chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE CHILLS; FEVER; HEADACHE; BODY ACHE; LOWER GI CRAMPING; VERTIGO; NAUSEA; 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, intramuscular, batch number: 043A21A, expiry: not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lower gi cramping. On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced nausea. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced severe chills. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.4 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, severe chills, fever, and headache on APR-2021, and was recovering from nausea, lower gi cramping, and vertigo. This report was non-serious.
p/vax pt devel large area of redness w/some edema 7"x 9" around rt arm;
father called 22AUG93 0800 stating pt was adm to hosp w/severe react to DTP-having szs; stated was told by MD sz were due to DTP-denies any fever etc;
Pain in arm (deltoid) within hours of vaccine => neuralgia. Responded partially to 800 3xd acyclovir, no rash =>"Post herpetic neuralgia" character.
21APR95 @ 7AM started w/nausea & severe diarrhea as well as h/a; 24PR went to MD prescribed something for diarrhea which helped but sl diarrhea cont & pain in abd; resolved 5-6 days after;
Immediately, her eyes started to itch and water.   She took a puff on her inhaler.  She was observed by onsite paramedics.  She was allowed to leave after 30 minutes with no progression of symptoms.  Later that evening, she began wheezing and was fatigued.  She continued to have symptoms over the weekend.  She saw her allergist on Monday Feb 1, who restarted her Singulair and advised to not get the 2nd dose.  Her symptoms are improving today, but remain.
Large number of hives, including a grouping of hives that was approximately 6 inches in length and 2-3 inches wide on her left inner thigh (opposite leg of injection site), hives on her stomach, and other smaller groupings on her legs. Later remembered that a small amount of hives had been noticed on her left ankle on 11/11/2014 at approximately 7:00 PM, though I didn't initially realize they were hives. Contacted doctor upon finding the large amount of hives on 11/12/2014 who advised to administer Benadryl if there was no fever and no difficulty breathing.
Pt was fine immediately after injection and stated that the vaccine didn't hurt as badly as she expected it to. However, the next day she states that she had a fever, chills, body aches, nausea (almost had to vomit) and diarrhea. She stated that she spoke with her doctor about the vaccine and the events that happened afterwards and she was informed that half of the people who received the SHINGRIX vaccine have reported similar outcomes postvaccination. I was informed and immediately wanted to report the event. No other patients have come forward with issues postvaccination.
Moderate to severe joint pain. Started in left hip. Added right knee. Knee pain resolved after four days. Hip pain continues to be moderate to severe. Today, for example, I am not able to bear weight on my left leg. I am not able to walk and stairs are not possible with the left leg. I go one step at a time with my right leg. I have never had any trouble with my hip and have had no injury.
Client reported they were 16 and received Pfizer dose even though they are 15 years old.
Pt felt chills, had a low grade fever, headache within 6 hours of vaccine. Lasted 1 1/2 days has regular flu vaccine in past w/out complications.
like there is something in the injection site; recurring uncomfortable feeling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (like there is something in the injection site) and FEELING ABNORMAL (recurring uncomfortable feeling) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 050C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE DISCOMFORT (like there is something in the injection site) and FEELING ABNORMAL (recurring uncomfortable feeling). At the time of the report, VACCINATION SITE DISCOMFORT (like there is something in the injection site) and FEELING ABNORMAL (recurring uncomfortable feeling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication provided by the reporter was  cholesterol medication.  No Treatment medications was provided by the reporter.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium
Reported Temp. of 101, headache and chills and neck pain 4 days after administration.
