chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in right arm, then, in a few days, sharp pain on my right side any time I took a deep breath: front, side, and back of chest area on right side!
Fever. Not herself x 2 days.. increased fussiness. Mother notes usually well mannered, now crying more. Pulling at ears last night, fever spike 101.5, 11:30pm last night. LEG PAIN, TREAT WITH IBUPROFEN. SEIZURES-SENT TO HOSPITAL.
TC received by grandmother; states pt has a red swollen mark - on upper arm and a quarter sized bruise. Instructions given to monitor area/pt. Warm soak and seek medical attention if necessary.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-DEC-2014, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
No adverse effect reported; improperly stored vaccine in use; This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. The patient's pertinent medical history and drug reactions or allergies were not reported. The concomitant medication included sterile diluent which was reported to be stored properly. On 18-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dosage information, route of administration and anatomical location were unknown) (lot # R019237 with an expiry date of 04-JUL-2020 or lot # S005078 with an expiry date of 19-FEB-2021 as the nurse was not able to determine which lot was given to the patient) for prophylaxis (product storage error). No adverse effect reported. It was reported that the vaccine was exposed to a temperature of -14 degree Celsius (C) to -10 degree Celsius (-9.74 C) for an unknown time frame. There was no previous temperature excursion reported. Data logger was involved. The outcome of product storage error was unknown. No product quality complaint (PQC) was associated with this report.
Fever, fever blisters, malaise, achiness onset the morning after receiving the Zostavax injection.
Urticaria, started ~10 days post vaccination treatment started with Benadryl on and off for a week, then adjusted by allergist  to 10mg Zyrtec and 180mg Allegra daily for 3 weeks, Hives mostly subsided by February but a lingering neck rash/hive is still there four months post vaccination.
Initial report received from a health care professional on 31 October 2013. A 73-year-old female patient who had no illness at time of vaccination, no pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported, had received FLUZONE HD in left deltoid (lot number U4764AA) on 10 October 2013. On 10  October 2013, the patient had soreness around the injection site for 21 days. Looks ok externally, no redness, no bruising. If she lies on the side it hurts. Laboratory investigations were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: none
heavy chill for about two hours, with 101.4 fever. sore knee joints for two days
have been sick and not able to get second dose yet; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 74-year-old female 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 sickness. Shingrix was discontinued. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had been sick after 1st dose of Shingrix and not able to get the second shot. The patient asked do I have any immunity.
Beginning on 1/24, I had left thigh paresthesias. The next day on 1/25 I had entire left side of my body paresthesias of left leg, arm, trunk and face/head. I also had associated left lower lip asymmetry/droop - it resolved with smiling but was noted at rest. I went to the ED on 1/25/21 evening to be evaluated due to facial asymmetry and paresthesias and had a brain MRI and C spine MRI which did not show any abnormalities (no signs of multiple sclerosis, brain tumor, stroke, etc) on 1/26/21. Vitamin B12 levels were sent and Lyme titers were sent. Lyme was negative and vitamin B12 was ultimately seen to be in low normal range at 223 on 1/26/21. I continued to have paresthesias on both right and left sides of my body but no other development of weakness anywhere with exception of slight facial asymmetry. I had iron studies and tissue transglutaminase as well to screen for malabsorption, which was normal, except for mildly low ferritin 12 on 2/1. I started IM vitamin B12 injections for 4 weeks. I also had TSH, free T4,  hepatitis C antibody on 2/1 to evaluate for other causes of paresthesias, which was negative, and lead testing on 3/17 which was normal. Due to symptoms persisting, I also had an EMG/NCS on 3/15 since symptoms were still present given concern for mild guillan-barre syndrome. This did not show results consistent with large fiber sensorimotor polyneuropathy such as guillan-barre syndrome. During this same time period, I began to have night sweats soaking through my pajamas and even the sheets of my bed on 2/10, 2/11, 2/24, 2/26, 3/9, 3/11 and 3/12. For these night sweats, I underwent a work-up as well with echocardiogram on 2/16 which was negative for endocarditis (showed incidental atrial septal aneurysm) and with LDH, uric acid, CRP, ESR, CBC and HIV testing that was all normal on 3/1. I had a chest x-ray on 3/12 and CPK, HFP, and FSH on 3/17 to evaluate for other causes of night sweats, which was all negative/normal. I had a CT abd/pelvis on 3/25 which was also reassuring against oncologic process. I had a bubble echo on 5/20 to ensure no PFO with atrial septal aneurysm, which was negative for PFO. Night sweats have improved, but I continue to have paresthesias that come and go.
