chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Globs" of stuff came out of nose; Unable to sleep; Fell down; Felt disoriented; Became foggy and groggy; Lost continence of urine; Head congestion; Fatigue; extreme chills; Injection arm became sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Became foggy and groggy), URINARY INCONTINENCE (Lost continence of urine), NASAL CONGESTION (Head congestion), RHINORRHOEA ("Globs" of stuff came out of nose) and DISORIENTATION (Felt disoriented) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0492119 and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy in 1983. Concurrent medical conditions included Acromegaly since 1970. Concomitant products included PROGESTERONE and ESTRADIOL (ESTROGEN) for Hypothalamo-pituitary disorder, HYDROCORTISONE for Pituitary tumor removal, LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (Fatigue), CHILLS (extreme chills), VACCINATION SITE PAIN (Injection arm became sore) and FATIGUE (tired). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Became foggy and groggy), URINARY INCONTINENCE (Lost continence of urine), NASAL CONGESTION (Head congestion), DISORIENTATION (Felt disoriented) and FALL (Fell down). On 27-Mar-2021, the patient experienced RHINORRHOEA ("Globs" of stuff came out of nose) and INSOMNIA (Unable to sleep). On 26-Mar-2021, CHILLS (extreme chills) had resolved. At the time of the report, FEELING ABNORMAL (Became foggy and groggy), URINARY INCONTINENCE (Lost continence of urine), NASAL CONGESTION (Head congestion), RHINORRHOEA ("Globs" of stuff came out of nose), DISORIENTATION (Felt disoriented), INSOMNIA (Unable to sleep), FALL (Fell down), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection arm became sore) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-073152, MOD-2021-073152 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: HCP details, patient demographics, patient medical history, concomitant products, AE progress/outcome added.
Shoulder pain at site of injection. Limited range of motion. Prescribed pain medication did not control pain.
a man that had both doses of the PBCV and the 2 booster doses then 13 days later he got COVID and is now taking PAXLOVID; a man that had both doses of the PBCV and the 2 booster doses then 13 days later he got COVID and is now taking PAXLOVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2, solution for injection), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "a man that had both doses of the PBCV and the 2 booster doses then 13 days later he got COVID and is now taking PAXLOVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with PAXLOVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
MIGRATORY JOINT PAIN decreased VISION INSOMNIA CHEST DERMATITIS #1 3-18-21 #2 4-8-21 #3 12-16-21 Booster #4 7-13-22 Booster
Nerve pain in the same leg she had Shingles (fall of 2019).; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration in the left arm on 06Mar2021 at 13:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid, penicillin allergy and shingles (fall of 2019). 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 COVID vaccine. Concomitant medications included vilazodone hydrochloride (VIIBRYD), lisdexamfetamine mesilate (VYVANSE), levothyroxine, liothyronine (NP THYROID), lisinopril (LISINOPRIL) and montelukast sodium (SINGULAIR); all from an unknown date for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 13Feb2021 at 13:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. On 07Mar2021, the patient experienced nerve pain in the same leg she had shingles (fall of 2019). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event  nerve pain in the same leg she had shingles (fall of 2019) was not resolved at the time of reporting.    No follow-up attempts are possible. No further information is expected.
(L) arm burning and tingling and weakness progressive since flu vaccine 5 days ago. Radial nerve distribution. Unresponsive to NSAIDs. Dropping objects.
3 days p/inject devel rash on chest, neck & face; area very red & swollen; pt sought medical attention; 10SEP93 awoke w/facial swelling & difficulty breathing;
This spontaneous report as received from a nurse practitioner refers to a unknown number of patients of unknown age and unknown gender. Patient concurrent conditions and relevant medical history was not reported. On an unknown date unknown number of patients were vaccinated with improperly stored GARDASIL (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was unknown. This case is linked to #1412USA001450 via same reporter link. Additional information has been requested.
Red rash, swollen, and itchy around injection site (continues after 2 weeks); Pain around injection site
Clear dripping nose, nausea, severe chills, rigors with body shaking, teeth popping, and headache all lasting for 3 or 4 hours.
Information has been received from a registered nurse concerning a 69 year old female patient with asthma and allergic reaction to antibiotics (CIPRO), who on 17-FEB-2009 was vaccinated subcutaneously with one 0.5 mL dose of ZOSTAVAX (Merck) (Lot # 663673/1710X). On 20-FEB-2009, the patient complained of hot burning pain like "shingles pain" on her waist. The pain shouted up on her front and back. The patient had not rash or blisters. The patient was seen by the physician and had a x-ray (results not provided). At the time of reporting, the patient had not recovered. Follow up information received from a registered nurse concerning the 69 year old retired female (weight 136 pounds) who on 17-FEB-2009 was vaccinated subcutaneously in her left arm with a 0.65 mL first dose of ZOSTAVAX (Merck) (Lot # 663673/1710X). On 20-MAR-2009 (also reported by the registered nurse as 20-FEB-2009) the patient experienced burning pain around waist. On an unspecified date lung and spinal x ray have been negative, seemed "neuropathic", those results were sent to ortho/spine doctor. Additional information has been requested.
