chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bumps are itchy; Rash she had bumps came; Itchiness; Bumps are going around her eyes; Itchiness is affecting her left eye; Bumps on the skin primarily on her arms and back; Swelling and tenderness around injection site; Swelling and tenderness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), PRURITUS (Bumps are itchy), MILIA (Bumps are going around her eyes), EYE PRURITUS (Itchiness is affecting her left eye) and SWELLING (Bumps on the skin primarily on her arms and back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PRURITUS (Itchiness), MILIA (Bumps are going around her eyes), EYE PRURITUS (Itchiness is affecting her left eye), SWELLING (Bumps on the skin primarily on her arms and back), VACCINATION SITE SWELLING (Swelling and tenderness around injection site) and VACCINATION SITE PAIN (Swelling and tenderness around injection site). On an unknown date, the patient experienced PRURITUS (Bumps are itchy) and RASH (Rash she had bumps came). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness), PRURITUS (Bumps are itchy), MILIA (Bumps are going around her eyes), EYE PRURITUS (Itchiness is affecting her left eye), SWELLING (Bumps on the skin primarily on her arms and back), VACCINATION SITE SWELLING (Swelling and tenderness around injection site), VACCINATION SITE PAIN (Swelling and tenderness around injection site) and RASH (Rash she had bumps came) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication also included Eucerin Cream.   This case was linked to US-MODERNATX, INC.-MOD-2021-034286 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: new AE added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-034286:Dose 1
Left deltoid, 2 inch diameter warm erythematous around injection site, no induration, minimal tenderness.  Cool compresses, ibuprofen x 48 hours.  Gradual resolution in 2-3 days.
Patient reports knot where vaccine was administered accompanied with small amounts of swelling, redness, and the site is warm to the touch. Patient has full ROM and is capable of moving the arm without pain.
PANIC ATTACK (INVOLUNTARY MOVEMENTS/DIZZINESS/UNABLE TO WALK/FEELING DRUGGED); This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included paxil allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Antipsychotics (unspecified). On 05-MAY-2021, the subject experienced panic attack (involuntary movements/dizziness/unable to walk/feeling drugged). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from panic attack (involuntary movements/dizziness/unable to walk/feeling drugged) on 05-MAY-2021. This report was non-serious.; Sender's Comments: V0.Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Per 11/16/2017 nursing telephone contact- Patient stopped by clinic to have her left arm assessed. She received PNEUMOVAX 23 injection on 11/13/17 in left deltoid. After going home she began to notice pain and hives above elbow, not at injection site. PCP assessed site and believes patient had a reaction to the medication. Allergy updated in system.
Immediately after receiving the 2nd dose of the Pfizer vaccine, I had muscle pain at the injection site and difficulty lifting that arm the next day (similar reaction as after the 1st dose). I received the vaccine Wednesday evening (6 p.m.) on 1/13/21. Around 2 p.m. the next day, I started having a fever (over 101 degrees); chills; body aches; and fatigue. These symptoms lasted for three days but the fever was slowly going down with Advil. By Saturday evening, my symptoms changed to headaches and diarrhea, which lasted for an additional three days after that. My nose suddenly started running the following afternoon (Wednesday, 1/20/21) for about an hour and then that stopped and did not recur. All symptoms were gone by Thursday, 1/21/21 and I had none of these symptoms prior to taking the second dose of the vaccine (other than the arm pain for 1-2 days following the 1st dose of the vaccine).
Patient developed hives 24 hrs after vaccine was administered.  He was examined on 9-30-04, 2 days after the vaccine, and still had hives which were treated with Benadryl.
Patient rec'd first dose of the Pfizer Covid-19 vaccine.  About 5 minutes after she reported a hot peppery taste and her tongue felt hot.  No other reported symptoms.  Had the patient sit in observation for a total of 45 minutes with no worsening or new symptoms. Called patient 2 hours after event and symptoms have resolved.
Syncope approximately 1 hour after receiving vaccine.  Felt progressively light-headed after leaving clinic and lost consciousness for a few seconds while walking.
Tooth ache; sore groin; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Tooth ache) and GROIN PAIN (sore groin) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced TOOTHACHE (Tooth ache) and GROIN PAIN (sore groin). At the time of the report, TOOTHACHE (Tooth ache) and GROIN PAIN (sore groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
This spontaneous report as received from a licensed practical nurse refers to a identifiable patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 19-SEP-2017, the patient was vaccinated with PEDVAXHIB dose 1 from lot number N012920 expiry date 07-FEB-2020 for prophylaxis. On 09-OCT-2017, the patient received second dose of PEDVAXHIB (lot number and expiration date were unknown by reporter). No adverse effects were reported. No product quality complaint was involved.
