chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report 2001013861-2 describes a seizure in a pt who rec'd hepatitis B vaccine (brand unspecified). The pt provider submitted this report directly to VAERS. Allergies were unknown. The pt presented to the vaccine provider with no medical records, no possibility of obtaining medical records, and no known immunization history. Therefore, the vaccine provider began a complete immunization series. On follow-up, the reporter stated that the pt had rec'd an initial dose of tetanus and diphtheria Toxoids and acellular pertussis vaccine (different manufacturer) on 10/12/00. Reportedly, the family stated that the pt had a gastrointestinal illness (NOS) the day prior to vaccination, although he had no symptoms the day of the immunization.  On 5/1/01, the pt rec'd the second 0.5 ml intra-muscular dose of hepatitis B vaccine (brand unspecified) the second 0.5 ml intra-muscular dose of tetanus, diphtheria, and acellular pertussis vaccine (Infanrix), the second 0.5 ml intra-muscular dose of inactivated poliovirus vaccine (IPOL, Aventis Pasteur), the second 0.5 ml intra-muscular dose of Haemophilus influenzae type B vaccine (brand unspecified), a 0.1 ml intra-dermal dose of purified protein derivative and the second dose of T-valent pneumococcal conjugate vaccine (Prevnar. Lederle labs), a few hrs later the pt experienced a seizure and was taken to the local ER. All tests (NOS) performed at the ER were negative. Seizure is considered GSK medically serious. The reporter indicated that the seizure was possibly related to Infanrix. The reporter also indicated that the seizure could be associated with possible mild dehydration. As of 8/7/01, the seizure had resolved.
Flushing, generalized itching, swelling of tongue. BENADRYL administered and brought to ED. ED observed and administered additional BENADRYL.
Janssen COVID-19 Vaccine EUA  Approximately 9 hours after vaccination, I had a temperature of 100.5F, a slight headache, and mild nausea.  Temperature reduced to normal within 10 hours of spiking.  Headache increased at this time and muscle pain and pain at lymph node sites began.  This report is being filed 24 hours after vaccination.
The pt states that he had "body aches" about 1 month ago and was getting better, then he got the flu shot and it all came back with body aches and fatigue. He has not seen an MD.
Patient presented to clinic for COVID 19 booster and was given a full-dose Moderna vaccine.  RN notified  patient of dosing error and advised him to call with questions/concerns.
Breakthrough case. 3 months after dose 4, was around someone who tested positive for COVID. Took home test and it came back positive. Went to urgent care, and was given PAXLOVID, started taking it 7/2/2022. On 3rd day of prescription I became so sick that I couldn't keep the pills down and was throwing up. On the 4th day I pushed through and finished the round of PAXLOVID. Took a home COVID test a week later and it was negative.
Developed pericarditis June 4, 2022 .  Was hospitalized after fluid was found around my heart .
In May 1999, the patient received her first injection with Lymerix with no untoward effects. In September 1999, she received the second dose.  The patient reported she became pregnant in February 2000. Her last menstrual period was January 30, 2000, and the estimated date of delivery is November 07, 2000.
This case was reported by a consumer and described the occurrence of severe arm pain in a 42-year-old female subject who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified) for prophylaxis.  A physician or other health care professional has not verified this report.  The subject's medical history, concurrent conditions and concurrent medications were not provided.  On am unspecified date, approximately two years from the time of reporting, the subject received an unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced severe pain and numbness in her left arm.  She thought she was having a heart attack.  She presented to the emergency room where it was determined that she did not have a heart attack.  At the time of reporting, the outcome of the events was unspecified.
Pain in right arm at injection site, sometimes radiating down to elbow and or hand. There is no swelling or redness. I hd the same pain for a few days after receiving the vaccine, but was not expecting it to reoccur almost 3 months later. Right arm was where I received my first injection on March 1, 2021. My second injection was received in my left arm on 3/30/2021. My left arm is not causing me any discomfort.
