chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm was sore for day and a half; This is a spontaneous report from a contactable consumer (patient). This is the second case out of two cases. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9269, Expiration date: unknown) via an unspecified route of administration on 05Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had shot of the Pfizer vaccine (Clarified as Covid vaccine) on 05Feb2021 and so her arm was sore for day and a half. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Syncopal episode 15 minutes after Pfizer vaccine.   He was unconcious for about 2.5 minutes.  He recovered spontaneously.  Vitals were normal.
Employee rec'd vaccine 10/8 @ about 2PM.  Awoke Saturday AM achy & having diarrhea off and on.  Took Tylenol and felt some better. Soon after this she felt achy & weak, stated her legs felt funny.  Her legs & elbows felt shaky as if her blood sugar was low.  She then donned a gown & gloves for a procedure, and got very hot, and she sat down for a few minutes.  She stated she then had to lay down, so she laid across the desk, and called the outpatient facility for help. She proceded to have nausea & dry heaves, and said she couldn't hold her head up.  She tried to get up to go to the bathroom, but said she couldn't stand.  After using the bathroom, she said she couldn't pull her pants up. She then was taken to the ED where she felt numb from her knees down, and her elbows down.  At this point she states she was unable to move anything except her head.  After a liter of fluids, she felt some better, she was admitted to the ICU overnight as her MD felt she may have acute onset of Guillian Barre' Syndrome (ruled out).  The next day, she was able to move, and had sensation back, was moved to a med surg floor, and discharged Monday.  Her medical doctor stated he found nothing, and referred her to a Psychiatrist, who also cleared her.  Today when she called, she states she still feels weak, has frequent headaches, and neck pain.  Her right hand, and both feet feel numb at times.  Friday 10/15 she states she had a lot of rib pain, and it hurt to take a deep breath.  She states one of the neurologists state she may have contracted the flu from the flu shot, as her immunity may have been down from a stomach ache (?virus) earlier the week that she had the shot.  She denies any fever, sore throat, cough or cold symptoms, and felt woozy last night.  She related while experiencing the paralysis, that she was told that she was hyperreflexive. Upon today's conversation, states that she had a reaction years ago when the vaccine was still a live virus vaccine, has rec'd it since without any problem. Medical Record received on 2/02/2005 states appetite impaired, dizziness, conversion disorder, and anxiety. Follow up 01/18/05: The pahysicians decided (at the patient's last report) that they don't feel this reaction was due to the vaccine.
SHE CAME ON 7.30.21 WANTING A 1ST DOSE OF PFIZER. THE VACCINATOR REQUESTED A CONFIRMATION OF VACCINATION. SHE WAS DENIED ANY ADDITIONAL VACCINE DO TO THE FOLLOWING: 6/1/21 MODERNA 033C21A 7/1/21 MODERNA 005C21A 7/21/21 JANSSEN 204A21A
This report was received from the investigator in the trial on 20 May 2010. A 24 year-old male subject with no significant medical history received the following vaccines on 25 September 2009: ACAM2000 (lot number not reported) and influenza vaccine live intranasal (other manufacture and lot number not reported). The subject received anthrax vaccine (other manufacturer and lot number not reported) the previous day (24 September 2009). Eleven days after receipt of the ACAM2000, the subject was diagnosed with unspecified disease of the pericardium. On Day 11 (06 October 2009), the subject had an abnormal echocardiogram and a normal electrocardiogram. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Patient requested her second shingles vaccine. She had received her first dose of Covid vaccine 15 days early. Her second Covid vaccine was administered instead of the shingles vacine.
Date and time of vaccination: (list both if they received both shots):1st vaccination 1/21/21, 2nd vaccination: 2/11/21  hives on face, neck, breast, no longer occuring
Arm tenderness; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm tenderness), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Arm tenderness), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, INJECTION SITE PAIN (Arm tenderness), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
warm to touch; red, hot area, like a rash on my left arm; swollen; red, hot area, like a rash on my left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (red, hot area, like a rash on my left arm), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (red, hot area, like a rash on my left arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included METFORMIN, FENOFIBRATE, SIMVASTATIN, DULAGLUTIDE, CETIRIZINE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (red, hot area, like a rash on my left arm), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (red, hot area, like a rash on my left arm). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (red, hot area, like a rash on my left arm), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (red, hot area, like a rash on my left arm) outcome was unknown.        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.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.
04/21/2021 11:48 AM Patient says she was lighted headed and dizziness. wasnt speaking dropped her phone and was not aware. BP WAS 79/37 Pupils were fixed with some movement.. mother was outside, called in. mother had stated earlier that she was afraid of needles. felt clamy and sweaty. patient taken to ER in wheelchair with mother for evaluation
7 x 5.5cm red swollen, warm area on right upper arm in vaccine site area.
