chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful lymph nodes all on left side esp in neck area which started within the first minute of receiving vaccine.; spleen pain; joint pain in hips, knees, ankles, under left shoulder blade pain; numbness in hands and feet which now is just in fingertips b/l of hands.; tingling; abnormal vaginal bleeding; This is a spontaneous report from a non-contactable nurse, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0108) via an unspecified route of administration in the arm left on 15May2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included ADHD (Attention deficit hyperactivity disorder). The patient had no known drug allergies. Concomitant medications included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (ADDERALL) and multivitamin all from an unknown date for an unknown indication and was unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 the patient experienced spleen pain, painful lymph nodes all on the left side especially in the neck area which started within the first minute of receiving the vaccine, joint pain in hips, knees, ankles, under left shoulder blade pain, numbness and tingling in hands and feet which now is just in fingertips b/l of hands, abnormal vaginal bleeding. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events spleen pain, painful lymph nodes all on left side especially in neck area which started within the first minute of receiving the vaccine, joint pain in hips, knees, ankles, under left shoulder blade pain, numbness and tingling in hands and feet which now is just in fingertips b/l of hands, abnormal vaginal bleeding were not recovered at the time of the report.  No follow-up attempts are possible. No further information is expected.
Pt was given all three vaccines. Pt then fainted and fell forward and hit head.  Pt immediately woke up and was laid on examination bed. Pt was asked name, date, and where he was at. Pt answered all questions correctly. Pt vitals and blood glucose was taken which were all in normal range. Pt given ice pack for head welt. Pt was assessed by MD.  Pt stayed at clinic for approximately 40 minutes for monitoring before being assessed again by MD and given the go ahead to DC home, but to come back to hospital if any symptoms occur.
The patient reported that she experienced significant pain, weakness, somess, chills, and muscle ache in her left arm; The patient reported that she experienced significant pain, weakness, somess, chills, and muscle ache in her left arm; The patient reported that she experienced significant pain, weakness, somess, chills, and muscle ache in her left arm; The patient reported that she experienced significant pain, weakness, somess, chills, and muscle ache in her left arm; This spontaneous report was received from a 66-year-old female patient referring to herself. The patient's pertinent concurrent conditions included an unspecified hernia, rheumatoid arthritis, and osteoporosis, her concomitant medications included hydroxychloroquine sulfate (PLAQUENIL) pantoprazole and TYMLOS. The patient had a history of drug hypersensitivity while on prior therapy with montelukast sodium (SINGULAIR) (case # 0806USA00025), also the patient had a previous drug reaction or allergy to diazepam (VALIUM), celecoxib (CELEBREX), codeine and tramadol.  On 14-APR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on shot in the left arm for prevention of pneumococcal infection (prophylaxis). On the same date, the patient experienced significant pain, weakness, soreness, chills, and muscle ache in her left arm after receiving the vaccine (pain, myalgia, chills and asthenia). The patient did not seek any medical attention, no treatment was given to the patient however an unspecified blood work was performed on an unknown date but no results were provided.  At the time of this report, the outcome of pain, myalgia, chills and asthenia was reported as not recovered.  The causality assessment between suspect therapy and the aforementioned events were not reported.; Sender's Comments:  US-009507513-0806USA00025:
AFTER THE SHOT I HAD EXTREME FATIGUE AND BODY ACHES. I CONTACTED MY DOCTOR BUT DIDN'T GO IN PERSON AND IT WENT AWAY AFTER A WEEK.
Circulatory problems; Numbness in feet; Lockjaw; Weakness; Tiredness; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOVASCULAR DISORDER (Circulatory problems), HYPOAESTHESIA (Numbness in feet), TRISMUS (Lockjaw), ASTHENIA (Weakness) and FATIGUE (Tiredness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), MONTELUKAST and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CARDIOVASCULAR DISORDER (Circulatory problems), HYPOAESTHESIA (Numbness in feet), TRISMUS (Lockjaw), ASTHENIA (Weakness), FATIGUE (Tiredness) and CHILLS (Cold chills). At the time of the report, CARDIOVASCULAR DISORDER (Circulatory problems), HYPOAESTHESIA (Numbness in feet), TRISMUS (Lockjaw), ASTHENIA (Weakness), FATIGUE (Tiredness) and CHILLS (Cold chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was provided.  The patient experienced tiredness, weakness, cold chills and circulatory problems after receiving the first and second dose. Patient also had some numbness in feet as well as lockjaw. These side effects seemed to last for a while. It took 2-3 weeks and maybe about a month to resolve.   This case was linked to MOD-2021-390859, MOD-2021-056268 (Patient Link).
