chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 total, (dose number in series was 2), administered on 01-DEC-2021 into left arm for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose) (dose number in series 2). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that, on 01-DEC-2021 they received approximately around 0.3 milliliter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210350, 20211210160, 20211209551, 20211209976, 20211209679, 20211209706, 20211209775, 20211209782, 20211209798, 20211209874, 20211209912, 20211210019, 20211210106, 20211210107, 20211210112, 20211210133, 20211210141, 20211210143, 20211210159, 20211210165, 20211210165, 20211210180, 20211210197, 20211210165, 20211210334, 20211210350, 20211210385, 20211210408, 20211210409, 20211210555, 20211210585, 20211210588, 20211210590, 20211210610, 20211210662, 20211210670, 20211210684, 20211209843, 20211209921, 20211209740, 20211209884, 20211210067, 20211210824 and 20211210733.
feeling sluggish; warm; headache; Soreness at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), SLUGGISHNESS (feeling sluggish), FEELING HOT (warm) and VACCINATION SITE PAIN (Soreness at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache), SLUGGISHNESS (feeling sluggish), FEELING HOT (warm) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, HEADACHE (headache), SLUGGISHNESS (feeling sluggish), FEELING HOT (warm) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT 0.2 milliliters. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated patient was administered expired dose which started on 13-Jan-2016. The outcome of the event of expired dose is unknown. The reporter's description of the event(s) was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious.
Initial symptoms were severe stomach/intestinal cramping which progressed to constant nausea and low grade headache. A lesion appeared at the injection site approximately 24 hours after administration measuring 1 inch x 3 inches. The lesion is scaly and started as pink progressing to purple/blue in appearance. An antibiotic was prescribed on 5/10/2016 for possible injection site infection.
This spontaneous report as received from a nurse practitioner refers to a 6 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K004541, expiration date: 04-DEC-2016 (dose, strength and route of administration were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Headache, Myalgia, NauseaVomiting, c/o muscle spasms,insomnia,fatigue
lost 20 pounds prior to the bivalent booster.; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient(a registered nurse, retired).  An 87-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 86 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose: , Time: unknown, Anatomical Site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EL9262), administration date: 24Jan2021, when the patient was 85-year-old, for COVID-19 immunization; BNT162b2 (2nd dose:, Time: unknown, Anatomical Site of injection: left arm, Route of Administration: intramuscular; , Batch/Lot number: EL9266), administration date: 14Feb2021, when the patient was 85-year-old, for COVID-19 immunization; BNT162b2 (3rd dose:, Time: unknown, Anatomical Site of injection: left arm , Route of Administration: intramuscular; , Batch/Lot number: FF8839), administration date: 02Nov2021, when the patient was 86-year-old, for COVID-19 immunization. The following information was reported: WEIGHT DECREASED (medically significant) with onset 2022, outcome "recovering", described as "lost 20 pounds prior to the bivalent booster.". The patient underwent the following laboratory tests and procedures: Weight: (2022) 24 lbs, notes: lost 24 pounds; Corrects information later in report as: states lost 6 pounds recently (as of 03Nov2022); (2022) 20 lbs, notes: lost 20 pounds prior to the bivalent booster.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Weight decreased" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The following day my left arm felt so hot, really red and started to swell.  It started off like a patch it was becoming bigger and bigger. The part of my left arm that I do have feeling in it could feel pressure and was really inflamed. I took pictures of my left arm and went to the clinic it was infected. I was told of my arm was ok it would go away give antibiotic three times a day and cortisone cream. My arm is discolored in the area slowly clearing up and the part that I do have feeling is still hot, itchy and pain is going away.
pain lt dealt radiating to lt shoulder & neck;dizziness;fever, chills, aches, pains, nasal drainage;
Within 2 minutes - severe dizziness, nausea, cold sweat, muscle weakness and very severe lower back pain.  I could not walk out of the pharmacy for fear of falling. I could not drive home. After approximately 45 minutes was able to walk and had to have my husband take me home.  Fever continued to worsen thru the night, and I took aspirin to help with aches and fever.  Fever escalated to 101.8.  At this writing 6:45 am. Fever has subsided, still have achy muscles. Slight headache. I have never had a reaction like this before. Received the flu shot for 65+ last year with no reaction like this.  This was a very scary event.
Developed a fine rash across her forehead and chest.  Cheeks were firey red and warm to the touch.  Rash lasted a couple of days.
