chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having difficulty walking; falling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 27Sep2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for COVID-19 Immunization. The following information was reported: FALL (non-serious) with onset 2021, 1 day after the suspect product(s) administration, outcome "recovering", described as "falling"; GAIT DISTURBANCE (non-serious) with onset 2021, 1 day after the suspect product(s) administration, outcome "recovering", described as "having difficulty walking". Additional information: He had taken the Covid booster two years ago and had a bad effect on him. Additionally, on 27Sep2023, it was reported that two years ago after getting a Pfizer COVID-19 booster he started having difficulty walking and started falling. He has had many falls since then. This problem has been going on for two years. He was getting better with the walking issues. Previous to the vaccine, he used to walk three miles a day and one day after the vaccine his issues started. He wanted to know if there was anything he could do to get over it. He also asked if there was someone currently studying the side effects of the vaccine as he was willing to volunteer.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312109 same reporter/patient, different event;
Painful, sore, red, welts/rash on the top of both hands. The left hand welts/rash are more painful then the right hand welts/rash. Heat is coming off of the rash.
1 month old received adult (1 mL) dose; 1 month old received adult (1 mL) dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 1-month-old male patient who received HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   On 6th September 2022, the patient received the 2nd dose of Engerix B adult 1 ml. On 6th September 2022, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's comment: The medical assistant reported that a 1 month old patient received an adult (1 mL) dose of Engerix. No symptoms were reported. The reporter consented to follow-up via email. Additional Supportive Information: 1 month old patient received an adult (1 mL) dose of Engerix, which led to overdose and adult product administered to child.
Significant Hair loss. Noticed 4 days after shot. Estimated 60% loss of the volume of my hair within the next 2 days. No hair loss experienced from the first 4 shots.
Red rash to left antecubital area 8.4cm x 9cm, circled to monitor spreading, lotion
I got my vaccine and later that night I started having a fever of 103 with medication. This lasted for the about 18 hours. In March it started with belly pain and tingling and numbness in my feet. I had an ANA blood work. It was medication induced based off the results. I went to see a GI specialist and a rheumatologist and my primary. There was no direct connection to confirm or deny. I am very hesitant to get another vaccine based off my experience.
Migraine Headache for two days, muscle soreness, joint soreness for three days, fatigue three days, chills two days, hot flashes on and off, restlessness and irritation three days, pins and needles feeling in feet 1 day, continued exhaustion.
pt recv vax & devel tinnitus & unilateral sudden hearing loss that was classified as profound;
no adverse event; patient inadvertently received a dose of PROQUAD instead of MMR II; This spontaneous report was received from an other healthcare professional (medical assistance) referring to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The patient's pertinent medication history and drug reactions/allergies were not reported. On 20-MAR-2020, the patient was inadvertently administered with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) of lot number S003865, expiry date 08-AUG-2020 (dose, strength, route of administration were not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, strength, lot number, expiry date, route of administration were not reported) for prophylaxis (wrong product administered). There were no adverse events.
Our facility only has the capability to store COVID19 vaccines in the refrigerator. Patient was given a vaccine that was outside of the 10 week expiration window. The 10 week expiration date was 6/10/22, patient was given the vaccine on 6/16/22. Patient has not reported any adverse events or symptoms to our facility
About 30 minutes after receiving the vaccine I began to lose my voice. I also had a headache, joint pain and felt fatigue later that evening and it lasted until the 23rd.  On the 23rd I developed a fever of 101. Today I still do not have my voice and the fever has went away. The injection site has a red and swollen patch. I still feel tired and fatigued today.
My Spouse received Covid-19 Vaccine  on March 24 2021. April 16th she started complaining of allergy and pain in the left shoulder. April 20th, Our general physician diagnosed her with Shingles and prescribed appropriate medicine. Vaccine Details Pfizer-BioNtech on 3/24/2021, The Lot:ER8727. She scheduled to take a second dose on April 21, we have canceled the same. Would appreciate  feedback on whether to schedule the second dose in this case.
