chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 22-Sep-2017. This case involves a 75-year-old male patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number: UI811AD, expiry date was not reported), in left arm via intramuscular route on 07-Sep-2017. The patient's medical history and concomitant medications were not reported. On 07-Sep-2017, same day post vaccination, the patient had large amount of bleeding at injection site. On 22-Sep-2017, 15-day following vaccination, patient had a large hematoma at the injection site of his left arm. No soreness, no pain experienced, no other symptoms reported. The patient's laboratory data was not reported. Corrective treatment includes aspirin. The events outcome reported as unknown. List of documents held by sender: none.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L014878, expiration date: 17-JAN-2018) intramuscularly (dose and frequency were unspecified) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. It was stated that the vaccines were exposed to a temperature of 9 Celsius degrees for a timeframe of 27 hours. No digital data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005145:
Fatigue; joint pain; aches; headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration on the left arm on 24Mar2021 at 13:15 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient was not allergic to medications, food, or other products. Concomitant medications included duloxetine hydrochloride(CYMBALTA) and  sertraline hydrochloride(ZOLOFT) for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 11:30, patient experienced fatigue, joint pain, aches and headache. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, joint pain, aches and headache was recovering.   No follow-up attempts are needed. No further information is expected.
Unresponsive episode, with upper extremity weakness by 9:00 PM resident more responsive
Per Patient: extreme dizziness at work.  Unable to finish work. Driven home by husband.  Starting 3/9/21 and lasting 14 days.
Pain in upper arm where shot was given and progressively got worse with time; went to DR. about 1 1/2 months later because pain was worse.  He gave me an RX for a compounded inflammation cream; did not help and pain is in upper arm and shoulder; getting dressed, putting my arm above my head and sleeping is disturbed when I stretch or sleep in certain positions.  I had my annual physical yesterday, 04/10/2013 and DR. has scheduled an MRI for shoulder/arm for 04/16/2013.
After administering vaccine, patient stated he had already received a flu shot this year.   No side effects or issues identified at the vaccination site.
Patient presented to Hospital ED on 11/23/21 with SOB, cough, chest tightness in the setting of recent covid-19 diagnosis. Patient was exposed to covid from family and was diagnosed with COVID PNA on 11/16/21. Patient is fully vaccinated and received monoclonal Ab on 11/22/21. Patient was appropriately treated and was discharged on 11/29/21 on home O2.
Swelling of left leg to approximately size of orange.  Started out as bright red area ~4inches after injection.  Developed into red, raised area very tender-hurt to walk-looked like giant hive-not hot to touch.  Benadryl and cold compresses.
24 hours post vax, one large ulcer formed on inside on left cheek. 6 days later, smaller ulcer appeared inside right cheek, which also spread under upper and lower lip (very swollen). Hives also appeared 10 days after on the hands and elbows near the joints.
Pt starting to cry constantly 2 days after vaccination. Mom thinks it is from the vaccination. Mom also starting him on oatmeal cereal the night prior to pt's crying.
SHE RECEIVED A THIRD DOSE OF COVID VACCINE (MONOVALENT). SHE SHOULD HAVE RECEIVED HER BIVALENT DOSE. THE PROVIDER HAS REACHED OUT TO THE FAMILY AND MADE THEM AWARE. SHE IS SCHEDULED FOR HER BIVALENT BOOSTER IN TWO MONTHS.
Since around 6 p.m. on 11/6/21 I've been dealing w/ diarrhea non-stop.
ITCHING; HIVES ON RIGHT HAND; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced hives on right hand. On 12-APR-2021 21:00, the subject experienced itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on right hand, and the outcome of itching was not reported. This report was non-serious.
No reaction with first shot-2nd shot arm bruised and had a large red/warm area-noticed day of injection has progressively gotten biger
Severe pain, redness of arm then rash and heat, stiffness in arm from shoulder to elbow; nausea, near fainting.
Fever, chills, body ache, vomit, 24 hours. Anti emetic medicine, Tylenol.
rash, arthralgia 2 days p/vax w/Engerix-B;seldane & tagamet po duration 2-3 days
No adverse event; Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 mL (50 mcg); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml (25 mcg) dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)).    No concomitant medications was reporter.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose.  It was unknown if patient experienced any symptoms after getting the vaccine.  No treatment medications was reporter.
Started with fever on the night of vaccination. Took Tylenol PM and went to sleep. Little after midnight, I woke up  with body ache and severe joint pains. Was unable to sleep and unable to bear the pain. Around 6AM, spoke to my doctor friend and took Tylenol 1000mg; then around 7:30 am went to sleep. Had the body ache through out the day and mild fever. Took Tylenol every 6 hours until 4/9. Today, it?s better but getting chills again at 7PM.
Diagnoses W/GBS 10/17/05. Middle back pain, tingling sensation on her arms and face, headache.