May not be related to vaccine, but 9 days after I developed itching on balls of feet. Next day developed rash on left hand (palm side), with severe itching (nothing on  right hand). Also found there to be an unusual amount of itching  all over body. over the course of the rash. Lasted about 5-6 days.  No rash appeared on arm at all (i.e., "Covid Arm")
sick to her stomach; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dsoe received on February or March, refer case US2020AMR161127).   On 12th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 13th August 2020, the patient experienced gastric disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the gastric disorder was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and gastric disorder to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm. The patient experienced a sore arm a few hours after vaccination. One day after vaccination (on the day of reporting), the patient was better but, woke up sick to stomach.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR161127:same patient
Got the injection 1/4/2021 in R deltoid at 1:50pm. Was fine that day, just had a temp of 99.8-99.9 degrees F that evening, but no symptoms. 1/5/2021 just had a sore right arm when raising it above 100 degrees flexion, and tenderness when touched. Everything else was fine. No other symptoms. Suddenly on 1/9/2021 I felt a burning sensation in my right armpit (anterior) and it lasted all day and I feared maybe the shingles was coming back (I had it back in August 2020), and Sunday 1/10/2021 still had the burning sensation in the armpit but it seemed to be getting less intense. Then on Monday 1/11/2021, the burning was gone, but when I went to take a shower, there was a significant lump in my right armpit where the burning was before. It was a bit tender to the touch but a pretty signifigant lump.  Upon inspecting the injection site on my right arm, I noticed that the bruise from the injection was still there, but now there was also a big red oval circle (almost the width of my arm), about an inch under the injection site that was not there before. I have called my doctor and have made an appointment to see him tomorrow morning at 11am.
R arm at site of injection is swollen, red and inflamed. Patient states it is very tender. Patient advised to apply heat and rub arm. Also told to call if not gone down in 7 days.
The  blood vessels on the back of my hands looked as if they were going to burst.  I also had redness on my chest and feet
Pt recv vax & devel approx 25 lesions & low grade fever (99.8).
patient given shot and then face started to get flushed and patient stating she was having more difficult time breathing.  I called doctor in the room to assess the patient and then went and got an epipen out of the cabinet. We administered the epipen and within minutes the patient was feeling better and breathing easier. Still c/o of some difficulty breathing.  O2 sat 99%. Emergency services called and transported the patient to the Emergency Room.
received the Pfizer Covid vaccine in April and the next day tested positive for Covid-19; It has been over 42 days since the first dose of the Pfizer Covid Vaccine; This is a spontaneous report received from a contactable pharmacist reported for male consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number was not reported) via unspecified route of administration at an unspecified location on an unknown date in Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Pharmacist on behalf of a patient who received the Pfizer Covid vaccine in April and the next day tested positive for Covid-19. It has been over 42 days since the first dose of the Pfizer Covid Vaccine, does he have to start the series over? When can she get the second dose of the vaccine after testing positive for Covid-19? Outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: As per the information in the case provided, the causal association between the event of COVID-19, Vaccination failure and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Case number PHEH2014US023971, is an initial spontaneous report received from a pharmacist on 01DEC2014, with a follow-up report received from the pharmacist on 17DEC2014, with a follow up report received from the pharmacist on 19JAN2015, with the follow-up information received from Quality Assurance Department (reference number: 343532) on 27FEB2015. This report refers to a 29  year old male patient. Historical condition and concomitant medication were not reported. His previous vaccinations (unspecified) were well tolerated. He was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14584P, expiration date: 30APR2015) intramuscularly in left arm on 30NOV2014 at 08:45 PM. It was reported that during administration the plunger of the FLUVIRIN pre-filled syringe (PFS) got stuck and could not be fully depressed. As a result the patient received a partial dose. No adverse event was reported following these administration errors (vaccine under dose and syringe issue). The complaint was raised for a stuck plunger for FLUVIRIN batch 14584P. No same was available for analysis. No root cause was identified during either the Catalent or BD investigation. The most probable root cause is that the needle, not provided by was plugged, although with no sample available for analysis it is difficult to determine the exact nature of the defect. THe root cause has therefore been determined as supplier/material defective due to a blocked needle. Follow up report received from the pharmacist on 17DEC2014: Updated vaccine expiration date. Follow up report received from a pharmacist on 19JAN2015: Updated vaccination details (vaccination history, site and time of vaccination). Follow-up information received from the Quality Assurance Department (reference number: 343532) on 27 FEB 2015: Updated FLUVIRIN 2014/2015 vaccine batch review report.