Deltoid, right arm swollen to twice it's size and swollen ,hot to touch the evening following.  It is painful, and had to cancel activities for next day...put ice on area and took Bayer 500
With the first shot, my arm was numb and felt like it had a bruise but there was no bruise. With the second shot, my arm turned red and hot at the shot site. Where the needle went in was white and the area around it was hard, red, swollen and hot. I have felt numbness in my cheeks and my head has had a slight headache and felt foggy or whoozy at times. I have had body aches as well.
Pfizer-BioNTech COVID-19 Vaccine EUA on 7/21/21, experienced chills, body aches, fever and fatigue; took two  extra-strength Tylenol (500mg ea) around 10pm. Around 1am on 7/22/21 took temperature at it read 100 degrees; chills and aches increased at this time. Took a sleeping pill and sucked on  frozen ice treat to help cool off. Around 4am on 7/22/21, woke up feeling less feverish with the onset of stomach cramps. Then had to go to the toilet and diarrhea began. The diarrhea continued every ten minutes on average until around 6am; it lessened, but the stomach cramps continued. Ate some grits and drank water and took Imodium to help with diarrhea around 10am. Then the afternoon of 7/22/21 fever went up to 100.7 degrees and took 1000mg of Tylenol. On 7/23/21, woke up with no fever and still had sore joints. Stomach cramps went away.
Temp 103, fatigue, weakness and swelling in right arm, had to go see doctor is was so bad.
Headache, head pressure, and foggy feeling began a little over 12 hrs after dose, continuing still. Ranges from mild to more severe especially at night.
Feels sick, chills, achy, sore all over, nausea, insomnia.
This case was reported by a healthcare professional and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included acid reflux. Concurrent vaccination included PENTACEL (Sanofi) and PREVNAR (Wyeth Labs) both given on 22 November 2011. Concurrent medications included ZANTAC. On 22 November 2011 at 15:30 the subject received 1st dose of ROTARIX at 1.0 ml, orally. On 25 November 2011, 3 days after vaccination with ROTARIX, the subject experienced diarrhea (12 to 15 times daily), increased sleep, diaper rash and mucus in stool (no blood). These events resolved on an unspecified date and were considered possibly related to vaccination with ROTARIX. Fever (99.4 to 100.9) was also reported with onset 25 November 2011. Resolution of fever and attribution to ROTARIX was not reported. The subject had been taken to the emergency room on 26 November 2011, but was not admitted. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). It was reported that a urine bag was used so the reporter assumed that a urinalysis and culture was performed, but results were not available.
Chills and shivering, headache, nausea all becoming increasingly more severe through 5pm on 6 Jan 2023 (next day).
Shot administered at 2:30pm. Felt fine all afternoon, until 8:30. Chills and mild headache for about 30 mins, then immediately deteriorated around 9pm into body aches, fatigue, and more severe chills. Patient began taking temperature sublingually, with the same device for each reading Sublingual temperature at 11:01pm: 99.4 degrees fahrenheit Sublingual temperature at 11:10pm: 100.2 degrees fahrenheit Sublingual temperature at 11:22pm: 100.7 degrees fahrenheit Sublingual temperature at 11:43pm: 101.2 degrees fahrenheit Sublingual temperature at 11:56pm: 101.6 degrees fahrenheit Sublingual temperature at 12:37am: 102.5 degrees fahrenheit at this point, patient took 800mg of Ibuprofen. Temperature at 9:30am the following day was 99.5, and remained constant all day. Chills, body aches, head ache, fatigue.  Sublingual temperature taken again at 9:37pm (the day after injection) and temp was 100.2 600mg Ibuprofen, patient felt fine the next morning except for lingering lower back aches
stiff neck/other side of her neck was stiff; face started tingling; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5130, expiry date unknown) via unspecified route of administration at left deltoid on 22Dec2020 at single use for COVID-19 immunization. Medical history included true nut allergies (has an epi pen at home), migraines (used Imitrex injections), menopause. The patient got the COVID-19 vaccination this morning 22Dec2020. They said to wait 10 minutes then she could leave. She felt fine. As she was leaving on 22Dec2020, employee services was far away from where she parked, she was almost to the parking lot and started feeling like she had a stiff neck. She thought she slept wrong, she did not think it was related. Then the other side of her neck was stiff. So she was waiting in her car and did not drive away in case she needed to go back inside. Then her face started tingling. It came on gradual and lasted 4-5 minutes and then it went away. She was fine now. She was at home. She feels fine, she was not short of breath. She did have an epi pen at home due to true nut allergies, but she has no concern over potential respiratory problems or anything like that. In the past she had migraines, and she would use Imitrex injections. Right before it would make her migraine go away, she would feel a muscle spasm in her neck and it would release and her headache would go away. She would compare her symptoms to that. She has not had an Imitrex injection in years. Her headaches went away after menopause and she has not needed them. Her primary care did not administer the vaccination. She received it at the hospital where she worked. She was wondering, should she get the second dose of vaccination. Again, she was not at all concerned, she had felt this similar feeling before, but the face tingling was new. She thought this should be reported as this was a brand new vaccine. The outcome of the events stiff neck/other side of her neck was stiff, face started tingling was recovered on 22Dec2020. The reporter considered the events non-serious and face started tingling related.
