chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: 10 minutes post vaccination, BP 68/39, HR 50, pulse ox 100%. Visual changes noted. EMS called. 15 minutes post vaccination, BP not improved, pulse ox 68%. EMS arrived and after roughly 15 minutes of EMS monitoring, patient's symptoms had resolved and EMS cleared him for discharge
Severe abdominal pain, inability to walk, nausea, flu-like symptoms.    Woke up with it, progressed quickly.   Taken by ambulance within 45 minutes to emergency room.
Suspected vaccination failure; Shingles outbreak; rash on head/itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In February 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the outcome of the suspected vaccination failure was unknown and the outcome of the shingles and itchy rash were recovered/resolved.   It was unknown if the reporter considered the suspected vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: The reporter was the patient. The age at vaccination was not reported. The patient received both doses of Shingrix in 2019. The patient experienced shingles outbreak approximately 2 weeks before the date of reporting.  The patient had a rash on right eyelid and on the head, and rash was itchy. In February 2022, rash, accompanying itch resolved and shingles were resolved. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were not unknown at the time of reporting. The reporter did not consent to follow-up. This case has been linked to US2022031562, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022031562:Same reporter.
COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) 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.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with BAMLANIVIMAB (intravenous) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Ten days after the first dose. Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Case number PHEH2011US01618 is an initial spontaneous report received from a health care professional on 10 Aug 2011. This report refers to a male child. He was given only the MenA powder conjugate component of MENVEO (batch number: A10052/X100030 and expiry date: Jan 2013/Sep 2012) intramuscularly on an unspecified date. No other adverse reaction was reported.
Chest pain, rapid heartrate, shortness of breath, feeling of pressure with deep inhalation beginning 3 days after vaccination and continuing for at least a week.  BP normal. Pain relieved somewhat with ibuprofen and seems to be improving gradually.
Patient is an 86-year-old female who presents to the emergency department from a local nursing facility for left-sided chest pain.  She states she has had it intermittently for a week.  Over the last 2 days it has been constant and sharp.  Patient does have a history of hypertension and diabetes.  Patient states the pain is directly under her left breast, movement, deep breathing, lying still and "just nothing" make the pain worse.   Patient has been given Ultram and Norco at the nursing facility without relief.  She denies shortness of breath, no nausea vomiting diarrhea or constipation.  No recent illness.  No fever. Associated Symptoms: chest pain
Pt returned following day to report that her left arm has been giving her discomfort since yesterday soon after getting high dose flu and pneumonia vaccine together. It appeared red, blotchy, and several inches in diameter. Recommended HC cream and ice pack & BENADRYL crm and to contact per primary MD.
mom reported pt exp sz approx 5PM, lasting few seconds-advised to go to ER; no medical treatment necessary;
TRANSIENT CEREBRAL ISCHEMIA 3/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is patient. A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Gout" (unspecified if ongoing), notes: Other medical history: Gout; "BPH" (unspecified if ongoing), notes: Other medical history: BPH. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course was reported as: Patient had no known allergies. The patient received Paxlovid (Lot number: 1918535A) from 07Sep2022 to 12Sep2022 for COVID 19 Treatment. Rebound covid infection after completing Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Lasted 12-16 hours.  Reported all over muscle aches, painful joints, arm soreness (on arm vaccine was administered), difficulty walking, hot and cold chills.
Maladministration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix. On an unknown date, an unknown time after receiving Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Maladministration after temperature excursion). The outcome of the incorrect storage of drug was 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: 13-APR-2023 The other healthcare professional stated that several vaccines like Shingrix, Pediarix, Infanrix, Menveo (2 vials presentation), Havrix, Engerix-B and Boostrix suffered temperature excursion from 3rd February 2023 to 6th February 2023 at minus 1.07 degree Celsius for 62 hours and 15 minutes total below the recommended storage conditions for GlaxoSmithKline vaccines. The reporter consented to follow up and requested to send an email with all adverse event details instead of providing them on the phone. This case was linked with case US2023054677, reported by same reporter. The patient received Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:Same reporter. US-GSK-US2023AMR056407:same reporter
This spontaneous report as received from a nurse refers to a patient of unknown age. On 25-MAR-2013 the patient was vaccinated with ZOSTAVAX. The patient received an expired dose of ZOSTAVAX lot # 1198AA, expiration date 25-OCT-2012. Dosing information and route of administration were not provided. No symptoms reported. Additional information has been requested.