Same day post vax, the pt became pale, clammy, and nauseated. Lie flat and cooled. Color improving, mild headache. Left walking with father feeling well and hungry. No nausea.
Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm; Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) and DEVICE CONNECTION ISSUE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced UNDERDOSE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) and DEVICE CONNECTION ISSUE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm). On 28-Mar-2021, UNDERDOSE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) and DEVICE CONNECTION ISSUE (Needle disconnected from syringe and 0.1-0.15 ml dripped down patient arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment information was provided.   This case was linked to MOD-2021-060889 (Patient Link).
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
two doses of Shingrix in 2019 / diagnosed with Shingles; two doses of Shingrix in 2019 / diagnosed with Shingles; started developing a rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9JG52, expiry date unknown) for prophylaxis.   The patient's past medical history included cancer (Twice).   On 12th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2020, 399 days after receiving Shingrix and 488 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: On 14th November 2020,Saturday, the patient started developing a rash and on 15th November 2020, Sunday, she was diagnosed with shingles. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown. The reporter did not consent to follow up.
patient was administered only the Dtap-IPV component of Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Agency (Reference number- 00437689) and transmitted to Sanofi on 20-Jan-2021.  This case involves a patient (age and gender not reported) who was administered only the DTaP-IPV component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via an unknown route in an unknown administration site on 12-Jan-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (product preparation issue, latency same day).  Caller asked about what needs to be done? And stated that she did not had any additional information and had referred to Pentacel for reconstitution video.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Vaccine was administered after the beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.  Patient was not involved with any adverse reaction.  No treatment medication was reported by reporter.
No adverse reaction. Inmate received Hep A vaccine on 3/19/2021 and then the C19 vaccine on 3/22/2021. Nothing happened but it was not supposed to be given for 4 weeks after last vaccine.
1.  The reaction began about 2 minutes after taking her first dose. It started as a painful numbness in the arm in which she was injected. Slowly this painful numbness decreased in intensity to the point she is now able to sublimate it away, except for a persistent moderate intensity pain in the left pinky and ring fingers.  2. About an hour after the injection the left side of her face also became afflicted with the same numbness. About two hours later her face hurt less and less and it has also decreased to the point of her being able to slowly sublimate it away. At present her main concern is that her left upper eye lid closes and it takes a conscious effort on her part to keep it open, preferring to keep it closed because it is more comfortable that way.  3. As the painful numbness receded in her left arm she began to develop an intermittent pain in the middle of her chest as if it were a heart attack. She has seen a variety of doctors and their advice is mixed and confusing. At the moment she is being seen by a cardiologist and is temporarily wearing a Holter monitor to keep track of her heart and eliminate any possibility of its complication. (She feels no radiating pain in her left arm.)
Extreme dizziness, nausea still Lasting after more than a month, though lessening
Intermittent facial palsy on left cheek, about one inch below the eye; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6205), via an unspecified route of administration in the left arm on 03Mar2021 16:00 (at the age of 44-years-old) at single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EB8727), via an unknown route, in the left arm on 25Mar2021 08:00 (at the age of 44-years-old) at single dose for COVID-19 immunization. Medical history included Slight gluten interance. Concomitant medications were not reported. The patient experienced Intermittent facial palsy on left cheek, about one inch below the eye on 04Mar2021 and intensified after second dose. Therapeutic measures were taken as a result of event are not reported. Treatment received was reported as no. The outcome of the event was not recovered.
Initial unsolicited report received from a non-healthcare professional on 19 August 2015. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number U5271AA, dose, route of administration and site of administration were not reported) on an unspecified date. On 17 August 2015, after vaccination, the patient experienced extreme swelling of axilla lymph nodes/swelling and pain redness of lymph node. It was reported that on 17 August 2015 and 18 August 2015, the patient was "called in sick" due to swelling and pain. On 19 August 2015, the patient still had extreme swelling of axilla lymph nodes. The patient did not experienced redness of lymph node. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of events was not reported. Upon medical review, the case was considered as serious due to important medical event: axillary lymphadenitis and feeling sick. Documents held by sender: none.
