chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 09-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 11-JUL-2011, prescribed by a physician and administered by a staff member, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-DEC-2015, the patient was treated at a medical facility for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. On or about 02-AUG-2016, the patient received subsequent treatment at a health care facility for ongoing and worsening symptoms of zoster, and the new diagnosis of post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to shingles infections. The patient has been prescribed LYRICA for management of her painful condition. 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.
This case was reported by a nurse and described the occurrence of stiffness in right arm and shoulder in a 39 year old male subject who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. The subject had no pre-existing medical conditions. On 2/2/06, the subject received the second dose of Engerix B in the right arm (lot AHBVB152DA). On 2/2/06, the subject also received an injection of typhoid vaccine. On an unspecified date on or after 2/2/06 and on or before 2/9/06, approximately one week after vaccination with Engerix B, the subject experienced stiffness in his right arm and shoulder and limited range of motion. The subject was seen at a physician's office. The nurse considered the events to be disabling. On 2/9/06, at the time of initial reporting, the events were improved. The nurse considered the events to be possibly be related to vaccination with Engerix B.
after COVID 19 vaccine #2, patient developed onset of rash at vaccination site within 20 min of vaccination which ultimately spread to her chest and neck, and developed generalized neck swelling. transferred to the ED
Can't use the arm; pain went across the shoulder and then to chest and back; pain went across the shoulder and then to chest and back; Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt; Pain; Overall aching feeling; pain went across the shoulder and then to chest and back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt) and PAIN (Pain) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 040CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt), PAIN (Pain), MYALGIA (Overall aching feeling) and ARTHRALGIA (pain went across the shoulder and then to chest and back). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt), PAIN (Pain), MYALGIA (Overall aching feeling) and ARTHRALGIA (pain went across the shoulder and then to chest and back) outcome was unknown.            Concomitant medications were not provided by reporter.
PAINFUL KNEE; HAND PAIN; GASTROINTESTINAL INFECTION; COVID-19; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, intramuscular, batch number :unknown, expiry: unknown) dose was not reported, 1 total, administered on 20-MAR-2021. It was unknown if patient experienced any adverse reactions following administration of covid-19 vaccine ad26.cov2.s. (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, intramuscular, batch number :unknown, expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination which reported for off label use and inappropriate schedule of vaccine administered. (dose number in series 2). On DEC-2021, the patient experienced gastrointestinal infection. (dose number in series 2). On an unspecified date, the patient had covid-19, Patient got covid after left hospital. Missed doses of Humira while in hospital and during covid and had painful knee and hand pain(dose number in series 2). The patient was hospitalized on an unknown date for five days. The patient received adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date therapy with adalimumab was discontinued. No concomitant medications were reported.  Patient received additional dose of Moderna (dose number in series was 3) (form of admin, intramuscular, and batch number were not reported) dose was not reported, administered on 04-DEC-2021 for covid-19 vaccination. It was unknown if patient experienced any adverse reactions following vaccination with Moderna vaccine (dose number in series was 3).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; treatment with adalimumab was withdrawn; and action taken with mrna 1273 was not reported. The patient was recovering from painful knee, gastrointestinal infection, and covid-19, and the outcome of hand pain, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220152328-COVID-19 VACCINE AD26.COV2.S-gastrointestinal infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220152328-COVID-19 VACCINE AD26.COV2.S-painful knee, hand pain. This event(s) is labeled per RA and is therefore considered potentially related.
Patient reported that her left arm was really sore and she had to try to get movement on her left side of her body for a couple of weeks to get feeling... also reported that is having issues with her right eye...has had tingling on her feet
Chills, nausea, vomiting, shaking, body aches, muscle pain/weakness, low-grade fever, teeth chattering, uncontrolled body movements; acetaminophen, Nauzene, gas-x, heating pad, ice pack; treatments didn't work; symptoms went away on their own (more or less) after about 10 hours.
Details NA. 12/17/08-records received-Sudden death in a 2 month old child. Undetermined causes.
Prolonged soreness- (>1 wk) developed warmth to sie (no obv. redness) -tx: ice Rx MOTRIN
1st dose of Moderna vaccine was administered to a 16yr old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna vaccine was administered to a 16yr old patient) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna vaccine was administered to a 16yr old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna vaccine was administered to a 16yr old patient) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information were reported.
