chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of inflammation in the area of injection in an 11-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk); Sanofi Pasteur; unknown; left deltoid given on 24 October 2013; BOOSTRIX; GlaxoSmithKline; unknown; unknown given on 14 January 2013. On 24 October 2013 the subject received 2nd dose of BOOSTRIX (.5 ml, unknown, right arm) and experienced extra dose administered. On 24 October 2013, 2 days after vaccination with BOOSTRIX, the subject experienced inflammation in the area of injection. The subject received a dose of BOOSTRIX on 14 January 2013 and accidentally received a 2nd dose on 24 October 2013. The subject returned to the office on 26 October 2013 with injection site reaction. The nurse reported the subject experienced a red inflamed area approximately one centimeter in size without blister secondary to BOOSTRIX. The subject received in the office an oral analgesic and topical antibiotic was administered on the area. At the time of reporting the inflammation in the area of injection was unresolved. The healthcare professional considered the inflammation in the area of injection was probably related to vaccination with BOOSTRIX. Follow up was received from healthcare professional on 28 January 2014. The healthcare professional documented that the diagnosis was "local reaction after Tdap". Per the reporter, the outcome of the events was resolved. The healthcare professional considered that the events were probably related to the BOOSTRIX. The reporter documented that a "2nd dose of Tdap given 9 months after a previous dose." A biopsy was not performed. Per the reporter, the symptoms did not recur following subsequent administration; however, the reporter also documented that the BOOSTRIX was not reintroduced. The healthcare professional documented that the subject had not experienced adverse events following previous vaccinations.
At the time of the family pediatrician visit at 11 months he was fine and talking up to 3 word phrases, but we lost our health insurance so at the time of his 1 year I took him to the clinic and they administered many vaccines in several doses, on the leg.  He soon became very despondent lost all words, did not respond either just sat in a foggy state or tantrumed, and banged his head, by 18 months it was very apparent and the symptoms continued to get worse and eventually was diagnosed with Autism,  PDD-NOS.  03/21/2008 Autism screening by school system dated 12/11/2006 received from parent. Testing c/w dx of an Autism Spectrum Disorder. Pt displays disruptions in the areas of play and interest in materials, language and communication, relating to others and use of sensory modalities. 1/20/2010 Patient still has autism/autism like symptoms. Language delay-behaviour/social difficulties/sensory dysfunction. He is getting better with therapy, but he still struggleing and is not as expected as typical.
depleted blood platelets, 0 platelets counts; 2nd dose: did not receive as advised by her HCP; Red spots on her tongue; bleeding around her gums; red dots and purple dots on her legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLATELET COUNT DECREASED (depleted blood platelets, 0 platelets counts) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced TONGUE PIGMENTATION (Red spots on her tongue), GINGIVAL BLEEDING (bleeding around her gums) and ERYTHEMA (red dots and purple dots on her legs). On 15-Mar-2021, the patient experienced PLATELET COUNT DECREASED (depleted blood platelets, 0 platelets counts) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose: did not receive as advised by her HCP). The patient was hospitalized from 15-Mar-2021 to 17-Mar-2021 due to PLATELET COUNT DECREASED. At the time of the report, PLATELET COUNT DECREASED (depleted blood platelets, 0 platelets counts), TONGUE PIGMENTATION (Red spots on her tongue), GINGIVAL BLEEDING (bleeding around her gums) and ERYTHEMA (red dots and purple dots on her legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose: did not receive as advised by her HCP) had resolved. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Platelet count: 67000 (Inconclusive) 67000. On 23-Mar-2021, Platelet count: 270,000 (Inconclusive) 270,000. On 12-Apr-2021, Platelet count: 200,000 (Inconclusive) 200,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were provided Treatment for the events included steroids The patient  visited urgent care on 14Mar2021, and the doctor advised her to go to the ER. The patient went to her primary care provider and her blood work came back and she had 0 platelets counts and depleted blood platelets and the doctor stated that it was due to the Moderna covid vaccine that the patient had received.The patient went to the emergency room immediately and was admitted into hospital on 15Mar2021 and received 2 bags of platelets and steroids to calm her immune system down.The doctor advised patient not to take any vaccines until next year.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On 7-6-11 - child had 6 wk vac and received PENTACEL, PREVNAR 13, ROTATEQ and Hep B given at approx. 9 AM. At 13:16 Mom called office and described child as "pool/blue" - instructed to call 9-1-1. Transported and admitted to hospital.
