chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details available; stored outside of recommended range; This spontaneous report was received from an office manager in charge of vaccine storage and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The concomitant therapies included sterile diluent used for vaccine reconstitution.   On an unknown date in2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U039722, expiration date 15-DEC-2023 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine underwent temperature excursion of 6 Fahrenheit degrees up tp 14 Fahrenheit degrees for 50 minutes and 14 Fahrenheit degrees up to 46 Fahrenheit degrees  (15 Fahrenheit degrees) for 30 minutes on 28-JUN-2022. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000544:Merck US-009507513-2207USA000563:Merck US-009507513-2207USA000680:Merck US-009507513-2207USA000470:Merck US-009507513-2207USA000561:Merck
On the second day of the MODERNA Vaccine, patient felt itchiness on arm. On third day, patient indicates that it became inflamed, or woke up with face swollen, and one eye was very swollen
shingles; This case was reported by a nurse and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, then in the waiting period for the 2nd vaccine, they developed shingles. The reporter asked, how long until they could have the second dose. The reporter did not consent to follow up. No additional information available and no permission for follow up.
Headache ARM SORENESS; BODY ACHES; FATIGUE Narrative:  Other Relevant History:
Symptoms - ? 1/7 at approximately 2:00 pm:  feelings of nausea; 10:00 pm:  myalgias, midnight:  chills and fever (Tmax 101.3).  EE denies COVID-19 exposure without proper PPE and denies travel. Home remedies? -   none Any improvement? ? at time of call at approx. 9:10 am, EE reports significant improvement in symptoms and denies fever at this time Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns.  EE verbalized back understanding and denied further questions at this time.
redness over the injection site; feeling tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (feeling tired) and INJECTION SITE ERYTHEMA (redness over the injection site) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Benadryl).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced FATIGUE (feeling tired). On 07-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness over the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (topical) for Injection site redness, at an unspecified dose and frequency. At the time of the report, FATIGUE (feeling tired) had resolved and INJECTION SITE ERYTHEMA (redness over the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient treatment includes topical cream/ gel Benadryl as a treatment. The treatment was topical as the patient is allergic to Benadryl. Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe nasua and vomiting, petechiae on face and neck, bone pain in left arm (arm that vaccine was administered), fever, chills
This spontaneous report as received from a nurse refers to a 75 year old patient. Medical history and concurrent conditions were not reported. On 12-MAR-2014, the patient was vaccinated with PNEMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Systemic hives, trying nettle tincture, benadryl continued redness and itching at this time
Patient described development of many round, flat bumps that began on her back and spread to her arms and hands. She said that some of the bumps "popped up like a wart" forming mole-like lesions. She said that several of these lesions had to be removed. She denied presence of pain but described them as being very itchy.
Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Continued into Saturday. Sunday, Monday and most of Tuesday felt normal. Tuesday evening started to fell worse and Wednesday 1.13.21, 6 days after shot, headache, nauseous, very tired, could not go to work. Called Doctors office and spoke to two different nurses who advised these were normal reactions although maybe delayed.  By end of day headache and nausea were gone but still felt unwell. 1.14.21 well enough to work, mostly normal. Took blood pressure and it was elevated by 20 points! BP is still elevated on 1.15.21.
Day 1-2 =injection site pain 10/10 (10 is the greatest) Narrative:  Other Relevant History:
Information has been received from a physician concerning a 60 year old female with allergic reaction to antibiotics CEFTIN who on 25-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23.  Concomitant therapy included fluoxetine HCl and alprazolam.  On 25-OCT-2007 the patient's arm swelled 1.5 times normal and she experienced a fever, aches, pains, her arm turned red and was tender to the touch.  No diagnostic laboratory studies were performed.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
He had vomiting, headache on 6/26/2021 and became comatose that night and got better after steroids. He is still weak in the right arm.
PATEINT WAS GIVEN DTAP IMMUNIZATION AT PUBLIC HEALTH DEPT 08/04/2016, PATIENT CAME INTO PCP OFFICE 08/06/2016 FOR TREATMENT OF CELLULITIS AND INFLAMMATION TO INJECTION AREA.