Fever, chills, fatigue. All went away after two or three days. Also "prickly skin" all over my body, but worse on my back and buttocks. And worse at night. That feeling never went away. Went to PCP on March 1, 2021. She ordered CT head scan, lumbar spine X-rays, and referred me to a neurologist. Saw neurologist November 2, 2021.
30JUN91 onset of lower back pain which on 3JUL spread to include hips & upper legs; Dec in severity w/use of Ibuprofen however on 8JUL-11JUL also exp achiness of joints in both hands;
This child had a fever and hives on 01/30/01. The hives started on her hands. No other cause of physical exam.
*08/19/2021 FIRST SHOT: Immediately felt dizzy.  *08/20/2021- Chest tightening and shortness of breath, which went away the next day.  Thingling on left arm and little finger. Thingling on both legs, and pooping a bit more than normal.   * 08/21/2021-Morning syncope/unconscious. It came with really bad cold sweat and pooping. Completely weak the entire day and could not get off bed. I felt like i was drunk.  *08/24/2021-still had thingling on both legs, left arm and left little finger.
Initial information was received from a consumer on 04 Mar 2014. The case is link to 2014SA029568 case (same patient). A patient whose demographic details, medical history and concomitant medication were not reported received, a dose of Tetanus Toxoid vaccine on an unspecified date (Route, site, dose and Batch number were not reported). It was reported that on an unspecified date after vaccination patient was very sick with a low grade fever, headache and aches. Laboratory investigations and corrective treatment were not reported. At the time of report outcome of event was recovered. List of documents held by sender: None.
Pruritic macular red patches of on back, chest, arms, legs, forehead, neck, axilla starting the day following MOderna Vaccination now 4 weeks ago.   Refused second vaccination he is following up with Public health clinic. .  Rash waxing and waning  over the first two weeks, macular without respiratory, oral or other symptoms.  Rash waxing and waning initally but now worse the past two weeks.   Phone consult done, Face to face evaluation pending.  No associated symptoms, No prior similar rashes.
Vaccine was expired when  administered on 4-11-2023. Vaccine expired 4-7-2023.
Cough, runny nose, congestion, fatigue starting 9/15/21 ln additiion, right eye is red and has been gritty and has had discharge the past couple of days
lesions of shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (lesions of shingles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A, 044A21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 27-Oct-2021, the patient experienced HERPES ZOSTER (lesions of shingles). At the time of the report, HERPES ZOSTER (lesions of shingles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  A pharmacist reported that she had the lesions of shingles on 27-Oct-2021 and the diagnosis was confirmed on 01-Nov-2021.   This case was linked to MOD-2021-426367, MOD-2021-425615 (Patient Link).
Narrative:  63yo patient with mental health issues and homelessness, chronic hepatitis, htn, gi reflux,carcinoma of prostate, anxiety, depression, ADHD was found deceased in the street by law enforcement on 9/17/2021. Pt had received covid vaccines from the agency on 2/24/2021 & 3/24/2021. Likely death is not related to vaccines given pt's issues surrounding his death and given long timeframe between date covid vaccines given & date of death.
