chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; severe injection site pain and swelling; severe injection site pain and swelling; swollen neck glands; scattered itching; This is a spontaneous report from a contactable consumer, the patient.  A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 12Jan2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation.  Medical history included end-stage renal failure and bipolar and the patient had known allergies to penicillin, sulfa, fish, shellfish, broccoli, and cauliflower. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medication included apixaban (ELIQUIS) from an unknown date at an unknown dose for an unknown indication.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  On 12Jan2021 at 01:15 (as reported) the patient experienced severe injection site pain and swelling, swollen neck glands, scattered itching, and dizziness. The patient was treated for the arm pain with paracetamol (TYLENOL). The clinical outcome of the severe injection site pain and swelling, swollen neck glands, scattered itching, dizziness was recovered on an unknown date in Jan2021.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Rash on face and neck; Rash on face and neck; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO158) via an unspecified route of administration in the left arm on 19Apr2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included Rheumatoid Arthritis (RA), lupus and Multiple Endocrine Neoplasia (MEN) type 1. The patient was allergic to contrast dye. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (XELL), carvedilol (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and benazepril (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8733) via an unspecified route of administration in the left arm on 29Mar2021 at 10:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 07:00, after the shot, the patient experienced rash on face and neck which lasted for several days. The event did not result in a visit to the doctors 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. The clinical outcome of the event rash on face and neck was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Cellulitis 6 inches by 6 inches right deltoid.  5-2x2mm vesicles.  On Keflex 500mg per mouth from 09/23/2003.
Injection given 6/4/08 - Onset of symptoms on 6/7/08 - not feeling well, itching. By 6/24/08 numbness in left leg and arm, itching and chest pain. Today 7/25/08, same symptoms of chest pain and numbness in both arms and legs.  9/22/2008 MR received from PCP beginning 6/11/2008 with pt c/o R arm pain, vomiting, H/A and upper arm numbness.  Unable to lif arm. PE WNL except pt is anxious. Pain meds given.  Several Cardiol consults 7/1,8,&22/2008 with c/o palpitations. Later had episodes of chest pain.  Impression:  Palpitations-uncertain etiology.  Probably benign ventricular ectopy. Seen 7/28/08 with c/o intermittant bilateral arm and leg pain with numbness since 6/08.  PE (+) for tenderness. Referred to orthopedics.
Leg was red and swollen. Fever of 101.8 that lasted a couple of days. Vaccine received Dtap had before. Never had any reaction prior.
chills; muscle aches; soreness at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, muscle pain and injection site pain. On an unknown date, the outcome of the chills, muscle pain and injection site pain were unknown.   It was unknown if the reporter considered the chills, muscle pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that after the 2nd dose of Shingrix patient experienced chills, muscle ache and  soreness at the injection site. Patient asked about how long these symptoms expected to last.
Erythema multiforme started aobut 10 hrs p/inject; Resolved p/5 days;
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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 27Oct2023 to 01Nov2023 .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left Deltoid cellulitis developed over two days.  Patient examined and placed on Keflex (200 mg tid x 7 days).
Patient fully vaccinated for COVID 19-  Moderna Dose #1 January 5th, 2021    Dose #2 February 5th, 2021 Became symptomatic on 18 May 2021 and Tested Positive for COVID 19 on 20 May 2021
Fever of 102 on 10-8-2018 for 2 days. Patient sought medical treatment at that time. On 10-10-2018 went to physicians office stating huge, red, swollen left arm, lymph nodes under the arm swollen, and disoriented. Was then sent to ER had ultrasound of arm to verify no abscess and no abscess was found. Patient was released with BENADRYL, famotidine, and steroids. Patient has since fully recovered.
This spontaneous report as received from a licensed practical nurse and healthcare worker (reported also as: Health Department Employee) refers to an unspecified patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date unspecified patients were vaccinated with M-M-R II (dose, route of administration, anatomical location, lot#, expiration date not reported) that was improperly stored on 27-APR-2014. No product quality complaint (PQC) was reported. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This was a series of 6 shots. 1st shot was 17March98. Swelling/soreness @ injection site. Nasal/sinus congestion with muscle burning in back and neck. Weakness over whole body. All symptoms lasted approximately 6 days. The 4th injection was on 10/13/98. I recieved flu-vaccine and Hepatitis B vaccine shots with the 4th injection of Anthrax. Five hours later I began to have fever, muscle aches over entire body, headache, chills, head congestion, nausea, diarrhea, stomach pain, and fatigue. These symptoms lasted a week. I felt like I was dying. On 29Oct99 I received 5th Anthrax shot with 3rd Hep. B shot. Lot #'s FA044, 7953A4. Four weeks later I had a Flu shot. I had flu-like symptoms for 2 weeks starting 29Oct99, and for another week after the flu shot the following month.