ACHINESS, BACK PAIN, CHEST PAIN, VOMITTING, DIARRHEA
Initial and follow-up information has been received from a registered nurse concerning a 27 month old male with no medical history or allergies who had clear rhinitis and a cough at the time of vaccination, who on 20-NOV-2006 was vaccinated subcutaneously in the left arm with a 0.5 mL first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of VARIVAX (Merck), SC. Two weeks later the patient developed "a varicella-like rash". The patient had contacted the office for medical attention. The patient's varicella-like rash persisted at the time of the report. Additional information has been requested.
Severe low back pain, high fever, headache, ringing in ear, severe muscle pain all over body
2-3d inconsolable crying w/dec sleep & dec breastfeeding & increase in fatigue; adm to hosp 16DEC93 for monitoring;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 78-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunization. The patient's relevant medical history included: "Essential Hypertension" (unspecified if ongoing); "obesity class I" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "acquired hypothyroidism" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "cat hair" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Allergy:Oxycodone"; Amlodopine, reaction(s): "Allergy:amlodopine". The following information was reported: COVID-19 (medically significant) with onset 25Jun2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (23Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: patient tested negative for covid on 23Jun2022 after completion of paxlovid. On day 10 she presents in telemedicine clinic with a new positive test and increased symptoms of covid which had previous resolved. Runny nose, 25Jun2022, lethargy, sneezing and congestion 26Jun2022 and 27Jun2022 with significant fatigue, lethargy, cough andcold sx and positive covid test, at home antigen  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
I felt fever, tried, muscle pain and chills in my body, and I felt pain in left arm over one week.  I drank much water and took the Muncinex strength medicine at two days. I also used cooler bag to cool down my fever and left arm. After three days I recovered.
The patient is a 4mo old female with a history of adverse reaction after receipt of 2mo vaccines (on or about 20 May 2016). The MOP states she received vaccine at 11:30 a.m. and at about 15:30 pm she developed severe crying, would not nurse, was inconsolable and screaming. She states about 10 minutes later she became lethargic, staring and not responding to stimulation or Interaction, although was conscious. She states she had two episodes of projectile vomiting. Baby was taken to the ER, treated, observed the released home hours later.
Initial unsolicited report received from a Nurse on 25-May-2018. This case involves 2-year-old patient (gender was reported as unknown), who was vaccinated with QUADRACEL (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to inappropriate age at vaccine administration as QUADRACEL is approved for use in children 4 through 6 years of age. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
All the sudden she didn't feel well intestinally/still not feeling right; Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping; Has some nausea in the morning; Little bit of constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Little bit of constipation), GASTROINTESTINAL DISORDER (All the sudden she didn't feel well intestinally/still not feeling right), GASTRITIS (Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping) and NAUSEA (Has some nausea in the morning) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONSTIPATION (Little bit of constipation). On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (All the sudden she didn't feel well intestinally/still not feeling right), GASTRITIS (Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping) and NAUSEA (Has some nausea in the morning). The patient was treated with ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) ongoing since an unknown date for Gastritis, at an unspecified dose and frequency. At the time of the report, CONSTIPATION (Little bit of constipation) and GASTROINTESTINAL DISORDER (All the sudden she didn't feel well intestinally/still not feeling right) had not resolved and GASTRITIS (Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping) and NAUSEA (Has some nausea in the morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Endoscopy: abnormal (abnormal) endoscopy showed inflammation of the lining in her stomach.         No concomitant medication was reported by reporter.
Urticaria that started at injection site, and spread throughout body, 5 days after immunization.
expired pentacel has been administered to a patient with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient and reporter reported that patient has been administered expired diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepa [Hepatitis A Vaccine]); Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) And Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination.  On 11-Oct-2023, the patient received a expired unknown (dose 2) dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 08-Oct-2023 and lot UJ7948B) via intramuscular route in the right thigh as immunization (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/21/21, 2nd dose01/10/21, Diagnosed covid positive:08/24/21, Symptom onset:08/23/21. Exposure: Symptoms: Cough, fatigue, muscle aches, runny nose, HA, congestion.
