chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No AE reported; Caller reports child received ROTATEQ on 3/21/2023, 7/12/2023 and ROTARIX on 9/19/2023.  No other information provided.  No additional AEs or PQC reported.; Caller reports child received ROTATEQ on 3/21/2023, 7/12/2023 and ROTARIX on 9/19/2023.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report has been received from a medical assistant concerning a child of unknown age and gender..  The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 21-MAR-2023, the patient was vaccinated with the first dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, taken orally for prophylaxis (strength, lot #, and expiry date were not provided); and on 12-JUL-2023, the patient received the second dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ( Inappropriate schedule of vaccine administered).   Then on 19-SEP-2023, the patient received the third dose of rotavirus vaccine live oral 1v (ROTARIX), (interchange of vaccine products) taken orally for prophylaxis (strength, formulation, lot #, and expiry date were not provided). No adverse events reported.
pt recvd vax & right arm became sore; red & swollen in approx 8cm diam area;knot appeared immediately & was itching;  arm was hurting & swelling from shoulder to elbow; red; painful & itches;
Patient said she felt fine at time of vaccination and requested that the pharmacist give them both in the same arm despite recommendation of pharmacist to do otherwise. Patient stated it became painful the evening after shot was given. She called me the morning of 10/30 complaining of not being able to move arm at all, pain, fever, fatigue, bright red area, can feel heat through shirt and having a baseball size knot under the skin. She had been applying compresses and taking ibuprofen and Benadryl the night before to sleep. I advised her to seek medical advice/attention since the pain was worsening. She said she would do so but at the time of the report, she has not followed up with any additional information.
PHYSICAL SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced physical symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from physical symptoms. This report was non-serious.
The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 02Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and from a contactable medical assistant via Pfizer Sales Representative. This medical assistant reported similar events on five patients. This is the fourth of five reports. A 73-year-old female patient of unspecified ethnicity received PREVNAR 13 (NDC number 0005-1971-02) via an unspecified route of administration, on the deltoid on 19Nov2015 at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on 19Nov2015. The event did not require admission to the hospital. The patient was treated with KEFLEX and recovered from the event on unknown date. Follow-up attempts completed. No further information expected.
This spontaneous report was received from a other health professional refers to a patient with unspecified age, gender, pertinent medical history or drug reaction / allergies. On 29-OCT-2012, the patient was vaccinated intramuscularly with 0.5 ml dose of LIQUID PEDVAXHIB (lot number 0236Z (in verification process)and exp date 19-OCT-2012). No other co-suspects were reported. No concomitant medications were reported. On 29-OCT-2012, the patient received a dose of LIQUID PEDVAXHIB (lot number 0236Z and exp date 19-OCT-2012) and vaccine expired on 19-OCT-2012. No treatment information was reported. The patient's outcome was unknown. No adverse effect reported. Additional information has been requested.
Patient stated she felt the need to cough and had an instant headache after the vaccine. She also had pain in her left arm and left leg for 7 days after the vaccine.
Felt horrible; This spontaneous case was reported by an other and describes the occurrence of FEELING ABNORMAL (Felt horrible) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Panuveitis.    No Medical History information was reported.   On 27-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In February 2021, the patient experienced FEELING ABNORMAL (Felt horrible). At the time of the report, FEELING ABNORMAL (Felt horrible) outcome was unknown. Not Provided          No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported in a literature article and described the occurrence of anaphylactic reaction in a 12-year-old male subject who was vaccinated with DTAP (manufacturer unspecified), Meningococcal vaccine and strain not specified. The subject's medical history included no food or drug allergy. The subject did not have any adverse event after previous vaccinations. The subject had a history of asthma and most recently had an acute exacerbation 3 months earlier. On an unspecified date the subject received unspecified dose of DTAP (unknown), unspecified dose of Meningococcal vaccine (unknown). Within 30 minutes after vaccination with DTAP and Meningococcal vaccine, the subject experienced hives and redness of his face and chest, wheezing and throat tightness. The subject was treated with Albuterol inhaler and the subject returned to the clinic, where he was treated with oral diphenhydramine and intramuscular Epinephrine. His symptoms completely resolved over the next 2 hours. This was very consistent with an immediate type Ig E-mediated hypersensitivity reaction. The subject was referred to an allergist for further evaluation. the reaction was considered as anaphylactic reaction. An additional dose of TD was indicated in 5-10 years. Additional doses of Meningococcal vaccine were not currently recommended. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The author considered the events were possibly related to vaccination with DTAP and Meningococcal vaccine.
