chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 minutes after injection patient developed numbness in right foot, which quickly traveled to both feet and eventually her entire body within 1 hr. She then went to the emergency room. She had cbc, cmp, esr, crp, which were all normal. ER doctor cautioned her about transverse myelitis. She continues to have full body numbness so much so that she cannot feel stool as it leaves the rectum, no longer has a cough from post nasal drainage that was irritating her throat, and no sinus irritation. Her exam today was normal neurological and with monofilament and sharp to dull touch sensation.
Injection site reaction: bleeding (stopped after applying pressure and elevating the arm), redness, swelling, itching within few minutes after administration.
she catch COVID; she catch COVID; heart issues from COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's sister-in-law). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, it was reported that, the patient got both doses and 2 months after she was fully vaccinated, not only did she catch COVID, the patient now has heart issues from COVID and had spread it to her in-laws as well. The patient was very confused on how this vaccine could protect her community the patient got sick. The patient was also the only one that developed severe issues while all the family did not have much symptoms at all. How was that safe and effective and protecting the community if her sister-in-law received both vaccines and had the worst symptoms of COVID than everyone else who did not receive the vaccine. Caller also asked if the vaccine would protect individuals in transmission of the COVID vaccine. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
12-18-2020 SLEEPY FELL ASLEEP 3 HOURS  POST VACCINE ADMINSTRATION, THAT EVENING HE WOKE UP WITH HEAD HURTING.  SLEEP A LOT ALL WEEKEND . DEVELOPED COUGH 12-22-2020. RECIPIENT STATES HE HAD MIGRAINE TWO DAYS PRIOR TO VACCINE ADMINISTRATION.  RECIPIENT REPORTS HE TAKES PERCOSET FOR BACK PAIN AND IT HELPS  MIGRAINES. COUGH CONTINUES AT THIS TIME 12-22-2020.
Patient was provided a moderna covid 19 vaccination in error. Patient is 16 years of age. Mother was present at time of vaccination. Mother informed immunizer that patient has a history of fainting after vaccinations. Patient was observed for 30 minutes after vaccination. patient experienced dizziness and became sweaty. Patient was provided water and was eased to floor to lay on her back. Patient did not loose consciousness. Patient was monitored and was determined to have recovered from dizziness episode and walked with mother to car to be driven home.
Chills, body aches, high fever, runny nose, cough.  Treated with Triaminic flu cold and cough.
Approximately 8 hours after receiving the injection (11pm) I became chilly and unable to bet warm despite warm drinks and heating blanket. Then severe shaking chills started and would not stop. BP hit 188/111 and doctor recommended calling ambulance. Taken to ER with infusion of warm saline and blankets. Normal BP 130/75 At end of visit: Temp: 97.7 p.106 Resp: 16  Ox Sat: 95% BP 112/56 Discharged approximately 4 or 5am.
Sore arm; Arm is stiff; swelling injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Arm is stiff) and INJECTION SITE SWELLING (swelling injection) in an 83-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 06VF22A, Q49L21A, Q77C21B and 004MA0A) for COVID-19 prophylaxis.     It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu. Past adverse reactions to the above products included No adverse event with Flu.   On 02-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 05-Nov-2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2022, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Arm is stiff) and INJECTION SITE SWELLING (swelling injection). At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Arm is stiff) and INJECTION SITE SWELLING (swelling injection) had not resolved. Not Provided          No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-745303 (Patient Link).
I discovered a lump on my left side, between my armpit and back. It was painful to touch and generally sore without touching. It was sore when I moved my arm around. You could see the lump sticking out when I raised my arm. It was about the size of a marble.
