chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My tongue deviates to the left instead of straight, this isn't causing me any pain but I went to the doctor and they still have to do an MRI and a cat scan later on.
The health care provider mistakenly gave undiluted COVID-19 vaccine to the patient, administering 0.3ml of undiluted solution. The patient had no apparent adverse effect. No redness or swelling occurred at the injection site, nor any systemic side effects.
Tdap given 11/20/08, pt adm to hospital, dx with Guillian-Barre Syndrome.  Neuro sx of progressive numbness, tingling, weakness bilateral upper and lower extremities, along with muscle aches and severe back pain which started 11/30 or 12/1 according to family. As of 12/23 client remains inpatient at Hospital. 2/23/09-records received-for DOS 12/10/08-DC DX: Guillain-Barre syndrome. Admitted with 2 week history of progressive weakness and paresthesias of extremities begin in feet and progressed to upper extremities. PE: decreased light touch sensation in bilateral lower extremities and upper extremities with weakness in all four. Treated with IVIG. During second course of IVIG creatinine doubled. Plasmapheresis.Transferred to rehab facility.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with hypertension and drug reaction/allergies to "iodides" (no further specified). On 29-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # J000494, expiry date 14-APR-2014) (number of dose, dose, route, frequency not reported) to prevent shingles. Concomitant therapies included PROPRANOL and LIPITOR. On 30-JUL-2013 the patient experienced redness that was spreading down the patient's arm from the injection site and a bulge at the injection site and bulge at the injection site. The patient was treated with BENADRYL. The outcome of redness that was spreading down the patient's arm from the injection site and a bulge at the injection was reported as not recovered/not resolved. No laboratory diagnosis was performed. The patient sought medical attention by contacting pharmacist. The reporter did not assess the relationship between the therapy with ZOSTAVAX and redness that was spreading down the patient's arm from the injection site and a bulge. This is one of several reports received from the same source. Additional information has been requested.
The vaccine hurt when the nurse did it. After 2/3 days of pain, that I thought was normal after a shot, the pain didn't disappeared, even increased. I cannot move my arm in many ways.  After almost 4 weeks, some movements are still impossible, it's like I'm stabbed with a knife.
Patient states at 6:30 PM he felt chest tightness, shortness of breath, sweating, fever, chills, body aches, coughing, feeling anxious and concerned. Symptoms subsided before he went to bed that evening.
Pt from home via EMS. Pt reports increased weakness since getting the covid vaccine on the 24th. Pt is normally ambulatory at baseline, but has not been able to get around his house. Pt was found to be 83% on RA  and was audibly wheezing per EMS. No history of respiratory issues. Denies fever, but has had a productive cough. A&O x4. Pt received Duoneb treatment in route. Acute respiratory failure with hypoxia   , Pneumonia due to COVID-19 virus , Elevated LFTs. Patient admitted to hospital on 2/3 and is still inpatient
Information has been received from a registered nurse concerning a 50 year old female patient who on 28-JUN-2007, was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot# 654977/0888F). Subsequently, the patient developed a severe injection site reaction described as redness from the shoulder to the arm, pain, axillary lymph node swelling and induration. Unspecified medical attention was sought. Within 2-3 days the reaction resolved. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of three reports from the same source. Additional information has been requested.
flu like symptoms; fever for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever for 12 hours) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever for 12 hours). On 13-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever for 12 hours) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: (abnormal) score of 20..         No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-085723 (Patient Link).
This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 24-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Body is itching; Vaccination site rash; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body is itching), VACCINATION SITE RASH (Vaccination site rash), PYREXIA (Fever) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash), PYREXIA (Fever) and FATIGUE (Fatigue). On 25-Mar-2021, the patient experienced PRURITUS (Body is itching). At the time of the report, PRURITUS (Body is itching), VACCINATION SITE RASH (Vaccination site rash), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
No additional adverse events reported; the patient was administered a dose of VARIVAX on 24-DEC-2019, that had been improperly stored; This spontaneous report was received from a vaccine coordinator (also reported as office manager), referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.   On 24-DEC-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number S021926 has been verified to be a valid, expiration date reported and validated as 15-JUL-2021). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse events were reported for the patient.  According to the reporter, the temperature excursion was 1.2 degrees Celsius for a time frame of 3 hours and 9 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.
