID-19 virus test was found positive on 01Jan2021.The patient recovered from back pain, sunburn and sleepy on 31Dec2020, recovered from tiredness on 01Jan2021, recovered from nausea and dizziness on 06Jan2021. Clinical outcome of the events, smell loss, cough, headache, and loss of taste was recovering. Final clinical outcome of positive COVID-19 test with symptoms was unknown at time of this report. The case was assessed as serious (medically significant). She is scheduled to get 2nd dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 13Jan2021 and is wanting to know if she is supposed to get it.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
My hair falling out and now have bag full of hair that I've been saving and bald areas on my head; My hair falling out and now have bag full of hair that I've been saving and bald areas on my head; My head is also very sensitive and sore; My head is also very sensitive and sore; My head is also very sensitive and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Jul2021 (Lot number: Ew0180) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hair loss" (unspecified if ongoing), notes: rare condition as a child where I experienced complete hair loss in one day for 5 years.; "Known allergies: gamma globulin" (unspecified if ongoing); "Known allergies: egg based protein shots" (unspecified if ongoing); "Known allergies: cashews" (unspecified if ongoing); "Known allergies: mango" (unspecified if ongoing); "Known allergies: cat hair" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0186, administration time: 03:45 PM, vaccine location: Right arm, Please note: First shot was done at (Urgent Care name & address withheld).), administration date: Jun2021, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), ALOPECIA (non-serious) all with onset Jul2021, outcome "not recovered" and all described as "My hair falling out and now have bag full of hair that I've been saving and bald areas on my head"; SENSITIVE SKIN (non-serious), HEAD DISCOMFORT (non-serious), HEADACHE (non-serious) all with onset Jul2021, outcome "not recovered" and all described as "My head is also very sensitive and sore". Therapeutic measures were not taken as a result of alopecia, alopecia, sensitive skin, head discomfort, headache.  No follow-up attempts are possible. No further information is expected.  Additional Information: It was reported that, facility type Vaccine: Pharmacy or Drug Store.  Patient did not receive any other vaccines within 4 weeks. Patient did not receive any other medication within 2 weeks. Adverse event: A week or so after the second dose of COVID19 vaccine I noticed my hair falling out and now have bag full of hair that I have been saving and bald areas on my head. My head is also very sensitive and sore. Even my hair dresser asked if something is wrong with me because so much comes out during one wash. The patient was not recovered from adverse events. The patient was not received any treatment for adverse events. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination. The patient other medical history includes rare condition as a child where he experienced complete hair loss in one day for 5 years. This seems different.  Follow-Up#01 (02Sep2021): Follow-up attempts are completed. No further information is expected.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 72-year-old female subject who was vaccinated with TWINRIX. On 17 July 2013 at 10:00 the subject received 1st dose of TWINRIX (1 ml, unknown route, left arm) and experienced expired vaccine used. On 17 JULY 2013, 10 minutes after vaccination with TWINRIX, the subject experienced injection site pain. At the time of reporting the events were resolved on the same date of 17 JULY 2013.
Dizziness & Palpitations Narrative:  Pt being observed after 2nd Covid vaccine; pt stated feeling dizzy and having palpitations: VS taken BP 134/80; HR 79; 02Sat 100%; pt agreed to go to the ED and was wheeled there by another RN at 1130
Initial case was received on 05 August 2010 for a consumer who is also the patient. A female patient (age not reported) received 1 year ago (2009), an injection of influenza vaccine (manufacturer and lot number not reported). Three days after receiving the vaccination, the patient experienced muscle aches, pain, severe chills, severe shaking and a fever of 103.0 F to 104.0 F. The patient reported she did not have medical insurance, so she drove to a foreign country for treatment and was hospitalized. She stated she had "whole body shut down" with kidneys not working and liver failure. She "had almost died." The patient had "many" lab tests and "all" were abnormal. Specific labs were not reported. The patient had no illness at the time of the vaccination. There were no pre-existing medical conditions. Concomitant medications were not reported. No vaccinations were given within 4 weeks of reported vaccination. She was still having unspecified problems one year later. Documents held by sender: None.
Swelling, redness measuring 2"x3", hot to touch, painful to touch. Slight fever.
Per pt's husband, she was sitting in a chair at home and rose up at her waist and became stiff. One eye was droopy and the other was fixed straight ahead. He called emergency services, who picked her up and had to shock her in the ambulance. She was treated for a stroke at the hospital and passed away 3 days later on 09/22/21. Also per pt's husband, the coroner's report showed that she had plavix and aspirin in her blood, so he is curious as to why she had the stroke.