Information has been received from a health professional concerning a 62 year old male with an erythromycin allergy an no other medical history who on 27-OCT-2006 was vaccinated with a dose of ZOSTAVAX (lot # 652936/0981F). On 30-OCT-2006, the patient developed a red rash on his right flank and right lateral ribs. The physician diagnosed this as a possible drug allergy and prescribed prednisone as treatment. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Patient with history of dementia. She was brought to the ED by EMS on 10/29 for evaluation of hypoxia, altered mental status, and nausea. She lives in a memory care unit and staff found her to be hypertensive with blood pressure of 270/140. EMS was called, who found patient's blood pressure to be 130s/70s. Patient's initial oxygen saturation was 80%, she was placed on 15L supplemental O2 which improved her sats to 92%. While in the ED, patient tested positive for COVID by PCR. She was admitted to the hospital from 10/29-11/2. Patient was found to have acute hypoxic respiratory failure secondary to COVID-19 pneumonia, superimposed bacterial pneumonia complicated by bacteremia. She was initially started on cefepime and azithromycin, however given her quality of life and poor prognosis the decision was made to continue with comfort cares while in the hospital. She was discharged to home with home hospice. Patient has received the COVID primary vaccine series.
Fever developed 12 hours after the second dose of the vaccine and lasted till 36 hours after second dose vaccination. Persistent 100 degree F temperature reported for the duration.; Severe body aches; headache; This is a spontaneous report from a contactable consumer. A 30-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, on 17Feb2021 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, on 26Jan2021 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. Patient had no known allergies. On 18Feb2021 04:00, the patient experienced Fever developed 12 hours after the second dose of the vaccine and lasted till 36 hours after second dose vaccination. Persistent 100 degree F temperature reported for the duration; Severe body aches; and headache. On 18Feb2021, the patient underwent lab tests and procedures which included body temperature: 100 degree F temperature. The patient spoke to Nurse over the phone who recommended Acetaminophen for the treatment of fever and body aches. The outcome for all the events was recovering.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
slight issue with some blood issues; Slight headache; A spontaneous report was received from a consumer concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight issue with some blood issues and slight headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient felt slight issues with some blood issues which lasted part of one evening and subsided and that he had no further problems other than a slight headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events, slight issue with some blood issues was recovered and slight headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested for details about the blood issue the patient experienced.
lightheadedness, chills, vomiting, headache, body aches, fatigue
12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, and the feeling of dizziness or fogginess for 36 hours. Writer missed 2 days of work due to symptoms.   Continued symptom - injection site is swollen, red, firm, tender to touch, arm sore to lift, and pain noted in arm pit.
The single use diluent that was used to prepare the COVID vaccines was used to prepare 2 other COVID vaccines given that day.  The manufacturer was called. Based on research, there is no need for revaccination but there is a risk for bacterial infection. Pt's mother informed of error and risk and confirmed understanding. As of now, patient has not shown any signs of infection. Mother advised to call back for any further concern or question.
Patient complained of pain, redness and swelling at injection site.   She states that the redness and swelling resolved but left arm pain continues and is interfering with activities of daily living.   Pt is concerned that the injection went into her bone and caused these issues
sensation of choking, throat irritation, tongue and lip swelling.  Epi-pen self administered and felt better shortly after
Approximately 3 weeks post vaccination from my 2nd dose of the Moderna vaccine, I developed persistent heart palpitations, which led to a 3/30/21 medical visit with my primary care provider, and a subsequent 14 day cardiac event monitor commencing on 4/2/21.  Because of the proximity of the symptoms to my vaccination, and another family member who experienced the same outcome following their second dose, I believe that the issue was caused by the vaccine.  It has taken approximately 6 months post vaccination for my palpitations to begin to resolve, although they are not completely gone.  Additionally, I have incurred medical expenses as a result of seeking treatment for this issue.
About 5 minutes after vaccine was given, tingling sensation occurred on left arm down to left hand (Thumb, index, middle finger.) Grip is good both hands On 12/31/2020 Patient experienced "Nickle sized welts on her elbow, wrist and stomach. She also experienced more tingling in her left arm. There was 2 welts on her left wrist and 1 welt on her left elbow. The welt on her stomach was on her right side. She took some Zyrtec and applied warm packs. The welts resembled an "ant bite", "raise but no pus" in them. As of today 1/5/2021, They are resolved and patient feels better.
pt recvd vax & exp rash 114OCT92 spread to arms, back & chest by 15OCT93, lymphadenopathy 16OCT-20OCT92 arthritis & arthralgia began in wrist & finger joints & rash began to fade on 20OCT93; tingling assoc w/sx;fatigue; gait disturbances;
pain in right upper inner thigh; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing), notes: gout in both feet. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "unknown", described as "pain in right upper inner thigh".  Additional information: The patient mentioned after receiving the first shot of the Pfizer-BioNTech COVID-19 Vaccine, he felt pain on his right thigh. Then, after the second dose, caller reported to have experienced swelling on the right foot for 5 days already. The patient has gout in both feet but nothing like this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills; fever; muscle ache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   In October 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache). On 20-Feb-2021, CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) to be probably related.    No concomitant medications were provided.  No treatment medications were provided.
