chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely swollen and tender lymph nodes under left arm/in left armpit; Extremely swollen and tender lymph nodes under left arm/in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06May2021 at 11:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 15Apr2021 at 11:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021, the patient experienced extremely swollen and tender lymph nodes under left arm/in left armpit. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely swollen and tender lymph nodes under left arm/in left armpit were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
C/o lower right arm hurting, states has a red lump, denies being hot to the touch. Instructed to apply cold pack 20 min on, 20 min off, mark borders of area, take medication for pain. Client scheduled to come in tomorrow for TB reading. Will assess then.
Information has been received from a consumer concerning her 15 year old daughter with no pertinent medical history and no known drug allergies who in August 2007, was vaccinated with the first dose of GARDASIL (lot# not provided), and on 24-AUG-2009 received her second dose of GARDASIL (lot# not provided). There was no concomitant medication. Patient also started feeling ill since she received the second dose. She experienced fever, headaches and nausea. Patient sought unspecified medical attention. No lab diagnostics studies performed. Patient's outcome was not reported. No further information is available.
This spontaneous report was received from a medical assistant referring to a 11 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 08-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot reported as "N021572" Expiry date: 01-MAY-2020) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 degrees F to 77 degrees F (67.3 degrees F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Low fever, nausea, fatigue, headache, pain at injection site Nausea, fatigue, and fever went away next day, and headache and pain at injection sight went away after two days
Case received from a healthcare professional in the USA on 03/Nov/2005. A 47 year old female patient with no known allergies , had received on 29/Oct/2005 in intramuscular dose of influenza vaccine, batch number U1811AA, in the left deltoid, and 30 minutes later, she developed white fuzzy tongue and she complained of her mouth felt slimy. Moreover, 2.5 days post-vaccination, the patient developed nausea and vomiting. She did not take any medication and did not present with any illness at time of vaccination. Patient outcome was not reported. Further information was requested. Follow up information received on 02/FEB/2006 from a healthcare provider. The patient's recovery status is unknown. Follow up information received on 17/Feb/2006 from a health care provider. The patient's recovery status is unknown.
Progressive worsening fatigue, fevers/chills, severe nausea and headache, fatigue prevented patient from all activities 6/7/18 -all symptoms resolved by 6/8 10am.
This spontaneous report was received on 17-MAR-2017 from a Registered Nurse referring to unspecified  number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not reported. On an unspecified dates, an unspecified number of unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX23 with lot# L024118 and expiration date 26-MAR-2016, (strength, dose number, dosage and route were unspecified) for prophylaxis. The vaccine was exposed to temperature of 49 °F; for time frame of 64 hours. There was no previous temperature excursion. No adverse effect was reported.   Additional information was received on 20-MAR-2017  from  a registered nurse  who reported some additional improperly stored  doses might have been given to unknown number of patients. No adverse effect reported. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1703USA008680:
Patient received her 1st Pfizer vaccination dose at 12:37PM. Patient was seated in the vaccination waiting area for her 15 minutes observation window. About 5 minutes after vaccination the patient fainted and fell out of her chair on to the ground. She hit her head on the wall behind her, and ground when falling. Pharmacy staff immediately went to check on patient. She was found to be breathing, but unresponsive for about 20 seconds. 911 was called immediately by another employee. She was positioned lying on the ground with her feet up and came to consciousness quickly. Once awake patient was alert, verbal, and seemed to have a normal mental status. She reported no respiratory issues, no throat or lip symptoms, and no itching or hives. She states that she felt fine other than her head hurting from the fall. She reported no symptoms prior to waking up on the ground. She was speaking in full sentences, responsive, and had a strong, steady pulse at 98 bpm and a normal respiratory rate. No hives, swelling were observed. Patient reported she was a type 1 diabetic and her blood sugar was found to be normal (approx. 145) after she was able to sit. No medications were administered on site as she did not report any additional symptoms indicative of anaphylaxis. The ambulance and local PD arrived quickly. She was walked outside for observation and appeared to be taken away in the ambulance.  The patient was not reached for a follow-up call to check in on her later the same afternoon.