Shingrix shot given IM in (L) Deltoid 9/21/20 at 2:43PM. Pt called today on 9/23/20 to let us know about redness and swelling to about size of 1/2 egg. She declined medical treatment and really just wanted to let us know. She will let us  know of any further changes
J&J (Janssen) COVID-19 vaccine use for COVID-19 under Emergency Use Authorization (EUA): Patient received J&J COVID-19 vaccine and within 24 hours was admitted to hospital in early AM of 11/24/21 with palpitations and was found to be in atrial fibrillation with RVR. 24 hours later she as in sinus rhythm and was discharged from hospital.
This spontaneous report was received from a 65-year-old female consumer regarding herself with high blood pressure, osteoporosis, aortic insufficiency and hypothyroidism and sensitive to narcotics. The patient's concomitant therapies included losartan potassium (+) hydrochlorothiazide (manufacturer unknown). On 15-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 route reported as injection, lot number reported as 013428 with expiration date 03-FEB-201, (dose and anatomical location were not reported) to prevent pneumococcal disease. On the same day, the patient experienced "chills" the evening after being vaccinated with PNEUMOVAX 23, she felt "like she was getting the flu" but she did not have high temperature. The patient sought medical attention by calling the nurse prescriber when she learned that the PNEUMOVAX 23 was expired but the office had not called back as of the time of this report. None laboratory diagnostics were performed and no treatment was prescribed for the events, although the patient self-medicated with ADVIL at 6 pm on the same day she was vaccinated with PNEUMOVAX 23 and again at 2 am in the following morning. At the time of the report, the patient recovered from the chill and influenza on unspecified date in 2017. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Day 0- Overnight I experienced chills, headache, generalized body aches Day 1- Very sore arm, nausea, headache, severe muscle aches, joint pain, palpitations (feeling of pounding heartbeat and skipped beat feeling) elevated resting heart rate in the 110s (baseline for me is upper 50s to mid 60s) Doctor made aware. Day 2- more mild headache, fatigue, improving palpitations.  Day 3- all symptoms seemed to have resolved
3 pm: Patient complaint - fast heartbeat and dizziness. Patient advised to go to ER via 911. Patient stated he would go via bus.
On 12/25/20 pt experience swelling of the R eyelid.  By 12/26 the eyelid was swollen shut.  Patient received treatment of antibiotics and MEdrol dose pack and swelling decreased.  As of 1/5 eyelid was still slightly swollen.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 06-AUG-2018, the patient was vaccinated with improperly stored dose of ROTATEQ lot number N034401 and expiry date 09-MAY-2019 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36 to 46 degrees Fahrenheit (°F) (35.9°F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36°F to 46°F for 10 hours and 25 minutes; and 32°F up to 35°F for 3 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. Sender's Comments: US-009507513-1811USA008122: US-009507513-1811USA008130: US-009507513-1811USA008124: US-009507513-1811USA008125: US-009507513-1811USA008126: US-009507513-1811USA008127: US-009507513-1811USA008128: US-009507513-1811USA008129: US-009507513-1811USA008121: US-009507513-1811USA008120: US-009507513-1811USA004452: US-009507513-1811USA008123.
Pt recv vax on 12/14/98; on 1/22/99 pt exp chicken pox blisters on body
acute anxiety; got really hot; Shortness of breath / still feel sense of mild shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (got really hot), DYSPNOEA (Shortness of breath / still feel sense of mild shortness of breath) and ANXIETY (acute anxiety) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced FEELING HOT (got really hot) and DYSPNOEA (Shortness of breath / still feel sense of mild shortness of breath). On an unknown date, the patient experienced ANXIETY (acute anxiety). On 21-May-2021, FEELING HOT (got really hot) had resolved. At the time of the report, DYSPNOEA (Shortness of breath / still feel sense of mild shortness of breath) and ANXIETY (acute anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not reported.  Treatment details was not reported .
pt recv vax 19SEP96 & 24SEP96 pt exp a rash;no further details were provided;
I26.99 ACUTE PULMONARY EMBOLISM 2/22/2023 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 2/22/2023 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 2/22/2023 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Developed a rash that my doctor is calling chronic hives.  Going through treatment to get them under control. Extreme itchiness, and red rashes on hands, legs, and stomach.