Patient reports that the quantity of his ejaculate since receiving the vaccine is significantly less than his "normal" amount during masturbation.  Sometimes there is no ejaculate at all.  Sensation and erection are unchanged.  He is indicating that this is a "serious" change and is not related to a change in frequency of masturbation.
Approximately 30 minutes post vax, the pt experienced an injection site that was reddened and the pt also complained of soreness at the site.
Information has been received on 12-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There is no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by the patient's healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
12/28 started having symptoms- Body aches, congestion, Fever 101, back pain, mild cough and nausea.    Today she still feels ill.
Left sided headache for ten days, followed by small lump above eye that was warm to touch and painful. Progressed to red rash at lump, swollen glands with burning and itching of rash. Increasing headache over three weeks. Rash continued down bridge of nose and into left eye. Tearing, burning, pain and photophobia in left eye.  Diagnosed by family practitioner as shingles on 6/29/2022.
This spontaneous report as received from a Nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 lot # M042853 for prophylaxis. Temperature was reported as 52.6 FR, timeframe: 2 hours 32 minutes. There was no previous temperature excursion. No adverse effects were reported. This case is linked to case 1707USA006520 and 1707USA006521 (same reporter link). Additional information has been requested.
Dizziness, cloudy judgement, feeling like about to pass out. Slept all day first day after the shot. Second day had a bit headache and still some cloudy judgement but was much better.  Third day fully recovered
Inpatient stay discharged after two days. 11/14-11/16/21 HOSPITAL COURSE: Pt is an 84 yo male who presented tot he ED due to AMS. He seen by his PA initially on 10/21 and diagnosed with left perihilar PNA and treated antibiotics. He followed up with his PA on 10/25 and was placed on steroid taper. He presented to the ED on 11/12 at which time CT thorax was obtained demonstrating no acute findings, but granulomatous lung changes and calcified pleural plaque suggestive of asbestos disease. He was discharged from the ED.   He returned to the ED on 11/14 with CXR demonstrating patchy alveolar infiltrates which may be representative of edema or infiltrate. Patient tested positive for COVID-19 and was admitted to the medicine service of acute hypoxic respiratory failure   # Acute Hypoxic Respiratory Failure # Acute on Chronic CHF exacerbation Felt secondary to mild CHF exacerbation, he was treated with IV lasix with quick resolution of hypoxia and able to wean to room air. He reported his dry weight to be 220 lbs with discharge standing weight being 98.6 kg (217 lb). Patient desired to discharge and not want to be monitored for 24 hours on resumption of his home oral lasix. He was instructed to monitor weight daily and maintain a 2 liter fluid restriction.    # COVID-19 Patient weaned to room air after lasix administration and given lack of findings suggestive COVID-19 on initial imaging, decadron was not given while hospitalized. Did receive dose in the ED. Patient was also noted to be vaccinated with J&J vaccine.    # Abnormal CT of the Chest Pulmonary was consulted given findings on chest CT and recommended outpatient follow-up with no additional workup while hospitalized.    Although patient did not reports any dyspnea with ambulation, he was noted to have oxygen saturation <88% at times while ambulating. Given his desire to discharge without further attempts to wean with IV lasix, pulmonary rehab was consulted an patient was discharged on 2 liters of oxygen via NC with activity. Patient was discharged home in stable condition with discharge instructions provided.
high pitched crying x 4hr;advised to call MD;p/warm bath & car ride pt slept 4hr;no further crying today 27AUG96;
My grandson went from a genteel and loving child to an aggressive and unpredictable child, this is still continuing today. He had loose and  smelly bowel movements for about two weeks after each H1N1 shot.
TDAP administered 1-21-09 pt wife notified us that w/in a few days he had broke out in rash on trunk which then spread, treated w/OTC Benadryl.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Additional Details: Patient was immediately nauseous after vaccination, but that resolved quickly.  Minutes after sitting down for the observation period, patient seemed to jerk and looked like he was seizing. He did not have trouble breathing.  He was lucid after going in and out of consciousness for a minute or so. He was hypotensive and pale, but after water and some candy, patient was feeling much better. After the 30min observation period, his blood pressure was up and he was able to walk without trouble.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-SEP-2015, the patient was vaccinated with improperly stored dose of (Merck) PROQUAD (lot # K013867, expiration date 05-MAR-2016) (dose and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
hives; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (hives) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZOA) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced URTICARIA (hives). On 18-Jan-2021, URTICARIA (hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Non significant follow-up. NNI
Patient received a singles shot on 11/19/19. Patient's wife called me today 11/21/19 to tell me patient has not been acting himself the last two days (since morning of 11/20/19 until now 11/21/19 ). He slept most of the day yesterday (11/20/19) and has been acting strange, forgetful, and not making sense. I asked patient's wife to take him to the Emergency room ASAP to make sure he wasn't dealing with an infection, rare side effect, or a possible stroke. Patient's wife agreed and asked me to call the Hospital ER to let them know what we had talked about and tell them that he had received a shingles shot on 11/19/19. I got off the phone with her and called ER to tell them and let them know that she was on her way with patient at 1522.