Subsequently the pt experienced fever, swelling, and pain with hand numbness. The pt sought unspecified medical treatment. The symptoms subsided within a few days without treatment. Ice packs were applied locally. Noted that another female pt experienced similar symptoms.
Severe rash over arms, chest and groin; Burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Severe rash over arms, chest and groin) and BURNING SENSATION (Burning sensation) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced RASH (Severe rash over arms, chest and groin) and BURNING SENSATION (Burning sensation). At the time of the report, RASH (Severe rash over arms, chest and groin) and BURNING SENSATION (Burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Patient went to HCP where he was given a steroid pack
Fainted immediately after the shot.  HR dropped to 48/ min.  He gained consciousness after he went down.  He was later given juice (he had not had breakfast).
Pt started to itch at injection site and progressively over the weekend the area became inflamed, red, and spread to cover the top part of the left deltoid.
Patient presented for her booster dose of Moderna vaccine, 0.25mL. Her prior Moderna COVID19 vaccination dates are 5/13/2021 and 6/10/2021. Her booster dose was given outside of the 4-day grace period of 6 months after completion of the primary series. She did not experience any symptoms of an adverse reaction and tolerated the booster dose well.
on April 30th I began to feel a tightness around the edges of my mouth. On May 1st the tightness became more aggressive followed by swelling around my mouth. I became light headed and began hyperventilating.  I called 911 because I became concerned of whether I would lost consciousness because at the time I was alone with my two kids.
itching rash - hives to chest, arms, abdomen, back for over  a week
Chest pain, hives, dyspnea, swelling. 3/14/08-records received-for DOS 3/2/08-Presented to ER with blood pressure 200/114. Woke up with hives all over and some itching, later noted chest tightness and chest pain on and off. Sharp stabbing pain. Impression chest pain, atypical for caridac angina.  Allergic reaction uncertain etiology.
Maculopapular pruritc rash on bilateral arms, chest, and back-improving 1/29/21 only with rash on arms-prescribed Zyrtec and Clobetasol cream She is recovering but 100% back to noraml
paralysis; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient had partial paralysis since getting the Pfizer vaccine last week (unspecified date). Her claim is that the paralysis was due to her getting the shot last Friday (unspecified date). The doctors that are tending to her say they are indeed looking into the cause and that a possible one could be the vaccine. The patient was hospitalized due the event. The event was assessed as life-threatening. Outcome of the event was unknown.   Information about the Lot/batch number has been requested.
administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU received with non significant information
I awoke at 2:00 AM on 2-14-21 with severe chills and copious perspiration. After that I slept only intermittently. When I arose at 10 AM, my left arm was swollen and throbbing with pain. I took Aleve with breakfast and that helped the pain, but not the swelling. However, this morning, 2-15-21, I noticed hives in the crook of both elbows and on my chest under both pectoral muscles. The hives don't itch or cause any discomfort except for causing some anxiety due to the fact that I haven't heard of hives being  mentioned as a side effect of the vaccine.
This initial foreign regulatory report (ADR20874085) received from the Medicines and Healthcare Products Regulatory Agency on 12 Jan 2011 has been transcribed from an Anonymised Single Patient Report: This pregnant patient received seasonal influenza virus vaccine (manufacturer and batch number unknown) on 09 Dec 2010. On 17 Dec 2010, an ultrasound was performed,  which showed normal foetal. On 18 Dec 2010, the patient presented with miscarriage of pregnancy. The patient was 20 weeks pregnant at the time of miscarriage. A clinical investigation on the same day revealed increased values for neutrophils (14.43) and white blood cell count (19.2). No unit and reference ranges were reported. High vaginal smear showed group B streptococci. There was no evidence of toxoplasma, cytomegalovirus or rubella IgM. The physician's causality assessment was not reported.
So the symptoms were the feelings of dizziness when bending over or exercising and when moving from side to side in addition a feeling of fullness in the head, then I started with ringing in my right ear.
30MAY97 10PM did not feel well;31MAy97 10AM vomiting when spoken to stared straight ahead;vomiting again;no response when spoken to, eyes not focused, head twitching side to side;no loss of bladder or bowels;to ER approx 1PM;released 5PM;