Received second dose 65 days after first dose; Body ache; Vaccination site pain; A spontaneous report was received from an other healthcare professional concerning a 28-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) received the second dose 65 days after first dose.and experienced pain at the site of injection,and body ache,     The patient's medical history was not  provided by the reporter. Concomitant medications were not reported.  On 30 Dec 2020,  the patient received her first of two planned doses of mRNA-1273 (Lot number: 036A21A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection.   On 4 Mar 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration in the unknown for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient felt pain at the site of injection, body ache, and received the second dose 65 days after first dose. Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported..   The events, received second dose 65 days after first dose, pain at the site of injection, and body ache, were considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with  associated injection site pain and body aches reported.
Headache, nausea, fatigue, chills, elevated temperature. Tylenol. Tylenol helped but symptoms come back after a few hours.
sore arm; This is a spontaneous report from contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had both Pfizer vaccines. Nothing but a sore arm after the first one. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Administered PNEUMOVAX 23 first, then gave FLUZONE HIGH DOSE. Immediately after giving FLUZONE patient said "Wow I'm seeing bugs flying. Those are some weird silver bugs I see" I asked her if she was ok, she said "I feel really funny, and seeing bugs" I asked her if her throat felt like it was closing she said "No my chest feels funny, like real tight" I asked again if finding it hard to breathe she said again my chest is getting tighter. I then directed my technician to call 911 and I informed he that I was going to inject her with an EPI-PEN which I did so. She quickly said that she was feeling much better and chest not tightening further, no longer seeing silver bugs. 911 arrived checked blood pressure 142/80 Hr 90 (which 112/70 is about normal for pt) Lungs clear, did EKG it was normal. Patient refused to go to hospital, even after EMS and I informed that she may relapse. We discussed with her about further medicating prophylactically with BENADRYL, and I gave her 50mg (20ml) in the pharmacy. She was alone and her spouse had no way of coming to get her. A member of management took her home, because we would not allow her to drive. Her husband later returned and informed me that she was fine and thanked me for taking care of her.
Presented to the emergency room 5/3/21 after the development of multiple symptoms after her second COVID vaccine on Friday. Symptoms consisted of perioral tingling, some possible oral swelling, and then subsequent shortness of breath with labored breathing. Initial treatments in the emergency room did result in some symptomatic benefit, however, the patient continued to have an oxygen requirement and demonstrated persistent symptoms of anaphylaxis. She was then admitted to the intensive care unit for higher level intervention.
Patient was given dose before turning 18yrs old. Checked CDC website and consulted pt and mother. Plan to continue with follow up dose in 28 days per CDC recommendations under "off-label use"
Narrative:  69yo male patient died on 12/28/2021 during inpatient admission. Death was caused by: Cardiopulmonary arrest secondary to severe sepsis (caused by UTI present on admission on 12/23/2021). Patient had received 3 covid vaccines on 4/23/21, 5/21/21, & 12/3/21. This death is not related to covid vaccines.
Vaccinia from vaccination generalized multiple raised wheals covering the front & back of pt's torso, front & back of both arms and areas the pt's head & neck. Treatment: Prednisone 10mg.
Lightheadedness, diaphoretic. Pt observed for 45 mins in observation area, had vasal vagal response after receiving vaccine. OK to D/C home. Vitals on D/C 114/96 BP HR 85 O2 99%.
