chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cannot walk again; Autism has increased; Shaking; Having trouble with daily activities; This spontaneous case was reported by a consumer and describes the occurrence of AUTISM SPECTRUM DISORDER (Autism has increased) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chromosomal anomalies (Potocki-Lupski syndrome since 14 years old.), Autism and Physical impairment.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AUTISM SPECTRUM DISORDER (Autism has increased) (seriousness criterion medically significant), TREMOR (Shaking) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Having trouble with daily activities). On an unknown date, the patient experienced GAIT DISTURBANCE (Cannot walk again). At the time of the report, AUTISM SPECTRUM DISORDER (Autism has increased), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Having trouble with daily activities) and GAIT DISTURBANCE (Cannot walk again) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications were provided by the reporter.  No treatment information was provided.  Reporter states that her daughter had shaking, trouble with daily activities and autism has increased. Patient saw her Psychiatrist that said this is not related to autism and referred the patient to a neurologist.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may remain as confounding factors. Further information is required.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received, events added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.However, multiple underlying co-morbidities may remain as confounding factors.Further information is required.
Head pressure located on perimeter of my head.   Foot pain - planters faciatis or neuropathy
lymph node under her left arm hurts, red and swollen.; arm was swollen at the side of the injection; This is a spontaneous report from a Contactable Consumer (reported for himself).  This 65-year-old male patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: EL9462) via an unspecified route of administration as a single dose on 14Feb2021 1130AM in the left arm, for Covid-19 immunization. Medical history included thyroid. He did not have any family medical history. Concomitant medications included Methimazole 5 mg once at night. By the night of 14Feb2021, his arm was swollen at the side of the injection. On 16Feb2021 from morning, he had a lymph node under his left arm that hurt, and it was red and swollen. It was hurting worse at the time of this report. He was scheduled to receive the second dose on 07Mar2021. The patient had no history of previous immunization with the Pfizer vaccine. There were no vaccines administered on same day of the BNT162B2 or within 4 weeks prior to it. He did not have any relevant test done. The patient recovered from the event arm swollen at the side of the injection on 15Feb2021. The outcome of the event of lymph node under his left arm that hurt, and it was red and swollen was not recovered.  No further information was available.
About 7 week's after my daughter received her second COVID-19 shot, she was diagnosed with Bell's Palsy.  I'm not sure if getting the shot is the cause but I thought it would be best to report this.  Thank you.
Diagnosed with Pityriasis lichenoides et varioliformis acuta (PLEVA), otherwise known as Mucha-Habermann disease approx.  14 days post vaccine. Symptoms: trunk rash that appeared out of nowhere Treatment- antibiotics for 2-3 months, steroid cream- can last for up to 1 year with reoccuring rash
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL) started on an unknown date. It was reported that there have been six breakthrough flu cases and all breakthrough patients tested positive for influenza A. The outcome of the event of MULITPLE PATIENTS TESTED POSITIVE FOR FLU A is unknown. The report was considered to be non-serious.
On July 11,2022 I had congestion, cough, headache, sore throat, tested but it was negative. In the evening everything was worse and the test was a faint positive. The next morning my positive came back fast. I now had runny nose, all the other symptoms were worse it felt like the worse cold I ever had. I had a telehealth visit with my doctor who prescribed PAXLOVID. I started taking it immediately and by day three by symptoms have decreased by half and I feel human.
chest x-ray to check for blood clots. EKG showed abnormal results; Severe chest pains the next day that woke me up out of a dead sleep; Severe chest pains the next day that woke me up out of a dead sleep; This is a spontaneous report from a contactable consumer (patient herself). A 33 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FA7484) via an unspecified route of administration on Jul2021(33-year-old at vaccination) as Dose number unknown, single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history was not reported. No known allergies. The patient's concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe chest pains the next day that woke her up out of a dead sleep. Continued to the point where she had to go to Urgent Care for an EKG, blood work, and chest x-ray to check for blood clots. EKG showed abnormal results. Now had to visit a cardiologist. These adverse event resulted emergency room/department or urgent care. Since the vaccination, patient had been tested for COVID-19 on Aug2021: result negative. Covid test post vaccination was reported as other. No treatment received for the event. The outcome of the event was not recovered.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Fever (102), unable to control body temperature (always cold), migrain, intense joint pain, periodic stabbing pain in right lower abdomen and right lower back. Obtained second dose of vaccine at 0900, 30 Sep 21. Pain and chills started at 0230, 1 Oct 21. Checked into ER at 1300, 1 Oct 21.  Released from at 2030, 1 Oct 21 after testing, Toradol, Zofran, and 100ml IV Tylonal.  2 Oct 21, abdominal pain continued. After the first dose I experienced 72 hours of fever, chills, migrain, vomiting, and body aches. This was the same as when I had covid.
pt recv vax 24JAN95 & approx 21FEB95 exp abd pain & bloating, marked lateral rib tenderness bilat, considerable paravertebral muscular tenderness bilat; addtl starting on approx 21FEB95; began to exp a fever which was 101; seen in ER & hos
Information has been received from a healthcare worker concerning a patient who on 11-DEC-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). On 04-JAN-2011 the patient was administered subcutaneously with a second 0.65 ml dose of ZOSTAVAX (Merck). No adverse effects reported. It was unknown if the patient sought medical attention. Follow up information has been received from the reporting clinical coordinator concerning the male patient who on 04-JAN-2011 received subcutaneously a 0.65 mL booster dose of ZOSTAVAX (Merck) (lot#669404/1359Z). On 04-JAN-2011, the patient experienced pain at injection site and there was no other reaction. On 04-JAN-2011, the patient had recovered from pain at injection site (duration reported as "1-2 days"). No further information is available.
