chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt spaced out/feels spacy; Tired; Achy; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on Left arm on 28Jan2021 13.00 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that caller received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 28Jan2021, this morning she felt spaced out, tired and achy. Caller would like to know if this normal 4 days after receiving the vaccine. From 01Feb2021 patient experienced Ongoing feeling spacy, tired and achy. Caller states she has a quick question, states she had second Pfizer vaccination last Thursday 28Jan2021, states she felt real well until today, states she feels spacy, tired, and achy. Wants to know if this is normal for four days later. States she got the vaccine in her left arm on 28Jan2021 at 1PM. Declined to provide HCP information. Does not have NDC, Lot, or Expiration Date to provide at this time. The caller was provided with a phone number of (phone ), option 3, and business hours prior to warm transfer to (name withheld), INT-#. The outcome of the event was "Not recovered".  Information on the Lot/batch number has been requested.
Tiredness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of rash erythematous (1st dose received on 6th November 2020 on Friday, and patient experienced chills, intense pain around the injection site,pain in her joints, back, feet and hands, nausea, sweating and chills.) and Zostavax.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness. At the time of call patient mentioned she gots the flu shot. She could not provide any additional information. The reporter did not consent to follow up. This is 1 of the 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222199:same reporter US-GLAXOSMITHKLINE-US2020222182:same reporter
injection site was still bleeding; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69 years old female patient whose injection site was still bleeding ((vaccination site haemorrhage), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation; and HEPATITIS A VACCINE INACT (HAVRIX) in left arm on 15-Oct-2019.  On 15-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AA, 20-May-2020 via unknown route in the right arm.  On 15-Oct-2019, the patient had a non-serious injection site was still bleeding (vaccination site haemorrhage) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site haemorrhage.   The patient was treated with clopidogrel for Vaccination site haemorrhage.  The patient outcome is reported as unknown for vaccination site haemorrhage.
it hurts; fever in the arm where they received it; Scratching; muscle part of the arm where they got the vaccine irritated; muscle part of the arm where they got the vaccine is red; it itches worse than the last time; a little rash where they got the shot; pain in the muscle part of the arm where they got the vaccine for the past couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it hurts), VACCINATION SITE WARMTH (fever in the arm where they received it), SCRATCH (Scratching), VACCINATION SITE IRRITATION (muscle part of the arm where they got the vaccine irritated) and VACCINATION SITE ERYTHEMA (muscle part of the arm where they got the vaccine is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Adhesive tape allergy (gave them rash), Adhesive tape allergy (gave them rash), Diabetes (probably) and Cardiac disorder (probably).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (it hurts), VACCINATION SITE WARMTH (fever in the arm where they received it), SCRATCH (Scratching), VACCINATION SITE IRRITATION (muscle part of the arm where they got the vaccine irritated), VACCINATION SITE ERYTHEMA (muscle part of the arm where they got the vaccine is red), VACCINATION SITE PRURITUS (it itches worse than the last time), VACCINATION SITE RASH (a little rash where they got the shot) and VACCINATION SITE PAIN (pain in the muscle part of the arm where they got the vaccine for the past couple of days). At the time of the report, PAIN (it hurts), VACCINATION SITE WARMTH (fever in the arm where they received it), SCRATCH (Scratching), VACCINATION SITE IRRITATION (muscle part of the arm where they got the vaccine irritated), VACCINATION SITE ERYTHEMA (muscle part of the arm where they got the vaccine is red), VACCINATION SITE PRURITUS (it itches worse than the last time) and VACCINATION SITE RASH (a little rash where they got the shot) outcome was unknown and VACCINATION SITE PAIN (pain in the muscle part of the arm where they got the vaccine for the past couple of days) had resolved.            No concomitant medication information was provided. No treatment medication information was provided. The patient received the first dose of the Moderna COVID19 vaccine on 09 Mar2021 and second dose on 06Apr 2021 and booster on Tuesday. Patient reported no side effect after the first dose. After booster the patient had same like the second dose. The patient enquired whether they can use antibody cream or anything to keep it from itching or use a cold or warm patch.   This case was linked to MOD-2022-456453 (Patient Link).
day following vax pt devel a low grade fever, was fussy & had diarrhea (2-3 stools/day); seen by MD 1/18, gain weight but having 4 stools/day; improving by 1/20; 1/26 pt devel bronchiolitis caused by RSV; 1/26 devel left otitis media
Upper abdomen inflammation; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: 330308D) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: GASTRITIS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Upper abdomen inflammation". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of gastritis.  Additional information: Upper abdomen inflammation; Gastric inflammation increased acid Related. When probed for vaccine expiration date, Nurse stated, It's "11302021" (further not clarified), she don't know if it's expiration, she don't know, what was that. She don't know because it doesn't have expiration date on here. No Prior Vaccination. No Family Medical History related to event.    Follow-up attempts are completed. No further information is expected.