Initial misuse report received from a nurse on 02-OCT-2103. The 55-years-old patient had received FLUZONE 0.25 ml. No adverse events was reported. List of documents held by sender: None.
Breakthrough COVID-19 infection. Pt received Moderna on 1/22/21 and 2/19/21
Mild swelling and pain at injection site, mild headache, mild fatigue,  and bad chills.  Pain and swelling started about a hour after injection and last 3 days. The headache and fatigue started about 4 hours after shot and resolved by late evening (around 8pm). I took a Tylenol for the headache.  I also got really bad chills and shaking around 9pm. I covered up and went to bed. It was resolved by morning. The warmth from covering up in bed made the chills go away. I did not have chills with first dose.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursions, one for 384 hours with a lowest temperature recorded of 34 F (1.111111111 Celsius) and the other one for 168 hours with a lowest temperature recorded of 33 F (0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5 mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sweating profusely, heart palpitation, visual disturbances and weakness/tired.
I felt very tired and dizzy; I felt very tired and dizzy; The pain in the head (mainly on top and ears) is aggravating; pain at injection site; severe headache; feverish feeling; I received my booster dose (3rd dose); pass my stools 2 times at night; hand pain reappeared; could not sleep well as the headache and hand pain reappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Dec2021 10:00 (Lot number: FF8841, Expiration Date: Mar2022) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot# EL3247), administration date: 24Feb2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, Lot# EL3248), administration date: 06Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 10:00, outcome "unknown", described as "I received my booster dose (3rd dose)"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 01Dec2021, outcome "unknown", described as "pass my stools 2 times at night"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021, outcome "not recovered", described as "hand pain reappeared"; DIZZINESS (non-serious), FATIGUE (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "I felt very tired and dizzy"; INSOMNIA (non-serious) with onset 01Dec2021, outcome "unknown", described as "could not sleep well as the headache and hand pain reappeared"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "pain at injection site"; HEADACHE (non-serious) with onset 01Dec2021 22:00, outcome "not recovered", described as "severe headache"; PYREXIA (non-serious) with onset 01Dec2021 22:00, outcome "unknown", described as "feverish feeling"; HEADACHE (non-serious) with onset 02Dec2021, outcome "unknown", described as "The pain in the head (mainly on top and ears) is aggravating". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, headache, pyrexia, headache.  Additional information: The patient took acetaminophen 575 mg before sleeping for pain at injection site, severe headache and feverish feeling. The pain in the head (mainly on top and ears) is aggravating that need pain reducer again.  Follow-up attempts are completed. No further information is expected.
pt recv vax; 2 wk later, devel mumps like rxn w/ swelling of neck;
Swollen lymph node; Could be an abscess; This case was reported by a nurse via call center representative and described the occurrence of axillary lymph nodes enlarged in a 22-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 8th July 2020, the patient received the 2nd dose of Engerix B. On 8th July 2020, less than a day after receiving Engerix B, the patient experienced axillary lymph nodes enlarged and axillary abscess. On an unknown date, the outcome of the axillary lymph nodes enlarged and axillary abscess were unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged and axillary abscess to be related to Engerix B.  Additional information was provided as follows: The patient developed a swollen lymph node to the left axilla. The health care professional stated that there was no redness and that it could be an abscess. No ultrasound had been performed The reporter consented to follow up.
Skin irritation (itching), red and swollen area size of softball.  Follow up 06/05/2000: "Patient recovered from adverse event.  Still have small lump on upper arm.  Just wanted to note a change to the original form that the redness and swelling covered my entire upper arm from shoulder to elbow for nearly 10 days.  The itching lasted for 7 days."
Herpes Zoster in a previously vaccinated individual. Patient had a painful unilateral rash located in 1 dermatome, beginning 4/19/2017 and lasting less than 4 weeks. Patient was given acyclovir.
