chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When I got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; My arm and the lymph node and everything was sore; When I got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; My arm and the lymph node and everything was sore; When I got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; My arm and the lymph node and everything was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown, Expiration Date: 03Apr2021) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "When I got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; My arm and the lymph node and everything was sore". The event "when i got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; my arm and the lymph node and everything was sore", "when i got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; my arm and the lymph node and everything was sore" and "when i got my first dose my arm was sore for a very long time; from the first dose my arm just went down with swelling and everything; my arm and the lymph node and everything was sore" was evaluated at the physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu symptons, Huge headache for days felt like I had brain injury. sick and vertigo and dizzy sweats  Messing with my normal brain thinking
Chills; Massive headache; Weakness; Leg cramps; Labored breathing.
Red arm; Swollen arm (arm blew up); Itchy arm; This case was reported by a nurse and described the occurrence of erythema of extremities in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. The patient was treated with prednisone. On an unknown date, the outcome of the erythema of extremities, swelling arm and itchy upper limbs were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: Registered Nurse unable to provide vaccine details and site of injection.  RN unsure if the vaccine was the patients first or second dose of Shingrix. The patient received a Shingrix dose and had a reaction of red, swollen (arm blew up), itchy arm. The patient was given prednisone and the events went away.  The reporter was unable to provide vaccine details and site of injection and was unsure if the vaccine was the patient's first or second dose of Shingrix. The reporter did not consent to follow-up.
Information has been received from an office manager concerning a patient who was vaccinated with a dose of Zostavax and then a couple weeks later developed shingles in their legs bilaterally. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Pt states red spot came up and kept getting bigger and bigger. Pain is burning. Hurts when something brushes up against it. Does not itch, measures 40 x 45 mm (MENACTRA sight), Tdap site small red spot.
huge lymhpnode on neck right side; awful pain in joints; didnt sleep at all last night; Chills/wild chills; headache was so bad; incredible joint pain; dont feel good; got sick wednesday night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (dont feel good), ILLNESS (got sick wednesday night), INSOMNIA (didnt sleep at all last night), LYMPHADENOPATHY (huge lymhpnode on neck right side) and CHILLS (Chills/wild chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache was so bad). On 18-Feb-2021, the patient experienced INSOMNIA (didnt sleep at all last night) and CHILLS (Chills/wild chills). On 19-Feb-2021, the patient experienced ARTHRALGIA (awful pain in joints). On an unknown date, the patient experienced FEELING ABNORMAL (dont feel good), ILLNESS (got sick wednesday night), LYMPHADENOPATHY (huge lymhpnode on neck right side) and ARTHRALGIA (incredible joint pain). The patient was treated with ACETAMINOPHEN on 17-Feb-2021 for Headache, at a dose of 1 dosage form and PROPRANOLOL HYDROCHLORIDE (INDERAL) on 17-Feb-2021 at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (dont feel good), ILLNESS (got sick wednesday night), INSOMNIA (didnt sleep at all last night), LYMPHADENOPATHY (huge lymhpnode on neck right side), CHILLS (Chills/wild chills), HEADACHE (headache was so bad), ARTHRALGIA (incredible joint pain) and ARTHRALGIA (awful pain in joints) had resolved.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Treatment medications were added, outcome of the events updated.
Information  has been received from a consumer concerning her 13 year old daughter with migraine and seasonal allergies who on 27-FEB-2008 was vaccinated with a first dose 0.5 mL of GARDASIL (lot # unknown). Concomitant therapy included AMERGE and INDERAL. The reporter reported that on 27-FEB-2008 her daughter received the dose of GARDASIL vaccine and within one or two minutes she fainted and hit her head, and had a seizure. She recovered within a short period of time. She also developed a rash around the injection site which lasted about ten minutes. It was reported that on 27-FEB-2008 the patient recovered. Upon internal review seizure was determined to be an other important medical event (OME). Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a adult male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis and SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (with no reactions). On 17th September 2018, the patient received the 1st dose of SHINGRIX and the 1st dose of Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 18th September 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season and not applicable after receiving SHINGRIX, the patient experienced feeling hot and feelings of weakness. On an unknown date, the patient experienced drug dose administration interval too long. On 20th September 2018, the outcome of the feeling hot and feelings of weakness were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the feeling hot and feelings of weakness to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient received both a SHINGRIX and flu shot on the day of his physical. The day after the vaccinations, he felt weak and feverish but these symptoms resolved within a couple of days. Since the patient never had a reaction to a flu vaccine, he was attributing these reactions to SHINGRIX. The purpose of the patient's call was for guidance on getting the 2nd dose at the time of reporting that it had been over six months since getting the 1st dose, which led to lengthening of vaccination schedule.
