chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose has not been given and more than 35 days o administration of the first dose have passed; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose has not been given and more than 35 days o administration of the first dose have passed) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose has not been given and more than 35 days o administration of the first dose have passed). On 08-Apr-2021, PRODUCT DOSE OMISSION ISSUE (second dose has not been given and more than 35 days o administration of the first dose have passed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included diabetic medications, not otherwise specified.  Treatment information was not provided.  The reporter stated that the patient went to see her mother and did not attend the appointment. And lost her vaccination card. Patient tested negative for COVID-19 4 times.
Patient was advised to sit down and stay inside the store for about 15min after vaccination. Shortly after receiving the 1st dose of covid vaccine, Patient throw up in the front of pharmacy. Patient was recommended to sit a little longer for observation and make sure everything is OK before he walk out. He felt fine afterwards and agreed to follow up with his doctor if he experiences any severe side effects later.
Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's concurrent condition, medical history, concomitant medications, previously drug reactions and allergies were not reported. On 27-FEB-2019, the patient received a pediatric dose of VAQTA intramuscular for prophylaxis (strength, anatomical location, lot number and expiration date were not provided) (inappropriate dose of vaccine administered). No adverse effects were reported.
This spontaneous report was received from a pharmacist and refers to a 20 plus year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. Approximately in March 2017 (reported as 7 months ago), the patient was vaccinated with the first dose of RECOMBIVAX HB 10/1.0 mcrg/ml injection (dose, lot # and expiration date were not reported) for prophylaxis. Approximately in September 2017 (reported as 6 months later), the patient was vaccinated with the second dose of RECOMBIVAX HB. At the time of this report (4 months after the second dose), the patient did not have the third dose of the vaccine. No adverse effects were reported.
Softball size lump at injection site, swollen lymph nodes under armpit, swollen lymph nodes in neck. All reactions lasted for 10 days.
Vision impaired.  Diagnosed as  (significant) Vitreous Detachment occurring 30 minutes after injection & 5 weeks post cataract (lense replacement) surgery in right eye.  Opthomoligist is monitoring for retina detachment.
Rash - scattered lesions - papules on face, head, neck, trunk, arms and legs.
This spontaneous report as received from a medical assistant refers to a 49 year old patient (gender not reported). On 28-APR-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route not reported) lot number H014283, expiration date 17-APR-2014. No adverse effect reported. Additional information has been requested.
Mom states that child started having hives a few hours after Hepatitis A vaccine received. Mom gave child Benadryl. Mom stats that child still have a few on his back and his ears the next day. Mom also states that child starting coughing too.
About 10 minutes after receiving vaccine client fainted and fell out of his chair and hit his head on the floor. Client regained consciousness, but was transported by EMS to Hospital for evaluation. Per client, he was evaluated for 2 hours in the ER, then discharged, no concussion found.
HCP accidentally grabbed Pentacel instead of Daptacel by mistake and administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious was received from other healthcare professional via  Medical Information (Reference number- 00620295) and transmitted to Sanofi on 28-May-2021.  This case involves an 18 months old female patient who was administered with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ389ABA and expiry date: 09-Oct-2021) via intramuscular route in the right thigh instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date were not reported) (wrong product administered) for prophylactic vaccination as administrator accidentally grabbed wrong vaccine by mistake on 28-May-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant vaccinations included HEPATITIS A VACCINE (HEPATITIS A VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  The reporter asked if receiving the extra Ipol and ActHIB will harm the patient. Reporter also asked what side effects she should look out for. As it turned out it was also time for the ActHIB, however the next Ipol vaccine is not due until ages 4-6 years of age. They stated that Stated that a patient was given pentacel but the patient only needed the dTap.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse 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.