20 m/o with temp of 101 with redness just below site of injection + edema, warm to touch (L thigh) 4-5cm area. Placed on Keflex (250/5) 4ml TID X 10 days. RTC for f/u.
dermatitis on my neck and legs/thighs and noticeable itchy inflammation of one of my lymph nodes on my left groin (highly atypical). This started after 24hrs and lasted another 48 hours.
The day following my vaccination I started to experience chills and body aches. I was having a hard time moving. I was vomiting and out of commission for about 4 days. In December 2021 I had a colonoscopy and EDG. But within the last two months I have had severe stomach issues. When the pain starts it is sudden and can lasts for hours. The pain is concentrated below my sternum. I was very bloated. I had a doctor visit on 03/15/22 and she said I should lose weight, see a dietician and add an iron supplement. I still experience the pain.
but tested positive for COVID; but tested positive for COVID; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on 26Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer COVID vaccine on 26Mar2021 but tested positive for COVID on 06Apr2021. The patient was positive on 14Apr2021 and tested negative on 22Apr2021. The outcome of COVID 19 was resolved in 22Apr2021 and outcome of drug ineffective was unknown.  Information about batch/ lot number has been requested.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported Lack of efficacy events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Received booster on Monday. Friday I moderate to severe joint pain in my left elbow. Duration of symptoms lasted 72 hrs
Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021302243.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Apr2021 10:45 (Lot number: EW0153) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Ovarian cyst" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: TOPROL taken for blood pressure abnormal (ongoing); METFORMIN taken for ovarian cyst (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for seasonal allergy (ongoing). Vaccination history included: Bnt162b2 (Dose 1, single, Time: 09:30 am, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: Lot EN6207, ), administration date: 16Mar2021, for COVID-19 Immunization, reaction(s): "Pressure in ear", "Neck tingle", "Tired", "Headache", "Ear red", "Splotches, rash on chest", "Rash possible side effect", "Shingles". The following information was reported: HEADACHE (non-serious) with onset 23Apr2021, outcome "recovered" (24Apr2021), described as "Headache"; CHILLS (non-serious) with onset 23Apr2021, outcome "recovered" (24Apr2021), described as "Chills".  Additional Information: The events onset latency was 13 hrs 15 min after vaccination.   No follow-up attempts are possible. No further information is expected.
ACUTE NON ST ELEVATION MI LEFT FACIAL MUSCLE WEAKNESS 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient received an extra dose of the Covid-19 vaccine. The patient received his first dose of Pfizer on 12/30/2020 and second dose of Pfizer on 01/19/2021 and then a third dose of Moderna on 04/07/2021. The clinic has not been able to make contact with the patient yet to see if he's bad any adverse reaction.
Patient and daughter reported that 4 hours after receiving the first dose of Moderna covid-19 vaccination her arm  became red and swollen. Then it started throbbing.  It was the same arm that received the vaccination. These symptoms lasted for 3 months and patient is afraid to get the second dose.
tenderness; pale redness changed to redness; soreness if touched; hot to touch; rash increased from size of quarter to size of baseball; itchiness; firmness; This spontaneous case was reported by an other health care professional and describes the occurrence of TENDERNESS (tenderness), ERYTHEMA (pale redness changed to redness), PAIN (soreness if touched), VACCINATION SITE WARMTH (hot to touch) and RASH (rash increased from size of quarter to size of baseball) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tenderness), ERYTHEMA (pale redness changed to redness), PAIN (soreness if touched), VACCINATION SITE WARMTH (hot to touch), RASH (rash increased from size of quarter to size of baseball), PRURITUS (itchiness) and INJECTION SITE INDURATION (firmness). At the time of the report, TENDERNESS (tenderness), ERYTHEMA (pale redness changed to redness), PAIN (soreness if touched), VACCINATION SITE WARMTH (hot to touch), RASH (rash increased from size of quarter to size of baseball), PRURITUS (itchiness) and INJECTION SITE INDURATION (firmness) outcome was unknown.        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.   No concomitant medication was reported.  No treatment medication was reported.
stomach flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who was having stomach flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route as prophylactic vaccination.  On an unknown date the patient had stomach flu (gastroenteritis viral) (unknown latency) following the administration of INFLUENZA VACCINE..  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (stomach flu).  At time of reporting, the outcome was Unknown for the event stomach flu.
sick; Initial information was received on 22-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who was sick (Illness), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, patient had been sick (illness) (unknown latency), following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.