This is a spontaneous report from a contactable other Health Care Professional (patient). A 59-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: En6198, Expiration date: Unknown), via an unspecified route of administration, in Arm Left on 05Mar2021 at 13:30 (at the age of 59-year-old) as 1ST DOSE, SINGLE for Covid-19 immunization at Public Health Clinic/Administration facility. The patient medical history included thyroid disorder from an unknown date (Low thyroid numbers), migraine from an unknown date (Chronic), hypotension from an unknown date (Low blood pressure), raynaud's phenomenon from an unknown date (Raynauds syndrome). The patient had no known allergies. The patient had received concomitant medications within 2 weeks included nifedipine (NIFEDIPINE), levothyroxine (LEVOTHYROXINE), trazodone (TRAZODONE) and tamsulosin (TAMSULOSIN) were taken for an unspecified indication, from an unknow start date. The patient did not receive other vaccines within four weeks of vaccination. The patient was not diagnosed with COVID-19, prior the vaccination. The patient was not tested for COVID-19, post vaccination. On 05Mar2021 at 12:00 AM (approximately 6 hrs post vaccination), the patient felt extreme weakness, dizziness, brain fog. The patient woke up for work but had to call in sick sure to extreme weakness and dizziness along with severe pain at injection site. The patient did not receive treatment for the events. The outcome of the event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
* attached. Two days after the flu shot. I had a terrible sore throat. So bad I had no saliva, that lasted one day. I also had a cough, runny nose and at times a stuffy nose. I had cough syrup w/codeine in it that I took. By Sunday evening I felt so bad, I decided to go to the doctor on Monday. When I got up Monday, I felt like a million dollars. From then on my cough got better and I was myself again. I have taken flu shots before and had no after effects. Could it be because I am over 65 and got a stronger dose?
100.0-100.5°f fever lasting 24 hours; Red rash around injection site about size of index finger down front of arm and 2 index fingers around arm. Rash is very hot to the touch and very sensitive to touch. It happened with the first vaccination as well.
pt recv vax 24FEB97 & 8MAR97 pt devel lesions on scalp & ears;
Patient injection site was swelling, itching can warm to touch. Pt also experienceing headache.
Hives and itchiness both sides of the body; Itchiness both sides of the body; She had bumps in the ears; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives and itchiness both sides of the body), PRURITUS (Itchiness both sides of the body) and EAR SWELLING (She had bumps in the ears) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient had no medical conditions.     On 02-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced URTICARIA (Hives and itchiness both sides of the body), PRURITUS (Itchiness both sides of the body) and EAR SWELLING (She had bumps in the ears). At the time of the report, URTICARIA (Hives and itchiness both sides of the body), PRURITUS (Itchiness both sides of the body) and EAR SWELLING (She had bumps in the ears) was resolving.            It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that couple of days after the fifth dose she started with hives and itchiness both sides of the body, which affected her face, eyes and ears, she had bumps in the ears, it was severe, not anaphylaxis but severe enough to go to hospital, she was given antiviral and antibiotics, and this was still ongoing at the time of reporting but was minimum compared to what it was earlier.   This case was linked to US-MODERNATX, INC.-MOD-2021-005967 (E2B Linked Report). This case was linked to MOD-2021-005967 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-005967:Monovalent dose
Developed Measles-like rash that made patient's eyes swell shut. Itching, malaise at 11 days post injection.   At 21 days post injection, patient developed a fever of 101 for 2 days, poor appetite, and swollen lymph nodes.   Treatment was Benadryl to try and decrease the rash and wait it out.
Patient at 15 minute mark animated that her brain was feeling like is was shaking, she denied lightheadedness. She was unable to speak. Attempted to walk her to stretcher patient fearful noted by expression of eyes. Stretcher brought to her. She transferred with/out difficulty or deficits. NP came evaluation, patient stated using thumb and index an increment of 1/2 into described her feeling of dyspnea. Non verbal, signing with AMD, VS 100 o2 HR 111. No BP.  From ICU arrived patient taken to ER.
red blotchiness; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotchiness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine. Concurrent medical conditions included Shellfish allergy.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red blotchiness). At the time of the report, RASH MACULAR (red blotchiness) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.  Patient asked if there was correlation to shellfish allergy or iodine as ingredient in vaccine that could have caused.
