chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received their second dose of Twinrix late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 06 May 2023).   On 15-SEP-2023, the patient received Twinrix. On 15-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received their second dose of Twinrix late).  The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-SEP-2023 The pharmacist called to inquire regarding how to proceed with the Twinrix Series. The healthcare professional reported that they had patients who received their second dose of Twinrix late. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter did not consent to follow up. The case is linked with US2023127573, same reporter.; Sender's Comments:  US-GSK-US2023127573:Second patient
Urticarial rash started on Left leg, and then moved to body and face. Pt had similar reaction after 4 month shots, so vaccines were spread out to determine cause, and has since done fine with vaccines.
The adverse event is the duration (8 days) of the symptoms experienced following the vaccine.   Symptoms included fatigue, low fever (99.2 at the hightest; her regular temperature is 97.6), significantly reduced appetite, and nausea.  No medical treatment was needed.  Paitent spent a significant amount of time in bed resting.  By the ninth day following the vaccine (7/23/21), all symptoms subsided.
General body aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07May2021 10:00 (Lot number: EW0176, Expiration Date: 31Aug2021) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SINGULAIR taken for mechanical urticaria (ongoing); XYZAL taken for mechanical urticaria (ongoing); ALLEGRA taken for mechanical urticaria (ongoing); PRAVACHOL taken for hypercholesterolaemia (ongoing); PRINIVIL taken for hypertension (ongoing); ZESTRIL taken for hypertension (ongoing); LOPRESSOR taken for hypertension (ongoing); TOPROL XL taken for hypertension (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); BIOTIN taken for hair texture abnormal, skin discomfort, nail discomfort (ongoing); PRE & PROBIOTIC taken for routine health maintenance (ongoing). Vaccination history included: Bnt162b2 (Dose: 01 of covid vaccine, Time: 13:00, Site and route of injection: , Anatomical site if injection: Right upper arm, Route of administration: Intramuscular, Batch/Lot number: EP7533), administration date: 16Apr2021, when the patient was 57 years old, for COVID-19 immunization, reaction(s): "No reaction reported". The following information was reported: PAIN (non-serious) with onset 08May2021 08:00, outcome "recovered" (May2021), described as "General body aches"; FATIGUE (non-serious) with onset 08May2021 08:00, outcome "recovered" (May2021), described as "Fatigue". Therapeutic measures were not taken as a result of pain, fatigue.  Additional Information: Patient took ongoing concomitant medication bladder probiotics taken orally for bladder protection. Patient took Aspirin (Acetylsalicylic acid) for CV Protection. No prior vaccinations. No family medical history relevant to AE(s). No relevant tests were done.  Follow-up attempts have been completed and no further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm 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. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxycillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: If vaccine received, Yes, Other medication in 2weeks Yes, product, COVID 19 Treatment, brand, Pfizer, treatment start date 29Jul2022 and treatment stop date 02Aug2022 for Treatment of COVID-19. other medication in 2 weeks product is Simvastatin started on 01Jul2022 and stopped on 28Jul2022. Patient not on blood thinners but when he was scratching his left he got a reaction like he was on blood thinners. After 5 days of Paxlovid he started feeling a little dizzy. He also have soreness in my muscles. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient is daughter of a pediatric nurse. Allergic type reaction beginning with a rash and itching on the chest. Was given a Benadryl. Tongue began thickening. Given another Benadryl and began drive to hospital. During the drive, developed chest tightening and some difficulty breathing. At ED, was given Decadron IV 11/17/2009 ED record for 11/10/2009,DC DX allergic reaction  patient with c/o's rash, itching, throat swelling, difficulty breathing. Tx: IV Decadron, sx resolved.    and resolved almost immediately and required no further treatment.
Headache  Narrative:  . I am experiencing a really bad headache and my  right arm is sore. I don't feel good I'm feeling nauseated.
Red, raised, hot area 6.5 cm L x 8 cm W. TYLENOL & ice packs.
She has experienced random numbness in her arm from the elbow down; She has 3 small black and blue marks on arm just below the injection site.; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7848), dose 1 intramuscular, administered in Arm Left on 28Jul2021 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation. The medical history included food allergy from an unknown date and unknown if ongoing (Allergy:Soy). The patient previously took yeast and experienced hypersensitivity and benzocaine and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks of Covid-19 vaccine. The patient had other medications as oral contraceptive, in two weeks. The patient was not diagnosed with covid, prior vaccination. On 28Jul2021, the patient experienced random numbness in her arm from the elbow down and she has 3 small black and blue marks on arm just below the injection site. The patient was not tested for Covid, post vaccination. The outcome of the event she has experienced random numbness in her arm from the elbow down was recovered on 02Aug2021 and the other event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected
A non-serious spontaneous report of "got two doses of H1N1 LAIV on the same day" was received from a father/consumer concerning his five-year-old daughter. No relevant medical history have been reported for this patient. On 21-Oct-2009, the patient received two full doses of H1N1, Intranasal. The doctor administered the entire contents of one H1N1 LAIV sprayer to one nostril and then immediately administered the entire contents of second H1N1 LAIV sprayer to her other nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered as resolved.