48 hours later dizziness for 5 days, less for 2-3 more. I'm never dizzy except on ships/boats. Rash - larger welts on lower back upper legs, some on arms & back. Its my usual reaction to wat too much sugar. This too lasted  5 days
Tested positive on 9/17 was hospitalized; was transferred to another hospital on 10/08 for swing bed status to receive therapy for strengthening.
patient was sick for 19 days; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.   This case involves a unknown demographics patient who was sick for 19 days (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick for 19 days (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was patient was illness.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Fever, chills, nausea, vomiting, diarrhea, body aches
G3P0020 1. 12/2020 missed abortion with D&C 2. 5/2021 chemical pregnancy 3. current  EDD: 10/18/22 Uncomplicated pregnancy aside from BMI of 48
Joint pain/hip joint; leg pain; neck pain; Pain upon movement; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a day after receiving Shingrix, the patient experienced joint pain, leg pain, neck pain and pain upon movement. On an unknown date, the outcome of the joint pain, neck pain and pain upon movement were recovering/resolving and the outcome of the leg pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain, leg pain, neck pain and pain upon movement to be related to Shingrix.  Additional details were reported as follows: The patient received her first dose of Shingrix vaccine about 5 weeks ago. The night of vaccination she experienced joint soreness all over the body. The soreness in her neck got better within 4 days, but the soreness in both of her legs was still present and more dominantly on the left legs. The hip joint pain was not gotten better and it was painful upon moving. The reporter consented to follow up. No further details were provided.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, the subject experienced general malaise. On 16-MAR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced tested positive for covid 19. Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general malaise, and headache on 17-MAR-2021, and had not recovered from tested positive for covid 19. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious
C/O PAIN IN AMR,NUMBNESS AND TINGLING, BUT DID NOT PRESENT TO PHYSICIAN WITH THESE SYMPTOMS UNTIL 03/16/07 AT WHICH TIME SYMPTOMS HAD RESOLVED.THIS WHAT THE PT.STATES.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, allergy, and overweight. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received Spikevax (Elasomeran) (Dose number in series 2) (form of admin, route of admin, batch number: 046C21A, expiry: unknown) dose was not reported, 1 total administered in left arm on 02-NOV-2021 for prophylactic vaccination. On 21-MAY-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive (Dose number in series 2).  On 21-MAY-2022 at 12:30, the patient experienced covid-19 test positive (Dose number in series 2). The action taken with Spikevax (Elasomeran) was not applicable. The patient received unspecified drug for covid-19 treatment from 12-MAY-2022 and date of last administration was 17-MAY-2022.  Concomitant medications included fluticasone propionate, and fluticasone propionate/salmeterol xinafoate. The patient had not recovered from covid-19 test positive. This report was non-serious.
Patient received vaccine, then immediately described that he had trouble seeing and felt faint. EMS was immediately called. He had difficulty sitting up and kept his eyes closed. He had no reports of difficulty breathing. His body had started to get warmer within 5 minutes. Patient felt better around 10 minutes later when EMS arrived.
This spontaneous report as received from a physician via company representative refers to a 12 year old male patient. Medical history and concurrent conditions were not reported. At the end of May 2015, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. On 07-JUN-2015, the patient experienced joint pain. The outcome of arthralgia was unknown. The causality was not reported. The patient sought medical attention (unknown if the patient had an office visit with the physician, or the patient called the physician). The physician mentioned the patient had an appointment to follow up with an unspecified neurologist on an unspecified date. Additional information has been requested.
3OCT91 tired, h/a, muscleache; 4OCT91 severe fatigue, flushing, chills, h/a, diarrhea, muscle ache, cold feet, heavy eyelids; 8OCT91 fatigue, chills, h/a, diarrhea, muscleache, sore throat, congestion, cough, dizzy;
Client received AstraZeneca COVID vaccine, no reaction. AstraZeneca vaccine unavailable in the  Janssen given as an alternative on 09/15/21.
Started with throat hurting and by around 9 AM the next morning her tongue was swollen about 4 times the normal size. So large that she could not keep her tongue in her mouth and her breathing was affected.