Within 15 minutes of receiving a second Moderna vaccine patient reported itching of face, arms back and chest. Also experienced shortness of breath, increased heart rate and tingling in hands. Patient evaluated by EMS
Arm was red and swollen from injection site to elbow and shoulder area. Swelling occurred day after vaccination, patient stated that at doctor visit was informed it was an allergic reaction.
soreness in arm; swollen lymph node in neck; discomfort in neck; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in arm), LYMPHADENOPATHY (swollen lymph node in neck) and NECK PAIN (discomfort in neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness in arm), LYMPHADENOPATHY (swollen lymph node in neck) and NECK PAIN (discomfort in neck). At the time of the report, MYALGIA (soreness in arm) and NECK PAIN (discomfort in neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.
Skin is turning yellow; 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 COVID-19 Vaccine - Manufacturer Unknown, administration date 17Mar2021 (Batch/Lot number: unknown) 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: YELLOW SKIN (non-serious) with onset 18Mar2021, outcome "unknown", described as "Skin is turning yellow".  Additional information: Patient wants to know if skin turning yellow after vaccination was normal and was provided with the number of Pfizer Medical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash at injection site 8 days following injection.  Approximately 3 x 2 inches.  Red, swollen, itchy, sore, hot to the touch.
Pt reported welt for  7 days with itching in throat 30 minutes after, Saw PCP who approved second vaccine and gave Epi pen.  Pt got second vaccine today reported throat itchy that resolved and dizzy that resolved also all sx resolved and Pt discharged with Epi pen instructions from RN
Because of a torn meniscus in my right knee I went to the Emergency Room. They did all kinds of test, including an ultrasound which showed 5 DVTs in right leg (3 in Femoral artery and 2 below the knee).
Flu like symptoms; Body ache; Low grade fever; Chills; Heaviness on both legs; Nasal congestion; Lump under the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old patient received bnt162b2 (BNT162B2) (Lot number: EN6205) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; PAIN (non-serious), outcome "unknown", described as "Body ache"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; CHILLS (non-serious), outcome "unknown", described as "Chills"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Heaviness on both legs"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Nasal congestion"; AXILLARY MASS (non-serious), outcome "not recovered", described as "Lump under the arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of axillary mass.  Additional information:No underlying condition was reported. Event was  took place after use of product.
Red rash, tender, warm to touch started on 1/17/19 symptoms continue to worsen.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 17-JUL-2014, at a pharmacy, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided), as recommended 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. On or about 15-SEP-2015, the patient was treated at a clinic by a certified physician assistant (PA-C) for the onset of a vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir and hydrocodone for management of her painful symptoms and chronic pain. On or about 29-SEP-2015, the patient sought subsequent treatment from the clinic, for a painful condition that affects the nerves of the skin, which was diagnosed as shingles polyneuropathy. The patient was prescribed LACLOTION, gabapentin and KEFLEX for management of her painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, shingles polyneuropathy was determined to be a medically significant event. Additional information has been requested.
About a half hour or so after patient rec'd her shot she passed out in the lobby. She was out for about 7 seconds. From hitting her head so hard on the floor she did have a concussion.  The Dr thought she probably passed out because of her missing breakfast (9AM appt) and also from stressing and being anxious about getting a shot.  We were kept at the office for about 45 min had some juice and cheese and crackers and she seemed much better. About an hour to an hour and a half after the shot she started getting seriously confused, couldn't remember simple things like how to unbuckle her seat belt, locking the door etc and her speech was very slurred and she couldn't makes complete sentences or produce understand able thoughts.
Left upper arm edematous, reddened, warm, itchy for 4 days after immunizations are given. no fever during this time.
rash at the injection site; very itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE PRURITUS (very itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder in 2012. Concurrent medical conditions included Drug allergy (Sulfa). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D NOS for an unknown indication.   On 28-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy). On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). On 12-Mar-2021, VACCINATION SITE RASH (rash at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (very itchy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Benadryl, Cholesterol and Prilosec used as a Treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: follow up received on 04-May-2021 included 2nd dose information, patient details like Hight, weight and rash, provided Allergy (Sulfa), patient med History (thyroid), mention the Concomitant drug details, change the events date ( rash - Initial date-08-Mar-2021-Not recovered and rash- Initial date- 11-Mar-2021 outcome Recovered on date 12-mar-2021.)
Crown of head is tender; arm hurting; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 12Jan2021 04:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on 12Jan2021 Tuesday afternoon, other than his arm hurting on 13Jan2021 Wednesday morning, which was gone now (15Jan2021), he had no headache or any other symptoms. Then, he woke up today (15Jan2021), and the crown of his head was tender and he wanted to know if there was a correlation to the vaccine. He was not ill or anything and it may be just a coincidence. The outcome of the event arm hurting was recovered on 15Jan2021 and unknown for the other event.  Information about Lot/Batch number is requested.