3/20/2021, 6am- headache, nausea, fever 100.7. 600 mg ibuprofen, orange juice, water, bedrest.
Woozy, nauseous, lightheaded, clammy, sweaty, out of it. Checked BP at 1415: 94/45, HR 61. Gave her cool compress & continued talking w/ her. She wanted something to eat or drink, but explained to her she would have to wait since we didn't know how bad her reaction would be. Started feeling better ~5minutes later. Rechecked BP at 1425: 119/70, HR 64. Pt looked and sounded better. Was no longer dizzy/woozy. Stood without dizziness and left with her husband. She will call if any further difficulties. She never experienced difficulty breathing.
Left arm pit lymph node swelling first reaction that started less than 4 hours after injection. Less than 8 hours from time of vaccination she woke up to fever. The next day she developed several blisters in mouth, painful swallowing, swollen submandibular lymph nodes and continued fever
shingles; Information has been received from a lawyer regarding a case in litigation concerning a lawyer refers to a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 15-AUG-2014, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) 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 physician 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.
Body Wide Rash that started 1 day after getting vaccine/ rash is itchy; Hacky cough and lungs are itchy/ Once she starts coughing it is hard to stop; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Body Wide Rash that started 1 day after getting vaccine/ rash is itchy) and COUGH (Hacky cough and lungs are itchy/ Once she starts coughing it is hard to stop) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Reactive airways disease (Reactive lungs.), Drug allergy (Allergy to steroids.) and Drug allergy (Allergy to oral benadryl.).    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced RASH PRURITIC (Body Wide Rash that started 1 day after getting vaccine/ rash is itchy) and COUGH (Hacky cough and lungs are itchy/ Once she starts coughing it is hard to stop). The patient was treated with FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) at an unspecified dose and frequency and ZINC OXIDE at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Body Wide Rash that started 1 day after getting vaccine/ rash is itchy) and COUGH (Hacky cough and lungs are itchy/ Once she starts coughing it is hard to stop) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included topical Benadryl and baking soda made into a paste applied topically and Allegra 24 Hour by mouth. No concomitant medication information was provided    Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up information received and contains No new information
Child received extra dose of Prevnar 13 and Pedvax on Jan 20, 2022.
This spontaneous report was received from a registered nurse and refers to a 16 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 1-OCT-2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 01-MAR-2016, the patient was treated at an eye facility for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
1205p  back to clinic c/o "whoozie" and hands tingling, water given, cool cloth to forehead, BP 147/84 P 73 R 18 SpO2 95% RA, 12:16p pt reports "better" denies any s/s, BP 135/78 P69 R 18 SpO2 96% RA, ambulated with RN to valet parking
Severe migraine headaches, light and noise sensitivity. We have been to the pediatrician and have now been referred to a neurologist
Left arm - large circular site reaction. Painful, raised, hot, itchy, red. Started day 2 following injection at injection site. Arm throbs and hurts to touch. Excessive thirst since night of vaccine. Have awoken every night at least 2 times to get a large glass of water (I never do this). I have also been craving water during waking hours since the day after vaccine.
This spontaneous report was received from a physician and nurse via a company representative refers to a male patient of unknown age. Approximately on an unknown date in September 2012 (reported as last week) the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) dose and route not reported. No concomitant medications were reported. Physician and nurse mentioned to the representative that a male patient received ZOSTAVAX last week and when patient went home and took off the band aid that was at the injection site, liquid came out of the injection site. There was concern the patient did not get the proper dose of ZOSTAVAX. The patient was not experiencing any known symptoms. The outcome of the event was unknown. No further information is available. Additional information has been requested.
