chrisvoncsefalvay/vaers-outcomes huggingface dataset:
short lived axillary adenopathy; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EN6201) at the age of 71 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Adult onset atopic dermatitis", start date: 01Jan2012 (unspecified if ongoing), notes: Treated with various beam UVB. Concomitant medication(s) included: TRIAMCINOLONE; CETAPHIL [CETYL ALCOHOL;SODIUM LAURYL SULFATE;STEARYL ALCOHOL]. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "short lived axillary adenopathy".  Clinical Course: Only side effect from vaccine was short lived axillary adenopathy or the side of the injection. Sender's Comments: Linked Report(s): PFIZER INC-202300066388 same patient and event, different dose number; PFIZER INC-202300066386 same patient and event, different dose number. PFIZER INC-202300066387 same patient and event, different dose number;
Died from Pulmonary Embolism. No leg pain, no leg swelling to indicate DVT in leg. Also was thrombocytopenic at the time of emergency/ER visit/treatment. He suddenly complained of very bad chest pain, could hardly speak to tell symptoms. Immediate resuscitation was started by family member and 911 was called. Ambulance detected tech, tried to electroconvert, but was not successful. Chest compression and bagging was done until patient got the hospital. There full resuscitation effort. Unsuccessful. Troponin normal, D-dimer sky high.
Patient experienced dizziness about 9-10 minutes post vaccination.   His blood pressure dropped but was able to bring back up after lying on the ground.
on 3/28, husband/family found Patient unresponsive, thinks insulin overdose, (Patient is diabetic), Husband also reports Patient seemed to have a "cold" but was mild, didn't think much of it, didn't consider testing. Patient tested positive for COVID upon hospital admission on 3/28, intubated, ventilated. Husband reports Patient is opening eyes, interacting, not sure level of alertness. Patient is still in hospital, still intubated/ventilated. Husband did not know diagnosis or treatments given.
Aprrox. 15min after first dose of Moderna vaccine patient reported feeling dizzy. Patients significant other reported patient feels dizzy prior to a seizure. Patient lowered to the floor and had a seizure lasting about 45 seconds. Paramedics activated @ 3:10pm. Patient alert with intermittent confusion. Blood sugar 94. Patient refused transport to the hospital. Paramedics stayed by, patient had a second seizure lasting about 15 seconds. Post seizure patient agreed to go to hospital for eval. Transported via paramedics to hospital.
I have been extremely and unusually fatigued since the 2nd vaccine.  I was walking approx 10 -12 miles a week and now am lucky if I walk 4.  I need to rest/nap constantly and have a constant headache.  I have never had headaches like this prior to 2nd  vaccine.
Patient seen on 12/20/2001 for rash around site of varicella injection which was given to thigh. Rash spread to right elbow and on right side of chest. There was itching at site and a low grade temperature. Advised to use Tylenol and Benadryl PRN, and Topical Hydrocortizone.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female pt. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 01-DEC-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced shingles and she was treated by a healthcare provider. The outcome of shingles was not specified and the reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Recovering from surgery, doing well after shot, back pain became signifantly worse (back to right after surgery).  Assume reaction caused swelling in the tissues of my back.
Facility had a temperature excursion in the freezer; Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion).    No concomitant medication was reported.    At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 mL and 5.5 mL.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was reported.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided
Administration error - Patient did not make it know that he had already had the Pfizer Covid-19 vaccination series and the Janssen Covid-19 vaccine was given
First developed severe headache and severe left back flank pain. Around 6:30pm I could not use my entire left side leg arm face I lost my vision. Called a nurse specialized in Covid reaction. She asked me many questions had me take my blood pressure witch was very high and my heart rate was very high. My skin was yellow especially on the left side. I was unable to walk or dress myself without assistance. She told me to call 911 get an ambulance immediately . So I did.
have a dry throat.; arm is still red and swollen; arm is still red and swollen; This spontaneous case was reported by a health care professional and describes the occurrence of DRY THROAT (have a dry throat.), VACCINATION SITE ERYTHEMA (arm is still red and swollen) and VACCINATION SITE SWELLING (arm is still red and swollen) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY THROAT (have a dry throat.), VACCINATION SITE ERYTHEMA (arm is still red and swollen) and VACCINATION SITE SWELLING (arm is still red and swollen). At the time of the report, DRY THROAT (have a dry throat.), VACCINATION SITE ERYTHEMA (arm is still red and swollen) and VACCINATION SITE SWELLING (arm is still red and swollen) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided. No Concomitant medication was provided.
