chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of hives in a male patient who received SHINGRIX for prophylaxis. On 22nd October 2018, the patient received SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced hives. The patient was treated with Steroid Therapy. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with SHINGRIX on Monday afternoon and experienced a bad chicken pox like hives all over his body. The patient was put on steroid therapy by the doctor for his problem. The patient inquired is there anything else he could do.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 32-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because the facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patient. Reporter confirmed that patients had administered doses while the temperature excursion assessment was ongoing. No treatment drug details was reported.   This case was linked to MOD-2022-501575 (Patient Link).
UNSPECIFIED SERIOUS REACTION DUE TO WHICH PATIENT STILL WAS ON A VENTILATOR; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age via social media. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified serious reaction. The patient was hospitalized on unspecified date and still was on a ventilator due to unspecified serious reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified serious reaction due to which patient still was on a ventilator. This report was serious (Life Threatening).; Sender's Comments: V0 - 20210556136-covid-19 vaccine ad26.cov2.s-Unspecified serious reaction due to which patient still was on a ventilator This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Short of breath after 1st dose; Pulse oximeter reading low after 1st dose; Nausea after 1st dose; Fatigue after 1st dose; Multiple bowel movements in one day after 1st dose; knee pain; arm in pain; Has a lot of mucus after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short of breath after 1st dose), HEART RATE DECREASED (Pulse oximeter reading low after 1st dose), NAUSEA (Nausea after 1st dose), FATIGUE (Fatigue after 1st dose) and FREQUENT BOWEL MOVEMENTS (Multiple bowel movements in one day after 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Short of breath after 1st dose), HEART RATE DECREASED (Pulse oximeter reading low after 1st dose), NAUSEA (Nausea after 1st dose), FATIGUE (Fatigue after 1st dose), FREQUENT BOWEL MOVEMENTS (Multiple bowel movements in one day after 1st dose), ARTHRALGIA (knee pain), PAIN IN EXTREMITY (arm in pain) and SECRETION DISCHARGE (Has a lot of mucus after 1st dose). At the time of the report, DYSPNOEA (Short of breath after 1st dose), HEART RATE DECREASED (Pulse oximeter reading low after 1st dose), NAUSEA (Nausea after 1st dose), FATIGUE (Fatigue after 1st dose), FREQUENT BOWEL MOVEMENTS (Multiple bowel movements in one day after 1st dose), ARTHRALGIA (knee pain), PAIN IN EXTREMITY (arm in pain) and SECRETION DISCHARGE (Has a lot of mucus after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is taking Inhalers Treatment information was provided as acetaminophen.
Information has been received from a certified medical assistant (CMA) concerning a patient (current weight 43 pounds, birth weight 8 pounds, 8 ounces) who on 20-APR-2004 was vaccinated subcutaneous (right side) with Varivax (lot # 646231/0542N). On 18-APR-2006 the patient developed 20-40 vesicles and papules all over the body, and the patient complained about being itchy. The patient was still having outbreaks. The patient's final outcome was not required. Additional information is not expected.
Child became disoriented, described by parent as not knowing where she was, and was hysterically crying. Event lasted about 45 minutes and resolved spontaeously. Child could not explain it afterwards.
Information has been received from a pharmacist concerning a 44-day-old male with no allergies who was hospitalized due to abdominal surgery for gastroschisis repair (at birth) who on 29-JAN-2007 was vaccinated with the first dose of Rotateq. There was no concomitant therapy. The pharmacist reported that on 31-JAN-2007, the patient developed diarrhea. Unspecified medical attention was sought. On 04-FEB-2007, one week after being discharged after gastroschisis repair, the patient was hospitalized for the diarrhea. While hospitalized, the patient was treated with IV fluids and a stool sample was tested for rotavirus (results not provided). At the time of this report, the patient was noted to be recovering. No further information is available.
This spontaneous report as received from a health care worker refers to an unspecified number of unspecified patients. Patients medical history and current conditions were not reported. On unspecified dates since 2-JAN-2015, the patients were vaccinated with unspecified number of improperly stored doses of COMVAX (lot # J013884 and expiry date 19-AUG-2016) via intramuscular route. No adverse effect reported. This is one of the two reports received from the same reporter. Additional information has been requested.
I had muscular aches and pain similar to flu symptoms. I had a fever up to 103 degrees, I was nauseous, fatigue, headache, upset stomach and shivering. These symtoms lasted for approx 4-5 days. I did not contact my health care provider as these symptoms were listed on the receipt I received from the pharmacy. I did take Advil to help reduce the fever and aches.