Not feeling well; Feels hot; Getting nauseated; Kind of chilling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA IX VACCINE), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset Oct2023, outcome "unknown", described as "Feels hot"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown", described as "Getting nauseated"; CHILLS (non-serious) with onset Oct2023, outcome "unknown", described as "Kind of chilling"; MALAISE (non-serious) with onset Oct2023, outcome "unknown", described as "Not feeling well". Therapeutic measures were taken as a result of malaise, feeling hot, nausea, chills.  Additional Information: Reporter reported about grand daughter. They all had flu and COVID shot yesterday at morning about, around 11:30, 12 O' clock. Patient was not feeling well, she feels hot, she was getting nauseated, she was kind of chilling and reporter gave her two Tylenol and asked what was the reporter supposed to do.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Fever. A nsg reported that a child received an injection of Prevnar and subsequently developed a fever of 103F. No further information was available at the date of this report.
This spontaneous report as received from a pharmacist refers to a 80 year old male patient. The patient's medical history and past drug history were unknown. On 16-AUG-2014 the patient was accidentally vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration not reported, lot# reported as J006246) that expired on 03-AUG-2014. Concomitant therapies included LEVEMIR, metformin, AMARYL, LIPITOR and JANUVIA. Pharmacist reported that no phone call was received from the patient reporting any adverse events. This is one of several reports from the same source. Additional information has been requested.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitants and Treatment medications were reported.
2-3min p/vax hypotens, gave epi;asymptomatic? (symbol) 24hr;hep A & hepB 10min exercise induced asthma;pt devel bradycarida immed p/vax;also PDH given;given 2nd shot series w/o incident;
Swollen lymph node under arm, near right breast, Fever, Extreme pain at injection site, headache
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received SHINGRIX. On 15th February 2019, 4 days after receiving SHINGRIX, the patient experienced swelling arm, erythema and skin warm. On an unknown date, the outcome of the swelling arm, erythema and skin warm were unknown. It was unknown if the reporter considered the swelling arm, erythema and skin warm to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in the left deltoid. The patient said that her arm was extremely swollen and it covered the majority of the upper arm. The area was hot to touch. The reporter did not consent to follow-up.
First sign was very sore arm, second day chills, low fever, then arm was hot to touch, fever went to 102.00 Used ice pack and ADVIL help.
Wheezing 27APR91 PM, no fever, cough & irritable; seen by MD ; tx Prelone & checked daily until 2MAR91;
Information has been received from a consumer's mother concerning her 11 year old daughter with no allergies and no medical history reported, who in October 2010, was vaccinated with a dose of GARDASIL dose unspecified (Lot# not reported). Concomitant therapy included CONCERTA. On 28-DEC-2010, "Three weeks ago" she noticed that her daughter had a swollen gland underneath one of her under arms (Axillary). The patient's mother stated that her daughter had been complaining of this ever since she had GARDASIL in October. There were no laboratories performed. At the time of the report the patient's outcome of the patient was unknown. The patient did not seek medical attention. Follow up information has been received from a physician concerning a 11 year old female who on 19-JAN-2011 at 10:30 A.M. was vaccinated with the second dose of GARDASIL on left arm "LA" (Lot # 666595/0992Z). No illness at the time of vaccination. It was not reported pre-existing allergies, birth defects and medical conditions. On a date unknown, the patient recovered from swollen gland of left axillary. Additional information is not expected.
myalgia, fever, h/a, pneumonia, sepsis; cultures pos-salmonella; hospitalized;
This non-serious initial spontaneous case, was received on 21-Sep-2017 from other health professional (nurse) concerning a 09-year-old female child. The patient's medical history and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number: 179002 (as reported), expiry date: May 2018, anatomical location: not reported). FLUAD vaccine was administered to the patient of 9 years (age less than 65 years) (explicitly coded as inappropriate age at vaccine administration) and the patient experienced headache. At the time of the report, the outcome of the event was not reported. The reporter assessed the event as non-serious. Follow up report received on 28-Sep-2017: The new event (headache) was coded and route of administration of the vaccine (intramuscular) were updated. It was reported that, the patient experienced headache after the vaccination. The narrative was amended accordingly.
about 1  hour after injection got a nose bleed,  then started experiencing on 2nd week after shot started feeling nauseous and fatigue, 3 rd and 4th week started feeling extreme fatigue, gut issues, no appetite, chills ,sweating profusely, muscle cramping all over body. Went to my Dr. April 6 & 13, all vitals good, had flu and Covid test both negative, Had labs drawn both times, liver enzymes was high with both results.  Still currently having all symptoms
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient reported appreciable lightheadedness within 2 minutes of receiving vaccination. Provided water from emergency kit and crackers at patient request. She later reported feeling better especially after consuming water.
