chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; left ear totally plugged up with tinnitus symptoms/Flushing out of ear; left ear totally plugged up with tinnitus symptoms; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose number unknown (booster), single (Lot number: GJ3277) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Propylene glycol, reaction(s): "Known Allergies: propylene glycol"; Thimerasol for Known allergies: thimerasol. Vaccination history included: moderna (vaccine brand: Other,, vaccine brand other: Moderna,, vaccine brand unknown: False,, vaccine administration date: 26May2023,, vaccine lot number: O45H22A,, vaccine lot unknown: False,, vaccine dose number: 2,, vaccine dose number unknown: False,, vaccine location: Left arm), administration date: 26May2023, when the patient was 82-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE Unknown manufacturer), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Oct2022, outcome "unknown"; CHILLS (non-serious) with onset 15Oct2022, outcome "not recovered"; TINNITUS (non-serious) with onset 15Oct2022, outcome "not recovered", described as "left ear totally plugged up with tinnitus symptoms"; EAR DISCOMFORT (non-serious) with onset 15Oct2022, outcome "not recovered", described as "left ear totally plugged up with tinnitus symptoms/Flushing out of ear". Therapeutic measures were taken as a result of chills, ear discomfort, tinnitus.  additional information: 2 days after Pfizer injection had chills, during night left ear totally plugged up with tinnitus symptoms/Flushing out of ear (on 15Oct2022 at 12:00 AM) with the treatment of antibiotics, Flonaseuse. Symptoms have continued since Pfizer injection. Injection Pfizer GJ3277 bivalent. Given left arm 13Oct2022, known allergies: propylene glycol, thimerasol. Patient did not receive any other medication in 2 weeks.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Fever documented at 101.1F approximately 12 hrs after inoculation.  In addition, I experienced abdominal pain, chills, fatigue, generalized body aches and nausea.
chest pain on his left side; hot sweats; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain on his left side) and HYPERHIDROSIS (hot sweats) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02B21A and A07A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHEST PAIN (chest pain on his left side) and HYPERHIDROSIS (hot sweats). At the time of the report, CHEST PAIN (chest pain on his left side) and HYPERHIDROSIS (hot sweats) had not resolved. Not Provided          Patient weight is 220 (units not reported) No concomitant medication reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076580:For first dose
The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 17-APR-2023; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 17-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Apr-2023, 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 17-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 17-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 17-APR-2023) 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 EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 17-APR-2023).    Concomitant medications were not reported.  It was unknown whether patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date.  The vial size was reported as 2.5 mL  The vial did not undergo had any temperature excursions. No treatment information was provided by the reporter.  This case contains information for the 4th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product administration date was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Patient 1
Dizzy; Little more tired; He had cotton mouth; He was parched; He thought he was dying/Felt like he was buzzed or had taken drugs; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (He thought he was dying/Felt like he was buzzed or had taken drugs), HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizzy), DRY MOUTH (He had cotton mouth) and THIRST (He was parched) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037b21a and MOD044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 rapid diagnostic test (Positive) on 27-Oct-2020.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced FEELING ABNORMAL (He thought he was dying/Felt like he was buzzed or had taken drugs), HYPERSENSITIVITY (Allergic reaction), DRY MOUTH (He had cotton mouth) and THIRST (He was parched). On 22-Apr-2021, the patient experienced FATIGUE (Little more tired). On an unknown date, the patient experienced DIZZINESS (Dizzy). At the time of the report, FEELING ABNORMAL (He thought he was dying/Felt like he was buzzed or had taken drugs), HYPERSENSITIVITY (Allergic reaction), DIZZINESS (Dizzy), DRY MOUTH (He had cotton mouth) and THIRST (He was parched) had resolved and FATIGUE (Little more tired) outcome was unknown.            Concomitant medications were not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Treatment for the event included IV (intravenous) therapy in emergency room.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-085424 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Patient demographics was added.Patient'smedical history was added1st dose date and time of administration was added.Event statrt date and outcome of the event was updated.