Headache, Myalgia, Fever, Chills, Fatigue Narrative:  Other Relevant History:
Patient complained of intense injection site irritation (swelling, temperature increase) after receiving co-administration of FLUZONE HD and PNEUMOVAX 23. Patient received both vaccines in the same arm, 1 inch apart, per patient consent. These symptoms fully developed on 12/10/2017. Patient presented to pharmacy on 12/10/2017 with prescription for Keflex 500mg to be taken twice daily for 7 days after vising medical center.
Information has been received from a physician concerning a male who was vaccinated with a dose of PNEUMOVAX vaccine (route not reported). A few days later the patient developed a rash. The patient was given antibiotics. It was unspecified that if the patient recovered from rash. Additional information has been requested.
shingles in the past and the vaccine woke it up a little\suspected vaccination failure; shingles in the past and the vaccine woke it up a little/shingles bumps on my ankles; shingles bumps on my ankles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included drug allergy.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and vesicular rash. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the vesicular rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient was reporter itself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingrix and experienced shingles bumps on ankles. The reporter mentioned that shingle bumps on ankles were not as bad as actually having shingles. The patient had past history of shingles. The patient was allergic to motrin and mentioned that simple  motrin tablet would kill. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Began feeling dizzy and lightheaded. After about ten minutes became nauseous, bp and pulse elevated for about 30 minutes.
acute fever, chills, body aches, nausea, headache starting 2 hours after injection and lasting 4 days.  on day 5 onset of right posterior shoulder pain,  with worsening numbness and weakness of the right arm and hand, specifically to wrist extension, grip strength and finger adduction.
Prior to the vaccine my blood sugar was completely controlled. It was averaging around 112 at the time. I've always been strict with my diet and exercise and was completely off all diabetes medication. A week after the 2nd dose vaccination my blood sugar started to decline. My doctor tried me on metformin, and it didn't have any success. Then I was put on glipizide, and it steadily continued to decline and my A1C was 10.2. I only eat a net 20 grams of carbs per day and the vaccine is the only variable because everything has been the exact same as before the shot and I just can't seem to get the blood sugar down.
Pt came to ED c/o of SOB with new onset of AFib. Pt tested + upon discharge for placement to snf
BODY ACHES; HEADACHE; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 285 pounds, and height was 72 inches. The patient's concurrent conditions included penicillin allergy, abstains from alcohol, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced body aches. On 19-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 20-JUN-2021, and had not recovered from headache. This report was non-serious.
Uncontrolled itchiness - body; Headaches; Mild fever; Nasal congestion; This is a spontaneous report from a contactable other hcp.  A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EL1283, intramuscular, in the left arm, on 24Jan2021 12:00 at SINGLE DOSE for covid-19 immunization.  Medical history included diabetes mellitus, asthma and hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EJ1685, intramuscular, in the left arm, on 03Jan2021, 12:00 for covid-19 immunization.  The patient's concomitant medications were not reported.  On 25Jan2021 19:00, the patient experienced uncontrolled itchiness - body, headaches, mild fever and nasal congestion. The patient underwent lab tests and procedures on 25Jan2021 which included fever: mild and nasal swab: negative.  The outcome of events was unknown. Patient did not received treatment due to the events. The events were considered as non-serious.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
in bed almost 2 weeks; sick; Initial information was received on 24-Oct-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves a patient (unknown demographic) who was sick and in bed almost 2 weeks (illness and bedridden), when received INFLUENZA VACCINE.  The patient's medical history, concomitant therapy, medical treatment(s), 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 (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (non-serious event) and was in bed almost 2 weeks (bedridden) (serious event) (Unknown latency) following the administration of INFLUENZA VACCINE.   Event bedridden was leading to disability.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case concerns a patient of unknown age, who had illness and was bedridden after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset was unknown. However, exact cause for bedridden, patient's medical condition at the time of vaccination, laboratory data and investigations were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
Migraine-like headaches, concentrated in occipital/neck area; This is a spontaneous report from a contactable healthcare professional, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 03May2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included diclofenac potassium (MANUFACTURER UNKNOWN) for an unknown indication, from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on an unknown date of Apr2021 at 12:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 14:00, the patient experienced migraine-like headaches, concentrated in occipital/neck area. The patient had migraine-like headaches, concentrated in occipital/neck area, beginning and early afternoon each day and lasting into the evening. Symptoms had begun the day following vaccination and had persisted every day (10 days) after, with no resolve. The patient did not regularly suffer from headaches. No therapeutic measures were taken as result of the event. The clinical outcome of the event migraine-like headaches, concentrated in occipital/neck area was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
JAN. 6  THIS WRITER RECEIVED FIRST DOSE OF PFIZER-BIONTECH COVID VACCINE, AT MY HOSPITAL. AFTER VACCINATION ONLY FELT SORENESS ON THE INJECTION SITE,  JAN.7 TO JAN 9 FEEL FINE, BY JAN 10TH PAST MIDNIGHT TO 1AM STARTED TO SNEEZE, LOSS OF VOICE, SORE THROAT AND NASAL CONGESTION. TODAY JANUARY MORE SYMPTOMS  ADDED LIKE  NON PRODUCTIVE COUGH AND HEADACHE.