On the evening of the shot and the whole next day, I felt flu-like symptoms with aches, fever, shivers, headache, and stomachache. I experienced NO symptoms with the first shot, except a painful arm for a few days so this was unexpected, but not beyond the possible symptoms of receiving the shot. I post this just to add to the data. It was tolerable, responded to NYQUIL, and is completely worth it.
got so sick from it; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that patient got his/her second shingles vaccination on Sunday.  The patient was so sick from it. But it was better than having the shingles they were the worst. The follow-up could not be possible as no contact details were available.
03/26/21 pt has shaking  chills , fever , and ll over body aches , 03/29/21  developed rash on left arm  red , warm & itchy , used hydrocortisone cream  and it felt better
pt recvd vax 10OCT94,had t & cranky during day 12OCT94;t inc 12OCT PM,eating,drinking,acting fine-no other sxs;13OCT PM in office-in AM had dec eating,emesis x1, bulging fontanelle,nuchal rigidity,poor response,tx w/ atb,adm to hosp
After patient received vaccine while sitting, stood up and felt warm. Felt warm around face cheeks, then at back of neck. Patient described warmth like a warm compress. Feeling came and went during 15 minutes of observation. Temperature was taken and was normal (about 98.6)
DAYS 1 AND 2 JUST ITCING ON THE STOMACH BUT NO VISISBLE SIGNS AT THE WASRTE AREA, DAY3 I HAD A LITTLE RERD DOT. AND DAY4 IT BECAME BIG RED DOTS AND BLISTERS WITH A OT OF PAIN. i STILL HAVE IT NOW BUT IS FINALLY SUBSIDDING, STILL SENSITIVE TO THE TOUCH, I CAN SEE THE SCARES THE SCAPES FELL OFF AND THE PAIN  HAS STATRTED TO SUBSIDED. I WOKE MY HUSBAND UP AND TOLD HIM I HAD TO GO  TO THE HOSPITAL ON THE 9/25/2022
This spontaneous report as received from a nurse refers to a 23-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 01-MAR-2017, the patient was vaccinated with the first dose in immunization series of GARDASIL 9 injection (one dose, intramuscularly; lot# reported as LO40164, expiration date: 20-FEB-2018). On 02-MAY-2017, the patient developed shingles. It was reported, that the patient received treatment for the adverse event. She sought medical attention and visited a physician. The outcome of shingles was unknown. The relatedness between shingles and GARDASIL 9 was not provided. Additional information has been requested.
Pharmacist incorrectly drew up 1ml and administered 1mL instead of 0.5mL which is the indicated dose for this vaccine.   Patient within the first 3 hours.
Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
pt has Sturge-Weber Synd;had focal sz 2 days p/vax;went into status 3 days p/vax;
Headache, body aches, fever, extreme tiredness. Took Tylenol every 4-6 hours to control fever. Nothing seemed to help with the headache. Slept more than usual. Symptoms began midday on Thursday. Fever and body aches were resolved by Friday late morning. Slight headache and tiredness on Friday. Saturday felt fully recovered except little more tired than usual.
Sudden Pain in neck. Thought it would go away next day but it did not. Took Advil, which didn't really help. Pain in left side, hurts to move. Shot administered on left side.
Flu-like symptoms - feeling off - like coming down with a cold; fever up to 102.4 F; diarrhea; joint aches; extreme fatigue; loss of appetite; sleeping longer than normal hours; chills; difficulty focusing & concentrating;   lasting more than 3 days
Pt. states that after receiving the 3rd Booster of Moderna 11/16/2021, started experiencing symptoms 11/17/2021 of pain at the injection site, chills (self-treated with Flexaril), fever, and fatigue. Symptoms subsided 11/18/2021. No noted Primary visit/communications.
Day 1: fatigue, headache, chills, mild fever treated with Tylenol Day 2: fatigue, severe nausea, severe vomiting treated with Tylenol and ondansetron odt from ER Day 3: fatigue, slight nausea treated with Tylenol Day 4: fatigue and headache treated with Tylenol
Initial reported symptoms: (almost 2 hours after the shot) redness and swelling in injection arm spreading downwards and upwards on to neck, tongue numbness Initial Treatment: Patient took a Claritin at advice of a physician she works for. Patient then later took a Benadryl and an unknown other medication pill and went home.  Next day: Tongue swelling, arm swollen more Next day treatment: unknown  Third day: Tongue back to numb, redness and swelling around site "oreo-sized" Third day treatment: unknown