I WOKE UP IN THE MORNING AND FELT LIKE A TRUCK RAN OVER ME AND MY JOINTS AND BONES STARTED TO HURT LIKE CRAZY. I CALLED MY DR AND ASKED IF THEY COULD DO A TEST. THEY DID A BLOOD TEST AND FOUND THAT I HAD SJOGREN SYNDROM AND RHEUMATOID ATHRITIS. SINCE THEN MY DIGESTIVE SYSTEM FOR 6 MONTHS WAS REALLY BAD- TERRIBLE REFLUX, DIARRHEA, BONES AND JOINT PAIN IS GETTING WORSE AND WORSE. I'VE BEEN TAKING PREDNISONE AND OTHER PAIN MEDICATION AND I GOT DIAGNOSED WITH NEUROPATHY IN MY HANDS, LEGS. I HAVE BRAIN CLOUDLYNESS, SOME DAYS I CAN'T EVEN THINK.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 20-FEB-2018 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Additional information has been requested.
for about 48 hours after vax I had fever, chills, body and muscle aches, fatigue this all cleared up expect the deep body aches. Right wrist and left lower back/hip lingered for more then 1 week. Wrist pain finally went away but leg/hip pain got substantially worse on 11/4 and  progressed down my entire left leg. Pain was deep and sharp. After unsuccessfully trying to treat at home I went to the ER 11/7. I was diagnosed with sciatica. I've never had this before unsure if it's a result of the vax or not.
Large itchy rash and lump in upper arm below injection site appeared a week after vaccine.  It has grown and spread to the size of a football about 6 inches by 4 inches over a weeks time.  I've taken Equate, Allergy Relief one day but otherwise I've not done anything. It is not severely itchy or painful. Other side effects that may be related are some nausea and sneezing.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 14-APR-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 04-AUG-2014, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Itchy rash in a big circle around the injection side. Never happened on my first two shots before. It's been 8 days since I had the vaccine. The rash is still showing on my left arm.   Treatment: 3000mg Vitamin C, SARNA lotion, and Benadryl
Fever, muscle aches, numbness on left side of body, headaches, dizziness.
Yellow Fever Vaccine was reconstituted using wrong Sterile Diluent of 0.7 mL vial for MERCK, for LIVE VIRUS VACCINES (sterile water) without preservatives. Sterile diluent provided with vaccines should have been used to reconstitute: Sodium Chloride 0.9%, 0.6 mL Injection USP For reconstitution of single-dose Yellow Fever Vaccine by SANOFI PASTEUR  Client declined having any adverse event after this vaccination. Immunizations specialists have advised to re-vaccinate using proper diluent in 28 days after vaccination error occurred in order to provide client with proper coverage.
Immediately upon waking up the next morning and fixing coffee, I felt like something was wrong and felt very weird and couldn't complete making coffee, felt so weak and unsteady, and put my head down to get the blood flowing to my head.  That is the last thing I remembered as I fainted, but regained consciousness about 20-30 seconds later.  My husband heard me fall and found me flat on my back in front of the coffeemaker.  I had to be in bed the entire day, sleeping and resting.  I had a nasty bump on the head and cuts and bruises on knees and arms.  The next day still feeling weak but am able to function.  Lots of aches but don't know if that is from the fall.
I was less than 12 weeks pregnant at the time that I received the vaccine. A few hours after the vaccine I had contractions on my lower belly for the rest of the day.  In December (about 20 weeks pregnant) during a routine ultrasound they notice my baby had a very slow heart beat and I was send to a local Hospital. At the hospital they determined that indeed my baby?s heart rate was dropping to 40 beats per minute. I was then transferred to another Hospital for higher level of care. After a referral to a third hospital in another county  with a fetal specialist it was determined that my baby in fact was suffering from a congenital complete heart block with hydrops with really poor outcomes. By baby was born at 29 weeks and was alive for less than 15 minutes.  Prior to this pregnancy, I had 2 healthy pregnancy with healthy babies, my first child was born four years ago  and my second child was born two years ago . Both of them are healthy and with no issues.