Case number PHEH2014US026064, is an initial spontaneous report from a pharmacist received on 23 Dec 2014. This report refers to a male patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in a hospital approximately two months after receiving FLUVIRIN (batch number: not reported) in 2014. No adverse event was reported following the maladministration.
as soon as the injection was administered she got a very strong metallic taste in her mouth that she still has 2 weeks later.  Pt has contacted her PCP that told her to reach out to her pharmacist where she got the vax.  She was to hold off on the 2nd dose to see if the symptom subsides.
Patient developed 104 fever within 12 hours of vaccines administration and had a 30' seizure.  Full recovery.  W/u (-) PE no source.  Hx/ROS N/C.
I developed itchy hives 40 minutes after the vaccine was administered. Hives appeared on my left arm, chest, neck, and right ear. Took 2 Benadryl tablets 1 hour after vaccine. Hives subsided approximately 45 minutes after taking Benadryl.
The pt was given 0.2 of the bivalent vaccine before it was reconstituted with diluent.  Pt is not currently having any s/sx
Days 1: knot on arm with fatigue; Day 2: severe body aches,headache , 7 on pain scale. Severe  fatigue; Day 3: swollen lymph node on right side underar.. same arw as injection. Headache.  Fatigue is diminished to normal level
Pt reported feeling her hands suddenly "swollen, tight, and tingling" 15-20 minutes after vaccine administration. RN noted some mild bilateral edema in pt hands. RN took pt to observation at 3:25 PM and advised administration of oral diphenhydramine; pt consented to medication, and RN offered 50 mg of oral diphenhydramine, which pt swallowed at 3:25 PM. Pt denied all other s/s of allergic reaction. RN continued to monitor pt, completing BP, HR, and SpO2 assessment q 5 minutes; all vitals remained WNL. Pt reported no worsening or new onset of symptoms. No signs of anaphylaxis developed, so RN released pt to home at 3:55 PM. Advised pt to contact her PCP the same day for futher evaluation/instruction.
tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14-JUL-2021 contains Non Significant Information.
Within 24 hours, significant left shoulder pain.  Noticeable limited mobility in the  shoulder, specifically unable to put arm behind back; unable to straighten arm completely over head.
Backache, muscle ache in legs. Stiff neck. Started after 24 hours of receiving vaccine and has persisted for at least 6 days. Taking Ibuprofen daily.
Red, swollen, warmth, itching surrounding injection site-no swollen lips, no difficulty breathing, no hives-pt given rx: diphenhydramine parents given ER precautions.
At the time of vaccine, was 34 weeks pregnant.  After my first dose vaccine, I developed a UTI but I did not have an infection. I then went to Urgent care where an ultrasound was performed showing I had a kidney stone not an infection. I do not know if it is related to the Pfizer vaccine.   I also had my second dose vaccine, 03-09-2021 in the morning. I only experienced left arm soreness and no other symptoms to report. (Lot#: EN6205)
Pt had near syncopal episode following vaccine. Pt states "he has fainted around needles in the past" Vitals taken, hypotensive, reassessed pt after 5 minutes to find vitals WNL. Refused transport to hospital
HR feels faster starting on march 7th, described as fluttery multiple times per day pruritis for  3 weeks after the first one. put on claritin.
This non-serious spontaneous case, initially received from other non-health professional on 19-Oct-2018, concerns a 17-month-old, infant of unspecified gender. On an unspecified date, the patient (less than 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). At the time of this report, no adverse event was reported.
Developed left-sided chest pain around 8pm on 11/19, pain worsened when laying down. Presented to emergency department on 11/20 after 16 hours of intermittent chest pain that did not resolve after taking ibuprofen. Diagnosed with myopericarditis and pericardial effusion. Was able to be discharged after 3 nights in hospital. Prescribed medications for treatment and lifestyle modifications for 3-6 months. Follow up appointments and tests with cardiologists to monitor heart function over time.