gum pain; mouth pain; swelling; infection; 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 GINGIVAL PAIN (gum pain), ORAL PAIN (mouth pain), SWELLING (swelling) and INFECTION (infection) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (gum pain), ORAL PAIN (mouth pain), SWELLING (swelling) and INFECTION (infection). At the time of the report, GINGIVAL PAIN (gum pain), ORAL PAIN (mouth pain), SWELLING (swelling) and INFECTION (infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Initiative FU
0934 am: per pt. daughter, pt reports SOB and dizziness. Pt. is slow to answer questions, EMT arrival 0939 am VS: BS 115, BP 154/73, REsp 19, HR 96, O2 98%. Rev BP: 124/73, HR 70, O2 95%
She states after her first vaccine dose her arm "was a lot more painful than the 2nd dose and lasted for days/sore arms; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She states after her first vaccine dose her arm "was a lot more painful than the 2nd dose and lasted for days/sore arms"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: The patient stated after receiving her dose on Tuesday, the nurse vaccinated her said, oh it was oozing and wiped it with an alcohol wipe and put a band aid on it. There was liquid 3 inches down my arm. The patient asked her if she was sure got all the medication and she said yes. But the patient was not so sure. The patient wants to know the full efficacy of the vaccine since she got both of the Pfizer Covid-19 Vaccine.  Medical Information (Live Operators Only): Were any unaddressed medical questions referred or forwarded to Medical Information: Yes . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patent states she was nauseated with vomiting fatigue and pain under her arm. This started the Saturday following the vaccine
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Additional Details: The patient became faint immediately after vaccination and before the needle was removed from the left deltoid. The patient was responsive enough to say "things are fuzzy". Did not lose conciousness that RPh is aware. RPh got some water for patient and laid them down on back. Patient was observed for 30 minutes. Pulse taken 60 bpm and BP 84/46.
Chills, body aches, headache, nauseated, fatigue that started in the night and lasted until about 3 pm the following day.
This case was reported by a healthcare professional and described the occurrence of arm pain in a 50-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included Tuberculin (TB skin test). On 16 October 2012 the subject received unspecified dose of FLUARIX (.5 ml, intramuscular, left arm). The healthcare professional stated the office carries two lots of FLUARIX, the subject may have received AFLUA702BA or AFLUA698AA, and both expire 30 June 2012. On 1 November 2012, 16 days after vaccination with FLUARIX, the subject experienced arm pain and unable to lift arm. The subject received FLUARIX and about two weeks later on 01 November 2012 she started noticing pain in her arm where she received the injection to the point that she can't raise her arm up above her shoulder. The subject consulted her physician and has a scheduled appointment at the clinic. She had a TB test done one day before receiving FLUARIX. At the time of reporting the arm pain and unable to lift arm were unresolved.
ramsay hunt syndrome. Fever 101-103 F.   Facial paralysis on the right side, severe pain and rash in the right ear, face, head, and roof of the mouth.   Difficulty closing right eye
Developed numbness in left foot. Numbness is constant and similar to foot falling asleep.  Experiencing extreme fatigue.
Swelling of throat; itching of face, throat and left arm; itching of face, throat and left arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received bnt162b2 (Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 16:15 (at the age of 58 years old) as single dose for covid-19 immunization. Medical history included high blood pressure, depression, diabetes, known allergies included Sulfa, codeine, phenergan, latex, mushrooms, ginger, carrots, celery, tomatoes, soy, bell peppers, romaine lettuce, mangoes, all mellons bananas, raw nuts. The patient did not have COVID prior vaccination. The patient did not have any other vaccine in four weeks and did not pregnant at time of vaccination. Concomitant medication in two weeks included Hydrochlorothiazide, Valsartan, Rosuvastatin, liraglutide (SAXENDA). The patient experienced swelling of throat, itching of face, throat and left arm on 05Mar2021 at 16:15. The patient had not been tested for COVID-19 post vaccination. Treatment for events included 50mg of diphenhydramine hydrochloride (BENADRYL); 2 hours later 50mg more of diphenhydramine hydrochloride. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
soreness was in arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose via an unspecified route of administration on an unspecified date as single dose, second dose via an unspecified route of administration on an unspecified date as single dose, for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced soreness was in arm, first shot barely sore for about 24 hours and second shot very sore for about 24 hours. Event took place after use of product. Outcome of the event was unknown.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
At first dizzy. That subsided. Then feeling tired. I got my shot at 11:11am. By 5pm on 2/27, I was feeling malaised and then nauseous. By 8pm, I started having diarrhea, vomited, whole body itching. On 2/28 at 9:06pm, still having whole body itching treated with Benadryl and azelastine spray, running a low-grade fever of 99.8, body aches, occasional sweating, chills, warmth at injection site, knot at injection site, sore arm, fatigue, vomiting. Drinking Gatorade.
I went into atrial fibrillation/flutter within hours after the shot.  I was totally fine and in sinus rhythm prior to the shot.