Case number PHEH2015US024667, is an initial spontaneous report received from a pharmacist on 20 Nov 2015 (combined report). This report refers to an 8 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801, expiry date: May 2016) intramuscularly at a dose of 0.5 ml on 19 Nov 2015. It was reported that before administration the vaccine was exposed to up to 28 degree Fahrenheit for up to 8 hours. The case was reported as non-serious. No adverse events were reported following the inadvertent administration. Combined follow up information received from a pharmacist on 20 Nov 2015: Expiry date of vaccine updated.
I had all side effects listed under common and not unusual. The worst lasted 36 hours with the fatigue, redness, swelling, itching and pain at injection site lasting 8 days. The continuuing side effect is very sore, achy gums and very impressive tooth sensitivity to the point I went to the dentist thinking I needed root canals. On x-ray, no tooth issues were noted.  As I have not seen these side effects noted elsewhere, I want to alert others to this possibility.
Acute bradycardia and subsequent cardiac arrest on 8/13 leading to ICU transfer on epinephrine, milrinone, amiodarone, and fentanyl drips. Patient ultimately passed away on 8/15 after another cardiac arrest.
Soreness and stiffness of the left arm following injection. Patient complains of inability to lift arm over head even after 2 weeks of injection.
Information has been received from a licensed practical nurse concerning a 72 year old male with no known allergies and hypertension, hypercholesterolemia, spinal stenosis, diverticulosis and proteinuria who on 01-MAR-2007 was vaccinated in the right arm with a single dose of Zostavax (lot# 656413/1477F). Concomitant therapy included simvastatin (MSD), hydrochlorothiazide, meloxicam (MOBIC), atenolol, lisinopril (manufacturer unknown), vitamins (unspecified) and aspirin. On 14-MAR-2007 the patient was diagnosed with shingles (with an onset date reported as 13-MAR-2007). Unspecified medical attention was sought. It was reported that the patient did not have pain but that he ached. The patient had vesicular lesions in clusters at the right lower back and buttock area. The patient was treated with valacyclovir hydrochloride (VALTREX) and prednisolone as a tapering dose. The Varicella Zoster Virus Identification Program was offered to the nurse and she declined. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 4/13/2007; 6/22/2007. Information has been received from a licensed practical nurse concerning a 72 year old male with no known allergies and hypertension, hypercholesterolemia, spinal stenosis, diverticulosis, impaired fasting glucose and proteinuria who on 01-MAR-2007 was vaccinated SC in the right arm with a single first dose of ZOSTAVAX (Oka/Merck) (lot # 656413/1477F). Concomitant therapy included simvastatin (MSD), hydrochlorothiazide, MOBIC, atenolol, lisinopril (manufacturer unknown), vitamins (unspecified) and aspirin. There was no illness at the time of vaccination. On 14-MAR-2007 the patient was diagnosed with shingles at the right lumbar dermatome and right buttock (with an onset date reported as 13-MAR-2007). Unspecified medical attention was sought. It was reported that the patient did not have pain but that he ached. The patient had vesicular lesions in clusters at the right lower back and buttock area. The patient was treated with VALTREX and prednisone as a tapering dose. The Varicella Zoster Virus Identification Program was offered to the nurse and she declined. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information received from the licensed practical nurse indicated that the patient also has arteriosclerotic cardiovascular disease and a history of prostate cancer. The patient had no adverse events following prior vaccination. The patient's outcome was not reported. Additional information from the physician indicated that the patient recovered on an unspecified date. Additional information is not expected.
Tinnitus (ringing in the ears) occurred almost immediately after receiving the vaccine.  The volume of the tinnitus varies but it disrupts my sleep. It has not cleared up in the 10 months since the April 17, 2021 Moderna injection.
On September 1st or 2nd, patient reports her left leg became swollen to the point she couldn't put on her pants, and turned purple. She sought care in her local urgent care, then ER. She was initially diagnosed with gout. She followed up two weeks later with her primary care doctor on 9/15/21, underwent left lower extremity ultrasound on 9/16/21 which showed extensive DVT. She was placed on Xarelto and is currently being followed for thrombus resolution
In 1999 (specific date not provided), the vaccinee received her 2nd injection of Engerix-B (lot ENG3090A6). On 11/17/99, post vax, she experienced generalized hives. She was seen by a physician and the event resolved with unspecified sequelae on approx. 11/23/99. The Engerix-B immunization series was discontinued. The reporter indicated the event was probably related to the thimerosal in vaccine.