Reported redness/swelling, increased warmth to right arm from lateral deltoid to elbow. Pneumonia vaccine given in right deltoid, seasonal flu vaccine given in left deltoid. Patient saw personal physician. Given oral antibiotics and diagnosed with cellulitis. This is patient's first pneumonia vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 78-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 27th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. In May 2018, less than a week after receiving SHINGRIX, the patient experienced swelling. On an unknown date, the patient experienced generalized pruritus. On 30th May 2018, the outcome of the swelling was recovered/resolved. On an unknown date, the outcome of the generalized pruritus was recovered/resolved. It was unknown if the reporter considered the swelling and generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported to GlaxoSmithKline by the pharmacist and the patient reported to the pharmacist on 26th June 2018 about the adverse events. The patient received SHINGRIX in the left arm. The patient experienced some swelling that resolved within a couple of days. Less than a month after vaccination, the patient experienced itching all over her body and that took a couple of weeks to resolve. The reporter did not have exact start and stop dates of the events but all were resolved at the time of reporting. The pharmacist was transferred to medical information for additional assistance. The pharmacist wanted to know whether the patient should proceed with the 2nd dose and if she did not, what type of protection did she have with just one shot.
Information has been received from a registered nurse concerning a 25 year old female who on 10-JAN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 655619/1427F). On 15-MAR-2007 the patient was vaccinated with a second dose of Gardasil (lot # 657006/0188U). On 16-JUL-2007 the patient had a beta-human chorionic gonadotropin test (unspecified) and the results were reported as negative. On that same day the patient was vaccinated with a third dose of Gardasil (lot # 658100/0525U). On 16-JUL-2007 the patient experienced dizziness and nausea after the vaccination. Unspecified medical attention was sought. The patient's lightheadedness and nausea persisted. Additional information has been requested.
Pain in arm the following day, lasted 1 day. Current issues come and go: Recurring headache, trouble concentrating, brain in a haze,  fatigue. My physician is doing current bloodwork to rule out other possible issues.
Pain in the injection arm; Pain in the neck; Pain in the Shoulder; Numbness of the Face; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the neck), PAIN IN EXTREMITY (Pain in the Shoulder), HYPOAESTHESIA (Numbness of the Face) and INJECTION SITE PAIN (Pain in the injection arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Psoriasis. Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced NECK PAIN (Pain in the neck), PAIN IN EXTREMITY (Pain in the Shoulder) and HYPOAESTHESIA (Numbness of the Face). On 02-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 26-Jan-2021, NECK PAIN (Pain in the neck), PAIN IN EXTREMITY (Pain in the Shoulder) and HYPOAESTHESIA (Numbness of the Face) had resolved. At the time of the report, INJECTION SITE PAIN (Pain in the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-248297 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received and contains information about 2nd dose, Concomitant medication was added and medical history was added.
sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th August 2021, the patient received Shingles vaccine. On 24th August 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot on the day of reporting and experienced sore arm. The follow up would not be possible as no contact details were available.
FEELING FOGGY; NERVE PAIN; JOINT PAIN IN FEET, CHEEK, TOP OF HEAD, TIP OF TONGUE; FATIGUE; HEADACHE; MUSCLE PAIN IN FEET, CHEEK, TOP OF HEAD, TIP OF TONGUE; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 200 pounds, and height was 72 inches. The patient's past medical history included autoimmune disorder, and concurrent conditions included sleep apnea, auto-immune disorder with nerve pain flare-ups, chronic nerve pain, seasonal allergy, alcohol user, non smoker, asthma, blood pressure, acid reflux, and gout control, and other pre-existing medical conditions included patient event occur at locations feet, cheek, top of head, tip of tongue the patient have no history of drug abuse or illicit usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070) dose was not reported, administered on 10-MAR-2021 09:00 for prophylactic vaccination. Concomitant medications included pantoprazole for acid reflux, formoterol fumarate/mometasone furoate for asthma, losartan for blood pressure, allopurinol for gout control, and oxycodone hydrochloride for nerve pain. On 10-MAR-2021, the subject experienced feeling foggy. On 10-MAR-2021, the subject experienced nerve pain. On 10-MAR-2021, the subject experienced joint pain in feet, cheek, top of head, tip of tongue. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced muscle pain in feet, cheek, top of head, tip of tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain in feet, cheek, top of head, tip of tongue, and muscle pain in feet, cheek, top of head, tip of tongue on 14-MAR-2021, and headache on 11-MAR-2021, was recovering from nerve pain, and had not recovered from fatigue, and feeling foggy. This report was non-serious.