No adverse event; A dose was administered to 2 patients, 2 days after the vial expiration date on 2/14/23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered to 2 patients, 2 days after the vial expiration date on 2/14/23) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered to 2 patients on 015B22A 2 days after the vial expiration date on 2/14/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose was administered to 2 patients on 015B22A 2 days after the vial expiration date on 2/14/23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose was administered to 2 patients  2 days after the vial expiration date on 2/14/23).    No concomitant medications were provided.  No treatment medications were provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-710659 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710659:Patient 2 out of 2
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 28-AUG-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004449.
Starting with left arm and then developing in right arm, serious numbness, tingling, and especially swelling. A few instances where whites of fingernails on left hand appeared tinted purple but then recovered. Existing likely carpal tunnel related symptoms worsened significantly.
migraines; shortness of breath (sob); This is a spontaneous report from a Pfizer sponsored program via contactable consumer or other non hcp (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, batch or lot number: was not reported), via an unspecified route of administration on 07Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included covid 19 last year, May 2020, and had severe reactions. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced migraines, and shortness of breath (sob) and visited emergency room 2 or 3 times. On unspecified date, the patient underwent lab tests and procedures which included Antibodies, Cardiolipin antibody: Positive, Tested Positive for antibodies by her pulmonologist. Her 2nd vaccine dose was scheduled on 28Apr21, and her HCP referred her to poison control for information regarding how long she should wait to get her 2nd dose. Unaddressed medical questions referred or forwarded. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm hurt at site of injection; Rash at site of injection 9 days after vaccination; Hardness to touch at site of injection; Redness at site of injection; Slept for 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for 16 hours), VACCINATION SITE PAIN (Arm hurt at site of injection), VACCINATION SITE RASH (Rash at site of injection 9 days after vaccination), VACCINATION SITE INDURATION (Hardness to touch at site of injection) and VACCINATION SITE ERYTHEMA (Redness at site of injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE, IBUPROFEN, GABAPENTIN and AMITRIPTYLINE for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced SOMNOLENCE (Slept for 16 hours). On 04-Jun-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt at site of injection), VACCINATION SITE RASH (Rash at site of injection 9 days after vaccination), VACCINATION SITE INDURATION (Hardness to touch at site of injection) and VACCINATION SITE ERYTHEMA (Redness at site of injection). At the time of the report, SOMNOLENCE (Slept for 16 hours), VACCINATION SITE PAIN (Arm hurt at site of injection), VACCINATION SITE RASH (Rash at site of injection 9 days after vaccination), VACCINATION SITE INDURATION (Hardness to touch at site of injection) and VACCINATION SITE ERYTHEMA (Redness at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
This spontaneous report as received from a physician via a company representative concerning a 51 year old female patient. Medical  history and concurrent conditions were not reported. On 12-JUL-2014, the patient was vaccinated with ZOSTAVAX dose reported as 1 single shot, subcutaneous (strength and lot number were not reported). Secondary and concomitant therapies were not reported. The physician reported on 12-JUL-2014, after receiving ZOSTAVAX the anonymous patient developed a red line from the injection site to the elbow that was raised and sensitive to touch.  The outcome of the events were reported as recovering. The treatment given for the adverse event was ibuprofen and cold compress. The patient did not seek medical attention. Additional information has been requested.
Rash around injection site, about 2-3" in diameter, itchy, hot.  Bothersome but not painful.
Unknown cause of death; Shot gave her shingles/ Suspected vaccination failure; Shingles; Tumor; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Shot gave her shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and neoplasm (Verbatim: Tumor).  The outcome of the vaccination failure was unknown and the outcome of the shingles and neoplasm were not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the vaccination failure, shingles and neoplasm to be related to Shingles vaccine.     It was unknown if the company considered the unknown cause of death to be related to Shingles vaccine. The company considered the vaccination failure, shingles and neoplasm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient's friend via interactive digital media. The reporter reported that the patient's who take vaccines and are lots of prescription drugs end up with skin afflictions.  The reporter stated that the heavy metals did not metabolize naturally in the body.  The reporter reported that Vaers gov or open Vaers vaccine adverse events report system Over 600,000 reported deaths due to Covid vaccine trash vaccines cause the afflictions observe.  The reporter reported that his or her friend died 4 months after received shingles vaccine.  The shingles vaccine gave her shingles and a tumor. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Pt got a phone call from her supervisor that vaccine was diluted with "wrong solution"- supervisor did not specify what the "wrong solution" was, patient feels fine other than slight headache, supervisor told her she will have to start the series again, patient has only gotten one dose of the vaccine, yesterday got her COVID-19 vaccination - pfizer - diluted with the wrong solution works at a pharmacy