Mistakenly administered Janssen 0.3 mg IM instead of Pfizer 0.3 mg IM. Patient declined to have full dose of Janssen administered and will return to clinic in 28 days to start Pfizer series.
Patient states that he began feeling pain and stiffness in his right arm about 2 weeks after receiving the vaccine.  He saw his physician in December 2014, and reported the problem, but the doctor did not address the issue.  The patient states that his arm began getting weaker and more stiffness after this time, but with some increase in exercise of the muscles, seem to get somewhat better.  The patient reported to me on March 25, 2015 of this issue for the first time. The arm showed no outward signs of swelling or infection, but the patient states that the pain is persisting.  I advised the patient to return to the doctor for a full evaluation of the problem.
Sensation of throat swelling, diffuse macular rash sparing palmon/planter surfaces, small follicular pustules on face, malaise, fatigue approximately 27-30 hours post vaccination. Rx'd with Predinisone 60mg po x 1, Benadryl acetomeophen. Hospitalized for observation and social (self-care support) considerations.
No adverse event; MMR II after an excursion / temperature (-15°C); This spontaneous report was received from a nurse referring to a 4 year old female patient. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.  On an unknown date in July 2020, the patient was vaccinated with an incorrect stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  (recombinant human albumin rHA) (Lot # S020161, expiration date 30-JUN-2021); dosage, frequency, route of administration, anatomical location were not provided for prophylaxis. The reporting nurse asked about the stability for incorrect stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) after an excursion and stated that two lots of the vaccine were administered to two patients. The excursion occurred on 26-JUL-2020. Temperature (-15°C), time frame 48 minutes, no previous temperature excursion was reported, the call was due to data logger. No additional adverse event or Product quality complaint (PQC) were reported.
BODY ACHES; LOW GRADE FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient medical history was unknown. the patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced low grade fever. On 17-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, low grade fever, and fatigue. This report was non-serious.
Five days after injection woke up with stomach acid, headache, chills, fever (100.1)and increased fatigue  after no side effects first four days except fatigue and arm soreness.
No additional adverse effects reported; a patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 17-JUL-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dosage regimen was not reported) lot # S013890, expiration date 14-FEB-2021, administered as prophylaxis.       The improperly stored dose of the suspect vaccine experienced a  temperature excursion of 48.7 degrees Fahrenheit (°F) during 2 hours and 30 minutes with no previous temperature excursion. The call was made due to a digital data logger. No adverse symptoms were reported.
Dizziness, Myalgia, c/o chills,fatigue,injection site sore. Told to follow up with primary care physician if promblems persist Narrative:
had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: had Covid, notes: her husband had Covid.  Clinical information: Caller was prescribed with Paxlovid. Caller states before she realizes, she and her husband had Covid, they got their second booster dose on Sunday. Caller states that she was getting her first dose of Paxlovid. Caller wants to know any information if it (Paxlovid) will reduce the effect of the Pfizer Covid-19 booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200784485 Same reporter/product/event, different patient
During the night after the vaccine, woke up and was not able to breathe very well. Also experienced a painful migraine/headache and the left side of my face lost feeling. Still mildly numb today.
Arm hurt/soreness felt days later. Then called on 9/27 still had pain in left arm and couldn't lift arm without major pain.
Sunday morning right tricep was swollen, red, had a rash. Whole arm became swollen within minutes, took benadryl to help with the swelling. Also did cortisone cream, helped within hours. Today, it feels good, is still itchy at the site, but no redness or swollen. Site is heated.
pt recvd vax & devel an inj site rxn characterized by redness & inflammation approx 2 inches in size
Left leg shin and inside calf pain. Took shoe and sock off at doctor office and a cluster of red blisters. Then Sunday 9/21/14 onset blurred vision. 9/25/14 repeat doctor visit confirmed I had shingles.