Rash is itchy; Rash near the injection site, which is 4 inches long and 2 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is itchy) and RASH (Rash near the injection site, which is 4 inches long and 2 inches wide) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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 30-Mar-2021, the patient experienced RASH PRURITIC (Rash is itchy) and RASH (Rash near the injection site, which is 4 inches long and 2 inches wide). At the time of the report, RASH PRURITIC (Rash is itchy) and RASH (Rash near the injection site, which is 4 inches long and 2 inches wide) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included anti-itch topical product for itching.
Patient was given the wrong dose of the COVID-19 vaccine.  Patient has no  symptoms.   I was distracted and grabbed the dose for the wrong age group.
DX: Vaccine induced measles - moderate fever > 101 starting, 4/11/14 and lasting 3 days. Multiple purple/violet macules noted ranging in size from 1-3 mm on face, trunk,  and upper/lower extremities bilaterally . Examination of the oropharynx showed petechial hemorrhages on the soft and hard palate. 1+ enlargement and erythema of both tonsils. Exudate also noted on both tonsils.
I was hospitalized with an acute kidney injury. (In ED they told me I must have gotten dehydrated but I was not dehydrated and had specifically drank lots of fluids in the 2 days after the vaccine in an attempt to prevent problems!)
Two hours following the administration of the vaccine (Booster #2) I developed a pain in my left shoulder.  By bedtime that night the pain was a '5' (out of 10).  The next day the pain increased and by bedtime the pain was a '7', with sharp pains radiating upward toward the left side of my neck and downward toward my left elbow and forearm.  It was nearly impossible to sleep, as the pain was constant, even with Tylenol, Advil and Oxycodone (10 mg).  My arm is so painful currently that I can't walk without sharp pains upward and downward, even into my forearm.  The shoulder is swollen and red at the injection site.
o 19yr old female experienced cardiac arrest at home, transported by EMS in cardiac arrest, was unresponsive to medical intervention, and was declared deceased shortly after arriving in the ED. o Patient declared deceased 02/15/2022 after failure to develop sustained perfusing rhythm. o COD: cardiac arrest Patient had multiple admissions in the weeks prior to death. 12/22/2021-12/26/2021: fever/pneumonia/ARDS/sepsis. Negative for COVID-19 during this hospitalization. Received first COVID vaccine on day of discharge. 1/28/2022-2/7/2022: fever/UTI/pyelo/dental caries; Negative for COVID-19 during this hospitalization. Received second COVID vaccine on day of discharge. 2/15/2022: cardiac arrest and death; SARS CORONAVIRUS 2 RNA detected in NP swab (acute infection)
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of Moderna COVID-19 Vaccine 3 days earlier than the allowed grace period) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A and 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of Moderna COVID-19 Vaccine 3 days earlier than the allowed grace period). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of Moderna COVID-19 Vaccine 3 days earlier than the allowed grace period) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.
EXTREME heart palpitations about 9 hours after vaccine, nose bleeding. Heart palpitations continue daily, abnormal EKG at doctors office weeks later when I had ZERO heart problems ever. Diagnosed with an arrhythmia.
within 8 hours of administration of Twinrix, pt developed rash in groin area and under arms, which persisted for 3 days.
The patient's left buttock was red and swollen from 09/18 thru 09/20. The patient was treated with Augmentin, Benadryl and ice compresses. The patient was completely recovered by 09/24/2001.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: el3302), on 04Feb2021 as dose 2, single (Lot number: en5318), on 01Sep2021 as dose 3 (booster), single (Lot number: en0173) and on 09May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: ROSUVASTATIN CALCIUM; PRILOSEC [OMEPRAZOLE]; ASPIRIN 81. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative, notes: Negative test on day 5; (Oct2022) Positive, notes: positive test 2 days afterwards. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid as treatment for COVID 19, Treatment start date was on 22Oct2022 and Treatment stop date was on 26Oct2022
Chills, headache, body aches;  Hard, warm, red, itchy circular rash at injection site
Patient stated gets anxiety from vaccines and bloodwork.  He got sweaty at 1045am. I gave him an ice pack and he laid down on the vision center floor.  This lasted 4 minutes and he was fine after 1049am. This was his first Covid Booster and he stated it happened with the first two covid shots also and only lasts a few minutes.  He was not light headed nor dizzy.  He stated laying down makes it pass quicker.