Vaccinated on 4FEB91; Rash onset on 19FEB91;
Information has been received from a consumer concerning her friends' 15 month old male child who on unspecified dates were vaccinated with the first and second doses of MMR II (LOT#s not reported). The child experienced autism after the second dose of the vaccine at the 15 months old. With intensive diet and therapy there has been some improvement. Unspecified medical attention was sought. No other information was provided. Upon internal review, autism was considered to be an other important medical event. This is the second of two reports which was received from same source. No further information is available.
Information has been received from a health professional concerning a 63 year old female with a history of colonic polyps who on 25-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) subcutaneous in the right arm (Lot # and dose were not reported). On 29-APR-2008 the patient returned to the physician's office and reported that she had "developed a large, not evenly indurated, bruise at the injection site. It was three inches in diameter and looked similar to a welt". The patient was treated with hydrocortisone cream to be applied three times a day (TID). At the time of this report, the patient was recovering from the adverse events of induration at the injection site, bruise at the injection site, and welt at the injection site. Additional information has been requested.
I received the vaccine at 5:30 pm and had no symptoms until I awoke around 2:30 AM with chills,  a fever, headache and muscle aches. I slept on and off until 12:30 pm drinking lots of fluids.
Sore arm began at 3:00 PM and lasted for four days, with pain lessening as time went on Fever began at 9:00 PM and went away sometime in the middle of the night (around 3:00 or 4:00 AM) Fatigue started at 09:00 PM and lasted until the morning of Friday, April 9, 2021
Fever times 7 days after administration of vaccine; arm red - lasted L48 degree.
8th day fever 99.4- 10.3 for 4 days. Sniffles, running left nostril, then 12th day left eye pain, redness, light sensitivity for 1 day, joint pain 8th-12th day. 13th day rash on face, neck, torso, arms for 3 days. Was having symptoms 8-17 days after MMR shot like a mild case of measles.
pt brought to ED with worsening right sided weakness, generalized weakness, has fallen a few times in past 3 wks; confusion; slurred speech; found to be positive for COVID; admitted to hosp; right lower lobe pneumonia; ABX given; DNR; pt's condition rapidly declined; there were plans to make him comfort measures, but pt expired before this was done
Vaccine given 11AM and 1 - 9/9/11 at clinic no complaints. At 1340 mother called, patient reporting tingling & numbness of left arm. Vaccines given in Rt arm. Symptoms started about noon have not gone away have not gotten worse.
This is a spontaneous report obtained from a contactable consumer. This consumer reported similar adverse events for three different patients. This is the third of three reports. A male patient of unknown age and race received on an unknown PREVNAR 13. Relevant medical history and concomitant medication were unknown. In Nov2013 the patient experienced fever and had rash, swelling and inflammation all on arm. It was also reported that since an unknown date in Nov2013 the patient had sores which lasted for seven days and due to which he was hospitalized on an unknown date in Nov2013. Relevant laboratory and therapeutic measures taken in response to the events were unknown. Patient recovered from "sores" on an unknown date in Nov2013 and clinical outcome of the other reported events was unknown at the time of report.
Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022; administered the vaccine from a vial that was open on 1Jun2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the vaccine from a vial that was open on 1Jun2022) and PRODUCT STORAGE ERROR (Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A and 076C21a) for COVID-19 prophylaxis.     It was unknown if patient ever had COVID positive test or diagnosis. Patient was not given any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Johnson & Johnson (Primary series: Dose 2) and Johnson & Johnson (Primary series: Dose 1). Past adverse reactions to the above products included No adverse event with Johnson & Johnson and Johnson & Johnson. Concurrent medical conditions included Penicillin allergy.   On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the vaccine from a vial that was open on 1Jun2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the vaccine from a vial that was open on 1Jun2022) and PRODUCT STORAGE ERROR (Vial initially stored on 01-Jun-2022 and then administered on 27-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial was initially stored on 01-Jun-2022 in the refrigerator.  The patient did not seek any medical care. The patient did not experience a similar event in the past.  Treatment information was not provided by the reporter.
This spontaneous report as received from a pharmacist refers to approximately 70-year-old female patient with no pertinent medical history and no drug reactions or allergies. On 14-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot number not provided) for shingles prevention. There were no concomitant medications. On an unknown date, the patient experienced "general" dry skin (unspecified location) and "a more serious" case of dry skin on the heels of her feet, the skin was actually cracking. The patient sought medical attention, she spoke with the pharmacist on 13-JAN-2016. Unspecified topical steroid cream was given for the events. No laboratory studies were performed. Outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Patient filled out paperwork that stated ?Pfizer-BioNTech Vaccination? consent. Patient told Moderna was no longer given at this facility. Patient handed vaccination card and told to double check correct spelling of name and birthday. Patient told she would be getting a Pfizer vaccine. Patient received the vaccine with no issues. Patient came back about 5 minutes later stating ?I had Moderna the first time and received the Pfizer shot this time.? Gave patient card back and reported to this website and job site.