Same day as vaccine, developed redness and warmth, followed by ache.  That night, pain worsened and awoke with chills.  +nasal congestion.  Continued pain, redness, warmth with blanching erythema approx 56 hours after injection.
Patient stated that felt palpitations, crawling sensations in her arms and a worsening of her GERD symptoms later in the day after her booster.
"Patient" started with pain from neck -> fingertips on same side as vaccine administered left one day after vaccine; she also had chills. The pain persists for 6 days with change of site to right arm, head and neck ache  at different times. At day 6 she was not responding to 2 mg Valium BID or 200 mg Ibuprofen 1-2 times per day. On day 6 we changed to 4 mg Valuim TID and increased Ibuprofen to 600 mg Ibuprofen Q 6 hours.
red (rash around her eyes),rash around her eyes; Vomiting; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red (rash around her eyes),rash around her eyes), VOMITING (Vomiting) and VACCINATION SITE PAIN (Pain at the injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red (rash around her eyes),rash around her eyes), VOMITING (Vomiting) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. On 15-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, RASH ERYTHEMATOUS (red (rash around her eyes),rash around her eyes) and VOMITING (Vomiting) outcome was unknown.            Concomitant medications were not reported by the reporter.    Reporter did not allow further contact
Pt received ZOSTAVAX on 6/30/17 at around 10:10 AM and noticed redness at injection site evening of 6/30/17 upon removal of bandage. The next morning 7/1/17, pt noticed swelling, rash, warmth, and itching. Then on 7/2/17 pt had chills and felt tired. Then on 7/3/17, pt feels fine but swelling is spreading downwards on arm. Pt went to see PCP and was prescribed ALLEGRA and KEFLEX on 7/3/17.
Have lymph node pain; Began to feel joint pain/aches; Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (Swelling), LYMPH NODE PAIN (Have lymph node pain) and ARTHRALGIA (Began to feel joint pain/aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced SWELLING (Swelling). On 31-Dec-2021, the patient experienced ARTHRALGIA (Began to feel joint pain/aches). On 01-Jan-2022, the patient experienced LYMPH NODE PAIN (Have lymph node pain). At the time of the report, SWELLING (Swelling), LYMPH NODE PAIN (Have lymph node pain) and ARTHRALGIA (Began to feel joint pain/aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Pt presented to clinic with swollen, red raised area at injection site - size 8mm, hot to touch.  Postive induration, no abscess.  Pt placed on Keflex for 10 days.  Advised to continue Benadryl and Motrin.
COVID-19/ Covid For 2nd Time; COVID-19/ Covid For 2nd Time; This is a solicited report received from contactable reporter(s) (Consumer). The reporter is the patient. Other Case identifier(s): 22K-163-4222940-00.  A 41-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, all intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for ankylosing spondylitis. 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) all with onset Dec2021, outcome "recovering" and all described as "COVID-19/ Covid For 2nd Time". The patient underwent the following laboratory tests: SARS-CoV-2 test: (unspecified date) Positive; (Dec2021) Positive. The action taken for adalimumab was unknown.  Additional information: It was unknown if patient was enrolled in a covid-19 vaccine Trial. In Mar2021, patient received first dose covid-19 vaccine manufactured by Pfizer. On an unknown date, patient received second dose covid-19 vaccine manufactured by Pfizer. On an unknown date, patient received booster dose covid-19 vaccine manufactured by Johnson and Johnson. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID/ COVID for 2nd time was no reasonable possibility.  The reporter's assessment of the causal relationship of "covid-19/ covid for 2nd time" with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Copper taste in mouth primarily on tongue.  Started shortly after injection, resolved around 20 minutes later.
Chron's disease flare up; Discolored stools; Inflammation; diarrhea; This is a spontaneous report received from a contactable physician. A 63-year old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on 07Apr2021 (at the age of 63-year old) at single dose for COVID-19 immunization and adalimumab (HUMIRA) solution for injection in pre-filled pen, subcutaneous on an unknown date at an unspecified dosage for Moderate to severe adult Crohn's disease and moderate to severe ulcerative colitis. relevant medical history and concomitant medications were not reported. On an unknown date the patient experienced dark stools, inflammation, diarrhea and Crohn's disease flare up. The action taken with adalimumab was unknown. The outcome of the events diarrhea and Crohn's disease aggravated was recovered while the outcome of the other events was unknown. The causality assessment with adalimumab was No reasonable possibility for events diarrhea and Crohn's disease aggravated and not reported for the other events. The causality assessment with BNT162B2 was not reported for all events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Was hospitalized due to shortness of breath and chest pain, was diagnosed as having had b/l pulmonary emboli.