Redness, swelling, tingling, hot, cellulitis 1-3 days after injection Tx: Antibiotics, cool compresses, BENADRYL.
Information has been received from a physician concerning an 11 week old who was vaccinated with a dose of ROTATEQ. About three weeks later the patient experienced a fever. Additional information has been requested.
patient was given Janseen vaccine left arm. After giving vaccine, the  pharmacist realized it had expired 5-25-2021. vaccine was given at 10 am  5-26-2021
Flu like symptoms; Sweaty; Tacky and does not feel good overall; Chills; Fatigue; Hip pain; Pain in ear; Pain in allover her left side; Arm pain; Throat pain; Did not feel quite herself; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel quite herself), EAR PAIN (Pain in ear), PAIN (Pain in allover her left side), PAIN IN EXTREMITY (Arm pain) and OROPHARYNGEAL PAIN (Throat pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Crohn's disease, Irritable bowel syndrome, Psoriasis, High cholesterol, Hypothyroidism, Fibromyalgia and Arthritis.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced FEELING ABNORMAL (Did not feel quite herself). On 14-Apr-2021, the patient experienced EAR PAIN (Pain in ear), PAIN (Pain in allover her left side), PAIN IN EXTREMITY (Arm pain), OROPHARYNGEAL PAIN (Throat pain) and ARTHRALGIA (Hip pain). On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweaty), FEELING ABNORMAL (Tacky and does not feel good overall), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (Did not feel quite herself), EAR PAIN (Pain in ear), PAIN (Pain in allover her left side), PAIN IN EXTREMITY (Arm pain), OROPHARYNGEAL PAIN (Throat pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (Sweaty), FEELING ABNORMAL (Tacky and does not feel good overall), ARTHRALGIA (Hip pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided          Concomitant medication list include infliximab infusion which was reported to be stopped 2 weeks before vaccination. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079426 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079426:Cross lin with Dose 1
Fatigue ,irritability,confusion, muscle spasms, tachycardia, dizziness, upon drifting off to sleep body will jolt gasp for air and heart racing, next day right leg was throbbing with moderate joint pain in ankle and knee, brain fog
Immediately after getting the first dose vaccine, I sat down and then I slumped over in seconds. I fell asleep and I could not wake up. I could not even speak and could not respond when they asked my name. It felt like an out of body experience and a feeling of impending doom. My blood pressure was elevated and when I came around later. I spoke to my Allergist later and he advised that if I get the second one I should be observed. The extreme exhaustion persisted for a week.
This case was reported by a nurse and described the occurrence of fever in a 2 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 9/10/03, the patient received an injection of Infanrix. Later that day, at an unspecified time post immunization, the patient's parents telephoned the physician to report that the patient was experiencing fever, malaise and an injection site reaction characterized by redness, swelling, and induration. The events resolved on an unspecified date prior to 9/17/03.
Patient c/o of upset stomach, being disoriented, states "balance was off" no fever. Mother notified student returned to class.
Swelling at the injection site; Pain of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain of the arm) and VACCINATION SITE SWELLING (Swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (no reported medical history).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain of the arm). On 20-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain of the arm) and VACCINATION SITE SWELLING (Swelling at the injection site) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Patient woke up dizzy in the middle of the night.  He has never been dizzy before.  He said his head hurt and asked for a tylenol.  He took one and walked back to his room.  Before he made it to his room, he blacked out and fell to the ground.  Thankfully he did not hit his head.  He fell on carpet but we did not know he passed out.   He was out for about 1 1/2 hours before he woke up, found himself on the floor, and came back to the room to let us know.
weakness; diarrhea; swelling; chills; high fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills) and PYREXIA (high fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills), PYREXIA (high fever) and VOMITING (vomiting). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills), PYREXIA (high fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug included Blood pressure medication. Patient reported that she began to feel better on 24-Mar-2021.  Treatment medication was not reported.
Patient had 20-30 sec. fainting spell after receiving Hepatitis A and typhoid, episode post Hepatitis A.
Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 64-year-old patient (gender not reported), who was vaccinated with a dose of DAPTACEL (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because a 64-year-old patient received pediatric Daptacel. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Had the semi quantitative AB test. Showed positive response.; Had the semi quantitative AB test. Showed positive response.; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program.  A 69-year-old (will be 70 on 05Apr2021) patient of unspecified gender received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot# unknown) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, patient had CLL and semi quantitative AB test that showed positive response. Patient would like to be in front of line for third shot. Patient was involved in CLL vaccine study with then CLL, getting the third shots that would provide useful information. The patient underwent lab test which included semi quantitative AB test with Positive result on an unspecified date. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sore arm; injection site is very warm; Its like someone injected her with warm water; Headaches; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (injection site is very warm), FEELING HOT (Its like someone injected her with warm water), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swollen injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (injection site is very warm), FEELING HOT (Its like someone injected her with warm water), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swollen injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (injection site is very warm), FEELING HOT (Its like someone injected her with warm water), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swollen injection site) outcome was unknown.            The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.   No concomitant medication was reported.
The pt experienced hives following vaccination. Treated with Benadryl. The pt recovered. Additional information has been requested.
Extreme full body weakness- Full body soreness Sore throat Headache Blurry vision Fever- lasted for 4 days- treated with lots of fluids Advil Tylenol. Slept as much as possible. 5th and 6th day sore throat bad headache. Missed 4 days of work
Fever 100.3 midway through day--took ibuprofen, fever broke about 4 hours after taking ibuprofen.  Has not returned. Muscle aches--had pulled a muscle in my upper back/neck the night before.  The pain was manageable early in the day, but became more intense as the evening went on.  Today (the next day) it is manageable again. Fatigue for most of the day after the injection.
Within about 30 mins of getting the vaccine I felt a little dizzy/disoriented.  This feeling passed within an hour.  That night, 3/27 around 9 PM I began to feel cold as if I was running a fever and started having body aches.  I did not take my temperature to see if I actually did have a fever.  The symptoms lasted most of the night.   The next day, 3/28 I had the flu-like symptoms again at night.
12/24/2020 generalized face tingling apprx. 10 minutes post vaccination.  Administered diphenhydramine 25mg PO.  Symptoms resolved within 5 minutes.  VS stable.  Observed for one hour and D/C'd in stable condition.   12/30/2020 F/U phone call.  States "mild" H/A evening of 12/24/20 but no other sxs.  Problems resolved.
A couple hours after the immunization, patient reported that everything seemed very small (almost Alice in Wonderland Syndrome-like).  Episode lasted for approx. 10 minutes  Seen in clinic a few hours after that and had normal neurological exam and normal mentation for age.  .  Happened a few more times also with brief duration and complete resolution-total 5 episodes on day of flu vaccine.   Reportedly had another episode a couple days later, then on e episode a week later than the last episode approx. 1 month later.  Described seeing a castle or Jack in the bean stalk during one of the later episodes and also reportedly had one episode (recorded on video) where she was coloring outside the lines then when over, she could color inside the lines.
Slight itch, red rash around injection site, skin warm for 3 days (so far)
The site got very hot, painful and swollen. Proceeded to swell at the face, neck with painful burning sensation and painful bone structure all over the face with difficulty breathing.
received the Covid-19 vaccine. She reports symptoms of headache 10 minutes post vaccine administration. No other symptoms reported. VS as follows at 1235: BP 133/95, 96%113, O2: 97% 1240: BP 118/85, HR 89, O2 96% 1245: BP 124/88, HR 90, O2: 96% 1250: BP 115/75, HR 88, O2: 99% Pt has a hx of seizure and migraines. Pt observed for approximately 25 minutes and discharged home accompanied of her mother in stable condition. Pt reported improvement in symptoms
Flu like symptoms: body ache chills hot throat pain rash from wrist up to injection site
joint pain so bad I could't move - 24 hours after injection - facial swelling and inside of mouth swelling - m2 days after injection  - extreme headache almost immediately after injection
her arm is still painful and unbearable; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information Team.  A female patient of an unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration in Right arm on 13Oct2021, as a Dose 3 (booster), Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received Dose 1 And Dose 2 of COVID-19 Vaccine (unknown manufacturer) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date in Oct2021, the patient arm was still painful and unbearable, and the patient queried if she could put ice or heat on the arm and was preparing to take ibuprofen. The patient also queried if she could be recommended for her painful arm with any treatment. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Intense headache, starting at the back of my neck,  chills, nausea,  diarrhea, pain & swelling at injection site, and my whole body ached.  Bedridden from Friday night until today, Sunday.  Feeling better now, but weak