7/14/2022 ; vaccination, end of July ; start short breaths and chest pain, 9/7/2022 heart attack 911 emergency double bypass surgery ( his platelets count only 25k ) with heparin. Massive bleeding open surgery again, 9/8 a lots of blood clots in chest so open surgery( 3rd ), in the meantime blood clots in his right foot, 10/24/2022 the right foot amputation surgery,
Vaccine administered on 08/2/00- Fever on 05/10/05, vessicle noted 05/11/05- Rapid outbreak of vessicles on trunk, scalp, face, mouth, continued to develop new lesions 05/15/05-> 100 lesions; typical varicella appearence.
Information has been received from a company representative who called to report that a news program ran about GARDASIL. A young lady was interviewed who received GARDASIL. The woman confirmed that it was painful but worth it because the vaccine can prevent cervical cancer. The anchor woman was the health link manager. The anchor woman reported that the vaccine can cause fainting and pain. No further information is available.
Left arm was red in a large area from the upper arm into the lower arm.  Actual injection site was not red, no swelling etc. It appeared to be more of a cellulitis and was treated by the MD as such.
Left arm red from shoulder to elbow, very swollen and painful. Treated with Cool compresses and Benadryl.
I woke up feeling a little hazy and I took my temperature and then my wife had me take a COVID-19 Home Test and it was positive. I then had an appointment with my pharmacy. They gave me Paxlovid. From there I was having a fever still, I had restlessness in my legs, was fatigued, and had a cough. By the third dose on the second day of taking the Paxlovid I was feeling really great. I have been a little tired but thus far the medication has really helped with all symptoms I was having.
Swollen left arm-deltoid area-was seen in ER on Sunday, Aug 9th.  Mother states was hughe yesterday.  No c/o fever. Full ROM of proximal and distal joints.  Had bug bites prior to immunizations and was in sun for quite a while after shots.  Whole deltoid area still red and swollen today but markedly less than yesterday going by the markers ER had put on arm yesterday.  Antibiotics were prescribed by ER.
Post vax on 12/19/2000 the patient complained of feeling dizzy. On 12/20/2000 at approximately 10:00 am the patient had a headache and broke out in a rash described as chickenpox. It was reported that on 12/27/2000 the patient had about 60 lesions and a temperature of 102.9F. Subsequently the patient recovered. No additional information is expected.
Patient was administered covid vaccine past the expiration time given for the dose.  Patient reported no adverse effects.
No adverse event; Patient received Monovalent instead of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead of Bivalent Booster).    No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-669163 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669163:MOD-2022-669144(Husband case)
asthma; fatigue/tiredness; low Vitamin D; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Lot number: ER8727) at the age of 48 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Mild Asthma" (unspecified if ongoing); "Heartburn" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8727), administration date: 06Apr2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: ASTHMA (non-serious) with onset 28May2021, outcome "not recovered", described as "asthma"; FATIGUE (non-serious) with onset 28May2021, outcome "not recovered", described as "fatigue/tiredness"; VITAMIN D DECREASED (non-serious) with onset 28May2021, outcome "not recovered", described as "low Vitamin D". The events "asthma", "fatigue/tiredness" and "low vitamin d" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthma, fatigue, vitamin d decreased. Additional information: Reported Event: Approximately 30 days after my second dose I noticed a marked fatigue or tiredness on a daily basis that I have never felt before in my life. It was so pronounced I went my GP. Blood tests only revealed low Vitamin D (started taking that daily). After the tiredness continued with no relief I went to cardiologist and pulmonologist ( I have mild asthma). Several blood tests indicated nothing out of the ordinary. Heart and lungs are all healthy. The only explanation I have at this point is the COVID vaccine because that is the only thing that changed around the time that this happened. I can function but I just feel tired all day long and I didn't experience this before the vaccine.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a patient of unknown age and gender. On 11-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees centigrade for 19 hours. This was one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006245, 1307USA006247, 1307USA006248, 1307USA006249, 1307USA006250 and 1306USA007793. Additional information has been requested.
Significant inflammation, redness, warmth, and tenderness at injection site. Area affected approximately 3 inches in diameter. Pt reports having a fever as well. Pt taking acetaminophen and applying ice packs to the area.
12/23 @ 2000: severe chills 12/24 @ 0100: severe chills, nausea, vomiting, body aches, fever of 102.4 12/24 @ 0900: body aches, fever of 101.5 12/25 @ 0800: body aches, fever of 100.8
pt recv vax & exp aches;pt seen in ER by MD & told to cont tx & report if sx become worse;