Headaches= next day  Lower back pain= excruciating pain the next day   Arm pain lasted for a week.  Bad taste in the mouth. For all these symptoms over the counter medications were taken such as advil or Tylenol as needed.
FEVER OVER 100 DEGREE; ARM SWOLLEN TO ELBOW AND RED; CHILLS AND ACHY
the red has faded out now and there are little puffy spots/dots and indentation in a couple of; left arm injection area is still sensitive; getting itchy; left arm was swollen; sore at injection site; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE SWELLING (left arm was swollen), VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive), VACCINATION SITE PRURITUS (getting itchy) and VACCINATION SITE ERYTHEMA (Red at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Solitary kidney. Concomitant products included Thyroid pills, CALCIUM, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and ASCORBIC ACID, COPPER GLUCONATE, FISH OIL, TOCOPHEROL, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (OCUVITE ADULT 50+ [ASCORBIC ACID;COPPER GLUCONATE;FISH OIL;TOCOPHEROL;XANTOFYL;ZEAXANTHIN;ZINC OXIDE]) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red at the injection site). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE SWELLING (left arm was swollen), VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive), VACCINATION SITE PRURITUS (getting itchy) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (the red has faded out now and there are little puffy spots/dots and indentation in a couple of), VACCINATION SITE PRURITUS (getting itchy), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown, VACCINATION SITE SWELLING (left arm was swollen) had resolved and VACCINATION SITE HYPERSENSITIVITY (left arm injection area is still sensitive) had not resolved.            No treatment medication was reported.   This case was linked to MOD-2021-033117 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Live significant follow-up appended for case ID MOD21-085628for AE"s - Arm Swelling, Vaccination site hypersensitivity.
About 1 month after dose 2, presented to urgent care March 8, 2021.  (Also had acupuncture treatment 1 week before symptoms began).  Unclear if related to vaccine but no other provider was willing to submit for patient. Symptoms include lower extremity weakness, dystonia of face, blepharospasm,  memory loss, nausea, vertigo, tremor, vision change, fatigue, muscle spasms/cramps, and headache.  Has been evaluated by numerous specialties including eye, rheum, cardio, neuro, psych, ENT, PT.  No change in the symptoms since onset in March.  Pt is now unable to drive or work due to this.
This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 20-AUG-2015, the patient was vaccinated with improperly stored doses of MMR II (lot # J010208, expiration date 23-AUG-2015, exact dose and route of administration were not reported) and VARIVAX (lot # J009987, expiration date 12-AUG-2015, exact dose and route of administration were not reported). The dose of VARIVAX was expired. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt claims once she received the vaccine she had a pain in her left side of her body. Eventually the pain went away, but she was left with a bruise on the left arm after 2 wks time had past.
One week after receiving the 2nd Moderna Covid-19 vaccine she had swelling and numbness on the right side of her face - mouth, lips & cheek.  She had pain in her right cheekbone.  The right side of her face drooped down.    She went to her doctor.  They told her to go to the dentist to be evaluated.  The dentist didn't find anything abnormal and by then the symptoms had subsided.  The swelling and pain subsided after a couple days.
Pt. states that after receiving the 3rd dose of Phizer 12/15/2021, started experiencing symptoms 12/18/2021 of shortness of breath and leg swelling. 12/29/2021 Primary visit with recommendations of Heart Exam/MRI. 01/03/2022 Heart Exam shows Enlargement of the Heart, Enlarged Aorta Valve. Pt. still experiencing symptoms.
A report had been received from a Health Professional concerning a 5 year old, male patient. The patient medical history and concomitant medications were not reported. The patient had been receiving nasal FLUMIST Quadrivalent  which was started on an unknown date. It was reported that health professional inadvertently administered expired FLUMIST Quadrivalent to three patients on 19-DEC-2014. The outcome of the events was unknown. The report was considered to be non-serious.
