chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MUSCLE SPASM; SORE ARM; MAJOR CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) 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 subject experienced muscle spasm, sore arm, major chills, headache, and fatigue. The action taken with covid-19 vaccine  was not applicable. The patient recovered from muscle spasm, sore arm, major chills, headache, and fatigue. This report was non-serious..
Severe diarrhea, fever, tiredness (still after a week) some nausea  during the weekend, I pooped out skin like chunks and water
The first shot- I was entirely fine. My arm was sore, but that was it. My second dose, I was extremely tired. It has been 5 days and I am still exhausted. I cannot stay awake without continuous coffee and soda. My right arm and right leg are extremely sore and I am experiencing muscle pains. My right ear feels filled/keeps popping and feels like i have a slight ear infection but my neighbor who is a nurse checked and it looks clear. But most irritating is my chin, cheeks and neck that are breaking out in a rash. I tried to put hydrocordizone on it but it did not work. will continue to try but i am extremely red, lots of bumps and super itchy.
Pt had ZOSTAVAX SQ inj 12/7/09 6 PM. At 200 AM 12/8/09 pt awoke with a feeling of being hit with "a bolt of lightening". Pt went to ER for evaluation later discharged with no recourse (headache, nausea, gas).
2/3/21 I started to have a very sore left arm for several days as well as a sore left leg.  2/10/21 I started to get a rash at the injection site.
The pt was noted to have 1 hive approx. 0.5" below injection site, less than 5 minutes, after MMR injection was given. Treated with 10mg of Benadryl po at 11:25. Pt observed for 20 minutes and dismissed at 11:45. No further hives noted and the 1 hive that was noted was deminishing in size and redness.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: pt says he is having swelling in armpit and down rib area in the arm shot given, having pain and tenderness, not hot, not red, no fever.
Pt noticed, 3 days ago, that right arm deltoid muscle area began itching. Has 2 areas approx. 2 1/2" below site of Tetanus that is red and slightly warm feeling and "looks better than they did; were almost red". Possible allergic reaction to TD vaccine.
Patient received the moderna shot one day after the beyond use date. Patient reports ongoing fatigue since this time.
Since vaccination which was April 16th , the patient has had dizziness, gait disturbance and speech disturbance.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 12-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
In observation post vaccine within 15 minutes c/o tired and "loopy" and when being evaluated continued to have a drop in BP with and Increase in HR= became unresponsive and 911 called.  NO resp issues or hives
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored PEDVAXHIB lot # reported as: M047666, expiration date: 24-OCT-2019 for prophylaxis (dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter.
Pt recvd vax 10NOV92 & later that day devel flu-like sx consisting of h/a, intermittent nausea, fever, dec appetite, nervousness & trouble sleeping; No further details were provided;
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter.
has a fever 100F; This is a spontaneous report received from a contactable consumer. This consumer reported for a 50-year-old female patient (reporters' friend) that: Received bnt162b2 (BNT162B2;solution for injection;Lot number was not reported), dose 1 via an unspecified route of administration on 21Jul2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced has a fever 100f. The patient underwent lab tests and procedures which included body temperature: 100f Fahrenheit on an unspecified date. Outcome of the event was unknown.  Lot/batch number is not available. Follow-up attempts have been completed and no further information is expected
After Flu shot, I became ill that afternoon 10/23/07 - I stayed in bed for 4 days and rested then went to hospital - On 10/30 visited doctor who put me on steroids. On 11/1 saw another doctor who put me on antihistamine. I was in bed for about 3 weeks. Follow-up: I do not wish to release my medical records, as this flu - shot was my fault. I was ill at the time I took it.
She yawned about 6 times and she doesn't usually yawn; She further stated that she was not hungry and did not want to eat anything; She also felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of YAWNING (She yawned about 6 times and she doesn't usually yawn), DECREASED APPETITE (She further stated that she was not hungry and did not want to eat anything) and FATIGUE (She also felt very tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced YAWNING (She yawned about 6 times and she doesn't usually yawn), DECREASED APPETITE (She further stated that she was not hungry and did not want to eat anything) and FATIGUE (She also felt very tired). On 08-Oct-2021, YAWNING (She yawned about 6 times and she doesn't usually yawn), DECREASED APPETITE (She further stated that she was not hungry and did not want to eat anything) and FATIGUE (She also felt very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported. Treatment medications were not provided.
Pt received the flu vaccine 2 days ago, unclear which type.  Felt unwell since then.  Presented to the ER in cardiac arrest - died shortly thereafter.
Mom called and state that daughter broke out in hives after receiving the injection. She was given Benadryl.