On 11/26/22, I noticed mild numbness and tingling in my left hand. Soon after I developed weakness in my left hand as well. I described this to my PCP on 12/6/22 but he disregarded it. My symtoms continued to progress and worsen over December and January. By February 2022, the numbness, tingling, and weakness had spread to my entire left hand and arm, both feet, and both legs. On 2/21/22 I noticed I had completely lost the ability to run and jump. I went to urgent care on 2/22/22 and was referred to a neurologist. On, 3/2/22 I saw a neurologist, who referred me to a neurologist specializing in neuromuscular diseases. (See continuation page)
28FEB96 presented in ER w/t40.1 R;hx of fever @ home102-103 on 28FEB & 29FEB, some vomiting;exam showed bilat ant cervical lymphadenopathy & papular rash over trunk arms, neck, & scalp
Metallic taste, chills, shivering, fever, joint pain. Ibuprofen helped with the fever, pain and shivering. Metallic taste still present day 2.
Information has been received from a registered nurse concerning a 14 year old female with respiratory issues, immunodeficiency and an allergy to amoxicillin + clavulanate potassium Augmentin and Sulfamethoxazole + trimethoprim Bactrim who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Concomitant therapy included an unspecified respiratory medication. It was reported that the patient received a previous dose of Pneumococcal 23v polysaccharide vaccine in 2004. On 6/7/05 the patient developed an injection site reaction. The nurse reported that on 6/7/05 the patient developed a rash at the injection site with redness. The patient was treated with an unspecified antibiotic by the physician. The outcome of the patients injection site reaction was unknown. Additional information has been requested.
Sleeplessness; This is a spontaneous report from a contactable other Health Care Professional (patient). A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration in left arm on 30Jan2021 at 12:00 (at the age of 47 years old) as single for covid-19 immunization. Medical history was None. Patient had no known allergies. There were no concomitant medications.  Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 09Jan2021 at 12:00 PM (at the age of 47 years old) for covid-19 immunization. The patient had no other vaccine in four weeks. The patient did not receive other medication in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 30Jan2021, patient experienced sleeplessness. The patient did not received treatment to the event. The outcome of event was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Fever and chills first first 24 hours. Red, swollen, hot, itchy large circle developed after the first 24 hours. Painful, hot, very itchy and uncomfortable.
After the shot by the weekend he started to decline visually in his health to get around. At the time I wasn't connecting it with his heart. By the next Tuesday I tried to get an appointment with his PCP, until 03/16/22. Continue to decline visually. Taken to the ER. Admitted on 03/14/2022. Admitted with Pneumonia. Later by Sunday it was reported that his kidney and live were failing and had a EF of 10. Began to improve later on. Transplant ICU. Hospital. By Monday morning, 3/15 around 10 am put ventilator in him. By Wednesday they put in coil to stop an internal bleed lower left back. Discovered a break of his back at the CT. Unable to submit to a surgery for his back. Blood clot in his left left (calf area). MG tube for nourishment and IV. Pipeline for his meds. Anal tube to collect accretion. By Next Thrusday 03/25/2022 took him off the ventilator and put a by pax breather on him. March 28th he experienced trigia mylagia... ventilate him by mouth. Select specialty hospital clam shell away. Drain diffusion. Severe hospital dilirium. June 1st, he was tranferred to rehab Hospital. In preparation for him to swallow again... only getting MG tube and IV fluids. 158 days until he was actually to take something by mouth. Once he came home in July 7th.. received multiple services.  At the end of July went out to speech therapy services at hospital to attempt to pass swallowing test to resume drinking and eating. It was not possible until the end of September. Continue with G tube. It was eventually remove in hospital on November 4th and able to swallow. By September his cardiologist determine his E7.  Hospital. He continues to treat with numerous specialist since his release from the hospital in July.
Became light headed, weak, shaking, flushed with rapid heart rate 3 hr 45 min after receiving flu shot.
Bodyaches, chills, headache 12 hours after the vaccine. 3 days after, she developed rash on arms, upper thighs, abdomen and jawline. HAd covid on 12/22/2020
Numbness and tingling in Left upper arm to finger tips.  Lasted less than 24 hours
Developed swelling of right eye with redness 1 hour after Immunizations, then developed swelling of left eye and approx 2 hours later had hives on face, neck, back, arms and later developed flat red rash on legs.  Child seen in Urgent Care & given Prednisone and Benadryl.  All symptoms subsided by evening of following day.
A nurse reported that a female resident of a long-term care facility received a dose of Flu Shield (2001-2002 formula) in 11/01. In 1/02, the resident developed a "severe" respiratory infection characterized by congestion and fever. A dx of influenza A was confirmed by rapid antigen testing. She recovered. No further information was available at the date of this report. This is 1 of 8 residents of this facility who experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018038. The reporter also indicated that 7 employees of the facility experienced adverse events following receipt of Flu Shield (2001-2002 formula) lot 4018028.
Client had no reaction at the time of departure. Client started the monovalent series about 4 weeks ago and she was instructed to come back for her 2nd dose in the series (Pfizer-Monovalent). We took into consideration that she would need to receive the bivalent at the time of this current appointment, but did not consider the time between the 2 doses until after the injection was given.