Headache; Lightheadedness and dizziness; Off label use; A third (booster) dose of BNT162b2 is administered subsequent to the initial 2 dose regimen of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 78-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Sep2021 at 11:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, ulcerative colitis, COVID-19 and known allergies to sulfa and opioids. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and ascorbic acid/tocopheryl acetate/zinc oxide/cupric oxide/betacarotene (PRESERVISION); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Feb2021 at 11:15 (at the age of 77-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Sep2021 at 08:00, the patient experienced headache, lightheadedness and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, lightheadedness and dizziness was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
sore arm for 2-3 days; This is a spontaneous report from a contactable consumer reported for a 86-year-old male consumer (patient) that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm for 2-3 days. What were the titer cut off levels during the trial. Caller got an antibody test with a reference point of .8 and a measurement of 250. What does this mean. Caller received second dose of Pfizer vaccine on 10Feb2021 and experienced no side effects. The clinical outcome of event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
pt recv vax & devel dimpling of thigh;dimpling is a result of necrosis of fatty tissue;MD felt needles were too short;
scan confirmed a stroke; foot was dragging; nurse forgot to reconstitute with the Shingrix antigen and injected just the Shingrix adjuvant; injected just the Shingrix adjuvant into an unknown arm; This case was reported by a consumer and described the occurrence of stroke in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus and fibromyalgia.   On 13th April 2021, the patient received Shingrix (intramuscular) and the 1st dose of Shingrix. On 13th April 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On 15th April 2021, the patient experienced stroke (serious criteria hospitalization and GSK medically significant) and leg dragging (serious criteria hospitalization). On an unknown date, the outcome of the stroke was not recovered/not resolved and the outcome of the leg dragging, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the stroke and leg dragging to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The caller was the daughter of the patient. On the 1st Shingrix injection, the nurse forgot to reconstitute with the Shingrix antigen and injected just the Shingrix adjuvant, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The Shingrix 1st injection was administered in unknown arm and after realizing her mistake, nurse reconstituted the Shingrix vaccine correctly and injected it into the patient's right arm. On 15th April 2021, the patients foot was dragging and she was transported to the emergency room (ER) and CT scan confirmed a stroke. The reporter was waiting for the results of the MRI that was done on 19th April 2021. The caller reports her mother was nursing home resident and the nurse called the caller to let her know her mother received both an injection of the adjuvant for Shingrix and a Shingrix vaccine.   The reporter does not give permission to contact the HCP.      The reporter did not consent to follow up.
Intermittent SOB for several weeks, progressively worsening over three days prior to presentation to ED. Presented with SOB, bilateral leg swelling. CXR obtained in ED showed perihilar and RUL opacities consistent w/ multifocal pna or pulmonary venous congestion. SARS-Cov2 PCR resulted as positive. CT of chest showed bilateral pna, began treating as COVID pna with dexamethasone, lovenox. Treated for CHF exacerbation with aggressive loop diuretic therapy. Required 2Lpm O2 via nasal cannula. Discharged home after 6 days in hospital.
Mom reported swelling at site of injection the next day, post vax. Seen back in clinic. Family reported going to ER on 3/25/2000 for increase in swelling. Swelling noted on 3/24/2000, included swelling of hip, knee and toes.
Fast heart rate, pulse, lightheaded, dizzy, blurry vision. Still feel a little off today.
Mixed 1st and 2nd dose from different manufacturers; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 IMMUNISATION (Mixed 1st and 2nd dose from different manufacturers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Astra-Zeneca COVID19 Vaccine (First dose). Past adverse reactions to the above products included No adverse event with Astra-Zeneca COVID19 Vaccine.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced COVID-19 IMMUNISATION (Mixed 1st and 2nd dose from different manufacturers). On 17-Jun-2021, COVID-19 IMMUNISATION (Mixed 1st and 2nd dose from different manufacturers) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist states that a female patient received a dose of Astra-Zeneca COVID19 Vaccine f, then a dose of Moderna COVID19 Vaccine.  No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received contains patient details, additional reporter and narrative supplement updated.
Patient received the Covid 19 vaccine on 12/23/2020. Twenty fours after vaccination she started to cough and wheeze (Hx of not well controlled Asthma, DM). Cough and wheezes relieve with nebuilzer. No fever, chills, or HAs. Symptoms have improved significantly and are stable.  She has reached out to her PCP and EH.   Covid Testing is scheduled on 1/4/2021 but awaiting for a sooner appt at EH.
Recent Measles outbreak in state . Suspected rash likely from vaccine.  Nasal congestion, decreased appetite, fussy and fever 101-103. Health Dept contacted and recommended further testing.
One episode of AFib in May 2016, followed by another episode in May 2017. The SHINGRIX vaccine may have caused a flare up of AFib and PVC. Patient was hospitalized for AFib on April 27th 2018 and had another severe AFib on April 30th 2018 and was transported by ambulance and hospitalized at another hospital. She has had almost continual PVC since April 27th and physician doesn't know how to stop the PVC. She is wearing a Holter monitor and the cardiac nurse reports that she is having continual, small AFibs.
The vaccine administration done 13 days after the beyond-use-date (BUD). Once received, vaccines must be stored refrigerated for up to 10 weeks. These vaccines were received on January 26, 2022. The BUD was April 5, 2022. Upon receipt, the staff confused the date and documented the BUD as May 4, 2022.