Profound weakness begining approx. 12 hrs post vaccination. Patient unable to get up off toilet. Improved approx. 6 hours later after sleeping. Since that time, weakness continued, gait unsteady and brain fog symptoms present. Some level of anosmia and taste aberration. Patient began PT twice weekly in late April and continues now with weekly only. Memory and brain fog symptoms intermittent Taste aberrations ongoing  Lab tests on 06/02/2021 WNL, Covid test Negative
approx 29mos p/vax pt exp herpes zoster on left lower trunk. no blistering. treated w/zovirax
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose04/08/21 2nd dose04/29/21 Diagnosed covid positive:09/02/21 Symptom onset:09/01/20 Exposure: Symptoms:SOB, Cough, FatigueMuscle aches loss of smell abd pain,sore throat,nausea,diarrhea,HA,runny nose
SWELLING, INDURATION, WARMTH, TENDERNESS AT LOCATION OF VACCINE - R UPPER ARM.
Fever and arm was sore, swollen, black and blue, and he felt slightly feverish for an hour; sx resolved.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Patient felt like he was going to pass out, said he has never had a reaction to needles or shots. EMS evaluated the patient and determined he could go home.
Severe cough that lasted 2-3 months. Lung pain secondary to cough. Sore throat from frequent coughing. Treated with over the counter cough suppressant.
Around 10:00pm, I started developing very intense chills and a fever. I went to sleep and awoke 2 hours later with the loudest ringing in my left ear (tinnitus) and a fever of 104. The ringing in my ear was the most disturbing part. I knew it was being caused by a ton of inflammation near my ear, so for 7 hours I sat up and drank water (and tried not to panic about the sound). The ringing went away hours later, but my fever was still high at 7:00am. I got up to go to the bathroom and fainted. My twin sister -- who also got the vaccine with me (same batch) -- had fainted the night before. But her symptoms were not as intense as mine. My fever continued on and off for 48 hours.
Menstral cycle has been every 4th Wednesday my whole life and after the covid vaccine it has fluctuated tremendously.
Headache, Sedation, Myalgia,  Chills, aches, nausea, fatigue, headache,  Narrative:
Rapid heart beat at 138-144 bpm with both doses, with blood pressure spikes, that lasted for hours, resulting in hospitalization, continued medial monitoring, medication, continued medical follow up and testing.
Hot, red injection site measuring 1.5 x 3 inches. Prickly itchy feeling on torso, head and arms. Woke up to a larger area of redness and headache and achy joints.  As the next day progressed the redness increased to 3" x 5" and chest felt tight.
autoimmune meningeal reaction/Prolonged headache; autoimmune meningeal reaction/Prolonged headache; Date of start of drug 14Jan2021/ Date of start of drug 22Dec2020; This is a spontaneous report from a contactable physician. A 37-year-old female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) intramuscular at left arm on 14Jan2021 09:00 AM at single dose for COVID-19 immunization in hospital. Medical history was none. No known allergy. No covid prior vaccination. Patient is not pregnant. Concomitant mediations were not reported. Patient previously received the first dose of BNT162B2 (lot number: EJ1685) intramuscular at left arm on 22Dec2020 11:00 AM at single dose for COVID-19 immunization. Concomitant medication was none (No other vaccine in 4 weeks, no other medications in two weeks). Patient experienced prolonged headache, seen by PCP and neurologist who diagnosed with autoimmune meningeal reaction on 14Jan2021 09:00PM. Prescribed steroids, waiting for response. event resulted in Doctor or other healthcare professional office/clinic visit. Lab test included PCR and Nasal Swab, both on 05Jan2021 with result negative. Outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event autoimmune/meningeal disorder cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
believe his son loss sperm count due to COVID-19 shot.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPERM CONCENTRATION DECREASED (non-serious), outcome "unknown", described as "believe his son loss sperm count due to COVID-19 shot.".
both arms painful at injection sites; flu-like symptoms; This case was reported by a consumer and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix, Influenza vaccine Quadrivalent 2020-2021 season and PNEUMONIA VACCINE. On an unknown date, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.   Additional details provided were as follows: The case was reported by patient herself. The patient stated that she received the Shingrix vaccine in one arm and the flu and pneumonia shot in the other about a year ago (September 2020), she did not remember exact date and on which arm. The patient after hours of vaccinations felt pain at injection sites in the arm. She stated that the next morning 1 day after vaccinations, she waked up with flu-like symptoms that lasted about 3 or 4 days. The patient was encouraged to call other pharma companies to report adverse events and spoke per content. The patient was referred to health care professional. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to Pneumonia vaccine.
After vaccination a rash appeared on my left forearm (itchy, raised red patchthat felt hot to the touch); Sweating; Dizzy; Itchy all over; Sore arm; This is a spontaneous report from a contactable consumer, patient. A 50-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8767) via unspecified route of administration in the right arm on 21 Mar2021 at 10:15 AM (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication includes Ibuprofen (UNKNOWN MANUFACTURER) on unknown date for unknown indications. The patient was allergic to sulfadrugs. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in the left arm on 28Feb2021 at 11:15 AM (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 12:45 (approximately 2-3 hours after vaccination), the patient experienced a rash appeared on her left forearm (itchy, raised red patch that felt hot to the touch). Shortly thereafter another appeared on her left forearm. Later, the patient woke up in the middle of the night sweating a lot, dizzy when she changed her positions and itchy all over. The patient was able to go back to sleep and she was fine when she woke up. Just a sore arm. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of event rash and included treatment with antihistamine. The clinical outcome for the events rash, sweaty, dizzy, sore arm and itchy were resolved on an unknown date.   No follow-up attempts are possible. No further information is expected.