Black stool; chills; nauseous; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nauseous), PYREXIA (fever) and FAECES DISCOLOURED (Black stool) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills), NAUSEA (nauseous) and PYREXIA (fever). On 28-Feb-2021, the patient experienced FAECES DISCOLOURED (Black stool). On 01-Mar-2021, FAECES DISCOLOURED (Black stool) had resolved. At the time of the report, CHILLS (chills), NAUSEA (nauseous) and PYREXIA (fever) outcome was unknown.            Concomitant product use was not reported  Treatment information was not provided   Reporter did not allow further contact
Information has been received on 13-APR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 27-FEB-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-DEC-2015, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed with herpes zoster, or shingles. The patient has been prescribed ZOVIRAX for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX, 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. Additional information has been requested.
headache, body aches, extreme fatigue,  Out of work from Oct 4-8 with flu-like symptoms.  Negative COVID Test Out of work from Oct 20-25 with flu-like symptoms.  Positive COVID Test still feeling flu-like at the date/time of completion of this form
Chills (no fever), sore throat, runny nose, cough, headache, muscle aches. All symptoms started shortly after 8 am and continued throughout the day until bedtime. Took DayQuil, Ibuprofen, Tylenol, slept, and increased fluids. Symptom management helped, especially extra sleep.
My first menstrual cycle following the vaccine was extremely heavy, with a lot of fatigue. I have never lost that much blood menstruating in the past, and at one point I briefly passed out due to the combination of fatigue and weakness from the blood loss. While it could be coincidence, I've never had a cycle like that before and figured it might be something that needed to be brought up.
Expired vaccine used; No adverse event; Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019H22A and 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Jun-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Jun-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023).    No concomitant medication was reported.  Patient was given expired dose, lot analysis determined vaccine maintained the activity necessary to protect. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.
infected wound @ site of MMR; distal 3x4 cm area of erythema, tenderness, induration central 4x4 area draining; tx warm soaks;
This spontaneous report was received from a licensed practical nurse (reported as licensed vocational nurse (LVN)), and refers to two patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot number M043307 with expiration date 24-APR-2018 for prophylaxis (dose, frequency, route of administration, and anatomical location were not reported), which was reconstituted with properly stored STERILE DILUENT, lot number reported as N000383 with expiration date 28-JUN-2019. No adverse events were reported. The vaccine doses were exposed to a temperature of 7.6 degrees Celsius for 4 hours and 20 minutes; the digital data logger was involved. No previous temperature excursion was reported.
Information has been received from a physician concerning a 51 year old patient who in March 2008, was vaccinated SQ with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot# 659147/1381U). Subsequently, the patient experienced a mild injection site reaction. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
L leg with redness, erythema, induration at injection site, warm to touch. Seen by Dr on 2/5/03. Afebrile. Tx ice as tolerated, Advil, call with fever or increased in size.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No medical history or concurrent conditions were provided. On 28-MAR-2014, the patient was vaccinated with MMR II INK (lot # 0496AE; expiration date 07-MAR-2014), 0.5 ml, subcutaneously. No co-suspect or concomitant therapies were provided. The reporter stated that the patient was inadvertently administered with MMR II that had expired. No adverse events reported. Additional information is not expected.
lymphedema flare up; lymphedema flare up; Right arm swelling/my right arm started to swell again; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (lymphedema flare up), CONDITION AGGRAVATED (lymphedema flare up) and VACCINATION SITE SWELLING (Right arm swelling/my right arm started to swell again) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 01M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema, Drug allergy (Prednisone.), Drug allergy (Medrol Pak.), Drug allergy (Tetracycline.), Drug allergy (Avalox.), Drug allergy (Lisinop.), Drug allergy (ACE inhibitors.), Drug allergy (Calcium blocker.), Drug allergy (Triamterene-HCTZ.), Drug allergy (Mucinex-D.), Drug allergy (Erythromycin.), Drug allergy (Phenergan.), Allergy (cats), Allergy (dogs), Allergy (dirt), Dust allergy (dust), Allergy to molds (mold), Allergy (features trees), Allergy to wool, Grass allergy and Cockroach allergy. Concomitant products included COLECALCIFEROL (VITAMIN D 3) for Vitamin D low.   On 02-Feb-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Right arm swelling/my right arm started to swell again). On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema flare up) and CONDITION AGGRAVATED (lymphedema flare up). At the time of the report, LYMPHOEDEMA (lymphedema flare up) and CONDITION AGGRAVATED (lymphedema flare up) had not resolved.            Treatment included compression sleeves and chiropractic therapy for 9 months.   This case was linked to MOD-2021-230205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Followup was received on 22-Jun-2021. Allergies, Concomitant medications and treatment updated. On 23-Jun-2021: Non-significant follow-up appended
No adverse even occurred. Patient was given the vaccines too early and provider did not catch beforehand. The immunization registry and pt. chart were different in terms of vaccines. Patents parents were notified of error and they informed the provider that no adverse reaction occurred, the child was doing well. Provider informed parents what to look for in case of any reaction later.