Received expired booster dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 24M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Non Significant follow-up.
Rec'd first dose of Engerix-B SEP90; 3 or 4 days later developed low-grade fever, malaise & jaundice. Hepatomegalia developed over the next month. Engerix-B was discontinued.
Blisters to mouth/lips with itchy, red macular rash to hand and arms.
PATIENT WAS IN OFFICE FOR VACCINES. RN GAVE VAXELIS TO PATIENT. PATIENT WAS BEHIND ON VACCINES. THE HIB IN THE VAXELIS WAS GIVEN TO EARLY. THE HIB NEEDED TO BE AN 8 WK INTERVAL. PATIENTS MOTHER WAS CONTACTED AND INFORMED OF ERROR. MOTHER V/U. PATIENT DID NOT HAVE ANY ISSUES WITH THE INJECTION PER MOM. PCP WAS NOTIFIED. MESSAGE LEFT WITH NURSE. MOTHER NOTIFIED TO CONTACT RN IF ISSUES ACCORD.
102 Fever; head to toe rash; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2015-2016 season) (batch number 33FF2, expiry date 30th June 2016) for prophylaxis.   The patient's past medical history included allergic reaction.   On 19th October 2015, the patient received Fluarix Quadrivalent 2015-2016 season (intramuscular). On 19th October 2015, less than a day after receiving Fluarix Quadrivalent 2015-2016 season, the patient experienced fever and rash. On an unknown date, the outcome of the fever and rash were recovered/resolved.   It was unknown if the reporter considered the fever and rash to be related to Fluarix Quadrivalent 2015-2016 season.  Additional details provided were as follows: Patient was called to enquired about Fluarix description.  Patient stated that she wanted to get a Covid-19 vaccine, but her allergist was concerned because of an allergic reactions she had from Fluarix in the past. The patient received the Shingrix vaccine at her job site and experienced head to toe rash with a 102 fever. Consumer stated that she came back to work the next day and her supervisor sent her back. VAERS details were captured. Reporter reported that emergency room visit is required. The reporter consented to follow-up.
Patient got her COVID-19 booster shot 1 week prior to admission.  Since that point the patient has become gradually more short of breath.  She admitted to a positive productive cough that was mostly clear with occasional yellow amounts.  The shortness of breath became severe enough that she developed dyspnea walking 10 feet.  The patient was unable to sleep at night because laying flat caused her shortness of breath to worsen. Found to have left lower lobe pneumonia which may have contributed congestive heart failure exacerbation.  Patient was hospitalized for total of 9 days for IV diuresis as well as treatment for the community-acquired pneumonia. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Moderate energy, numbness, funny breathing  sounds on February 7th, 2021. Forgot to do vsafe on February 7th, 2021.
Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111401, 2019SA111409, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446  (same literature). Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 46 years old male patient who experienced acute asthmatic bronchitis, wheezing and subsequent cardiopulmonary arrest, while he received vaccine INFLUENZA VACCINE (TRIVALENT). The patient's past medical history included, asthma; unspecified allergies; chronic headaches; gout and Hypertension. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious acute asthmatic bronchitis (asthma) with wheezing and had subsequent cardiopulmonary arrest (Cardio-respiratory arrest) (unknown latency) following the administration of INFLUENZA VACCINE, (TRIVALENT). The event acute asthmatic bronchitis was leading to death. Brighton level was 2. Lab test not reported. Final diagnosis was (fatal) Acute asthmatic bronchitis and subsequent cardiopulmonary arrest. It was not reported if the patient received a corrective treatment. It was not reported if an autopsy was performed or not, however documented cause of death was reported as acute asthmatic bronchitis. Outcome for all the events was fatal. List of document held: none; Sender's Comments: This case is from a literature article concerning a 46-year-old male patient who died due to Acute asthmatic Bronchitis followed by wheezing with Subsequent cardiopulmonary arrest after vaccination with INFLUENZA VACCINE (TRIVALENT). Time to onset is unknown. Past medical history included Asthma; unspecified allergies;  chronic headaches; gout; hypertension. Autopsy results confirming the cause of death was due to Acute asthmatic bronchitis. Further information with patient's medical condition at time of vaccination and clinical course of the events, laboratory results, concomitant therapy, family history are needed for reassessment. Based upon the available information and considering the reported cause of death which is unrelated to vaccination, the role of individual vaccine is unlikely.; Reported Cause(s) of Death: Acute asthmatic bronchitis.