Migraine in the evening of the 8/27/12, red hot swollen arm. Seen Dr. for cellulitis. Was given Prednisone and Bactrim.
Lymphadenopathy in left arm pit sore arm Slight fever of 100.1 headache fatigue muscle and joint aches
No adverse reaction that we are aware of. Came across the misuse of KINRIX vaccine when quarterly report was printed.
No adverse event; Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 37-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 14-Dec-2022, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported.  The vaccination site was reported as right FA.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up information included patient's age group updated. On 28-Dec-2022: Follow-up information included patient demographics (age, date of birth, race), vaccine start date, suspect vaccine lot number and event start date were added.
Severe Allergic reaction which required intervention from the hospital. I received 125 mg of Solumedrol IV, 65 mg of Benadryl IV, 50 mg of Hydroxizine IM, and 20 mg of Famotidine to stop the severe allergic reaction.
Vaccine was given in wrong spot and 4 days later I developed a red/blue spot about the size of a quarter that itches and feels like it has a knot below the skin.
VOMITING, DIARRHEA, DEHYDRATION, GENERALIZED PAIN, HEADACHE, FEVER, CHILLS, TIREDNESS
Right arm swollen.  Ice Compress, Motrin 3 tsp every 6 hours
Tiredness; feeling unwell; joint pain; chills; muscle pain; This is a spontaneous report from a contactable non-health care professional (patient). An 83 Year(s) old male patient received BNT162B2 (Pfizer-BioNTech COVID Vaccine), batch/lot number# EL9269, via unspecified route of administration on his left arm as first dose, single on 07Feb2021 at 12:45, (age at vaccination 83 years) for Covid-19 immunization. Patient's medical history was not reported. The patient was allergic to Thimerosal, lactose and cucumber. Concomitant medication included lisinopril 10 milligram (mg) for chest congestion relief PE. Patient did not receive any other vaccine within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 09:00, the patient experienced chills, feeling unwell, joint pain, muscle pain and tiredness. He did not receive treatment for the events. The patient was recovering from all the events. No follow-up attempts are needed. No further information is expected.
I got vaccine and still got shingles/suspected vaccination failure; Mild case of Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got vaccine and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Mild case of Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine couple of years ago and right now he/she experienced mild case of shingles. The patient stated that he/she received shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Tested positive for COVID after being fully vaccinated. I got the antibody infusion in April for the second COVID outbreak. Not for the third time.
Bruising and large, erythematous circular rash that was pruritic on left thigh around injection site of Varicella and Kinrix (Dtap/IPV) injections.
Headache, Fatigue, body pain, pain at injection location, took pain killer to manage the pain
Arm sored but now it's gone; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm sored but now it's gone) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Arm sored but now it's gone). At the time of the report, INJECTION SITE PAIN (Arm sored but now it's gone) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient had a swollen arm with hematoma on the day after the injection.  She states that ever since, her arm has been progressively painful and she is now experiencing arm immobilization from elbow to the upper arm.
Information has been received from a physician concerning a 12 year old male who on 09/12/1995 was vaccinated with a dose of varicella virus vaccine live.  On 03/11/2005 the patient developed a rash with lesions on his mouth, scalp and scattered on his trunk.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Fever of 103.5 that would not go down with acetaminophen for over 6 hours.
A spontaneous report has been received from a field employee who reported on behalf of a pharmacist. The pharmacist reported that an unspecified patient received ZOSTAVAX on an unspecified date. The patient experienced redness, pain and swelling at the injection site on unspecified date. Medical history and concomitant medication were not reported. The outcome of redness, pain and swelling at the injection site was reported as recovered. No further information was provided. Additional information has been requested.
Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in cases: 2014SA07124, 2014SA071260, 2014SA0762, 2014SA071266 and 2014SA071268. A 15-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.