Dry Cough; Painful to Swallow; Itchy Sensation - Near Injection Site; chills; headache, head pain; This spontaneous case was reported by a health care professional and describes the occurrence of COUGH (Dry Cough), ODYNOPHAGIA (Painful to Swallow), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), CHILLS (chills) and HEADACHE (headache, head pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced COUGH (Dry Cough), ODYNOPHAGIA (Painful to Swallow), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), CHILLS (chills) and HEADACHE (headache, head pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, COUGH (Dry Cough), ODYNOPHAGIA (Painful to Swallow), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), CHILLS (chills) and HEADACHE (headache, head pain) outcome was unknown.        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.   Concomitant medication used include Blood Thinners. Treatment medication include Tylenol to alleviate symptoms.  Patient gave consent to safety for Follow-up.
Patient presenting with complaint of heart racing and feeling flush.  Vital Signs at 10:31 BP: 130/85 HR: 80 Respirations:18  Provider assessed patient per provider notes. Patient has history of positive covid  3/3/2021 is day 90. 10 min after receiving vaccine patient felt a slight flush/heart racing vital signs WNL. Given water monitored for 30 min patient improved no more symptoms.  Patient advised to go to ER if symptoms worsen.
After an hour was unable to catch balance. Blurred vision, minor headaches, severe stomach pains.
Headache; feeling tired; little bit of chills; joint pain; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 24Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on unspecified date for covid-19 immunization. The patient experienced headache, feeling tired, little bit of chills, joint pain on an unspecified date. Would like to take Aspirin or Tylenol. Clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Noticed hives on chest, neck and forearms at 11pm last night (10-03-2011). Sprayed BENADRYL on hives at that time.
Rash on the face; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the face) and VACCINATION SITE PAIN (pain at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CARVEDILOL and LOSARTAN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced RASH (Rash on the face) and VACCINATION SITE PAIN (pain at the injection site). The patient was treated with HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Rash on the face) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: States left arm and hand were numb and getting better 1 day after vaccine given. States also had stiffness behind both knees and floaters in his eyes (both of which have went away 1 day later).
Hep B vaccine given on 1/11/12. Call from Mom on 1/13/11 to report fever 100-102 degrees, fussiness, followed by rash on 1/16/12. Rash improved - no fever 24 hours 1/17/12.
Information has been received from a physician (reported also as a health care professional) referring to a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 19-MAY-2017, the patient was inadvertently vaccinated with a unspecified dose of VAQTA intramuscularly, lot # M022924 (dosage scheduled, expiration date, number and anatomical location were not provided) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Feeling very groggy; Lost her balance; Felt like someone is pushing her; Drunk feeling; Very light headed; Arm started hurting; Chills; Headache; Cold feeling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold feeling), SOMNOLENCE (Feeling very groggy), BALANCE DISORDER (Lost her balance), FEELING ABNORMAL (Felt like someone is pushing her) and FEELING DRUNK (Drunk feeling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FEELING COLD (Cold feeling), VACCINATION SITE PAIN (Arm started hurting), CHILLS (Chills) and HEADACHE (Headache). On 05-Feb-2021, the patient experienced SOMNOLENCE (Feeling very groggy), BALANCE DISORDER (Lost her balance), FEELING ABNORMAL (Felt like someone is pushing her), FEELING DRUNK (Drunk feeling) and DIZZINESS (Very light headed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (Cold feeling), SOMNOLENCE (Feeling very groggy), BALANCE DISORDER (Lost her balance), FEELING ABNORMAL (Felt like someone is pushing her), FEELING DRUNK (Drunk feeling), DIZZINESS (Very light headed), VACCINATION SITE PAIN (Arm started hurting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were unspecified blood pressure medications.
I got the shot Dec. 19, 2009. On Jan. 20th my left arm got sore, my body was shaking and cold. I had a fever. My head, heart and nose, chest congestion and coughing up a lot sometimes blood.
Erythematous large (4 inch by 5.5 inch vertical oval) rash with swelling and warmth to touch. No associated pain.
Approx 5 min after vaccine given pt became plae/ashen color.  Pt was responsive and alert, heart rate, breath sounds, both WNL.  Pt stimulated, she cried and color improved within 5-10 min.  Observed for 20 min. then refered to private physican for evaluation.