Patient describes sensation of numbness in arm receiving immunization. Patient says numbness has not subsided as of date of reporting - 10/30/2012.
he first intradermal attempt did not result in a wheel. No physical adverse event occured. A second attmept was administered by an expert, and was successful.
flu; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient get a flu shot every yea, also the child of patient getting one. He also gets his vaccines. Science has come to far, for us to neglect it, still get the flu, patient would rather feel and be contagious for two days than two weeks. Allergies lead to sinus infections that can create weak immune systems to leave us, others open for what builds up and can spread by a simple sneeze. Get a shot! It hurts alot less (FOR YOU IN THE BACK) than getting the flu.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Information has been received from a doctor of pharmacy concerning a 12 month old white male, with a history of diarrhea, who on 18-JAN-2007 was vaccinated with a subcutaneous expired first dose in the left anterior thigh of MMR II (Lot# 648157/0603R).  Concomitant vaccines administered on the same day included a dose of VARIVAX and a dose of PREVNAR.  The patient was noted to have diarrhea at the time of vaccination.  There were no adverse events following prior vaccination.  It was reported that the patient experienced additional diarrhea for two weeks from 18-JAN-2007.  The patient was reported to be recovered on 15-FEB-2007.  There were no laboratory or diagnostic tests performed.  Additional information has been requested.
Patient woke up and noticed a hot, red circle at the injection site that was not there for the previous 9 days post vaccination.
pt got Moderna Bivalent Booster Friday night, 3/24. Pt states that Saturday night, around 24 hours after the vaccine, she felt severe pain in her left hip (post-surgery ~ 2 years).  Pt took  some Ibuprofen and Acetaminophen Saturday night and went  to bed. Pt awoke Sunday and went to church, experienced pain again in L hip, took more med, called pharmacy.
4APR91 pt felt warm, temp unk; 5APR91 fussy; 6APR91 was okay-breastfeeding; 7APR91 mom dressed child for church noticed pale & listless; didn't br feed, vomited; Seen by MD told pnemonia; given ATB & APAP; Also bowel obstruction;
Swelling of Lf. arm - red - soreness. Heat. Extreme weakness in extremities - wobbly - shaking severely - needed assistance. Teeth chattering - hives. Extreme - shaking - weakness in extremities. Teeth chattering - making speaking difficult. Soreness - redness of arm. Hives on back and chest. Needed wife's assistance to get to bed. Had every blanket in household to control shaking. Am an active healthy orthodontist who was not suffering from any cold, illness, sniffle etc. for at least a month, in fact longer.
Muscle pain - discomfort - tiredness. Redness not at site of injection but inside arm below armpit up to above wrist.
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again) and PYREXIA (Fever for two days) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She got Covid in Dec) in December 2019.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Fever for two days). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again) and HEADACHE (really bad headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again), PYREXIA (Fever for two days) and HEADACHE (really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. second dose is scheduled on 14Apr2021.  patient feels like she has COVID again which she had in December and called out of work both days.
Severe fatigue lasting at least two weeks prior to onset date above in combination with aches across the entire body, wide spread severe pain and inflammation up the skin and superficial muscles. I have been seeing doctors ever since trying to get well. Diagnosed with Fibromyalgia, Chronic Fatigue Syndrome, Chronic Pain Syndrome, degenerative discs and Central Sleep Apnea to date.
shaking all over,  cold,  heart,  pancreous ,  blood affected  spent four days in hospital
Pt started having soreness the next day after vaccine. There was a red spot swollen at the site which continue gets bigger the next couple days. Pt went to see MD and was prescribed KEFLEX for 7 days. 3 days after the KEFLEX, the redness and swollen start going away.
got the flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient got the flu (influenza) (approximately 1 month latency) following the administration of influenza vaccine. Reportedly Got my Flu shot and still got the Flu a month later.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event got the flu.
injection site is now swollen and stiff, 1 week after injection.  After the shot, experienced a little swelling and pain, but it went away within 2 days.  Now, 1 week later, it is back.
3-27-200 (1300) Area from Above knee to top of upper leg on Front side red & Swollen warm to touch. Denies hives, seen by Doctor advised Tylenol & Ice to area. Per mom by (1500) that day swelling gone, gave tylenol.