Burning sensation on my esophagus and lungs; swelling of left ankle; I developed a lot of joint pain; Almost like a chest pain; Muscle pain; Right lymph node by neck got very swollen; Allergic reaction to fluoroquinolones (Cipro/Levaquin ) that causes continued pain in joints and muscle weakness. Vaccine exacerbated the symptoms to the point I was laying down for at least 4 of those days.; Vaccine exacerbated the symptoms to the point I was laying down for at least 4 of those days.; Vaccine exacerbated the symptoms to the point I was laying down for at least 4 of those days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 12Apr2021 at 12:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included pain in joints and muscle weakness. The patient previously received fluoroquinolones which are (ciprofloxacin) (cipro) (MANUFACTURER UNKNOWN) and levaquin (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included escitalopram oxalate (LEXAPRO), clonazepam (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN) started at unknown date for unknown indication. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Apr2021 at 16:00, the patient experienced right lymph node by neck got very swollen and swelling of left ankle. The patient developed a lot of joint pain and muscle pain and also felt a burning sensation on esophagus and lungs. Almost like a chest pain. This that took over seven days for all symptoms to go away. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent SARS-CoV-2 test and was found to be negative. The clinical outcome of the events right lymph node by neck got very swollen, swelling of left ankle, lot of joint pain, muscle pan, burning sensation on esophagus and lungs, almost like a chest pain, muscle weakness and was laying down for at least four of those days was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 76 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Fatigue and trouble breathing.  Blood tests led to diagnosis of Acute B Lymphoblastic leukemia. Current treatment is aggressive chemotherapy. Blood transfusions
Received Pfizer COVID vaccines on 1/21/2022 and 2/11/2022. Hospitalized at Hospital on 9/9/2021 with COVID-19, COVID pneumonia, hypoxia
Symptoms started approximately 6 hours after immunization. Donor experienced chills, uncontrollable shivering, felt cold and weak with a temperature of 103.1 degrees F. Donor took Extra Strength Tylenol and temperature was 102 at approximately 10:30 PM.  Applied cold compresses to her head and arms.  Donor awake at 6:00 AM on 10/09/2014.  Stated she still felt weak.  Temperature was approximately 101 degrees F at approximately 10:30 AM. All symptoms resolved by morning of 10/10/2014.
Big, red, warm swelling on arm where shot injected and severe fatigue.  Face and arm felt warm/feverish.
48 hr post injection: affected arm (L) became very hot; Rash developed upper L arm; developed upper L arm pain; Spiked a temperature of 102F; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0151) via an unspecified route of administration in the left arm on 07Apr2021 at 16:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included verapamil (MANUFACTURER UNKNOWN), hydrochlorothiazide, losartan (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient previously took flu vaccine (INFLUENZA VACCINE) for unknown indication on unknown date and experienced allergy. Also the patient previously took tizanidine hydrochloride(TIZANIDINE) for unknown indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206) via an unspecified route of administration in the left arm on unknown date in Mar2021 at 16:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. On 08Apr2021, 24 hours post injection, the patient experienced spike in temperature for 102 degree Farenheit (degF) and fatigue. On 09Apr2021, 48 hours post injection, the patient upper left arm developed very hot, rash and pain. On 08Apr2021, the patient underwent lab test which included body temperature and the result was 102 (degF).Therapeutic measure was taken for the event spike in temperature which included MOTRIN. No therapeutic measures were taken as a result of the other reported events fatigue, upper left arm hot, rash and pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events spike in temperature for 102F was recovered after 4 hours on 08Apr2021, while that of the events upper left arm hot, rash and pain lasted for 3 days on 12Apr2021 and the outcome of the event fatigue was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Itchy internal hives on lower half of torso and thighs/had internal hives inside her torso; Itchy internal hives on lower half of torso and thighs; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).  A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch no: not reported/lot number: EP7534) via an unspecified route of administration on 09Mar2021 (Age at vaccination 65 years old) as dose 1 single for covid-19 immunization at Pharmacy. Medical history included ongoing Hashimoto she has had thyroid issues for 40 years. The patient's concomitant medications were not reported. Family Medical History Relevant to AE(s) was none. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the vaccine. Patient reported a side effect related to the Covid Vaccine. On 26Mar2021 17 days after getting the dose 1, the patient experienced itchy internal hives on lower half of torso and thighs/had internal hives inside her torso, they were itchy in her torso. Patient emphasizes that the hives were not on the outside of her skin, but on the inside on her entire lower torso and upper thighs and scratching does not help. The reaction was worse the first time around. AE(s) require a visit to Physician office through telehealth appointment for the reported events Itchy internal hives on lower half of torso and thighs and did not require to visit Emergency Room. Her doctor told her to wait until event subsided to take dose 2 and her doctor thinks the patient had a Cytokine reaction. She did not know if it was a side effect of the vaccine at that time and Itching was worse at night. Events lasted for about 5-6 days. She was asking for any analysis why she was getting this. Relevant Tests were reported as none. Her sister- in law recommended Benadryl cream and stated that helped her as therapeutic measure as the result of the events. Investigation Assessment was reported as no. Patient stated that it was related to the vaccine. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
pt recvd vax; 8aug95 devel blisters on back, chest & scalp;also devel fever which persisted for few days;dx a full case of chicken pox;pt described eruptions as mild;
fever, irritable, lethargic ond ay of vax;twitching, jerking, irritable 5JUN97 @ 7:30;
More than 36 days have passed and patient did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and patient did not get the second dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 (More than 36 days have passed and patient did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and patient did not get the second dose) had resolved.            No concomitant medication reported.  No treatment information was provided.