FIRST FEW DAYS JUST SORE ON SHOULDER  WORK ALL   THE WAY DOWN ARM BY THE 8 TH.     AFEVER AT SHOT LOCATION STARTED ON THE 11TH    MORE ON THE 12TH      ON THE 13TH A HASH THAT ITCHED STARTED   THIS IS THE 14TH  INJECTION SITE IS  HOT, SWOLLEN  ITCHES WITH HASH   ALONG WITH A HEAD ACH
Slight swelling and moderate pain from the axillary lymph nodes started: Friday morning, swelling disappeared Sunday morning; pain still persists
Developed a rash on face and trunk also a temperature of 102.00 for a day. Rash went away 3 days later. No treatment was necessary.
shortness of breath, numbness and pain in left arm,  lymphedema, for months.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06May2023 at 10:00 as dose 6 (booster), single (Lot number: GJ6742) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 26Jun2023 to 01Jul2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300249432 same reporter/patient, different drug/event;
She received the H1N1 influenza vaccination to the left deltoid at approximately 1000 11/2/09. She immediately developed tingling sensations in the left 4th and 5th fingers. No weakness or numbness. She experienced some achiness in the left deltoid. She was seen by doctor at 14:30 11/2/09. No treatment prescribed except heat application PRN and ibuprofen or TYLENOL PRN.
Hives, itching, redness, traveling from location to location on arms, back, legs, torso, scalp , chest, feet, buttocks. started 3-9-21, still in going despite steroid injection at the Hospital on 3-10 @ 330am, started prednisone 50 mg orally today 3-11.
Patient is 17 but Moderna is approved for 18 and above. Vaccine was given for under age group. There was no adverse reaction occurred.
Shakes; Cold; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Shakes) and NASOPHARYNGITIS (Cold) in an 84-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030338) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Patient had no known allergies. No health conditions were reported.  The patient's past medical history included Stent placement (Caller had a couple of stents put in around 2014.) in 2014 and Surgery (Caller had an operation on spine 5 weeks ago.) in 2023.   On 11-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 12-Oct-2023, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 11-Oct-2023, the patient experienced TREMOR (Shakes) and NASOPHARYNGITIS (Cold). At the time of the report, TREMOR (Shakes) and NASOPHARYNGITIS (Cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Heart rate: Pulse rate went to 110 and it was hours before it got down to a 70. Probably about 6 or 7 o'clock this morning..     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  On 12 March 2021, patient took 1st dose of Moderna vaccine having batch lot number 027A21A and on 10 March 2022, patient took 2nd dose of Moderna vaccine that having batch lot number 001M21A.  The patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had the Moderna shot yesterday around noon and did not experience symptoms around 4:30PM and had severe shakes and really really cold.  Patient definitely had the most severe symptoms that they ever had for being cold. Patient was surprised because he had no symptoms of the previous ones.   Treatment Medication use information was not provided by reporter.
Patient received 2nd dose of her Covid Vaccine which was Moderna.  However, her first dose was Pfizer and was received on 2/4/21.
patient received moderna vaccine on 8Feb2021 and would like to know if she can still receive the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient received moderna vaccine on 8Feb2021 and would like to know if she can still receive the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received moderna vaccine on 8Feb2021 and would like to know if she can still receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received moderna vaccine on 8Feb2021 and would like to know if she can still receive the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
02/13/2021 I developed mild side effects of pain at injection site & minor body aches,  These resolved on 02/14/2021.   02/15/2021 I developed an altered sense of smell.  I smell an medicinal or chemical smell.  Husband does not smell this so it is not an environmental odor.  Received a covid test on 02/22/2021 which was negative.  The altered sense of smell is still persisting.  Notified my doctor of it & she asked that I notify the CDC as it may be a potential side effect from covid vaccine.
This case was reported by a other health professional and described the occurrence of shingles in a 68-year-old patient who received SHINGRIX. On 24th April 2018, the patient received SHINGRIX 50 mcg/mg. On 19th May 2018, 25 days after receiving SHINGRIX, the patient experienced shingles, pain and sleeplessness. On an unknown date, the outcome of the shingles, pain and sleeplessness were unknown. It was unknown if the reporter considered the shingles, pain and sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient never had shingles previously. The patient received SHINGRIX and diagnosed with shingles (diagnosed by the patient's doctor). It was very painful and the patient cannot sleep. The patient wanted to know that how this happened besides vaccination. The patient said that since the vaccine was supposed to be the newest and best and no one told the patient that the SHINGRIX would give the shingles not even literature. The patient would have never got the vaccine. The patient want $168 back for the shot, and said that who knows how much work the patient would miss. The patient would be posting this on GlaxoSmithKline website and social media unless GlaxoSmithKline could show literature where it said the vaccine could give the shingles.