Vasovagal syncope. Patient stood up and walked around immediately after getting vaccine and then fainted shortly after.
itchy rash in the area of injection; each day rash gets a little larger; cortisone relieves any discomfort
approx. 1 hr after vaccines, was fussy. 11pm had 4 episodes of shaking 30 seconds each. approx. 10-15min apart. temp 100.1 taken  to EE. baby was calm. temp 100.6 (r) transferred to other for futher eval. BMP/CBC/UA, BCx and UCx. all neg. admitted overnight for neuro w/u (7/20-7/21/19) which was negative. discharged to home with PCP f/u. baby is to f/u with neuro in 3 mon
Severe headache and neck pain. Became worse overnight and was unbearable by the morning of 5/22/11.
I tested positive for COVID-19 on 4/21/22.  I developed a tickle in my throat and extreme fatigue.  Reached out to my doctor on 4/26/22.  Had a stuffy head and lethargic.  Developed a dry cough about 6 days later.  I tested negative on the 10th day.
This case was reported by a physician via other manufacturer and described the occurrence of drug allergy in a patient who received Influenza vaccine for prophylaxis. Concurrent medical conditions included, adhesive tape allergy (refer case US2019GSK032238), bee sting hypersensitivity (refer case US2019GSK032238) and drug allergy (Cefaclor, CEFITIN, Codeine-Nausea, Vomiting, KEFLEX-Diarrhea, Nifedipine-Swelling (refer case US2019GSK032238)). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced nausea, vomiting due to Codeine and diarrhea due to KEFLEX. It was unknown, if the reporter consented to further follow-up. It was unknown, if the patient/consumer/caregiver provide consent to contact the prescribing healthcare professional.
This spontaneous report was received from a nurse and refers to a 23 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 26-JUL-2016, the patient was vaccinated with a first dose of GARDASIL 9 lot # L045711, expiration date 08-MAY-2017, intramuscularly (dose was not reported). On 27-JAN-2017, the patient showed in the office for the second dose. Product quality complaint (PQC) was not involved. No adverse effects were noted. Additional information is not expected, as there was no consent to contact a physician.
This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Malaise), VACCINATION SITE INDURATION (Tenderness at injection site), FATIGUE (Generalize fatigue) and VACCINATION SITE SWELLING (Swelling at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for an unknown indication. No Medical History information was reported. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Tenderness at injection site), FATIGUE (Generalize fatigue) and VACCINATION SITE SWELLING (Swelling at injection site). On an unknown date, the patient experienced MALAISE (Malaise). At the time of the report, MALAISE (Malaise), VACCINATION SITE INDURATION (Tenderness at injection site), FATIGUE (Generalize fatigue) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Two large red blotches on upper arm.  One on bicep and one on back of arm.  Both sore to the touch.
Immediately after vaccine - I noticed fatigue - that lasted for just part of a day.  Mammogram in May and that showed a mass. I had a biopsy in June 3rd. It was an ultrasound guided needle biopsy. That result was positive for breast cancer. I just had surgery - lumpectomy and a lymph node biopsy on the 19th of August. My lymph nodes were negative and all the margins on the mass they removed were clean. The out come is good so far. I have recovered from the surgery. I have to see a radiation and medical oncologist but I won't see them until the 17th of September.
Patient had his 2nd dose of the pfizer vaccine 05/25/2021. Patient is c/o left arm pain and chest pain with pressure that started since last night, 05/24/2021. He denies any SOB, fevers, abdominal pain, or swelling, redness, or tenderness at injection site on the left upper arm. Told the patient to please go to the nearest ER for evaluation of the chest pain; patient verbalized understanding and states that someone will take him to the ER
BODY SORENESS; SHORTNESS OF BREATH; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, problems with kidneys, and ovarian cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced body soreness. On 17-MAR-2021, the subject experienced shortness of breath. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and headache on 19-MAR-2021, and was recovering from body soreness. This report was non-serious.
vaccines completed at 1225. Approx 1230, mother yelled and pt witnessing having seizure activity resembling a grand mal seizure. Seizure activity lasted approx 7-8 seconds. Pt was not incontinent. Pt diaphoretic. Pt looked over at mother post activity and asked what happened. Pt stated she felt like she had been in a long dream. vitals taken several times and stable.  Pt sees neuro for seizure activity--mother states she has frequent focal seizures but has not had grand mal activity for several /years. Called and talked to mother on  08/15/2023 and she stated pt has had zero seizure activity since and is awaiting guidance from neuro doctor of plan of care.
Information has been received from a nurse concerning a 12-13 year old female with allergy to DTaP (manufacturer unknown) and cerebral palsy who on approximately 01-SEP-2008 was vaccinated with VARIVAX (Oka/Merck). Concomitant therapy included tetanus toxoid. That same day, patient went to the doctor with a cold and cough. The patient came back 3 days later on approximately 04-SEP-2008 for a chest x-ray, at which point physician indicated that the patient had pneumonia. The patient was then hospitalized and was still there. While she was in the hospital, developed sores in the mouth and body and she had chickenpox. She was put on a ventilator. The patient was recovering from pneumonia, sores in the mouth and body, and chickenpox. Additional information has been requested.