pt recvd vax & 24-48 hrs post vax exp pain & swelling @ inj site,inj site felt warm to touch & there was an abscess-like nodule w/stuff coming out;sx resolved 24-48 hrs p/onset;exp occasional sharp pain on movement
"COVID Arm"  - round ,red, itchy  swelling at injection site - on the 8th-9th day after the first vaccine
Vaccinated on 06/28/2006. Evening of 06/29/2006, developed fever (100-101 degrees per dad) and had approximately 1 minute generalized seizure, sleepy afterward, then acted normal after 10 or more minutes. Parent's called 911 then drove child to walk-in clinic after she was seen by ambulance personnel. Medical record states hypocalemia msv
Patient reports chills on/off, one episode week of 11/8/21 and on 11/18/21 as well as fatigue on/off starting 5 days after booster dose administered 10/30/21. She also reports an irregular heartbeat detected on her home blood pressure monitor a couple of times, states no additional symptoms when detected. Patient saw cardiologist for routine appointment before her booster with no concerns reported and also saw her primary care physician after her booster for a routine visit and reports no irregular heartbeat detected, no other concerns noted. Patient also notes she felt fine after her first two doses and these new concerns started 5 days after her booster.
VACCINATOR INJECTED PFIZER PEDS DOSE TO LEFT ARM AND RIGHT ARM INSTEAD OF 1 SHOT OF 12 Y/O AND ABOVE PFIZER COVID-19 VACCINE
Pain in Hips; Injection Site Pain; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in Hips), INJECTION SITE PAIN (Injection Site Pain) and MYALGIA (Body Aches) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ARTHRALGIA (Pain in Hips), INJECTION SITE PAIN (Injection Site Pain) and MYALGIA (Body Aches). At the time of the report, ARTHRALGIA (Pain in Hips), INJECTION SITE PAIN (Injection Site Pain) and MYALGIA (Body Aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain Right after Injection - all the way down arm to elbow - Pain continued next day (THurs) reported Friday pm. Noticed Round circle (6" from injection site), size of 50 cent piece. Red & Hot to touch - No itching. Next day (Saturday) still red and "spot" starting to diffuse. Noticing a "Hive" center of spot - itching. used Hydrocortisone cream - 2 days later, bruised at spot site. This redness continued x 12 days
Breakthrough case admission after 3 vaccines Moderna 3/1/21 lot# 023M20A;  Moderna 3/29/21 Lot# 018B21A;  Moderna 12/29/21 LOt# 028K21A;
Fainting passed out for 5 minutes. Following day rash on legs after receiving Gardasil Vaccine dose number 1.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a day after receiving Flu vaccine, the patient experirenced injection site erythema, injection site warmth and rash. The patient was treated with BENADRYL. On an unkonwn date, the outcome of the injection site erythema, injection site warmth and rash were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and rash to be related to Flu vaccine. Additional details provided were as follows: This case was reported by the patient herself. Recently on an unspecified date, the patient received a dose of Flu vaccine at her workplace and experienced the adverse events. On an unknown date, within 24 hours after vaccination, the patient experienced warm and red at the injection site and rash which covered the patient's face and torso. The patient took BENADRYL and the events were resolved in 2 days. At the time of reporting, the patient was fine.
Next day red spots on chin, cheeks, back of hands. Dr. prescribed BENADRYL to stop burning itching. Became blotches, looked like burns on chin, cheeks, back of hands. Rx steroid cream. Didn't help. Dr prescribed ZANTAC and ZYRTEC finally cleared up hives after weeks.
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19.21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.    There were 22 patients who received the COVID vaccination during this time frame.  The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Extremely swollen arm; Itchy blotchy spot; Swollen lymph node on collar bone; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph node on collar bone), PERIPHERAL SWELLING (Extremely swollen arm) and RASH PRURITIC (Itchy blotchy spot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node on collar bone). On 19-Apr-2021, the patient experienced PERIPHERAL SWELLING (Extremely swollen arm) and RASH PRURITIC (Itchy blotchy spot). On 14-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph node on collar bone), PERIPHERAL SWELLING (Extremely swollen arm) and RASH PRURITIC (Itchy blotchy spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
7-6-2021-chest pains, elevated troponins 7-25-2021-elevated heart rates, chest pains and palpitations. Pericarditis/myocarditis. Elevated d-dimer