Mild swelling and erythema 10 min after injection at vaccination sites. No treatment.
On June 1, 1999 the pt developed shingles in her right leg and buttocks. The pt was presented to a physician with symptoms. It was that the pt experienced leg pain two weeks prior to the episode. Reporter believed there was no association with pts sx and vax.
Fatigue - all day  Nausea - early afternoon and early evening Tenderness all over body - evening Achey joints - all day Limbs felt heavy - all day Dizziness - sporadically  Brain Fog - all day Waves of being too hot or too cold - all day Pain at and surrounding injection site - all day
Intense itching and burning and breakout on neck, right side of face, and nose after 12:30 am Thursday am. By Thursday afternoon, eruptions began on chest from shoulder to shoulder. Pain still persists where the rash presented. Diagnosis-Shingles
No additional AE details; Just found out they had another TE / Varivax has been administered; This spontaneous report was received from an unspecified reporter (customer, reported as "Other") referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  The reporter informed about a temperature excursion (TE) "1 week ago" for vaccines of varicella virus vaccine live (Oka/Merck) (VARIVAX), as follows: temperature -14 Celsius degrees up to -10 Celsius degrees for 2 hours 5 minutes 0 seconds; -10 Celsius degrees up to 8 Celsius degrees (-0.4C) for 1 hour 25 minutes 0 seconds; previous temperature excursion: -14 Celsius degrees up to -10 Celsius degrees (-12C) for 0 hours 50 minutes 0 seconds.   On an unknown date between 11-MAY-2022 and 24-MAY-2022, the patient was administered a dose of these varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines (lot # U039949 has been verified to be a valid lot number, expiration date: 16-DEC-2023; dose and route of administration not reported) administered for prophylaxis (Product storage error); additional product reported included sterile diluent (MERCK STERILE DILUENT) (reported as "DILUENT MRK"). There were no additional adverse event (AE) details provided (No adverse event). There was no product quality complaint (PQC).
Information has been received from a physician concerning a 5 year old male patient who on approximately 3/30/03 was vaccinated with a second dose of MMR (second generation) (lot # 640841/1482L). Upon the receipt of the vaccination it was reported that the patient began to vomit before leaving the MD office. The patient went home and had some mild recurrence. The MD called the patient back to the office and he was observed to have had some dyspnea and flushing without itch. The patient was treated with epinephrine and sent to the emergency room. It was reported that the patient was treated with IV steroids and observed in the ER for 6 hours. It was noted that the patient recovered from his experiences. Upon internal review, dyspnea was considered to be an important medical event (OMIC). Additional information has been requested.  Received on 06/03/2003: "The reporter expressed concern regarding the lot number.  The records of testing prior to relsease of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  This report no longer meets criteria for submission because it was determined that the child was diagnosed with an anaphylactic reaction, which is a labeled event.
One week plus one day post vaccination patient developed universal urticaria, which persisted over several days. Included swelling of throat and difficulty swallowing.  Administration of OTC antihistamines has little effect on symptoms. Patient was prescribed a methylprednisolone course of tablets to be taken over 6 days.
sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 28 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat".  Additional information: It was reported that the patient took the first vaccine three weeks ago and today she has an appointment for the second dose. For the last couple of days, patient has woken up with a sore throat but it re-solved quickly after waking up and thought this had to do with the climate changed. However, today (day of report) has been different as her sore throat has not gone away since she has woken up. The reporter would like to know if she should get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, dizziness starting several hours after vaccine administration and persisting for the past week.
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA lot# N022924 with expiration date of 31-AUG-2018, lot# M039202 and lot# N005274 (expiration dates were not reported) (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003935: US-009507513-1708USA004395: US-009507513-1708USA004392: US-009507513-1708USA004393: US-009507513-1708USA004408: US-009507513-1708USA004409.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 16-OCT-2012, the patient was administered an incorrectly stored dose of ZOSTAVAX, lot# 0468AE, expiration date: 04-APR-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.