chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; This is a spontaneous report from a contactable consumer   A patient of unspecified age and gender received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date of Jun2021 as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Customer reported that four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated. Exposure could not have occurred before Monday 21Jun2021 and symptom onset (all positive tested individuals were symptomatic) was by 25Jun2021. They were all researchers and recognize the impossibility of this not being a variant. Patient was totally willing to participate in any studies that might help understand variants and the efficacy of the vaccine on them. On 25Jun2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
welts & hives devel rt arm, lt arm, lt inner thigh approx-started feeling achy & congested, pain in L-S area 2hr p/vax;welts appeared approx 16hr p/vax
Pt given varicella vaccine in error, should have been given zostavax.  No adverse reaction noted.  Zostavax will be given in 4 weeks, due to it being a live vaccine.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included MTHFR gene mutation in 2000 and Heart murmur in 2000. Concurrent medical conditions included Allergic reaction to antibiotics, Dust allergy, Ragweed allergy, Food allergy, Migraine (Migraine severity has been worse), Hypothyroidism, Hashimoto's thyroiditis (The patient had been on Armour Thyroid medication 22mg for years, Abnormal TSH level/ thyroid medicine discontinued) since 2000 and Osteoporosis (But before vaccine) since 2006.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with DIAZEPAM (rectal) ongoing since an unknown date for Spasms, at a dose of 10 mg once a day; ACETYLSALICYLIC ACID (ASPIRIN 81) ongoing since an unknown date for Clotting disorder, at a dose of 81 mg once a day; UBROGEPANT (UBRELVY) (oral) ongoing since an unknown date for Migraine, at a dose of 100 milligram; THYROID (ARMOUR THYROID) (oral) for Hypothyroidism, at a dose of 22 mg once a day and DIHYDROERGOTAMINE MESILATE (MIGRANAL) (nasal) ongoing since an unknown date for Migraine, at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: negative (Negative) Rapid(PCR was negative) Date:11/???/2020. In 2020, Thyroid function test: extremely low (Low) Extremely low, , despite being on Armour, which she had been taking for years.. On 25-Feb-2021, Thyroid function test: low (Low) Recovered with residual effect.. On 30-Mar-2021, Thyroid function test: abnormal (abnormal) Result was abnormal when retested.. On 30-Apr-2021, Thyroid function test: low normal (Inconclusive) Result was Low normal. On 01-Jun-2021, Thyroid function test: normal (normal) Patient latest test indicated patient's thyroid stimulating hormone level(TSH) was starting to come back to normal..     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 information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received and contains significant information: Patient demographics, medical history, lab data, concomitant medications and events was added and event date was updated.
feels the tingling, prickly sensation; her legs are somehow red; Something is crawling beneath my skin; itchy skin more whenever she is on bed already; rashes on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feels the tingling, prickly sensation), ERYTHEMA (her legs are somehow red), FORMICATION (Something is crawling beneath my skin), PRURITUS (itchy skin more whenever she is on bed already) and RASH (rashes on her arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced PARAESTHESIA (feels the tingling, prickly sensation), ERYTHEMA (her legs are somehow red), FORMICATION (Something is crawling beneath my skin), PRURITUS (itchy skin more whenever she is on bed already) and RASH (rashes on her arm). At the time of the report, PARAESTHESIA (feels the tingling, prickly sensation), ERYTHEMA (her legs are somehow red), FORMICATION (Something is crawling beneath my skin), PRURITUS (itchy skin more whenever she is on bed already) and RASH (rashes on her arm) outcome was unknown.            No concomitant and treatment information was reported.  Patient did not have any side effects with first dose of vaccine.
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022; No Adverse event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022) and NO ADVERSE EVENT (No Adverse event) in a 15-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022).    No concomitant medications were reported.  It was reported that administered approximately 50 doses of Moderna COVID-19 Vaccine after 30-day use by date. reporter mentioned vials were initially stored in the fridge on 08-Jul-2022, and vaccines were administered from 07-Aug-2022 to 11-Aug-2022.  HCP was not aware of any symptoms for patient after the vaccine was given.  Number of doses were reported as around 50 doses from 5 vials.  The vial did not undergo any temperature excursions.
The soreness is always there and it really bothers me; Left arm where they gave him injection has been sore since vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 2, single, Lot Number: EC3180, caller uncertain of anatomical location of the vaccine, thinks it was his left arm.), administration date: 09Aug2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, single, Lot Number: FA6780, caller uncertain of anatomical location of the vaccine, thinks it was his left arm.), administration date: 19Jul2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "not recovered", described as "Left arm where they gave him injection has been sore since vaccine"; PAIN IN EXTREMITY (non-serious) with onset Feb2022, outcome "unknown", described as "The soreness is always there, and it really bothers me".  Additional information: They advised him to take Ibuprofen and put ice on it. Caller states that's not what he needed. Says he just wants to know if he should be concerned and if there is any information related to this. Caller states it has been ongoing since 09Feb2022 and even holding the handle on his zero-turn lawnmower causes pain.    No follow-up attempts are possible . No further information is expected.