Muscle pain 4 hours post injection. Muscle pain in arm and shoulder increased in severity. Treated with ice and Ibuprofen. By ^p.m. arm showed signs of inflammation, hot to touch, raised red welts, bruising in lower arm. Continued with ice and Ibuprofen and went to urgent care clinic in the morning. Diagnosis of allergic reaction, given Rx for 20mg Prednisone for 6 days (3-tabs x 3days, 2 tabs x 2 days and 1 tab x 2 days).
Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021). On 20-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021) 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.   Concomitant medications were not provided by the reporter. Treatment information was not provided.
PT IS A 15 Y/O MALE WHO WAS NORMAL UNTIL 4 DAYS AFTER SECOND PFIZER COVID VACCINE. WOKE UP AT 6:00AM WITH SHARP CHEST PAIN.  PATIENT THEN MADE AN APPOINTMENT WITH THEIR PEDIATRICIAN FOR PALPITATIONS AND CHEST PAIN. THE PEDIATRICIAN REFERRED PATIENT OVER ON 06/14/2021 AND WAS SEEN BY OUR CARDIOLOGIST ON 06/15/2021. WHERE AN EKG AND ECHO-CARDIOGRAM WAS  PERFORMED AND CONFIRMED ABNORMAL EKG AND mild septal flatttening ( on m-mode) in the proximal muscular septum. A MRI WAS ORDERED AND WAS PERFORMED ON 06/23/2021 WHICH CONFIRMED MYOCARDIAL SCARRING.
2 blotches 1.5 inches and a dime size; Tender to touch; Itching sensation; Burning sensation; paresthesia in both the hand and wrist in the opposing hand from injectionP; Arthritic pain awaken; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Jan-2021 and was forwarded to Moderna on 01-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (2 blotches 1.5 inches and a dime size), TENDERNESS (Tender to touch), PRURITUS (Itching sensation), BURNING SENSATION (Burning sensation) and PARAESTHESIA (paresthesia in both the hand and wrist in the opposing hand from injectionP) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 27-Jan-2021, the patient experienced RASH MACULAR (2 blotches 1.5 inches and a dime size), TENDERNESS (Tender to touch), PRURITUS (Itching sensation), BURNING SENSATION (Burning sensation), PARAESTHESIA (paresthesia in both the hand and wrist in the opposing hand from injectionP) and ARTHRALGIA (Arthritic pain awaken). At the time of the report, RASH MACULAR (2 blotches 1.5 inches and a dime size), TENDERNESS (Tender to touch), PRURITUS (Itching sensation), BURNING SENSATION (Burning sensation), PARAESTHESIA (paresthesia in both the hand and wrist in the opposing hand from injectionP) and ARTHRALGIA (Arthritic pain awaken) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Rapid heart beat (180 bpm) & shortness of breath. Walked 240 feet in 6 minute walk test due to desaturation
Information has been received from a pharmacist concerning a 12 week old hospitalized male with renal insufficiency, no drug reaction or allergies and who was born prematurely who on 17 Jan 2006 was vaccinated with a 2 ml oral dose of Rotateq. Concomitant therapy included israpidine, amoxicillin, Prevacid and vitamins (unspecified). On 29 Jan 2007 the patient developed rotavirus. Lab test that were preformed included, rotavirus stool test, various system cultures, RSV and influenza. The results of these tests were not reported. The patients hospitalization continued. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
October 19, 2022, I saw blood in my urine. I ended up in the ER and they did a CT scan, Pet scan, and urine sample. The CT and Pet scan which both came back negative, but the urine sample indicated that I did have blood in my urine. I got back from a trip and went to a urologist. My blood work came back that I had evidence of Prostate Cancer. My PSA score was 4.8 on Oct. 17, came back elevated in January which confirmed Prostate Cancer.
Received both covid vaccination doses and had major hair loss.; Dose 1- 20Jun2021 and dose 2- 12Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Aug2021 (Lot number: FC3181) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number=1, Lot number=EW0178), administration date: 20Jun2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Aug2021, outcome "unknown", described as "Dose 1- 20Jun2021 and dose 2- 12Aug2021"; ALOPECIA (non-serious) with onset 13Aug2021, outcome "not recovered", described as "Received both covid vaccination doses and had major hair loss.". The event "received both covid vaccination doses and had major hair loss." was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient received treatment as Needles in head to try to help hair growth. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.