This spontaneous report was received from a nurse referring to a patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of VARIVAX (dose and route of administration were not reported; lot # K018961 with expiration date: 15-OCT-2016), which underwent defrost cycling. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
He had seizure or seizure like incident lasting 1-2 minutes. Was very upset after incident. Also, very tired after incident.
Patient developed Bell's Palsy. Left-sided facial palsy. Patient was in emergency room.
Nausea, vomiting, abd cramps. Pt given Pepcid OTC instructions.
Fever (100 deg F), sweating and chills, headache, body aches, joint pain. Symptoms lasted 24 hours. Unable to work secondary to symptoms. Tylenol as directed for treatment.
had Covid shot on left arm and they are to be sore but gone into the lymph node; had Covid shot on left arm and they are to be sore but gone into the lymph node; little bit pain into the chest; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6198, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 02Mar2021 (at the age of 65-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included "Glucop" (as reported) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Mar2021, the patient had COVID shot on left arm and they are to be sore but gone into the lymph node and little bit pain into the chest. It was reported that on third day still it was getting worsen not "bad". It was in the left lymph node on which received the shot and seems to be, the pain was getting worsen not better and she was getting nervous about it. The outcome of the events was unknown.   No follow-up attempts are possible. No further information expected.
Dose was given to patient before patient turned 12 years old.; This is a spontaneous report from a contactable pharmacist. An 11-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via intramuscular route in the left arm on 21May2021 at 17:00 (at the age of 11-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known drug allergy. It was unknown whether the patient received medications within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 17:00, first dose of vaccine was given to the patient before patient turned 12 years old (product used in unapproved population). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. No follow-up attempts are needed. No further information is expected.
6 days after the shot I thought I had a sinus infection. I received a  steroid shot and  z pak prescription on the morning of February 18. Was still feeling bad and checked myself into a local ER February 22 where I was diagnosed with congestive heart failure. Never had heart issues. I was in the hospital 6 days. I feel much better and now worried about getting second shot.
Beginning on day of dose one, tired, achy I had redness. Second dose was end of May. I was pregnant at the time. I started having a lot of bleeding and I went to ER.
Around noon had pain in left area of forehead, took Rx Midril 2 tablets for migraine then 2 tabs more @ 2am 11/16/06.  Had nausea, light sensitivity & dull ache for 4 more until noon on 11/17/06.
Pt rec'd flu vaccine 11/16/01. On 11/17/01 R arm at injection site developed hives, welt, itchy, redness, site warm to touch. On 11/19/01 R deltoid site size of small lemon, warm to touch and still itchy. Pt put ice on the area on 11/17 and warm compress 11/18/01. On 11/26/01 inflammation subsiding.
Blood vessels shrunk-cant see them as much; hand are ice cold; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VASOCONSTRICTION (Blood vessels shrunk-cant see them as much) and PERIPHERAL COLDNESS (hand are ice cold) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VASOCONSTRICTION (Blood vessels shrunk-cant see them as much) and PERIPHERAL COLDNESS (hand are ice cold). At the time of the report, VASOCONSTRICTION (Blood vessels shrunk-cant see them as much) and PERIPHERAL COLDNESS (hand are ice cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Pt was limp, unresponsive to all stimuli (i.e.) blowing in face, rubbing back, calling name loudly, hitting back sl harder to evoke same response but to no avail; head was slumped to chest & eyes rolled back; bronchiolitis
pt recvd vax; 12 hrs later exp general aches, fever & ha; resolved;
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 26-JUN-2008 the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, route unknown). On 04-SEP-2013, the patient was then administered 2nd dose of GARDASIL (lot number, expiry date, route unknown). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Information has been received from a physician assistant concerning a 78 year old female patient who on 04-FEB-2010 was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). Physician assistant stated that no adverse effect. Additional information has been requested. This is one of several reports from the same source.
Did not feel good after reciving the Moderna vaccines/felt as sick as a dog; Had muscle soreness; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Did not feel good after reciving the Moderna vaccines/felt as sick as a dog) and MYALGIA (Had muscle soreness) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Did not feel good after reciving the Moderna vaccines/felt as sick as a dog) and MYALGIA (Had muscle soreness). At the time of the report, ILLNESS (Did not feel good after reciving the Moderna vaccines/felt as sick as a dog) and MYALGIA (Had muscle soreness) outcome was unknown.            No concomitant drug was reported.  The reporter stated that her husband received Moderna Covid-19 primary vaccine series and did not feel good after receiving the Moderna vaccines.  No treatment drug was reported.   Reporter did not allow further contact