chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breakthrough COVID-19 infection despite receiving  both doses of Pfizer vaccine in 3/2021. Hypoxia requiring O2, hospitalization. with underlying hematological malignancy, atypical CML
i feel very sick; Fever; Head pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (i feel very sick), PYREXIA (Fever), HEADACHE (Head pain), CHILLS (Chills) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (i feel very sick), PYREXIA (Fever), HEADACHE (Head pain), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MALAISE (i feel very sick), PYREXIA (Fever), HEADACHE (Head pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.   Reporter did not allow further contact
This spontaneous report as received from healthcare worker refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored PROQUAD (Merck) recombinant human albumin (rHA) lot # L045676 with expiration date: 14-JUN-2017 and lot# L045676 with expiration date: 09-MAY-2017 (dose, route of administration and injection site were not reported). No adverse effects were reported. Data logger was involved. Administered doses of PROQUAD (Merck) underwent temperature excursions at 13.9 Fahrenheit degrees for 20 minutes and at 10.8 Fahrenheit degrees for 20 minutes. There was no previous temperature excursion. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, Headache, NauseaVomiting, diaphoretic, lightheaded Narrative:  Other Relevant History:
Left elbow pain and unable to move elbow x 24-36 hours. This occurred distal to the site of injection (L deltoid)
Swelling of that portion of it started immediately; Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow) and VACCINATION SITE SWELLING (Swelling of that portion of it started immediately) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) 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) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE SWELLING (Swelling of that portion of it started immediately). In August 2021, the patient experienced VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. In August 2021, VACCINATION SITE SWELLING (Swelling of that portion of it started immediately) had resolved. At the time of the report, VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  The patient took Tylenol initially for 2 days and then Advil was used when it started hurting again and was put hot prior to work and then iced it.  The patient's pain and swelling went away after vaccination but it started again during training that was probably around 17th or 18th of August and was still painful. Patient had no other symptoms.
patient read the fact sheet which states that if there may be a lump when having the shot. Stated when he got his, he got it immediately and it went away; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VCCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported as on Jul2021 patient read the fact sheet which states that if there may be a lump when having the shot. Stated when he got his, he got it immediately and it went away. The outcome for the event was reported as resolved on an unspecified date in Jul2021.   Information about Lot/batch number has been requested.  Follow-up (01Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
At about 4-5 hours after the shot, Patient started feeling chills, shaking to the point he couldn't hold a glass, with rapidly rising fever. His temperature readings between 11pm and 8 am next morning were around 106.6, with the highest reading of 107. We were extremely concerned as he has never had a fever that high in his life (I can attest to that as a parent). The fever did not subside with ibuprofen (2x500 mg), aspirin (500 mg), acetaminophen (750mg), given in 1.5-2 hr intervals between 10 pm and 4:30 am. He did not take any medicine after  4:30 am, as it was not having any effect.  He was given fluids to drink, 500ml every 30-40 min, for the entire time  He remained conscious, but had extreme headache, muscle pain and weakness. Starting at around 9 am (about 15 hrs after the injection), the fever started going down, and remained at 104-105 for the next 18 hrs.  The temperature went down to 100-102 the next day, and was down to normal on day 4.
Child seated on mother's lap, vaccines given, child smiling and fine,  he stood up, I turned my head to get him a sticker and felt him collapse. Mother and I caught him. We lay him down on her lap and I put his feet up. He regained consciousness after about 5 seconds. Vitals were taken and all within normal range. We kept him supine for 20 additional minutes, he responded appropriately and walked out with his mother.  Instruction was given on adverse effects and appropriate actions to take. No ill effects noted. Phone message left for mother on 1/6/22 but they don't call back right away. Has had other vaccines in the past without adverse events.  Mother stated grandfather has history of fainting at the sight of blood.
I was barely pregnant at the time, but didn't know it.  Due date is October 16, 2022.  I had a previous reaction to the Covid moderna vaccine in July 2021 with chest pain and heart palpitations for a week.  The day after I received the Janssen vaccine I woke up in the middle of the night with severe heart palpitations that felt life-threatening.  They woke me up multiple times that night and another night a couple of nights later.  I experienced more severe palpitations on and off during the days for 2 weeks following the vaccine.
1-  extremely tired couldn't get out of the bed for several hours (5-6hours) 2- entire body paralyzed for 1-2 hours couldn't move any extremity in bed had to have help to turn over  #3 BOOSTER  had red blistery rash from top of fingers to elbows and across upper chest that lasted for  5-6weeks very painful
Superficial infection, 3 X 3 erythematous area with tenderness and redness.
Swollen lymph nodes on neck and jaw; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced swollen lymph nodes on the neck and under the jaw.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 05 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 06 Jan 2021, the patient experienced swollen lymph nodes on the neck and under the jaw after vaccination. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event swollen lymph nodes on the neck and under the jaw was unknown.
Patient received the Fluad shot in her left arm. After getting the shot the patient proceeded to go shopping in the store. About 20 minutes later , the patient went to grab an item from the top shelf and she locked her right arm and could not move. An associate on the isle quickly helped her and made her sit on the chair. Patient stated that she was having spasms in the back and her right hand was shaking. EMS was called and patient left with EMS. Patient was not in pain, was consious when she left the pharmacy.
Near Syncopal Episode; Dizziness; This is a spontaneous report from a contactable other health professional. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the right arm on 03Mar2021 12:30 (batch/lot number: EN6206) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No Covid prior to vaccination. It was unknown if Covid tested post vaccination. The patient experienced near syncopal episode and dizziness on 03Mar2021 12:30. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Adverse event treatment reported as "evaluation/transportr". The outcome of the events was unknown.