Chills, Internal Hot feelings, Fever, Headache, Muscle Aches, Bruising, Red Dot the evening of.  Instructed to take OTC Tylenol and to monitor the area, instructed to see PCP if symptoms worsened.
Headache, Myalgia, Fever, NauseaVomiting,  site soreness/swelling/redness/itching; fatigue; joint pain; chills  Narrative:  Other Relevant History:
onset 12MAY93 approx 1155PM, t103, seizure activity w/twitching both arms & legs & incontinent of urine; taken to ER; no treatment other than APAP & tepid bath to dec temp;
Low grade temp 99.2; Extreme arm discomfort.; Pounding headache.; Extreme tiredness; Body aches; This is a spontaneous report from a contactable consumer (patient).   A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in right arm on 04Jun2021 at 19:15 PM (Age at Vaccination 35-years-old) as dose 2, single for Covid-19 immunization at Pharmacy or Drug Store. Medical history included allergies with latex, Benadryl, bee venom. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173) via an unspecified route of administration, administered in right arm on 14May2021 at 19:45 PM (Age at Vaccination 35-years-old) as dose 1, single for Covid-19 immunization. Patient did not take any prior Covid vaccination, and she did not get tested for Covid post vaccination. On 05Jun2021 patient experienced Extreme arm discomfort, pounding headache, extreme tiredness, body aches and low-grade temp 99.2, she did not take any treatment and no other medications in 2 weeks. The patient underwent lab data and procedure which include Body temperature abnormal Low-grade Temp 99.2 on 05Jun2021. Outcome of all events was recovering.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
I gave the patient 2nd injection of Hep A on 11/11/17 around 12:00pm. The patient is doing fine after the injection. She stands outside waiting for her husband to have his HEP A injection. She fainted after her husband finished his injection. Her head hit the floor. Her face is pale. She feels dizzy. The pharmacy team notified the store management. We called fire department for assisting. The EMS arrived 10 minutes later. The patient is alert and responsive. However, she is still feeling dizziness. The EMS took her to the hospital. I called her husband at 2:20pm to follow up. He said she is doing fine. She is still waiting for the doctor to check her head.
My lymph nodes under my arms and in my groin are swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 07Apr2021, outcome "unknown", described as "My lymph nodes under my arms and in my groin are swollen".  Additional information: The patient informed that lymph nodes under the patient arms and in my groin are swollen. The patient was enquiring if that go away or was asking if somebody else who can hear the patient and stated was screaming into the telephone. Appropriate response could not be provided as patient's voice was not completely audible to the Call handler. A Call back was done to gather more information but was not successful. Limited information was available over the call.  Comment: Name of the suspect product was not available over the call, hence captured as Unspecified Medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case reported by a consumer (patient), describes the occurrence of headache, myalgia (body aches), arthralgia (joint pain), nausea and severe fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included systemic lupus erythematosus. On Feb 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced headache, myalgia (body aches), arthralgia (joint pain), nausea and severe fatigue. At the time of the report, headache, myalgia (body aches), arthralgia (joint pain), nausea and severe fatigue: resolving. No concomitant medication, laboratory details or treatment information given. Patient will see a rheumatologist. Reportedly symptoms are slowly improving. Most recent follow-up information incorporated: On Jun 19, 2021: Follow-up received on Jun 19, 2021. Reported symptoms are slowly improving (outcome updated).
was sick with flu for 14 days; Initial information received on 16-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced was sick with flu for 14 days while receiving vaccines fluarix and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dose, expiration date and lot number not reported) via unknown route in unknown administration site for Flu. On an unknown date, the patient received a  dose of suspect fluarix not produced by Sanofi Pasteur (strength, formulation, dose, expiration date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious was sick with flu for 14 days (influenza) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  Corrective treatment was not reported for the event (was sick with flu for 14 days).  Outcome was Unknown for the event was sick with flu for 14 days.