Since the day I received the vaccine (April 2, 2021 ), I have been experiencing chest pressure on the left side of my chest, vein pain, tiredness,  dizziness, nauseas, and headaches.
Information has been received from a physician concerning a 23 year old female with sulfonamide allergy and cefaclor allergy who on approximately 15-AUG-2008 (18 months ago) was vaccinated with the first dose of GARDASIL. The patient fainted after getting her first dose of GARDASIL and recovered on the same day. On 15-FEB-2010 the patient came to the physician's office to received the second dose of GARDASIL. Unspecified medical attention was sought. Additional information has been requested.
I95.9 HYPOTENSION 3/24/2023 CERVICAL LYMPHADENOPATHY I95.9 HYPOTENSION 3/24/2023 ASTHMA, UNSPECIFIED
Generalized myalgias, arms, shoulders, legs and elevation of liver enzymes (SGOT and SGPT).
Tinnitus started approx 4 days after the 2nd vaccine dose administered and had progressively gotten louder over several weeks slightly lessening in loudness at this time
This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA, (Lot# K007791, expiration date: 22-AUG-2016; Lot# K010812, expiration date: 12-FEB-2017), dose and route of administration were not provided. No adverse effect reported. This service request was first opened on 30-JUN-2015, when a pharmacist called to report a vaccine temperature excursion but any adverse event was reported at that time. However, this adverse event was reported on 11-AUG-2015, during a call back by this healthcare worker. This is one of several reports received from the same source. The lot# K010812 is not valid for VAQTA. Additional information has been requested.
rash below injection site; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received her first Shingrix dose and did not have any reaction).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. The patient was treated with antihistamine and medication unknown (Topical (Nos)). On an unknown date, the outcome of the injection site rash was unknown.   The reporter considered the injection site rash to be related to Shingrix.  Additiopnal details were provided as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix, and did not have any reaction. After vaccinated with 2nd dose, the patient had local reaction, rash, below the injection site. The patient did not receive any other vaccines at the time. The patient was treated with antihistamines and topical medications. The physician did attribute the rash to the Shingrix vaccine. The physician agreed to be followed up.
Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
I was given a 30 minute hold due to my medical allergies.  About 10 minutes after the injection I started to feel like my tongue and throat were swollen.  I immediately took some chewable Benadryl that I had.  After about 10-15 mintues it seemed like  it wasn't getting any worse anymore.  I didn't seek medical attention because the symptoms weren't severe.  I did wait an extra 10 mintues beyond my 30 minute hold before leaving.  It look a few hours before symptoms seemed to subside.  My throat still feels constricted, but I can't say if that is due to the vaccine or other allergies (it's still pollen season).  I also experienced  soreness at the injection site for about three days.
I received the vaccine yesterday at 9am and I start noticing the side effects from the vaccine at midnight. I had body aches, chills, fever, and now I have a headache.
Patient seen in office with papular vesicular lesions. Received vaccine at age 15mo. Suspected Varicella. Varicella Vaccine breakthrough.
4" X 4" hardness under the immunization site. Soreness, muscle aching, lower back pain, nausea, headache. These are ongoing for 3 days.
15-year-old male presents to the emergency department with mother for some nausea and vomiting as well as frontal headache that started this evening. Apparently got the polio vaccine around 430, seem to have developed a headache that was progressive after that. Denies any head injury or trauma. Patient has had some progressive weakness and fatigue over the last several months, did have a low iron level previously, was told that his hemoglobin was in the eights today based on rapid check in the office however it was 14.2 on labs done today. Denies fever, vision changes, chest pain or shortness of breath, cough, congestion sore throat, hematemesis, abdominal pain, change in bowel or bladder habits, Of note mother does not state that he has had headaches intermittently for the last several months.