First 2 minutes-- heat and pressure lower right tailbone, then upper left side of neck.  Lasted a couple minutes  After 15 minutes -- lightheaded and dizzy - lasted 90 minutes Also after 15 minutes -- upper left quadrant of face and scalp (eye area to ear and back past scalp hairline) went numb and contracted, feeling of not being able to control my forehead muscles, a rush of sensation that made me feel unwillingly teary. This lasted a minute  or two.  Feeling returned to forehead but remained slightly numbed (like after drinking alcohol) for another 20 minutes or so.
This solicited report was received from a consumer and refers to her daughter, a female patient of unknown age. The patient was enrolled in a Market Research. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with a dose of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Shortly after receiving the vaccine, on an unspecified date, the patient experienced immune thrombocytopenic purpura (I.T.P.). Shortly after, the patient was in hospital with "no platelets" (platelet count decreased). Laboratory exams for the plague ("peste") virus came back negative. At the time of the report, the patient was "conic" (adverse event). The outcome of the event immune thrombocytopenic purpura was unknown. The reporter did not assess the causality between the events immune thrombocytopenic purpura and "conic" (adverse event") and therapy with M-M-R II. Upon internal review, the event immune thrombocytopenic purpura (I.T.P.) was determined to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the product therapy and the reported event cannot be established. More information is requested. This report includes a non serious adverse event. Company Comment- No changes to the product safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of the country, continues to monitor the safety profile of the product. Sender's Comments: US-009507513-1702USA009655.
09/11/22 presents to EC ED for "fatigue, corona virus concern". PMHx of "severe kyphocoliosis, chronic pain"
tested positive for Covid two days after getting vaccine; tested positive for Covid two days after getting vaccine/nasal swab/ NP PCR and result was positive; This is a spontaneous report from a contactable physician.  A 39-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), intramuscular on the left arm on 24Dec2020 at 08:30 at a single dose for Covid-19 immunization. There were no medical history and no concomitant medications. The patient has no known allergies to medications, food, or other products. On 25Dec2020 at 09:00 am, also reported as 26Dec2020, the patient was tested positive for Covid two days after getting vaccine. He was wondering if he should get the booster dose in 3 weeks or not since he will have natural immunity. The patient did not receive any treatment for the events. The patient had a nasal swab/ NP PCR and result was positive on 26Dec2020. The outcome of the events was not recovering. The events were assessed as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the COVID-19 PCR test positive represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Adverse reaction to the PNEUMOVAX 23, patient reports blister and rash from the arm to the face. Patient felt ill the evening of the immunization (10/5) and woke the next morning with the rash, which had spread on Friday to the face and formed blisters.
12/9/2009: treated by pediatrician for conjuctivitis & croup. 12/20/2009: treated in ER for pneumonia symptoms. 12/28/2009: patient collapsed & fell, ultimately resulting in 5 night stay in pediatric hospital with post infectious encephalitis.
2 days after first dose pain and swelling in rt knee resolved after 2 weeks.    2 days after the second dose had sever incapacitating pain in rt knee again.  Pt does have thallasemia minor
About 2 hours after receiving the shot at work, I started to get itchy on my chest and eyes.  Then when I woke up on the 30th, I had a rash on my chest and my eyes were itchy still....I started taking Benadryl, but nothing has changed yet.
This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # L023870 Expiry: 20-APR-2017). No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
3. Days Following 2nd shot developed feeling lump in throat with swallowing. Assumed it was related to immune response however has not resolved. No other symptoms at the time.  Developed noticeable palpitations and flushing of skin within the past 2 weeks and following CT scan and u/a the thyroid is very large and pressing on airway and esophagus.
Pain, flu like symptoms, the pain present 6/10 on pain scale. Arm shot area with pale ring around injection site.
A report has been received from a Health Professional . It was reported that a 1 year old child was potentially inadvertently administered Nasal FLUMIST. FLUMIST started on an unknown date. The outcome of the event of potential inadvertent administration is unknown. The report was considered to be non-serious.
The patient reported pain and discomfort in right shoulder, at the injection site, 5 days after receiving the injection. The patient was instructed to place a cold compress to the injection site and to take acetaminophen. The pain and discomfort subsided 24 hours later.
Moderate pain in arm of the injection, some all over body aches, fatigue approximately 1 day after the second injection.  After the first injection only pain in the arm which received the injection.   Took 2 Tylenol with onset of the pain and repeated when necessary with the first injection.  For second injection took 2 Tylenol pills and arm pain and body aches subsided.   After both injections, side effects only lasted a day.
Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: Rph gave first pfizer covid vaccine to patient and she felt nauseaus within a couple of minutes.  Mother reports daughter lighter in color and needed a bag in case she needed to vomit.  PT's mother declined to be brought into ER because daughter (patient) appeared to have recovered.  Instructed by parametics to f/u with primary doctory.
Not feeling well a few hours post vaccination, face turned red and right arm is painful and swollen.
Pain in arm on day of vaccine.  Next morning, swelling around injection site.  Generalized Malaise, headache, stomach ache, cervical neck pain without stiffness, fever 105 degrees orally.  No treatment except Tylenol as needed.
vomiting a few hours after getting the vaccination. Along with diarrhea, headache, dizziness, and abdominal pain.
Patient was a new admission since our 1st dose clinic.  The facility failed to notify us that the patient was given the 1st dose on 1/7/2021 at another facility. We, therefore administered the second dose on day 21 instead of the 28 day interval for Moderna.  The patient has not experienced any severe side effects as a result.
Patient forgot card. Verified Moderna vaccine to be given several times. Moderna given. Later patient stated Pfizer given resulting in mixed series mRNA vaccine delivery.
Reported onset of sustained dizziness assoc w numbness and tingling of bilateral hands and change in sensation of thumbs 10 minutes after vaccine admin. She did not notify clinic staff, self administered Benadryl 50mg and waited until staff checked on her at 20 min mark to report. Upon assessment pt is sitting up, appears mildly anxious, denies SOB, CP or difficulty swallowing. Dizziness is persistent despite change in position and fluids, removal of N95 mask. VSS, b/p 106/68, p 68, RR 26. Pt encouraged to push fluids, recline in seat and take slow deep breaths. Hand sensation w/ mild improved but did not resolve after 10 minutes, dizziness unchanged. Pt and husband verbalized understanding of further care options. Pt and husband chose to return home and verbalized understanding of when to seek further care. Pt agrees to contact PCP for further direction prn.
Several months later, I experienced left arm pain. It felt vascular in nature, then affected the nerves. The pain was severe, awakening during the night. It happened 5 nights in a row. Then several weeks later, it happened again. This time in my right arm. I attributed that to being on Levaquin, for an infection but once again after 4-5 days it disappeared. A few weeks later, I lost vision in my left eye, lasting about 2-3 minutes at time. There were several episodes of this over the course of 5 days. The optometrist took pictures and stated that the blood vessels were irritated and that I could have a stroke in it at any time.  Once again, I thought it might be a reaction to Levaquin as I was on it for a procedure. But, the initial left arm pain did not include Levaquin. I am not sure if this is truly a symptom from the shot, but I am afraid to get my second dose.
severe headache, fever, could hardly walk, chills, severe stomachache; severe headache, fever, could hardly walk, chills, severe stomachache; severe headache, fever, could hardly walk, chills, severe stomachache; severe headache, fever, could hardly walk, chills, severe stomachache; severe headache, fever, could hardly walk, chills, severe stomachache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm left on 09Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), multi vitamin CBD (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took loratadine (LORATAB) and experienced drug allergy. On 09Apr2021 at 14:00 the patient experienced severe headache, fever, could hardly walk, chills, severe stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headache, fever, could hardly walk, chills, severe stomach ache was recovered on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm left on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected
This spontaneous report was received from a physician via a company representative and refers to an adult patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications, concurrent conditions, drug reactions or allergies was provided. On 27-JAN-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). No adverse events were reported. Additional information is not expected, since there was no consent for further contact with the reporter.
Client presented to local facility foot site to receive Pfizer Dose 2. Client informed RN that when she received Pfizer Dose 1 on 08/13/21 she experienced dizziness a few minutes after. Client stated she had just given birth and was already feeling not so well. She stated she laid down for 15 minutes and felt better after. Dizziness resolved. She stated it had never happened with a vaccine. Client has no allergies and has a history of high blood pressure.  RN submitted a medical consult to Clinical Project Coordinator Client was approved to receive Pfizer Dose 2 by MD. Client received Pfizer dose 2 Lot# FK9895 by RN. Client was educated on Emergency Precautions for any adverse reactions by RN. Client waited 15 minutes in observation and no reactions were reported. At Client left vaccination area in a steady gait.
Some redness at injection site, swelling started at injection site and moved down arm all way to hand,, swelling started 1-2 hours after injection.  Ext morning, couldn?t move hand to mouth. Visited his MD,  said nothing to be concerned about. Day 2, swelling has gone down in arm but hand swelling has increased.
Mom states that he has been cranky and sleeping more than normal since shots were given on Friday, 1/28.  Woke up screaming the other night, mom gave Tylenol and helped.  Winced and moved his leg when touched area of shots - but mom states that injection sites look good.  He feels warm to the touch but no fever registered.  Also not eating as well - only taking 2-3 oz at a feeding since Monday (usually takes 6 oz).