on or about 5/4/21 noticed a rash on both legs they had been itchy prior to that, the rest of my body is itchy w a few rash spots present. 5/8/21  noticed my left thumb twitching.    As far as Item 20 rash is still still present and the thumb twitching is still present
itchiness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a and 011m20a) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (itchiness) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness) and PYREXIA (Fever) outcome was unknown. Not Provided          Patient reported that she is on lot of medications.
chilling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chilling".  Additional information: Product: Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), patient had the shot and the flu shot and the COVID shot and the flu shot and she's chilling and.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given 0.3mL of the Pfizer vaccine mixed with 1.8mL of the diluting saline. He was watched for over an hour without any SE. He was monitored overnight without SE. Since then, he reported only "sore arm" at the vaccination site. No other sequelae to report.
Please note I am unable to provide the lot number and vaccination site at this time since the nurse who administered the injection never finished documenting the administration. The patient came into clinic for a routine visit for follow-up on his ADHD medication and was also offered a COVID booster dose at the same time. He is a 15 year old male, who had previously gotten 2 doses of Pfizer on 5/14 and 06/04/21. The provider note indicates he was to receive a booster with Pfizer, which would be appropriate based on his age. There was not a formal order placed for the vaccine in Epic and the nurse did not complete documentation in Epic other than the fact that it says a Moderna booster (0.25 mL) was ordered and given to the patient.  RN noted on 2/22/22 that the patient had received the Moderna vaccine in error and called the patient's mom, who reported that the patient:  "had mentioned on the ride home from his appointment that "his heart was beating weird". She states he had no other symptoms at that time. I asked if this had occurred since Friday and patient had told his mom that it happened yesterday while in class. Mom denies patient having any dizziness, shortness of breath. She would like to follow up with an appointment with Provider as this is a new concern for Patient.    I did tell her if Patient's symptoms were to worsen, if he the "heart beating funny" were to last a long period of time, or if any new symptoms occur to bring him to the ED. I did also let mom know about triage after hours. "  The patient was then scheduled for a follow-up appointment on 2/23 with the same PCP to evaluate his symptoms. A chest X-ray was also completed on 2/23 and found to be normal. Per the PCP note:   "Since (receiving immunization) he has had a couple of intermittent episodes of palpitations with last episode being on Monday 2/23.  These episodes only last for a couple of minutes.  He denies any skipping of beats, he just feels as if his heart is racing.  He states he is slightly short of breath when these episodes happen.  He states he does strength and conditioning at school and has been able to do this without any concerns over the last few days.  Pt has been referred to cardiology and had a 3 day Holter monitor placed.  On 2/24, patient noted shooting sharp pain in chest.
Flu-like symptoms: body aches, bad headache, nausea, chills, and extreme lethargy for 2 days. Began to recover Monday, but still had h/a and I was very tired, I didn't feel normal until Tuesday, 10/26. My husband received the same vaccination at the same time and didn't have these symptoms, just a little tired over the weekend. I just slept and sipped on drink.
The day after vaccination in the afternoon. I started feeling feverish. The temp was 101.9 degrees for 24 hours. I had a horrible headache on the same side of my head as vaccine. Which lasted for 13 days. It felt like a Migraine with light sensitivity and no medicine worked to relieve the pain. I got my Migraine medicine and the headache subsided. I kept having intermittent every few days headaches on and off until the second dose. The headache was similar to the headache I had with Covid-19. I got the second dose caused similar headaches but I had the Migraine medicine and the symptoms were less severe. Now I need Migraine medicine as a shot monthly to combat Migraines
paralyzed; Initial information was received on 31-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional.  This case involves an unknown age of female patient who experienced paralyzed after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine (produced by unknown manufacturer) (lot number, formulation, strength, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a serious event of paralyzed (paralysis) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available.   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (paralyzed).  At time of reporting, the outcome was Unknown for the event paralyzed.  Seriousness Criteria : This event was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 04-Jan-2023: This case involves an unknown age of female patient who experienced paralyzed after receiving influenza vaccine. Further information regarding past medical history, concurrent condition, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Injection given Left Deltoid without incident or complaint.  Pt. left health department and traveled to Walmart where she received a flu shot in her Right Deltoid (this vaccine information is not available).  Approximately 30 to 60 minutes later, the pt's left arm began to hurt and became red at the injection site.  The symptoms progressed to swelling, then the area became hard and warm to touch.  Patient states she had difficulty sleeping that night because of the pain.  Pt. also states the area had a "welt" like appearance at the injection site; denied respiratory difficulties. States that after two sleepless night, due to the arm discomfort, symptoms diminished.  States by the third day, she has full functioning and mobility of the arm, denies any residual numbness or pain.  This was the patient's second shot, previous one was seven years prior, so it is not necessary for the injection to be repeated in the future.  Patient did not see her physician for these complications.