chrisvoncsefalvay/vaers-outcomes huggingface dataset:
receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd booster dose. No concomitant medication was reported. No treatment medication was reported.
A report has been received from a Health Professional  concerning, two patients of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patients experienced BLOODY NOSE. The patients recovered from the event of BLOODY NOSE on an unspecified date. The report was considered to be non-serious by the reporting health professionals.
Patient experience vasovagal syncope and LOS for approximately 10 seconds. Sustained a 4 cm laceration to right forehead. EMS was called and patient was treated in ED. 11 sutures placed. Imaging was not performed. ROS normal except as noted.
Symptom started with a very itchy head. Awhile after (30min or less) a very itchy face that turned into red raised spots that resembled mosquito bites. I then took kids Benadryl (1hr after or less), since that was all I had.  10ml The Benadryl worked. It stopped the itching and the red itchy bumps on my face also went away. I took Benadryl the next day also as a precaution.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. Approximately on an unknown date in August 2015 the patients were vaccinated with Oral ROTATEQ Lot K014826, expiration date 28-MAY-2016 which were exposed to temperatures outside of the recommended range since 06-AUG-2015. This case is linked to the cases 1508USA010627, 1508USA010363 via same reporter link. Additional information has been requested.
it was rpt concerning pt who in jul98 was vax & subsequently has twice had a recurring vesicular rash that resembles chickenpox, w/6 vesicles scattered all over body. had more lesions w/1st outbreak
dizziness; headache; joint pain; body ache; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (body ache) and FATIGUE (exhaustion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A12A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included COVID-19 (was exposed a year ago ) since an unknown date.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (body ache) and FATIGUE (exhaustion). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (body ache) and FATIGUE (exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) had a year ago, her antigen test showed that she still had antibodies..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were birth control pills with estrogen.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Physical address updated
Patient presented with a rash and bump on the same are that received the vaccination. She had a fever that last about 48 hours post-vaccination. The bump appeared about 24 hours post-vaccination. She only had mild symptoms after her first vaccination. She was taking OTC Ibuprofen at this time.
Information has been received from the registered nurse concerning to an approximately 4 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-NOV-2014, the patient was vaccinated with improperly stored dose of ROTATEQ (lot number: J012522 with expiration date of 31-JAN-2015) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with ROTATEQ was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Slight fever of 99;  all over aching;  extreme fatigue and tiredness for about 24 hours.
A report has been received from a Physician concerning a 2 year old, Female subject, Height: 39.5 IN; Weight: 38.5 LB, who had been receiving Nasal FLUMIST, 2.0 Millilitres, Once/Single administration. FLUMIST started on 05-Sep-2012. The patient experienced HEADACHE, FEVER and RUNNY NOSE which started on 09-Sep-2012. The patient recovered from the event of HEADACHE, FEVER and RUNNY NOSE on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 03-Oct-2012: new reporter, vaccinated by reporter; patient details; vaccine details; outcome of the adverse event added.
Mild headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Feb2021 as a 1st dose, single for COVID-19 immunisation. Co-suspect medication included Aimovig (ERENUMAB AOOE) for migraine. The patient's medical history included migraines for 67 years. The patient's concomitant medications were not reported. Stated that she took the first dose of covid vaccine on the 05Feb2021 and she did not have any side effects aside a mild headache (patient said that she always gets a headache since she had migraine for 67 years). Patient stated that she takes an injection of Aimovig (for Migraine) every 10th of every month and she would like to know whether if it interferes with the covid vaccine and she should skip/take it later. The patient stated that she usually take 2 Tylenol for a headache and she was good to go. On an unspecified date in Feb2021, the patient experienced headache. Treatment medication included Tylenol. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Rash; Herpes zoster (Shingles); Throbbing and sharp pain at lower left rib and back; Throbbing and sharp pain at lower left rib and back; Pain increased; Dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 (Lot number: FH8024) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; SPIRONOLACTONE; MIRTAZAPINE. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin"; Lidocaine, reaction(s): "Known allergies: Lidocaine". Vaccination history included: Bnt162b2 (dose number=2, Product=COVID 19, brand=Pfizer , lot number=ER8735, administration date=07May2021, vaccine location=Left arm), administration date: 07May2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (dose number=1, Product=COVID 19, brand=Pfizer , lot number=ER8735, administration date=15Apr2021, vaccine location=Left arm), administration date: 15Apr2021, when the patient was 40 years old, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "Dose number=3"; MUSCULOSKELETAL CHEST PAIN (non-serious), BACK PAIN (non-serious) all with onset 19Dec2021 12:00, outcome "not recovered" and all described as "Throbbing and sharp pain at lower left rib and back"; PAIN (non-serious) with onset 19Dec2021 12:00, outcome "not recovered", described as "Pain increased"; RASH (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Rash"; HERPES ZOSTER (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Herpes zoster (Shingles)". The events "throbbing and sharp pain at lower left rib and back", "throbbing and sharp pain at lower left rib and back", "pain increased", "rash" and "herpes zoster (shingles)" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of musculoskeletal chest pain, back pain, pain, rash, herpes zoster.  Additional information: The patient did not receive any other vaccines within 4 weeks. Treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Mar2021 as dose 1, single (Lot number: 044A21A), in right arm and on 10Apr2021 at 15:00 as dose 2, single (Lot number: 036B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: (30-39.9). Concomitant medication(s) included: TYLENOL; IBUPROFEN; NAPROXEN SODIUM. Past drug history included: Amoxicillin, reaction(s): "Known allergies : Amoxicillin", notes: Known allergies : Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 30-39.9; SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine, COVID 19 Treatment, from 27Aug2022 to 31Aug2022, Lot number- FY9906, Onset with sore throat followed by headache, sinus congestion, some sneezing/coughing, general fatigue.