On 10/4/00, phone call from pt stating that about 2 hours, post vax, she felt like she had a fever and 4 to 5 hours later, she started having nausea and vomiting. She went to ER on 9/30/00, stayed 10 hours and was treated for dehydration and told to see a cardiologist because her heart was skipping beats. Left arm and left leg still feels numb and feels like she has a fever but has never checked it; still having nausea and vomiting. Advised to see her MD or go back to ER.
Report received by the mother of the patient on 03-Nov-2009.  The patient, a 5-year old male received seasonal flu shot 5 months ago (??-Jun-2009) and developed cough and wheezing that same day.  The symptoms lasted for about 1 week.  The patient received H1N1 vaccine and experienced similar symptoms the same day which lasted about one week.  The patient had also been on concomitant Vivaglobin for 5 months.  The mother stated the MD is not aware of these reactions.  Upon follow-up conversation with the mother (10-Dec-2009): Her son was vaccinated at the pediatrician's office and she provided the contact information.  She confirmed her son received vaccination for both the seasonal flu and two doses of H1N1 at this office.  The mother stated the purpose of her original call was not to report AEs to the vaccinations, but to request information about contraindications for vaccination since her son is on Vivaglobin.  We do not know if these were CSL products, and are awaiting information from the pediatrician's office.  Reference case 2009021793 (seasonal flu).  The company assessed the event causality as unassessable in relation to the suspect drug, H1N1 vaccine, as time to onset and date of administration were not known.  Information derived from this AE report does not change the safety profile of the product.
I inadvertenly administered Menquadfi to a patient because he answered to another patient's name that I called. No adverse effects noted at the time. Parent notified. On site manager notified. Current supervisor notified.
Patient received vaccine on Wednesday 28 Oct 15 at 10:12 A.M. and stated that his left arm started swelling at the injection site that after noon. Came to clinic this morning 30 Oct 15 att 8:40 A.M. with swelling and redness of left arm from injection site to elbow, warm to touch.
Pt treated with AUGMENTIN for dog bite and received both seasonal and H1N1 influenza immunizations on 10/22; developed hive-like skin rash on 10/28.
Mom called. Says child last eve -no appetite. This Am would not eat breakfast (very unusual), sleeping "a lot" , threw fit (behavioral, not seizure) in floor. Exhausted. Mom states same kind of behavior if gets gluten. Went to school but still tired.
Narrative: 96 yo patient who was treated for urinary retention, AKI, and acute COVID 19 infection. The patient remained asymptomatic with COVID 19 and was placed on contact and droplet precautions. He was seen by Urology and started on Finasteride and Tamsulosin. It was noted in the chart that the patient's PSA gradually increased through the course of the last five years. Repeat PSA was 101. UA was negative for bacterial growth. The patient remained afebrile. Renal u/s and CT abd/pelvis revealed 8.2 cm enlarged prostate. The patient underwent nuclear bone scan which was negative for neoplasm. Urology plans to complete Eligard injection within two weeks post discharge for enlarged prostate. The patient will keep foley catheter in place and allow bladder rest for 2-4 weeks. The patient will resume ASA at 81 mg po daily given history of CAD and not 325 mg po daily.The patient's hematuria cleared without recurrence and hgb remained stable. The patient was medically stable for discharge on 12/30/21 and left hospital without incidence.
12:31 pm   Female received Imovax (rabies #1), Ixiaro #1 and booster hep B @ 11:00 am today. Pt was at her desk and started experiencing breathing difficulty. Upon arrival to the clinic--- slight erythema noted on upper lip, anterior chest and palms. No hives. + coughing spasms. Talking in full, complete sen. Lungs cta, no wheezes. VS: Pox 97% - 98% ra, rr 18 even, unlabored, hr 89, bp 130/89. All: --cillins family  Meds: bcp  PHx: none sig. 12:32 pm   Benadryl 50 mg IM to lt deltoid. EMS activated. 12:50 pm   VSS; palms' erythema subsided along w/her coughing spasms. EMS arrived. Pt signed out AMA w/EMS crew @ 12:50PM. 13:25   Pt signed out AMA w/EMS crew outside on drive way. Returned back to clinic c/o severe abd. cramps 10+/10 (0-10). Denied nausea. Temp 97.3 /tym. Appear. in severe distress d/t abd pain. +  abd. guarding, doubled over in pain. No c/o breathing difficulty, hives or skin erythema noted at this time. Adamantly refused to go to ER. Pt verb no recent change in bowel pattern. Last BM this AM--nl.