The first night after getting the vaccine, I had a severe shooting pain through the base of my neck. It was so bad, I couldn?t even see straight. The pain level was a 10.   The next morning, I woke up and my right hand was so swollen, I couldn?t take the rings of my fingers.   The spot of injection had a painful hive about the size of a lemon and it had a fever. It was present for at least 3 days.   I also was exhausted and just laid in bed and slept for 2-3 days.
feelings of depression; feelings of depression sparked along with lack of motivation; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, on 10Feb2021 at 15:45 (at the age of 25-year-old), as dose 2, single in left arm for COVID-19 immunization. The patient's medical history included Prolonged post-traumatic stress (PTSD) due to childhood sexual assault, which was under control and was supposed to be weaning off medication in the near future. Patient was allergic to apples and had seasonal allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration, on 20Jan2021 (at the age of 25-year-old), as single dose in left arm for COVID-19 immunization. Concomitant medications in two weeks after COVID vaccine included venlafaxine hydrochloride (EFFEXOR) 150 mg; taken for unspecified indication, start and stop dates were not reported. Patient did not receive any other vaccine in four weeks after COVID vaccination. On 11Feb2021, 1 day after second dose of vaccine, the patient had feelings of depression sparked along with lack of motivation. Patient did not receive treatment for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of both the events was not resolved.   Follow-up attempts completed. No further information expected.
INJECTED INFLUENZA FLUBLOK 2020-2021 FORMULA TO THE PATIENT LESS THAN 18 YEARS OLD.
Paresthesia/ tingling; the muscle is a little sore; electric shock-like down the right arm in the ulna nerve distribution; This non-serious case was reported by a physician via call center representative and described the occurrence of paresthesia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, 3 weeks after receiving Shingrix, the patient experienced paresthesia (Verbatim: Paresthesia/ tingling), muscle soreness (Verbatim: the muscle is a little sore) and electric shock sensation (Verbatim: electric shock-like down the right arm in the ulna nerve distribution). The outcome of the paresthesia, muscle soreness and electric shock sensation were not resolved.   It was unknown if the reporter considered the paresthesia, muscle soreness and electric shock sensation to be related to Shingrix.     It was unknown if the company considered the paresthesia, muscle soreness and electric shock sensation to be related to Shingrix.   Additional Information: GSK receipt date 26 Oct 2023: The reporter is the patient.  The patient received the first dose of SHINGRIX at the end of July / beginning of August 2023 in the right arm. Three weeks later, the patient began to experience tingling, paresthesia, electric shock-like down the right arm in the ulna nerve distribution.  To this day, when the patient presses on the right deltoid, the muscle was a little sore, and it reproduces the tingling sensation in the hand. The reporter consented to follow up with HCP (pharmacy).
Pt developed fever of 102 degrees and screaming for 12 hours at 8 hours after immunization. The follow up states vomiting and elevated WBC (leukocytosis). Sepsis was ruled out.
Information has been received from a female consumer with no pertinent medical history and no drug reactions or allergies who on unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot # not reported). Concomitant therapy included vitamins (unspecified) and omeprazole. On unspecified date the patient experienced redness, puffiness and soreness at the site of her injection. The patient didn't seek medical attention and no lab diagnostics studies were performed. At the time of the report, the status of the patient was not reported. Additional information has been requested.
Itching, heat, raised bumps, hard swelling at injection site occurred one week after first vaccination
Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: blisters-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Weakness-Medium, Additional Details: blisters appeared around the injection site. pt left it alone and the blisters popped and dried up. pt reported the adr 20 days after the injection. pt still has some blisters
inappropriate schedule of vaccine administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 027B21A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AMLODIPINE, OLANZAPINE, METHIMAZOLE, HYDROXYZINE and ESCITALOPRAM for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.