Lymph nodes under arm and under jawline swelling and sore..Injection site swelling 2? around site of injection going on 4 days tried taking ibuprofen but doesn?t seem to help much.
Pt. states that after receiving the 1st dose of Moderna 08/18/2021, started experiencing symptoms 08/18/2021 of weakness and numbness (Neuropathy). Pt.'s Neuropathy has worsened resulting in use of a cane to be mobile. No noted Primary visit/communications. Kidney Specialist recommendations to not receive the 2nd dose of Moderna.
Covid arm: Large rash appearing two days after shot. Doesn't hurt or itch.  Is hot. Today is Day 5. It's still there but decreasing.
Information has been received from a healthcare worker concerning a female who experienced groin pain and a lump in her groin after receiving a dose of GARDASIL (660616/0570X). The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
A large local reaction appeared (erythema); This is a spontaneous report from a contactable physician.  A 22-year-old male patient of an unspecified ethnicity received his TRUMENBA, via an unspecified route of administration on 02Jun2017 at single dose for immunization.  The patient medical history and concomitant medications were not reported. The patient experienced a large local reaction appeared (erythema) on an unspecified date. The outcome of the event was unknown.
About 20 minutes after shot left side of face started to tingle.  Moved up face and grew numb.  Felt like shot of novocaine from Dentist.  Felt very nauseous, thought I would throw up.  Hand started tingling, some numbness in arm, some pressure in chest, no pain.  Called Dr., went to walk-in clinic.  By that time, teeth were chattering, very fatigued and would have slept except for nausea.  They did EKG.  Doctor said all fine but probably related to shot. Went home.  Severe headache that night, could not lie down.   Arm sore, not painful.  Sore throat, swollen glands.  Week later, lower cheek still numb, headache better.  Jan 18 - Arm starts intense itch and breaking out in rash.  Spreading under arm.   Left eye very sore and bloodshot.  Face increasing numbness (left side).  Headache back.  Extreme fatigue, tinnitus.    Jan 19 - Arm worse, feels like shingles, fatigued laid down and could hardly move.  Husband woke me.  Could not form words because of numb lips.  Arm burning, extreme itch.  Throat sore.  Jan 21 - Face very numb, rash improving, eyes itching, throughout sore, swollen.  New rash at shot site.  Jan 23 - Lips tingling, numb face, headache, arm much more sore.  Very nauseous.  Jan 27 - Face numb, rash on face.  Jan 29 - Face numb, nauseous, sweating, arm breaking out itchy.  Jan 30 - Left eye very sore/bloodshot.  Burning and red welt at shot site.  Rash on left side of face and numb.  Feb 1 - Left eye very sore, neck sore. Feb 2-4 - Can't smile the same.  Left side weaker,  Tongue numb.  Feb 16 - Face now tingling, not as numb.  Rash on arm.  Nauseous.  Eye painful.  Feb. 24 - Woke in night - lips numb, Left eye numb into brow.   April 21 - Still having original symptoms.  Face numbness increase/decrease.  Heart fluttering, palpitations, chest discomfort that has become painful, have trouble getting enough breath.  Constant.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. No concurrent conditions, medical history and concomitant medications were reported. The temperature excursion occurred on 26-SEP-2016; the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes, and a maximum temperature of 6.2 F for 20 minutes. On 28-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 (dosing details was not reported) subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA012216.