Rash, Swelling of the legs,  Doctor said to elevate legs. I kept going back to him but he kept blowing me off. I told him i have had a stroke or something, he did not believe me. It took me 3 months to get an appointment with Dr. I was so sick that day I had an appointment with him I couldn't make the appointment. The following day, I called and begged to see him saying I was dying. I drove, I don't know how, but I drove and got there and insisted on seeing him. He did a questionnaire and he admitted me. I was transported by Ambulance. I was in the hospital for 7 days and no one knew what to do with me. No diagnoses. I was furious and went home AMA. I went home. I was so sick that the cab driver had to carry me into my house. Later I called my housekeeper to come on the next Sunday, a few days later, and she showed up and I had been sitting on the couch trying to put pants on and I didn't know I had AFIB or a leaky heart valve. I had been wheelchair bound for months not knowing what was wrong.   I was on the toilet trying to get up and had to call for help. He referred to MD Neurologist in city 09/29/2021. I told him there was something wrong. He ordered a CAT scan and CT. He said  I have had 2 strokes. He asked why I was walking with my head down. I told him I was unable to drive and I could not keep my balance. I ended up having a 3rd stroke and am blind in one eye from cataract surgery and stroke. I saw a Dr. who is a retinal specialist after seeing Dr. who did my cataract surgery.   I ( the patient) have ALL of my medical records. Thousands of papers. There may be a few missing from the past 4-6 weeks.
approx. 4 days following this 3rd dose of the Moderna vaccine, an itchy rash appeared at the injection site (upper right arm) which had been painful/swollen for 3-4 days.  Shortly thereafter, the rash appeared on my upper right thigh (inner and outer) as well as right buttock.  It also appeared to a lesser extent on my right ankle, as well as on my lower back.  The rash also occurred on my outer and inner left thigh.  Saw the dermatologist today and he suggested either a shot of Kenalog (which i declined) or topical cream to apply 2X/day. I don't know the cream name, but will pick it up tomorrow.  Note: i've had no changes to diet, supplements, or lotions.  .  On 08/26/21, recvd cortisone shot in left shoulder joint
Cold feet in the evening when vaccine was given.  1AM woke up with chills that continued through the next day.  Extreme body aches that started in the middle of the night that continued into the next day.  Extreme headache which made me nausea until 5PM the next day.  Felt 100 percent better on Sunday at 1PM.  Vaccine was given on Friday at 1PM.
Patient received 1st dose of Covid -19 vaccine Moderna Lot # 025J20  01/8/2021 Patient received 2nd dose Covid -19 vaccine Moderna Lot 042L20A with a HCF in Left Deltoid 02/09/2021 Patient received a 3rd dose Covid -19 vaccine Pfizer Lot # EW0169 Right Deltoid at a HCF 05/14/2021
swelling @ vax site devel into small hard ball which persisted x 2wk;hives (red, itchy spots) devel under both arms & sides of chest 2 days p/shot;lasted 2 days;
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 10th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461: Master case
stomach is upset; just don't feel good; Little nauseous; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is upset), FEELING ABNORMAL (just don't feel good), NAUSEA (Little nauseous) and HEADACHE (headache) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach is upset), FEELING ABNORMAL (just don't feel good), NAUSEA (Little nauseous) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach is upset), FEELING ABNORMAL (just don't feel good), NAUSEA (Little nauseous) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  No treatment  medication were provided   Reporter did not allow further contact
Information has been received from a 31 year old female with a "sulfa minocin" allergy and a history of caesarean section (September, 2000) who on 26Jul2002 and 28Sep2002 was vaccinated with a dose of varicella virus vaccine live. There were no concomitant medications. On 01Oct2002, the patient discovered that she was pregnant. Unspecified medical attention was sought. On 07Oct2003, follow-up information from the physician revealed that the patient delivered a female patient with a birth weight of 7lb 3oz. via C-section on 27May2003. The apgars "were 9 and 9 and there were no complications with the baby". It was noted that the mother had an incision abscess post operatively and was seen in the office. The incision abscess was treated with "wound care". Additional information is expected.