pt recv vax 29AUG97 sore red lt arm inj site;lesions  (like ringworm) on legs;circular red lesions w/clear centers;not bothersome;itchy feet (soles of feet);cleared by 1SEP97;
Initial non-serious case received from a Healthcare Professional on 21 July 2008. A 58-year-old female patient developed a general feeling of not feeling well, lightheadedness, trouble focusing, right arm axillary tenderness and swelling with a possible lump, right deltoid nodule at the injection site, intermittent episodes of profuse sweating and nausea 24 hours after receiving an intramuscular right deltoid injection of ADACEL (lot number C2766AA) and an intramuscular left deltoid injection of PNEUMOVAX (manufacturer Merck, lot number 1381U). The patient was seen at the doctor's office and received treatment with CLARITIN, BENADRYL and an allergy shot (not specified). Patient outcome was reported as 'not recovered'. The patient was to follow-up with the doctor's office in 24-48 hours. Follow-up received from a Healthcare Professional on 15 August 2008. Date of ADACEL and PNEUMOVAX vaccinations was amended from 17 July 2008 to 16 July 2008 and the adverse event onset date was amended from 18 July 2008 to 17 July 2008. The symptom, "trouble focusing", was clarified to mean trouble focusing mentally, rather than blurred vision; coding was amended accordingly. It was initially reported that the patient had a possible axillary lump. Findings from a physical exam performed on 21 July 2008 stated, "swelling and tenderness in axillary region, diffuse"; coding of this symptom was also amended. Another finding from that exam was firmness in the deltoid region. At the time of the vaccinations, the patient had sinusitis. No additional medically relevant information was provided. Follow-up received from a Healthcare Professional on 29 September 2008. Progress Notes dated 21 July 2008 indicated that, in addition to the previously reported symptoms, the patient reported feeling groggy. Her blood pressure was 139/70, pulse 62, oral temperature 97.7 degrees Fahrenheit. The patient's lungs were clear to auscultation and percussion. The event was reported to be a questionable reaction to the ADACEL. Treatment included alternate cool compresses/warm moist compresses to the axillary region, allergy injection per patient request, CLARITIN, BENADRYL at night, hydration and rest. The patient indicated that she was fine before being vaccinated. Follow up information was received on 23 December 2008 from a health care professional. The patient had sinusitis at the time of vaccination. The patient recovered on 21 July 2008 and did not return for follow up within 24-48 hours. No further information was provided.
soreness; tiredness; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced soreness and tiredness on an unspecified date. The outcome of the events was unknown.    Information on the lot/batch number has been requested
Got Covid after having the vaccine; Got Covid after having the vaccine; The initial case was missing the following minimum criteria: suspect product is not reported or specified. Upon receipt of follow-up information on 22Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's friend). An 84-year-old male age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EN6200), via an unspecified route of administration on an unspecified date (at the age of 84-years-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test and results unknown. On an unspecified date it was reported as the 84-year-old patient got COVID after having the vaccine. Reporter stated that the patient was tested for COVID the following week after the vaccine was administered. He was home for about 1 month and he was glad. Then After 1 month he went and got antibodies, they injected him with the antibody infusion as outpatient in unknown hospital. He was waiting to get the second dose of vaccine. Outcome of the events was unknown.
sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN, PARACETAMOL (ACETAMINOPHEN) and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-239201 (Patient Link).
Woke up at 5am the following morning with slight nausea and became diaphoretic and felt faint. This only lasted a few minutes, but later in the morning around 9am, body aches, fever, chills, fatigue began and lasted until 10pm. After this time, all symptoms ceased. I also had an extremely sore deltoid where injection site occurred for 48hrs, much worse than I've ever had for any vaccine or IM injection.
Gout in third toe pad from the right big toe. Uric acid crystals. Hard to walk but managing okay.
Collapsed in the morning during PT'ing at training after 2 weeks of headaches, upper respiratory tract infection, sore throat, joint pain, abdominal pain, cough, nausea. Was diagnosed with bilateral pneumonia & hospitalized 08/26/2016 to 08/29/2016.
BOOSTER; suddenly dies in his sleep 2 weeks after 3rd covid jab; This is a spontaneous report received from non-contactable Consumer. A 52-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The prominent (Institution) Cardiologist suddenly died in his sleep just two weeks after getting his 3rd covid jab. The cardiologist who said he 'won't cry at funeral' for "selfish" unvaccinated people. The following information was reported: IMMUNISATION (death), outcome "fatal", described as "BOOSTER"; DEATH (death), outcome "fatal", described as "suddenly dies in his sleep 2 weeks after 3rd covid jab". The patient date of death was unknown. The reported cause of death was "suddenly dies in his sleep 2 weeks after 3rd covid jab", immunisation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: BOOSTER; suddenly dies in his sleep 2 weeks after 3rd covid jab
Patient thigh had a raise of approx. 4in round site was red and warm to touch. Complained of itchiness, pain; Treatment was Benadryl 12.5mg and Childrens Tylenol