Varicella rash appeared on child the 3rd day prior to office visit on 3/7/01. Received vaccine on 6/2/99.
Injection site discomfort within 3 hours, increased pain day 1 & 2.   Significant headache at 12 hours post-vaccine, persistent through day 3. Significant fatigue and drowsiness on day 2 (none like I've ever experienced before) - slept 18 of 24 hours.  Mild on day 3.  Sore throat day 3.
It has been 3 weeks since my first does and my arm still hurts. There is a deep pain at the injection cite and a weakness sensation at the arm.  It hasn't gotten much worse or much better since the initial injection.
This spontaneous report as received from a pharmacist refers to 2 patients of unspecified demographics. The patient's concurrent conditions or medical history were not reported. On 12-OCT-2015, two doses of improperly stored ZOSTAVAX were administered to the unspecified patients, lot L021612, expiration date 10-SEP-2016 (dose, route and anatomical location not reported). No adverse events were reported. Additional information has been requested.
muscle pain (left arm); injection site swelling; fatigue; stiffness in arm of injection; hard to move around; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jul2021 12:00 (Lot number: EW0198) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scoliosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "muscle pain (left arm)"; VACCINATION SITE SWELLING (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "injection site swelling"; FATIGUE (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "fatigue"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "stiffness in arm of injection"; MOVEMENT DISORDER (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "hard to move around"; PAIN (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "pain". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, fatigue, musculoskeletal stiffness, movement disorder, pain.  Additional information:  The patient did not receive any other vaccine within 4 weeks. The patient did not receive other medications in two weeks. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Patient was experiencing some asthma symptoms before her vaccination and asked about using her inhaler in the vaccine room, which the person administering the vaccine indicated was okay. She was vaccinated at 10:40 am per the form. Patient started experiencing increase shortness of breath shortly after vaccination, approximately at 10:50 am. Patient was taken into the vaccine room to treat. She declined use of the epi pen. She continued to use her albuterol inhaler while the paramedics were called. Paramedics arrived and took patient to local Hospital where she was treated.
Patient administered Moderna Vaccine for 3rd dose 09/15/2021, later information was provided indicating patient?s 1st and 2nd doses were of Pizer-BioNTech Vaccine. Patient presented to the Health Department requesting a third dose of Moderna Covid 19 vaccine. Covid vaccination card reviewed; dates verified, vaccine type wasn?t legible.  Patient reported he had received Moderna vaccine for doses 1 and 2 at another vaccination site. Attestation form, Imm 66 form, and checklist reviewed. Moderna vaccine administered and 15-minute observation period completed without side effects or reactions. While putting information into Web Roster, it was determined the first two doses patient had received was Pfizer. Medical Officer notified and provided the following information.   1. Covid 19 mRNA vaccine dose should be the same vaccine product as the initial 2-dose mRNA Covid 19 primary series (Pfizer-BioNTech or Moderna).  2. If the mRNA Covid 19 vaccine product given for the first two doses is not available, the other mRNA Covid 19 vaccine product may be administered.  3. A person should not receive more than three mRNA Covid 19 vaccine doses. The patient was contacted to inform him of the circumstances. He was unaware that the first two doses were Pfizer-BioNTech.  Patient continues to deny any adverse side effects or reactions. Reinforced procedure to review immunization record in ImmPrint prior to vaccination.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On multiple unspecified dates the patients received doses of improperly stored GARDASIL 9 (lot#/expiration date, dose and route were unspecified). The reporter stated that the thermometer temperatures were out of correct storage range (low of 30.2 F and high of 50 F) for an unknown time frame. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
18JAN dose was 3rd of DTAP and IPV, 23FEB dose was the 4th of each; received an extra dose; 18JAN dose was 3rd of DTAP and IPV, 23FEB dose was the 4th of each; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number g9n2m, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number g9n2m, expiry date 14th April 2024) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2023, the patient received the 2nd dose of Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 18th January 2023, the patient received the 1st dose of Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 18th January 2023, not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device and unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On 23rd February 2023, the patient experienced inappropriate schedule of vaccine administered and extra dose administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered, inappropriate schedule of vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 23-Feb-2023 and 27-Feb-2023. Reporter's Comment: Reporter stated that patient accidently received an extra dose of Kinrix. Patient stated that 1st dose of Kinrix was 3rd dose of DTP and IPV and 2nd dose of Kinrix was 4th dose of DTP and IPV. The reporter consent to follow up. Additional Supportive Information: Patient received an extra second dose of kinrix than the recommended schedule, which led to  extra dose administered. Patient received 1st dose of Kinrix as 3rd dose of DTP and IPV and 2nd dose of Kinrix as 4th dose of DTP and IPV than the recommended schedule, which led to inappropriate schedule of vaccine administered.