Nausea beginning at 830pm, slight body aches and slight headache. Increasing fever to 101 degrees, which lasted a few hours and broke at 3am. Second day felt mostly fine except for continued body aches which ended around 3pm
Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 16Nov2021, outcome "recovering", described as "Chest pain". The event "chest pain" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of chest pain. Additional information: Ibuprophen was received for treatment of adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
As per maternal grandmother the evening of the 26th August pt became very pale, limp & hard to arouse; t102, eyes rolled back, no extremies jerking; resolved p/sev hrs;
Adverse Reaction Timeline:  09:30 am: I received a flu vaccination (FLUARIX). 10:30 am: I began to experience the onset of a headache. 10:45 am: I began to experience pain and soreness in my right arm. 11:00 am: My headache had become more painful. 11:30 am: I ate lunch and took extra strength Tylenol hoping to alleviate the pain I was experiencing. 12:30 pm: My headache is now throbbing and I am feeling a slight fever/sweat. 12:45 pm: I depart outside to get some fresh air; it was cool and raining outside.  1: 30 pm:  I took another extra strength Tylenol to try to alleviate the pain of my severe headache, and the pain/sore/stiffness in my right arm. 2:00 pm:   I drank a lot of cold water, but my headache is still throbbing and is more painful as I move my head. 3:00 pm:   I began to experience a slight relief from my headache, but my arm is still sore and painful. 4:00 pm:   The pain of my headache is still there, but is no longer throbbing and as intense. My arm is still painful to move. 5:00 pm:   I took another extra strength Tylenol with dinner and now the pain of my headache is starting to lessen. My arm is still painful when moving or touching. 6:00 pm:   I lied down to take a nap and awoke at 7:00 pm still feeling the pain of my headache and arm. 9:00 pm:   The pain of my headache is lessening, but my arm is still painful. 10:00 pm:  I went to bed still feeling slight pain of my headache, and my arm continues to be painful. 11-08-2006 05:00 am:  I get up still feeling a light headache, but the pain in my arm has now lessened. 06:00 am thru 4:30 pm:  I continued to have a slight headache throughout the day, the pain had lessened in my arm and head, but I experienced extreme and frequent urination all day long. I had to urinate constantly throughout the day, which I thought was very unusual. I had to urinate approximately every 20-30 minutes through out the day, and forced myself to drink water to prevent dehydration. 4:30pm thru 10:00pm: The pain in my arm is very slight, but I continued to have a slight headache. 11-09-2006 I had experienced a light headache throughout the day with some light dizziness and a muffled feeling in my left ear.  11-10-2006 I continue to have slight headaches off and on and experience slight dizziness at times throughout the day. I decided to complete the VAERS-1 form, and called the clinic for information to complete the form. They were very uncooperative and would not give out the full name of the person who administered the vaccine, or the name of the Doctor. They also tried to convince me that the PROBLEMS I was experiencing were not related to the flu vaccine. They did not ask how I was doing, or what measures I should take to alleviate my symptoms. I had to ask them many times for the information required to complete the Form VAERS-1(FDA). They were very uncooperative and extremely unprofessional!! As of 11-10-2006 at 5:31pm I still have a slight headache/dizziness, and if the pain continues I will go to urgent care tomorrow to find out why I am still having these PROBLEMS from the FLU VACCINATION.
Rashes in the days after the vaccine; Rashes in the days after the vaccine Seems to be related to heat; This is a spontaneous report from a contactable consumer, the patient. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9261), via an unspecified route of administration, administered in arm left on 19Feb2021 08:00 as dose 1, single (at the age of 35-years-old) for covid-19 immunization. The patient medical history was not reported. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took amoxicillin and experienced hypersensitivity. On 19Feb2021 10:00, the patient experienced rashes in the days after the vaccine and it seems to be related to heat. The patient did not receive any treatment for the events. The patient did not receive any other vaccine in four weeks. The patient had not covid prior to the vaccination and the patient had not tested for covid post vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a nurse refers to a 64 year old patient. Medical history and concurrent conditions were not reported. On 14-MAR-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
stage 4 breast cancer; This is a spontaneous report from a contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to ask if she needed to get the booster or third shot of the Pfizer BioNtech COVID-19 vaccine. The patient stated that she already took the first and second dose of the vaccines and that she had stage 4 breast cancer on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.