Nausea and fatigue for 2 days after and body aches and fever for 1 day after. Drank fluids, slept and used Tylenol and ibuprofen as needed.
I am feeling nauseated; slight tension headaches; This is a spontaneous report from a contactable consumer (Patient, Self-reported).  A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: not provided), via an unspecified route of administration, on 27Apr2021, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received the second dose on the 27th of the month and then the patient felt nauseated and slight tension headaches, patient ask the question response was given, spoke from attached documents and referred to HCP. The outcome of the events was unknown.  Repot received date 30Apr2021  follow-up attempts are needed. Information about lot/batch number cannot be obtained.
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 28-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004698: US-009507513-2207USA004691: US-009507513-2207USA004707: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004700: US-009507513-2207USA004710: US-009507513-2207USA004709: US-009507513-2207USA004714: US-009507513-2207USA004715:
Patient called 10 days after received flu shot and stated arm still sore, pain radiating down arm, shoulder sore. Pt. said has had pain since getting shot.
No adverse effects; the administration of one dose of an improperly stored vaccine, PROQUAD; PROQUAD was administered to a 58 year old male patient; This spontaneous report as received from a registered nurse refers to a 58 year old male patient. No pertinent medical history, concurrent conditions, drug reactions or allergies were provided.  On 20-AUG-2019,  the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) (lot # S009756 expiration date 27-SEP-2020) 0.5 milligram/once time, first dose for prophylaxis (route and anatomical location were not reported). The sterile diluent used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored in the correct temperature storage range. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 46 degrees Fahrenheit for 336 hours. Data logger was involved. There were no previous excursions reported.
ITP Rash (have pictures) the major concern.  I had exceedingly intense pain in my hands, feet, and knees, shaking throughout the body.  The more common side effects that I had were diarrhea, nausea, fever, and body pain.  I know feel tingling in my toes.  Several days later, I also had an event that lasted a few minutes where my right arm shook.
Patient admitted for acute hypoxic respiratory failure, multifocal pneumonia, COVID-pneumonia, aspiration pneumonia.  He received treatment for COVID with remdesivir, steroids.  During his stay he had worsening of his respiratory status with oxygen demand increased.  He was noted to need BiPAP for improvement of oxygen. Due to his aspiration plans were for PEG tube however PEG tube was unable to be placed because of his poor respiratory status.  Despite antibiotics, steroids BiPAP, nebs patient continued to deteriorate.  Repeat imaging with CTA ruled out PE and confirmed worsening pneumonia.  Patient and family eventually decided on DNR CCA and later DNR CC.  Patient later passed away at 6:25pm 2/7/23 with family at bedside. RIP.   Clinical Summary   Assessment and Plan The patient is a 83 y.o. male with history of recently diagnosed dementia prostate cancer hyperlipidemia diabetes diverticulosis DVT status post 6 months of therapy GERD presented to the Hospital with worsening shortness of breath and cough from primary care's office.   Acute respiratory failure with hypoxia, worsening Sepsis 2/2 Multifocal pneumonia Probably aspiration pneumonia Covid pneumonia Patient on BiPAP, wean as tolerated Completed remdesivir and dexamethasone Received duo nebs every 4 every 6 as needed ID consulted IV Zosyn Repeat CTA - no PE, worsening Lung disease DC bipap, transition DNRCC   COVID PNA Completed remdesevir and decadron DC'd COVID isolation 2/5/23   Ileus- resolved KUB shows mild distention of small bowel large bowel with persistent contrast throughout the colon continue bowel regimen continue tube feeds   Dysphagia with aspiration S/p modified barium swallow study No need for PEG tube now Remove NG tube- DNRCC   Depression Mirtazapine   DM Sliding scale   Hyponatremia-resolved Mild, continue to monitor
Patient states following vaccine administration she experienced nausea, vomiting, fever, chills, and tiredness. She has experienced these symptoms for the past 8 days.
12/30/2020 Almost immediately after the shot, I had mild soreness at the injection site that increased a little around 9:45pm.  I remember having weird dreams all night and woke up with severe pain in  my right arm, extreme swelling in my right arm  also hardness and warm to the touch in my whole upper arm, it was difficult to lift my arm as well.  Also that morning around 6 AM in the morning I started having chills, I did not take my temperature because I did  not feel as though I had a temperature.  I almost called in sick to work at about 8:30 am for work.  I was able to lift my arm so I decided to go to work because I work a desk job.  My husband drove me because I did not feel safe.  I remember being very frightened about getting the second shot because I was told the second was the worse.  By day 3  I was feeling so much better.  Symptoms have subsided.
pt recvd vax & 3 days later devel vesicular lesions;No further details were provided;
A non-serious spontaneous report of we gave 14 doses of expired FLUMIST was received from a health professional concerning an 11-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 22-Jan-2012. On 26-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
UTI; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (fatigue). On 09-Apr-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included Antibiotics.