Narrative: REPORTED LEG PAIN/DISCOMORT, BILATERAL ARM PAIN,  SKIN TIGHTNESS ALL OVER, AND ELEVATED BLOOD PRESSURE THAT  BEGAN APPROXIMATELY 8 DAYS AFTER FIRST VACCINE. REPORTS  PRIOR HISTORY OF GUILLAIN BARRE SYNDROME AND BEING  WHEELCHAIR BOUND/NON-AMBULATORY SINCE 2005. HOME BLOOD  PRESSURE READING REPORTED WAS 153/75 WITH HEART RATE OF 70.  REPORTED TO CLINIC PROVIDER AND INSTRUCTED TO VISIT NEAREST  EMERGENCY FACILITY FOR FURTHER EVALUATION.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with dose 1, 0.5 ml GARDASIL (lot number unknown) in July 2012. Route of administration and site was not reported. In November 2012 the patient was vaccinated with dose 2, 0.5 ml GARDASIL (lot number unknown). Route of administration and site was not reported. No adverse effect was reported. The original reporting source was provided by a nurse practitioner. Additional information has been requested.
Around 9pm 10/25 (~28hrs post vaccination PPSV23), developed rash on left arm, which started as patches but then consolidated to about a 4inch diameter, hot, hard area. Also developed bone pain (severe in left arm, moderate throughout), chills, fever (101.4 Tmax sustained), and throat swelling, with some respiratory distress. Self treated with Zyrtec 20mg x 1, Hydroxyzine 25mg x 1, and Albuterol 2 puffs q 15 minutes x3, Naproxen 440mg x1; throat swelling and respiratory distress resolved. On 10/26 am, rash still evolving; re-dosed Hydroxyzine 25mg x1. Sustained rash, bone pain, and fever for >48 hours (despite ATC Naproxen). As of today (10/30), still residual left arm bone pain and golf-ball size lump in arm with erythema.
04/12/06 17:00 body aches, T 100, fatigue, swollen, tender, red at site of injection. Took Advil 600mg and went to bed at 20:00. Slept. Fever broke during meddle of night approx 0400. 4/13 no fever, took 400mg Advil before work. Continued feel achy and fatigued. Site less red, but tender and swollen, red pinpoint injection site.
pt recvd vax & devel thrombotic thrombocytopenia purpura;
Numbness and tingling in my right side of my face and right arm.  Went to Urgent Care but symptoms were gone.  Suggestion was to take baby aspirin.  The next day the symptoms came back and I went to the ER.  They drew blood samples and did a CT scan.  Everything appeared to be normal.  Referred to a neurologist but couldn?t get in until July.  Follow up the following week with my Dr.  She said since the CT scan showed no sign of stroke, cancer or tumor, there really wasn?t a need to get an MRI.  No further outbreak of symptoms.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Swelling started day one near injection site. Day 3 swelling and redness, tightness and a few blisters shoulder to elbow.
Headache; fever; diarrhea on the day and night of the vaccine; all but diarrhea gone the next day.
lt upper arm is larger in circumference than rt upper arm;tenderness around lt elbow;cannot flex elbow fully wrist is somewhat stiff;finger are uninvolved;afeb;tx DPH, warm compresses & warm soaks;
Information has been received from a pharmacist referring to 2 newborns (numbered 53 and 54). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 26-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Patient ID:   72 y.o.     Admit Date:  9/1/2022     Discharge Date: 9/4/22     Principal Dx/ Final Dx:  COVID-19     Relevant Inpt Dx:  Principal Problem:    COVID-19  Active Problems:    Acute respiratory failure with hypoxia    Type 2 diabetes mellitus    Malignant neoplasm of upper-outer quadrant of right breast in female, estrogen receptor negative           HPI:     Hospital Course:    This72 year old woman with breast cancer was admitted with covid.  She had hypoxia.  She did get remdesivir and steroids.  Today her lungs are without wheezing and she is not hypoxic on room air.  She will complete steroids orally.  She will call oncology beginning of week about next chemo treatment.        She does have diabetes and will resume home diabetes medications.              Consults:    IP CONSULT TO SOCIAL WORK        Disposition:  home     Discharge Condition:  fair
After not having a period for over 2.5 years I got a period 3 days after the shot; This is a spontaneous report received from a contactable consumer(patient).A 56-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 17:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. Medical history included and concomitant medications were not reported. The patient did not had allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks of vaccination. There was no other medication within two weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021, the patient experienced menstrual disorder. It was reported that patient did not had a period for over 2.5 years, and she got a period 3 days after the shot. No treatment was received for the events. The outcome of the events was reported as recovered on unspecified date 2021.   Information on the lot/batch number has been requested.
Worse pain/lingering pain; lingering pain when I'm tired; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included migraine.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the pain and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that, worse pain than his/her migraines and he/she still had lingering pain when tired.  Shingles shot had helped but had not taken the lingering pain totally away. Additional Supportive Information: The follow up would not possible as no contact details were available.
generalized pain/generalized body aches; shortness of breath; chills; sick; fever; feeling run down; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced generalized pain/generalized body aches, shortness of breath, chills, sick, fever, and feeling run down; all on 28Dec2020. The reporter didn't know if the patient had tested positive for COVID after receiving the COVID vaccine. This patient was not in the hospital at time of reporting. The outcome was unknown.   Information on the lot/batch number has been requested.