Issues with getting a full penile erection.  Erectile Dysfunction.My 19-year-old son experienced the same thing 2 days after receiving the Pfizer vaccine 2nd does.; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection via an unspecified route of administration, administered in Arm Left on 23Apr2021 16:00 (at the age of 55-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Apr2021 16:00 (at the age of 55-year-old) as single dose for covid-19 immunisation. On 28Apr2021, the patient experienced issues with getting a full penile erection. Erectile dysfunction. His 19-year-old son experienced the same thing 2 days after receiving the pfizer vaccine 2nd dose. No treatment was received to treat this adverse event. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-202101103077 similar report from same reporter
I received a high dose FLUZONE shot on Monday, October 19, 2011 about mid-day at a Pharmacy. That afternoon I developed a slight headache and felt a little ill later. Went to bed at usual time, about 11:00 PM. Awoke at 6:20 got up and shaved. Felt tired so went back to bed for about an hour. When I got up I was dizzy and weak, fell to my knees twice due to weakness and dizzy feeling. Took my BP with a home BP machine: 83/61 with heart rate of 134. Felt so weak that my wife (a retired RN) drove me to the ER. They said I had Atrial Fibrillation, gave me EKG, etc. and had me transferred to another hospital by ambulance. My heart had returned to normal sinus rhythm without medication prior to leaving the ER. Admitted to hospital, kept overnight. Given another EKG and an Echo Cardiogram, etc. Was able to be discharged the next afternoon. I've never had a reaction to a flu shot previously in my 81 years.
Approx 3 hours after vaccine was administered to left arm, itching and swelling occurred. In 8-9 hours all of upper arm very swollen, red and extremely painful. Called doctor, prescribed Benadryl and to ice affected area. Developed fever 101.6. Fever continued all thru next day. Redness and swelling continued to worsen until redness and swelling reached my wrist. Felt very sick. Swelling slowly began to subside after 3 days. Some soreness still apparent after 1 week.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 5:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 5:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The information about allergies, acute illnesses, chronic or long standing health conditions, information about other medications (prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit.  The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator.  The vials were returned to the freezer/refrigerator, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  Treatment medications were not reported.   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report as received from a pharmacist via Novartis refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. Other suspect therapies included influenza virus vaccine (manufacturer unknown) (subcutaneous). An unspecified adverse event was reported with ZOSTAVAX injection. The outcome of the adverse event is unknown. No PQC involved. Additional information has been requested.
muscle and joint aches; muscle and joint aches; teeth and bones hurt; teeth and bones hurt; chills; weakness; I can hardly walk right now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unspecified route  of administration on an unspecified date (4 weeks and 2 days after the first dose) (at the age of 78-year) as single dose for COVID-19 immunization. The patient medical history included lumber stenosis. The patient concomitant medications were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On an unspecified date, patient felt awful with muscle and joint aches, teeth and bones hurt, chills, weakness. She stated that she could hardly walk right now and could not get over to her primary care physician. The patient informed that she received a steroid injection of some kind on her back for lumbar stenosis 2 weeks and 2 days after the first dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness, swelling (hardness), itchiness, and sensitivity at the injection site. This has been ongoing for over a week and I am starting to get concerned.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 08-OCT-2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-AUG-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX23 (Lot # not reported) (dose and route not reported) when the patient was less than 60 years old. No other co suspects were reported. No concomitant therapy was reported. The nurse reported that a co-worker was administered a second dose of PNEUMOVAX23 (dose, route, lot number and expiration date were not reported) less than 5 years later on an unspecified date in 2012. The reporter stated to nurse that could not feel and could not move the arm in which she received the PNEUMOVAX23. The events were described further as her arm was "paralyzed'. Treatment reported was the application of ice to the affected arm. The events resolved within 4 to 6 hours. Upon internal review, the events of the patient could not feel the arm and could not move, was paralyzed was considered to be medically significant. Additional information has been requested.
She had recieved the HPV(Gardsil)# 2 vaccine in her left deltoid, when she got home a few hours later her whole left side of her body turned red and was itchy. This lasted for a couple of hours and went away, she did not seek medical attention.
patient received half dose of the Moderna vaccine as 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received half dose of the Moderna vaccine as 1st dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (GLUCOPHAGE), MODAFINIL, MONTELUKAST SODIUM (SINGULAIR), SEMAGLUTIDE (RYBELSUS) and BUMETANIDE for an unknown indication.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient received half dose of the Moderna vaccine as 1st dose). On 03-Dec-2021, ACCIDENTAL UNDERDOSE (patient received half dose of the Moderna vaccine as 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.
4 mo with intussusception.  9/14/07 Reviewed ER medical records which reveal patient experienced vomiting, lethargy & bloody stools x 3 on 8/13/07.  DX w/acute GI bleed & transferred to higher level of care.  10/5/07 Received vax record from community health center which confirms lot # but reveals 7/13 dose was 1st dose.  VAERS database updated w/same.  Vax record faxed to CDC. 10/5/07 Received hospital medical records which reveal patient experienced bloody stools, bilious vomiting, abdominal distention & reduced oral intake x 1 day.  Seen in outlying ER & transferred to higher level of care.  Admitted 8/13-8/15/2007 for peds surgery. Proximal bowel noted to be significntly dilated & NGT placed for decompression.  Able to d/c NGT next day & tolerated oral feeds.  Progressed well & d/c to home. FINAL DX: Intussusception w/obstructive symptoms, s/p difficult air enema reduction.  Records faxed to CDC.
Fever 103, chills, vomiting x 2, swelling L/arm, redness & warmth x 1 week.