The next day after the Moderna Booster, I experienced a heavy period that lasted 9 days. Today, 11/24/21 I started again heavy period bleeding.
This initial spontaneous case, was received from a other health professional on 17-Nov-2017, concerning a patient of an unspecified age and gender. On 16-Nov-2017, the patient was administrated with FLUCELVAX (TIV) (batch number: 195235, expiry date: May-2018, route of administration, anatomical location: not reported). It was reported that the vaccine reached minimum temperature at 1C for 15 minutes and one vaccine was administered that was stored outside the recommended range (explicitly coded as incorrect product storage and drug administration error). The reporter assessed the events as non-serious.
6-7 days post vaccine I experienced a swollen axillary lymph node on the same arm in which I received the vaccine. I have never had a swollen lymph node in this area so it appeared unusual for me.  I had no signs or symptoms of any virus or infection. Additionally, on day 8, while palpating it to assess for firmness I had a vaso-vagal response and nearly lost consciousness. I went to my PCP that day to have the lymph node assessed. No treatment was recommended besides monitoring for improvement. If the areas soreness/tenderness does not improve in the next week then they will follow-up with an ultrasound.
The arm that I received the vaccine is still swelled/puffy; The arm that I received the vaccine is still swelled/puffy; muscles are sore; lymph node is swelled/puffy; still in pain and discomfort; still in pain and discomfort; This is a spontaneous report from a contactable 30-year-old female consumer reported for herself. A 30-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 30Jan2021 12:30 as single dose for covid-19 immunisation. Medical history included asthma, blood pressure increased, and allergies: penicillin. Concomitant medication included biotin (BIOTIN) and multivitamin. On 01Feb2021 the patient had, the arm that I received the vaccine is still swelled/puffy, muscles are sore, arm pit/lymph node is swelled/puffy, still in pain and discomfort after 5 days. The was no treatment for the events. Facility the most recent COVID-19 vaccine was administered in Hospital. The outcome of the events was not recovred
Patient received first dose of the Pfizer COVID vaccine, approximately 5-10 minutes later parent alerted that she had syncopal episode while sitting in a chair. Parent noticed her eyes were dilated. Called 911 while parent and pharmacist watched patient. Patient regained consciousness about 1 minute later. Noticed lips were blue in color and pale skin. EMS came to escort patient to nearest medical facility.
Within 10 minutes - tingling sensation of upper lip which progressed to intermittent tingling sensation of face, arms, legs,   Weakness with shakiness in the mornings Initially treated with Benadryl 50mg 3x daily with no improvement.  3 days later treated with Prednisone 40mg daily x 4days with no improvement.  Prednisone increased to 80mg daily on decreasing dose schedule to 60mg, 40mg, 20mg , 10mg with no improvement in 8 days.  Continuing symptoms.
Tenderness in the armpit on the shoulder; Did not notice the pain until he touched the arm.; General soreness; It really hurt for a while, right in the muscle below the armpit.; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in the armpit on the shoulder), VACCINATION SITE PAIN (Did not notice the pain until he touched the arm.), ARTHRALGIA (General soreness) and MYALGIA (It really hurt for a while, right in the muscle below the armpit.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness in the armpit on the shoulder), VACCINATION SITE PAIN (Did not notice the pain until he touched the arm.), ARTHRALGIA (General soreness) and MYALGIA (It really hurt for a while, right in the muscle below the armpit.). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form. At the time of the report, TENDERNESS (Tenderness in the armpit on the shoulder), VACCINATION SITE PAIN (Did not notice the pain until he touched the arm.), ARTHRALGIA (General soreness) and MYALGIA (It really hurt for a while, right in the muscle below the armpit.) outcome was unknown.            No concomitant medication was provided.  Ice bag was used to treat symptoms.
Sore Arm, Tiredness, Nausea, Heart Palpitations, Headache, Sweaty/Clammy Skin, Dry Mouth, Light Headedness, Confusion, Poor Sleep
WAS GIVEN EXPIRED VACCINE/PRODUCTS (HAD REACHED THEIR LISTED EXPIRATION DATES); This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 22-SEP-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 22-SEP-2022, the patient experienced was given expired vaccine/products (had reached their listed expiration dates). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of was given expired vaccine/products (had reached their listed expiration dates) was not reported. This report was non-serious. This case, from the same reporter is linked to 20230149982, 20230150157, 20230150423, 20230150600, 20230150588, 20230150716, 20230150777 and 20230150340.
Severe Vertigo; A spontaneous report was received from a physician concerning a 65-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe vertigo.  The patient's medical history, was not reported. Concomitant medications reported included aspirin 81 mg.  On 04 jan 2021, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient experienced severe vertigo.   No laboratory details was provided. Treatment for the event included meclizine.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, vertigo, was considered as resolved on 07 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.