Painful rash developed on palms of hands and fingers, including finger tips 2 weeks after 2nd vaccination.  Conservative treatment with lab evaluation, supportive care and moisturizer to peeling skin. Improving over 4-5 weeks, still with mild symptoms. No systemic symptoms.
Information has been received from a physician concerning a patient who was vaccinated 2mL, orally with ROTATEQ. Subsequently the patient experienced diarrhea that lasted for 6 weeks after receiving the second dose of the vaccination. Subsequently, the patient recovered from diarrhea. The patient sought unspecified medical attention via an office visit. Additional information has been requested.
The pt experienced several papules, pruritic. The next day, more appeared on the scalp, ears, trunk, proximal arms, genitalia. The pt also had a case of chicken pox at 15 months of age.
Patient developed rhabdomyolysis discovered on 6/2/2022 (he is at higher risk for this due to CPT2 deficiency, peak CK 36k) and subsequently myocarditis discovered on 6/3/2022 (per Hospital metabolism department, he is NOT at higher risk for myocarditis due to his underlying condition). Cardiology consulted. ECHO performed showing nl systolic function but some signs of inflammation. He received IVIG for treatment as cannot get NSAIDS due to his CPT2 deficiency. No hemodynamic compromise.  Troponins down trending as of 6/5 (peaked 1.24). Remains admitted for likely side effects of IVIG (severe headache) and continued hydration in setting of poor PO intake.
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 17-years old female patient who received FLUZONE QUAD 0.25 instead of the 0.5 ml, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was actual medication error due to vaccine underdose. It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
No adverse event; adults received 0.5 ml of Moderna vial intended for ages 6-11; adults received 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adults received 0.5 ml of Moderna vial intended for ages 6-11).    No concomitant medication were reported.  The pharmacist stated they accidentally gave a group of people the wrong dosage of the Moderna booster. They wanted the bivalent booster, but they gave the one intended for ages 6-11.  No treatment information was provided by the reporter.
pt recv vax 1992 & pt exp an intermingling of lupus-like synd & lichen planus synd;lab eval antinuclear antibodies negative;MD did not have a definitive dx;
11/10/10 headache, temp 100.1 11/16/10 this is third headache (today again) since receiving VARIVAX 11/8/10 11/17/10 felt fine H/A gone.
Patient developed redness and swelling below site of injection.  Advised ice/TYLENOL/ADVIL.
Patient received vaccine on 02/03/2014 at public health. Presented to clinic to see FNP on 02/05/2014. Diagnosis was outlined urticarial L upper arm. Was booster injection.
Missed 2nd dose last week and more than 36 days have passed since first dose; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose last week and more than 36 days have passed since first dose) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose last week and more than 36 days have passed since first dose) and FATIGUE (Tired). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose last week and more than 36 days have passed since first dose) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF RIGHT POPLITEAL VEIN HYPOTENSION
fever, confluent maculopapular eruption of face & trunk; marked improvement w/in 24 hr;
I was already on day 4 of my regular menstrual cycle when I got my first dose (3/19/21). That night I felt warm but never had a fever, had usual arm soreness and my tongue was a little swollen but possibly from the food I ate too. No other symptoms that I could tell. The weekend after my bleeding was SUPER heavy although I didn't have cramps that usually are associated with my heavier times. The amount slowed to a "normal" period day but I kept bleeding for days after it should've ended. I dismissed my symptoms after discussing it with an RN who suggested maybe it had more to do with my age than the shot. I was still bleeding although it had lessened to a small amount the weekend of April 9 and 10th and then on the 11th I started bleeding like a normal period again. The bleeding during this cycle was the most I've ever bled, in my life (!) and continued for 5 days. (Usually I have 1-2 heavy days in a 4-7 day  "normal" cycle). I was supposed to get my second shot April 16th but cancelled and scheduled an MD appt instead. At that point I had been bleeding for 31 days straight. They suggested I come in so they could do blood tests to make sure I wasn't getting anemic. I saw an OBGYN on Friday 4/16, they did an ultrasound 4/22 and all results have come back normal. I started a round of ibuprofen and my bleeding cycle seemed to cease around April 22nd.
positive test for covid after receiving 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive test for covid after receiving 1st dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive test for covid after receiving 1st dose of vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (positive test for covid after receiving 1st dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N007931, expiry date: 17-NOV-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.