Began experiencing tachycardia, dizziness, headache, and started shaking about 5 minutes after receiving the vaccine.  50 mg Benadryl given IM to R deltoid at 1000. Symptoms began to resolve. Started experiencing some chest pain. Individual states she has a pacemaker, which felt like it was "combating" the tachycardia. Was monitored for 45 additional minutes and all symptoms subsided. Individual was able to return to work.
3 DAYS AFTER iMMUNiZATiON, PT SAiD SiTE DEVELOPED A GOLF BALL SiZED LUMP ON THE RiGHT SiDE OF HER NECK AND A SMALLER LUMP ON THE LEFT SiDE. BUMPS ARE 3" UNDER EACH EAR AND PAiNFUL. PT SOUGHT MEDiCAL ATTENTiON AND REPORTED THAT MD WAS UNSURE OF CAUSE BUT THOUGHT LYMPH NODES MiGHT BE iNVOLVED. NO TREATMENT GiVEN AT THAT TIME.
Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosigned by: MD at 3/23/2021  1:28 PM Expand AllCollapse All    COVID VACCINE CLINIC 3/22/2021     Date:  3/22/2021                                                                                                Subjective Patient is a 38 y.o. female who was seen at COVID Vaccine Clinic today for her second  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She also had some tingling in her left arm.  She denied rash, hives, difficulty breathing and difficulty swallowing. She admits to eating lunch around noon and drinking lots of water today.    This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes.     ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing and headaches    +lightheaded. +tingling in left arm:     Previous Reactions: Denies. No reaction with her first COVID vaccine.     Objective    Vitals Vitals:   03/22/21 1337 03/22/21 1344 03/22/21 1359 BP: 138/83 124/80 129/79 Pulse: (!) 103 91   SpO2: 98% 99%          Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Musculoskeletal:     Comments: Equal grip strength bilaterally. 2+ radial pulses bilaterally.   Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: water Follow up response to treatment: good. Lightheadedness resolved prior to discharge. BP improved. She was escorted out of the building and denied symptoms while ambulating out.  Patient discharge: Stable to go home and follow up with PCP.               PA-C Electronically Signed 3/22/2021 2:01 PM
Patient noticed small rash on left and right forearm (second shot). Patient said that same thing occurred on the first shot. Patient took prednisone last time and it helped. Patient took own Prednisone 10 mg tablet at 2:50 PM.
Pt started screaming 1 hr p/shot; cried-screamed all evening hit self in face; cried next day; senn by MD 2PM 20MAR92; t100.8 R; lt leg swollen & red; MD felt was rxn to pertussis to recvd DTs future; DPH tx;
Muscle pain in right upper arm and soreness. Causing weakness to the whole right arm. The situation gets more severe after 24 hours. The recovery started after 48 hours of injection.
Nausea, dizziness, muscle aches, fever,  and extreme bone and joint pain
Systemic: Dizziness / Lightheadness-Severe, Systemic: numbness in left pinky-Severe, Systemic: Stroke-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium, Additional Details: Pt came is the 02/25/22 in the morning with complaint of diziness and numbness throughout left side of body the day of the shot but now at the time of speaking to pt the next day his main complaint was tingling/numbness on the left pinky (slightly in left arm) and slight dizziness. He came to the pharmacy able to walk, speak clearly, no odd movements/gait. Pt went to hospital 2/25/22 later in the day and was diagnoised with a stroke and is being treated at the hospital. Pt speaks mandarin only.